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< Back Presentation, In-Person 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

Asa's Speaking Schedule & Event Recordings Asa's Regulatory Education Series & Guest Appearances Presentation, In-Person 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. Read More Webinar Wednesday Dec 3, 2025 Regulatory Reality Check: What Supplement Brands Need to Know About the Healthspan Category Naturally Informed Webinar Active Aging: Mastering the Market Read More Panel Discussion, In-Person Thursday Oct 30, 2025 The dietary supplement/food and beverage pipeline: Bridging the gap with science-backed ingredients SupplySide Global Mandalay Bay, Las Vegas Learn how supplement, food and beverage categories are converging, and what it means for ingredient positioning, innovation and future growth. Read More Podcast Wednesday Oct 22, 2025 Honest Health with Jeffrey Burke S02 E60 - Asa Waldstein Honest Health with Jeffrey Burke Podcast Host Jeffrey Burke welcomes Asa Waldstein, a regulatory expert in the natural products industry. They discuss the importance of marketing compliance, the risks associated with misleading claims, and the evolving landscape of regulations in the health sector. Asa shares insights on how to navigate marketing-language effectively, the role of social media in compliance, and the significance of consumer safety. The pair also discuss the challenges faced during the CBD boom and the importance of awareness in the industry. Read More Presentation, In-Person Monday Oct 13, 2025 Microbiome & Probiotic Supplements: Best practices for compliant marketing Global Engage 13th Microbiome R&D & Business Collaboration Forum San Diego Asa Waldstein examines FDA, FTC, NAD, and litigation enforcement trends for dietary supplement and CPG products. He also shares risk-based insights for compliant marketing and provides an overview of the differences between food and pharmaceutical regulations. Join us for this interactive discussion. Read More Online, Workshop Monday Sep 29, 2025 Herbal Product Marketing Claims & Strategies: Pitfalls to Avoid and Best Practices American Herbalists Guild Join Certified Clinical Herbalist and supplement industry expert Asa Waldstein for a practical session on current enforcement trends, FDA warning letters, and how to minimize regulatory risk while maintaining truthful communications. Learn to spot high-risk language, create safer messaging, and explore digital marketing best practices for blogs, social media, product reviews, and influencer partnerships. Read More In-Person, Workshop Monday Sep 15, 2025 Small Business Bootcamp AHPA Cincinnati, OH Join AHPA for their first-ever Small Business Bootcamp, a 1-day workshop in Cincinnati, OH, held in conjunction with AHPA's Botanical Congress and United Plant Savers' International Herb Symposium. Read More In-Person, Presentation Friday Sep 12, 2025 AI in Legal and Regulatory Compliance Nutritional Law Symposium Lehi, UT Asa's presentation will include information on the use of AI tools for claim monitoring, internal document review, and competitive tracking. Read More In-Person, Presentation Friday Sep 5, 2025 Marketing Compliance & Best Practices For Natural Product Marketers: An exploration into enforcement trends and technology solutions SENPA Natural Industry Alliance SOHO Expo Orlando, FL Join Asa Waldstein for an interactive deep dive into the evolving world of marketing compliance for natural product marketers. This session explores enforcement trends, such as FDA warning letters and litigation, to help inform compliant and effective marketing. This presentation provides actionable insights and pitfalls to avoid for independent retailers or brands of all sizes. Attendees are encouraged to bring their questions to this discussion. Read More Webinar Tuesday Aug 26, 2025 Keeping up with Claims: Navigating Marketing Compliance AHPA Webinar Dietary supplement claims are your face and foundation for effective product positioning. Strong, substantiated claims reinforce your product’s health benefits and differentiate your product from other brands. Unsubstantiated or violative claims will undermine your brand and put you in the crosshairs of private plaintiffs. Read More In-Person, Panel Discussion Wednesday Jun 25, 2025 Leveraging AI in Dietary Supplement R&D: Harnessing Innovation While Navigating Key Regulatory and IP Risks  American Conference Institute New York, NY As the dietary supplements industry continues to evolve, innovation is driving new product development and improved efficiencies.  