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Tick-borne disease often feels like it takes everything from you. Meghan Bradshaw is no exception. As a healthy 20-something, Meghan's health suddenly declined. Her journey led her from misdiagnosis to multiple joint replacements, fusions, and physiological and emotional devastation. Rather than sitting back and accepting her illness, Meghan instead chose to use her experience to inspire change. Check out her story and listen in to what she's doing now!To learn more about the work Meghan is doing visit: https://www.meghanbradshaw.com/Be sure to follow Meghan on social media platforms @mcbradshawTo learn more about Center For Lyme Action and the 2025 Virtual Fly In visit: https://centerforlymeaction.org/events/The Alpha-gal Allergen Inclusion Act (HR 9382)In August 2024, Congressman Van Drew introduced H.R. 9382, the Alpha-gal Allergen Inclusion Act (AGAIA). This bill will amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal to the definition of “major food allergen.” If enacted, the bill will require labeling of alpha-gal on packaged foods sold in the U.S. in the same way other top allergens such as milk, eggs, and peanuts are currently labeled.To fill out the two-minute form asking your Representative for support visit: https://alphagalaction.org/take-action-on-the-alpha-gal-allergen-inclusion-act/
Luna Stower, Head of Impact at Ispire Technology, joined the conversation to discuss her role as a leader and advocate in the rapidly evolving cannabis industry. With a passion for social justice, regulatory reform, and technological innovation, Luna illuminated the path Ispire is forging to shape the future of cannabis. From groundbreaking partnerships with global icons to pioneering regulatory solutions, Luna shared insights into the company's impact-driven mission and its commitment to inclusivity, quality, and transparency.Luna began by highlighting Ispire's exciting partnerships with Afrobeats star Burna Boy and cannabis icon Snoop Dogg. These collaborations underscore the brand's commitment to cultural relevance and authenticity, leveraging the global influence of these artists to advocate for safe and responsible cannabis use. Luna emphasized how these partnerships reflect Ispire's dedication to quality assurance and reliability, ensuring consumers have access to premium products while elevating cannabis as a lifestyle choice.Ispire's strategic pivot to an asset-light model was a key focus of the conversation. Luna explained how this approach allows Ispire to expand internationally with agility, focusing on Africa and other emerging markets. This model also supports the company's efforts to maintain efficiency while scaling its innovative product offerings to new regions. Luna expressed her excitement about the global growth opportunities and the chance to bring Ispire's cutting-edge technology to underserved markets, fostering inclusivity and economic opportunity.As the discussion turned to regulation and policy, Luna shared her perspective on the global cannabis industry's challenges and opportunities. She emphasized the importance of understanding the distinction between legalization and commercialization, highlighting how the latter ensures tax control, regulation, and consumer safety. Luna also underscored the critical role of lobbying and media work in influencing lawmakers and shaping public perception of cannabis. She noted the threat posed by pharmaceutical companies, warning against the monopolization of the industry and stressing the need for a unified message around cannabis use.The conversation touched on Ispire's commitment to innovation in regulatory compliance, particularly its efforts to prevent youth vaping and expand the adult market. Luna highlighted the company's advancements in age verification and identity verification technology, ensuring that cannabis products reach the intended audience safely and responsibly. She emphasized the importance of industry stakeholders working closely with governments to develop regulatory solutions, advocating for a universal framework that could include existing acts like the Cosmetic Act of 1930 for hemp-related CBD products.Luna also shared her thoughts on the importance of fostering inclusive workplaces and empowering marginalized communities within the cannabis sector. She spoke passionately about the need for mentorship and networking opportunities for women entrepreneurs, as well as the value of having diverse voices in decision-making processes. Drawing on her work with the Indigenous Cannabis Business Association, Luna outlined her advocacy for social equity and her commitment to providing resources for marginalized communities to succeed in the industry.The discussion also addressed the importance of supporting social equity licensees, with Luna calling for financial, legal, and business assistance from companies and organizations. She emphasized that these resources are essential for fostering a truly equitable industry and ensuring that opportunities are accessible to all. Luna's advocacy extended beyond business operations, reflecting her belief that the cannabis industry has a unique role to play in addressing historical injustices and creating a more inclusive future.Advertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy
For many years in talks that I gave, I showed a slide with an ingredient list from a food most people know. Just to see if the audience could guess what the food was. based on what it was made of. It was very hard for people to guess. A few people might come close, but very few people would guess. And it was pretty hard because the food contained 56 ingredients. This is in one food. And the ingredient list had chemical names, flavorings, stabilizers, and heaven knows what else. But 56 things in one, just one food in the food supply. Pretty amazing to think what kind of things we're bombarded with in foods we eat in our everyday lives. So, one key question is do we know what all this stuff does to us, either individually or in combination? So, how does ingredient 42 interact with ingredient 17? Even if we happen to know what they do individually, which we may not. And, who's looking out for the health of the population, and who has regulatory control over these things? Today we're joined by the author of a new article on this topic published in the American Journal of Public Health. Jennifer Pomeranz is an attorney and is Associate Professor of Public Health Policy and Management in the School of Global Public Health at New York University. The food, by the way, was a chocolate fudge Pop Tart. Interview Summary So, who has regulatory oversight with these things that are added to foods? The FDA has the authority over all of those packaged foods. So, Pop Tarts, all of that type of packaged foods and the ingredients in there. Can you explain the nature of their authority and the concept of GRAS and what that stands for? Yes. So, there are two main ingredients in our food, but there is also color additives and other things that we didn't get to in our study. But the two main ingredients are called 'food additives' and then 'generally recognized as safe' or GRAS substances. And these are the two ingredients that are in all the processed foods. They're both complex substances, but they're regulated differently. GRAS is assumed to be safe. And food with GRAS substances is presumed to be safe as long as there's a generally agreement among scientists that it's safe, or if it's been in use in food since 1958. Food additives, on the other hand, are presumed to be unsafe. And so, foods that have food additives must have the food additive be approved for the condition of use. So actually, the FDA issues regulations on the food additives. Is it true that the FDA authority covers lots of these chemical type things that get put in foods that we discussed? But also, things that occur naturally in some things like caffeine? Yes. And so, caffeine is considered GRAS or generally recognized as safe. The FDA has a tolerance level for cola-type beverages for caffeine. It actually doesn't enforce that as you see, because we have energy drinks that far exceed that type of level. So, there's different types of GRAS substances. But they can be very complex substances that are actually not so different than food additives. Who decides at the end of the day whether something's safe or not? You imagine this battalion of scientific experts that the FDA has on hand, or consults with, to decide whether something's safe or not. But how does it work? Unfortunately, that's not exactly the case. When it comes to food additives, the industry must petition the FDA and provide evidence showing that it's safe. And the FDA promulgates a regulation saying that it agrees it's safe and it can be used for the things that it set forth in the regulation. For GRAS, there are two mechanisms. One is the industry can notify the FDA that it thinks something's safe. And then it actually goes through a similar transparent process where the FDA will evaluate the evidence submitted. Or, shockingly, the industry can actually decide that it's safe for themselves. And they don't have to notify the FDA. And they can add it to their food without the FDA or the public actually knowing. Now they might disclose this on a website or something, but it's actually not even required to be based on peer reviewed literature, which is actually one of the concerning aspects about this. Concerning is polite language for what one might call shocking. So, in the case of some of these things that go into the food, the industry itself decides whether these things are safe. And in some cases, they have to at least tell the FDA that something they declare as safe is going into the food. But in some cases, they don't even have to do this. Right. So, they only have to if they've determined that it's a food additive. But actually, the industry itself is deciding that it's a food additive versus GRAS. Once it made the decision, it's GRAS, it doesn't even have to notify the FDA that it considers it safe. If they do, they are supposed to rely on their own research saying that it's safe. But actually, there's some alarming parts about that as well. The other outside research that's not my own found that the panels of experts that they employ, 100 percent of the people on those panels have financial conflicts of interest. So, that's already worrisome. They're receiving money from the food industry in some way. Yes. To say that the ingredient is safe. Another scary part is that if they do notify the FDA and they're not happy with how the FDA is reacting to their GRAS notification, they can actually request a cease and desist. The FDA will issue a cease and desist letter, and then they can actually go to market with that ingredient. Pretty amazing. Like loopholes that not only a truck can go through, but a train and everything else. That's really pretty remarkable. So one could say that the risk built into this system is hypothetical, and it works pretty well. But is that true? I mean, are there cases where things have gotten through that probably shouldn't have? Or is it just that we don't know? I think there's a lot of unknowns. The Environmental Working Group does that research and they have identified things that they find to be concerning. A lot of it is that we actually don't know what we don't know, right? So even the FDA doesn't know what it doesn't know. And that is, is part of the concern, that you can't just identify this by looking at the nutrition facts label where they list ingredients. Sometimes they just use terms like spices, flavorings, colorings, chemical preservatives. But that could be masking an ingredient that has never been examined and for which It's unclear that it's actually safe. I know there have been some policy efforts in places such as California to prohibit use of some of these things that have otherwise been considered safe by the FDA, or perhaps just by industry. Is that true that's happening more and more? Yes, actually there has been. Because of the gap in the FDA's oversight, we are seeing states, and it's actually a pretty shocking situation, that California banned four ingredients that the FDA did not. And it's saying that those ingredients are not safe to be in food in California. And given what a huge market California is, the thinking is that the industry will have to change their ingredients across the nation. And frankly, they've already taken those ingredients out of the same foods in Europe, where those ingredients are not allowed. So how much do you trust this self-policing by the industry? To be honest, I'm quite concerned about it. The FDA has the authority to review substances post market, so after they're already in the ingredients. But we see that it can take years or even decades. In the case of, remember, partially hydrogenated oils, which were artificially produced trans-fat. It took decades for them to get that removed from the food supply, despite significant research showing that it had caused health harm. So, even when there is evidence of harm, it takes quite a long time for the FDA to remove it. And in the case of another ingredient recently where California banned it, then the FDA decided to ban it. So, it does worry me that even their post market authority is not being utilized to the extent that it should. Let's think about what a good set of defaults might be and how this might actually play out in practice. If you'd assume these things that go into foods are not safe by default, then the question is what would it take to make sure they're safe before they're allowed in the food supply? And it would take toxicology studies, studies with lab animals perhaps, studies with humans. I don't know exactly how these things are tested, but one can imagine it's not an easy or a quick process. Nor probably an inexpensive one. But somebody would have to do it, and if government can't do it, you can't rely on industry to do it. I wonder if the default might be fewer things in the food supply and whether that might not be a pretty good thing? I love that you said that because that's the conclusion I came to as well. Why do we need all these new ingredients? We already have ultra processed foods, which are by definition contain all these ingredients that we don't really know what they are. And why do we even need new ingredients? I think they could even put a moratorium on new ingredients and say, let's take a, take an analysis of what we've got in the food supply at this point. And to be honest, it would take Congress to act to change FDA's authority to give them more authority to do what you just suggested. And of course, resources, which would be personnel like you described. So maybe that chocolate Pop Tart that has 56 ingredients could get by with 41 or 32 or 17. And you know, maybe we'd be just fine having it with fewer ingredients. One interesting thing that I've heard about, but I'm not an expert in because my background isn't law, is I know it's possible for outside parties to bring lawsuits against government for failing to execute its duties. Has there been any talk about possible lawsuits taking on the FDA for failing to protect the public's health with regard to these things? Well, actually, there was a lawsuit already. These consumer protection organizations sued the FDA, arguing that they weren't protecting the public. And that they were actually ceding authority to the industry, which, they by definition are. But according to the law, because Congress didn't require them to review these ingredients pre market, the court found that the FDA did not violate the Food, Drug, and Cosmetic Act. And so, they were operating according to the law. But also, to your point, I could see other lawsuits would be possible about them not actually exercising their post market authority to protect the public. Those could be from private lawsuits or a state attorney's general. There are different ideas there. So, what do you suggest going forward? You know what? Don't eat the Pop Tart. I think you got to avoid the many truly ultra processed foods and go for the lower processing levels. It's kind of that original advice. If you can't understand the ingredient list, maybe pick something different. And there are options within the same categories, right? There are potato chips that have three ingredients and there's potato crisps that have something like 12. So there are different options in that way. Bio Professor Jennifer Pomeranz is a public health lawyer who researches policy and legal options to address the food environment, obesity, products that cause public harm, and social injustice that lead to health disparities. Prior to joining the NYU faculty, Professor Pomeranz was an Assistant Professor at the School of Public Health at Temple University and in the Center for Obesity Research and Education at Temple. She was previously the Director of Legal Initiatives at the Rudd Center for Food Policy and Obesity at Yale University. She has also authored numerous peer-reviewed and law review journal articles and a book, Food Law for Public Health, published by Oxford University Press in 2016. Professor Pomeranz leads the Public Health Policy Research Lab and regularly teaches Public Health Law and Food Policy for Public Health.
HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast
In this episode, we discuss the efficacy and safety of semaglutide and tirzepatide for weight loss with a particular focus on the legal, regulatory, and safety aspects of these “compounded” GLP-1 receptor agonist medications. Key Concepts Semaglutide and tirzepatide have growing evidence that their clinical benefits extend beyond the treatment of diabetes. Evidence now shows benefit in a variety of obesity-related disease states regardless of a patient's diabetes status. Insurance coverage and drug cost is a major barrier to these medications, with cash prices exceeding $1000 per month in the US. There are many companies that are combining telemedicine visits with “compounded” GLP-1s to provide these medications at a reduced cost. The Food, Drug, and Cosmetic (FD&C) Act regulates compounded drugs. These regulations provide the legal context for pharmacies to compound GLP-1 medications. These regulations describe who can compound, what drugs can be compounded, and other unique circumstances (e.g. compounding in the context of a drug shortage). The FDA has released warnings regarding safety risks of compounded GLP-1s. The main safety concern is dosing errors; however, the warnings also include concerns of patients accessing drug products that are outside of the legal scope of the FD&C Act. The recent ADA statement recommends against the use of compounded GLP-1s due to these concerns. References Karagiannis T, Malandris K, Avgerinos I, et al. Subcutaneously administered tirzepatide vs semaglutide for adults with type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials. Diabetologia. 2024;67(7):1206-1222. doi:10.1007/s00125-024-06144-1 Müllertz ALO, Sandsdal RM, Jensen SBK, Torekov SS. Potent incretin-based therapy for obesity: A systematic review and meta-analysis of the efficacy of semaglutide and tirzepatide on body weight and waist circumference, and safety. Obes Rev. 2024;25(5):e13717. doi:10.1111/obr.13717 Jastreboff AM, Le Roux CW, Stefanski A, et al. Tirzepatide for Obesity Treatment and Diabetes Prevention. New England Journal of Medicine. 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2410819 Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (CMS-4208-P). https://www.cms.gov/newsroom/fact-sheets/contract-year-2026-policy-and-technical-changes-medicare-advantage-program-medicare-prescription Human Drug Compounding. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. https://www.fda.gov/media/98973/download FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. https://www.regulations.gov/document/FDA-2017-N-2562-0029 Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP 1 and dual GIP/GLP 1 receptor agonists: A statement from the American Diabetes Association. Diabetes Care. 2024 Dec 2:dci240091. doi: 10.2337/dci24-0091.
What does TFCA stand for? Toxic Free Cosmetic Act. Shawna and Misty connect over an interesting discovery of a topic that will affect the beauty industry and is set to start in January 2025. The Department of Ecology in Washington state is undertaking to remove extremely toxic chemicals from cosmetics in Washington state to protect people from cancers, birth defects and many more tragic potentials..... Companies will have to rethink a lot of things in order to stay in business. Join us in this eye-opening chat about the Toxic Free Cosmetic Act.
Can the FDA really pull THC-infused edibles off the shelves? We'll take you inside a gripping congressional hearing where FDA Deputy Commissioner for Human Foods, James Jones, found himself in the hot seat, interrogated by Congresswoman Kathy McMorris-Rogers. Unravel the complexities of the Federal Food, Drug, and Cosmetic Act and understand the real-world implications of the Blumenauer Amendment, which ties the FDA's hands when it comes to medical marijuana dispensaries that also sell recreational products.Follow the work of SAM and FDPS below:https://learnaboutsam.org/https://gooddrugpolicy.org/https://thedrugreport.org/On X: https://twitter.com/learnaboutsamhttps://twitter.com/GoodDrugPolicyhttps://twitter.com/KevinSabethttps://twitter.com/LukeNiforatosOn Facebook: https://www.facebook.com/learnaboutsam
In this special episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the final rule issued by the U.S. Food and Drug Administration (FDA) on April 29, 2024, to make explicit its plan to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act.Their discussion includes:Highlighting key points, exceptions, and the phased implementation plan of the final rule.How the FDA's final rule compares to its proposed rule from last year.How the news may impact laboratories, health systems, health agencies, and manufacturers.Uncertainties that still remain regarding the future of laboratory-developed tests.
Deborah Milito, Pharm. D. Director of Skilled Facility Consultants, Adverse Drug Reaction Coordinator and Joint Commission Performance Improvement Coordinator Dr. Milito is the Director of Clinical and Consultant Services-Skilled Division for Diamond Pharmacy Services. She also serves as the team leader for the Joint Commission's Performance Improvement, Provision of Care, Medication Management, and National Patient Safety Goals initiatives. Dr. Milito is responsible for overseeing the education of the Skilled Consultant Pharmacists in Pennsylvania and Ohio. She has 28 years of acute care experience, 8 years of correctional experience, and 13 years of Long-Term Care (LTC) experience. Darshan Kulkarni PharmD, shares 5 Legal Tips to prepare your pharmacy for sale! Joe Lipari, Director of Product Management for Systech joins Todd Eury on "This Week in Pharmacy" to talk about the sensitive and important topic of DSCSA. The Drug Quality and Security Act is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs. Systech is a provider of track & trace, serialization, and brand protection solutions. We hear about key strategic components to consider now, to avoid penalties later. This podcast covers: Exchanging data with authorized trading partners Leveraging a Verification Router Service (VRS) Utilizing a credentialing service with the VRS Implementing a traceability platform Systech now offers three new service packages in conjunction with its software to help manufacturers understand how to meet the Enhanced Drug Security Requirements: Readiness GAP review, compliance testing and master organizational validation. These services will address endpoint data connections, product registrations, authorized trading partner verifications and record keeping requirements.
