Schedule your free 15-minute introductory consultation today to get started. Please review our list of services to understand Supplement Advisory Group's offerings. https://www.supplementadvisorygroup.com/ You may also enjoy reviewing my regulatory hints video channel. https://www.youtube.com/c/DietarySupplementCBDRegulatoryCompliance I look forward to meeting with you! Kind regards, Asa **My services are not intended to replace legal advice. There are many wonderful attorneys out there. If you need a suggestion please let me know.

We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is why I write the weekly Warning Letter Wednesday post on LinkedIn, Twitter, and Facebook. This blog post is an extended version of my Warning Letter Wednesday posts. This warning letter is a great teaching case. Here are the learning targets. FDA Inspections Trigger Website Reviews Marketing Claims Distributors Responsibilities Common GMP errors *Writing and Following Specifications *Writing Procedures *Product Returns *Product Complaints Certain Herbs Are Not Allowed Common Allergen Labeling Domestic Street Address or Phone Number Languages Must Contain The Same Information Serving Size and Suggested Use Plant Parts Must Be Disclosed Correct Plant Listing Supplement Fact Panel: Line Thickness Percent Daily Values Label Requirement Expiration Dating FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here. Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. I write these letters here and here. This is a fascinating enforcement trend to watch and a good reminder for companies to clean up their website claims if they have been inspected. This is one of my favorite services Supplement Advisory Group offers. Marketing Claims ➡️From warning letter: Although studies (of PS, an ingredient in your product) in humans with Alzheimer’s disease were less dramatic, they still produced significant improvements in cognitive function. In patients with mild dementia, significant cognitive and behavioral enhancing effects were observed. 👉Asa's commentary: These mistakes have been reviewed in previous Warning Letter Wednesday posts; High risk words and video, citing studies, and discussing ingredient benefits. Distributor Responsibilities The company uses a contract manufacturer to make their products. This does not mean the company does not have any GMP responsibilities. ➡️From warning letter: Quality control must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement 👉Asa's commentary: This means a company has to conduct some type of review and release before selling the product. This does not have to be complicated but it has to be written down and followed. If it's not written down it didn't happen is an FDA mantra. ➡️From warning letter: Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. 👉Asa's commentary: This is boilerplate language but a good reminder that although working with a contract manufacturer does mitigate some risks, the basics of quality assurance should be in place. We discuss many of these topics here. Common GMP Errors Writing and Following Specifications ➡️From warning letter: You failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, your firm distributes the dietary supplements that are contract manufactured for you, but you had no records of a quality control review, approval, or rejection for your finished dietary supplement products. During the inspection, you informed our investigator that you do not review the documentation related to the finished dietary supplement products you receive from contract manufacturers to determine if those finished dietary supplement products have met specifications. 👉Asa's commentary: Not having and following specifications is one of the most common GMP violations. Specifications should be reviewed by a member of Quality and then approved, rejected, or quarantined. This allows problems to be found before products are shipped to the public. I write about this here. Writing Procedures ➡️From warning letter: You failed to establish and follow written procedures for holding and distributing operations, to comply with 21 CFR Part 111.453 that include the requirements for holding components, dietary supplements, packaging, and labels, 👉Asa's commentary: Writing and following procedures is an important part of GMPs. Procedures are the "directions" for doing things, commonly referred to as Standard Operating Procedures (SOPs). Product Returns ➡️From warning letter: You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, 👉Asa's commentary: We talk about the requirements for 21 CFR 111 Subpart M (Holding & Distributing) here, and we discuss how to handle a partially damaged shipment here. Product Complaints ➡️From warning letter: You failed to establish written procedures for the requirements to review and investigate a product complaint. 👉Asa's commentary: This is one of the most important parts of being a distributor of dietary supplements. If you are on contact name on the label, you are responsible for reviewing product complaints and informing the FDA of Serious Adverse Event Reports. Certain Herbs Are Not Allowed The FDA does not allow the use of certain plants they consider to be dangerous. Pinellia ternata, a TCM ingredient, was called out in this warning letter because it contains ephedrine alkaloids. Learn more about this here. In general, if a plant is not widely used in commerce, it is a red flag of potential danger, or a New Dietary Ingredient (NDI). Common Allergen Labeling ➡️From warning letter: ..the finished product label fails to declare the specific species of shellfish allergen sources as required. 