Podcasts about cosmetic act

Peggy Hoyt, host of "All My Children Wear Fur Coats," interviewed Bill Bookout, president and board chair of the National Animal Supplement Council (NASC), to discuss pet supplement safety and upcoming legislation. Bill explained how NASC has worked for 25 years to establish quality standards for animal health supplements through co-regulation with regulators, representing over 330 brands in the industry. He highlighted significant concerns about low barriers to entry in the supplement market, sharing examples of scam companies creating fake products and misrepresenting NASC membership. Bill discussed the proposed Animal Health Supplement Act, legislation that would formally recognize health supplements as a distinct category under the Food, Drug, and Cosmetic Act, providing FDA oversight while maintaining reasonable barriers for small businesses. He emphasized that while the legislation would require companies to register with FDA, it would not necessarily mean product approval, and consumers should look for NASC quality seals and verify company credibility before purchasing. Bill also mentioned NASC's expansion into pet treats and global markets, and encouraged listeners to support the legislation by contacting their elected officials through the website saveanimalsupplements.org when the bill is introduced.Support the show

Host: Cindy Allen Published: July 3, 2026 Length: ~15 minutes Presented by: Global Training Center Summary This week on Simply Trade: Cindy's Version, Cindy Allen unpacks another busy week in international trade, covering updates on CAPE refunds, post-summary correction payments, Section 232 investigations, the future of USMCA, and a major Department of Justice settlement involving Alibaba. Using Taylor Swift's "This Is Why We Can't Have Nice Things" as this week's theme, Cindy explores a broader question facing the trade community: Where should responsibility begin—and where should it end? As government enforcement expands beyond importers to brokers, online marketplaces, and other supply chain participants, the episode examines how increased accountability may reshape global trade while raising important questions about fairness, due diligence, and practical implementation. This Week in Trade Members of Congress urged USTR to allow the current Jones Act waiver to expire as scheduled. The Department of Commerce launched a new Section 232 investigation involving certain coal imports. Beginning August 5, CBP will require ACH payments for duties owed on Post-Summary Corrections. CAPE continues expanding, including refund eligibility for qualifying reconciliation entries, while CBP reported significant processing progress. The United States formally initiated the USMCA withdrawal process, beginning the review and renegotiation timeline. The Department of Justice announced a $600 million settlement with Alibaba related to alleged violations of the Food, Drug, and Cosmetic Act. Main Topic The episode's central discussion focuses on the growing trend of expanding legal responsibility across the supply chain. Using the Alibaba settlement as an example, Cindy explores whether online marketplaces, customs brokers, and other intermediaries are increasingly being held accountable for actions traditionally associated with manufacturers or importers. She compares this trend to recent customs enforcement initiatives that place greater expectations on brokers and service providers to identify and report potential violations. The discussion raises an important question for trade professionals: How much responsibility can reasonably be placed on parties who facilitate commerce but may not own, manufacture, or control the products themselves? Key Takeaways CBP continues refining the CAPE refund process as filings increase. ACH payments will soon become mandatory for duties owed on Post-Summary Corrections. USMCA has officially entered its formal review and withdrawal process. The Alibaba settlement signals expanding government expectations for e-commerce platforms. Customs enforcement continues moving toward broader supply chain accountability. Companies throughout the supply chain should expect increasing due diligence expectations. Resources & Mentions Global Training Center Trade Force Multiplier Alibaba USMCA Jones Act Credits Host • Cindy Allen – LinkedIn Producer • Lalo Solorzano

Interview Transcript Kate - Welcome to the Leading Voices in Food podcast. I'm Kate Stanley, a researcher at the World Food Policy Center at Duke University. I'm joined today by my co-host, Katariina Koivusaari, a researcher at North Carolina State University. Together, we collaborate on policy research for the Bezos Center for Sustainable Proteins at NC State. Katariina - Great to have you. Greg, you have been involved in food and agriculture policy in Washington, D.C. for several decades and have worked with both Democratic and Republican administrations. Are food policy politics caught up in party differences depending on which political party is running the executive branch? A very relevant question right now. I guess it would be wrong to say that the political party in office doesn't make a big difference in the policies being carried out by the executive branch. However, in the food and agricultural space, and especially in the areas that I focus on, which is really around these new technologies in food and Ag and how do those get into the marketplace and adopted, that difference hasn't been so big. Let me give you an example or two. I'll take you back first to about 2000, and we had the Clinton administration. We have the regulation at FDA of biotech crops, and they had a voluntary consultation process and there were a number of stakeholders and others who felt that that wasn't sufficient. The Clinton administration interpreted the Food, Drug, and Cosmetic Act to try to turn that into what they called a mandatory consultation, and they proposed a pre-market notification rule. It didn't get finished in, before the end of the administration in January of 2001. Then we had the Bush administration come in, so we went from a Democrat to a Republican. And the Bush administration looked at the same law and looked at that same proposed regulation and said, "We don't have the legal authority to do that." And they withdrew that proposal, and so we still have to this day this voluntary consultation. And I give you that example for two reasons. One, I think what we've seen when it comes to food and policy regulation by different administrations is how they interpret the law. And I can say this in very general, the Democrats have tended to be a little more expansive in how they interpreted the law to try to find more legal authority to do things that they might want to do. And the Republicans have tended to look at that language much more restrictively or look at just exactly what that language said and not try to interpret anything into it. And so, you see that difference here between what happened in the Clinton administration versus what happened in the Bush administration. I mention this example because as many of your listeners may know, right now in this administration, we have the question about voluntary GRAS and whether that's going to become mandatory or not. And some of us who have followed that know that the current FDA has submitted to OMB, to the White House, a proposed rule to make GRAS mandatory. Well, that is-- the regulatory process for those biotech crops is also a GRAS process. It's interesting now that we have a Republican administration who's finding the authority to do that, and we'll see what actually comes out and what the courts do with it. But I think this shows that sort of difference in policies between Democrats and Republicans. But overall, we haven't seen a lot of difference. In this new administration, I think one of the questions people had was what would happen with a technology like cell-cultivated meat? Where would the regulation of it go forward? There's many in the MAHA movement, I think, that felt that that wasn't consistent with what they wanted. But we've seen that those approvals continue to happen. Similarly, pesticides have been an issue in many administrations. Sometimes Democrats have argued to be much more restrictive in the use of pesticides and to make the regulations much harder. And Republicans have oftentimes said to make those easier for the agencies. But what we see is pesticides have moved forward under both administrations. People understand the need for pesticides to produce agriculture. We have some differences in policy, but on the whole, in this area, I think, whether it's Democratic or Republican, they have generally supported following the law. Kate - Greg, you shared some interesting examples of across administrations how we've seen different actions be taken. And I'm curious. Under this administration, for some of these areas you work in, like these novel technologies, what do you see as driving the new federal legislative actions in food policy? The legislative area has generally always been more partisan than the executive branch to some extent. I mean, the executive branch is interpreting laws from Congress; the Congress is setting those. But I think again, in the area of food policy, we've seen many good laws come out that have been bipartisan. And when I look at how did those laws come to be, I sort of see a couple different scenarios. One, and I don't think this is unique to food policy or ag policy, we tend to see legislation when some crisis has occurred. The example I would give in the food space was the establishment of the Food Safety Modernization Act more than a dozen years ago. And to a large extent, that was reaction to a number of outbreaks: spinach outbreaks, peanut butter outbreaks, egg outbreaks. And people getting sick, and some people even dying from those outbreaks. And so that brought a bipartisan coalition together to say, "We need to give more authority to FDA to address our food supply and ensure it's as safe as it could be." So that's one way we've seen that. A second way we see policy change is when a policy is old or that is no longer in favor. And the example I give there is most recently, in this Congress passed the whole Milk for Healthy Kids Act, and that is a definite change in policy from the Hunger-Free Kids Act of 2010. This changes what milks, whether they're flavored, and how much fat they can have and be in the school programs. And I think in both cases, those bills were relatively partisan at the time, and yet they do opposite things. So that would be another reason that we see changes in laws. But the third way, and I wanted to focus a little more on this, is one way the federal government gets involved and Congress gets involved is when states start regulating an area, and we start getting different standards. And then there's a push at the national level to have some sort of uniformity, some sort of have national standard for markets to work properly, for efficiency's sake and so forth. And I can give several different examples. We can go all the way back to the National Organic Law that was passed back in 1990. You had a number of states who had defined organic; they had different organic labels. Congress came together and said, "Hey, let's set up a national organic standard." We had the same thing happen with the National Bioengineered Disclosure Law, that I think happened around 2017 or 2016. In which case you had a number of states proposing legislation. You had Vermont that had passed legislation requiring mandatory labeling of genetically engineered ingredients. And in fact, the law that was passed by Congress was passed, I think, within a week or two of when the Vermont law was about to go into effect. And people felt it was better to come together and have a national standard than have different states doing different things. Because the reality is, consumers and manufacturers don't just purchase things in one state or produce things for one state. They produce it for the nation. We're a nationwide market. And then we see even those kinds of things happening today, and I go back to the pesticide area as another example. We've had different states having pesticide laws or regulations that have been different than the federal situation. We have a Supreme Court case now that the Supreme Court is going to hear in April of this year about whether that's those state regulations are preempted by the federal law. But Congress and the Farm Bill has also put in language that would ensure that the federal standard is the standard that is applied, not having multiple different state standards. So that's been a way that we've seen a lot of things happen in this food and Ag space. Kate - We've seen a lot of food policy action at the state level in the past few years. Katariina and I were on this podcast not long ago talking about state legislation aiming to restrict how cell-cultivated meat products are labeled or even banning those products altogether. We've seen action in a variety of other areas as well. Are there issues that states have started regulating where you think we could see federal action in the near future? I do. I think that the MAHA movement in particular has really set up a