How did the Nutrition Facts label come to appear on millions of food products in the U.S.? As Auburn University historian, Xaq Frohlich, reveals in his new book, "From Label to Table: Regulating Food in America in the Information Age," these seemingly innocuous strips of information reveal the high stakes politics that can help determine what we eat and why. In today's podcast, Frohlich will explore popular ideas about food, diet, and responsibility for health that have influenced what goes on the Nutrition Facts panel and who gets to decide that. Interview Summary I'm really happy to have you on today's podcast. So, why don't we just jump right in. What would you say are the key historical moves in the food policy arena with respect to labeling? One of the things I talk about in this book is an informational turn in food politics. And what I'm specifically referring to there is a shift since the 1970s from an older way that the Food and Drug Administration approached regulating the market to its current focus on informative labeling. So, at the beginning of my book and at the beginning of the story, in the 1930s, 1940s, the FDA was trying to handle this big market full of lots of different products, especially packaged and processed foods. And under the legislation in the 1938 Food, Drug, and Cosmetic Act, authorized food standards. And the idea was that for any mass-produced food, they would hold hearings. People would say, "This is what we think the food should look like." They would then publish the standards, which would look kind of like a list of ingredients and ranges of the ingredients they could use, and then say, "Okay, all foods have to be the standard form of food. If not, we will either remove them from the market or call them imitation." And this was a system they used for decades, and it created a lot of problems. Then, late 1960s people started to get unhappy about this. There was this big turning point connected to the White House Conference on Food, Nutrition and Health where Nixon administration brought together lots of nutrition scientists. And one of the conclusions that came out of that is we need to change the FDA's system. And so, in the early 70s, the Food and Drug Administration says, "We're going to pivot away from these food standards and start focusing on informative labels." This is when you get the requirement of ingredient labeling on all foods, including standard foods, and you also get the first voluntary nutrition information label. My book looks at this change in strategies away from standardizing foods towards standardizing information about foods and creating these kinds of consumer-oriented information labels. I love the fact that you helped us understand this idea of the information age, because once you read that and think, "Oh, well you're talking about something about the internet," but it's even more foundational about how we communicate what is a product. I found it really fascinating to read in your book where you talked about what I perceive to be really laborious conversations around what exactly is peanut butter or some other product. I mean, it seems like that took up a lot of space. Do you think that was ultimately productive? Is that the reason why we see this information change? Or was there something important about that effort on its own? So, there were advantages and disadvantages of the old food standards approach. One of the advantages is that everybody who wanted to raise an issue was invited to attend those hearings. This meant that you could have really colorful exchanges. There is one woman who ran a homemaker's association who would show up and she would get a lot of attention because she was very colorful in her criticisms of proposed standards. It could be a very democratic space in that sense. On the other hand, they could run on for years. And there were contentious hearings where you would have dozens of lawyers from different food companies. It was held like a kind of legal court proceedings, and there would be objections, and counterevidence, and counter-witnesses. One of the complaints in the 1970s is that this was another example of an overly burdensome centralized government agency and process that was expensive. And the switch towards using informative labels and moving away from food standards was seen to be a kind of lighter touch form of governance. The disadvantage is that now you have an even more backstage discussion about what goes on this label, and it means that consumers have even less access to who's making those decisions for them. Can you talk a little bit more about that? What's in the backstage that we're not privy to? I think one of the misconceptions about the food label is that it is this window into the food, right? Especially something like nutrition and ingredients. You look at packaged food and you don't know what you're seeing, and therefore if they require the company to print the ingredients and nutrition, then you can look at that and now you have the kind of answer. In practice, it's more complicated deciding what kind of information appears there, which nutrients do you want to do, how do you calibrate those in terms of the daily diet? Or how do you name the ingredients? Do you use the scientific name? Do you use the common name? Those questions are decided by people backstage. This could be FDA regulators. They could allow companies to make those decisions. And so, the label is actually a translation of those kinds of decisions. One of the arguments in my book is that you can't get away from the values of these expert communities in deciding what goes on that label. Yes, and thank you for that. I am really intrigued by how you are talking about the role of FDA, and I want to come back to that in a moment, this sort of panel of experts, and something that we think is so foundational, foods that we eat. We should know what they are. We believe we know what they are. They're part of our larger history. But what I'm also hearing is actually government organizations mediate what we understand food is. I'm intrigued to learn some more. Given what you've learned about the history of food labeling, what do labels offer as a policy tool? Often the way people see food labels is that is a kind of knowledge fix, especially with packaged foods. Because you don't know what's in them, there is this sense that there's a kind of uneven playing ground between the producer and the consumer, right? The producer knows how it was produced. They know what's in the food. They're selling this to consumers and there's concern that they might mislead the consumer. And so, this idea is that the label is a kind of technical solution to that market problem. And in many ways, it can work this way, but there's actually a kind of translation work involved in there. It's a more complicated story than just a knowledge fix. And in fact, a lot of studies that look at how people read ingredient labels, and especially nutrition labels, will talk about how they fail to understand this or that aspect of the nutrition label. Because consumers are dealing with decision fatigue, they're in this, what people call the attention economy, where they don't have a lot of time to look at labels. So often, reading the label is the least important part of food labels for policy. In fact, over and over again, in this history, I discovered that when the FDA was introducing changes to the food label, regulators and others would comment on how actually the biggest impact is that it would lead to companies changing the foods before. So, even if consumers aren't reading the label, they're affected by those changes because companies are reformulating the foods. I'm really interested in that. I know that there is a body of literature that talks about this idea that by having to put the information out in the public, what you're saying is companies reformulate because they want their products to look better, or maybe they actually are making the products better. Is that a fair assessment? I think this is where you get into the tricky aspect of what we mean by better. So, taking the example of the nutrition label, one of the problems that you get with the beginning of nutrition labeling in the 1970s is it really favors a particular idea of what is better. So, if better means more of certain nutrients like protein or vitamins, and less of other nutrients like fats, or certain bad fats and sugars, then companies might reprocess a food, right? They'll take out sugar. They'll take out fat in it. And maybe they'll add in other ingredients to make it taste good anyway. And they'll kind of game that profile. And for people who are concerned about nutritional health in this sort of sense of nutrition, this might be great. But if your idea of good for you is less processed, you know this older idea of wholesome, you have this idea that the food was made in a kind of traditional sense, now you have a less good food. One of the problems that nutrition labeling raises is that it's not that it's misleading consumers, but it's getting them to focus on certain attributes of the food and not thinking about other things that may be important for health. That's really helpful. I'm doing some work on date labels, and I've been thinking about this idea of how far can these labels go, and helping people make the best choices possible, however we define best. And that these labels are, as you said, the beginning. They're definitely not the end of that decision or that process. So, this is a really a rich conversation. I want to ask you about misconceptions. What would you say is the biggest misconception about food labels from the point of view of consumers? You gave us a little bit of an idea about that, but I'd love to hear your thoughts on this. One of the misconceptions about the food label is that it is this window into the food, right, especially something like nutrition and ingredients. When consumers receive this information label, they often take it at face value as sort of, "I now have this information about the food." And therefore, if they require the company to print the ingredients and nutrition, then you can look at that and now you have the kind of answer. In practice, it's more complicated. Deciding what kind of information appears there, which nutrients do you want to do, how do you calibrate those in terms of the daily diet? Or how do you name the ingredients? Do you use the scientific name? Do you use the common name? Those questions are getting decided by people backstage. This could be FDA regulators. They could allow companies to make those decisions. And so the label is actually a translation of those kinds of decisions. One of my arguments is that you can't get away from the values of these expert communities in deciding what goes on that label for the informative label. And in my book, I really try to argue that it's not just a kind of conduit into the product. It's not like suddenly you have the information. Instead, you need to read these labels as kind of value and political discussions among people who often have to make compromises. My favorite example of this with the nutrition facts panel was a decision to use the 2,000-calorie amount for daily values for the average American consumer. I remember interviewing a guy at the FDA, and I asked him about that, and he said, "Well, actually that's not accurate." It's not like if you averaged out everyone's caloric needs. Even in the 1990s, based on what they knew then, it would've been 2,000. For men, it was much higher. It was like 2,350. For women, it was lower. But they settled on 2,000 as a kind of pragmatic decision for multiple reasons. One, they hoped that if it was rounded, consumers wouldn't think of it as like a precise tool and it would be easier to do math with. And also it was on the low end of what you should get. So, the idea was that this would discourage people from eating too much. So, they made all these kinds of compromises in it. But if consumers see this and they see it as a kind of science, then they tend to think it's more rational than it really is. And that's the kind of thing I was most surprised about from doing this history was discovering that actually consumers aren't reading these labels as rational calculators. They're reading them emotionally. And the best example of this I got was interviewing Burkey Belser, who recently passed, and he was the head of the design firm that designed the nutrition box label. And he described it as a government brand. And he said, you know, "Seeing this thing everywhere, it's not just about how people read it. It's there in the background, kind of like brands and logos." And it's that emotional relationship to the information that I think policymakers really need to think about with labels, not just seeing them as a kind of rational decision-making device, but as something that is shaping consumers' emotional decisions about the food they eat. You've raised an important point for me, because I was going to ask, what do you think policy makers may be misunderstanding about these labels? I'm wondering, do policy makers understand these labels as a brand, a government brand? Are they capturing or dealing with the things that you're just talking about, the emotional connection that consumers have with these products or these labels? I think that one of the advantages of labeling, and I think this is why the FDA started looking at it more as an important tool in the 1970s, is that it's a lot easier to focus on the package as a kind of site where you can police market behavior. So, it's much easier to do that than to go into manufacturer's factories to kind of say, "This is good, that is bad." You can use it as a kind of accountability device. I think from the point of view of regulation in a big national and increasingly international market, that's one of its advantages. The limitations of this for reforming food systems in my opinion, is it also ends up being a kind of outsourcing of work onto consumers, right? Instead of saying, "We want to make sure foods are safe and nutritious. We want to avoid certain kinds of ingredients or discourage certain kinds of unhealthy foods." Governments are basically saying, "All right, we're going to put it on the label and let the consumer do that work." And I think that is one limitation of them. The other thing that I also think happens is it's not just outsourcing to the consumers, but it's also putting that in the market and using the market to solve those kinds of problems. And for mandatory labels, like the nutrition facts panel, this means that consumers who have the time and resources might end up adopting a healthier diet because of it. But many consumers who don't have those kinds of choices aren't going to be helped by this informative fix. For voluntary labels, and this is something I talk about at the end of the book. I call them lifestyle labels or risk labels, depending on what you're talking about. So organic, carbon footprint labels, concerned about the environment, these kinds of third-party certificate labels, it becomes this kind of opt out. Instead of reforming the political system, you're providing this kind of market upsell option for consumers to have those resources. I'm intrigued to think about the FDA in its historical place. Your book provides a history of past FDA activities on food labeling, and you talked wonderfully about those already. How does it speak to current policy concerns at the FDA? And you were giving a little bit of an indicator of that with the front-of-pack labeling. I'm wondering are there other spaces about FDA concerns today? I think if you're really committed to reforming the food system, then food labels are only ever just the start to that reform work. They can't be treated as the solution. And I think in the past you have had a lot of cases, particularly with public government, where the label is put forward as the kind of answer to a political problem. And then they don't think about the need for staff to keep the education up about the label or enforcement. And so, they don't treat it like the beginning of that reform work. One of the things I find really exciting about what your book is doing, that you're a historian and you're talking about the development of this policy and it has important implications. What do you think history offers us in the current policy discourse? What do you bring to the table that we miss out by not talking with historians? So, when I was doing this research, this event that I didn't know happened that turned out to be really important in this story was this White House conference in 1969. At the time, the impetus for this conference was the sort of sudden public awareness of ongoing hunger in America. In the 1960s, people who were involved in civil rights realized that if they could focus on the issue of hunger, they could get a broader attention to problems of poverty and disparity in America. In 1968, this became a big public issue because of widely watched TV documentary. Everyone was talking about hunger and its connection to poverty and inequalities in America. And when the Nixon administration created the White House conference, the language of poverty and the concern of poverty was central. Then, there was a kind of shift over the course of the conference. Initially it's talking about hunger and how that's a malnutrition issue related to poverty. But by the end of the conference, they're starting to focus on consumer education, better labels, better information. And in some sense, we haven't got away from that framing shift. I really saw this recently with the Biden administration. It held its own White House Conference on Hunger, Nutrition and Health in 2022, and nowhere in its report was there a mention or discussion of poverty. They were really focused on foods as a vehicle for health, improving labels instead of talking about poverty as the kind of root concerns. Again, the kind of overall framing is if we engineer better foods in this nutritional sense, or we give you better information labels, then we'll solve the health problems America's facing. I think that that policy focus is ignoring the broader context of how Americans eat and how they're making their decisions. So, I see my book as kind of providing a broader lens to think of the issues, not just historically, but also looking beyond sort of the field of nutrition or considerations of government, but looking at how these different institutions are all interacting with each other to shape policy. I think the two important things here are about what history can offer in present policy. One is that I actually think a lot of people working on these issues today have no idea where they came from. I've experienced this as I've given talks. I've had people in industry, or people who work on policies sort of say, "I didn't realize that that was where the standard for milk came from," when they were talking about recent changes in terms of the nomenclature for milk. Or "I didn't understand that," you know, "healthy, as it was defined in the 1990s, was in the context of one kind of health war, but today there's a kind of new public health concern about other types of foods." So, part of it is that I think that policymakers will really appreciate getting that older context. I often call it institutional memory because you lose that institutional memory. The other thing that's really striking is, at the beginning of my story in the 1930s and 1940s, nobody was using words like saturated fats or carbohydrates. It was a different era and people were really talking about food differently. So, it's useful. I think of it as like study abroad. You know, you go to this place, you see that people are talking very differently, and then you come back to your home country, you know, or the president, and you realize, "Oh," you know, "there's this aspect of food that I was taking for granted that has really changed in the last," you know, "five, six decades." Bio Xaq Frohlich is Associate Professor of History of Technology at Auburn University. He works on issues relating to food and risk at the intersections of science, law, and markets. His research focuses on the historical intersections of science, law, and markets, and how the three have shaped our modern, everyday understanding of food, risk, and responsibility. His work explores questions relating to consumerism and the changing relationships between the state, experts, and the public in the production of everyday knowledge: how do we “know” what we know about food and its relation to health? In what ways has our informational environment for food changed with the industrialization of food production and retailing? Frohlich earned his PhD in history, anthropology, and STS at MIT. He teaches courses on food and power, the intersections of science, technology and the law, and the history of business and capitalism.
HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast
In this episode, we speak with Janeen Winnike, the Associate Dean for Student Affairs at Rosalind Franklin and a co-course director for the Pharmacy Law course at the university. We review some of the key points regarding federal and Illinois pharmacy law – a must-listen especially for graduates preparing for their MPJE exam after graduation! Key Concepts The FDA (via the Food, Drug, and Cosmetic Act) primarily regulates manufacturers. Most regulation for pharmacies and pharmacists is via the federal Controlled Substances Act and state-based regulations (acts and administrative codes). An IND (investigational drug application) is required to begin human clinical trials (phase I-III). An NDA (new drug application) is used for the FDA to consider whether a drug should be approved for use in the US. The Federal Controlled Substances Act outlines which drugs are scheduled I-V. State law can be more restrictive. C-II drugs have special regulations related to prescribing, ordering/distribution, refills, partial fills, etc. In Illinois, pharmacists, student pharmacists, and pharmacy technicians are permitted to vaccinate patients aged 7 years and older (or temporarily 3 years and older per the PREP act for COVID-19 and influenza vaccines). Pharmacists can order and administer COVID-19 and influenza vaccines; other vaccines require a standing order or a prescription in order prior to administration in a pharmacy. References Illinois Pharmacy Practice Act (225 ILCS 85) https://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24 Illinois Pharmacy Practice Act Administrative Code (Part 1330): https://www.ilga.gov/commission/jcar/admincode/068/06801330sections.html Illinois Controlled Substances Act (720 ILCS 570) https://ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941&ChapterID=53 Illinois Controlled Substances Act Administrative Code (Part 3100) https://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html Pharmacist's Manual: An Informational Outline of the Controlled Substances Act. Drug Enforcement Administration. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist%27s_Manual_DEA.pdf
The Department of Justice announced that a regulatory affairs specialist for a medical device manufacturer was sentenced to prison for his role in distributing devices that lacked FDA clearance.The actions led to the illegal sale of two medical devices in the U.S., amounting to tens of thousands of dollars. The sentence follows last year's guilty plea by the individual, Peter Stoll III, to one felony count of violating the Federal, Food, Drug and Cosmetic Act. He had been charged with causing the introduction of misbranded and adulterated medical devices into interstate commerce.Download and listen to the audio version below and click here to subscribe to the Today in Manufacturing podcast.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Today's episode is a testimonial from a customer who used Alara Ridge Farm CBD for their pet. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
A lot of people have come up to me lately wanting to know if we sell delta-8 products. These are not the kinds of people who I suspect are interested in getting high, so it strikes me as interesting that many of them are asking me about it. Since it seems a lot of people don't know what it is, I thought I'd take a few minutes to talk about it and help you understand what delta-8 THC is. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
If you have trouble sleeping, there may be many reasons. You may have insomnia because the anxiety and stress of the day just won't let your brain slow down. You may have sleep problems because of chronic pain. Your sleep issues may even arise from things like Restless Leg Syndrome (RLS). No matter what is causing you to not get enough sleep, this episode will help you find some answers. Believe it or not, CBD helps many people with sleep and this episode will help you understand how. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
If you're like a lot of people, you may be worried about what CBD tastes like, so much so that you may be scared to try it. So why does CBD have the taste that it does and should you get a variety that has added flavor? Let's find out. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Somewhere between 7 -10 % of Americans are on an anti-anxiety drug. In 2016, 1 in 3 Americans were prescribed a pain medication! One statistic I read stated that 1 out of every 5 people who are prescribed a narcotic pain medication will become addicted on that very first prescription -- often just because of a standard order after a non-emergent, elective surgery. We are a nation of overmedicated people many of whom feel trapped. For one reason or another, it seems nearly everyone is on something. If you're not taking any prescriptions, you've become an anomaly. What are we to do? We know these medications are harmful to our bodies long term and some are even harmful short term. How do we get back to "normal" and get off of these meds? Let's talk about that today. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Look around you. Chances are somebody you just saw is dealing with inflammation and the effects of it. It might even be you. We are a chronically inflamed nation and most people who suffer from the symptoms of inflammation don't realize that is what is causing their problems. The root of many common diseases and disorders is actually inflammation, so today we're going to look at 4 natural ways to help your body decrease inflammation. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
If you're one of the 1 in 4 people in America struggling with arthritis, I bet you're listening to this episode with a bit of desperation. You're tired of hurting and you want to get back to what life used to be like. If other things aren't working and you're ready to try a more natural route, I've got some good news for you today, so stick around and I'll tell you all about it! There is a natural remedy for arthritis that may provide real, lasting pain relief that actually works! Keep listening to learn more! Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
The 4th of July is loads of fun for humans, but for our pets, it can be a time filled with stress, anxiety, and fear. After all, they don't know why they keep hearing all these explosions. For all they know, the world is blowing up right outside their door! Today we're going to talk about how CBD may help your dog be less stressed and anxious when the fireworks start for Independence Day this year. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Have you ever found yourself telling a friend that you tried CBD once and it just didn't work for you? If so, this episode is for YOU! We're going to dig into 3 reasons CBD may not have worked for you and how to make sure you have better results next time around! Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
CBD is a great thing. It can help with so many things including many types of pain, anxiety, and inflammation. I love that I get to hear so many stories from you about how CBD is helping you. But a few weeks ago I learned about a type of pain CBD can't heal and I wanted to share this story with you so that hopefully this type of pain does not become a part of your life. Links from today's episode: Calm Parenting Podcast Parent Wise Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Many people struggle with nerve pain from all kinds of issues. Whether it be neuropathy, nerve damage, or neuralgia, all cause significant discomfort and pain. Whether the problems come from diabetes, chemotherapy, or spinal injury, today's episode will look at whether CBD products might help with nerve pain and which route is best based on which problem you may be having. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
YOUR BIRTH, GOD’S WAY - Christian Pregnancy, Natural Birth, Postpartum, Breastfeeding Help
We have become convinced that prenatal nutrition comes from a prenatal vitamin and without swallowing a pill or chewing a pill or gummy, there's no way to be properly nourished during pregnancy. But is this really true? For thousands of years, humanity managed to obtain its nutrition from food. Is that just a thing of the past, or does the food God provided us from the beginning sustain us like it always has? Is bread a "bad guy" that makes us sick? Is gluten a toxic substance that we need to avoid? Stay tuned to have your eyes opened to yet another thing that the world has convinced us is bad that is actually life-giving. This is the entire interview that was previously published in 3 parts. [Note -- The audio is not quite as good as normal and you will hear some papers rustling and writing sounds in the background. I was taking notes and I hope you do too! Even though I've been learning from Sue for nearly 6 years, I still learn more every time I listen to her. I hope you can overlook the sounds -- my mic was more sensitive than I thought!!] Bread Beckers Store - breadbeckers.com Bread Beckers Co-Op Delivery Information - https://www.breadbeckers.com/blog/co-ops/ Sue's Healthy Minutes (Sue Becker's Podcast) - https://www.breadbeckers.com/blog/sues-healthy-minutes/ Or search "Sue's Healthy Minutes" on your favorite podcast app No Bread Beckers Co-op near you? Azure Standard is another place you can source organic grains and SO MANY other great foods -- Click Here Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
YOUR BIRTH, GOD’S WAY - Christian Pregnancy, Natural Birth, Postpartum, Breastfeeding Help
We have become convinced that prenatal nutrition comes from a prenatal vitamin and without swallowing a pill or chewing a pill or gummy, there's no way to be properly nourished during pregnancy. But is this really true? For thousands of years, humanity managed to obtain its nutrition from food. Is that just a thing of the past, or does the food God provided us from the beginning sustain us like it always has? Is bread a "bad guy" that makes us sick? Is gluten a toxic substance that we need to avoid? Stay tuned to have your eyes opened to yet another thing that the world has convinced us is bad that is actually life-giving. This is part 3 of a 3-part series. [Note -- The audio is not quite as good as normal and you will hear some papers rustling and writing sounds in the background. I was taking notes and I hope you do too! Even though I've been learning from Sue for nearly 6 years, I still learn more every time I listen to her. I hope you can overlook the sounds -- my mic was more sensitive than I thought!!] Bread Beckers Store - breadbeckers.com Bread Beckers Co-Op Delivery Information - https://www.breadbeckers.com/blog/co-ops/ Sue's Healthy Minutes (Sue Becker's Podcast) - https://www.breadbeckers.com/blog/sues-healthy-minutes/ Or search "Sue's Healthy Minutes" on your favorite podcast app No Bread Beckers Co-op near you? Azure Standard is another place you can source organic grains and SO MANY other great foods -- Click Here Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Many people ask me if CBD oil can just be used as you need it or if it is something that needs to be taken daily. In today's episode, I will answer that question for you. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
YOUR BIRTH, GOD’S WAY - Christian Pregnancy, Natural Birth, Postpartum, Breastfeeding Help
We have become convinced that prenatal nutrition comes from a prenatal vitamin and without swallowing a pill or chewing a pill or gummy, there's no way to be properly nourished during pregnancy. But is this really true? For thousands of years, humanity managed to obtain its nutrition from food. Is that just a thing of the past, or does the food God provided us from the beginning sustain us like it always has? Is bread a "bad guy" that makes us sick? Is gluten a toxic substance that we need to avoid? Stay tuned to have your eyes opened to yet another thing that the world has convinced us is bad that is actually life-giving. This is part 2 of a 3-part series. [Note -- The audio is not quite as good as normal and you will hear some papers rustling and writing sounds in the background. I was taking notes and I hope you do too! Even though I've been learning from Sue for nearly 6 years, I still learn more every time I listen to her. I hope you can overlook the sounds -- my mic was more sensitive than I thought!!] Bread Beckers Store - breadbeckers.com Bread Beckers Co-Op Delivery Information - https://www.breadbeckers.com/blog/co-ops/ Sue's Healthy Minutes (Sue Becker's Podcast) - https://www.breadbeckers.com/blog/sues-healthy-minutes/ Or search "Sue's Healthy Minutes" on your favorite podcast app No Bread Beckers Co-op near you? Azure Standard is another place you can source organic grains and SO MANY other great foods -- Click Here Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
YOUR BIRTH, GOD’S WAY - Christian Pregnancy, Natural Birth, Postpartum, Breastfeeding Help