👉Asa's commentary: The company disclosed the common allergen (crustaceans) but not the type of crustacean (e.g., Contains: shrimp). This is a common error that can be easily prevented. Here are the specific common allergens that need to be disclosed. The specific type of nut (e.g., almond, pecans, walnut, coconut). The specific type of fish (e.g., bass, flounder, Pollack). The specific type of crustacean shellfish (e.g., lobster, shrimp, crab). Domestic Street Address or Phone Number ➡️From warning letter: ..the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 👉Asa's commentary: I review a lot of labels, and it is commonly overlooked. This is how supplement companies track customer complaints and inform the FDA of serious adverse events such as hospitalization Languages Must Contain The Same Information ➡️From warning letter: ..your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 👉Asa's commentary: I do not review multi-language labels,, so this is a new one to me. There is so much to learn about GMPs. Serving Size and Suggested Use ➡️From warning letter: The “Directions” for your Hemorlyn product states to take “2-4 capsules per day with meals,” but the serving size lists “2 Capsules.” The serving size listed should be four capsules. 👉Asa's commentary: The maximum suggested amount consumed at one sitting is a serving size. For example, a serving size that reads take 1-5 capsules daily is a serving size of 5 capsules, which would need to be in the supplement facts panel. This is an amateur error that could have been prevented. Plant Parts Must Be Disclosed ➡️From warning letter: ..the labels fail to identify in English the part of the plant (e.g., root, leaves) for each of the botanical dietary ingredients in the products, as required by 21 CFR 101.4(h)(1). We note “herb” is not a recognized plant part. Furthermore, we note if an entire or whole plant is used, 👉Asa's commentary: Yes, it really is a rule to list the plant part. Replacing "herb" with "leaf" would be been accurate. This is a great example of what I call a "secondary claim" or a "minor violation" which is something not likely to attract a warning letter on its own/ Correct Plant Listing ➡️From warning letter: ..each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient used. 👉Asa's commentary: The American Herbal Products Association's (AHPA) Herbs of Commerce is the reference for standardized common names. Thanks AHPA! Supplement Fact Panel: Line Thickness ➡️From warning letter: The Arthrolyn product’s Supplement Facts label fails to separate the (b)(2)- from the (b)(3)-dietary ingredients with a heavy bar. 👉Asa's commentary: Having the correct line thickness is part of a compliant label. Here is an example of correct line thickness and Supplement Fact Panel layout I made just for you. Label review is one on the many aspects of regulatory compliance my company covers. Percent Daily Values Label Requirement ➡️From warning letter: The Goldenlife product’s Supplement Facts label bears the following statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required. 👉Asa's commentary: This is the first time I have seen this in a warning letter, wow. Expiration Dating ➡️From warning letter: Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life 👉Asa's commentary: A company needs to have stability data in order to substantiate expiration, best, before, or freshness dates. Many of the items, such as label formatting and layout issues are not likely to lead to a warning letter. Incorrect label formating however is a red flag that the company is not following the basics of GMP-labeling compliance, and this may be a sign of deeper issues. The quickest way to attract a warning is by making disease claims. This, in combination with serious GMP violations, adds to the risk. The FDA's duty is to protect public safety and not verifying a product's quality may, in some rare circumstances, lead to serious health issues. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

Dietary supplements are great for hydration and liver support, but they cross the compliance line when marketed for hangovers. There have been 14 hangover-related FDA warning letters since the beginning of the pandemic including two this month. This is an enforcement trend that is top of mind for the FDA. Here Are The Learning Targets: FDA’s rationale for hangover being a claim Amazon storefront claims Discussing Ingredient Benefits Are Considered Marketing Claims Referencing Clinical Studies Can Be Looked at as Marketing Implied Claims Will Attract a Warning Letter Blogs Are Marketing Claims Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow In the past making a hangover support statement would have been a relatively low risk, but in July 2020 the FDA issued seven warning letters to companies making hangover claims. In the accompanying policy statement press release Steven Tave, former director of FDA’s Office of Dietary Supplement Programs, stated Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption. Here is my guess as to why the FDA considers the word hangover a claim. Anything that prevents, treats, or cures symptoms of a disease is a medical claim. Amazon Storefront Claims In the past claims made on Amazon were considered "the unholy grail" of compliance, with little enforcement of the egregious claims used to market products. I am glad to see the FDA enforcing this and expect to see many more