From AI-powered R&D to advancements in manufacturing and supply chain optimization, companies are embracing cutting-edge technologies to stay competitive. However, these innovations also introduce complex regulatory, intellectual property, and compliance risks that must be carefully navigated.  Read More Online, Panel Discussion Thursday Jun 12, 2025 How a rapidly evolving world is transforming dietary supplement innovation – summit Inside the Bottle Summit Learn how supplement industry growth requires persistent transformation in the ways it approaches innovation, while maintaining integrity and its core vision for health. Join the 2025 Inside the Bottle Summit, uniting industry stakeholders, where data intelligence and scientific research are at the center of the narrative. Read More Webinar Wednesday Mar 26, 2025 Women's Health Claims: Compliance, Risk, and Marketing Best Practices Naturally Informed Mastering the Market: Women's Wellness The women’s health market is experiencing some major growth. After decades of being under-served and under-researched, the category is booming thanks to cutting-edge science, innovation, and the leadership of women advocating for change. This is your chance to be part of the conversation shaping the future of women’s wellness. Read More Webinar Wednesday Mar 12, 2025 Beyond the Aisle: Navigating Marketing Compliance in the Supplement Industry SENPA Staying compliant with marketing claims is a major challenge for retailers in the natural products industry. With increasing regulatory scrutiny, understanding DSHEA is more important than ever! Join us on March 12th at 2:00 PM EST for the next Beyond the Aisle: Navigating Natural Products Retail session, featuring Asa Waldstein, regulatory expert and founder of Apex Compliance®. He’ll break down what retailers need to know to stay on the right side of compliance. Read More Panel Discussion Wednesday Feb 19, 2025 Key Takeaways for Dietary Supplement Marketers NutraIngredients: Weight Management Summit San Diego Navigating the Future of Weight Management: Innovations, Insights, and Natural Solutions Read More In-Person, Panel Discussion Thursday Jan 23, 2025 Our Commitment to Product Integrity Organic & Natural Health Association Fort Lauderdale, FL The Organic & Natural Health Association 11th Annual Conference Read More Online Tuesday Dec 10, 2024 Navigating GLP-1 Regulatory Compliance: Marketing Best Practices in the Supplement Industry Naturally Informed Active Aging Event This presentation will delve into the current marketing landscape surrounding GLP-1 in the U.S. supplement industry. Asa will look at biomarker enforcement, such as LDLs, to gain insights into marketing best practices, focusing on compliant strategies and pitfalls to avoid when promoting GLP-1-related products. Read More Podcast Wednesday Dec 4, 2024 Unveiling Supplement Regulations: Asa’s Insights on Compliance and Ethical Marketing Natural Products Marketer Podcast Unlock the secrets of dietary supplement regulations with Asa Waldstein, a seasoned regulatory consultant with a background in clinical herbalism. Discover the intricacies of FDA oversight in the supplement industry and learn why the notion that dietary supplements are unregulated is a myth. Asa’s journey from herbal studies in Boulder to advising companies on maintaining compliance provides unique perspectives and invaluable lessons for anyone navigating this complex field. Read More Panel Discussion, Workshop Monday Oct 28, 2024 Education session – Ingredient claims and legal flames: An interactive workshop to dodge regulatory heat SupplySide West Las Vegas, NV Noncompliant dietary supplement ingredient claims can be one of the reasons the Food and Drug Administration comes knocking. In this education session and interactive workshop, experts will dissect the U.S. regulations, laws and guidance that govern ingredient claims, as well as applicable court cases. Read More Webinar Tuesday Sep 24, 2024 