We have become convinced that prenatal nutrition comes from a prenatal vitamin and without swallowing a pill or chewing a pill or gummy, there's no way to be properly nourished during pregnancy. But is this really true? For thousands of years, humanity managed to obtain its nutrition from food. Is that just a thing of the past, or does the food God provided us from the beginning sustain us like it always has? Is bread a "bad guy" that makes us sick? Is gluten a toxic substance that we need to avoid? Stay tuned to have your eyes opened to yet another thing that the world has convinced us is bad that is actually life-giving. This is part 1 of a 3-part series. [Note -- The audio is not quite as good as normal and you will hear some papers rustling and writing sounds in the background. I was taking notes and I hope you do too! Even though I've been learning from Sue for nearly 6 years, I still learn more every time I listen to her. I hope you can overlook the sounds -- my mic was more sensitive than I thought!!] Bread Beckers Store - breadbeckers.com Bread Beckers Co-Op Delivery Information - https://www.breadbeckers.com/blog/co-ops/ Sue's Healthy Minutes (Sue Becker's Podcast) - https://www.breadbeckers.com/blog/sues-healthy-minutes/ Or search "Sue's Healthy Minutes" on your favorite podcast app No Bread Beckers Co-op near you? Azure Standard is another place you can source organic grains and SO MANY other great foods -- Click Here Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
There's a lot of terminology in the CBD world that is hard to understand for those who don't work in it or those who are new to it. The terms full-spectrum CBD oil, broad-spectrum CBD oil, and CBD isolate are three of the terms that I was clueless about before we began growing hemp and making CBD oil, so while I've touched on these terms and definitions in previous episodes, I want to make an episode for you that addresses this and only this all in one place so there's no confusion. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
CBD gummies are super popular. Many people take them because they love the ease and convenience they bring. But are CBD gummies a better choice than CBD oil? It depends on how you look at it. Today's episode looks at the pros and cons of each and what we recommend. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
There is a whole world of health and healing that you may not even know exists. Holistic healing and functional medicine are gaining popularity in today's culture that doubts conventional medicine more and more -- and rightfully so! Holistic healing is the idea of healing the whole person from the root of the cause, not just treating a symptom to mask a problem. My guest is Alexandra Yu, a registered nurse and host of "Her Holistic Healing" podcast. She is going to introduce us to holistic alternatives so that we can take back our health more naturally! Learn more about Alexandra Yu and holistic healing here: Her Holistic Healing Podcast Her Holistic Healing Facebook Group Her Holistic Healing Website Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Have you ever wondered what a hemp-growing operation looks like? While some operations are massive, I bet what you've imagined ours looks like isn't exactly the same. Today, I want to give you a sneak peek into how we grow our hemp here at Alara Ridge Farm. Video of our hemp growth progression in 2020 -- https://youtu.be/C6Yco5YbD9E Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
I have many people ask me if CBD is addictive. I think this likely stems from it being so closely related to marijuana which is an illegal drug in most places and many people associate it with being an addictive substance. Many of the people who tend to turn to CBD want the benefits of cannabis but are scared of becoming addicted for all kinds of reasons, whether it be morals or a family history or a personal history of being addicted to substances. So today we'll talk about whether CBD is addictive so you can be sure to make the right decision for you. I think you're going to like what you hear. Article referenced: Cannabidiol as an Intervention for Addictive Behaviors: A Systematic Review of the Evidence Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
I've gotten messages from some of my listeners concerned that using CBD means they are choosing not to trust God. They are well-meaning and want to do what's right which I commend them a lot for that in a world of people who don't care too much what God says or wants. You need to be sure on your own that you are right when you make a decision. Today I want to look at what the Bible can show us about what it means to trust God with our health and we'll consider whether using CBD or other natural products means that you are not trusting God. This is going to be a deeply introspective episode, so pour you a nice cup of coffee or tea and let's sit down and talk this through. Related Episodes: EP 8 How Does CBD Work? Teach me Like I'm 5! An Introduction To The Endocannabinoid System Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
Episode Description On March 1, 2023, Rep. Jan Schakowsky (D-IL) introduced the Medical Device Nonvisual Accessibility Act in the House of Representatives. The goal of this act is to make home use medical equipment and devices accessible to blind and visually impaired individuals in the United States. If passed, this legislation would amend the federal Food, Drug, and Cosmetic Act to establish non-visual accessibility standards for Class II and III devices with digital interfaces. Class II and III devices include devices that are more invasive and involve a higher risk of injury or death, so it is much more important that these devices are used safely and as directed. The FDA would, in consultation with the U.S. Access Board, set regulations and a final rule according to those standards. The passage of this legislation would make it easier for people who are blind and low vision to manage their health safely and independently by ensuring that product manufacturers incorporate accessible design in the beginning stages of development for home use medical devices. This bill has 32 original co-sponsors and is bipartisan with 3 Republicans and 29 Democrats. Learn more about this 2023 ACB Legislative Imperative. Find out more at https://acb-advocacy-update.pinecast.co
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
You can CBD pretty much everywhere today. It's online. It's at gas stations. It's in shops. There are entire stores dedicated to it. I mean it seems like it is EVERYWHERE. ..because it is. How in the world can you know where you should buy it and where you can trust? I hope to help you weed through it all today so you can know where to get it. Related Episodes: Episode 3 - What Is CBD Anyway? Is It The Same As Hemp Oil? Episode 12 - Do You UNDERSTAND What Is In Your CBD Bottle? 4 Things To Know And WHY You Need To Know Them Episode 15 - Ready To Try CBD But Don't Know Where To Start? How To Get Started With CBD - 4 Things To Consider Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
You know those drug commercials and all the fast-talking you get right at the end with the laundry list of side effects up to and including the death of you, your firstborn, and your favorite dog? Yeah...that stuff is scary. I don't know about you, but it seems to me that stuff is about as bad as whatever the ailment is that it is supposed to be treating. It's always better to find a natural alternative if you can because they tend to have minimal side effects. Is CBD any different? Does CBD have adverse effects? Let's find out. Now What? Start here: Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure, or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
SHOW NOTES: If you work at a job that requires urine drug screenings and you are considering CBD, no doubt you are concerned with whether CBD oil can make you fail a drug test. I get that question ALL the time. So today I'm going to dive into what drug tests are looking for and how you can know whether or not you can talk CBD oil without failing your drug test. Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
One of the questions I get asked a lot when I'm talking to customers is how can they know whether or not their CBD is working. They may have heard from friends that it works great or that it doesn't work at all so they want to know how to tell if it's working for them. Today we're going to talk about that very question. I'll give you 3 ways to tell if you CBD is working and also give some suggestions for what to do if you decide it hasn't been working. If you get value from the show, please leave me a 5-star written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Dogs are "man's best friend" but they often suffer from some of the same things we humans do. Many dogs struggle with anxiety, from storm anxiety to anxiety from fireworks or just situational anxiety when you leave for work for the day. Vets are expensive and so are the medications they prescribe. Did you know there's a natural remedy for anxiety in dogs? CBD Oil can help dogs the same way it helps humans! Today we dive into this topic! Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou or Email info@alararidgefarm.com Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
Entertaining podcast with Mark and Paul from Pure Konopie. They farm, make, and produce high quality CBD products right here in Wisconsin. Fascinating conversation with them about the science, regulations, laws, and so much more relating to Hemp based products! Please check them out and use FRAGOUT20 for 20% off at check out! The statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. These products should not be used if you are pregnant or nursing. No statements on this episode #176 are offering medical advice. Please consult a healthcare professional before use of any product mentioned on this episode. Wisconsin Veteran, LLC and The Fragout Podcast is not responsible for any legal charges that may come as a result of local or State laws. It is the buyer's responsibility to determine if any transaction with Pure Konopie and its affiliates is in violation of local regulations or laws. The Federal Food, Drug, and Cosmetic Act requires this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Are you a stay-at-home mama and you think you're doing just fine and you probably don't actually need CBD oil? Today I talk directly to my fellow SAHM's and we talk about why every SAHM might benefit from using CBD whether she knows it or not. You don't have to have a diagnosis of anxiety to need a little help making it through your days of raising kids, homeschooling them, and still having your sanity intact. Give this short episode a listen and see why CBD might be a good choice for you! Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got episode ideas or questions you want to be answered on the show? Leave me a voicemail here - https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
If you're looking for an episode that boils down to the main things you need to consider when you're ready to try CBD, this is the episode for you. Episodes 12 and 13 have more in-depth information about some of the points I touch on here today, but this will give you the "quick and dirty" version of 4 things you need to consider when you're trying CBD for the first time so you can make the best choice for you. Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice. Links for products may be affiliate links. If you choose to purchase through these links, I will receive a very small commission. This doesn't cost you anything, but it allows me to continue offering you the content you love.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
So you say you tried CBD after agonizing about it forever, and now you feel guilty like you did something wrong? You're a Christian and you wanna do right -- so did you do something wrong? Is God mad at you?? Inside of this episode, we're going to talk about 3 truths you can stand on so you can get rid of guilt and instead lean on Him. Please leave me a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Got a question you want to be answered or an idea for a future podcast episode? Leave me a voice mail here and I'll try to work it into a future episode --> https://www.speakpipe.com/cbdandyou Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like and Follow Us on Fb - fb.com/alararidge Contact me - info@alararidgefarm.com NEW SISTER PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
How in the world are you supposed to know what is in a CBD bottle and what it all means? It's a lot and can be hard to understand. Inside today's episode, I share with you some of the concerns I used to have about CBD and how I overcame those. Then I give you some quick tips about weeding through the elements of a CBD label so you can understand what is inside the bottle. I also talk to you about why it is very important to use a reputable brand who you personally know and trust, like Alara Ridge Farm, so you can know that what the label says is actually truthful. We live in a world of imitation, so it's more important than ever to make sure you're getting the real thing. NEW PODCAST -- Your Birth, God's Way -- https://podcasts.apple.com/us/podcast/your-birth-gods-way-empowering-christian-pregnancy-peaceful-natural-birth-postpartum-education-breastfeeding-help/id1662245078 Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com DISCLAIMER: The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
One of the biggest push backs I get when talking to folks considering taking CBD oil is that they don't want to have to take a CBD dose so frequently. They don't want to feel like they're taking medicine and I totally get that. But there IS a reason why we recommend you take it more than once per day, and I want to help you understand that. This episode will talk about the half-life of CBD and will dig into how often you need to take CBD oil for different indications like sleep, pain, and anxiety -- and WHY. We'll touch on the endocannabinoid system again as well as metabolism and more. Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
Happy Furry, Furbulous Friday! Marlo Clingman from the Dallas Animal Services, or DAS, joins us with a plea to all listeners to please consider fostering or adopting a dog who has been exposed to canine upper respiratory infection, or URI, in the shelter. Those who can foster one of these dogs will get a lot of support, and a $150 amazon gift card! Find out more at bedallas90.org. Next, Paola Brown joins us along with Laura Held to talk about the new FDA guidelines for homeopathic drugs. These guidelines would give the FDA the power to remove properly formulated homeopathic products currently legal under the Food, Drug & Cosmetic Act. Paola is the president of Americans for Homeopathy Choice, and Laura is the Grassroots Director. They advocate for consumer rights to access homeopathic medicine, and are fighting these new guidelines and need our help. Learn how you can help at homeopathychoice.org.Thank you to our sponsors!enviromedica – The BEST probiotics on the planet!Children's Health Defense - Listen every Monday for News & Views with Mary Holland of CHD!sunwarrior - Use the code OLR for 20% off your purchase!The Well Being JournalThorne - Get 20% off your order and free shipping!
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
There's a lot of bad, confusing information out there about CBD products. Many people think that CBD and marijuana are the same. While they are similar, they are anything but identical. Inside this episode, we'll talk about how you can know that hemp-derived CBD products will NOT get you high or cause any psychoactive effects. We'll talk about why this is and what the differences are between CBD and marijuana. Perhaps most importantly, we'll look at why CBD products work better when they are "full-spectrum" which means they have a small amount of THC in them, but nowhere near enough to become intoxicated. Alara Ridge Farm produces Premium CBD Products that are full-spectrum because of the immense benefits that are received from an unadulterated product through what is known as the Entourage Effect. Get ready to learn about how CBD may help with so many things including pain, anxiety, inflammation, sleep, insomnia, immunity and the immune system, autoimmune disorders, and maybe even cancer! Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your health care professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Today we are putting 2022 in the rear view mirror and fully switching our focus to the new year that God has seen fit to give us, 2023. Let's pause together to look at 3 steps we all can take to guarantee that 2023 will be the best year ever. Putting these 3 steps into practice are a guarantee because they are not about worldly success. No, instead they shift us into a spiritual mentality that will prepare us to roll with any punches that may come our way without losing our faith and hope in the promises that He's given us through His word. We'll talk about FAITH, PRIORITIES, and HEALTH, and how when we get those three things right, everything else will fall into its rightful place. Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
You've heard of CBD and you hear people saying it works, but does it really? How can you know? Inside of today's episode, I share with you the beauty of the "endocannabinoid system" which is your body's God-given system that works hand-in-hand with the molecules that grow on the hemp plant known as cannabinoids. Cannabidiol (CBD) and tetrahydrocannabinol (THC) are just two of the cannabinoids. There may be as many as 100 there that scientists are still working to discover. Each of these special molecules that come to us from cannabis carries a wide variety of potential benefits. Today I'm going to teach you how this system works to help your body stay balanced and help improve things like pain, anxiety, depression, sleep problems/insomnia, inflammation and so much more! Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Inside today's episode, we're going to talk about 10 ways to optimize your gut health using natural sources of probiotics. We'll talk about why natural forms are better than pills forms. We'll also talk about how CBD may contribute to improved gut health and microbiome. These 10 gut-health HACKS will have you on your way to improved health and wellness in no time. Not only do I tell you about these 10 tips, but I talk about which ones are good options to DIY at home an even coach on how to find what you need to do it yourself! My source for water kefir - breadbeckers.com Here's a jar like what I use for our kombucha here Check out my absolute favorite vitamins with probiotics from real food sources here Jars I use for making sauerkraut (set of 4) here Best Apple Cider Vinegar Here Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice. Links for products may be affiliate links. If you choose to purchase through these links, I will receive a very small commission. This doesn't cost you anything, but it allows me to continue offering you the content you love.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
The holidays are supposed to be the most wonderful time of the year, but often instead, they're the most stressful, most anxious time of the year. It can seem impossible to please everyone and come out on the other end with your sanity intact. We only have about 18 Christmas seasons with each of our kids at home. If we are stressed and anxious through them, we'll look back and wonder where the time went (even worse than we will anyway). This year, put these 4 easy, healthy things into practice and you'll be able to embrace the beauty of the season and enjoy it without the negative emotions that all the commitments can bring. Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Inside this episode, we dive into some of the scary common side effect that come along with conventional medications many people take to treat pain and inflammation. We look at how they impact your gut health as well as your gut microbiome, which is essential to optimal immune function. You will learn the reasons why it is a good idea to avoid these meds whenever possible and you'll learn more about how CBD can be a great natural alternative to try when you're dealing with pain and inflammation that will NOT negatively impact your gut health. Inside this episode, we dive into some of the scary common side effects that come along with conventional medications many people take to treat pain and inflammation. We look at how they impact your gut health as well as your gut microbiome, which is essential to optimal immune function. You will learn the reasons why it is a good idea to avoid these meds whenever possible and you'll learn more about how CBD can be a great natural alternative to try when you're dealing with pain and inflammation that will NOT negatively impact your gut health. Next steps: Join the family Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Joy, a wife and mother of 2 children, was struggling with pain she didn't realize had gotten so bad and her stress and anxiety had her snapping at her kids so much that they expected her to yell at them even for honest accidents. This testimonial tells the story of how Joy decided to try Alara Ridge Farm CBD and how she realized how much her pain, sleep, and general mood improved after only making that one change. Want me to read YOUR testimonial on a future episode? Send your story to info@alararidgefarm.com Please leave us a written review here - https://podcasts.apple.com/us/podcast/cbd-you-helping-christian-women-take-back-their-health-through-natural-remedies/id1655268460 Learn more about us here - https://alararidgefarm.com Limited time offer for 20% discount -- for first 20 people ONLY! - bit.ly/cbdandyoushow Like us on Fb - fb.com/alararidge Got questions for future show topics? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
America is chronically TIRED. Most Americans are not getting enough sleep. As many as 1 in 3 report having some insomnia. Many turn to medications, but of course, medications bring unwanted side effects. Inside today's show, I'll give you 4 tips on NATURAL ways to get a GREAT night's sleep and we'll also talk about one thing you're going to want to avoid. You'll be on your way to catching zzz's before you can get started counting sheep. Next steps: Join the family LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
In today's show, you'll learn the difference between CBD oil and hemp oil so you can know what you're buying. There's a lot of confusion out there and there's tons of bad info, so this quick listen will clear things up for you in no time! Next steps: Join the family LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
In today's show, I introduce you to ME, Lori, your host! I tell you all about me and our CBD farm so that you can get to know me and know who I am as we begin this journey together. This podcast will be a show with short episodes providing you juicy, digestible bites of info to help you find balance and relief both through natural means and through using our premium CBD products which we grow, process, and produce at our farm here in Tennessee. Next steps: Join the family LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
CBD & YOU - Natural Remedies, Healthy Solutions, Benefits of CBD
Today's episode dives into 3 great reasons to give CBD a try. You'll learn why CBD might be a great option for you if you deal with things like pain, sleep problems, and anxiety, among other things. This is great information to share with your family if you're worried about what they will think if you tell them you've started using CBD oil. Don't worry -- grandma won't be too judgy if you share what you learn here! Next steps: Join the family LIMITED TIME OFFER -- bit.ly/cbdandyoushow - 20% off your entire cart plus FREE SHIPPING Learn more about us here - https://alararidgefarm.com Like us on Fb - fb.com/alararidge Got questions? Email info@alararidgefarm.com The statements made regarding our products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from health care practitioners. Please consult your healthcare professional about potential interactions or other possible complications before using any product. The Federal Food, Drug, and Cosmetic Act require this notice.
Whether an aromatherapy product is a cosmetic or a drug under the law is determined by the product's intended use. The Federal Food, Drug and Cosmetic Act defines “cosmetics” by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Florida Statute §499.003(12) adopted the FDA's definition of “cosmetic” verbatim, but further stated that the definition does not include soap. The law doesn't require cosmetics to have FDA approval before they go on the market. But FDA can take action against a cosmetic on the market if they have reliable information showing that it is unsafe when consumers use it according to directions on the label, or in the customary or expected way, or if it is not labeled properly. The FDA Act defines “drugs”, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims. Intended use may be established by claims stated on the product labeling, what consumers expect it to do, in advertising on the internet, or in other promotional materials. Ultimately, the FDA makes decisions on a case-by-case basis. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. It may also be established that a product is a drug based upon the ingredients that have a well-known therapeutic use. Essential oil fragrances marketed for promoting attractiveness is a cosmetic. However, a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Under Florida Statute §499.005(5) it is a crime to disseminate false or misleading advertisement of a drug, device or cosmetic, which is punishable as a misdemeanor of the second degree. It is also a violation of the Florida Drug and Cosmetic Act to disseminate any false advertisement of any drug, device or cosmetic, which includes misleading advertisements according to Florida Statute §499.0054(1)(a). These advertisements include those on a website or social media account. Keep in mind that a cosmetic product must be labeled according to cosmetic labeling regulations. Web: www.JonesHealthLaw.com Phone: (305)877-5054 Instagram: @JonesHealthLaw Facebook: @JonesHealthLaw Youtube: #JonesHealthLaw --- Support this podcast: https://podcasters.spotify.com/pod/show/joneshealthlaw/support
Our guest today is my friend Regan Nelson, host of This or Something Better podcast. Her podcast is dedicated to the stories of innovators and positive change makers committed to making the world better. Regan is also a consultant of Beautycounter, the leader in clean beauty products. "The $63 billion beauty industry in the US is predominantly governed by the Federal Food, Drug, and Cosmetic Act, which was signed into law by President Franklin D Roosevelt on June 25, 1938. Despite the industry's rapid growth, these regulations have stood largely unchanged." - PRNewsireIn this episode:What is in your supplements, sunscreen, powder makeup, laundry detergent, shampoo and conditioner, tape, etc that could be harming your health. Not So Pretty - the first-ever comprehensive large-scale investigative expose of the trillion-dollar cosmetics, beauty and personal care industry.Million Marker - fertility testing related to endocrine disruptors and environmental toxins. Environmental Working Group - consumer guides to help you learn about the hidden health dangers in your food, water and everyday products to make better decisions.Schedule a consultation with Regan here. Contact your state representatives here regarding Cosmetic Reform.
What a keen eye will notice in reading the legislation is that nothing under the FDA's statutory authority involves the decisions physicians make every day for their patients. In fact, the Federal Food, Drug, and Cosmetic Act, section 1006 expressly state that nothing in this act shall be construed to limit of interfering with the authority of a...
What a keen eye will notice in reading the legislation is that nothing under the FDA's statutory authority involves the decisions physicians make every day for their patients. In fact, the Federal Food, Drug, and Cosmetic Act, section 1006 expressly state that nothing in this act shall be construed to limit of interfering with the authority of a...
After a hiatus of two years, the US Food and Drug Administration resumed its onsite inspections of drug manufacturing units outside its borders – including China and India. It has been following this practice to make sure that all the medicines which enter into the country follow the set standards. Most inspections were put on hold in March 2020, when the world was hit by the pandemic. Indian pharmaceutical companies, on their part, try to adhere to the norms as any departure may hit their export adversely. In one such inspection at Sun Pharma's Halol facility this month, the US FDA team issued a Form 483. The next morning of May 10, the share price of Sun Pharmaceutical Industries fell over four per cent. So, apparently, the Form 483 and 10 observations made in it were not good news for the firm. The company said that it was preparing a response to the observations, which would be submitted to the USFDA within 15 business days. The Food and Drug Administration has the responsibility of protecting public health in the US. In its own words, on the one hand, it does this by ensuring the safety, efficacy, and security of both human and veterinary drugs, biological products, and medical devices. On the other hand, the FDA is responsible for ensuring the safety of the US' food supply. It also deals with cosmetics and products that emit radiation. According to the USFDA, an FDA Form 483 is issued to the management of the firm being inspected. It is issued at the end of the inspection if the FDA's investigators find that they have observed any conditions that might constitute violations of the Food Drug and Cosmetic Act and related Acts of the US. Observations are made when the investigators find that the conditions or practices observed indicate that any food items, drugs, devices or cosmetics have been adulterated. Or, if in their judgement, these products are being prepared, packed, or held under conditions in which they might become adulterated or rendered injurious to health. On their part, the company that has been inspected is supposed to respond to the Form 483 in writing, along with its corrective action plan. The FDA expects that subsequently, the company will implement said plan expeditiously.
Kansas's House Bill 2056 would amend the Kansas Food, Drug and Cosmetic Act to regulate products containing kratom. As always, some are on board, others are not! (Sources in this episode can be found below.) Email me with questions or comments for the show at anythingeverythingkratom@gmail.com, or send a recording that talks about your experience with kratom, and I'll share it on the podcast: https://anchor.fm/everything-kratom/message Get 25% off orders from ETHA Natural Botanicals with coupon code EVERYTHINGKRATOM, or visit their website using this link - https://ethalivefully.com/discount/EVERYTHINGKRATOM?aff=243 Thank you all so much for listening! * https://www.ksnt.com/capitol-bureau/war-on-kratom-sparks-push-for-protection-in-kansas/ --- Send in a voice message: https://anchor.fm/everything-kratom/message Support this podcast: https://anchor.fm/everything-kratom/support
Welcome to CVAR, a #Covid-Vaccine-Adverse-Reactions podcast. I'm your host, Von Galt. Today, we talk to pharmaceutical researcher and scientist, Mr. Craig Paardekooper about his discoveries organizing the CDC's VAERS website to see which batch lot numbers had deaths and adverse reactions. Watch the video presentation here: https://rumble.com/covidvaccineadversereactions https://www.bitchute.com/covidvaccineadversereactions/ https://www.brighteon.com/channels/covidvaccineadversereactions https://odysee.com/@covidvaccineadversereactions:9 Podcast audio version: https://anchor.fm/covidvaxadversereactions Donate to Mr. Craig Paardekooper's research here: https://howbadismybatch.com/donatecreditcard.html Look up your batch number here: https://howbadismybatch.com/ VAERS Lot# Look-up tool: https://wonder.cdc.gov/vaers.html MedAlerts: https://medalerts.org/vaersdb/index.php Do not despair. For more information about the #Defeat-the-Mandates march on Jan. 23, 2022 at Washington DC, USA: https://defeatthemandatesdc.com/ The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act US Code Title 21, Sections 351 (Adulterated Penalties) & Sections 352 (Misbranded Penalties) https://uscode.house.gov/view.xhtml?req=(title:21%20section:351%20edition:prelim)%20OR%20(granuleid:USC-prelim-title21-section351)&f=treesort&edition=prelim&num=0&jumpTo=true https://uscode.house.gov/view.xhtml?req=(title:21%20section:352%20edition:prelim)%20OR%20(granuleid:USC-prelim-title21-section352)&f=treesort&edition=prelim&num=0&jumpTo=true 2020 Prep Act authorizes the Secretary of the Department of Health and Human Services to give vaccine administrators immunity except for “willful misconduct”: https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx#q3 Under Title 21 of the FDA's Code of Regulations section 50.20 regarding Informed Consent of Human Subjects: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.20 For more information about CICP, contact 1-855-266-2427 (CICP) or cicp@hrsa.gov #Covid-Vaccine-Adverse-Reactions,#How-Bad-Is-My-Batch, #VAERS, #Craig-Paardekooper, #Defeat-the-Mandates-DC
The FDA stands for The Food and Drug Administration, but they are also key in regulating the cosmetic industry. In 1938, The Federal Food, Drug, and Cosmetic Act gave the FDA the responsibility for regulating cosmetics and protecting customers. To explore how cosmetics are regulated, Charmain Rodriques, Regulatory Affairs Manager at LVMH joins us to explore how the FDA, FTC, and even customers shape the cosmetic industry. Hope you enjoy!