situation where we see states taking the lead on a number of issues, and we'll see whether the federal government decides to come in, and particularly Congress, to address those at a national level. For example, in the area of synthetic dyes and food additives, I think there's some 30 states that have introduced bills. And a number of which have passed, either restricting those use at all in any foods, restricting their use in school lunches, having different labeling associated with many of those ingredients. And we've seen some of those laws pass, and we've already seen some court cases. A court case in West Virginia which said that those laws are preempted by federal law. One could envision either something at FDA or in Congress that would set some uniform standard for how this moves forward federally. You mentioned cell-cultivated meat and the three of us were involved in a paper that looked at the state regulation in that area, especially around labeling. And again, if we don't have a lot of those products on the market yet, but as those products get closer and get on the market, I could definitely see a push again to have some uniform labeling. Either again from the federal executive branch or from the legislative branch. And also, in areas like ultra-processed foods is another one. California has passed a law defining how they're going to define ultra-processed foods. We've heard that FDA may issue a definition about ultra-processed foods, but I could also see Congress getting involved eventually and setting a standard. Katariina - I'm sure that in working with US regulatory agencies for so long, you've seen trends develop and persist over time. What would you highlight right now for our listeners? Well, as I said, I've worked very much in this space where we talk about new science, new technology, new kinds of products coming into the marketplace and how do we regulate that? What are the policies and regulations to ensure that that's safe for humans and safe for the environment, and that there's information and access that's necessary for those safe products to, to thrive in the marketplace. And when you look at that, I think I have some observations, I guess, about the US regulatory agencies and what they've done in this area. The first one is that the science tends to move faster in the private sector and in the research community, like you're both in, than it does in the federal government. And so generally, the people in the federal government, who I have the utmost respect for, the career people, tend to always be playing catch up on the science. That the science is moving faster and they're not there. An example I would give is cloned animals. When the industry went to FDA and said, "Hey, can we put these cloned animals into the m- into the marketplace?" FDA sort of said, "Well, wait. We need to look and see whether we need to do a risk assessment to see if there's any risks out there." And they spent a couple years doing that, and they asked for a voluntary moratorium while they were figuring that out. In the end, they figured out that for many cloned animals, there was no risk and there didn't need to be regulation, but they had to catch up. They had to catch up on the science. And I think that's the first thing. It's important for industry and public sector scientists like yourselves to make as much information about new technologies and new products available in the public realm so that those experts in the federal government can stay as close as possible to what is happening. Second is, anytime you have a first-of-a-kind product. You talked about cell-cultured meat, Kate, a little while ago. We can talk about biotech crops. We can talk about a number of genetically engineered salmon. We can talk about a number of different new products of methane-reducing feed additives. The first-of-its-kind is always going to take a little longer to figure out what is that regulatory pathway. It's great to be the first into the marketplace. You get a lot of advantages, but I guess one of the disadvantages is that you probably have a little slower regulatory timeframe. That again bodes for that transparency for that additional information. The third thing I'd mention, and you would think, oh, this is something that is sort of a given and expected, and that is the level of transparency that we have in our federal government. But that's not true. I've traveled around the world, and many governments don't have that. But interestingly, most of our regulations are, you know, they're all publicly available. There's lots of guidance documents out there. We can go online today and see GRAS applications and decisions made at FDA. We can see what information was submitted for cell-cultivated meat crop, meat, meat products, and what decision the agency made on those. We can do that for genetically engineered animals and for genetically engineered plants. And so, we do have a fair amount of transparency, and I impress upon people to use that to their advantage. I think that builds trust for consumers, but also for people in the industry. It helps them learn so they can be as efficient as possible when they go through the regulatory process. And the final thing I might mention is it may look like from the outside the government moves slow all the time. But I think having been inside the government and in the role, I played as the Chief Regulatory Officer at USDA, that slowness, in part, is to make sure that the government speaks as a single voice. We've been talking a lot about FDA, and we talk about USDA, but there are actually some 18 or 20 different agencies that actually regulate different parts of the food supply, for example. A decision made in one agency may have some indirect impact on a decision or a regulatory process in another agency. And so, it's important before major decisions are made or major regulations are promulgated, that we have an interagency review of those things to make sure that the government is speaking consistently with one voice about how they interpret laws; about how they apply risk assessments; about how they look at safety and so forth within the context of their laws. And that sometimes takes some time. It is a big bureaucracy, a big government, and again, that could be looked at upon negatively. But at the same time you can look at upon that positively as an opportunity to make sure that the decisions that are made in one place are consistent with other decisions and other statutes in another place. Katariina - Thank you for sharing that. It's really helpful to get more insight into the policy process. Let me ask you one final question. For organizations seeking to navigate through state and federal regulations in order to bring a food product to market, what are the key, what are key takeaways you would highlight? Well, there are a number of them. First, I would tell companies or public researchers, whoever is bringing a product to market, to be as transparent as possible. Put as much information about your product and your technology in the public record, especially if it's in peer-reviewed journals that are accessible to everybody. That is only going to come to your benefit. That's going to help the regulators. They know that information is out there. They know that other people have that information. They can utilize that to help make decisions about whether there is a food safety or a risk to the environment, and then how maybe to address those risks. So that would be my first response. The second one is, and I think, again, this is something that I thought was going to be universal when it came to interactions between the regulated community and the regulators, but it's not around the world, and that is to consult. All the agencies that I've worked for have open door policies where they say, if you have a question, as you're thinking of bringing a product to market, come in and consult with us. Come in and talk to us. Let us help you figure out what the regulatory pathway is going to be, what the data you are going to need is, why we need that data, and go through all of that. And, in my consulting business, that's one of the things I do. I help facilitate those conversations between one of the agencies and a client. And I think that just the earlier you do that and the more often you do that, the more efficient you will be, the less money you will spend, the quicker your review process will be. And while I have clients who don't always agree with the decisions by the agencies of what information they might need or what regulatory process they have, it's still better to know that upfront and earlier in the process than later in the process. The third thing I'd mention is to be a little creative. The regulators, you know, they're trying to ensure they're representing the public, and they're trying to make sure that a product is safe for human consumption, for animal consumption, for the environment. They don't always have all the answers, and sometimes they are fitting square pegs into round holes because new technologies come along that aren't exactly a perfect fit. But be creative. Try to help them. I think, you know, sometimes working with people like me or others to help think about what a good regulatory pathway would be, what are the potential risks that really need to be addressed here that can be really helpful. The fourth thing is, you know, that the devil is always in the details. The details and the science matter, and that is something that is very important. And so, we want to look for analogies of your product or your technology to other ones that have happened in the past, and that's always good. But also understand the differences. And so, really, I think, sometimes people think, "Oh, they don't need to engage with the regulators as much about exactly what I'm doing," or "They don't need to know all those details." Those details actually do matter, and I do think those are important. And then I would finally say that, you know, it does take time, especially when we're talking about new technologies and new products, to figure out what that regulatory process will be. And we don't have neat situations. Our laws are written a long time ago. We don't want to write a new law for every new kind of product or every new kind of technology. I'm not sure that's the most efficient way to do it. But by not doing that, we're sometimes, as I mentioned earlier, fitting square pegs into round holes. We have a law, for example, the Food, Drug, and Cosmetic Act, dealt with food, but it never envisioned genetically engineered crops. It doesn't talk about biotechnology. We have a meat law that regulates meat at USDA. Didn't think about cell-cultivated meat. And we have to think about how those fit together. And sometimes we can do that without the new laws, and sometimes you need new laws. When I was at USDA, we worked on methane-reducing feed additives. FDA regulates them, but they really don't fit very well. They're not a drug, but they're also not a feed because they don't have a nutritional benefit. And so how do we fit those into the regulatory system? FDA's come up with a temporary regulatory pathway, but there's also a bill in Congress to set up a more definitive regulatory pathway. And we see that for some of these new technologies that we might see some legislation. And then the final point I would just make is to temper everybody's view that a compromise is essential in this area. No one company or no one stakeholder gets everything they want. Governing and the government's job is to, you know, figure out what's the appropriate balance. They want to ensure safety, but they also want to make sure that safe products can get to market and that consumers can get to take advantage of those products, and we can get the benefits from those products. And so all of this is always a balancing. There will always have to be some sort of compromise. And I'm not saying that's a bad thing, just pointing it out as something that people should be conscious of. BIO   Gregory Jaffe is President of Jaffe Policy Consulting, which provides strategic advice on national and international policies involving agriculture and food, with specific expertise in sustainability, climate, bioeconomy, biotechnology, PFAS, pesticides, food safety, and food loss and waste. He recently worked as the Senior Advisor for Regulatory Affairs in USDA's Office of the Secretary and the USDA's Chief Regulatory Officer. He managed a broad portfolio of policy issues, including bioeconomy, biotechnology, biofuels, pesticides, PFAS, food safety, sustainability, and scientific research and development. Before joining USDA, Greg worked for at the Center for Science in Public Interest (CSPI), a non-profit consumer organization working on food and nutrition issues. While at CSPI worked extensively in Sub-Saharan Africa and Southeast Asia on projects funded by USAID and the Gates Foundation. He worked with government officials and stakeholders helping them develop laws, policies and regulations that allow for the adoption of agricultural technologies, including biotechnology. He advised on agricultural policy, sustainability, and trade issues, conducted capacity building, and worked on international treaty implementation.