Technology solutions for marketing and manufacturing supplements in the US FoodChain ID Navigating the complex landscape of dietary supplement regulations in the U.S. can be challenging. To help you stay ahead, Apex Compliance and FoodChain ID have teamed up to bring you an exclusive webinar. Read More Panel Discussion, Webinar Thursday Jun 27, 2024 Microbiome: Mastering the Market 2024 Naturally Informed Join industry experts Miguel Freitas, PhD, Vice President of Scientific Affairs for Danone North America; Kristina Campbell, Science and Medical writer; and Asa Waldstein, Principal of Supplement Advisory Group, for a look at ‘biotic supplement consumers. Read More In-Person, Solo presentation Wednesday Jun 5, 2024 The Regulatory Process The Mushroom Summit Monterey, CA Evaluate the Regulatory Landscape and Identify What You NEED to Know to Bring Your Functional Mushroom Product to Retail Shelves Read More In-Person, Presentation Tuesday May 14, 2024 Vitafoods Europe Startup Innovation Challenge 2024 Vitafoods Europe Geneva, Switzerland Apex Compliance has been invited as a start up finalist. Asa Waldstein will be on stage as a "top 6" finalist in the most innovative digital solution for the nutraceutical industry. Read More In-Person, Solo presentation Thursday Apr 11, 2024 Labeling & Making Claims NoCo Hemp Expo Estes Park, CO 10th Annual NoCo Hemp Expo Read More Panel Discussion, Webinar Tuesday Apr 9, 2024 New Technology: Opportunities and challenges in the dietary supplement industry AHPA Webinar If you're curious about how new technology -- such as AI and blockchain -- can be applied to the dietary supplement industry, join us for the next AHPA webinar on April 9. Read More Webinar Thursday Mar 7, 2024 Pitfalls to Avoid When Marketing Products Velocity CPG Asa reviews common pitfalls when marketing products that can lead to expensive litigation or agency action such as social media engagement, citing clinical studies, blogs, and influencer best practices. Read More Presentation, Online Thursday Feb 29, 2024 The Regulatory Universe & AI Naturally Informed Asa participates in "The Regulatory Universe & AI" discussion with Akash Shah. Read More Solo presentation, Panel Discussion Wednesday Feb 14, 2024 Sports & Active Nutrition Summit USA Sports & Active Nutrition Summit USA San Diego Asa Waldstein speaks about Apex Compliance and accepts a NutraIngredients Start Up Stars Award. He also participates in Start Up Stars entrepreneur panel discussion. Read More Panel Discussion Thursday Jan 25, 2024 Amazon: Opportunities and Threats in 2024 and Beyond Organic & Natural Health Association Cape Coral, FL Asa Waldstein participates in a panel discussion on AI and Amazon with David Trosin (NSF), Ryan Sensenbrenner (Enzymedica), and moderated by Quality of Life, Dan Lifton. This discussion takes place at the Organic and Natural Health Association's annual conference. Read More Virtual Fireside Chat Friday Jan 19, 2024 Radicle Perspectives: Elevating the supplement industry Radicle Science Reading the Tea Leaves (Part I): What 2024 Has In Store for Dietary Supplements Regulations and Compliance Read More Presentation, Online Thursday Dec 7, 2023 Making Your (Compliant) Message Shine: Best Practices for Reaching & Engaging Consumers Naturally Informed Active Aging: Mastering the Market 2023 Read More Interview Thursday Nov 23, 2023 Managing Dietary Supplement Marketing Risks, with Asa Waldstein of the Supplement Advisory Group NutraPreneur Bridging Compliance & Marketing with Asa Waldstein’s Unique Perspective Read More Panel Discussion, In-Person Wednesday Nov 15, 2023 Avoid the Lawsuit - Top Labeling Mistakes Colorado Food Works Arvada, CO We will be reviewing top labeling mistakes that can result in lawsuits and costly re-prints. Read More Panel Discussion, Online Tuesday Nov 14, 2023 The claims they are a-changin’ AHPA Botanical Congress Moderated by Asa Waldstein (Supplement Advisory Group), this session will feature discussion of the new FTC dietary supplement advertising guidance, the notices that followed, and the impact of both, as well as adequate claim substantiation. Read More Presentation, In-Person Thursday Oct 26, 2023 Microbiome Products: Enforcement & Marketing Compliance Supplyside West Las Vegas Claims, regulatory