Track 1: Introductions Jenna's Story Call about definition of homeopathy Start Track 2: 20:37 Track 2: Call about Oscillococinum Hahnemann: only non-politician statue in Washington DC Homeopathy is used in allopathic medicine ex. Ritalin Start Track 3: 41:54 Track 3: Call about encouraging people to use homeopathy and not give up right away Text about anxiety and glaucoma Call about snake poison and placebo effect Homeopathy Research Institute - great research studies about homeopathy Start Track 4: 1:00:50 Track 4: James Taylor Kent - most famous homeopath in US Example about the law of homeopathy - Bee sting Many texts! Start Track 5: 1:23:21 Track 5: FDA attack on homeopathy homeopathychoice.org 1939 Food-Drug and Cosmetic Act
The Problem with Vaccine Mandates and Vaccine Passports NCLA Litigation Counsel Jenin Younes joins the show to discuss two questions: (1) may the government lawfully compel citizens to take a new, experimental vaccine? and (2) does New York's vaccine passport program, which purports to be voluntary, constitute government compulsion? D.C. Circuit Vacates FDA Final Rule Wrongfully Regulating Practice of Medicine “When Congress has spoken in a statute, we assume that it says what it means and that the statute means what it says,” concluded the U.S. Court of Appeals for the D.C. Circuit in an opinion this week in The Judge Rotenberg Educational Center, Inc. v. U.S. Food and Drug Administration. The Court declared that the Food and Drug Administration's (FDA) Final Rule banning one specific use of an FDA-approved medical device improperly interferes with the practice of medicine. The Court further agreed with NCLA that the Food, Drug & Cosmetic Act does not permit FDA to ban an already-approved device for some uses, but not others. NCLA filed a November 2020 amicus brief making these two points, as well as arguing that FDA ran roughshod over petitioners' procedural rights and arrogated to itself powers not delegated by Congress. Read more about the case here: https://nclalegal.org/amicus-brief-the-judge-rotenberg-educational-center-inc-v-u-s-food-and-drug-administration-et-al-luis-aponte-et-al-v-u-s-food-and-drug-administration-et-al-ncla-brief-asks-dc-circuit-to-st/ See omnystudio.com/listener for privacy information.
This week we talk about smallpox, the FDA, and Aducanumab.We also discuss Biogen, regulatory capture, and the Food, Drug, and Cosmetic Act. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit letsknowthings.substack.com/subscribe
This week we talk about smallpox, the FDA, and Aducanumab. We also discuss Biogen, regulatory capture, and the Food, Drug, and Cosmetic Act. Support the show: patreon.com/letsknowthings & letsknowthings.com/support Show notes/transcript: letsknowthings.com My daily news summary: onesentencenews.com My other podcast: brainlenses.com
Photo: Manila hemp industry, Philippines: cutting down the tree."Hemp seeds are a rich source of nutrients. Part of the hemp plant, these seeds are technically a nut that can be eaten raw or used to make milk, oil, cheese substitutes, or protein powder." While related to the cannabis plant, hemp seeds have little to none of the psychoactive compound THC found in marijuana. The US Congress introduces H.R. 841 in order to move the hemp story to the American consumer. Jason Mitchell, CEO and Co-Founder, HempFusion Wellness.OTC: CBDHFCanada CBD.Uhttps://www.hempfusion.com/about/H.R. 841: "To make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the Federal Food, Drug, and Cosmetic Act as a dietary ingredient in a dietary supplement, and for other purposes." https://www.govtrack.us/congress/bills/117/hr841/text
The FDA’s Acting Commissioner Dr. Janet Woodcock brings listeners inside the FDA. While the agency’s hands are full with a global pandemic, the FDA is also still tasked with shepherding accelerated approvals for rare and chronic disease treatments, improving clinical trials, and assessing the cost effectiveness of medications. Plus, the patient perspective of FDA-accelerated approval medications. Sickle cell advocate Teonna Woolford stresses the urgency behind approving medications. And patient correspondent Nichole Davis shares her journey with fibromyalgia and the importance of health literacy. Guest:Dr. Janet WoodcockActing Commissioner, Food and Drug AdministrationAs Acting Commissioner, Dr. Woodcock oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products.Dr. Woodcock began her FDA career in 1986, joining the agency’s Center for Biologics Evaluation and Research (CBER) as Director of the Division of Biological Investigational New Drugs, as well as serving as CBER’s Acting Deputy Director for a period of time. She later became Director of the Office of Therapeutics Research and Review in CBER, which included the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis during her tenure.Links:Dr. Janet WoodcockTeonna WoolfordThe Sickle Cell Reproductive Health Education DirectivePatients Rising Diversity, Equity, and Inclusion CouncilOp-Ed: How long-haul COVID-19 could offer clues for treating other puzzling chronic illnessesDrug Board is Wrong Rx for Colorado What Do You Do When Kids Are Still Unvaccinated?Supply vs. Demand: When Will the Scales Tip on COVID-19 Vaccination in the US?Patient Correspondent: Nichole DavisPatients Rising Concierge Need help?The successful patient is one who can get what they need when they need it. We all know insurance slows us down, so why not take matters into your own hands. Our Navigator is an online tool that allows you to search a massive network of health-related resources using your zip code so you get local results. Get proactive and become a more successful patient right now at PatientsRisingConcierge.orgHave a question or comment about the show, want to suggest a show topic or share your story as a patient correspondent?Drop us a line: podcast@patientsrising.orgThe views and opinions expressed herein are those of the guest(s)/ author(s) and do not reflect the official policy or position of Patients Rising.
Genetic Engineering and Society Center GES Colloquium - Tuesdays 12-1PM (via Zoom) NC State University | http://go.ncsu.edu/ges-colloquium GES Mediasite - See videos, full abstracts, speaker bios, and slides https://go.ncsu.edu/ges-mediasite Twitter - https://twitter.com/GESCenterNCSU Regulatory Decision-Making Tools for Novel Food Technologies While the sections of the Federal Food, Drug, and Cosmetic Act governing food ingredient regulation have remained largely unchanged since the passage of the Food Additives Amendment of 1958, the FDA has shown that it is able to effectively regulate ingredients manufactured using new technologies under these existing broad statutory authorities to ensure the safety of substances added to food. As emerging technologies are adopted in food ingredient production, FDA’s Office of Food Additive Safety will continue to rely on these long-standing statutory authorities in combination with policy and scientific knowledge to regulate the safe use of food ingredients. To illustrate how the agency has developed science-based policy within its authority under existing federal law as science and technology evolve, we will describe the 1992 Policy Statement: Foods derived from new plant varieties and the 2014 Guidance to Industry: Assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances Guest Speaker Dr. Jeremiah Fasano is a Senior Policy Advisor in the Office of Food Additive Safety’s Regulatory Review Branch at the Center for Food Safety and Applied Nutrition. He has worked on a variety of issues during his time at CFSAN, including premarket safety evaluation of new food ingredients, assessment of genetically engineered new plant varieties, strategies for tracking sodium reduction in the US food supply, and development of safety assessment frameworks for new food technologies and functionalities. He received his doctorate in plant cell physiology and molecular biology from the Pennsylvania State University. Links & Resources - Office of Food Additive Safety, Center for Food Safety and Applied Nutrition at the US Food and Drug Administration https://www.fda.gov/about-fda/fda-organization/center-food-safety-and-applied-nutrition-cfsan GES Center - Integrating scientific knowledge & diverse public values in shaping the futures of biotechnology. Find out more at https://ges-center-lectures-ncsu.pinecast.co
In this episode we discuss the newly signed Cares Act aimed at providing aid to businesses and individuals that have been impacted by the Coronavirus and the resulting economic shut-down. The application process for the Cares Act loans will take the form of a modified 7a SBA loan and will be processed through SBA approved lenders. On this episode, we have bank representatives, employment attorney, FSU Economics professor and business leaders in the restaurant industry. A recent post re: the summary of the Cares Act:Senate Passes the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”)26 March 2020 Coronavirus Resource Center BlogAuthors: Frank S. Murray Jr Jared B. Rifis Leah R. Imbrogno Jamie N. Class Matthew E. Sierawski Julia Di Vito Kaitlyn M. Foley As the coronavirus outbreak continues to wreak havoc on markets and industries in the United States and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges will require thoughtful and comprehensive planning. Foley has created a multi-disciplinary and multi-jurisdictional team, which has prepared a wealth of topical client resources (see Foley’s Coronavirus Resource Center) and is prepared to help our clients meet the legal and business challenges that the coronavirus outbreak is creating for stakeholders across a range of industries, including manufacturing, technology, solar, hospitality and travel, healthcare, food, fashion and apparel, and sports and entertainment. The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) – Summary of Bill Language and Key TakeawaysOn March 25, 2020, the Senate unanimously passed (96-0) the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), commonly known as “Phase Three” of coronavirus economic relief. The CARES Act provides much needed stimulus to individuals, businesses, and hospitals in response to the economic distress caused by the coronavirus (COVID-19) pandemic. The bill passed on March 25 is not yet law. Until the CARES Act is passed by the House of Representatives and signed into law by the President, it is subject to revisions. The bill will now go to the House, which is currently not in session. The House may reconvene to address the bill or pass the bill by unanimous consent agreement. The House is expected to pass the bill without changes on March 27, and it will then be presented to the President for his signature.Additional information, updates, and analysis regarding the CARES Act will be posted on Foley’s Coronavirus Resource Center. Please check back frequently for updates. Foley is available to assist in interpretation of the CARES Act for your business and can help you find ways to claim and/or use available funding for your company. The CARES ActTop 10 Takeaways:Provides stimulus to individuals, businesses, and hospitals in response to the economic distress caused by the coronavirus (COVID-19) pandemic.Creates a $349 billion loan program for small businesses, including 501(c)(3) non-profits and physician practices. These loans can be forgiven through a process that incentivizes companies to retain employees.Allocates $500 billion for assistance to businesses, states, and municipalities, with no more than $25 billion designated for passenger air carriers, $4 billion for air cargo carriers, and $17 billion for businesses critical to maintaining national security. The remaining $454 billion may be used to support lending to eligible businesses, states, and municipalities.Allocates $130 billion in relief to the medical and hospital industries, including for medical supplies and drug and device shortages.Expands telehealth services in Medicare, including services unrelated to COVID-19 treatments.Provides $1,200 to Americans making $75,000 or less ($150,000 in the case of joint returns and $112,500 for head of household) and $500 for each child, to be paid “as rapidly as possible.”Expands eligibility for unemployment insurance and provides people with an additional $600 per week on top of the unemployment amount determined by each state.Expands the Defense Production Act, allowing for a period of two years when the government may correct any shortfall in resources without regard to the current expenditure limit of $50 million.Provides the Secretary of the Treasury with the authority to make loans or loan guarantees to states, municipalities, and eligible businesses and loosens a variety of regulations prior legislation imposed through the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Economic Stabilization Act of 2008, and others.Accompanied by supplemental appropriations to help the government respond to this pandemic.Summary of the CARES Act:Division A - Keeping American Workers Paid and Employed, Healthcare System Enhancements, and Economic Stabilization Title I – Keeping American Workers Paid and Employed Act Foley Title I Contacts: Jamie Class, Erin Toomey, Jessica Glatzer Mason, and Frank MurrayPaycheck Protection ProgramThe Paycheck Protection Loan Program, at a price tag of $349 billion, covers the period February 15, 2020 through June 30, 2020 and greatly expands SBA loan eligibility. The loan program will allow businesses suffering due to the coronavirus outbreak to borrow money for a variety of qualified costs related to employee compensation and benefits, including (i) payroll costs, (ii) continuation of health care benefits, (iii) employee compensation (of those making less than $100K), (iv) mortgage interest obligations, (v) rent, (vi) utilities and (vii) interest on debt incurred before the covered period.The legislation greatly expands the number of businesses (including non-profits) that are eligible for SBA loans and raises the maximum amount for such a loan by 2.5 x the average total monthly payroll costs, or up to $10 million. The interest rate may not to exceed 4%.Companies that employ no more than 500 employees are (or a greater number based on the size standard applicable to the industry) may be eligible. Certain companies in the Accommodation and Food Services Industry (NAICS Code 72) may be eligible if they have no more than 500 employees per physical location. In most cases, the number of employees is counted together with all affiliates.Waives affiliation rules under 13 C.F.R. 121.103 for any business with less than 500 employees in the Accommodation and Food Services Industry, certain franchise businesses and small businesses that receive financing through the Small Business Investment Company Act. Affiliation rules otherwise apply to determine eligibility.Waives the credit available elsewhere, personal guaranty and collateral requirements.For eligibility purposes, requires lenders to determine whether a business was operational on February 15, 2020, and had employees for whom it paid salaries and payroll taxes, or a paid independent contractor. (This is likely to be interpreted to replace the determination of repayment ability which is not possible during the crisis.)All or a portion of the loan may be forgivable and debt service payments may be deferred for up to 1 year.Entrepreneurial DevelopmentProvides funding to educate small businesses and their employees regarding (i) Federal resources available during this time, (ii) Hazards of COVID-19 and (iii) best practices around teleworking to prevent the spread of COVID-19.iii. State Trade Expansion ProgramAllows for federal grant funds appropriated to support the State Trade Expansion Program (STEP) in FY 2018 and FY 2019 to remain available for use through FY 2021.Waiver of Matching Funds Requirement under the Women’s Business Center ProgramEliminates the non-federal match requirement for Women’s Business Centers for a period of three months. Loan Forgiveness Establishes that the borrower under the Paycheck Protection Program shall be eligible for loan forgiveness equal to the amount spent by the borrower during an 8-week period after the origination date on (i) rent, (ii) payroll costs for workers making less than $100K, (iii) interest on a mortgage, and (iv) utility payments. The amount forgiven may not exceed the principal of the loan. Incentivizes companies to retain employees by reducing the amount forgiven proportionally by any reduction in employees retained compared to the prior year.To encourage employers to rehire any employees who have already been laid off due to the COVID-19 crisis, borrowers that re-hire workers previously laid off will not be penalized for having a reduced payroll at the beginning of the period.Minority Business Development Agency Empowers the Department of Commerce, through the Minority Business Development Agency, to provide grants to minority business centers and minority chambers of commerce to provide education, training and advising related to accessing federal resources.vii. United States Treasury Program Management Authority The Department of the Treasury, consulting with the Small Business Administration and the Chairman of the Farm Credit Administration shall establish criteria to allow other lenders to participate in the Paycheck Protection Program, so long as such participation does not threaten the safety and soundness of the lender, as determined in consultation with the relevant federal banking agencies.viii. Emergency Economic Injury Disaster Loans (“EIDLs”) For the period between January 31, 2020 and December 31, 2020 (the “covered period”) EIDL eligibility is greatly expanded to include any business with not more than 500 employees operating under a sole proprietorship or as an independent contractor, and any cooperative, ESOP and tribal small business concern with not more than 500 employees. The number of employees is determined together with affiliates.Furthermore, EIDLs may be approved solely on the bases of an applicant’s credit score or by use of alternative methods to gauge the applicant’s ability to repay. Additionally, applicants may request an advance of up to $10,000 within three days after the Administrator receives the application, subject to verification that the entity is eligible under this program. The advance may be used for any allowable purposes under §7(b)(2) of the Small Business Act and is not subject to repayment, even if the loan request is ultimately denied.Importantly, the CARES Act waives: (1) the requirement of personal guarantees for loans up to $200,000, (2) the requirement that the applicant must be in business for a year (but must be in operation on January 31, 2020), and (3) the credit elsewhere test.Establishes that an emergency involving Federal primary responsibility determined to exist by the President under Section 501(b) of the Stafford Disaster Relief and Emergency Assistance Act qualifies as a new trigger for EIDLs.Importantly, the CARES Act waives: (1) the requirement of personal guarantees for loans up to $200,000, (2) the requirement that the applicant must be in business for a year (but must be in operation on January 31, 2020), and (3) the credit elsewhere test.Subsidy for Certain Loan PaymentsFor loans under §7(a) of the Small Business Act, Title V of the Small Business Investment Act, and for loans made by an intermediary using §7(m) loans or grants, the Administrator shall pay the principal, interest, and fees owed for loans in regular servicing status for any such loans, whether on deferment or not, that were made before the enactment of the Act for the following 6-month period, and for any such loans that were made between the date of enactment of the Act and six months from such date. This does not apply to Payroll Protection loans or EIDL loans which have separate subsidy and repayment requirements.The payments shall be made not later than 30 days from when the first payment is due and shall be applied such that the borrower is relieved of any obligation to pay that amount. The Administrator shall coordinate with relevant banking agencies to request that lenders not be required to increase reserves because of these payments.The Administrator will waive limits on the maximum loan maturities for loans given deferral and extended maturity during the year following enactment. The Administrator will extend lender site visit requirement timelines as necessary because of COVID-19, to within 60 days of a non-default adverse event, and 90 days of a default. $17 billion is appropriated for the foregoing.BankruptcySection 1182(1) of Title 11 is amended to define “debtor” as persons engaged in commercial or business activities and their affiliates (excluding persons who primarily own single asset real estate) that have aggregate, noncontingent, liquidated secured and unsecured debts (at the date of petition filing or the order for relief) of $7,500,000 or less (excluding debts owed to affiliates or insiders), half or more of which arose from those activities. Exempt from this new definition are any members of a group of affiliated debtors that has aggregate, noncontingent, liquidated secured and unsecured debts over $7,500,000 (excluding debt owed to affiliates or insiders); corporations subject to 1934 Act reporting requirements; and affiliates of an issuer under the 1934 Act. National Emergency Act payments for COVID-19 by the President are exempted from “current monthly income” and “disposable income” when determining the power of courts to approve debtor plans rejected by trustees or claim holders. Debtors that have experienced material financial hardship due to COVID-19 can modify a plan confirmed prior to this Act’s enactment date if approved after notice and hearing, but only if that plan doesn’t provide payments more than seven years after the first payment was due under the original plan, and follows requirements of 1322(a)-(c) and 1325(a). This modification terminates one year after the enactment of this Act.Title II – Assistance for American Workers, Families, and Businesses Foley Title II Contacts: Julie Lutfi, Ashley May, and Dick RileySubtitle A: Unemployment Insurance ProvisionsEligibilityThe law expands the scope of individuals who are eligible for unemployment benefits, including those who are furloughed or out of work as a direct result of COVID-19, self-employed or gig workers, and those who have exhausted existing state and federal unemployment benefit provisions.The only individuals expressly excluded from coverage are those who have the ability to telework with pay and those who are receiving paid sick leave or other paid benefits (even if they otherwise satisfy the criteria for unemployment under the new law).Administration of BenefitThe benefits are administered by each state and upon the state’s written agreement with the Secretary of Labor to provide the specific benefits. States that enter into such an agreement with the Secretary of Labor will be reimbursed in whole or in part for the cost of the benefits plus administrative expensesTypes of Benefits ProvideThe law provides an increase of $600 per week in the amounts customarily available for unemployment under state law. This increase applies for unemployment payments made from the date of the law’s enactment through July 31, 2020 (approximately four months).States can agree to provide pandemic emergency unemployment compensation to individuals who have either exhausted all of the benefits available to them under existing state and federal law or who are not otherwise eligible for benefits under existing state and federal law. Individuals must be able and available to work and actively seeking work, unless they are unable to do so as a result of COVID-19 illness, quarantine, or movement restriction.States can agree to waive the waiting period for receipt of benefits so that individuals do not experience gaps in income.The federal government will temporarily fund short-time compensation under existing state plans. States that do not yet have short-time compensation plans in place may agree to implement a plan, provided that employers who enter into short-time compensation plans must be required to pay to the state half of the short-time compensation paid under the planTime Periods for Expanded BenefitsThe law provides unemployment benefit assistance to covered individuals who are not otherwise entitled to benefits under existing state or federal law for weeks of unemployment, partial unemployment, or inability to work caused by COVID-19 during the period January 27, 2020 through December 31, 2020. This includes any waiting periods for benefits under applicable state law.The total benefit may not extend beyond 39 weeks (including any unemployment benefits or extended benefits received under existing state or federal law), unless, after the law is enacted, the duration of extended benefits is extended, in which case the total benefit may extend beyond 39 weeks by that same additional period of extended benefits.The $600 weekly benefit increase will be applicable to weekly payments made through the end of July 2020.Protections Against Fraud and OverpaymentAny fraudulent intent or misrepresentations to obtain payments to which an individual is not entitled will result in ineligibility for any other unemployment compensation benefits under the new law as well as criminal prosecution. Overpayments may be clawed back by the state agencies.Social Security TreatmentThe additional unemployment compensation provided is not considered “income” for purposes of Medicaid and CHIP.Subtitle B: Rebates and Other Individual ProvisionsTax CreditsBeginning in 2020, "eligible individual" taxpayers can benefit from a tax credit equal to the sum of: (i) $1,200 for single filers ($2,400 for those filing a joint return) plus (ii) an amount equal to th eproduct of (a) $500 multiplied by (b) the number of qualifying children. However, the aforementioned tax credits will be “phased-out” by 5% (but not below 0) when such eligible taxpayer’s adjusted gross income exceeds: (i) $150,000 for joint-filers, (ii) $112,500 for heads of household, and (iii) $75,000 for all other types of filers.This means, for example, the tax credit will phase out entirely at $198,000 for joint-filers with no children.