Search Results

Blogs can be considered marketing < Back When “Educational” Blogs Become “Labeling” Blogs can be considered marketing I love educating about enforcement trends and regulatory marketing compliance, and I've been writing this weekly post for almost three years. I have two small companies in the dietary supplement marketing compliance space. Supplement Advisory Group is my consulting company that focuses on dietary supplement labeling and online marketing compliance support. Apex Compliance ™ is my subscription software product that helps find and replace risky marketing phrases on websites, videos, and content before publishing. I've dedicated my life to understanding enforcement trends as a way to inform compliant marketing. Today's post sums up common compliance oversights I commonly see in both of my companies. There have been no dietary supplement warning letters this week and I am attending a conference in NYC, so today's post will be brief. I'm writing this from beautiful Bryant Park, my NYC "office." I often see companies with compliant labels and product pages but have blogs on their websites filled with disease claims. In this post, we'll help demystify when "educational" blogs become marketing. If a supplement company writes about practices such as meditation or exercise being useful for diseases like anxiety, this is generally low risk. If the company mentions the benefits of ingredients they don't sell, again, this is low risk. Now, if there are blogs that talk about ingredients in products they sell, this crosses the line from education to product marketing, even if there are no hyperlinks or cross-linking. Just mentioning ingredients and then suggesting that they can help with diseases is enough to attract a warning letter. Here is an example of what I call the "common blog writer trap." Let's say a company writes a blog such as "5 Tips For Beating The Winter Blues." Typically, it would discuss winter blues and references disease names such as "depression." The blog would then talk about health-giving activities like meditation, snowboarding, working out, and journaling. The company may even talk about how there are studies suggesting that vitamin D supplementation can help. If the company doesn't sell vitamin D, then this blog is likely to be considered educational. However, if vitamin D is in any of their products, this crosses the line for product marketing. The more explicit the statement is, the more likely it is to be cited in a warning letter. For example, "Recent studies show that vitamin D supplementation can help alleviate many of the symptoms associated with depression." When in doubt, resist the urge to overexplain ingredient benefits, as this can result in a 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!

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q4 2024 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Each quarter, Asa provides updates on notable FDA warning letters and enforcement trends. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional or dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others? FDA likes to make examples of companies not following the rules in areas they want to focus on, many of which Asa reviews here. Staying ahead of trouble is one of the critical and fun reasons to follow enforcement trends. 2024 has been noticeably light in dietary supplement warning letters, and I don’t have a good guess as to why. Dozens of companies continue to make extreme disease claims — such as the treatment, prevention or mitigation of cancer — about their products or ingredients. I expect more regulatory action in the months to come. Read More for Asa's 2025 Predictions. Read More Previous Next