compliance and messaging around microbiome ingredients Read More Interview Saturday Aug 12, 2023 Regulatory Expert Asa Waldstein The Herbalist Hour Ep. 55 HerbRally In this episode, Mason and Asa delve into all sorts of topics, and chat about substantiation dossiers, using puns as claims in marketing, general business advice, and more! Read More Virtual Fireside Chat Friday Jun 16, 2023 Substantiation Dossiers: Building Trust in Label Claims for Retailers, Influencers, and Consumers Radicle Science June 16, 2023 (10:00 am PT / 1:00 pm ET) Join Radicle Perspectives with Asa Waldstein, Principal of Supplement Advisory Group, as we discuss how to mitigate label claim risk, the impact recent headlines have had on dietary supplement consumers, and what Asa sees is next when it comes to the FTC drama. Read More Symposium Friday Jun 9, 2023 16th International Herb Symposium at Wheaton College in Norton, Massachusetts, on June 9-11, 2023 International Herb Symposium Asa teaches various GMP and marketing compliance classes at this three-day event. Read More Presentation Tuesday May 23, 2023 Regulatory compliance and reducing class action risk Naturally Informed - Microbiome: Mastering the Market 2023 This three-day intensive virtual conference will examine not only probiotics, prebiotics, synbiotics and postbiotics, but also numerous other microbiome- modulated interactions including the impact of stress and diet. Experts will examine leading-edge science, and deliver practical tools to leverage this science to competitive advantage and truly mastering the market. Read More Virtual Course Friday May 19, 2023 Ethics in Marketing Dietary Supplements: Common Practitioner Pitfalls to Avoid AcuHealth Academy Upcoming CEU Course May 19th @ 12pm CST Read More Panel Discussion, Online Tuesday May 16, 2023 The Label: Getting to the truth on natural product claims AHPA Botanical Congress In this session, Asa Waldstein (Supplement Advisory Group) will provide an overview of key considerations for label claims, with Amber Littlejohn (Ice Miller) and Jake Hebert (One Step Closer) expanding on health-related claims and environmental claims, respectively. Read More In-Person, Panel Discussion Thursday May 11, 2023 Considerations in entering the US market: Pitfalls, best practices, regulatory and innovation needs Vitafoods Insights Theatre Geneva, Switzerland Regulatory and marketing panel Read More Podcast Monday Apr 24, 2023 GMPs and Dietary Supplements: A Conversation With the Experts CHPA Chat Asa Waldstein, Larisa Pavlick, Josh Long discuss dietary supplement GMPs and best practices. Read More Podcast Monday Apr 17, 2023 The Hoban Minute - Episode 170 with Asa Waldstein of Supplement Advisory Group The Hoban Minute Xavier interviews Asa Waldstein, founder of Apex Compliance and principal at Supplement Advisory Group. Read More Panel Discussion Thursday Apr 13, 2023 Marketing Claims and Protecting Your Brand Naturally Los Angeles Leaders in the natural products space share their experience on how to market claims and protect your brand. Read More Panel Discussion Wednesday Mar 29, 2023 Claims, Compliance, COA panel NoCo Hemp Expo Colorado Springs, CO Certifications, COA’s, Compliance & Claims Read More Podcast Wednesday Feb 1, 2023 Asa Waldstein - Principal @ Supplement Advisory Group | FDA Enforcement Trends + Social Media Ingredients for Success Podcast FDA Enforcement Trends + Social Media Read More Presentation, Online Friday Nov 18, 2022 Naturally Informed: Living Longer, Stronger & Healthier Virtual Conference Registration Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in emerging categories such as brain health; bone, muscle, and joint health; libido; immunity; heart health; eye health; and more! Read More Presentation Tuesday Nov 15, 2022 Decoding the Regulations Around Cannabinoid Enforcement & Marketing Claims MJBizCon, Las Vegas, NV Read More Online, Presentation Monday Nov 7, 2022 Labeling and Marketing Hemp-CBD Products: Best Practices & Pitfalls to Avoid Smither's Hemp & CBD Workshop Asa Waldstein reviews best practices, and common mistakes companies make when marketing and labeling hemp-CBD products. Read More

< 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

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!