“Coronavirus-Related Distribution”A “coronavirus-related distribution,” as defined under the CARES Act, is generally defined as any distribution from an eligible retirement plan made: (i) on or after January 1, 2020 and before December 31, 2020, (ii) to an individual (a) who is diagnosed with COVID-19, (b) whose spouse or dependent is diagnosed with COVID-19, or (c) who experiences adverse financial consequences as a result of being quarantined, furloughed, laid off, had hours reduced, or other factors as determined by the Secretary of the Treasury during the COVID-19 pandemic.Tax Treatment of Coronavirus-Related DistributionsIndividuals who elect to receive a “coronavirus-related distribution” will not be subject to the traditional 10% tax penalty imposed under the Internal Revenue Code of 1986, as amended (the “Code”) for early withdrawals from eligible retirement accounts,unless the aggregate amount of such distributions from all plans maintained by the employer (and any member of any “controlled group” which includes the employer) to such individual exceeds $100,000. Coronavirus-related distributions made from both traditional eligible employer sponsored retirement plans and individual retirement accounts (“IRAs”) may be excluded from gross income.Repayments of Coronavirus-Related DistributionsAny individual who receives a coronavirus-related distribution may generally, at any time during the three (3) year period beginning on the day after the date such coronavirus-related distribution was received, make one (1) or more contributions in an aggregate amount not to exceed the amount of such distribution to an eligible retirement plan of which such individual is a beneficiary . The aforementioned repayments of coronavirus-related distributions for eligible retirement plans, will, to the extent of the amount of the contribution, be treated as having received the coronavirus-related distribution in an eligible rollover distribution,” and as having transferred the amount to the eligible retirement plan in a direct trustee to trustee transfer within sixty (60) days of distribution.Effects on the Limits on Loans from Qualified Employer PlansThe limitation on loans from any qualified employer plan made to qualified individuals will be increased from $50,000 to $100,000, and should the due date of any such loan occur between the date of enactment of the CARES Act and December 31, 2020, it will be delayed for one (1) year.Effects on Minimum Distribution ThresholdThe CARES Act temporarily waives the minimum distribution requirements for all “eligible deferred compensation plans.” This includes: (i) certain contribution plans (e.g. an employer purchased annuity contract), (ii) deferred compensation plans that are maintained by an eligible employer, or (iii) IRAs. This applies for all distributions made on or after January 1, 2020.However, if this section applies to any pension plan or contract amendments, such pension plan or contract amendments will not fail to be treated as being operated in accordance with the terms of the plan during such period, solely because the plan operates in accordance with the CARES Act, so long as the amendment or contract in question has been in effect from its effective date until December 31, 2020.Any plan or contract amendments to which Section 2203 of the CARES Act (the section on temporary waiver of required minimum distribution rules) applies will not fail to meet the requirements of either the Internal Revenue Code or the Employee Retirement Income Security Act as a result of making such an amendment. However, this provision only applies to those amendments which are in effect during the period beginning on the effective date of the amendment until December 31, 2020.Tax Treatment of Charitable DonationThe CARES Act allows taxpayers to take an above-the-line tax deduction for charitable contributions of up to $300 for the tax year beginning in 2020.Additionally, except for certain exclusions specified below, the percentage and excess carryover restrictions on charitable and other “qualified contributions” (e.g. a contribution to a corporation, trust, a state, or an organization of war veterans, etc.) are disregarded.Exceptions to the CARES Act General Disregard of the Percentage and Excess Carryover Restrictions on Qualified ContributionsThe CARES Act treats individuals and corporations differently regarding the aforementioned exceptions, and such different treatments are described below.Qualified contributions for individuals will be allowed as deductions to the extent that the combined contributions do not exceed (i) the excess of the taxpayer’s adjusted gross income over (ii) the amount of the charitable contributions made by the individual under certain other provisions of the CARES Act (e.g., donations to a church, educational organization, private foundation, etc.). If such contributions exceed the foregoing limitation, they will be added to the qualified contribution excess, which is eligible to be treated as charitable deductions for up to the next five (5) successive tax years. Any qualified contributions made by corporations will be allowed as deductions only if these contributions do not exceed 25% of the taxable income of the corporation over the amount of all other charitable contributions allowed under the CARES Act. To the extent a corporation exceeds this limit, it will carry over the excess which will be eligible to be applied as charitable contribution deductions for the subsequent five tax years. This is provided that the excess qualified contribution amounts in question meet certain other restrictions, specifically, they must not exceed the lesser of: (i) 10% of the corporation’s taxable income or the total charitable deductions taken by the corporation during the taxable year over the sum of the contributions made in such year plus the aggregate of the excess contributions which were made in taxable years before the contribution year and which are deductible under this subparagraph for such succeeding taxable year; or (ii) in the case of the first succeeding taxable year, the amount of such excess contribution, and in the case of the second, third, fourth, or fifth succeeding taxable year, the portion of such excess contribution not deductible under this subparagraph for any taxable year intervening between the contribution year and such succeeding taxable year.iii. Subtitle C: Business ProvisionsEmployee Retention Credit for Employer Subject to Closure Due to COVID-19Eligible employers will receive a credit against applicable employment taxes for each calendar quarter in an amount equal to 50% of the qualified wages with respect to each employee. The amount of qualified wages taken into account for each eligible employee, however, will not exceed $10,000 per calendar quarter and the credit will not exceed the applicable employment taxes owed for such calendar quarter. The aforementioned credit is not applicable if the employer is alto taking advantage of the small business interruption loan. An eligible employer is defined as any employer: (i) which was carrying on a trade or business during calendar year 2020, and (ii) with respect to any calendar quarter for which, (a) the operation of their trade or business was fully or partially suspended due to governmental order as a result of COVID-19, or (b) the calendar quarter is within the period beginning with (1) the calendar quarter after December 31, 2019 for which gross receipts for the calendar quarter are less than 50% of the gross receipts for the same calendar quarter of the prior year and the ending with (2) the calendar quarter following the first calendar quarter beginning after the calendar quarter described in (1) for which gross receipts of the employer are greater than 80% gross receipts for the same calendar quarter in the prior year.Delay of Payment of Employer Payroll TaxesThe CARES Act will allow for most employers to defer paying their share of applicable employment taxes from the time the CARES Act is signed into law through December 31, 2020. Half of this deferred amount would be due on December 31, 2021 and the other half by December 31, 2022.Modifications for Net Operating Losses (“NOL”)There will generally be a temporary repeal of taxable income limitation including (i) in the case of a taxable year beginning before January 1, 2021, the aggregate of the net operating loss (“NOL”) carryovers to such year, plus the NOL carrybacks to such year, and (ii) in the case of a taxable year beginning after December 31, 2020, the sum of (a) the aggregate amount of NOLs arising in taxable years beginning before January 1, 2018, carried to such taxable year, plus (b) the lesser of (1) the aggregate amount of NOLs beginning after December 31, 2017, carried to such taxable year, or (2) 80% of the excess of certain taxable income.In the case of any NOL arising in a taxable year beginning after December 31, 2017, and before January 1, 2021, whereby (i) such NOL will be a net operating loss carryback to each of the five (5) taxable years preceding the taxable year of such loss and (ii) certain rules applicable to farming losses and insurance companies shall not apply. There are additional rules that apply specifically to “real estate investment trusts” and life insurance companies.Modification of Limitation on Losses for Taxpayers Other Than CorporationsFor any taxpayer other than a corporation:For a taxable year beginning after December 31, 2017 and before January 1, 2026, subsection (j) (relating to a limitation on excess farm losses of certain taxpayers) would not apply; and ii. For any taxable year beginning after December 31, 2020 and before January 1, 2026, any excess business loss of the taxpayer for the taxable year will not be allowed.In regard to treatment of capital gains and losses for purposes of calculating “excess business losses”: Deductions for losses from sales or exchanges of capital assets will not be taken into account.The amount of gains from sales or exchanges of capital assets taken into account will not exceed the lesser of (1) the capital gain net income determined by taking into account only gains and losses attributable to a trade or business, or (2) the capital gain net income.The amendments made in the aforementioned section shall apply to taxable years beginning after December 31, 2017.Modification of Credit for Prior Year Minimum Tax Liability of CorporationsThe corporate alternative minimum tax (AMT) was repealed as part of the Tax Cuts and Jobs Act, but corporate AMT credits were made available as refundable credits over several years, ending in 2021. The CARE Act accelerates the ability of companies to recover those AMT credits, permitting companies to claim a refund now and obtain additional cash flow during the COVID-19 emergency. Modification of Limitation on Business InterestThe CARES Act temporarily increases the amount of interest expense businesses are allowed to deduct on their tax returns, by increasing the 30-percent limitation (as imposed under the Tax Cuts and Jobs Act) to 50 percent of taxable income (with adjustments) for 2019 and 2020. As businesses look to weather the storm of the current crisis, this provision will allow them to increase liquidity with a reduced cost of capital, so that they are able to continue operations and keep employees on payroll.Qualified Improvement PropertyThe CARES Act enables businesses, especially in the hospitality industry, to write off immediately costs associated with improving facilities instead of having to depreciate those improvements over the 39-year life of the building. The provision, which corrects an error in the Tax Cuts and Jobs Act, not only increases companies’ access to cash flow by allowing them to amend a prior year return, but also incentivizes them to continue to invest in improvements as the country recovers from the COVID-19 emergency. Temporary Exception from Excise Tax for Alcohol Used to Produce Hand SanitizerFor distilled spirits removed after December 31, 2019 and before January 1, 2021, such distilled spirits will be free of tax for use in or contained in hand sanitizer produced and distributed in a manner consistent with any guidance issued by the FDA related to the outbreak of COVID-19.Title III – Supporting America’s Health Care System in the Fight Against the Coronavirus Foley Title III Contacts: Rachel O’Neil, Erin Horton, Anil Shankar, and Paul JosephSubtitle A, Part I: Addressing Supply ShortagesProvides for the National Academies to examine and report on the security of the U.S. medical product supply chain in order to assess U.S. dependence on critical drugs and devices sourced outside of the U.S., and to develop recommendations to improve resiliency of the U.S. supply chain for critical drug and devices.Requires the Strategic National Stockpile to include certain types of medical supplies, including personal protective equipment (PPEs), and identifies respiratory protective devices as covered countermeasures for use during a public health emergency.Prioritizes the review of drug applications to mitigate emergency drug shortages.Creates additional reporting requirements for drug manufacturers to report a discontinuation and disruption of the sourcing of active pharmaceutical ingredients.Requires manufacturers of certain drugs and medical devices critical to public health during a public emergency to develop, maintain, and implement risk management plans related to shortages, creating an annual notification requirement of the same. Such manufacturers are also subject to shortage-related inspections by the Secretary of Health and Human Services (HHS).Subtitle A, Part II: Access to Health Care for COVID-19 Patients Permits group health plans and insurers to cover and reimburse providers of diagnostic testing relating to COVID-19 at pre-emergency-period negotiated rates, and sets reimbursement rates in instances without previously negotiated rates equal to the cash price for services listed on a publicly-available website or the plan or insurer can negotiate with a provider for a rate lower than such cash price. All providers of a diagnostic test for COVID-19 are required to publicize cash price for such tests. Failure to comply with these requirements could result in HHS assessing a civil monetary penalty of up to $300 per day.Requires health plans and issuers to provide for rapid coverage of “qualifying coronavirus preventative services” – an item, service, or immunization intended to prevent or mitigate coronavirus—and vaccines for coronavirus.Appropriates $1.3 billion for FY 2020 for supplemental awards to health care centers for the prevention, diagnosis, and treatment of COVID-19.Amends Section 330I of the Public Health Service Act, relating to Telehealth Network and Telehealth Resource Centers Grant Programs, and Section 330A of the Public Health Service Act, relating to the Rural Health Care Services Outreach, Rural Health Network Development, and Small Healthcare Provider Quality Improvement Grant Programs—an individual or entity affected by these grant programs should seek out an attorney to examine the effect of such amendments.Limits potential state and federal liability for volunteer health care professionals—who provide services without compensation or other thing of value—for harm caused to patients relating to the diagnosis, prevention, or treatment of COVID-19. This provision expressly preempts more restrictive state or local law.Amends certain federal regulations governing the confidentiality and disclosure of substance use disorder patient records (Part 2), including allowing certain re-disclosures to covered entities, business associates, or other programs subject to HIPAA after obtaining the patient’s prior written consent.Permits a state agency or area agency on aging to transfer, without prior approval, not more than 100% of the funds received by the agency to meet the needs of the state or area served, and provides that the same meaning shall be given to an individual unable to obtain nutrition due to social distancing as one who is homebound due to illness.Provides that within 180 days of the passage of the Act, the Secretary of HHS shall issue guidance on the sharing of patients’ protected health information (PHI) related to COVID-19, including guidance on compliance with HIPAA regulations and applicable policies.Provides that the Secretary of HHS shall carry out a national awareness campaign relating to the importance and safety of blood donation, and the need of for donations for the blood supply during a public health emergency.iii. Subtitle A, Part III: Innovation Provides for using competitive procedures to enter into transactions to carry out public-health emergency health related projects and prohibits canceling those contracts solely because the emergency ends.Includes new provisions to expedite the development and approval of drugs to prevent or treat diseases in animals that are could have significant adverse consequences for humans.Subtitle A, Part IV: Health Care WorkforceApproves appropriations for a variety of health professions-related programs, with particular focus on programs serving medically underserved populations (rural and geriatric).Subtitle B: Education ProvisionsWaives requirement for certain higher education institutions to match federal funding and allows certain institutions to transfer unexpended allotment.Permits certain higher education institutions to use their allocations of Supplemental Educational Opportunity Grants for emergency financial aid for students.Permits certain higher education loan borrowers flexibility in repaying loans or returning grants during a qualified emergency.Permits certain students to complete distance education and certain students of foreign institutions to take classes in the United States.Allows the Secretary of Education to issue waivers upon request relating to assessments, accountability, and related reporting requirements, and requirements for state and local educational agencies and Indian Tribes to receive funding.Allows the Secretary of Education to grant a deferment to an institution that received a loan under Part D of Title III of the Higher Education Act.Payments on student loans held by the Department of Education are suspended for 6 months, and the Secretary of Education shall suspend all involuntary collection activities during the period of payment suspension.The Corporation for National and Community Service can allow individuals to accrue service hours and may permit certain grants funds.Not more than 20% of the total amount allocated to a local area under 29 U.S.C. 3151 et seq. may be used for administrative costs.For the program year 2019, not more than 20% of the total amount allocated to a local area under 29 U.S.C. 3151 et seq., may be used for administrative costs of carrying out certain local workforce investment activities, if the portion of the total amount that exceeds 10% of the total amount is used to respond to qualifying emergency. For the program year 2019, certain unobligated funds reserved by a governor for statewide activities under the Workforce Innovation Opportunity Act may be used for statewide rapid response activities, or in certain circumstances, released to local boards impacted by the coronavirus.Gives the Secretary of Education authority to waive certain eligibility requirements, wait periods, and allotment requirements under the Higher Education Act for a period of time.Authorizes the Secretary of Education to modify the required and allowable uses of funds for grants and to modify any federal share or other financial matching requirement for a grant awarded under certain provisions of the Higher Education Act to an institution of higher education or other grant recipient (not including an individual recipient of Federal student financial assistance) as a result of a qualifying emergency.Allows the Secretary of Education to modify the categories of extenuating circumstances under which a grant recipient may be excused from fulfilling a portion of a service obligation under title IV of the Higher Education Act and must consider teaching service that is part-time or temporarily interrupted due to the emergency to be full-time service. Requires the Secretary of Education to waive certain years of teaching service requirements under the Higher Education Act in certain circumstances.Subtitle C: Labor ProvisionsPaid Public Health Emergency Leave MinimumsEmployers may, but are not required to, pay any more than $200 per day and $10,000 in the aggregate for each employee for public health emergency leave under section 110(b)(2)(B) of the Family & Medical Leave Act of 1993 as amended by the Emergency Family and Medical Leave Expansion Act.Rehire Eligibility for Paid Public Health Emergency Leave EmployersFor purposes of public health emergency leave under the Emergency Family and Medical Leave Expansion Act, an eligible employee is an employee who has been employed for at least 30 calendar days by an employer with respect to whom leave is requested. The employee must be employed for at least 30 calendar days, which includes an employee who was laid off by that employer on or after March 1, 2020, had worked for employer for not less than 30 of the last 60 calendar days prior to the employees layoff, and was rehired by the employer.Emergency Paid Sick Leave MinimumsEmployers may, but are not required to, pay any more than:$511 per day or $5,110 in the aggregate for each employee when taking emergency paid sick leave if the employee is subject to a federal, state or local quarantine or isolation order related to COVID-19, the employee has been advised by a health care provider to self-quarantine due to concerns related to COVID-19, or the employee is experiencing symptoms of COVID-19 and seeking medical diagnosis; or $200 per day or $2,000 in the aggregate for each employee when taking emergency paid sick leave if the employee is caring for an individual who is subject to a federal, state or local quarantine order, or is caring for an individual who has been advised to self-quarantine due to concerns related to COVID-19, the employee is caring for the employee's son or daughter, if the child’s school or childcare facility has been closed or the child’s care provider is unavailable due to COVID-19 precautions, or the employee is experiencing any other substantially similar condition specified by HHS in consultation with the Department of the Treasury and the Department of Labor.Advance Refunding of Payroll Credits for Required Paid Sick Leave and Required Paid Family LeaveEmployers can apply a credit in the amount calculated under subsection (a) of section 7001 or 7003 of the Family First Coronavirus Response Act, subject to the limitations placed by subsection (b) of section 7001 and 7003, both calculated through the end of the most recent payroll period in the quarter. In anticipation of a credit, the credit may be advanced according to forms and instructions to be provided by the Secretary of Labor. The Act ensures employers that the Secretary of Treasury shall waive any penalty under section 6656 of the Internal Revenue Code of 1986 for failure to make a deposit of the tax imposed under section 3111 (a) or 3221(a) of such Code if failure was due to anticipation of credit allowed.vii. Subtitle D: Finance CommitteeAn additional safe harbor provision is added to section 223(c)(2) of the Internal Revenue Code, providing that a plan shall not fail to be treated as a high deductible health plan (HDHP) by reason of failing to have a deductible for telehealth and other remote care services. Section 223(c)(1)(B) of the Internal Revenue Code is adjusted to include “telehealth and other remote care.” This addition allows an individual to have an insurance plan (for plan years beginning on or before December 31, 2021) that includes telehealth and other remote care without disqualifying the individual from owning an HDHP.Inclusion of Certain Over-the-Counter Medical Products as Qualified Medical ExpensesMenstrual care products are now included under the term “qualified medical expenses.” Increasing Medicare Telehealth Flexibilities During Emergency Period The amendment removes some limiting qualifications to section 1320b-5(b)(8), which allows for the Secretary of HHS to temporarily waive or modify the application of portions of the Social Security Act in the case of a telehealth service furnished in any emergency area during an emergency period. The provision that sets out the defined term “qualified provider,” which limited 1320b-5(b)(8), is removed in its entirety. Enhancing Medicare Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics During Emergency PeriodA new provision is added under Section 1834(m) of the Social Security Act (42 USC 1395m(m)), enhancing payment for telehealth services furnished via a telecommunications system by a federally qualified health center (FQHC) or rural health clinic (RHC) during an “emergency period” notwithstanding that the FQHC or the RHC providing the telehealth service is not at the same location as the beneficiary. Payment methods for FQHCs or RHCs that serve as distant sites shall be based on payment rates similar to the national average payment rates for comparable telehealth services under the physician fee schedule under section 1848.Temporary Waiver of Requirement for Face-to-Face Visits Between Home Dialysis Patients and PhysiciansAmended section 1395rr(b)(3)(B) to allow the Secretary of HHS to waive the requirement that individuals with end stage renal disease receiving home dialysis must receive certain periodic face-to-face (non-telehealth) clinical assessments in order to be eligible to receive end stage disease-related clinical assessments via telehealth. Use of Telehealth to Conduct Face-to-Face Encounter Prior to Recertification of Eligibility for Hospice Care During Emergency PeriodSection 1395f(a)(7)(D)(i) is amended to allow a hospice physician or hospice nurse practitioner during an “emergency period” to conduct a face-to-face encounter via telehealth to determine recertification for continued eligibility for hospice care.Encouraging Use of Telecommunications Systems for Home Health Services Furnished During Emergency PeriodDuring an emergency period, the Secretary of HHS shall consider ways to encourage the use of telecommunications systems.Improving Care Planning for Medicare Home Health ServicesCertain Medicare sections are expanded from being limited to the services of a physician to include services of nurse practitioners, clinical nurse specialists, and physician assistants that provide home health services.Adjustment of SequestrationA temporary suspension of Medicare sequestration put into effect during the period of May 1, 2020 through December 31, 2020. The Medicare programs under title XVIII of the Social Security Act shall be exempt from reduction under any sequestration order during the period.Medicare Hospital Inpatient Prospective Payment System Add-On Payment for COVID-19 Patients During Emergency PeriodThe Secretary of HHS will increase the weighting factor for coronavirus-diagnosed patients discharged during the emergency period. The weighting factor is used by the Secretary of HHS to reflect the relative hospital resources used with respect to discharges for a particular group compared to discharges within other groups.Increasing Access to Post-Acute Care During Emergency PeriodDuring the emergency period, the Secretary of HHS will waive the requirement that patients of inpatient rehabilitation facilities receive at least 15 hours of therapy per week. For long-term care hospitals furnishing services during the emergency period, the Secretary of HHS will further waive discharge percent requirements and the general application of site neutral payment rates.Revising Payment Rates for Durable Medical Equipment Under the Medicare Program Through Duration of Emergency PeriodThe Secretary of HHS shall apply the transition rule, described in 42 C.F.R. § 414.210(g)(9)(iii), to items and services furnished in rural areas and noncontiguous areas as planned through December 31, 2020, and through the duration of the emergency period. For areas other than rural and noncontiguous areas, the Secretary of HHS shall apply the transition rule described in 42 C.F.R. § 414.210(g)(9)(iv) through the remainder of the emergency period.Coverage of the COVID-19 Vaccine Under Part B of the Medicare Program Without Any Cost-SharingThe term “medical and other health services” is expanded to include “COVID-19 vaccine and administration.” The deductible described in section 1395l(b) shall not apply with respect to a COVID-19 vaccine and its administration.Requiring Medicare Prescription Drug Plans and MA-PD Plans to Allow for Fills and Refills of Covered Part D Drugs for up to a 3-Month SupplyDuring the emergency period, a prescription drug plan or MA-PD plan shall permit a part D eligible individual reenrolled in such plan to obtain a single fill or refill the total day supply prescribed for such individual for a covered part D drug.Providing Home and Community-Based Services in Acute Care HospitalsThe prohibition that nothing in section 1395a allows the Secretary of HHS authorization to limit the amount of payment that may be made under a plan for home-and-community care is expanded to include home and community-based services, self-directed personal assistance services, or home and community-based attendant services. The provision is also expanded to clarify that the section shall not be construed to prohibit receipt of any care or services specified in paragraph (1) in an acute care hospital, provided certain requirements are met.Clarification Regrading Uninsured Individuals The Families First Coronavirus Response Act, enacted last week, added subsection (ss) to section 1396a, which defined “uninsured individual” as those not described in section 1396a(a)(10)(A)(i) and not enrolled in certain health care programs. The CARES Act amends this definition to exclude subsection VIII if the individual is a resident of a state that does not furnish medical assistance as described. Clarification Regarding Coverage of COVID-19 Testing ProductsThe Families First Coronavirus Response Act, enacted last week, added COVID-19 testing to section 1396d, which provides medical assistance payments under certain conditions. The CARES Act amends this section by removing the requirement that the in-vitro diagnostic products administered are approved, cleared, or authorized under sections 510(k), 513, 514, or 564 of the Federal Food, Drug, and Cosmetic Act.Amendment Relating to Reporting Requirements with Respect to Clinical Diagnostic Laboratory TestsThe CARES Act extends the dates by one year for the reporting periods in section 1395m-1(a)(1)(B). The applicable prohibition that payment amounts determined under section 1395m-1 shall not result in a reduction in payments, as defined by the subsection, for a clinical diagnostic laboratory test is expanded to 2017 through 2024. The applicable percentages used to determine the limits on reductions in payment defined in 1395m-1(b)(3)(A) are adjusted to include a new clause for 2021, which makes the new applicable percentage zero (0) for 2021.Expansion of Medicare Hospital Accelerated Payment Program During the COVID-19 Public Health EmergencyMandates that the Secretary of HHS expand the accelerated payment program to hospitals experiencing significant cash flow problems during the “emergency period.” Exception for Certain States from Enhanced FMAP Requirements Provides that states may receive the temporary increase of Medicaid Federal Medical Assistance Percentage (FMAP) (authorized under the Families First Act enacted last week) notwithstanding the requirement to not impose premiums on beneficiaries, for a period of 30 days.viii. Subtitle E, Part I: Medicare ProvisionsExtension of Funding for Quality Measure Endorsement, Input, and SelectionThe Social Security Act is amended to increase the amount allotted for this fiscal year ending on October 1, 2020 from $4,830,000 to $20,000,000 and for the period beginning on October 1, 2020 and ending on November 30, 2020, the amount equal to the pro rata portion of $20,000,000. Extension of Funding Outreach and Assistance for Low-Income ProgramsThe amount allocated for state health insurance programs shall be $13,000,000 for this fiscal year. