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  • Regulators mostly silent on GLP-1 supplement claims

    GLP-1 products introduced in the supplement industry, Informa Markets' Larisa Pavlick said, typically fall into one of two categories: products that provide nutritional support for users of GLP-1 drugs, and products that claim to “mimic the pharmaceutical-like effect of those pharmaceutical products.” < Back Regulators mostly silent on GLP-1 supplement claims Rachel French Interview GLP-1 products introduced in the supplement industry, Informa Markets' Larisa Pavlick said, typically fall into one of two categories: products that provide nutritional support for users of GLP-1 drugs, and products that claim to “mimic the pharmaceutical-like effect of those pharmaceutical products.” The number of dietary supplement brands that make GLP-1-related claims is spiking. Yet, the emerging category of supplements has been largely met with silence from regulators, creating ambiguity for brands. Ozempic and similar drugs, classified as GLP-1 (glucagon-like peptide-1) agonists, were initially designed for the treatment of type 2 diabetes, but now are commonly used for weight loss. The drugs have seen immense popularity in recent years. One study published in the Annals of Internal Medicine identified a 700% increase in prescriptions for GLP-1 drugs in patients with overweight or obesity diagnoses over a four-year period. The study — which tapped 45 million de-identified medical records — found about 21,000 patients in the U.S. were using GLP-1 drugs to treat overweight or obesity in 2019, compared to 174,000 in 2023. Read More Previous Next

  • Meet Asa Waldstein

    UNPA Member Spotlight < Back Meet Asa Waldstein UNPA Interview UNPA Member Spotlight What are your areas of expertise, products, or services? Any milestones or wins you’re especially proud of? I focus on understanding enforcement trends and using those insights to inform compliant marketing. Essentially, knowing what can get a company in trouble helps define the creative parameters for their marketing. I brought this knowledge and these principles to Apex, and have trained our NovaAI Regulatory Assistant in the nuances of compliance. I’m especially proud of Apex’s ability to identify and understand net impression marketing risks. For example, the phrase “immune support” is an allowable structure/function claim, but if that phrase appears alongside someone wearing a mask in a video, brochure, or webpage, Apex can flag it as a potential implied cold and flu prevention claim. We’ve taught the AI to think like a regulatory expert. I’m also especially excited that we received API approval from Meta, which allows Apex to scan text and images on business accounts. It’s a unique integration, and we’re already finding many “regulatory landmines” on companies’ social media before they lead to bigger issues. Read More Previous Next

  • FDA warning letter surrounding herpes products underscores potential misuse of AI

    A U.S. Food and Drug Administration warning letter issued earlier this year is continuing to spur conversation about the appropriate use of AI to comply with the agency’s regulations. < Back FDA warning letter surrounding herpes products underscores potential misuse of AI Claudia Adrien Interview A U.S. Food and Drug Administration warning letter issued earlier this year is continuing to spur conversation about the appropriate use of AI to comply with the agency’s regulations. Read More Previous Next

  • National Advertising Division recommendations on Tru Niagen upheld

    The National Advertising Review Board upheld the National Advertising Division’s recommendations that Tru Niagen discontinue use of its “clinically proven” claims. Niagen argued this goes against established precedent from the NAD and Federal Trade Commission. < Back National Advertising Division recommendations on Tru Niagen upheld Interview The National Advertising Review Board upheld the National Advertising Division’s recommendations that Tru Niagen discontinue use of its “clinically proven” claims. Niagen argued this goes against established precedent from the NAD and Federal Trade Commission. What does “clinically proven” mean? What is the future of “clinically proven” structure/function claims on dietary supplements? These are two questions to arise from a recent ruling handed down from the National Advertising Review Board (NARB), the appellate advertising body for the Better Business Bureau (BBB) National Programs. ‘Clinically proven’ comes with a high bar. “‘Clinically proven’ is a strong claim, and a reasonable consumer could think the finished product — or at least a very comparable product form, dose, strength and use pattern — has been clinically studied and shown to deliver the stated result,” said Asa Waldstein, founder and principal at Apex Compliance, a regulatory and marketing compliance firm specializing in dietary supplements. Waldstein isn’t surprised by challenges to “clinically proven” claims, stating they are an easy target for litigation, but the threshold for such claims is higher than others. “For a ‘clinically proven’ claim, the bar is high, and a double-blind, placebo-controlled human trial is often the gold standard for this kind of claim,” Waldstein said. “The real question is whether the evidence is competent, reliable and closely matched to what consumers are likely to take away.” His key takeaway is that companies can still discuss NAD+ (nicotinamide adenine dinucleotide) and ingredient research, with a caveat. “Once the language moves into ‘clinically proven’ territory, the claim needs to stay tightly aligned with the evidence,” Waldstein said. “If the evidence is narrower than the claim, the claim usually needs to be narrowed too.” Read More Previous Next