A weekly exploration of FDA warning letters and enforcement trends A weekly exploration of FDA warning letters and enforcement trends Get Warning Letter Wednesday in your Inbox Sign-Up Now! Select category Reset “Gum Detoxify” Claims Challenged Qualifying claims makes them easier to substantiate 8/20/25 Read More FTC Letters to Amazon, Walmart & Other Sellers Use caution with Made in USA claims 7/30/25 Read More NAD Case: Supporting Substantiation Ingredient studies may support product claims 7/9/25 Read More When Topical OTC Manufacturing Goes Wrong Test glycerin for contaminants 6/18/25 Read More Avoid Comparing Products to Drugs (most of the time) Use FDA’s helpful resource (criterion 6) 5/28/25 Read More Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 5/7/25 Read More OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant 4/16/25 Read More Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance 3/26/25 Read More Unallowable Ingredient “Enough” to Trigger Regulatory Action Delta-8 is a high-risk ingredient 8/13/25 Read More When Nutrient Claims Become Disease Statements Carefully review all marketing materials 7/23/25 Read More Dietary Supplement Manufacturing & Marketing Lessons Learn from others’ mistakes 7/2/25 Read More Labeling Lessons Minor label issues signal deeper compliance issues 6/11/25 Read More Unallowable Ingredient Results in Warning Letter Here are tips on using FDA’s ingredient directory 5/21/25 Read More Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging 4/30/25 Read More Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) 4/9/25 Read More Injectable CBD Warning Letter Curated testimonials are marketing claims 3/19/25 Read More Product Reviews Are Marketing Claims Kratom 7-OH products are highly scrutinized 8/6/25 Read More Diseased Population Study Helps Trigger IND Requirement Dietary supplement clinical triggers should be thoughtfully considered 7/16/25 Read More Failure to Report Serious Adverse Events Investigating customer complaints is a cornerstone of supplement safety and compliance 6/25/25 Read More Delta-8 Inhalable Product Dangerous products will be cited even if they do not contain disease claims 6/4/25 Read More 3 Animal Product Companies Receive Warning Letters Extra attention is paid to animal CBD products 5/15/25 Read More Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) 4/23/25 Read More In-Process Quality Testing A look at the manufacturing and quality process 4/3/25 Read More Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute 3/12/25 Read More 1 2 3 ... 9 1 ... 1 2 3 4 5 6 7 8 9 ... 9

Latest News I love writing guest articles and collaborating See appearances for Asa's events and podcasts Feb 5, 2026 Interview NutraIngredients Danielle Masterson A new generation of energy: Are pouches the next ‘big thing’ in active nutrition? Mouth pouches have emerged as one of the fastest growing CPG categories, signaling a major trend in nootropics as consumers seek functional ways to boost performance—sans nicotine. Read More Dec 3, 2025 Guest Article Nutraceuticals World Asa Waldstein Compliance in the Digital Age: Navigating Enforcement, Marketing Risks, and the Rise of AI | State of the Supplement Industry Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims Read More As part of Nutraceuticals World’s 2026 State of the Industry review, Asa Waldstein, Principal at Apex Compliance , highlights emerging enforcement trends shaping supplement marketing and GMP compliance. He notes continued FDA focus on documentation and identity testing, increased scrutiny of online disease claims and influencer disclosures, and new risks tied to AI-related marketing and digital content oversight. Nov 24, 2025 Interview NutraIngredients Cassandra Stern SSG 2025: Asa Waldstein on FDA, FTC and NAD enforcement trends Apex Compliance’s Asa Waldstein shares valuable insights for those seeking to avoid an FDA warning letter, a competitor case with the NAD or a referral to the FTC due to ad claims non-compliance. Read More Nov 5, 2025 Interview NutraIngredients Cassandra Stern NAD+ health ads scrutinized as NAD recommends