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $13,000,000.The amount allocated for area agencies on aging shall be $7,500,000 for the fiscal year of 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $7,500,000.The amount allocated for aging and disability resource centers shall be $5,000,000 for fiscal year 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $5,000,000.The amount allocated for grant or contract with national center for benefits and outreach enrollment is now $12,000,000 for the 2020 fiscal year ending on October 1, 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $12,000,000.Subtitle E, Part II: Medicaid ProvisionsExtension of the Money Follows the Person Rebalancing Demonstration ProgramThe Deficit Reduction Act of 2005 section 6071(h)(1)(G) is amended to allocate $337,500,000 for the period beginning on January 1, 2020 and ending on September 30, 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $337,500,000.Extension of Spousal Impoverishment ProtectionsExtends the protections through November 30, 2020.Allows the State to disregard the income of a spouse and conduct an analysis solely on an individual’s eligibility for medical assistance on the basis of reduction of income.Delay of DSH ReductionsThis section removes the $4 billion DSH reductions for federal fiscal year 2020 and delays the cuts from taking effect December 1, 2020. Extension and Expansion of Community Mental Health Services Demonstration ProgramExpands the Protecting Access to Medicare Act of 2014.According to this section not later than 6 months after the date of enactment, the Secretary shall select two states, in addition to the eight States already listed, to participate in two-year demonstration programs that meet the requirements of this subsection.The requirements are states that:Were awarded planning grants, Applied to participate in the demonstration programs under this subsection but were not selectedThe Secretary shall use the results of its evaluation of the state’s original application and shall not require the submission of any additional application.If a state is selected it is required to: Submit a plan to monitor certified community behavioral health clinics under the demonstration program to ensure compliance with certified community behavioral health criteria during the demonstration period; and Commit to collecting data, notifying the Secretary of any planned changes that would deviate from the prospective payment system methodology outlined in the state’s demonstration application, and obtaining approval from the Secretary of any such change before implementing change.The Federal matching percentage applicable to amounts expended by states participating in the demonstration program under this subsection shall apply to amounts expended by the state during the fiscal period that begins on January 1, 2020 if the state was participating in the demonstration program as of January 1, 2020 and shall apply to amount expensed by the state during the first fiscal period the state participates if the state was selected pursuant to the expansion. Subtitle E, Part III: Human Services and Other Health ProgramsExtension of Sexual Risk Avoidance Education ProgramSection 510 of the Social Security Act is amended to extend the time through 2020 instead of ending in May 22, 2020 and to change the fiscal year to 2021. Extension of Demonstration Projects to Address Health Professions Work-Force NeedsActivities authorized by section 2008 of the Social Security Act shall continue through November 30, 2020. Extension of the Temporary Assistance for Needy Families Program and Related ProgramsActivities authorized by part 1 of title IV and section 1108(b) of the Social Security Act shall continue through November 30, 2020. Subtitle E, Part IV: Public Health ProvisionsExtension for Community Health Centers, the National Health Service Corps, and Teaching Health Centers that Operate GME ProgramsThe amount allocated for community health centers under the Patient Protection and Affordable Care Act is increased to $4,000,000,000 for fiscal year 2020 and $668,493,151 for the period beginning on October 1, 2020 and ending on November 30, 2020.The amount allocated for the National Health Service Corps is now $310,000,000 for fiscal year 2020 and $51,808,219 for the period beginning on October 1, 2020 and ending in November 30, 2020.The amount allocated for teaching health centers that operate graduate medical education programs now extends through fiscal year 2020 and $21,141,096 is allocated for the period beginning on October 1, 2020 and ending on November 30, 2020.Diabetes ProgramsThe amount allocated under the Public Health Service Act for Type I will extend through the fiscal year of 2020 and $25,068,493 will be allocated for the period beginning on October 1, 2020 and ending on November 30, 2020.The amount allocated under the Public Health Services Act for Indians will extend through the 2020 fiscal year and $25,068,493 will be allocated for the period beginning on October 1, 2020 and ending on November 30, 2020.xii. Subtitle F, Part I: Over-the-Counter DrugsAmends Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to insert a new section regulating certain nonprescription drugs that are marketed without an approved drug application under section 505 of the FD&C Act. This new section primarily achieves two goals: (1) reforms the regulatory process for over-the-counter (OTC) drug approvals permitting the FDA more flexibility to make changes administratively, rather than through the time-consuming full notice and comment rulemaking process; and (2) incentivizes pharmaceutical companies to research and manufacture innovative drug products by providing an 18-month market-exclusivity period to reward investments for new OTC drugs.Amends Section 502 of the FD&C Act, to clarify that an OTC drug which does not comply with the requirements of its OTC monograph, which is essentially an approved recipe for a drug product, is considered misbranded. The FD&C Act prohibits the introduction of misbranded drugs into interstate commerce.Clarifies that nothing in the CARES Act will apply to drugs previously excluded by the FDA from the Over-the-Counter Drug Review under the original 1972 Federal Register document.Clarifies that sponsors of sunscreen ingredients with pending orders have the option to see review in accordance with the Sunscreen Innovation Act (SIA) or to see review under the new monograph review process. The election must be made within 180 calendar days of the date of enactment of the CARES Act. Provides an annual procedure to update Congress on the appropriate pediatric indication for certain OTC cough and cold drugs for children under the age of six. The evaluation consists of conditions under which nonprescription drugs are generally recognized as safe and effective.Makes technical corrections to the FDA Reauthorization Act of 2017 (Public Law 115-52).xiii. Subtitle F, Part II: User FeesDeclares that the fees paid pursuant to this section will be dedicated to FDA review of over-the-counter monograph drugs as set forth in the goals section and in letters from the Secretary of HHS to certain congressional committees.Establishes a new FDA user fee to allow the agency to hire additional staff members to ensure there is adequate agency oversight to approve changes to OTC drugs.Title IV – Economic Stabilization and Assistance to Severely Distressed Sectors of the United States Economy Foley Title IV Contact: Christopher SwiftTitle IV of the Coronavirus Aid, Relief, and Economic Securities Act provides the Secretary of the Treasury with the authority to make loans or loan guarantees to states, municipalities, and eligible businesses and loosens a variety of regulations created in the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Economic Stabilization Act of 2008, and others.ii.Subtitle A – Coronavirus Stabilization Act of 2020Emergency Relief and Taxpayer ProtectionsThe Act authorizes the Treasury Secretary to make up to $500 billion worth of loans and loan guarantees to eligible businesses, states, and municipalities. The term “eligible business” includes passenger air carriers or any other business that has not already received adequate economic relief in the form of loans or loan guarantees under other provisions of the Act. The Act reserves $46 billion to support passenger air carriers, air cargo carriers, and businesses important to maintaining national security. The Act establishes a $454 billion credit facility for Federal Reserve programs designed to support lending to eligible businesses, states, and municipalities. This program contemplates various loans and loan guarantees for distressed businesses.Businesses that receive loans through these Federal Reserve programs are prohibited from paying dividends or repurchasing stock (or other outstanding equity interests) while the loan or loan guarantee is outstanding, as well as for the 12 months following repayment. These businesses are subject to the same employee compensation restrictions as listed for air carriers, air cargo carriers, and businesses deemed important to maintaining national security. Although the Treasury Secretary can waive these restrictions, he must identify and explain the rationale for such waivers in testimony before Congress.Businesses that receive loans or loan guarantees through these Federal Reserve programs can only make loans (or other advances) to business that are incorporated in the United States. Transfers to subsidiaries and affiliates incorporated outside the United States are prohibited.The Act directs the Treasury Secretary to establish a program to provide low-interest loans for eligible businesses (including nonprofit organizations) with between 500 and 10,000 employees. Although these loans will require no repayment for at least six months, businesses and non-profit organizations seeking this support must provide a good-faith certification that they meet the following criteria:The company intends to maintain at least 90 percent of their current workforce;The company will not pay dividends or repurchase stock (or other equity securities);The company will not outsource or offshore jobs during the loan period or two years thereafter;The company will not abrogate existing collective bargaining agreements with labor unions; and The company will remain neutral regarding current or future union organizing activity.Limitation on Certain Employee CompensationThe Act also imposes certain compensation caps for officers and employees at companies receiving loans or loan guarantees. Under these caps, officers or employees that received $425,000 or more in total compensation in 2019 will have their future compensation capped at the amount they received that year. This cap applies while the loan or loan guarantee is in effect, as well as to the 12 consecutive months after the loan or loan guarantee is no longer outstanding. The same restriction also applies to severance payments or other compensation received upon termination from businesses participating on the loan and loan guarantee programs.Additional caps apply for officers and employees whose total compensation exceeded $3,000,000 in 2019. Under the Act, these individuals may receive compensation up to $3,000,000 plus 50 percent of the excess over $3,000,000 of the total compensation received by the officer or employee in 2019. For example, an officer or employee whose total 2019 compensation was $3,000,010 would be restricted to total compensation of $3,000,005 in subsequent years. Like the lower cap discussed above, this restriction applies while the loan or loan guarantee is in effect, as well as to the 12 consecutive months after the loan or loan guarantee is no longer outstanding.Continuation of Certain Air ServicesThe Secretary of Transportation may require any air carrier receiving loans or loan guarantees under Section 4003 to maintain scheduled air transportation services as the Secretary deems necessary to maintain service to any destination the carrier served before March 1, 2020. The Secretary of Transportation is to consider the needs of “small and remote communities” and “health care and pharmaceutical supply chains” when enforcing this portion of the Act.Suspension of Certain Aviation Excise TaxesThe Act suspends the imposition of aviation excise taxes as otherwise required under the Internal Revenue Code through December 31, 2020.Debt Guarantee AuthorityIn order to backstop solvent depository institutions, it appears that the CARES ACT allows the FDIC to establish a program to insure these institutions without regard to a maximum amount. All such guarantees are to last at least until December 31, 2020.Temporary Government in the Sunshine Act ReliefIn the event that unusual and exigent circumstances continue to exist, the Board of Governors of the Federal Reserve System may conduct meetings with less restrictive and formal meeting notification and record-keeping requirements until December 31, 2020. Temporary Hiring FlexibilityWithout regard to certain statutory hiring requirements, the Secretary of Housing and Urban Development and the Securities Exchange Commission are given flexibility to recruit and appoint candidates for temporary and term appointments as necessary to prevent, prepare for, or respond to COVID-19 during the “covered period” of the CARES Act.Temporary Lending Limit WaiverEnlarges exception to requirement on the maximum amount of loans and extensions of credit by a national banking association to include a nonbank financial company (as defined in Section 102 of the Financial Stability Act of 2010) and allows the Comptroller o
H.R. 2227 – Gold Star Spouses and Spouses of Injured Servicemembers Leasing Relief Expansion Act of 2019, as amended (Rep. Bustos – Veterans’ Affairs) This bill authorizes spouses of military servicemembers to terminate leases of premises and motor vehicles in certain situations. Specifically, the bill allows the spouse of a servicemember lessee to terminate the leases within one year of the date on which the servicemember incurs a catastrophic injury or illness connected with their military service.Agreed to by voice vote.The bill also allows the spouse of a servicemember lessee who died in military service to terminate a motor vehicle lease within one year of the death of the servicemember. Agreed to without objection. H.R. 4852 – GIVE Act (Rep. Torres – Veterans’ Affairs) Agreed to by the Yeas and Nays: (2/3 required): 412 – 0 (Roll no. 72). H.R. 3749 – Legal Services for Homeless Veterans Act, as amended (Rep. Panetta – Veterans’ Affairs) to direct the Secretary of Veterans Affairs to make grants to entities that provide legal services for homeless veterans and veterans at risk for homelessness. Agreed to by voice vote. H.R. 4613 – VA Reporting Transparency Act (Rep. Rose (NY) – Veterans’ Affairs) to establish and maintain a website of the Department that allows the public to obtain electronic copies of certain legislatively requested reports of the Department of Veterans Affairs, Agreed to by voice vote. H.R. 561 – Protecting Business Opportunities for Veterans Act of 2019, as amended (Rep. Bergman – Veterans’ Affairs) Agreed to by voice vote H.R. 35 – Emmett Till Antilynching Act, as amended (Rep. Rush – Judiciary) This bill specifies that an offense involving lynching is a hate crime act. A violator is subject to criminal penalties—a prison term, a fine, or both. Agreed to by the Yeas and Nays: (2/3 required): 410 – 4 (Roll no. 71). H.R. 560 – Northern Mariana Islands Relief Act, as amended (Rep. Sablan – Natural Resources) This bill provides Commonwealth of the Northern Mariana Islands (CNMI) Resident status to certain otherwise qualifying aliens who do not meet a current requirement of having resided continuously and lawfully in the Northern Mariana Islands from November 28, 2009, through January 25, 2019.Specifically an alien shall be exempt from this residency requirement if the alien (1) was admitted as a Commonwealth Only Transitional Worker during FY2015 and every subsequent fiscal year before July 24, 2018, or (2) resided in the Northern Mariana Islands as an investor and is currently residing as a Northern Mariana Islands-only nonimmigrant under the immigration law.To qualify for CNMI Resident status, the alien must meet other existing requirements related to such status. Agreed to by voice vote. H.R. 2427 – Chesapeake Bay Gateways and Watertrails Network Reauthorization Act of 2019 (Rep. Sarbanes – Natural Resources) To amend the Chesapeake Bay Initiative Act of 1998 to reauthorize the Chesapeake Bay Gateways and Watertrails Network. Agreed to by voice vote. H.R. 473 – To authorize the Every Word We Utter Monument to establish a commemorative work in the District of Columbia and its environs, and for other purposes, as amended (Rep. Neguse – Natural Resources) This bill authorizes the establishment on federal land in the District of Columbia of the Every Word We Utter Monument in commemoration of the passage of the 19th Amendment to the Constitution, which gave women the right to vote. Agreed to by voice vote. H.R. 2490 – To amend the National Trails System Act to direct the Secretary of the Interior to conduct a study on the feasibility of designating the Chief Standing Bear National Historic Trail, and for other purposes (Rep. Fortenberry – Natural Resources) Agreed to by the Yeas and Nays: (2/3 required): 402 – 10 (Roll no. 73). H.R. 2819 – Gold Star Mothers Families National Monument Extension Act, as amended (Rep. Kim – Natural Resources) To extend the authority for the establishment of a commemorative work in honor of Gold Star Families, Scheduled H.R. 3399 – To amend the Nutria Eradication and Control Act of 2003 to include California in the program, and for other purposes (Rep. Harder – Natural Resources) To amend the Nutria Eradication and Control Act of 2003 to include California in the program Agreed to by voice vote. H.R. 1492 – Yucca House National Monument Expansion Act (Rep. Tipton – Natural Resources) This bill authorizes the Department of the Interior to acquire, by donation, the approximately 160 acres of land and any interests in such land that is identified as the Yucca House National Monument Proposed Boundary Addition. Agreed to by voice vote. H.R. 2339 – Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2019 (Rep. Pallone – Energy and Commerce/Ways and Means) (Subject to a Rule) To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale and marketing of tobacco products .Scheduled S. 995 (Lifespan Respite Care Reauthorization Act of 2019). The committee reported substitute amendment was agreed to. The bill passed as amended by Voice Vote. Motion to Invoke Cloture on the Motion to Proceed S. 3275 (Pain-Capable Unborn Child Protection Act). The Motion to Invoke Cloture was not agreed to by a vote of 53-44. Motion to Invoke Cloture on the Motion to Proceed S. 311 (Born-Alive Abortion Survivors Protection Act). To amend title 18, United States Code, to prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion. The Motion to Invoke Cloture was not agreed to by a vote of 56-41. Motion to Proceed S. 3275 (Pain-Capable Unborn Child Protection Act). This bill establishes a new criminal offense for performing or attempting to perform an abortion if the probable post-fertilization age of the fetus is 20 weeks or more. A violator is subject to criminal penalties—a fine, a prison term of up to five years, or both. The bill provides exceptions for an abortion (1) that is necessary to save the life of the pregnant woman, or (2) when the pregnancy is the result of rape or incest. A physician who performs or attempts to perform an abortion under an exception must comply with specified requirements. A woman who undergoes a prohibited abortion may not be prosecuted for violating or conspiring to violate the provisions of this bill. Senator Durbin asked Unanimous Consent to call up and pass S. 916 (MOMMA’s Act). To improve Federal efforts with respect to the prevention of maternal mortality, and for other purposes. Bill would increase taxes on tobacco products believed to be a cause of maternal deaths at childburth. 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This show spends a lot of time exploring the health, environmental and ethical implications of the food we eat.But what we put on our bodies is just as important as what we put in our bodies.Today we shift gears to explore how vastly uninformed most of us are when it comes to the consequences caused by the innumerable products we slather daily on our largest organ: our skin.You might be surprised to learn that approximately 84,000 chemicals currently find their way into commercial products -- with over 1,500 new chemicals released annually. Despite evidence of health harms, most of these chemicals have not been adequately tested for their impact on humans. Nonetheless, many of them find their way into a vast and problematic array of skincare, beauty and cleaning products.Moreover, due to laws that haven’t been updated in 80 years, I was shocked to discover that the Food and Drug Administration -- the regulatory authority charged with ensuring the safety of such products -- doesn't necessarily screen product ingredients for safety. In fact, it provides very little oversight when it comes to what ends up in beauty products. Worse yet, the FDA has zero authority to recall products even in the event of a proven harm.When entrepreneur Gregg Renfrew learned that the US has not passed any major legislation about the safety of ingredients in personal care products since 1939, she became determined to make the business of beauty better. Hence was born Beautycounter -- a market disrupting, direct-to-consumer line of cleaner, safer skincare products and cosmetics that made Fast Company’s 2019 list of the 50 most innovative companies.Gregg's been at the helm of Beautycounter since its 2011 inception, driven by a desire to provide toxic-free fare and greater economic opportunity for women. In addition to overseeing 150 employees and 40,000 consultants, Gregg is also a ferocious fixture on Capitol Hill, where she lobbies relentlessly for cosmetic industry reform. And she somehow does it all while remaining a present and involved mom to three of the most incredible kids I have ever met.Her ultimate goal? Overhauling the archaic laws that currently govern her industry -- so we can all be beautifully clean.Similar to a handful of past podcast guests, I struck up a friendship with Gregg in 2018 at The Nantucket Project. Over the last year and a half, I've had the privilege of observing her in action -- at work, on stage, and at home. Let's just say it's all very impressive.Today she shares her story.It's a conversation about an entrepreneurial journey that humbly began with cleaning houses before founding Wedding List -- a company she built and later sold, leading to lessons learned working tricky stretches under powerful women like Martha Stewart and Susie Hilfiger.It's about the experience that motivated her to start Beautycounter, and the unorthodox decisions that followed. Like the 1,500 potentially harmful ingredients that she vowed never to use in her products. And eschewing retail for a direct-to-consumer business model driven by a network of independent consultants.But more than anything, this is a powerful primer on the perils of conventional beauty products that will leave you completely rethinking what you put on your body (and your children's bodies) -- and well armed to make more educated decisions about the companies and products you patronize going forward.The visually inclined can watch it all go down on YouTube. And as always, the audio version streams wild and free on Apple Podcasts and Spotify.Gregg is a true force of nature. And this conversation is a gift. May you receive it with gratitude.P.S. Special thanks to Gregg for letting me occasionally kidnap her husband Mark, my new best friend and go to workout partner. I promise to bring him back from Ötillö Catalina in one piece (but in truth I think it's Mark that needs to worry about bringing me back intact).Peace + Plants,Listen, Watch & SubscribeApple Podcasts | YouTube | Spotify | Stitcher | Google PodcastsThanks to this week’s sponsorsNative: Safe, effective protection against odor & wetness. For both men & women, Native is deodorant that isn’t a chemistry experiment – no aluminum, parabens, phthalates or talc. All ingredients are non-toxic and it lasts all day. For 20% off your first purchase, visit nativecos.com and use promo code Roll during checkout!Quip: Your one stop solution for oral health! Quip starts at just $25 and if you go to: getquip.com/richroll right now, you can get your first refill pack for FREE!Seed: Stewarding the future of how we will use bacteria to restore and sustain human and planetary health, Seed’s Daily Synbiotic combines 24 clinically-verified, naturally-occurring, probiotic strains with plant-based prebiotics. Head on over to seed.com/RICHROLL to learn more about their game-changing Daily Synbiotic.Note: One of the best ways to support the podcast is to support the sponsors. For a complete list of all RRP sponsors and their respective vanity url's and discount codes, visit my Resources page and click "Sponsors".SHOW NOTESBackground, Context & ReferenceConnect with Gregg: Instagram | Twitter | FacebookBeautycounter: beautycounter.comDocumentary: Transparency - The Truth About MicaFDA: Federal Food, Drug, and Cosmetic Act (1938)NY Times: Gregg Renfrew of Beautycounter on Toxic Chemicals and Getting Fired by MessengerFast Company: The World's 50 Most Innovative Companies 2019Fast Company: How A Beauty Brand Raised An Army Of 30,000 Political ActivistsFast Company: Meet The Natural Beauty Company That’s Making Advocacy A Selling PointPolitico: Why Beautycounter’s Gregg Renfrew wants to regulate your makeupFortune: Why being candid at work is good for businessRefinery 29: Why Beautycounter Is The #1 Trending Beauty Brand Of 2018Environmental Health News: The consequences of status quo chemical policy are becoming increasingly clearThe Nantucket Project: nantucketproject.comRelated Podcasts You Might EnjoyRRP #314: Amanda Chantal Bacon On Building A Wellness EmpireRRP #353: Zach Bush, MD on GMOs & GlyphosateRRP #432: David Bronner On Conscious CapitalismRRP #399: Scott Harrison Is Not Afraid of Work Without EndThanks to Jason Camiolo for production, audio engineering and show notes; Margo Lubin and Blake Curtis for video, editing and graphics; portraits by Ali Rogers; and theme music by Ana Leimma.*Disclosure: Books and products denoted with an asterisk are hyperlinked to an affiliate program. We are a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for us to earn fees by linking to Amazon.com and affiliated sites.for 1000s of delicious, customized plant-based recipes & so much more, check out our Plantpower Meal PlannerHOW CAN I SUPPORT THE PODCAST?Tell Your Friends & Share Online!Subscribe & Review: iTunes | Spotify | Stitcher | Soundcloud | Google PodcastsDonate: Check out our Patreon accountSupport The Sponsors: One of the best ways to support the podcast is to support our sponsors. For a complete list of all RRP sponsors and their respective vanity url's and discount codes, visit my Resources page and click "Sponsors". See acast.com/privacy for privacy and opt-out information.