Amazon-related warning letters in the future. From Warning Letter: Crocin Rich plus is good for: … Help recovery of nerve and traumatic injury....Reduce Hangovers From another Warning Letter: Cure Your Hangover Fast; Milk Thistle … helps speed up the recovery process for your liver, getting rid of your hangover faster!” “Taking the product on a regular basis before drinking may also aid in reducing the possibility of a hangover in the morning. Using words such as cure and symptom demonstrate the intended use of a product to treat disease. It is important to remember the DHSEA disclaimer (Not intended to treat, diagnose, prevent, or cure) when developing marketing content. Here’s a video I made to help companies identify if a claim is being made. If accurate, replacing cure with support and replacing symptom with ailment can help to lower risk. I write about identifying and replacing high-risk buzzwords here. Other possible words for a hangover; imbibe or overindulge. From Warning Letter: Hangovers! Does anybody like them? Not a soul, but how can we stop ourselves from encountering one after a long night? Nutrovape now has the answer. With the new Nutrovape recover, you can make sure your hangovers don't ruin your days after a night of drinking. Discussing Ingredient Benefits Are Considered Marketing Claims From Warning Letter: The “Dihydromyricetin (DHM)” page in the “Health” section of your website: Dihydromyricetin . . . is used for anti-inflammatory, anti-hangover . . . benefits. Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers: . . . This is a common mistake made by well-intentioned writers and webpage designers that do not understand the nuances of dietary supplement marketing. Best practices here are separating the ingredient benefits discussion from the product page, removing high-risk words, and ensuring that a reasonable consumer will not think this is intended to sell a product. Here is a Warning Letter Wednesday post on this topic. Referencing Clinical studies Can Be Looked at as Marketing From Warning Letter: Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers. Here is a post and a video about clinically proven types of statements. Although not hangover-related, here is a NAD case decision and FTC administrative compliant that are interesting reads. Implied Claims Will Attract a Warning Letter From Warning Letter: More recently, Dihydromyricetin has received attention for its purported anti-hangover activity. Several studies suggest that it may lower markers of inflammatory liver disorders. Anecdotal reports indicate that this may carry over to alcohol-induced liver inflammation. Stating anecdotal reports indicate then adding a disease word is considered a suggested implied claim. Other examples of this include using “may” and “should” followed a high-risk buzzword. See my post on this here. Blogs Are Marketing Claims Informational blogs are considered extensions of the label. This warning letter references a light implication that CoQ10 is useful for hangover support. This statement was made about the ingredient CoQ10 in an educational blog. The FDA makes the correlation this is a marketing claim because a product sold on this website CoQ10 has the same name as the ingredient. From Warning Letter: Holiday Hangovers: After All That Partying, Which Nutrients Do You Need the Most (which references the ingredient Coenzyme Q10 contained in the product Nanoemulsified CoQ10) The compliance line between "informational" blogs and product blogs is very thin and is open to interpretation. If a company must use informational blogs on a commercial website it is important to make it clear the blog is for educational purposes only and remove all CTA's (Call To Actions) that link to a shopping cart or product page. Here is a detailed Warning Letter Wednesday post and a helpful video I made on the topic. Please share these with your content team as training tools or contact me for a free consultation. I love talking about this aspect of marketing and compliance. Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing, but the warning letters continue. As exemplified by the hangover enforcement timeline, what was a lower risk in the past may be high-risk tomorrow. I love enforcement trends; they give us an opportunity to learn from others' mistakes and course correct. Read my Reasons to Follow Enforcement Trends post for a detailed discussion. Also, reading my weekly Warning Letter Wednesday post or anything by Josh Long or Nathalie Bougenies are great ways to stay up to date with what the FDA is focusing on. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

The popularity of medicinal mushrooms shows me the world is finally ready to embrace natural medicine. It is no surprise however to see mushroom product marketers being called out in warning letters for making high-risk claims. Here's a recent warning letter that covers many of the common mistakes to avoid. Most of this I've talked about here in my blog or my #WarningLetterWednesday LinkedIn post. Here Are The Learning Targets: * Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk *Hashtags Are Claims *High-Risk Words Should Be Avoided *Implying "Clinically Studied" Is High-Risk * Clean Up Claims On Old Social Media Posts * Social Media is Marketing Many warning letter recipients are not bad folks but perhaps just do not know any better. A purpose of my free Regulatory Education Series platform, my public speaking tour, and my free video channel is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together! Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing. I love enforcement trends, they give us an opportunity to learn from other's mistakes and course correct. Read my Reasons To Follow Enforcement Trends post for a detailed discussion. Hashtags Are Claims It is pretty obvious but in this warning letter, the following hashtags were called out. #DepressionAndAnxiety #BeatDepression #BeatAnxiety The quickest way to wave a stick at the FDA/FTC is by using non-compliant hashtags, High-Risk Words Should Be Avoided I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk categories: cancer, COVID, Alzheimer’s, depression, PTSD, Diabetes should never be used. Words such as pain and inflammation carry a risk level of 3 of 5. For context, anything 3+ is likely to attract a warning letter. Contact me for a list of other high-risk words to avoid with some possible lower-risk alternatives. Here are some tips to know if a claim is being made! I also made a video on this! Implying "Clinically Studied" Is High-Risk This is definitely a trend to watch out for. We are seeing references to clinically studied types of claims showing up not just in warning letters but also in class action lawsuits. A company cannot imply their commercial product has the same uses as a clinical study. We talk about what defines clinically proven here. There are many factors including serving amount, formulation, and delivery size which play a role in this. Here are some egregious examples from the warning letter in grey. On the scientific studies webpage, under the heading “Lion’s Mane Scientific Studies”: • “Lion’s Mane May Be Effective in Combating Dementia/Alzheimer’s Disease” • “Lion’s Mane Has Shown In Studies That It Could Reduce Anxiety And Depression” • “Animal Testing Shows Lion’s Mane Helps Control Diabetes Symptoms By Keeping Blood Sugar Low” This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. I loved that post and poured by 20 years of experience into it! Clean Up Claims On Old Social Media Posts The authorities look at a very old social media in the same manner as a current one! In this warning letter, a 2019 tweet is referenced! Please please please, delete or clean up old non-compliant social media posts. I really don't want to tell you I told you so! Read about this in my Operation CBDeceit blog. From the warning letter in grey. Notice the 2019 date! On your social media website • “LVL:MAX . . . Protects Against Ulcers in the Stomach: Goodbye Pain… Relieves Depression and Anxiety… Lowers Cholesterol: Live Longer…Lower Inflammation…” [From a Nov 12, 2019 post] Social Media is Marketing Anything used to sell a product, including all commercial social media posts are marketing, and therefore must be compliant. Most warning letters reference social media I find it helpful to think of all marketing as an extension of the label. We wouldn't use the word anxiety on a label, so it's important to not use disease claims in any marketing, including social media infographics. Anything used to market must be truthful and not misleading. I hope you enjoy this warning letter report from the front line of compliance. I read every FDA warning letter and report back on enforcement trends. I love this aspect of compliance! For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

Latest News I love writing guest articles and collaborating See appearances for Asa's events and podcasts Aug 24, 2026 Interview NutraIngredients Cassandra Stern When the influencer isn’t real: AI amplifies familiar supplement advertising risks Synthetic spokespeople may be new, but industry experts say brands remain responsible for substantiated claims, truthful endorsements and transparent marketing. Read More A recent New York Times investigation has identified hundreds of AI-generated wellness personalities promoting supplements to U.S. consumers on social media, including personas presented as doctors and other health experts. "The biggest mistake would be using AI to create credibility or personal experience that is not real. A mistake would be assuming that an AI disclosure fixes everything...saying that a character is AI-generated does not allow it to make a disease or unsupported health claim acceptable." - Asa Waldstein Aug 19, 2026 Interview NutraIngredients Cassandra Stern Qunol faces class action over omega-3 claims Quten Research Institute is facing a proposed class action alleging that its Qunol Ultra Omega-3 Fish Oil contains less omega-3 than the 1,000 mg advertised on the product label. Read More "I expect these types of lawsuits to continue, so now is a good time for brands to review their labels and GMP documentation again to help mitigate the risk of lawsuits." -Asa Waldstein Aug 4, 2026 Interview NutraIngredients Cassandra Stern Ryse sued over alleged protein shortfalls in Clear Protein Drinks Ryse Up Sports Nutrition is facing a proposed class action alleging its Ryse Clear Protein Drinks contain between 6% and 11% less protein than the 22 g declared on the label. Read More "Companies should not treat protein labeling as copying a number from a raw-material specification or formulation sheet," said Asa Waldstein, principal at Apex Compliance and chair of the Supplement Advisory Group. Aug 3, 2026 Interview, Roundtable Discussion Nutrition Industry Executive Mike Straus Formulating the Perfect Product Asa and others contribute to this discussion Online Read More Nutrition Industry Executive’s roundtable of experts discusses what’s involved in formulating superior products in the modern era. Formulators help ensure finished products meet regulatory standards and are efficacious by building regulatory review into the earliest stages of product development. - Asa Waldstein Jul 27, 2026 Interview SupplySide Supplement Journal Rachel French 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.” 