Reus Research modify or discontinue certain claims The National Advertising Division (NAD) has recommended that Reus Research LLC modify or discontinue several advertising claims related to its Cata-Kor NAD+ Core and Advanced dietary supplements. Read More Oct 27, 2025 Podcast Interview Building Fortunes Radio Stephen Lukawski KISC My Health Radio Show with Captain Cran Man Stephen Lukawski with Asa Waldstein and cohost Peter Mingils Asa Waldstein is our guest on KISC My Health Radio show with Peter Mingils and the King of Cranberries Stephen Lukawski. Read More This week on KISC My Health Radio, Captain Cran Man Stephen Lukawski and Peter Mingils have the privilege of interviewing Asa Waldstein. Oct 16, 2025 Guest Article SupplySide Supplement Journal Asa Waldstein FDA warning letter trends: Third-party reviews, eye products, 'Made in USA' claims In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters and other enforcement impacting manufacturers and marketers of dietary supplements. Read More At a Glance FDA warns companies blurring lines between foods and supplements. FDA flags misuse of reviews — curated or highlighted customer reviews may count as product labeling. FTC cracks down on 'Made in USA' claims; what to do now. Sep 24, 2025 Interview NutraIngredients USA Cassandra Stern Ryze Superfoods drops mushroom coffee and matcha health claims after NAD inquiry The case highlights compliance risk for functional beverages and ingredient claims among dietary supplement and food‐adjacent product manufacturers. Read More Sep 19, 2025 Press Mention NutraIngredients USA Claudia Adrien AHPA leans on past to embrace high-tech future at botanical congress The American Herbal Products Association hosted its first botanical congress outside the confines of the SupplySide Global trade show. Read More Sep 15, 2025 Interview NutraIngredients Claudia Adrien Supplement weight management claims in the GLP-1 era Asa and other industry leaders weighed in Read More Earlier this year, California resident Christina Robins sued wellness brand Lemme Inc. accusing it of misleading marketing practices surrounding the company’s GLP-1 Daily supplement. Aug 7, 2025 Guest Article SupplySide Supplement Journal Asa Waldstein Q2 2025 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More At a Glance Disease claims made on social media like Facebook and Instagram are fair game for an FDA warning letter. Ingredients not permitted for use in dietary supplements have a high likelihood of attracting scrutiny. CBD and delta-8 products are still a concern for FDA and FTC, especially when their packaging may attract children. Aug 1, 2025 Interview Nutrition Industry Executive Magazine Mike Straus Formulating For Quality Asa and other industry leaders weigh in Read More What formulators say about the challenges and opportunities related to bringing new products to market. Jun 26, 2025 Interview NutraIngredients USA Cassandra Stern Three recently filed lawsuits highlight legal risk in protein labeling compliance Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California Read More May 27, 2025 Interview SupplySide Supplement Journal Rachel French Regulators mostly silent on GLP-1 supplement claims Asa and other industry leaders weigh in Read More 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. Apr 15, 2025 Guest Article SupplySide Supplement Journal Asa Waldstein Q1 2025 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Jan 31, 2025 Interview NutraIngredients USA Cassandra Stern Olly and BrainPack NAD decisions highlight challenges in supplement advertising Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. Read More As Olly appeals NAD’s decision and BrainPack modifies its claims, industry experts weigh in on the potential implications for dietary supplement advertising. Jan 15, 2025 Guest Article NutraIngredients USA Asa Waldstein Cognitive and memory warning letters and litigation trends: Best practices for reducing risk Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. Read More Jan 7, 2025 Guest Article SupplySide Supplement Journal Asa Waldstein Q4 2024 