  • Moringa recalls spotlight pathogen risks across botanical supply chains

    The FDA investigation, which closed April 1, tied recalled moringa supplements to more than 100 illnesses, drawing renewed industry attention to testing, traceability and supplier verification practices. < Back Moringa recalls spotlight pathogen risks across botanical supply chains Cassandra Stern Interview The FDA investigation, which closed April 1, tied recalled moringa supplements to more than 100 illnesses, drawing renewed industry attention to testing, traceability and supplier verification practices. Moringa outbreaks triggered recalls across multiple brands. "We have already seen over 20 total FDA recalls so far this year, with nearly a dozen of those specifically involving pathogens like Salmonella and Listeria ." -Asa Waldstein Read More Previous Next

  • Using Technology to Review and Develop More Compliant Claims | Asa Waldstein

    < Back In-Person, Presentation Tuesday May 19, 2026 Using Technology to Review and Develop More Compliant Claims 2026 NASC Annual Conference Arizona Grand Resort & Spa Phoenix, AZ Explore how technology can help teams proactively identify and correct compliance issues across websites, social media, existing materials, and pre-published content. This session will highlight practical approaches for using digital review tools to improve consistency, reduce manual burden, and support more confident, compliant communications in an increasingly fast-moving marketplace. Read about it here . Asa presenting at the 2026 NASC Conference Agenda & Registration Previous Next

  • FDA flags eBay listing over GLP-1 claims in rare warning letter

    The U.S. Food and Drug Administration (FDA) rarely goes after eBay sellers, which is exactly why it caught Asa Waldstein’s eye. < Back FDA flags eBay listing over GLP-1 claims in rare warning letter Danielle Masterson Interview The U.S. Food and Drug Administration (FDA) rarely goes after eBay sellers, which is exactly why it caught Asa Waldstein’s eye. According to Waldstein, founder and principal of Apex Compliance, there have been only four eBay-related warning letters in recent years – two of which occurred recently. "What is notable about this warning letter is that the FDA does not appear to have purchased or tested the product, which is often the case with more shady-looking weight-loss product," he said. Instead, the apparent basis for the warning letter is the drug-related claims made for the product. "Usually it has to do with more disease claims, so it might be GLP-1, blood sugar support and then maybe a claim in a hashtag or a claim in social media," he said. "But usually these types of claims are not enough for a warning letter. They usually are enough for FDA to test the product. And in this instance, FDA actually didn't test the product. They said GLP-1, blood sugar support claims – that's enough for a warning letter. So that was significant." Read More Previous Next

  • Compliance as a competitive edge for pet supplement, treat companies

    Companies that build proactive regulatory frameworks are scaling faster, earning retailer trust and outpacing competitors that treat compliance as an afterthought. < Back Compliance as a competitive edge for pet supplement, treat companies Lisa Cleaver Interview Companies that build proactive regulatory frameworks are scaling faster, earning retailer trust and outpacing competitors that treat compliance as an afterthought. For pet supplement and treat companies eyeing sustainable growth, regulatory compliance is no longer just a box to check — it is increasingly a business strategy. According to Asa Waldstein, principal, Apex Compliance, the companies best positioned for long-term success are those that build compliance into their operations long before they are required to. Read More Previous Next