Learning from others' mistakes helps you be compliant < Back Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 200 weeks of writing this weekly post. Wow, what a journey it's been! Finding my voice on LinkedIn and beyond was not easy. I didn't want to create drama and be too inflammatory, as this is not my style. I also didn't want to misrepresent my level of knowledge in areas I am not an expert in, as this felt contrived. Also, I know that LinkedIn is not Instagram, and memes and viral cat videos were not my style either. I first started by liking and then commenting on others' LinkedIn posts and following my guiding principles of being kind and helpful. Then I came to realize I REALLY LOVE writing about enforcement trends, as they can help us "read between the lines" of where future enforcement will happen. This allows companies to adjust their marketing and learn from others' mistakes before serious regulatory or litigation occurs. I started posting more about interesting enforcement trends, and since FDA's weekly newsletter used to be sent on Wednesdays, I decided to call this post Warning Letter Wednesday . Thank you to Steven Yeager for helping with this name! Over the past 200 weeks, enforcement trends have come and gone. Here are some of the key enforcement trends since I started writing WLW. 🔹 Targeting Opioid Withdrawal: Supplements marketed for opioid addiction or withdrawal continue to see increased enforcement. Even though some companies are well-intentioned and trying to be helpful, making these claims has a high likelihood of attracting a warning letter. 🔹 Hangover Cures: Claims about preventing hangovers went from lower to high-risk in July 2020 when FDA issued seven warning letters to hangover supplement companies. FDA stated that claims to treat hangover symptoms are essentially disease treatment claims since being inebriated is the disease-state of alcoholism. These letters also included FDA's temporary battle with NAC, which has now subsided. I use this group of letters as an example of why following enforcement trend changes is a critical part of marketing compliance. 🔹 CBD Enforcement Surge and Decline: The cannabinoid sector experienced a boom-and-bust enforcement trend. From 2018 to 2021, dozens of CBD companies received warning letters for disease claims (e.g., cancer, Alzheimer's). Enforcement then started to drop in 2022 when the FDA issued 34 warning letters to CBD and delta-8 products, and then in 2023 that number dropped to 15 – a 56% year-over-year decrease. Now, CBD enforcement, other than some very risky delta-8 type letters, seems to be nearly non-existent. FDA has been issuing about one CBD warning letter about every 3-6 months. Follow my SupplySide Supplement Journal quarterly Warning Letter Roundup for more information on this. 🔹 COVID Enforcement: FDA and FTC crack down on COVID-19 claims. Several dietary supplement firms received joint FDA/FTC letters for COVID support claims. After this initial surge, COVID-related letters tapered off by late 2021 as the worst offenders were cited by regulatory action and updated their marketing. 🔹 Continued Reminders of GMP Compliance: FDA continues to focus on core compliance areas like labeling and GMPs. Since the beginning of WLW, a number of warning letters have cited the basics, such as products missing mandatory label elements, lack of allergen labeling, or specification-related GMP violations. These letters are a good reminder that FDA still enforces manufacturing and labeling accuracy. For example, one letter discussed in WLW described how a company's half-hearted recall and response on an undeclared allergen led to a warning letter, essentially for failing to follow through on promised corrective actions. 🔹 Rise of Biomarker Claims Scrutiny: In 2022 FDA sent out the "Big 7" warning letter, which was a group of letters citing biomarker claims related to heart disease. In the past, making biomarker claims like lowering cholesterol and lower LDLs was not "enough" to attract a warning letter unless higher risk words like hypertension were used. These letters signaled a more rigid shift in the FDA's enforcement of biomarker claims, which continues today. 🔹 Old Content Is "Active" Marketing: A theme over the past 200 weeks is that nothing on the internet or socials ever truly "expires" in FDA's eyes. Warning letters now routinely reference years-old Facebook posts, YouTube videos, or blog articles that companies may have forgotten to update. Here is a post where the FDA cited a 7+ year old re-tweet. 🔹 Major Retailers and Marketplace Enforcement : FDA is holding platforms like Amazon accountable for the products they distribute. Amazon has received several warning letters , including three in 2023. FDA stated that by fulfilling orders, Amazon "introduced" an unapproved new drug into interstate commerce by distributing. 👉 Here are SOME of my more notable and favorite posts. 🔹 MLM Company Cited For Claims Made By Their Affiliates : Marking the one-year anniversary of WLW, this post highlighted an FDA warning letter to a direct selling company for disease claims made by its independent consultants. It was the first time I could remember when a company was cited for its affiliates' claims, showing that brands can be held responsible for influencer/affiliate content. Key takeaway: Train and monitor all affiliates to avoid unapproved disease claims. 🔹 Product Tags and Meta Tags : This post revealed how even website tags can trigger enforcement. An FDA/FTC joint warning letter to a CBD company cited the use of a "COVID-19" category tag linking to a blog post about fighting COVID. 🔹 Unauthorized NDI Leads to Warning Letter: This post spotlighted the enforcement of the New Dietary Ingredient (NDI) rules. A company received a warning letter for using N-Methyltyramine even though the product made no disease claims. FDA rarely issued letters solely for unapproved ingredients unless other violations existed. Here, the absence of any disease or GMP violations "should give companies pause" about using ingredients lacking NDI notifications. 🔹 GLP-1 Product Receives Warning Letter: This is one of the "cringiest" cases I've seen. This recent post detailed a company marketing a purported supplement as a natural alternative to Ozempic. The firm claimed their product was "FDA approved," better than the prescription GLP-1 drug, had "no side effects," and was proven in clinical trials. It was the first warning letter involving a GLP-1 weight-loss "supplement" and came alongside letters to several vendors selling actual semaglutide (the active ingredient in Ozempic) as research chemicals. 🔹 Influencer Material Connection Disclosure: This recent post shifted focus to advertising compliance, using Kevin Hart as a case study. The comedian had promoted a sportswear brand and a bank on social media without obvious disclosure that he was a paid partner or owner, leading to an inquiry by NAD. The motto, " when in doubt, disclose," is a key takeaway here. Free Warning Letter Wednesday stickers for you all! Learn more here . I've written WLW while sick with COVID, while on family vacations in eight countries, including Tanzania, New Zealand, and my current travels in Laos and Thailand, and this has been a labor of regulatory love. Thank you to all my readers and supporters! You are very appreciated! DATE ORIGINALLY POSTED: 5/7/25 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!

