Celebrating 200 Weekly WLW Posts!

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.