  • Compliance For Natural Products Marketing with Asa Waldstein | Asa Waldstein

    < Back Podcast Wednesday Mar 25, 2026 Compliance For Natural Products Marketing with Asa Waldstein Natural Products Marketer Podcast I f you sell supplements or natural products and you market online, you can’t assume you’re “too small” for regulators to notice. We sit down with compliance expert Asa Waldstein to map the real enforcement trends we’re seeing, from FDA warning letters to behind-the-scenes demand letters that can escalate into expensive litigation. We also dig into what happens after a warning letter, why the response matters, and how public enforcement can ripple into reputation damage and investor hesitation. We get practical about the everyday situations that trip up independent retailers and brands: ingredient blogs that reference diseases, “educational” clinical study links that quietly turn into illegal disease claims, and the persistent myth that a couple clicks away from the shopping cart keeps you safe. Asa shares a simple way to sanity-check content through a reasonable-consumer lens, plus how old posts, inherited websites, and multi-year social content still count as active marketing in FDA’s eyes. Then we tackle a major modern landmine: reviews and testimonials. Google Business Profile reviews, website review widgets, social comments, and even automated carousels can create compliance risk, especially when your team replies, likes, or reacts to disease-claim testimonials and accidentally “adopts” them as marketing. We also talk regulatory technology and how tools like Apex Compliance can flag trigger words, assign risk levels, and suggest safer wording so you can move faster with more confidence. If you want to grow with better supplement marketing, smarter SEO, and fewer compliance headaches, listen through and share this with someone who touches your website or social media. Listen to the podcast Previous Next

  • From “Gut Health” to Litigation: Marketing Microbiome Supplements Without Stepping Over the Line | Asa Waldstein

    < Back Presentation, Online Wednesday Mar 25, 2026 From “Gut Health” to Litigation: Marketing Microbiome Supplements Without Stepping Over the Line Naturally Informed 2026 Microbiome Event Asa Waldstein breaks down how current enforcement is shaping microbiome supplement marketing, how to communicate gut, immune, metabolic, mood, and “whole-body” benefits without drifting into disease claims. We’ll cover structure/function boundaries, common missteps that attract scrutiny, and litigation trends driving demand letters and class actions. Using microbiome-specific examples (including biomarker-adjacent language and clinical-study “spin”) Learn more and register Previous Next

  • OTC Companies Cited For Refusing Records Request

    Test ingredients for common adulterants < Back OTC Companies Cited For Refusing Records Request Test ingredients for common adulterants When FDA asks for records, companies should generally comply or they can face warning letters. This year FDA has sent eight warning letters to OTC companies refusing to respond to FDA’s request for records requests. This is a steep jump from only two similar letters in all of 2022. 🔷Yes, I know these are OTC-related and not supplement warning letters , but we can still learn a few things and also be amused by some of the responses, such as a company saying they were “not prepared to allow the FDA to audit and inspect.” Here is the timeline: 🔹March 17, 2023, the FDA sent an electronic request for records and other to the contact email address provided in your registration file. This request went unanswered. 🔹Second and third requests were sent via email on April 6 and April 18, 2023. 🔹On April 19, 2023, you responded stating that you were “not prepared to allow the FDA to audit and inspect” your firm. 🔹The Agency sent a follow-up written request for such records and other information on April 28, 2023, to your registered address on file; however, we received a delivery failure notification. 🔷Testing for contaminants: These “refusal to comply” letters were issued to OTC companies, four of whom were selling products with ingredients like glycerin. FDA pays extra attention to these types of ingredients as they may be susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination. Dietary supplement companies can learn from this and test glycerin and ethanol for these common adulterants. This is good business, and FDA will want to see these tests when inspecting your or your comanufacturer’s facility. I write more about this here . 🔷This is not to be confused with the FDA’s Remote Regulatory Assessment (RRA) program, which is voluntary. Complying with this can help deprioritize FDA from visiting your facility and seems like a good idea if documents are in order. What are your thoughts on RRAs? Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

  • Update on Cannabinoid Product Regulation | Asa Waldstein

    < Back Panel Discussion Friday Jun 25, 2021 Update on Cannabinoid Product Regulation Hemp Leaders Summit, Fort Lauderdale, Fl Asa Waldstein moderates this FDA and legal compliance panel. Richard Cleland , Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission Dr. Matthew Curran , Food Safety Director, Florida Department of Agriculture and Consumer Services Learn More Previous Next

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Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.  Rule #1 in compliance is to ensure marketing is truthful and not misleading.

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