Welcome back to the communal Schauer, make sure to don your tin foil hat because this week we're wading into the murky waters of interventionism and bungled progress. A word of warning to those of childbearing age: I swear a lot in this and it has been scientifically proven that profanity makes your ovaries grieve.  Tear. Pour. Live More. Go to https://LiquidIV.com and get 20% off your first purchase with code SCHAUER at checkout Download Hily Dating App from the App Store or Google Play, or visit https://hily.go.link/jRMKW And yes, I do apologize for the late upload, I'm trying to get the hang of recording at home. I appreciate everyone's patience, you all are incredible and should be celebrated. I hope you all enjoy this week's episode! The Allen Institute's Collab w/ KEXP  https://alleninstitute.org/kexp  I helped with this! General Resources: Alzheimer's Disease https://emedicine.medscape.com/article/1134817-overview#a2  Anatomy, Abdomen and Pelvis: Celiac Ganglia https://www.ncbi.nlm.nih.gov/books/NBK538129/#article-19097.s6 Federal Food, Drug, and Cosmetic Act of 1938 https://www.ncbi.nlm.nih.gov/books/NBK585046/ Toxic Effects of Mercury on the Cardiovascular and Central Nervous System https://pmc.ncbi.nlm.nih.gov/articles/PMC3395437/  Tampons as a source of exposure to metal(loid)s https://www.sciencedirect.com/science/article/pii/S0160412024004355  Patents on Psychedelics: The Next Legal Battlefront of Drug Development  https://harvardlawreview.org/forum/no-volume/patents-on-psychedelics-the-next-legal-battlefront-of-drug-development/ Caffeine-Induced Psychosis: A Case Report and Review of Literature https://pmc.ncbi.nlm.nih.gov/articles/PMC11376648/  The effect of caffeine and stress on auditory hallucinations in a non-clinical sample https://www.sciencedirect.com/science/article/abs/pii/S019188691000591X  Scientists Stop Pancreatic Cancer Before It Starts in Landmark Preclinical Study https://scitechdaily.com/scientists-stop-pancreatic-cancer-before-it-starts-in-landmark-preclinical-study/  The Brain Waste System Disrupted by Alzheimer's Mapped https://neurosciencenews.com/glymphatic-brain-waste-clearance-30785/  The Resurgence of Hallucinogen Drugs in Clinical Research https://www.sciencedirect.com/science/article/pii/S0034837625001457  Residential psychedelic (LSD) therapy for the narcotic addict. A controlled study https://pubmed.ncbi.nlm.nih.gov/4575166/  This study is from 1973 - if you would do me the favor of scrolling down to the “similar articles” section I'd like you to note the dates of publication for related research. If you're seeing what I'm seeing, psychedelics could've really helped a lot of people. Books Clean: The New Science of Skin and the Beauty of Doing Less - James Hamblin Natural Capitalism: Creating the Next Industrial Revolution - Paul Hawken Undermining Science: Suppression and Distortion in the Bush Administration - Seth Shulman Sweet and Deadly: How Coca-Cola Spreads Disinformation and Makes Us Sick - Murray Carpenter How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence - Michael Pollan Unwell Women: Misdiagnosis and Myth in a Man-Made World - Elinor Cleghorn A History of Transgender Medicine in the United States: From Margins to Mainstream - Carolyn Wolf-Gould, Dallas Denny, Jamison Green, Kyan Lynch, Editors Food & Lobbying Resources: Nutrition Websites & Databases https://libguides.regiscollege.edu/nutrition/intro EWG's Food Scores https://www.ewg.org/foodscores/ Open Secrets https://www.opensecrets.org/  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Deb (00:03.606)Within the next seven months, up to 1.5 million Americans could lose access to a medication that they’ve relied on for decades. Not because it’s dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you’re one of them, your doctor may already have told you about this issue and stopped prescribing it.This isn’t a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they’re the same ones manufacturing the only product that might survive.Today on Let’s Talk Wellness Now, we’re exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I’m about to share what could save your access to the medication keeping you alive.Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I’m Dr. Deb, naturopathic doctor, your medical detective, and today we’re diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,for hypothyroidism or if you’ve struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I’m about to reveal will make your blood boil. Now grab your cup of coffee, don’t forget your notebook and settle in because what’s happening to this medication right now is a masterclass in how pharmaceutical companies use regular Deb (02:06.544)agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts. Deb (02:20.982)Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.Now let’s really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn’t some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn’t have to Deb (04:08.112)go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here’s what matters. Some patients…a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval. Deb (06:04.654)a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA’s official statement, FDA’s actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.This wasn’t a guideline. This wasn’t a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it’s an estimation of 1.5 million patients receiving prescriptions for these medications.could potentially lose their thyroid access. Now, here’s where it gets interesting. The FDA didn’t wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what’s really happening in this industry.The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding. Deb (08:13.972)This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.Then two months later, in November of 2022, the FDA’s Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?I honestly don’t know of any other drug that’s been around this long that’s used by this many people. Now granted, I haven’t done the research on it either, which I can do for you guys, but I’m just thinking if a drug is on the market today and it causes harm, it doesn’t make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?Hmm, just thought. But here’s the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down. Deb (10:09.806)August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.The FDA cited, and I’m quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.Second, the agency expressed concern about batch inconsistency. According to the FDA’s official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let’s back up. I want you to remember I said that Deb (12:11.216)because further down in this podcast, we’re going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material, including potential for viral contamination due to the animal source and supraphysiological levels of T3.the FDA statement on impurities, viral contamination and super physiological T3 levels. Now I will tell you, I’ve been prescribing armarithograde for 20 years. I’ve rarely seen a super physiological dose given of T3 in lab results, unless the patient takes their medication like four or five hours before you do the blood test, then you’ll see a false rise because you’re actually seeing the medication. You’re not seeing people walking aroundsuperphysiological T3 levels. Nobody would like that feeling. So anyway, I digress. Now let me pause here because this is where I need to give you some context that the FDA hasn’t quite emphasized yet. Of course, we have another connection and it is the China connection.So the FDA’s concerns about contaminated drugs and quality issues don’t exist in a vacuum. In 2024, the U.S. over 828,000 metric tons of pharmaceuticals, seven times the level from 2000. And here’s the kicker. China and India supply the majority of active pharmaceutical ingredients. APIs for U.S. generics accounting for 70 to 80 % of the total genericdrug supply. According to Reuters industry report in 2024, they state that China supplies 82 % of the APIs for critical drugs. Deb (14:08.204)Got to question that, right? Why are we giving all of our drug formulas to China and allowing them to import them into our country? In fact, roughly 20 % of the critical drugs have APIs exclusively sourced from China. And China controls 80 to 90 % of the global production for antibiotics and other key compounds. This was also cited by Reuters industry data thatcontrols 80 to 90 percent of the global production for antibiotics and other key compounds. Now just think about this. They control 80 to 90 percent of our medication. They control 20 percent of our critical drugs and we just put what kind of tariff on them? Hmm.In 2025 alone, the FDA issued multiple warning letters to foreign manufacturers for contamination issues and failure to follow good manufacturing practices. This is also cited by the FDA warning letters 2024 through 2025 and multiple citations to foreign manufacturing facilities. This is a systematic problem affecting the entire US drug supply, not just desiccated thyroid.So when the FDA suddenly became concerned about DTE quality and contamination, part of that concern was legitimate. But this is crucial. The same inconsistencies and contamination issues exist across the entire generic drug supply. And the FDA has not taken the same enforcement action against them. Let that sink in.They have not taken the same enforcement action against the other drug companies. So what’s behind all of this? Where is this all coming from? Hmm. Let’s address something directly, because you deserve to know it. And I’m going to cite my sources precisely so that when the medical boards have something to say about this, and they might, I have a documentation for every single word that I am about to speak. Deb (16:24.878)According to the court documents filed in October 2025, in the case ofa urine, a urine. I’m going to say that wrong. Pharmaceuticals versus Dr. George Tidmarsh from ABBV, the multinational pharmaceutical company that manufactures armor thyroid, reportedly petitioned the FDA in 2024, asking the agency to reclassify DTE as a biologic and to prohibit other manufacturers from selling unlicensed DTE products unless they havehad an investigational new drug application, we call this an IND, and a clinical development program aimed at eventual approval. This is cited in the court filing a Urena pharmaceuticals lawsuit versus Dr. George Tidmarsh, October 2025, reported by Fierce Pharma. Now let me explain why this matters and why this is one of the most brazen examples of regulatory capture I’ve ever seen in my career.AbbeVee is one of the world’s largest pharmaceutical companies. In 2024, they reported over $54 billion in revenue. Drop the mic on that one.They have the resources, the regulatory expertise, the legal teams, and the financial capacity to navigate a biologics license application process that costs between $500 million and $1 billion. Let that sink in. Deb (18:07.882)A drug that’s been on the market since the 1800s that was grandfathered in 1938 that’s making plenty of money right now. They’re going to spend 500 million to $1 billion to get a biologics license application. Why would they do that? Well, we’re about to find out. Most otherDTE manufacturers, smaller companies like Acela Pharmaceuticals, which makes NP-thyroid, and RLC Labs, which made WP-thyroid, do not have those same resources. And this is cited in Pharma Voice in 2025. Why a treatment older than the FDA is getting new regulatory scrutiny. So when you petition the FDA to reclassify a drug in a way that requires this type of expensivetime-consuming biological approval, you’re not just asking for safety. You’re asking to eliminate your competitors from the marketplace. Now, I want to be very precise here. These allegations are documented in federal court filings, and it hasn’t been approved in court. It’s also been reported by multiple industry sources, including Fierce Pharma. But I’m telling you,what has been reported in legal proceedings, not stating it as an absolute fact because you deserve to know the difference and because I have to protect my license. Now, what do we know for certain?AbbeVee is working on a biologics license application for Armour thyroid through clinical trials called Avantia. This is cited by the AbbeVee corporate statement 2025 Avantia clinical trial for Armour thyroid. A cell of pharmaceuticals has been pursuing BLA approval for NP thyroid for seven years since 2017 and it completed its phase two trials successfully in 2025. They’re now moving Deb (20:15.448)into Phase 3 trials. This is also cited by the Acela Pharmaceuticals CEO statement 2025 seven-year pursuit for BLA approval completed Phase 2 trials moving to Phase 3.RLC Labs, which manufactured WP thyroid, has made no public announcement about pursuing BLA approval and really probably don’t have a plan to do this since they’ve been off the market for some time now. About five years, I think maybe a little longer. Here’s the market manipulation.If only ABBV is successful and obtains a BLA approval for Armour thyroid, that company would effectively have a monopoly on the DDT market. And in pharmaceutical markets, monopolies historically lead to price increases.We’ve seen this pattern over and over again when turning pharmaceuticals acquired Daraprim and raised their price from $13.50 to $750 per tablet overnight. When Myelin raised EpiPen increased prices by 400 % when insulin manufacturers colluded to raise prices in lockstep. This is the playbook.use regulatory barriers to eliminate your competition and then exploit pricing power. For a drug that’s been on the market since the 1800s, guess corporate greed is everywhere. They’re not making enough money on this product already and they’re taking advantage of the rules that they can manipulate their competition by. And here’s what really makes me furious. The American Thyroid Association, the professional organization Deb (22:06.672)representing endocrinologists sent letters to the FDA commissioner on October 8th of 2025 and September 18th of 2025.advocating for continued patient access to DTEs. This is cited in the American Thyroid Association statement and letter to the FDA commissioner dated October 8th, 2025 and September 18th, 2025. The American Association of Clinical Endocrinologists issued a statement on September 9th of 2025 supporting equitable access and personalized medicine for DTE. This was also cited in the American AssociationAssociation of Clinical Endocrinologists, AACE, statement dated September 9th, 2025. Even the medical establishment, which has historically favored levothyroxine, is saying, wait, this is going too far. Patients need