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Dec 3, 2024 Interview Nutraceuticals World Sean Moloughney 2025 State of the Industry Asa and other industry leaders weigh in Read More Experts discuss business drivers, regulatory challenges, and market opportunities. Nov 21, 2024 Press Mention WholeFoods Magazine WholeFoods Magazine Staff The Buzz in Natural: December 2024 A roundup of thought-provoking posts we saw on social media! Read More Oct 8, 2024 Guest Article Supplyside Supplement Journal Asa Waldstein Join me for SupplySide West workshop on nutritional ingredient claims, legal flames Regulatory consultant Asa Waldstein previews a SupplySide West education session on substantiating claims and clinical trials. Waldstein is moderating the Oct. 28 session that features two attorneys and two experts from contract research organizations. Read More 1 2 3 4 5 1 ... 1 2 3 4 5 ... 5

Reporting of a SupplySide West presentation < Back Sales soar for probiotic-containing soft drinks Jeff Gelski Interview Reporting of a SupplySide West presentation Read More Previous Next

Ensure vendors are properly qualified < Back 7 Homeopathic Eye Product Warning Letters Ensure vendors are properly qualified Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics. Most of these companies were selling ophthalmic homeopathic products with some disease claims. I assume that if there were no GMP concerns, the products were not for use in the eyes, the target audience was adults, and there were no serious disease claims, many of these companies would not have received warning letters. FDA probably cited this group of products because they are (ophthalmic) added to the eyes, which may potentially endanger eye health. There are allowable OTC monographs for these types of products, but it seems the products were homeopathics, not labeled as OTCs (Drug Facts Panel), or in at least one instance, the product was labeled as an OTC but was not submitted to the required National Drug Code Registry . Products added to the eyes can be dangerous, and eye two lubricant products contain NAC, which I don’t think is approved for ophthalmic delivery. When I was a supplement manufacturer, I always said NO to making these types of products. From warning letter, “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.” Here are some other highlights: 🔷 This company was cited for making disease claims in testimonials. It is worth noting that testimonials were showcased and promoted in a banner. If the testimonials were part of a 3rd party review widget, such as those uncurated reviews that come in through a service like Trustpilot, they probably would not have been cited. 🔷 My “day job” is running a regulatory consulting company. Contact me to discuss reviews, labels, or online marketing compliance questions. This helps support my WLW writing passion (smiles). 🔷 Normally, there has to be commerce for a company to receive a warning letter. This company does not appear to conduct commerce on its website and only offers a practitioner login option. The company was selling ophthalmic products with disease claims, which led to the warning letter even though there does not seem to be public commerce on the site. This is VERY INTERESTING and should be a wake-up to companies using this strategy to push the compliance boundaries. 🔷 This well-known homeopathic company was cited for not only making ophthalmic homeopathic products and disease claims, but this warning letter also includes numerous GMP violations. Products from this company were placed on import alert, which speaks to the severity of the alleged GMP issues. I assume that FDA “followed the breadcrumbs” for other products made at this facility, which led to the Walgreens and CVS warning letters. This highlights the need for supplier qualification, something consultant Nate Call is an expert at. 🔷 A four-year-old social post was cited, which is another reminder to remove language from all social media, no matter how old. 🔷 From warning letter. “February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” 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!