Many consumers quickly glance at the label on a dietary supplement, blindly purchase it, and never question where it was made or if whatâs listed on the label is actually in the bottle. But what if you donât even know what youâre buying? Has the product been tested to meet label claims, where is it manufactured, and how pure really is it? Regardless of the myths that surround the supplement industry of ânot being regulated by the FDAâ, this news story will change your mind. Because this one involves a serious indictment after plenty of warning letters, strikes, and failed audits. FDA indicts major contract manufacturer in ABH Pharma After years of playing “whack-a-mole” by sending warning letters to small brands, the FDA — and now the Department of Justice — have gone after the root of the supplement industry's biggest problem: underhanded contract manufacturers. These are the companies that are actually bottling the products, and we have long stated that they are a better “pinch point” for strict enforcement of current Good Manufacturing Practices. On January 17th, 2020, a major contract supplement manufacturer under the names of ABH Pharma, ABH Natureâs Products, and Stocknutra.com published a press release on BusinessWire issuing a nationwide recall on all lots of dietary supplements manufactured and sold between January 2013 â November 2019, after an indictment was posted in New York on December 26, 2019. Major offenses over several years The DOJ indictment, which names Mohammed Jahirul Islam (âIslamâ) as the owner of the three companies, alleges that their facilities distributed adulterated and misbranded dietary supplements and unapproved and misbranded drugs. They signed a consent decree forcing Islam to destroy all dietary supplements (and drugs) in their possession within 15 days, which has now also been posted on the FDA's website. The DOJ indictment report stated that ABH failed 6 FDA audits over the years, had warning letters dating back to 2012, and neglected to conduct at least one appropriate test for ingredient identity. The indictment itself (which is linked at the bottom of the DOJ's report web page) includes new infractions from a November 2018 inspection. Such infractions include some egregious drug claims made on products they manufactured, such as “Whey protein in the form of protein powder can help in reducing the symptoms associated with anxiety and depression”. In addition, ABH Nature's products had a voluntary recall in June 2017 and January 2018 due to possible salmonella contamination. âAs demonstrated by the consent decree, this Office and the FDA will work tirelessly to protect consumers who take dietary supplements, ensuring that manufacturers comply with good manufacturing practices and do not distribute unapproved and misbranded drugs in violation of the Food, Drug, and Cosmetic Act.” — Richard P. Donoghue, U.S. Attorney for the Eastern District of New York A long time coming The indictment lists several inspections at the Defendants' Edgewood, NY facility, including inspections that occurred in or about July 2012, May 2013, August 2013, November 2016, and February 2018, on top of the most recent November 2018 inspection. The FDA's warning letter from 2012 lists seven major cGMP (Current Good Manufacturing Practice) violations, such as adulteration, mislabeling, misbranding, failure to verify finished supplements, failure t... Read more on the PricePlow Blog
Craft Brew News - 12/06/2019(Stories Courtesy of BrewBound – www.brewbound.com)New Belgium to be Acquired by Kirin-Owned Lion Little World BeveragesAnother member of the old guard of craft brewing sold today when Kirin-owned Lion Little World Beverages announced a “definitive agreement” to acquire 100% of New Belgium Brewing Company in an all cash transaction.Financial terms of the deal were not disclosed, although it is expected to close at the end of 2019, pending approval from government regulators, as well as co-owners in New Belgium’s Employee Stock Ownership Plan (ESOP).Once closed, the transaction will mark the end of New Belgium’s 100% employee-owned status, which was fully implemented in 2012, and the end of the company’s status as a small and independent craft brewer as defined by national trade group the Brewers Association (BA).Co-founder Kim Jordan will also remain involved in an advisory role and will collaborate with other founders within Lion’s portfolio.Lion’s acquisition of New Belgium, the fourth largest BA-defined domestic craft brewery, will give the Australasian company a foothold in the U.S. market. In 2018, New Belgium produced just under 850,000 barrels of beer, a decline of 11% from 2017 levels.Coca-Cola Files Complaint Against Mark Anthony’s ‘White Claw Hard Seltzer Surge’ Trademark ApplicationCoca-Cola filed a complaint with the U.S. Patent and Trademark Office last week claiming that Mark Anthony Brand’s application to register “White Claw Hard Seltzer Surge” infringes on its Surge brand of citrus sodas.Mark Anthony Brands filed an application with the USPTO on May 24 to register the brand name White Claw Hard Seltzer Surge, a product that has not yet been announced.According to Coca-Cola’s complaint filed November 20, White Claw’s proposed use of the Surge name is similar in “sound, appearance, connotation and commercial impression.”Surge soda launched in the 1990s as a competitor to Pepsi’s Mountain Dew brand and was discontinued in 2003. Coca-Cola resurrected the brand in 2014 and filed a trademark application for it on December 31, 2013.TTB Accepts Offer in Compromise From Seven Brides BrewingThe Alcohol and Tobacco Tax and Trade Bureau (TTB) has accepted an offer in compromise from now-shuttered Seven Brides Brewing in Silverton, Oregon.According to the TTB, Seven Brides offered to pay $18,230 of the $132,802.81 it owes in fines for violations that took place from April 2010 to September 2018. Seven Brides has offered to pay $3,630 up front and $1,000 each month for 14 months and the $600 balance in the fifteenth month.Before closing in October 2018, Seven Brides produced 650 barrels of beer, according to the Brewers Association.The TTB has accepted 18 compromise offers from wholesalers and producers this year.FDA Issues Warnings to 15 Companies for CBD Products, Cannot Declare CBD ‘Generally Regarded as Safe’The U.S. Food and Drug Administration announced that it cannot yet determine that CBD is safe for consumption and issued warnings to 15 companies for promoting products with it in ways that violate the Food, Drug and Cosmetic Act, according to THCNet.The Food, Drug and Cosmetic Act prohibits companies from adding CBD to food, marketing products for children or infants, and claiming that CBD products can treat diseases, provide any kind of therapeutic relief or serve as a dietary supplement. So far, only one drug with CBD has been approved for use in humans; it treats two forms of pediatric epilepsy, Abernathy noted in the release. In order to declare CBD “generally recognized as safe,” the FDA must conduct more research on the substance’s affect on humans.Craft Beer Storm Website: www.craftbeerstorm.com If your Company, Hotel or Restaurant wants to book a CraftBeer Weekend or Craft Beer Evening for your guests or employees send an email to Michael@craftbeerstorm.com Linked In: https://www.linkedin.com/in/craft-beer-storm-podcast-30776075/Subscribe to Craft Beer Storm Podcast iTunes: https://itunes.apple.com/us/podcast/craft-beer-storm/id1438117278?mt=2*** A Top 20 Podcast in Food on iTunes ***Michael Potorti is the Host of Craft Beer Storm and Founder/Brewer at Beara Brewing Co. in Portsmouth, NH*** Interested in starting your own brewery? Our Portsmouth, NH TURNKEY facility is for sale! Follow link for more info:https://www.neren.com/Listing/2800-Lafayette-Rd-12A/5cdda2dabf34cb9150a7faebMichael PotortiFounder/BrewerHost of "Craft Beer Storm" Podcastmichael@craftbeerstorm.commichael@bearairishbrew.com*** Come visit our brewery for some delicious local craft brew! ***Beara Brewing Co.2800 Lafayette RoadPortsmouth, NH 03801Tel. (857) 342-3272 www.bearairishbrew.com Like us onInstagram: https://www.instagram.com/bearairishbrew/?hl=enFacebook: https://www.facebook.com/BearaIrishBrewingCo Twitter: https://twitter.com/BearaIrishBrew Linked In: https://www.linkedin.com/in/beara-brewing-co-30776075/**LISTEN to our Craft Beer Storm Podcast and share with a friend**Craft Beer Storm Podcast iTunes: https://podcasts.apple.com/us/podcast/craft-beer-storm/id1438117278Craft Beer Storm You Tube: https://www.youtube.com/channel/UCp3PVuCGmywNWlGFh0N0ukg?view_as=subscriberCraft Beer Storm Podcast Stitcher: https://www.stitcher.com/podcast/podcast-center-la-2/craft-beer-stormCraft Beer Storm Linked In: https://www.linkedin.com/in/craft-beer-storm-podcast-30776075/Craft Beer Storm Facebook: https://www.facebook.com/craftbeerstorm/Craft Beer Storm Instagram: https://www.instagram.com/craftbeerstorm/
This episode featured a conversation with Ally Hasbun, PhD student researching cannabis. CBD (Cannabidiol) cosmetics is a big trend right now, but how much do we really know about this cannabinoid? Pertinent to this discussion, just a couple of days ago, the FDA issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act. The FDA also published a revised Consumer Update detailing safety concerns; based on the lack of data supporting safety, the FDA indicated that it cannot conclude that CBD is generally recognized as safe (GRAS). In my conversation with Ally, we talked about what CBD is, the available data we have, regulations, quality control, and lots more. Something I found very interesting - CBD readily oxidizes… with all of the cosmetic products indicating a 1-year shelf life, without any suggestions of refrigeration to keep the CBD intact, how much CBD is actually in these products when they reach consumers?
Call to Action: Gluten in Medicine Disclosure Act of 2019Update: there are now 38 Co-Sponsors - but more is better! We have an opportunity to make the difference: please use your voice and personal experience to get our medications labeled!On April 3, 2019, Representative Tim Ryan [D-OH] introduced H.R. 2074, the Gluten in Medicine Disclosure Act of 2019 to the congressional floor. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.PLEASE, take a minute and ask your representatives to support the Gluten in Medicine Disclosure Act of 2019. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require ✳️ gluten be labeled in all medications.✳️Learn more and find a link to your local representative here: https://www.beyondceliac.org/celiac-news/the-gluten-in-medicine-disclosure-act-of-2019/Beyond Celiac's Step Beyond Celiac 5K is happening on Sept. 29, 2019 in Kansas City. Please consider supporting this event that furthers the great work of Beyond Celiac. See acast.com/privacy for privacy and opt-out information.
Call to Action: Gluten in Medicine Disclosure Act of 2019Update: there are now 31 Co-Sponsors but more is better! On April 3, 2019, Representative Tim Ryan [D-OH] introduced H.R. 2074, the Gluten in Medicine Disclosure Act of 2019 to the congressional floor. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.PLEASE, take a minute and ask your representatives to support the Gluten in Medicine Disclosure Act of 2019. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require ✳️ gluten be labeled in all medications.✳️Learn more and find a link to your local representative here: https://www.beyondceliac.org/celiac-news/the-gluten-in-medicine-disclosure-act-of-2019/ See acast.com/privacy for privacy and opt-out information.
Does your store place gluten free flour next to - or underneath - wheat flour? This is obviously a huge cross contact issue for people with celiac disease. If your store does this, please ask them to stop placing gluten-free flour alongside/between leaky bags of wheat flour. Gluten Free Watchdog has the perfect form letter to send to your store manager requesting the change.UPDATE: The Gluten in Medicine Disclosure Act of 2019, HR 2074 has gained 24 sponsors since being introduced by Rep. Tim Ryan. The bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications. Please take 5 mins and write your representative. More info and link to your rep here: https://www.beyondceliac.org/celiac-news/the-gluten-in-medicine-disclosure-act-of-2019/ See acast.com/privacy for privacy and opt-out information.
Call to Action: Gluten in Medicine Disclosure Act of 2019On April 3, 2019, Representative Tim Ryan [D-OH] introduced H.R. 2074, the Gluten in Medicine Disclosure Act of 2019 to the congressional floor. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.PLEASE, take a minute and ask your representatives to support the Gluten in Medicine Disclosure Act of 2019. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require ✳️ gluten be labeled in all medications.✳️Learn more and find a link to your local representative here: https://www.beyondceliac.org/…/Celiac-…/1395/postid--113777/ See acast.com/privacy for privacy and opt-out information.
Tonight Dr. Dean will be joined by two amazing, visionary women who have dedicated their work and lives to the practice of homeopathy - a specific paradigm within natural medicine that can be a highly effective approach to health and wellness. In our first hour, we'll be joined by Paola Brown, President of Homeopathy Choice, a non-profit organization dedicated to advocating for the rights of consumers and professionals to use and have access to homeopathy. We'll learn about her own journey of health recovery using homeopathic remedies and her charge to protect homeopathy and its practice from being disrupted by the FDA. The U.S. Food and Drug Administration (FDA) has proposed new guidelines for homeopathic remedies that would give it the power to ban properly formulated homeopathic products currently legal under the Food Drug & Cosmetic Act which governs the FDA. In hour two, we'll be joined by Mary Aspinwall, a Classical Homeopath (registered with the North American Society of Homeopaths) and CEASE practitioner. She has helped thousands of people return to health since she began her practice in 1995. Mary studied at the College of Homeopathy in London and is a graduate of The Dynamis School of Advanced Homeopathy, the world’s leading organization involved in testing new homeopathic remedies. Mary designed a range of homeopathy kits that are international bestsellers and has spent the past 20 years educating the public as a professional speaker, teacher, and advocate. She is a former national spokesperson for the Irish Society of Homeopaths and currently offers her services as an expert contributor in the U.S. She is the author of Basic Guide to Homeopathy, editor of The Clinical Medicine Guide, and regular columnist for Homeopathy Today. Let's also remember that our very own Dr. Carolyn Dean has an amazing journey with homeopathy, being one of the only doctors who worked successfully with homeopathic remedies and AIDS patients in the 1990s. Dr. Dean's passion for homeopathy and her determination to remain forever on the leading edge of medicine has been incorporated into many of her protocols and can even be considered part of the inspiration behind the development of the RnA Drops!
Tonight Dr. Dean will be joined by two amazing, visionary women who have dedicated their work and lives to the practice of homeopathy - a specific paradigm within natural medicine that can be a highly effective approach to health and wellness. In our first hour, we'll be joined by Paola Brown, President of Homeopathy Choice, a non-profit organization dedicated to advocating for the rights of consumers and professionals to use and have access to homeopathy. We'll learn about her own journey of health recovery using homeopathic remedies and her charge to protect homeopathy and its practice from being disrupted by the FDA. The U.S. Food and Drug Administration (FDA) has proposed new guidelines for homeopathic remedies that would give it the power to ban properly formulated homeopathic products currently legal under the Food Drug & Cosmetic Act which governs the FDA. In hour two, we'll be joined by Mary Aspinwall, a Classical Homeopath (registered with the North American Society of Homeopaths) and CEASE practitioner. She has helped thousands of people return to health since she began her practice in 1995. Mary studied at the College of Homeopathy in London and is a graduate of The Dynamis School of Advanced Homeopathy, the world’s leading organization involved in testing new homeopathic remedies. Mary designed a range of homeopathy kits that are international bestsellers and has spent the past 20 years educating the public as a professional speaker, teacher, and advocate. She is a former national spokesperson for the Irish Society of Homeopaths and currently offers her services as an expert contributor in the U.S. She is the author of Basic Guide to Homeopathy, editor of The Clinical Medicine Guide, and regular columnist for Homeopathy Today. Let's also remember that our very own Dr. Carolyn Dean has an amazing journey with homeopathy, being one of the only doctors who worked successfully with homeopathic remedies and AIDS patients in the 1990s. Dr. Dean's passion for homeopathy and her determination to remain forever on the leading edge of medicine has been incorporated into many of her protocols and can even be considered part of the inspiration behind the development of the RnA Drops!
Today, Hillary and her friend Katrina talk about beauty products and how they could be interfering with your fertility. They list the top ten chemical and ingredient offenders (out of 1,300!) to look out for and avoid, give recommendations on natural beauty product and product lines, and share some practical ways to make small shifts away from slathering ourselves daily in a chemical cocktail. More women are becoming savvy as consumers, and aware of how much of an effect what we put on our body has in with what happens inside of it. To share your own fertility story, please email me at hillary@ladypotions.com. I look forward to connecting with you, as you are what this podcast is all about. Takeaways: [1:37] The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), has not been changed since 1938. Europe and Canada have higher regulatory standards, and hopefully, the United States will catch up in the close future. [9:30] Top 10 ingredients we don’t want in our personal care products: Sunscreen Chemicals. Common Names are Benzophenone, PABA, Avobenzone, Homosalate, and Methoxycinnamate. Parabens. Parabens are widely used preservatives that prevent the growth of bacteria, mold, and yeast in cosmetic products. Read more on parabens. Synthetic Colors. FD&C or D&C represent artificial colors. F (food) and D&C (drug and cosmetics). These letters precede a color and number (e.g., D&C Red 27 or FD&C Blue 1). Synthetic Fragrance. Phthalates. The main phthalates in cosmetics and personal care products are dibutyl phthalate in nail polish, diethyl phthalate in perfumes and lotions, and dimethyl phthalate in hairspray. Triclosan. Triclosan is a widely used antimicrobial chemical found in toothpastes, antibacterial soaps, and deodorants. Sodium Lauryl Sulfate (SLS) / Sodium Laureth Sulfate (SLES). This surfactant can be found in more than 90 percent of personal care and cleaning products (think foaming products). Formaldehyde. Formaldehyde and formaldehyde-releasing preservatives are used in many cosmetic products to help prevent bacteria growth. Toluene. A petrochemical derived from petroleum or coal tar sources and it can be found in nail polish, nail treatments, and hair color /bleaching products. Aluminum. Used in antiperspirants. Read more on aluminum. [18:21] Now on to… what to actually use? Hillary’s friend Katrina Hall shares her evolution into natural beauty, and some of the top natural products she finds to be the ones she can trust the most with great results. [22:55] Katrina’s gateway product was an oil cleanser from the Crude Personal line, and she still uses it to take off her makeup. [26:32] Here are some other of Katrina’s top picks! Beauty products are a very personal choice, but hopefully, these will give you some hope that there are some great options out there, and even just changing one is a step in the right direction. Cleanser Marie Veronique Gel Cleanser Probiotic Skin Cleanser Sunscreen HYNT Suntegrity Marie Veronique Foundation Sappho Essentials Foundation Crunchi Setting Powder 100% Pure Bamboo Blur Powder Bronzer/ Contour RMS Lily LoLo Brows Ecobrow Plume Eyeshadow Lily LoLo Mascara Tarte Amazonian Clay Harvest Fitglow Lash Serum Eyeliner ZuZu Luxe Lip Gloss Fitglow Lip Serum Chapstick Zi Zai Lip Sticks Axiology Lip Liners Gabriel Cosmetics ZuZu Luxe References: Fertile Minds on LibSyn Fertile Minds on iTunes @ladypotions4u Think Dirty EWG’s Healthy Living App Parents on Demand App Crude Continue Your Journey: Link to sign up for free 29-day meditation challenge @ladypotions4u on Twitter @ladypotions4u on Instagram My Website: Ladypotions.com Special Thanks to Christopher Lloyd Clarke for music Disclaimer * You must not rely on the information in this podcast as an alternative to medical advice from your doctor or another professional healthcare provider. If you have any specific questions about any medical matter you should consult your doctor or another professional healthcare provider. If you think you may be suffering from any medical condition you should seek immediate medical attention. You should never delay seeking medical advice, disregard medical advice, or discontinue medical treatment because of information on this website or in this podcast.
In 1902, chemist Harvey Wiley launched a unique experiment to test the safety of food additives. He recruited a group of young men and fed them meals laced with chemicals to see what the effects might be. In this week's episode of the Futility Closet podcast we'll describe Wiley's "poison squad" and his lifelong crusade for food safety. We'll also follow some garden paths and puzzle over some unwelcome weight-loss news. Intro: In 1887, an inadvertent dot in a telegram cost wool dealer Frank Primrose $20,000. For 25 years, two Minnesota brothers-in-law exchanged a weaponized pair of moleskin pants. Harvey Washington Wiley's poison squad dined in formal clothing and wrote their own inspirational slogan. Sources for our feature: Bernard A. Weisberger, "Doctor Wiley and His Poison Squad," American Heritage 47:1 (February/March 1996). Oscar E. Anderson Jr., The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food, 1958. Paul M. Wax, "Elixirs, Diluents, and the Passage of the 1938 Federal Food, Drug and Cosmetic Act," Annals of Internal Medicine 122:6 (March 15, 1995), 456-461. James Harvey Young, "Food and Drug Regulation Under the USDA, 1906-1940," Agricultural History 64:2 (Spring 1990), 134-142. Cornelius C. Regier, "The Struggle for Federal Food and Drugs Legislation," Law and Contemporary Problems 1:1 (December 1933), 3-15. Donna J. Wood, "The Strategic Use of Public Policy: Business Support for the 1906 Food and Drug Act," Business History Review 59:3 (Autumn 1985), 403-432. E. Pendleton Herring, "The Balance of Social Forces in the Administration of the Pure Food and Drug Act," Social Forces 13:3 (March 1935), 358-366. Carol Lewis and Suzanne White Junod, "The 'Poison Squad' and the Advent of Food and Drug Regulation," FDA Consumer 36:6 (November-December 2002), 12-15. Mike Oppenheim, "Food Fight," American History 53:4 (October 2018), 68. Bette Hileman, "'Poison Squads' Tested Chemical Preservatives," Chemical & Engineering News 84:38 (Sept. 18, 2006). Wallace F. Janssen, "The Story of the Laws Behind the Labels," FDA Consumer 15:5 (June 1981), 32-45. G.R. List, "Giants From the Past: Harvey W. Wiley (1844-1930)," Inform 16:2 (February 2005), 111-112. Bruce Watson, "The Poison Squad: An Incredible History," Esquire, June 27, 2013. Deborah Blum, "Bring Back the Poison Squad," Slate, March 2, 2011. Lance Gay, "A Century Ago, the Federal Government Launched One of Its Most Unusual and Controversial Investigations," Pittsburgh Post-Gazette, Dec. 30, 2002, A-8. "Harvey W. Wiley: Pioneer Consumer Activist," FDA Consumer 40:1, (January-February 2006), 34-35. "Harvey Washington Wiley," Science History Institute, Jan. 10, 2018. Karen Olsson, "We Must Eat, Drink and (Still) Be Wary," Washington Post, Sept. 6, 1998, C01. O.K. Davis, "The Case of Dr. Wiley," Hampton Columbian Magazine 27:4 (October 1911), 469-481. A.A. Langdon, "Food Expert Defends Borax," What-to-Eat 22:3 (March 1907), 91-92. "To Investigate Wiley's Food Squad Methods," National Provisioner 36:2 (Jan. 12, 1907), 1. "Letter Box," Pharmaceutical Era 37:22 (May 30, 1907), 514. "The Case of Dr. Wiley," American Food Journal 4:2, Feb. 15, 1909, 16. "Food Law's Anniversary," New York Times, June 30, 1908. "Wiley's Foes Think They've Beaten Him," New York Times, Dec. 29, 1908. H.H. Langdon, "Why Wiley Is Criticised; His Radical Views Said to Justify Tests by the National Commission," New York Times, April 7, 1907. "Benzoate Indorsed; Wiley Loses Fight," New York Times, Aug. 27, 1909. "Health Rather Than Money," New York Times, Aug. 21, 1910. "Germans Verified Wiley Poison Tests," New York Times, Aug. 19, 1911. "Forbidden Fruit," New York Times, Oct. 11, 1911. "Pure Food in One State Is Poison in Another," New York Times, Jan. 25, 1914. "Dr. H.W. Wiley Dies, Pure-Food Expert," New York Times, July 1, 1930. Listener mail: Listener Rob Emich discovered Spring-Heeled Jack London-Style Porter in Cape Cod last month (see Episode 34). Brittany Hope Flamik, "Australia's Endangered Quolls Get Genetic Boost From Scientists," New York Times, July 26, 2018. April Reese, "Ecologists Try to Speed Up Evolution to Save Australian Marsupial From Toxic Toads," Nature, July 23, 2018. Jesse Thompson and Liz Trevaskis, "Questions Over Quarantined Astell Island Quolls Who Lost Their Fear of Predators," ABC Radio Darwin, Aug. 9, 2018. Wikipedia, "Garden-Path Sentence" (accessed Aug. 17, 2018). "Garden Path Sentences," Fun With Words (accessed Aug. 17, 2018). BBC Sound Effects. Dave Lawrence, "RNN of BBC Sound Effects," Aardvark Zythum, Aug. 2, 2018. Dave Lawrence, "More Sound Effects," Aardvark Zythum, Aug. 3, 2018. This week's lateral thinking puzzle was contributed by listener David Palmer. You can listen using the player above, download this episode directly, or subscribe on Google Podcasts, on Apple Podcasts, or via the RSS feed at https://futilitycloset.libsyn.com/rss. Please consider becoming a patron of Futility Closet -- you can choose the amount you want to pledge, and we've set up some rewards to help thank you for your support. You can also make a one-time donation on the Support Us page of the Futility Closet website. Many thanks to Doug Ross for the music in this episode. If you have any questions or comments you can reach us at podcast@futilitycloset.com. Thanks for listening!