access to this medication. But the FDA is moving forward anyway. Why? Well, where does it always lead us? Follow the money trail.Okay, so I need to explain what a biologics license application actually is because this is where the rubber meets the road for what’s going to happen to pricing and availability. What is a BLA?A BLA is a biologics license application. It’s a formal request submitted to the FDA to market a biologic product in the United States. A biologic is defined under the Public Health Service Act section 351 as a product derived from or made using living material, in this case, animal thyroid glands. And this is cited in the FDA definition for biologic products. So they’re putting armor thyroid right Deb (23:57.377)right up with stem cells and exosomes. Think about that. Stem cells and exosomes cost thousands of dollars per application because of how they have to be harvested, stored, freezed, all of that. But we’re talking about a thyroid gland. Good Lord, people.Unlike regular drug applications for synthetic medications which follow a simpler pathway, the BLA process is designed for complex biological products like monoclonal antibodies, vaccines, and gene therapy products. It’s a much more expensive, much more time-consuming process. The BLA processis what manufacturers have to do. And we’re going to talk about that. So according to Reprocell and Forge Biologics analysis of the FDA’s BLA process, here’s what companies need to submit. First, they need to complete a clinical trial data, phase one, two, and three trials, proving safety and efficacy for desiccated thyroid. Haven’t we done that since it’s been on the market since the 1800s? Just saying.This means they have to conduct large randomized controlled trials comparing it to levothyroxine, measuring safety outcomes, efficacy outcomes, and quality of life metrics. Second,Chemistry, Manufacturing and Controls, CMC’s data. Detailed information about how the product is manufactured, quality control measures, stability testing and specifications that must be met for every batch. Third, preclinical and animal safety data. Fourth, labeling and product information. Now, I think we have labeling and product information. Deb (25:53.717)since the 1800s? But just saying. Fifth, they need Pharma Covigilance Plan, a detailed plan for monitoring safety after the product is on the market. Haven’t they had to do that since the 1800s? And they have to have a timeline. And this is the critical part. The FDA’s standard review time for a BLA is 10 months.That’s after the application is deemed complete and accepted for filing. So this is cited by the FDA standard review timeline, BLA submission, and FDA review.Now, before you even get to filing, you need to conduct the clinical trials and compile all the data that’s typically several years of work. How are you going to prove safety and effectiveness in a large clinical trial long term? What do they consider? What do they deem long term? Three months, six months, a year, two years. These companies had 10 months.Well, maybe 12. They did it a year in advance. But unless you knew this was coming, how are you going to put together a trial, enroll the people, have all the trial components set up and ready to go in less than 12 months unless you knew it was coming beforehand? Even ifhad started all their clinical trials in 2024, completing them, compiling the data, and getting a complete application ready for submission, this would likely take you through mid-2026, then add another 10 months for FDA review. We’re looking at 2027 at the earliest for most of these companies to receive a BLA application. Deb (27:54.319)But the FDA gave the manufacturers until August of 2026. That’s approximately 19 months from when the August 2025 letters were sent. Most companies cannot reasonably complete the BLA approval in that timeframe. And when I’m talking about the 19 months, I’m talking about the information they would have had earlier. Now the cost.This gets me even more frustrated. Why are we spending this kind of money? The BLL process is extraordinarily expensive. The current FDA user fee for a BLA submission is approximately $483,560 just for the filing fee. And this is cited at the FDA user fees prescription drug user fee rates for 2025.The full cost of conducting clinical trials, CMC studies, and all the supporting documentation typically ranges from $500 million to over $1 billion, depending on the scope of the trials and the complexity. And this is cited in JAMA’s network, Open2023. A cell of pharmaceuticals has been pursuing the BLA approval since 2017. That’s eight years. And it’s just now.moving into phase three trials with a planned enrollment of approximately 300 patients. This is cited by the Acela Pharmacies CEO statement of 2025. Now that’s unusual. That’s typical for this process. This is not unusual. This is typical for this process to take seven, 10 years to get approval for this. So if Abby’s the one that requested this,Abby V. And Acela started this in 2017. Was Abby V threatened by Acela that Acela might get this approval and it would be quietly done without anybody seeing it? And maybe Abby V would be left out of the market after a century? Who knows? It’s possible. Deb (30:13.112)But for smaller manufacturers without billions in revenue, this cost is completely prohibitive. And this is why this matters. When you push an old established medication through an extraordinary, expensive approval process with a compromised timeline, one of three things happen. First, only the largest companies can afford it, creating a monopoly. And when that happens, the company that holds the only approved product can set pricing withminimal competitive pressures. Two, smaller manufacturers can’t afford it and their products disappear and the market shrinks and access decreases. Three, we see a combination of both and who pays the price? Literally, patients do. Now here’s whereThere’s something I want you to really think about because this is where the regulatory argument falls apart when you look at it carefully. The FDA’s concern about DTE is that, and I’m quoting their official statement, tablets from the same manufacturing batches may not always provide the same thyroid hormone levels. This is from their FDA statement.And that’s a legitimate quality concern, right? It is. Thyroid medications have a narrow therapeutic window like any other hormone, meaning the difference between an effective dose and the dose that causes problems can be quite small. But here’s what the FDA doesn’t emphasize. Generic drugs have the exact same dosing inconsistency issue, and it’s considered acceptable and has been since we allowed generics on the market.So how does a generic drug dose work anyway? Well, for generic drugs to be approved as bioequivalent to a brand name medication, the FDA requires that the generic drugs bioavailability fall within 80 to 125 % of the brand name product. Isn’t that a dose inconsistency? Deb (32:22.894)from the brand name medication? 800 or sorry, 80 to 125%. According to the pharmacy times analysis of the FDA’s bioequivalent standards, the 80 to 125 % bioequivalence rule means that a generic drug can have 20 to 45 % variability compared to the original brand product.Now, most generics are much closer than that. The FDA study data shows that the mean difference for an AUC value between generic and reference products is about three and a half percent in the two year post-Waxman hatch period, and 80 % of the generics fall within a five percent range. But the FDA’s regulations allow for that much higher variability. And this is cited in an FDA study data mean difference for AUC.Now, let me put this in plain language. A patient could take a generic levothyroxine tablet where one batch provides, say, 75 micrograms of an active thyroid hormone. And the next batch from a different manufacturer, a different generic manufacturer, could provide up to 93.75 micrograms, 125 % of that 75. That’s an 18 microgram difference.in the same prescribed dose. Now, this is considered acceptable and patients tolerate it and this system works.Yet the FDA’s argument against DTE is that batch-to-batch inconsistency is unacceptable and requires this expensive biologic approval? That’s a double standard. So why is batch inconsistency acceptable for generic levothyroxine, but supposedly unacceptable for desiccated thyroid? I’ll give you the regulatory answer. Deb (34:29.366)because DDT is a biological product derived from an animal tissue and the FDA considers biological products to require more rigorous control. That’s the regulatory answer, but I’ll give you the real answer.because there’s no billion dollar pharmaceutical company with a patent pending on generic levothyroxine who petitioned the FDA to regulate their competitors more strictly. The inconsistency argument is legitimate, but it’s selectively applied. And that matters when you’re trying to understand whether this is really about patient safety or whether it’s about market control.Now I want to talk about something that hasn’t gotten nearly enough attention in this discussion and it’s something that makes me absolutely furious. What is Armour Thyroid? According to the official prescribing information published by AbbeV and available through rxabbev.com and the FDA’s daily med database, Armour Thyroid contains the following inactive ingredients. Calcium steroid,dextrose derived from corn, mycocrystalline cellulose,sodium starch glycolate and a opadri white coating. Now let’s talk about dextrose. Dextrose is a sugar derived from corn and while manufacturers claim that the corn derived dextrose in armor thyroid is gluten free, here’s the problem. Cross contamination during corn processing can introduce gluten proteins especially if the corn is processed in facilities that also handle Deb (36:18.808)wheat, barley, or rye. Corn sensitivity is extremely common in patients with celiac disease and non-celiac gluten sensitivity, and studies show that up to 50 % of the celiac patients react to corn proteins due to molecular mimicry, and the corn proteins look similar enough to gluten that the immune system attacks them. And this is cited by RestartMD.com.And here’s what’s documented in peer-reviewed medical literature in a 2023 case report published in Case Reports in Endocrinology. These researchers documented five patients with gluten intolerance or celiac who were taking natural desiccated thyroid. Three of those patients also reported lactose intolerance. Now these patients had to switch from DTE to liquid levothyroxine formulations to avoid the inactiveSo here’s my question. If AbbeV becomes the only manufacturer with an approved DTE product and their formulations contain corn-derived dextrose that triggers reactions in celiac patients, what are those patients supposed to do? They can’t take armor because of the corn. They can’t take compounded DTE because the FDA is banning compounding of these biologics. They can’t take NPKsor WP thyroid because those companies may not survive the BLA process. So they’re left with a synthetic version of levothyroxine which may not work for them.Now the NP thyroid and WP thyroid difference. Now here’s what’s interesting according to drugs.com comparison of inactive ingredients and P thyroid and P thyroid has calcium steroid dextrose also derived from corn, mineral oil, multi-crystalline cellulose. Deb (38:19.31)cross carmelicin sodium and a opadri to white. So NP thyroid also has corn-derived dextrose. WP thyroid on the other hand was specifically formulated to be hypoallergenic according to ROC labs, but it’s no longer available and its ingredients were inulin from chicory root and medium chain triglycerides. No corn, no gluten, no common allergies. So todayWe do not have a glandular thyroid, a DTE, that is not potentially contaminated with gluten. Yet, patients with autoimmune thyroid disease are supposed to avoid gluten.Now, some of these people can handle a DTE and many cannot, so that argument could be a mute point. But at the end of the day, the one product that we had that was designated for patients with multiple chemical sensitivities, celiac disease and coron allergies, has been off the market for a long time already.We have a monopoly problem. So if ABBV becomes the only approved manufacturer, patients with these celiac diseases and corn allergies will either be forced to take a medicine that makes them sick and triggers their immune reaction or switch to a synthetic that doesn’t adequately treat their hypothyroidism or choose to go without treatment. This is not hypothetical. This is real patients with real medical needs who are about to lose accessto the only formulation that works for their body. And the FDA’s response is silence. Deb (40:07.69)Now I want to highlight something that hasn’t gotten nearly enough attention in this discussion. Compounding pharmacies. What is a compounding pharmacy? Compounded medications are custom made by licensed pharmacists to meet a patient’s specific needs. Maybe you need a different strength that was commercially available, but you have an allergy to a filler or a dye in the commercial product. Maybe you need a liquid formulation or instead of a tablet or you need a capsule. That’s when compoundingin. And the FDA’s, this is the FDA’s definition of compounding. And for decades, compounding pharmacies have been making desiccated thyroid extract for patients who needed customization. Some patients couldn’t take the commercial products because of the dyes and the fillers, and some needed strengths that were not available. And these compounding pharmacies filled the gap.But reclassification changes everything. When the FDA reclassified DTE as a biologic in 2022 and reinforced that decision in August of 2025, explicitly stated, and I’m quoting directly from the FDA’s official statement, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biologic products under the Public Health Service Act.How can that be? These products have been approved since 1938 and the Biologics Act didn’t go into effect or doesn’t go into effect until August of 2026.So how in 2022 were they able to say that the compounding pharmacies could not make these products? Anyway, what this means is after August 2026, compounding pharmacies will no longer be permitted to compound a desiccated thyroid extract, even for patients with specific medical needs. Now, compounding pharmacies can still compound T4 and T3 separately, synthetic versions of levothyroxine and liothyronine, according to Deb (42:12.728)healing dose compounding pharmacy. These pharmacists can create custom ratios of these two synthetic hormones to approximate what a patient was receiving from a DTE. But that’s