Learn from other’s mistakes < Back Arthritis Claims Enforcement Learn from other’s mistakes Since the beginning of 2023, 11 warning letters have been issued for arthritis-related supplements and topical product claims. Here, I explore these warning letters, look at common trends, and share key takeaways. Higher-risk disease claims : I have always wondered if making arthritis claims alone is enough to trigger a warning letter. The answer is surprisingly “not really.” All warning letters since the beginning of 2023 have included high-risk words like cancer, depression, and fibromyalgia, except one. This warning letter accompanied GMP citations and included arthritis claims that were part of an out-of-compliance OTC drug that did not follow the official monograph. Social media and YouTube : 45% (5 out of 11) mention claims on social media and YouTube. This is not a surprising number, and it shows FDA’s continued focus on social media marketing claims. Some of the cited social posts were a couple of years old, which is a reminder to ensure even those old posts are “clean” of disease claims. Are you interested in finding the high-risk statements on your website, videos, and content before publishing? My software product, Apex Compliance, can help you identify and replace these high-risk phrases before they lead to warning letters and lawsuits. Our AI has been custom-trained on compliance principles, including warning letters, and it helps you understand what compliant language looks like. Learn more and set up a free demo here . Blogs : 18% include claims made in blogs. I’ve written a lot of this before, such as in this post . GMP Inspections Lead to Marketing Review : 27% of letters started with a GMP inspection, which led to a marketing review. I write more about this here . Drug-spiked ingredients were mentioned in 18% of these letters . The moral of the story is to keep disease words like arthritis out of marketing, and they will signal to authorities to look deeper for other high-risk marketing phrases. 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!

Discussing ingredient benefits is marketing < Back Website “About Us” Claims Cited in Warning Letter Discussing ingredient benefits is marketing This warning letter cites claims made in the “About Us” section of the company’s website. Usually, when “About Us” claims are mentioned in warning letters, there is some hyperlinking to a shopping cart, but this letter mentions CBD and high-risk disease words such as Dravet Syndrome without any clear linking. The lesson here is simply talking about an ingredient can lead to a warning letter if that ingredient is sold on the website. From warning letter. “On your “About Us” webpage…CBD is FDA approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex.” This is the 34th CBD-related warning letter this year, up from just seven in 2021. This year certainly has been the year of the CBD warning letter, and I expect many more in 2023, including a crackdown on delta-8 and other isomer products. This company cited in this letter also sells fruits, such as mango and pineapple, that were apparently sprayed with CBD. FDA has been cracking down on CBD in food due to being favorable to children and the possibility of creating a safety concern. Read more about this here . This CBD fruit citation is another example that the days of “putting CBD in everything" are gone. Hashtags also play a prominent role in this warning letter. One post lists # anxiety and # depression. Over 30% of this year’s CBD warning letters mention the one-two punch of anxiety and depression. This post includes these two words together in hashtags is an excellent example of what not to do. From warning letter. “…promising results regarding #cannibidiols [sic] potential to assist with cognitive illnesses, including #anxiety and #depression.” Read the full warning letter . 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!

< Back Virtual Fireside Chat Friday Jun 16, 2023 Substantiation Dossiers: Building Trust in Label Claims for Retailers, Influencers, and Consumers Radicle Science June 16, 2023 (10:00 am PT / 1:00 pm ET) The dietary supplement industry has no shortage of attention lately when it comes to the Federal Trade Commission and the recent notices of penalty offenses on label claims. Brands are reaching for substantiation dossiers as a means to provide their retailer partners, influencers, and customers assurance that their label claims are factually accurate. Join Radicle Perspectives with Asa Waldstein , Principal of Supplement Advisory Group , as we discuss how to mitigate label claim risk, the impact recent headlines have had on dietary supplement consumers, and what Asa sees is next when it comes to the FTC drama. Key Topics: Understanding label claim risks in the dietary supplement industry Strategies to mitigate label claim risk through substantiation dossiers Insights into the future of FTC regulations and its implications for the industry Watch On Demand Previous Next

< Back In-Person, Panel Discussion Thursday Jan 23, 2025 Our Commitment to Product Integrity Organic & Natural Health Association Fort Lauderdale, FL 12:15 – 1:30 pm Our Commitment to Product Integrity Amy Summers Founder & President Pitch Publicity & INICIVOX- Moderator Deleo de Leonardis, CEO Co- Founder, Purity IQ Erin Taraborrelli, Program Manager, Labeling & Training Services, SGS nutrasource Ray Martinez, President, Florida Supplement Sandra Baek Lee , CEO, NJ Labs Asa Waldstein, Founder and Principal, Apex Compliance Learn More Previous Next