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Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims < Back Compliance in the Digital Age: Navigating Enforcement, Marketing Risks, and the Rise of AI | State of the Supplement Industry Asa Waldstein Guest Article Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims Although the pace of FDA warning letters to dietary supplement companies appears to have slowed over the past 12 months, several important enforcement themes continue. GMP compliance remains a central focus, particularly regarding incomplete identity and finished product composition testing. The FDA’s long-standing mantra still applies: If it’s not written down, it didn’t happen. Read More Previous Next

Latest News I love writing guest articles and collaborating See appearances for Asa's events and podcasts 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 Oct 3, 2024 Guest Article Natural Products Insider Asa Waldstein Q3 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 1 2 3 4 5 1 ... 1 2 3 4 5 ... 5

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. < Back SSG 2025: Asa Waldstein on FDA, FTC and NAD enforcement trends Cassandra Stern Interview 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. Regulatory scrutiny from the Federal Trade Commission (FTC), National Advertising Division (NAD) and the Food and Drug Administration (FDA) has gained momentum in 2025 across CPG categories, including dietary and nutritional supplements. At SupplySide Global in October, Asa Waldstein, principal at Apex Compliance and chair of the Supplement Advisory Group, discussed recent cases and shared insights on the latest trends shaping FDA warning letters, FTC oversight and NAD actions. Read More Previous Next

Asa's Speaking Schedule & Event Recordings Asa's Regulatory Education Series & Guest Appearances 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 Interview Wednesday Nov 2, 2022 ‘Warning letter geek’ decodes marketing compliance SupplySide West The self-proclaimed 'warning letter geek' said lately the FDA is cracking down on mental health related-claims. Read More

< Back Webinar Wednesday Dec 3, 2025 Regulatory Reality Check: What Supplement Brands Need to Know About the Healthspan Category Naturally Informed Webinar Consumers aren’t just living longer... they want to live better. Consumers are demanding more than just longer lifespans—they’re seeking healthspan . This shift is transforming the supplement and functional foods markets. With global sales for older adult supplements projected to hit $265 billion by 2032, now is the time to understand where the market is headed—and how your brand or business can lead. At this three-day virtual event, you’ll hear from world-class experts covering: - The latest research in aging, longevity, and performance - Nutrition, lifestyle, and formulation insights driving product success - Opportunities in women’s health, mobility, cognition, and beauty-from-within - Marketing and regulatory perspectives shaping this high-growth sector Learn more and register Previous Next

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. < Back NAD+ health ads scrutinized as NAD recommends Reus Research modify or discontinue certain claims Cassandra Stern Interview 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 Previous Next

Asa Waldstein is our guest on KISC My Health Radio show with Peter Mingils and the King of Cranberries Stephen Lukawski. < Back KISC My Health Radio Show with Captain Cran Man Stephen Lukawski with Asa Waldstein and cohost Peter Mingils Stephen Lukawski Podcast Interview Asa Waldstein is our guest on KISC My Health Radio show with Peter Mingils and the King of Cranberries Stephen Lukawski. This week on KISC My Health Radio, Captain Cran Man Stephen Lukawski and Peter Mingils have the privilege of interviewing Asa Waldstein. Click "read more" below to learn more and listen to the interview. Read More Previous Next

< Back Panel Discussion Wednesday Mar 29, 2023 Claims, Compliance, COA panel NoCo Hemp Expo Colorado Springs, CO For nearly a decade, NoCo Hemp Expo — the world’s most comprehensive industrial hemp exposition and conference — has brought together international business and government leaders, academia, nonprofits, media and the public to collaborate on important initiatives, opportunities and solutions for the future of a crop and an industry that can have significant positive impact on human, animal and planetary health. Claims, Compliance, COA panelists include: Asa Waldstein Marielle Weintraub, Ph.D. Christopher Hudalla Holly Bell Jackie Bowen Learn More Previous Next

Review of NAD case < Back Finished Product: Clinical Study Required Review of NAD case Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic. Full disclosure: I like NAD, and their cases are a wealth of learning opportunities, but the interesting and somewhat mind-boggling portion of this case has to do with performance claims. Based on the information provided, it seems that NAD requires a finished product study to substantiate the “helps maintain healthy eyesight and visual performance” statement. 🔹 NAD states this is “because the studies and meta-analysis relied on by the advertiser were not conducted on the (product).” 🔹 NAD goes on to say, “NAD recommended the claim be discontinued but noted that nothing in its decision prevents (product) from tailoring its claims to the benefits specific ingredients in (product).” A takeaway here is attributing substantiated structure-function claims to ingredients like “vitamin C for skin health” rather than simply stating the product is used for skin health is a risk-lowering strategy. I still feel like I am missing something here because I can’t imagine agencies or courts requiring finished product studies for low-risk structure-function claims that do not state the product is clinically proven. I write more about these important points from the FTC’s Notice of Penalty Offence letters here . There’s more to this case , including bioavailability claims, and I suggest everyone read it. Please let me know your thoughts. 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!

Nutrition fact panels must be in a compliant format < Back Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts and eggs, which led to an anaphylactic death. 👉From warning letter. “On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with …. your firm recalled the cookies. The products contained peanuts and eggs but your printed label on the package did not contain an allergen statement or ingredient declaration for peanuts or eggs.” The warning letter goes on to state that there are missing and extra ingredients on the label, which shows that the company’s quality control procedures need a serious review. Disclosing major allergens is easy. Here are the two options. I always prefer the “Contains” option as it’s more apparent to the consumer. 👉The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or 👉The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)]. The Nutrition Facts Panel (NFP) is also not in the correct format. There are differences between a Supplement Fact Panel and an NFP. This FDA reference is pretty good. 👉From warning letter. “The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii). b. It lacks the declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii) c. It lacks the declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii)” Here are some examples of compliant NFPs . Read the warning letter here . DATE ORIGINALLY POSTED: 11/27/24 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 Interview Thursday Jul 15, 2021 Effective and practical marketing compliance Insider in the Afternoon We speak about structure-function claims, disease claims, marketing risk versus reward, and clever product names. Watch Previous Next

< Back Workshop Tuesday Apr 19, 2022 Marketing and Regulatory Compliance for 5th Year PharmD Students (2022) Massachusetts College of Pharmacy and Health Sciences This course reviews common product online and social media marketing pitfalls to avoid. We also discuss strategies to give graduates a leg up in nuanced and competitive world or product marketing Learn More Previous Next