not the same thing. Some patients respond better to the whole DTE preparation than to a compounded synthetic combination. And for patients with specific allergies to standard fillers like your celiac patients that I just talked about, losing the ability to get a compounded DTE alternative isreal hardship. This is going to be a ripple effect. For a subset of patients, maybe 5 to 10 percent of those on DTE compounding was their lifeline and it was their way to get a medication formulation that worked for their unique body. When compounding goes away, these patients lose that option as well and for some it will be a significant problem. Now let’s talk about what this likely means for your wallet.The current pricing right now, according to SingleCare and GoodRx, Armour Thyroid costs approximately $150 to $157 for a 90-day supply of 60-milligram tablets, about $1.67 per tablet. With discount cards, some patients can get it down to $101 to $152 for a 90-day supply.Generic levon thyroxine costs about $70 for a 90 day supply, less than half that price. And p-thyroid costs approximately $133 for a 90 day supply of 60 milligrams with a discount card about $83 to $101.What happens after we get BLA approval? Well, here’s the pharmaceuticals pricing model. When a company spends 500 million to $1 billion to bring a product to market, including conducting massive clinical trials, the cost tens of millions of dollars they recoup in that investment through pricing power. And this is cited in the pharmaceutical pricing models. If ABBIEV is the only company with an approved BLA of DTE, Deb (44:18.248)They have pricing power. They don’t have competitors. They can set their price, whatever they want. And historically, when drugs transition from grandfather status, which is basically unregulated to formal formally approved status, prices often increase significantly, not always, but often. And typically they have to get re-approval for insurance. SoTouring Pharmaceuticals acquired DARPM and raised the price again from $1,350 to $750 overnight, a 5,000 % increase. This is the playbook.Let’s talk about insurance coverage. This is the other consideration. Insurance companies sometimes have different coverage policies for approved versions versus unapproved drugs. And right now, many insurance plans cover armor thyroid or NP thyroid, even though they’re technically unapproved because they’ve been on the market for decades and patients are on them. Once a drug becomes formally approved, insurance companies may have new contractual relationships, prior authorization requirements, or preferred drugs.list that could affect your coverage. If 1.5 million people have to get a prior auth for their insurance to cover this new medication, this is going to drive the doctor’s offices crazy. We do not have the staff to man this. We do not have the manpower. We do not have the time. This is going to interrupt people’s ability to get their medications. This is going to create chaos within the system. And some patients might see better coverage, but manymost likely are going to see worse coverage and some might find themselves in a situation where they need to try to get the drug approved first or get an approval for something else like levothyroxine and they’re going to have to document that it didn’t work and the documentation that they had from 20 years ago is probably not going to be enough because it’s not documented anywhere. It’s lost in the system after 10 years. So for patients the practical takeaway is expect Deb (46:25.774)a price increase. I would say possible, but I don’t think that’s true. think you’re going to see a price increase if they get approved. Expect possible insurance complexities, budget accordingly, talk to your insurance company now about what your coverage is going to look like in 2027 if they even know. And if you want my honest assessment of what is likely to happen,I’ll give you a scenario, 30 % likelihood. The FDA enforces the August 26 deadline and DTE products not approved by then are pulled from the market. Patients will have 30 to 90 days to transition to other medications. Some patients suffer significant symptom relapse. Compounding for DTE becomes illegal and this disruptiveness of the system creates a real hardship. Scenario two.which is 50 % likely. This is actually what the FDA commissioner, Marty McCreary suggested on August 13th of 2025 when he posted on social media. The FDA is committed to pursuing the first ever approval of desiccated thyroid access pending results of the ongoing clinical trials. In the meantime, we’ll ensure access for all Americans. Hopefully that continues. What this likely means is the FDA uses enforcement discretion to allow continuedsales while approvals are being pursued and the deadline gets extended. Maybe patients get access for another two to three years while companies work on a BLA approval. This would be the least disruptive scenario, but it’s also legally uncertain because the enforcement letters have been formally rescinded. And scenario three, which is 20 % likelihood, one or two companies get BLA approval. Those products stay on the market at higher product prices and companies, products, other companiescompanies, products are pulled, the market shrinks, availability is limited, prices are higher, but patients can still get something. This is likely if a seller successfully completes phase three trials for NP-thyroid. And my assessment is based on the regulatory language and the enforcement letters that have not been rescinded yet, that the pattern of FDA enforcement, I believe scenario two enforcement discretion with an extended time frame is most likely what we’re going to see. Deb (48:49.488)doesn’t mean patients should sit back and do nothing. It means you should be prepared for change while advocating for access. If you want to keep Arm or Thigh Right on the market, 1.5 million people need to start talking about this publicly and flooding our Congress people, Bobby Kennedy, the FDA, with what you want to see happen. We have the ability to shape this and to change this with our voice. But if we sit back on our laurels and we do absolutelynothing. What is going to happen is what the FDA wants to have happen and ABV wants to have happen because they’re going to simply think people don’t give a shit. And if the American people are going to be lazy and not want to step forward and actually start using their voice for some good and instead of just going to social media and bitching and hoping something is going to happen, well, then we’re going to get what we deserve. But if you start taking someaction and you start advocating for the things that you want. Contacting your representatives, contacting your U.S. tell them the FDA has done this. Many of them may not know this, may not be on their radar. Tell them what you want. Start going after this. Start writing to the FDA Commissioner’s Office. They have a website. They have a Commissioner’s Office at fda.hhs.gov. Be responsible.respectful, but be firm. Explain your scenario. How long you’ve been on DTE. Why levothyroxine doesn’t work. What symptoms you experience when not adequately treated. How this decision will affect your quality of life and your pocketbook. Let’s do something proactive. So let’s consider this. Moving forward, work with your provider who understands the regulatory landscape around DTE. You can discuss the evidence for and against combination therapy.You can monitor for thyroid function with free T3 and free T4 testing, not just TSH. If you’re willing to try individualized approaches, you can do that. If you need help finding a functional medicine provider who understands this issue, come to serenityhealthcarecenter.com or explorethevanari.com. It’s a self-directed functional medicine support group. And right now what is happening is going to shape how history Deb (51:19.024)is made with not just armor thyroid, but many drugs to come. And it is important for you to take action. So I want to thank you for joining me today on Let’s Talk Wellness Now. This episode is about far more than thyroid medication. It’s about your right to personalized medical treatment. It’s about your regulatory capture and corporate influence. And it’s about what happens when billion dollar companies shape healthcare policy in ways that reduce patient choice and increase their profits.this episode resonates with you or you know somebody who’s going to be affected by desiccated thyroid, please share it. Post it on social media, send it to your doctor, email it to your representatives, tag AbbeVee, tag FDA. Make noise because the only way we stop this is if we make it too politically costly for them to continue. Your voice truly matters. Your health truly matters and you deserve access to treatments that work best for your unique body.If you’re ready to explore comprehensive personalized health care that puts you in control, visit us at SerenityHealthCareCenter.com. Learn more about functional medicine approaches to thyroid and beyond and explore my new platform, Venari.com, which is a self-directed functional medicine tool. Thank you for joining me today. Until next time, I’m Dr. Deb reminding you, your health is your responsibility, your choice, and your right. Be well, stay informed, fight back.and I’ll see you in the next episode. And if you’re looking for a full citation list of this episode, you can head over to letstalkwellnessnow.com and I will post all the citations for you so you have them in your arsenal as well. Thank you again.The post Episode 259 – The Desiccated Thyroid Crisis: FDA's Unseen Impact & Corporate Manipulation first appeared on Let's Talk Wellness Now.

Peptides are everywhere in longevity and functional medicine, but what does the law actually say? In this episode, Dr. Matt Kaeberlein breaks down what a peptide is and the complex regulatory landscape governing peptides in the United States, from FDA approval frameworks to the legal gray zones surrounding compounding pharmacies and unapproved substances.Drawing on the Federal Food, Drug, and Cosmetic Act and real-world enforcement cases, this episode offers a clear-eyed, non-judgmental examination of what is legal, what is tolerated, and what carries genuine risk for physicians, pharmacies, and patients alike. An essential listen for anyone navigating the rapidly evolving world of peptide therapeutics.Timestamps:00:00 — The Tailor Made Compounding Case: Criminal Prosecution & FDA-Flagged Peptides00:54 — Welcome & Episode Overview: The Regulatory Environment of Peptides01:36 — What Is a Peptide? Definitions and Biological Context03:26 — Are Peptides Regulated by the FDA?04:16 — Two Regulatory Frameworks: Biologics vs. Chemically Synthesized Drugs05:17 — The Food, Drug, and Cosmetic Act: Which Peptides Fall Under It?06:11 — Why Two Frameworks Exist: A Brief Legislative History07:06 — The Core Rule: FDA Approval vs. Unapproved Status07:54 — FDA-Approved Peptides: What Can Legally Be Prescribed09:11 — Compounding Pharmacies: When Is It Legal?10:01 — The Unapproved Peptide Bucket: A Long List10:55 — Legal Status of Unapproved Peptides Under U.S. Law12:34 — The Bulk Drug Substances List: What It Is and What It Isn't14:11 — FDA's "Significant Safety Risk" Flagged Peptides15:04 — Why Some Pharmacies Still Compound Unapproved Peptides16:44 — The Gray Area: Speeding Analogies and Cultural Norms17:38 — Degrees of Risk: Formulation, Approval Status, and Data Quality18:38 — Who Bears Legal Liability? Pharmacies, Physicians, and Patients19:39 — The Tailor Made Compounding Case: DOJ Action and Criminal Conviction20:34 — Risk to Physicians and Patients Summarized21:24 — Self-Sourcing Peptides Online: What Consumers Should Know22:14 — Prescription Drugs Without a Prescription: Legal Nuance23:06 — Final Thoughts: The State of Peptide Medicine Today23:58 — How Enforcement Norms Can Shift and Why It Matters Now24:48 — Questions to Ask Yourself: Risk Tolerance and Physician Choice25:21 — An Informed Consent Framework for Peptide Use26:03 — Coming Up: Individual Peptide Deep-Dives in Future Episodes

Neoborn Caveman unpacks a pro-humanity critique of agency loss and non-consensual testing, exposing the 2016 21st Century Cures Act's Section 3024 allowing waiver of informed consent for minimal risk clinical investigations, ties it to MK Ultra experiments and DARPA tech like nanobots or neuralinks, warns of hidden implications in COVID vaccines and digital IDs enabling mass surveillance and control, questions government ethics in bypassing human rights for profit, and urges awareness to counteract manufactured consent through unity and truth.Music guests: pMadKey TakeawaysInformed consent waivers erode human rights.Minimal risk criteria enable unethical experiments.Government acts prioritize profit over safety.Historical abuses like MK Ultra persist today.Vaccines and tech risk non-consensual alterations.Digital IDs facilitate total control.Awareness counters manufactured narratives.Unity protects against elite agendas.Truth demands questioning authority.Humanity requires vigilance for freedom.Sound Bites"Chronical testing of investigational medical devices and drugs no longer requires the informed concern to subjects if the testing poses no more than minimal risk for the subject and includes safeguards.""In 2016, President Obama instituted the 21st Century Cures Act and it was sold for American citizens as a way of fight an opioid epidemic crisis.""It is legal to experiment on American citizens without their consent as long it does not exceed minimal risk criteria.""This provision modifies the investigational drug and device statutory authorities to allow for waver or alteration of informed concern""Prior to the Act HHS Human Subject Regulations permitted an IRB to waive or alter informed concern for certain low-risk research while a federal food drug and Cosmetic Act, FDCA did not contain a similar provision.""it is already happening so how can you stop it? Well evil only is afraid of darkness is scared scared of what?""talk about it. Think about it. Question it. Could be? Should it be? How would we?""when you feel this never ends is it your feeling or is it a generated manufactured feeling"Join the tea house at patreon.com/theneoborncavemanshow—free to enter, real talk, lives, no ads, no algorithms.keywords: 21st century cures act, section 3024, informed consent waiver, non-consensual testing, mk ultra, darpa experiments, covid vaccines, digital ids, agency loss, human rightsHumanity centered satirical takes on the world & news + music - with a marble mouthed host.Free speech marinated in comedy.Supporting Purple Rabbits.Viva los Conejos Morados. Hosted on Acast. See acast.com/privacy for more information.