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. Jun 17, 2026 Interview United Natural Products Alliance UNPA Meet Asa Waldstein UNPA Member Spotlight Read More "I love the sense of community, and the UNPA communications feel personal and like I am talking to a well-informed friend!" - Asa Waldstein "To build a sustainable business, GMPs and regulatory compliance should be woven into the company’s DNA." - Asa Waldstein Jun 15, 2026 Interview NutraIngredients Claudia Adrien 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. Read More The FDA warning letter issued to Purolea Cosmetics Lab was the fourth sent by the agency to mention artificial intelligence. May 22, 2026 Interview SupplySide Supplement Journal 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. Read More At a Glance The National Advertising Division’s recommendations on Niagen product claims were upheld. “Clinically proven” claims may come with a higher burden of proof than other claims. NAD believes criteria for advertising claims to be a separate issue than FDA oversight of structure/function claims. May 20, 2026 Interview NutraIngredients Cassandra Stern 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. Read More Recent Salmonella outbreaks linked to recalled moringa-containing dietary supplements have intensified industry scrutiny around pathogen controls and sourcing oversignt for botanical ingredients used in finished products. May 5, 2026 Interview NutraIngredients Danielle Masterson 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. Read More Asa Waldstein broke down an atypical enforcement action involving GLP-1 and blood sugar support claims that appeared to raise regulatory red flags for FDA. Apr 10, 2026 Interview Pet Supplements PRO Lisa Cleaver 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. Read More Regulatory readiness is becoming a real competitive advantage in pet supplements. 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. 1 2 3 ... 6 1 ... 1 2 3 4 5 6 ... 6

Synthetic spokespeople may be new, but industry experts say brands remain responsible for substantiated claims, truthful endorsements and transparent marketing. < Back When the influencer isn’t real: AI amplifies familiar supplement advertising risks Cassandra Stern Interview Synthetic spokespeople may be new, but industry experts say brands remain responsible for substantiated claims, truthful endorsements and transparent marketing. The findings have drawn attention to how longstanding rules around health claims, endoursements and advertising disclosures apply when the person delivering the message is synthetic. Existing advertising rules still apply. The FTC's rule covering consumer reviews and testimonials does not impose a blanket prohibition on AI-generated avatars or virtual influencers. The agency has said an AI-generated avatar could be considered a testimonial under the rule and could be prohibited if the underlying testimonial is fake or false. Asa Waldstein, founder and principal at Apex Compliance, told NI this allows brands to use virtual spokespeople to communicate truthful and substantiated product information, provided they comply with the advertising rules that would otherwise apply. "I see a legitimate and positive role for AI influencers," Waldstein said. "In some ways, a well-managed virtual spokesperson may be easier to control than a human influencer because the brand can preapprove the script, limit the character to substantiated claims, standardize disclosures and prevent the off-script statements that frequently create influencer risk," he illustrated. Read More Previous Next

Asa's Speaking Schedule & Event Recordings Asa's Regulatory Education Series & Guest Appearances In-Person, Panel Discussion Wednesday Oct 28, 2026 Science and sales: The right way to use social media trends Supplyside Global Las Vegas Health and wellness influencers have enormous power. Not only can they dramatically impact sales of products already on the market, they can also drive future trends. This session aims to help product developers harness this power effectively. Read More In-Person, Panel Discussion Tuesday Oct 27, 2026 Compliance, claims and legal frameworks in dietary supplements Supplyside Global Las Vegas This session will focus on the regulatory hurdles shaping the dietary supplement industry, offering a practical guide to balancing compliance, quality and innovation. From Food and Drug Administration GMPs and supplier qualifications to claims substantiation and novel ingredient pathways, attendees will uncover how early-stage decisions in sourcing and formulation can prevent costly recalls and regulatory scrutiny. Read More 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. Read More Podcast Wednesday Mar 25, 2026 Compliance For Natural Products Marketing with Asa Waldstein Natural Products Marketer Podcast If you want to grow with better supplement marketing, smarter SEO, and fewer compliance headaches, listen to this episode and share it with someone who touches your website or social media. Read More 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. 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