“Discovery requires serendipity but serendipity is not a chance event alone. It is a process in which a chance of event is seized upon by a creative person who chooses to pay attention to the event, unravel its mystery and find a proper application for it.” In this episode of Made You Think, Neil and Nat discuss Happy Accidents by Morton A Meyers. In this book we look at the serendipity of so many scientific discoveries and the author suggests how we can foster these chance happenings to make giant leaps in research and discovery. “Penetrating intelligence, keen perception, and sound judgment — is essential to serendipity. The men and women who seized on lucky accidents that happened to them were anything but mindless. In fact, their minds typically had special qualities that enabled them to break out of established paradigms.” We cover a wide range of topics, including: Penicillin, Petri Dishes and Moldy Mary The impact of freedom on research Tangents on Private Schools, Social Media & Conspiracy Theories Modern Diets, Drugs and Toxins turned into cures Self experimentation, Ostracism and changing Medical opinions A possible special kayaking retreat for supporters And much more. Please enjoy, and be sure to grab a copy of Happy Accidents by Morton A Meyers! You can also listen on Google Play Music, SoundCloud, YouTube, or in any other podcasting app by searching “Made You Think.” If you enjoyed this episode, be sure to check out our episodes on Skin in the Game by Nassim Taleb where he shares other stories of scientists trying treatments firsthand, and Merchants of Doubt by Naomi Oreskes and Erik Cornway for more on controversial science, academia and Pharma companies. Be sure to join our mailing list to find out about what books are coming up, giveaways we're running, special events, and more. Links from the Episode Mentioned in the show Bottom Up Methodology [01:31] Scientific Method [1:48] Penicillin [05:27] LSD Discovery [05:48] Contact High [06:01] Dogmatic [06:19] Petri dishes [08:01] Lifehacker [08:47] The Structure of Scientific Revolutions by Thomas S. Kuhn [9:31] Narrative Fallacy [16:17] Fleming Nobel Prize Speech [17:38] Peoria, Illinois [26:03] Corn Steep Liquor [26:09] Merck [26:48] Squibb [26:48] Pfizer [26:48] World War I [27:42] Aquatic Apes [29:04] Sippy Diet [30:27] Tetracycline Antibiotic [31:47] Acid Inhibitors [34:14] Statins [34:36] Carbohydrates [36:16] LDL [36:20] LDL receptors [36:33] Viagra [38:26] Asbestos [39:46] Facebook Groups [42:14] Discord Groups [42:15] Carnivore Diet [42:49] Shake Shack [44:04] M&M’s [44:07] Purina Dog Food [46:08] Stats of College Debt – Tweet [46:32] CMU [52:40] Choate School [53:45] Sidwell Friends [54:23] Boarding Schools [54:34] Alkylating Agents [57:15] Geneva Convention [58:08] Patreon [01:02:08] Google Trends on episode 35 [1:02:00] Epidemics [01:02:27] SARS [01:02:54] Influenza [01:02:56] Syphilis [01:03:22] Fish Aquarium Antibiotics [01:04:53] FDA [01:07:51] Nazi Testing [01:08:04] Japanese testing on Chinese prisoners [01:08:08] Tuskegee Study of Untreated Syphilis in the Negro Male [01:08:19] Eugenics [01:10:18] Darwinism [01:10:31] (related podcast) Russian Gulag [01:11:38] Thalidomide [01:11:52] Diethyl Glycol [01:12:59] Food, Drug and Cosmetic Act [01:13:10] Accutane [01:15:06] Doxycycline [01:16:26] Microbiome [01:16:52] Eczema [01:17:43] Steroids [01:17:36] Spartan Race [01:20:09] Nat’s Instagram [01:20:15] Blockchain [01:21:06] X-Rays [01:22:29] Morphine [01:23:51] American Urological Association [01:24:48] CVS patient statistics for Viagra [01:29:42] Netflix [01:31:18] Spleen [01:32:47] Confirmation bias [01:34:43] Ego death [01:39:38] Dissociative experience [01:39:40] Magic mushrooms [01:40:02] LSD Therapeutic Research Study [01:41:03] NASA [01:46:22] Direct to Consumer Drug Advertising [01:46:29] ADD [01:47:41] Premenstrual Dysphoric Disorder [01:47:58] Prozac / Seraphim [01:48:09] Paxil [01:48:18] Female Sexual Dysfunction [01:48:24] Lipitor [01:48:57] Zoloft [01:49:16] UBI [01:53:07] Ethereum [01:59:48] Books mentioned Happy Accidents by Morton A Meyers Beginning of Infinity by David Deutsch [00:42] (book episode) The War on Normal People by Andrew Yang [00:51] (book episode) Antifragile by Nassim Taleb [07:02] (Nat’s notes) (book episode) The Structure of Scientific Revolutions by Thomas S. Kuhn [9:31] Boron Letters by Gary C. Halbert [14:44] Skin in the Game by Nassim Taleb [30:00] (Nat’s notes) (book episode) Merchants of Doubt by Naomi Oreskes and Erik M. Conway [01:02:02]] (Nat’s notes) (book episode) Merchants of Doubt by Naomi Oreskes and Erik M. Conway [01:02:02] (Nat’s notes) (book episode) Homo Deus by Yuval Harari [01:02:36] (Nat’s notes) (book episode) Words that Work by Frank Luntz [01:28:24] LSD My Problem Child by Albert Hofmann [01:40:51] Brave New World by Aldous Huxley [01:48:46] People mentioned Morton A Meyers David Deutsch [00:42] (Beginning of Infinity episode) Andrew Yang [00:51] (The War on Normal People episode) Winston Churchill [05:04] Alexander Fleming [05:29] Nassim Taleb [07:02] (Antifragile episode) (Skin in the Game episode) Thomas Kuhn [09:21] Peter Thiel [10:12] Gary C. Halbert [14:44] Charles Darwin [18:39] (Daniel Dennett’s book) Ernst B Chain [22:31] Moldy Mary [25:56] Barry Marshall [31:07] Robert Koch [32:10] Bill Clinton [01:00:32] George W Bush [01:01:18] Erik M. Conway [01:02:02] Yuval Harari [01:02:45] (Homo Deus episode) (Sapiens part I and part II) FDR [01:13:08] Claude Bernard [01:22:24] Frank Luntz [01:28:24] John William Gofman [1:31:35] President Eisenhower [01:34:48] Timothy Leary [01:40:28] Albert Hofmann [01:40:51] Steve Jobs [01:41:00] Louis Pasteur [01:45:32] Aldous Huxley [01:48:46] Show Topics 00:26 – The book is fun to read, light, enjoyable, easy going. An exploration of scientific discovery and progress and how consistently it is influenced and driven by the role of Serendipity. A case opposite or complementary to the Scientific Method. Serendipity defined as a combination of accidents and sagacity. 05:05 – Not all discoveries are immediately realized or understood. Winston Churchill – “Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing had happened”. Penicillin and LSD examples. The dangers of being dogmatic without leaving room for the unexpected. 06:53 – Central theme of the book–How do you foster that serendipitous mindset? Nassim Taleb says that serendipity comes from chance encounters, like a cocktail party. The potential gain from a chance encounter is worth the effort of stepping outside your comfort zone. 07:42 – Trying to harness serendipity for your own benefit. Serendipity through disorder and randomness. Investigating how scientists can foster serendipity in their lab work and how academia and education and research grants, peer review could change because of that. 09:41 – Normal vs revolutionary science, Meyers is dismissive of puzzle solving. Normal science is making incremental improvements on existing knowledge, whereas serendipity fosters revolutionary discoveries as they come from a change in the ordinary methods. 10:51 – Two stages to serendipity. You need something unusual to happen and you have to recognize it to take advantage of it too. 11:21 – Innovation departments rarely come up with paradigm-shifting ideas and products. Need a certain mindset to make the most of these opportunities. Reason, intuition and imagination. Too much experience in a field can cloud your judgement on new ideas. 13:51 – The book is primarily about serendipity in medicine and science but it can be applied to most fields. Breaking out of the norm and finding inspiration for innovation in other industries. Looking at magazines to apply to blog copywriting. 15:33 – "Analogical thinking has certainly been a cornerstone of science." Another theme in the book is looking for one thing but ending up on a totally different path. All of the people making discoveries seemed to have a level of independence in their research to follow a new path when it interests them. The narrative fallacy involved in serendipitous scientific discovery or startups growth. 17:40 – Alexander Fleming and discovery of Penicillin as anti-bacterial. Fleming said that if he was working on a research team at the time it would have been ignored as it wasn’t what he was working on. Being free allows you to pursue these anomalies. 19:04 – Darwin and the finches in the Galapagos. Being told to go and study something brings different results than if you’re free to follow your own curiosity. The constraints of research impose harmful limits on discoveries. 19:54 – Structure of the book is Introduction of the premise, 30+ chapters of examples and the conclusion. Myers suggests at the end of the book that the structure for scientific research and funding is counter to the ability for these serendipitous events to happen. 20:50 – More on Fleming and Penicillin. Odds of it happening were astronomically low. He was away for two weeks and on returning and viewing his petri dishes on his desk discovered an anti-bacterial zone around the mold. It wasn’t until 7 years later that another researcher realized what he had found. 23:09 – For Fleming it took a number of environmental factors that allowed Penicillin to be discovered at all: heat, location, time. Penicillin wasn’t originally pitched as a drug, originally suggested as a way to isolate bacterial colonies. Then there was the huge scale up and production process of the drug. Peoria (IL), the role of corn syrup, and the mold discovered by chance. 29:00 – Bonus Material Discussion, Aquatic Apes, Patreon, future episode ideas. 29:52 – Causes of ulcers, used to be thought of as stress and spicy food. Discovery that it is caused by bacteria in 1981. Marshall ran an experiment on himself to take the bacteria, give himself ulcers and cure himself with antibiotics. Pharmaceutical industry had a strong incentive to not prove this as the cause, current drugs of acid inhibitors were reaching sales of $6 Billion dollars in 1992. 35:04 – Pharma companies lobbying to decrease acceptable cholesterol ranges to induce more people into treatments. Changing opinions of statins within last 10 years. Effects of low cholesterol on longevity, links to all-cause mortality. Reducing cholesterol and precursors to creating testosterone in diet has lead to a reduction in testosterone and erectile dysfunction requiring a need for Viagra. 39:59 – What are we currently doing in society now that we will look back on and question in the future? Possible future problems associated with over consumption of social media. Mental and physical health complaints are unknown. 41:53 – Pull away in society from open sharing, moving towards private communities. Effectiveness of diets, feeling good vs having long term health benefits. Benefits of adopting a new diet may be equal to reducing other harmful choices – like stopping drinking for a month. The changing conventions of meal-times, quality of dog food, college debt. 47:12 – Tangent. Education and the need to change the K through 12 program instead of starting with College reform. The benefits of private vs public school. Mixing with different socioeconomic backgrounds, expense of private school. Both build very different sets of social and academic skills. Bay Area dystopia, where citizens pay lots in taxes that go into public schools, but parents end choosing private ones. 55:53 – Chemical weapons, World Wars and the changing use of toxins into cures. Bombing a ship leading to the first chemo treatments for cancer. North Korea and the development of nuclear tech (more info in the Bonus material). Google health trends being able to predict health outbreaks based on search volume. Sex hormones and noticing the change of tumors in animals after castration. 01:07:55 – Consequences of controversial testing on wartime prisoners that have given us useful data. Study of African-American men with syphilis, they were told they were having free medical treatment but they were mislead and were being studied for the untreated effects of syphilis over 40 years. Possibilities of current testing on prisoners or other conspiracies. 01:11:52 – History of Thalidomide being marketed as a sedative and pain management. Widely distributed before it was realized it had the side effect of severely inhibiting fetal development. U.S avoided this because the FDA already setup due to a drug being administered alongside Diethyl Glycol which was toxic, killing over 100 children. Testing required before products could be marketed. Thalidomide now used as an anti-cancer drug as it inhibits new blood vessel growth. 01:15:05 – Acne treatments and the imbalanced side-effects on fertility. Use of cleanser on the face strips natural oils. Use of antibiotics for acne which causes destruction of the microbiome. Latex gloves that may transmit more bacteria than your hands. Effects of steroids and keto on curing eczema. Nat not using shampoo even after a Spartan race. Body naturally cleansing. 01:21:06 – Tangents, aquatic apes, blockchain, negative reviews. 01:21:59 – Heart chapter and testing of catheterization. Self-experimentation and the need to prove theories. Ostracism and dangerous procedures. 01:24:44 – Viagra, originally for treating angina, it was found that this medication increased blood flow and became a cure for impotence – renamed to erectile dysfunction. Self-experimentation on erectile dysfunction. "The annual scientific meeting of the American Urologic Association is usually a pretty staid Affair but one meeting has entered the annals of folklore in the early 1980s. During the course of his lecture on the effectiveness of injecting substances directly into the penis to increase blood flow one urologist announced that he had performed such injections on himself only an hour earlier. Stepping from behind the lectern and he dropped his trousers and proudly demonstrated to the audience his own erect manhood. Urologists who attended this meeting still shake their heads at the memory." 01:28:00 – The power of names and the words used, like pro-life and pro-choice. How you phrase something changes the impact. Pharmaceuticals changing the names of conditions to promote sales of new drugs. Sales of Viagra were $780 Million in the first 9 months of 1998. 01:30:02 – 1% of women take Viagra to increase arousal and sensation and orgasm strength. Netflix’s biggest competitor is sleep, Viagra’s biggest competitor is death. 01:31:48 – Cholesterol testing on rabbits. Cholesterol data seems outdated with the book being 11 years old. Comparison of Chinese soldiers and lifestyle and diet. Lack of nutrition education in Doctors, mostly educated by pharmaceutical companies. People seem to want to take a pill rather than change their lifestyle or diet and doctors have lack of trust in the patient that they will try to improve their own situation. 01:38:07 – Psychiatric stuff. Hoffman discovering LSD by accidentally pouring it over his skin. LSD microdosing experiences. 01:42:40 – Tangents on kayaking, LSD microdosing and the Made You Think – Patreon $1000 Tier. 01:43:06 – Conclusion. Modern sciences are antithetical to the process of serendipity and how our institutions penalize our ability to take advantage of it. Government contracts and grants impose constraints. If you're getting money to research a specific topic you will be disincentivized from exploring things that deviates. If you're a free agent, then you can run down those rabbit holes. 01:44:31 – Peer reviews. Most businesses are judged by their customers but academia is judged solely by their peers. Ostracism as a consequence of investigating fringe theories. Direct to consumer advertising for drugs. Diseases and disorders that seems to be created and renamed just to increase drug sales. Long terms effects of drugs. 01:52:19 – On Patreon you get all kinds of goodies. Bonus materials, detailed notes for each episode and book highlights. You get a space to discuss the show with both of us. You can also join for our monthly live Hangouts. If you join the $1000 a month tier you can join us for a major excursion – Made You Trip! 01:54:57 – Patreon is a great way to support the show and let us keep doing this ad free. So we don't have to break up the episode with ads and we keep rolling with the tangents. 01:55:48 – Leave a review on iTunes that is super helpful for us because we show up as a recommended podcast and also is a great way for us to book guests. Other ways to support the show, you can go MadeYouThinkPodcast.com/support and tell your friends. 01:57:58 – If you want to talk to us, you can talk to us on Twitter anytime. I'm @TheRealNeilS and I am @NatEliason. If you're shopping on Amazon click through on our link. We super appreciate that. All right, we will see everyone next week. See you guys next time. 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It’s hard to know what this episode is really about. Government bullying private enterprise? An evil conspiracy to crush a competitor? Confused consumers unable to read a label? All of the above? In a nutshell, on 12 August 2015 the US Food and Drug Administration sent a warning letter to Josh Tetrick, CEO of Hampton Creek Foods, informing him that two of Hampton Creek’s products: are in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and its implementing regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Just Mayo and Just Mayo Sriracha are the two products, and their crime is that they do not contain eggs. So they cannot be called “mayo”. Who sicced the FDA on Hampton Creek? has become the big question, as a pile of emails winkled out of the government by a Freedom of Information Act request seem to show that the American Egg Board orchestrated a campaign against Hampton Creek. I mentioned the story in my newsletter three weeks ago, which prompted Peter Hertzmann, an independent researcher and a friend, to suggest that the reality, as ever, is not quite so straightforward. Peter was good enough to fill me in on some of the background. Notes Peter Hertzmann’s website is well worth exploring for all sorts of good things. The American Egg Board is just one of several commodity checkoff programs. There have been some very interesting challenges to the whole idea of a mandatory checkoff, one of which recently featured on BackStory, a history podcast. I did ask if I could use it, but no reply yet; you can hear the segment here, but you will need a sharper legal brain than mine to decide whether mandatory funding of something called government speech raises First Amendment concerns. What got Peter and me into the sciencey discussion of mayonnaise and emulsions was his mention of the Harvard University Science and Cooking lecture series. I’m mortified to admit that I didn’t know about it. Many of the lectures are on YouTube, and one in particular that Peter pointed me to showed Nandu Jubany from Can Jubany restaurant in Spain making an aioli from nothing but garlic, salt and olive oil, and a bit of water. You can see him do that from about 13:30 to 17:30 in this video, but the intro, on emulsions, is worth watching too if you want to a better understanding. I’m sharing, without comment, some of the AEB material obtained by Ryan Shapiro. The FDA’s letter is, of course, online. The banner image of a mayonnaise emulsion under the microscope is from a scientific paper on substituting eggs with a modified potato starch.
Episode 7: Nutritional Deficiencies and Dietary Supplements Public Interest in Nutritional Supplementation 50% of the U.S. adult population uses dietary supplements 1990-1997 400% growth in dietary supplement sales for humans Currently growing at 15% per year $37 billion annually 85% of regular supplement users believe that dietary supplements are good for health 82% of Americans would try herbs for terminal illness { http://www.cfsan.fda.gov/~dms/fdsupp.html; Boothe DM. 2004 Vet Clin Small Anim 34:7-38 ; Blendon RJ. 2001 Arch Intern Med 161:805-810 } Similar interest in supplement use for pets 30% of pet owners have used or have considered using dietary supplements 90% of veterinarians sell some type of herbs or nutraceuticals $20-50 million in annual sales {Boothe DM. 2004 Vet Clin Small Anim 34:7-38} Important Questions Concerning Nutritional Supplements What are nutritional supplements? Terminology, Definitions, Contents Why do we need nutritional supplements? Evidence for nutritional deficiencies - When should we use nutritional supplements? How do we recognize/suspect the need? What nutritional supplements should we use? - What kind of nutritional supplement is best? How do we use nutritional supplements? Conventional Thinking About Nutritional Supplementation “The proper role of a supplement is to correct a diagnosed nutrient deficiency” {Small Animal Clinical Nutrition 4th Ed p. 116} However, diagnosis is difficult with current tools and difficult to recognize based on conventional definitions of deficiency “ The most common form of veterinary supplements is a wide variety of vitamin and vitamin-mineral combinations that are used by 10% of animal owners” {Small Animal Clinical Nutrition 4th Ed p. 116} Predominantly consist of isolated, or synthetic, vitamins “Routine use of vitamin mineral supplements is not needed when a dog or cat eats typical commercial pet food” “…dogs and cats consuming commercial dry rations were ingesting from two to five times the daily allowance of vitamins” {Small Animal Clinical Nutrition 4th Ed p. 116} They are already receiving potentially excessive amounts of isolated, or synthetic vitamins The conventional approach to nutritional supplementation is to provide more of the same isolated and synthetic nutrients that are already present in high amounts in the pet foods, expecting a better outcome It has been claimed that insanity is continuing to do the same thing, expecting a different result Confusion in Terminology: What Are Nutritional Supplements? Food: (according to section 201(f) of the Food, Drug, and Cosmetic Act) “a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption” “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.” This includes “dietary supplements and dietary ingredients” { http://www.cfsan.fda.gov/~dms/fsbtac13.html http://www.cfsan.fda.gov/~dms/fc01-1.html1 http://www.cfsan.fda.gov/~ear/ims-a-30.html} Drugs: “articles [food or non-food] intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” “ articles (other than food) intended to affect the structure or any function of the body of man or other animals” { http://www.cfsan.fda.gov/~dms/fsbtac13.html http://www.cfsan.fda.gov/~dms/fc01-1.html1 http://www.cfsan.fda.gov/~ear/ims-a-30.html} “Medical Food” originally applied to humans For dietary management of a disease or health condition Under the direction of a physician Label must state that the product is to be used to manage a specific medical disorder or condition
Cosmetics are a critical part of a woman's daily routine and enable them to look sexy, young and vibrant. There is always going to be a cost involved but it is not necessarily what you may think! Kayla Fioravanti discusses The Safe Cosmetics Act of 2010