Retatrutide is years away from FDA approval and yet the fight over access, price, control of this medication is already well underway. That's what this podcast is going to be about today. There's well over a hundred thousand people by my estimates who are already on some form of this medication today. And that should tell you enough about how disruptive this molecule is and will be. It is a game changer among game changer. We've been talking about it for three years here at On The Pen, well before any of your favorite gym bros were talking about Retatrutide. We were talking about Reta, who tried Retatrutide here at On The Pen. And that's because we identified this triple agonist as a game changer among game changers. So This is going to be a very Retatrutide heavy episode, and so I hope you'll join us and stick with us if this is a topic you enjoy, because I think this is really going to effectively lay the groundwork for what accessibility to this medication will look like. So let's get into it. Welcome to the On The Pen Podcast with your host, Dave Knapp. Welcome to the On The Pen, the weekly dose podcast. This is our weekly roundup in incretin memetic news. And frankly, there's no news that is bigger than Reta-Trutide news. Just find me any news that is bigger than the data that we got on Reta-Trutide. Now, we already did a video about the Triumph Phase II clinical trials that we got in osteoarthritis of the knee. You can go back and check out that video if you'd like more data. So we're not gonna super... rehash the data. We'll go over at a high level what the data showed us. We're not going to go over how the medicine works, because by now we all know that it's the triple agonist, right? If terzapatide was a dual agonist, GLP-GIP, Retatrutide is the triple agonist that adds to it a glucagon component, which is absolutely just shredding, shredding liver fat. It is absolutely revving up people's metabolism and showing a tremendous amount of weight loss. So let's get into what the weight loss looked like in this first trial, because there are longer obesity trials where, where the primary outcome is the weight loss this was again a specific trial in measuring pain reduction in folks with osteoarthritis of the knee but check out these numbers these are placebo adjusted meaning it's taking the two percent out that people lost on placebo but looking at these numbers Folks on one milligram over forty eight weeks lost seventeen percent. They bumped up to four milligrams. Those folks lost twenty two percent. So right there at the lowest dose, you're already reaching the efficacy of today's drugs that are on the market, like triseptide and semaglutide in their various forms. If you bumped up to eight milligrams, you saw twenty four percent placebo adjusted weight loss and at twelve milligrams, twenty six point four percent weight loss. Adding back in that two percent of the placebo that those on placebo loss, that's twenty eight point four percent weight loss in these forty eight weeks at the highest dose. When you adjust for some of the more real world outcomes, you kind of ding the numbers a little bit based upon people who quit the drug, et cetera. Those numbers look more like a twenty percent weight loss and twenty three point seven percent weight loss at the highest dose. But even then, you're still seeing a drug that is better than the current drugs that are on the market. around forty eight percent of patients on Retatrutide lost greater than twenty five percent. And then if you were at that twelve twelve milligram dose, that highest dose patients lost fifty nine percent of patients lost more than twenty five percent of their body weight. There was a subset that lost thirty percent of their body weight and some even over thirty five percent of their body weight on Retatrutide. So the lower doses compete with today's best drugs and the upper doses are entering into bariatric surgery level weight loss. And that's putting the whole obesity system on notice and probably a lot of surgeons nervous because typical body weight loss was something like the street sleeve gastrectomy. For example, it's about eighteen to twenty five percent body weight. The Roux-en-Y gastric bypass twenty five to thirty five percent weight loss or the duodenal switch thirty to forty percent weight loss. So the upper doses of Ritutrutide overlap with sleeve and bypass outcomes without any surgery. It's incredible. It is a game changer among game changer. It is the new benchmark in obesity medicine. And there's actually more data, like I said, landing in later twenty twenty six. The longer duration will historically, if history is a marker, equal more weight loss than we even see here at this forty eight weeks. We have an interview that will be airing later this week on our channel and on our podcast with our friend Mimi from Australia who just wrapped up her clinical trial on Retatrutide. They ended it like ten weeks early on her, which was a huge bummer to her. So we're going to hear from her because she had to end abruptly. We're going to hear her story, an incredible story. She's one of those folks that got up that thirty five percent body weight loss in the time that she was on Retatrutide. So, this is just showing you that these drugs are not simply an alternative to bariatric surgery. We are approaching a point in time where these are on par with bariatric surgery, and as people are on this Reta-Trutide trial, you see that these numbers aren't plateauing either. So we will see stronger weight loss numbers the longer that these folks are on this trial. And I think you'll see some of those numbers in that population of folks on the higher doses eclipse maybe even some of what we see with some of these bariatric surgeries. the real story that i think is taking shape here is not in how powerful Retatrutide is because we've literally been expecting or anticipating this kind of data for more than three years at on the pin we've been talking about this and i think that's sort of reflected in the fact that you didn't see this massive spike in eli lilly stock wall street was expecting this as well Um, so it was on par, I think with expectations, but the expectations are astronomical compared to previous options that were available to patients and all the innovation in the world. All of these drugs, we talked at last week about WV, E double Oh seven, the James Bond of weight loss that targets fat, not only targets fat loss, but it also targets the promotion of building of, of lean muscle mass. We're talking about an insane future in obesity medicine. But none of it means anything if people can't access it. And that's really where we are today in terms of ensuring that there's going to be an option for everyone. And that's sort of what I want to get into today, because Lilly wants Retatrutide to be classified as a biologic, so not a traditional small molecule drug like you've seen every other incretin and nutrient-stimulated hormone-treating obesity on the market to date. They're trying to get this classified as a biologic. Now, we talked about this before on the podcast. That matters in three major ways. It affects the exclusivity length of time that a pharmaceutical company has on a drug. That goes from, I believe, five years of market exclusivity to twelve. It affects compounding rules because biologics cannot be compounded. And then that gives the pharmaceutical companies a tremendous amount of pricing power in the marketplace, because essentially there's no competition and there's no competition for a long time. But this whole argument about getting this classified as a biologic is not about safety. It's about protection and we're going to get into it. So let's explain this here. This is why Retatrutide really is not a biologic arguably. So biologics are large proteins. There are hundreds of or even thousands of amino acids grown in living cells that are sensitive to tiny manufacturing changes. Retatrutide is a short chain peptide. It's chemically synthesized and it is below the traditional biological size thresholds when it comes to how those things are defined. We'll just leave it at that. So even though it acts like a biologic in the body, it's made like a drug. It's made like a small molecule drug. And if it's treated as a drug, they get, like I said, five years of market exclusivity. Now, really a lot of confusion around what this means, but essentially the first five years of the life of a drug, the patent can be challenged for a number of reasons. We've seen patent challenges right now are going on in the courts for both semaglutide and terzepatide. But these companies are guaranteed that five years of market exclusivity, no matter how those patent lawsuits shake out. That five years jumps to twelve years with the biologic. So ultimately, there's no biosimilars that are allowed during that twelve year window. Again, with terzapatidin and semaglutide, it's five years. They could lose their market exclusivity within five years of the release of the patent. twelve years with a biologic. So if they lose their patent challenges on Trezabitide, they still have some time left with market exclusivity for the drug. They likely will not lose those, but that jumps to twelve years. And I think the most important thing to understand about the reclassification of Reta-Trutide to a biologic would mean that, 503A and 503B pharmacies are effectively locked out of compounding this medication, 503Bs would have some latitude arguably, but they would face extreme barriers. Routine compounding becomes legally and technically restricted because biological status doesn't slow compounding down. It actually shuts the door or almost completely shuts the door. Biologics not only would allow Lilly to have longer market exclusivity, no compounding, but it would allow them to command a higher price in the marketplace because A, they get this designation and there's an assumption when they bring this to market that they're harder to manufacture, that they're harder to copy, that there are fewer negotiating alternatives for payers. They can command a higher price with the insurance companies, and the price pressure stays muted for much longer because, again, you don't have those pressures of compounding. You don't have the pressures externally from lawsuits that could end your market exclusivity in that first five years of the drug's existence. So there's just a lot of price pressure upwards on a biologic compared to a normal small molecule drug. And when there's no credible alternative or backup option, which to Retatrutide, there wouldn't be, it'd be the first drug that has bariatric surgery level results. The prices won't come down. They'll command a massive price and the prices won't come down. So let's talk about where this currently stands because ultimately the Eli Lilly went to the FDA. We've been covering this for well over a year, maybe close to two years now, a year and a half at least. Lily went to the FDA, they said, we want this classified as a biologic, here are the reasons why. The FDA initially said, no, we're not gonna do that. So Lily challenged that decision in court. So the point that we're at today is the court told the FDA to reconsider and better explain itself So the first no given to the FDA to Lilly didn't stick. The courts looked at it and they said, you need a better, you need to reconsider your decision and you need to explain your decision better to Lilly. So ultimately we're sitting now at the point where the court has made its decision that the FDA has to go back and now we await basically what the FDA has to say on this. But if this thing is classified as a biologic, that would be a massive massive loss for patients. Now, again, we're, we're focusing on the accessibility of this drug into the future. And, and I think that this is an important conversation to have. One of the interesting points that I have to bring into the conversation is the fact that I got to sit in on a, on a closed session question and answer with the media. I didn't get to answer or, excuse me, excuse me, ask a question at this time, but shortly after the most favored nations announcement, with eli lilly and the trump administration in the oval office that day there was a press briefing that i was invited to dave ricks was asked by max bayer reporter of endpoints who we've interviewed here on this very podcast and he was asked was Retatrutide included in the most favored nations discussions meaning will we get a cash pay version of Retatrutide uh that is you know circumventing the pbms uh will we get these cheaper prices will will it be be two hundred fifty dollars also and there was a hard no there was a hard no like no that was not included that was not part of these discussions even though what we heard from the trump administration was that those these companies that were jumping on to the most favored nations agreement were also agreeing to offer future drugs at most favored nations pricing now was lily saying that no they're not going to offer it at the it wasn't part of the negotiations in terms of the price points that they had discussed for triseptide maybe or did it mean altogether there won't be a cash pay option of this medication i don't know um that we would love to get clarity on But I highly doubt we're going to get any more information than necessary at this point in time. So, Reta-Trutide is being positioned to be a drug that, and well so, should be offered at a premium. This is a drug that is far exceeding the current drugs that are on the market. I think that we're gonna see even the indications of Reta-Trutide far beyond simple obesity, but it is going to be their crown jewel for the next decade, more than likely. Reta-Trutide is going to be a massive drug, and so they're attempting to build a moat around it. And these are things that we need to be aware of as a community so that we can hold our positions and conversations about these and basically, you know, be able to articulate to people in positions of power like this is an important thing to us. This is an important thing in the advocacy of obesity and sort of the next frontier of the fight of accessibility, which marches on. each and every day because of course the current drugs, while as great as they are and as much as access is expanding, there are still people with sicker or rather more advanced versions of metabolic disease that are gonna need these newer treatments and price is going to be a huge factor. So let's talk about the gray market right now because I think it's also nearly impossible to talk about this topic without including a discussion about the gray market because there are, as I mentioned at the outset, hundreds of thousands of people on this medication already. So research grade Retatrutide exists. It's in the gray markets of the Internet. It's where people are going and they're buying, you know, basically versions of these these peptides that are