The case highlights compliance risk for functional beverages and ingredient claims among dietary supplement and food‐adjacent product manufacturers. < Back Ryze Superfoods drops mushroom coffee and matcha health claims after NAD inquiry Cassandra Stern Interview The case highlights compliance risk for functional beverages and ingredient claims among dietary supplement and food‐adjacent product manufacturers. Read More Previous Next

Delta-8 is a high-risk ingredient < Back Unallowable Ingredient “Enough” to Trigger Regulatory Action Delta-8 is a high-risk ingredient There has been a recent enforcement trend where having an unallowable ingredient in a product can result in a warning letter, even if no disease claims or GMP violations are mentioned. This warning letter is the sixth CBD or delta-8 related warning letter this year, which shows that FDA is still taking this enforcement seriously, especially when delta-8 is added. Here’s a recent write-up on an unallowable (or possibly an un-submitted NDI) ingredient triggering a warning letter. I usually don’t call out company or product names, but this one is too strange to pass up. From warning letter: “Trippy Smak’d Fuk’d Blend Watermelon 1500 mg Gummies” I would call this letter a “low effort” warning letter, but FDA actually purchased the product and tested it for delta-8. The moral of the story is that any company selling delta-8, even if they are not making disease claims, should be put on notice that the FDA is paying attention, especially if the delta-8 products are in packaging and formats favorable to children. Learn more about FDA’s position and its safety concerns here . Read the letter here . DATE ORIGINALLY POSTED: 8/13/25 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!

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. < Back Cognitive and memory warning letters and litigation trends: Best practices for reducing risk Asa Waldstein Guest Article 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. 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. This leads to warning letters, competitor challenges and lawsuits, but it can be confusing to know how to discuss ingredients and products without crossing the compliance line or becoming an easy lawsuit target. In this article, I’ll review enforcement trends and best practices to help keep you out of trouble while continuing to educate your consumers and grow your business. Read More Previous Next

Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. < Back Olly and BrainPack NAD decisions highlight challenges in supplement advertising Cassandra Stern Interview Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. "Small words can impact the amount of substantiation needed, which is why it is important to build a company culture of compliance and help the marketing, sales, regulatory, and social teams understand the guardrails or substantiation and what can go wrong if they are not followed." - Asa Waldstein Read More Previous Next

< Back Presentation, Panel Discussion Saturday Nov 6, 2021 Presenter: What Can Marketers Learn From FDA/FTC Action? Panelist: Business and Marketing Panel Lucky Leaf Expo, Houston, TX In this session, we review recent enforcement trends and discuss ways companies operating in the hemp-CBD marketplace can limit their risk, while still be truthful and not misleading. This includes identifying high-risk verbiage and providing examples of lower-risk ways to get the same message across. This discussion reviews the dos and don'ts of digital marketing such as best practices for blog posts. Learn more Previous Next

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 FDA warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Previous Next

Biomarkers claims elevate enforcement risk < Back Animal Product Testimonials Lead to Warning Letter Biomarkers claims elevate enforcement risk Claims about animal products were cited in today’s warning letter. Most statements involve customer testimonials with biomarkers such as “kidney values,” and “liver count,” and some other disease statements. Animal product claims seem to have a lower “acceptance level” than human supplements. For example, mentions of “pain” or “anxious feelings” are probably not enough to attract a warning letter for a human product, but these seem to tip the scale into warning letter category for animal products. This, of course, is not the case with this letter, where several very high-risk statements like “kill most urinary infections” are present. 🔷Here are my thoughts on testimonials. The authorities have been “hands off” in going after companies for third-party user-generated non-compensated reviews, such as those that appear to come through widgets like Trust Pilot. These “protections” go away when the review is engaged with , or showcased such as in a website banner, social post, or on their own review page. This warning letter congregated product reviews on their own page, which means they are curated and are, therefore, marketing. 🔷Here are my thoughts on biomarkers. In the past, claims about biomarkers such as “lowers LDLs” were not cited in warning letters unless higher-risk words were present. This changed last year when FDA sent warning letters to companies solely based on heart disease-related biomarkers, even when no disease words like “heart disease” were present. I write about this here . Heart disease-related biomarkers are high-risk, but others, such as creatine or bilirubin, do not seem to attract the same scrutiny. This is what makes this warning letter interesting, and I wonder if there were no high-risk disease words used if FDA would have cited the company simply for statements like “liver levels.” Read the full warning letter . DATE ORIGINALLY POSTED: 7/26/23 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 Presentation, Online Wednesday May 18, 2022 Microbiome: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in the microbiome space. Watch Previous Next

All social media is “fair game” for enforcement < Back LinkedIn Posts Mentioned in Warning Letter All social media is “fair game” for enforcement It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This is a new aspect of enforcement, as previously, I have only seen claims made on a company's LinkedIn page mentioned in warning letters. I find it interesting the FDA is looking at actual posts on LinkedIn, which is an important reminder that all marketing must be compliant and is "fair game" for regulatory scrutiny. This warning letter is Covid-related, which, of course, is a very high risk; however, it is a reminder that hashtags and reposting content elevate risk. In this example, a "Covid study" is shared, and the material connection is solidified with a covid hashtag and a hashtag containing the product's name. From Warning Letter "More evidence that respiratory diseases should be treated in the nose and throat! .... # biovanta # science # covid" [from a post on your social media webpage at...." Read the full warning letter here. This joint FDA and FTC warning letter includes an FTC cease and desist prohibiting the company from making future Covid claims. This sets the FTC up to potentially impose financial penalties and has more "teeth" than a standard 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!