made in factories overseas. They're being imported into the United States, oftentimes illicitly in shipments that are marked as something else. The FDA has tried to crack down. There's no doctor involved in this. It's a very, that's why it's called the gray market, right? So it's not a prescription medicine, but the demand for this is massive. And all you have to do is really scroll your TikTok for about fifteen minutes. You're going to come across a insane amount of content on the topic of Retatrutide. An insane amount of, and oftentimes, you know, what I find most disturbing is oftentimes it looks like very young people. very young people taking Retatrutide. Crazy, it's crazy. But the demand is massive and there's a whole gray market for it proliferating over on TikTok and in the far reaches of the internet. And I would estimate that tens, if not hundreds of thousands of people are already or have already used it. And I think it's a testament to a to to the effectiveness of this drug. It's also a testament to the fact that there needs to be more guardrails, I think, around this stuff than there currently is, because gray markets appear and they thrive when legal access lags the reality of the demand for the medication. And you saw this earlier this week as we launched a petition to fight back against the Safe Drug Act of twenty twenty five, a drug, a drug act that is in theory designed to put guardrails around compounding. But in practice, I think is creating a new battlefield for Eli Lilly and Novo Nordisk to shut down compounding on the current classes of medications, which is why We as a community need to be loud about our opposition to it. If they were really concerned about the safety of compounds, they would do two very simple things. They would require reporting around the active pharmaceutical ingredient of a compound. Patients ought to be able to know where the actual source of their medication is coming from. And they should know that those places are FDA approved and inspected. And the second thing is they should require adverse event reporting. Those are required of 503Bs. They should be required of 503As as well. 503As are making a tremendous amount of money. They're making thousands and thousands of these scripts. So when there are adverse events, they should be required to report those to the FDA. Simple. None of that is in this bill. None of it. None of it. Instead, it seeks to put caps on the amount of compounds that can be made by a compound pharmacy without them having to report to the FDA. And then it seeks to codify the definition of essential copy. Again, all of these things that will become law and then argued in court and then a battlefield for Lilly to potentially win a legal battle and thwart compounding. It's creating a new battlefield for them. They're losing in the courts. They're losing with the current language that exists in the Food, Drug, and Cosmetic Act. So we create new language. We create new law. Just vague enough to pull some threads and hopefully win something in court. That's how I see it. You may see it differently. If you do, curious to hear from you. But if you want to fight back against this legislation, you can go to otplinks.com and fight back against that. piece of legislation, because I think that we need as a community to have our voices heard on this, especially those who have gotten healthier by way of compounded medications. So the rumor on the gray market, to get back and close the thought loop here, There's been no specific FDA cutoff announced, but what the rumors going around are that that the compounded versions of GLP ones, especially obesity medicine in the gray market, are all going to turn off like a sieve on January first. Now, I seem to feel like this is probably more of a marketing tactic by these companies to sell a whole bunch of peptides at the end of the year. I think that's probably creating some panic and probably panic buying on people's parts. And so these companies are benefiting greatly. Again, that's why there should be guardrails around this. There's no guardrails around this at all. I mean, at the end of the day, they can say whatever they want to say, so long as they cloak everything in research grade. And these rumors proliferate around and people spend thousands, tens of thousands of dollars. I've heard of people having twenty years worth of Retatrutide in their freezer. Why? For what purpose do you need that? So just a massive amount of money made in this gray market. And that's not to knock people who use it. I say this all the time, but I think it's worth qualifying the statement. It's not knocking people who use it. I get it. But at the same time, we're talking about an industry that is, there's no altruism here. They're in it for money just as much as Eli Lilly is, except they have actually done nothing in the way of advancing medicine. They've just taken intellectual property, copied it, and sold it to you with a label that says, don't put this in your body. So you know where I stand on the gray market. I've heard from many people who've been injured by gray market stuff. It's just what it is. It's a gray market. You're taking your health into your own hands. Please, whatever you're doing out there, as risky as it may be, please involve your doctor and let your doctor know what you're doing so you can be monitored for the things your doctor believes you should be monitored for if you're using this. But this all underscores, again, the need for accessibility to these medications, the need for us to be aware of the fact that a moat is already being built around the most advanced metabolic drug in the pipeline. And we just need to be aware so that when it comes time to fight, we're all ready and informed. And that's what this podcast is serving to do. Before we jump into the next topic, I do want to thank our sponsor, our headline sponsor of this podcast. is a company called Shed. Now, if you are looking for access to care for obesity, then look no further than our partners at Shed who believed in this podcast enough to help us do it full time. You can go to Trished.com and use code OTP25 to save twenty five percent at Trished.com, where you're going to get connected to a doctor who will when medically necessary prescribe medication to treat your obesity. You also get access to coaching. You'll get access to all sorts of medication, whether it's the branded or the compounded versions, depending on your specific situation. All of it is available at Trished.com. They use one of my favorite compound pharmacies in the game, Strive Pharmacy, which I've gotten the chance to dig into on my own. I really love what they do there. They're a It functionally operates a lot more like a 503B. Uh, and I think that they're doing great work over at a strive pharmacy. They partner with shed. So I just love this, this, and when we were looking for somebody to offer a compounded versions, I wanted to make sure that I trusted the pharmacy. People always ask me, Dave, who, who should I go to? I'm like the pharmacy matters more than anything because you want to trust the source of your medication. So try shed.com use code OTP25. Listen, you're going to want to learn about taking any new medication before you take it. Learn about the potential side effects. Learn about the trade offs. There's no free lunch, but all of the information that you're going to need, you can find it. Try shed.com and be familiarizing yourself with all of your options there. So thank you to Shed for being a wonderful partner here at On The Pen. Now let's talk about some data that dropped. We're talking about accessibility and all of the sort of advancements in the world mean very little if people can't access it. That's why I think this data that dropped this past week from our friends over at Rowe is incredible. Absolutely game changing data. So check out this data. Real world telehealth data looking at sixty eight weeks. This is looking at patients who were enrolled in their row body program and on a GLP one specifically some maglutide mean weight loss in this study looked at again patients in over sixty eight weeks. The mean weight loss was sixteen point six percent on average. Thirty three percent of patients lost more than twenty percent and the safety in this study and looking at this data match the clinical trials. So what we're seeing here is that care for obesity can be delivered through a telehealth platform at scale and match clinical trial results. So that scalability decides how many people get access. There are not enough doctors out there to serve the over hundred million people in the United States living with overweight or obesity. so when you hear these blowhard doctors online calling all telehealth platforms except their own a pill mill or as i like to say pin mill the data is actually showing something quite different in that this type of obesity care can be delivered at scale through telehealth platforms it can meet people where they're at and allow people to get care without the shame, without the stigma, without their doctor just pointing to the door and saying, if you want a GLP-I, get out of my office. I ain't going to get it here. How ridiculous. But these people can go to platforms like Rho or Shed or any number of telehealth platforms that are out there and not only get access to medicine, but get access to care. So of course, not all telehealth companies are created equal. Of course, not all compound pharmacies are created equal. You want to do your homework and all of that. But this is data that shows that This kind of care can be delivered at scale via a virtual platform and show similar results to a clinical trial. I think, and this is peer reviewed data, and I think that this is just absolutely great news because when we talk about the problem, we need scalable solutions. The old brick and mortar ain't going to work when you don't have enough doctors to serve enough patients. If we want to get life-changing treatments like ritatratide or terzapatide, semaglutide, whatever, into the hands of the people who need it the most, we need companies to innovate scalable tech platforms that can meet patients where they are, that can leverage current technologies to find people the care that they need. And in this case, it's access to a doctor. It's access to a platform. It's access to prescription medication when appropriately prescribed. And it can be done, and it is being done. So I think this is great news, and will play a huge part in the future. As we talk about Retatrutide, even though it's a year and a half away, maybe a little bit longer, it's already exposing – the issues around accessibility and pricing. Hopefully there will be compounded versions available if they're medically necessitated, if there are shortages. We hope that the battleground for that is not already set and won by Lilly before this drug even comes to market. But there are strategies being done to keep people boxed out But I can tell you that whatever happens with Retatrutide, the future of obesity medicine is in virtual care. And platforms are rising to the occasion. Retatrutide hasn't reached patients yet, but it's already forcing the system to show us, you know, are you ready? Are you ready to deliver bariatric surgery level results at scale to the people who need them? So I am so thankful that you joined me here on this podcast today. Again, we love to talk about we're at a Retatrutide. If you're interested, we've been going live every Monday, Wednesday and Friday at eleven a.m. Central Time here on our YouTube channel, on our tick tock, on our X platform. We're doing that because there's enough news to bring you just about every single day. And we've been doing it for the last couple of weeks. If you've enjoyed it, let me know in the comments of the video on YouTube. Send me an email at David on the pen dot com. Uh, so every single Monday, Wednesday, Friday, and then we do a weekly rundown of the obesity medicine news every Tuesday. That's what this is. The weekly dose podcast. You can catch this on all of the platforms that you listen to your podcasts on, and please make sure to leave us a five star rating and review before you log out of your podcast app. That helps so much. I don't think you guys understand how much that helps, uh, the work that we do here to just train the podcast algorithms that this one is worth listening to. I hope you enjoyed today's podcast. If you did, drop it a thumbs up, five-star review, subscribe on YouTube, do all the things. Thank you for being here, and thank you for being the best part of what we do. We will catch you on the next one. Thank you, my friends. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Pharma meds were never designed to “fix” you. In this video, we'll discuss some of the pharmaceutical industry's secrets, the truth about prescription drugs, and the money-making scheme known as the US healthcare system. Pharma meds were never designed to “fix” you. In this video, we'll discuss some of the pharmaceutical industry's secrets, the truth about prescription drugs, and the money-making scheme known as the US healthcare system. In 1938, the Food, Drug, and Cosmetic Act redefined the word “drug,” giving Big Pharma a monopoly over your body. By this new definition, any natural remedy, such as a plant, herb, or food that helps an ailment in some way, can now be classified as a drug.In 1900, there were fewer than 200 diseases. There are now over 17,000! This has allowed disease to become a huge, profitable business. Drug patents are protected and policed by the FDA. This means you can not sell or profit from a natural remedy, even if it's backed by legitimate research, without FDA approval. Dr. Eric Berg DC Bio:Dr. Berg, age 60, is a chiropractor who specializes in Healthy Ketosis & Intermittent Fasting. He is the Director of Dr. Berg Nutritionals and author of the best-selling book The Healthy Keto Plan. He no longer practices, but focuses on health education through social media.Disclaimer: Dr. Eric Berg received his Doctor of Chiropractic degree from Palmer College of Chiropractic in 1988. His use of “doctor” or “Dr.” in relation to himself solely refers to that degree. Dr. Berg is a licensed chiropractor in Virginia, California, and Louisiana, but he no longer practices chiropractic in any state and does not see patients, so he can focus on educating people as a full-time activity, yet he maintains an active license. This video is for general informational purposes only. It should not be used to self-diagnose, and it is not a substitute for a medical exam, cure, treatment, diagnosis, prescription, or recommendation. It does not create a doctor-patient relationship between Dr. Berg and you. You should not make any change in your health regimen or diet before first consulting a physician and obtaining a medical exam, diagnosis, and recommendation. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition.

See all the Healthcasts at https://www.biobalancehealth.com/healthcast-blog You will learn: What holds up new treatments for diseases and conditions How long the FDA sits on a known safe medical medication before it is released to the public. Why safe and effective drugs are NOT approved by the FDA Why doctors are forced to use medications off label How you can help During my 44 years of medical practice, I have encountered conditions for which there is no approved medication or surgical treatment available as recognized by the American College of OBGYN or the FDA. This situation can present challenges both for physicians managing these patients and for individuals seeking relief from their symptoms. This issue is not often addressed on Dr Oz, in the news, or at medical conferences. For many conditions, physicians wait for the development of approved medications or treatments, and in the meantime may inform patients that there is currently no treatment or cure available. Some doctors may attribute a patient's concerns to aging, stating that it is a universal experience. While this may be accurate, such explanations may not provide comfort to patients seeking solutions to their symptoms. This lack of helpful guidance can discourage individuals from seeking medical care when they feel their concerns are not acknowledged. This seems to result from insurance companies prioritizing cost savings by minimizing patient care.  Every year insurance companies decrease what they pay doctors for their services, while their expenses go up, and the Government requires more and more work behind the scenes like HIPPA, OSHA, and Clia requirements that costs more to deliver the same service.  If you have a problem with the time your doctor spends with you then blame the insurance companies whose profits rise every year…Soon doctors will do what I do and only take cash.  The practice of medicine is not working in a free market. While insurance limits the prescriptions of medication to those meds that are FDA Approved, the FDA and medical specialty colleges often delay approval of new, low-risk treatments for up to 20 years after their effectiveness is demonstrated. This lengthy process should be reconsidered to treat people who are ill and suffering, now. There is plenty of research in the medical journals that explain the safety of new and effective treatments that can save peoples' lives that are not FDA approved yet. The FDA is not interested in expediting the release of medication/ devices quickly to those people who need help now. They drag out the testing of a medicine that has been effective for years and may or may not approve it. On the flip side they have approved many drugs that later are found to have severe side effects, and they just change the warnings on the medication inserts. They don't take them off the market except in severe cases. Drugs that have worked treating patients successfully are being used but are not FDA approved. These “grandfathered drugs” don't need to go through the testing that new drugs go through because they work with few well-known risks. I use many if these medications because they are inexpensive for my patients and are often more effective than new meds for the same problem. One of the drugs that the FDA has not had to approve is Armour Thyroid, a natural thyroid replacement. My experience with treatments not approved by the FDA Armour Thyroid: Armour Thyroid (AT) has been prescribed by doctors to replace thyroid hormones for about 100 years. It is natural, made from Pig thyroid. It only comes from “medical Pigs” that are raised for medical purposes.  We use medical pigs for skin grafts, and other parts of the pig to treat human diseases like heart valve replacements.  Armour Thyroid is composed of the four thyroid hormones that humans make: T4, T3, T2, T1. The synthetic thyroid replacement, Synthroid/levothyroxine is only T4.  The active form of thyroid is T3, and it requires an enzyme to convert T4 into T3. If a person can't convert T4 into active T3 then nothing improves except the blood levels of T4, and TSH. The majority of women cannot convert T4 into T3. Therefore, if they take Synthroid or levothyroxine and their doctor only checks their TSH level and not the level of free T3 and free T4 to see if the Thyroid is working, then women are told that they are healed, yet they know they are not because none of their low thyroid symptoms are resolved. When this happens, doctors tell female patients that it is all in their heads and dismiss us when we tell them we are not cured with this synthetic T4 medication. Yet Synthroid is a chemical, and AT is natural from medical pigs, so the FDA is trying to Bann the only drug that has successfully treated millions of women. PS. Synthroid was not tested on women like many other drugs that were passed through the FDA before 2014! If you think this is a small problem, think again. Thyroid hormones are vital to human life, and the thyroid gland requires Iodine in the diet. The Midwest US has no Iodine in the soil or water. Therefore, this area is overburdened with hypothyroidism. I have been on AT for 50 years without complication and I have prescribed it thousands of times ever since I went into private practice.  AT works to relieve the symptoms of hypothyroidism for women and men, and it works better for women that the “new” drug Synthroid/levothyroxine, which is FDA approved. You ask how could the FDA approve a drug that doesn't successfully treat women? It is because Synthroid was not tested on women!  Until 2014 the FDA did not test women in the required drug trials.  AT works for us (women), Levothyroxine does not. Now the FDA wants to ban AT. It is not approved because it was around for decades before they started testing medications like they do now, and the history of successful treatment should stand on its own merit! Example 2: Bio-Identical Hormones BIH:  BIHs had not been approved by the FDA until recently and there was no announcement that they are now approved for women who have hormone deficiency symptoms or postmenopausal symptoms. Most doctors and women who have been afraid of the only hormones that can help them, bioidentical hormones, haven't yet been told that NOW, FINALLY the medical colleges and the FDA finally have quietly approved BI hormones.  There are no pure estradiol and pure testosterone pellets that are made by a drug company for women. My patients get their estradiol and testosterone pellets from a compounding pharmacy.  I have been prescribing BIH since 1985 without FDA approval because the oral estrogen formulations that were available at pharmacies caused weight gain and put women at high risk for blood clots. Non-oral BI hormones have fewer risks than FDA approved estrogens.  I waited more than 45 years for the FDA to approve BI hormones for treatment of women.  All those women in the last 45 years who were taking FDA approved estradiol and those who couldn't tolerate them have been harmed by FDA goals of never approving compounded or bio-identical hormones.  The delay has harmed 50% of American women. Example #3 Devices for Weight Loss I was involved in the discovery and testing of a unique device that stimulated acupuncture points with a TENS-unit-type patch connected to your cell phone for easy adjustment of your hunger or “fullness”. The FDA requires testing to approve any new device so the group of investors I was part of had to invest thousands of dollars for a device we already knew worked. The FDA told the investigators of all new devices who they should test, who they can't have in the study, and how long the testing should take. I found their parameters for the study of this device to be unrealistic. The women in our test group could not be taking hormones of any kind (birth control, ERT, HRT), and could not be on antidepressants, could not have diabetes or insulin resistance or be on any drug that assisted in weight loss. These women subjects had to be a certain BMI (level of obesity) and had to be tested repeatedly with weight and body composition measurements None of my patients who needed weight loss could participate.  Most GYN patients are on some medication or supplement, so the FDA made this study of our device so narrow that REAL WOMEN weren't tested! Sadly, we lost many women in the control group from the study because they were NOT losing weight while the ones on the device were obviously dropping pounds, so we had trouble maintaining test subjects. The testing phase of this simple device took 7 years! Our device works and no one will ever know about it or be able to use this non-medicinal weight loss device because when the FDA rejects your device you will be breaking the law if you produce and sell it directly to the public. It has no side effects or dangers..it just controls the amount you eat with stimulation of an acupuncture point. There are many ways to change this situation, and it takes years and billions of dollars to change the whole system of bringing treatments to patients quickly.  I'm afraid I won't see a revolution of the way we bring medicines and devices to market during my lifetime. Currently there is a 17-year delay between proving a drug or device works for a particular illness or condition and when it becomes available to doctors and patients. So what do we do in the meantime?  I seek treatments for patients who are unresponsive to traditional medicine by reading journals like Life Extension, that inform doctors and patients alike about new effective solutions for common medical complaints and diseases that the FDA has ignored or stymied with endless drug trials.  Life Extension Magazine highlights studies on new medications for diseases without an FDA approved solution and publicizes diagnostic tests often overlooked by mainstream publications because they are not yet FDA approved. The medical journals I read (New England Journal of Medicine, JAMA, Menopause, Metabolism and Endocrinology, Journal of Age management, to name a few) offer treatments for orphan diseases or even common problems that haven't been blessed by the FDA. It takes an average of 17 years from the culmination of research on a new drug, test or device until it is approved for use by the public! At the end of this Blog, I will give you a link to make your voice heard by signing a petition to shorten the approval of new treatments and medications from the average of 17 years to 3 years! My patients don't have time to wait for relief, and that may be the case for you as well. If you want to do something to help, please click this link and let the FDA know how you feel. Please sign a Petition to enact an amendment to the FOOD, DRUG and COSMETIC ACT, by going to: https://age-reversal.net/fda/

From Gluten Free Watchdog, LLC:Great news on the allergen labeling front: the ADINA Act (H.R. 3821) was reintroduced into the 19th Congress on Friday, June 6, 2025 by U.S. Representative Kelly Morrison (MN-03). The ADINA Act is co-led by Representatives Mike Lawler (NY-17), Doris Matsui (CA-07), and Ben Cline (VA-06). ⭐️ This bill would amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain. ⭐️Because this bill was again reintroduced with bipartisan support in the House, we are hopeful that it gains traction.

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.

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.  

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

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.    

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.