Q3 2024 warning letter roundup with Asa Waldstein

Each quarter, I provide updates on notable FDA warning letters and other enforcement actions. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional and 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 I review here. Staying ahead of trouble is one of the critical and fun reasons to follow enforcement trends.

Labeling lessons. Getting back to the basics: Minor label violations, such as fact panel line thickness, continue to be cited in warning letters. Unless egregious, they are unlikely to attract a warning letter on their own, but ensuring compliance is important as uncompliant labels signal to FDA that there may be deeper issues, such as manufacturing violations. Also, minor labeling issues can cause an imported supplement product to be flagged at U.S. Customs and Border Protection. Here are some of the recent warning letter call-outs.

Read more about this here and find my nutrient content claims guidance here.

FTC/NAD disclosure enforcement: A recent NAD (National Advertising Division) case involving a popular children's YouTube channel (with 405 million subscribers and 220 billion views) highlighted the complexities and need for material disclosure, which has special additional rules for children's products. The channel was cited for not adequately disclosing its material connections when promoting its own branded products. NAD determined that the relationship between the videos, the advertiser and CMG — which produces the videos and shares in product revenue — constitutes a material connection requiring clear disclosure.

Standard phrases like "sponsored by," "paid promotion," or "#ad" in the video description are not sufficient if the endorsement is made verbally. The Federal Trade Commission and The Children's Advertising Review Unit (CARU) recommend that disclosures be made in both text and audio within the video itself, using language clearly and frequently presented in the video.

The key takeaway is to provide clear and conspicuous disclosures — both verbal and written — whenever there is a material connection. Admittedly, this is challenging in social media stories, reels and reposting. I explore this in more detail in the Q1 2024 warning letter roundup.

Additional trends to keep a close eye on are:

Biomarker claims like those related to GLP-1: GLP-1 claims may attract a warning letter, and this is an interesting space to watch. My guess is that FDA will eventually select companies that also make "Nature's Ozempic" and other risky statements like "reduced risk of obesity-related cholesterol issues." A quick web search shows many violators, so FDA will have its pick of over-the-top examples.

Clinical study citations: Recent FDA warning letters highlight that elaborating on studies or posting about them on social media can cross into unauthorized marketing. FDA's Small Entity Compliance Guide on Structure-Function Claims states that citations implying treatment or prevention of a disease are considered disease claims, particularly if they are prominently placed. To remain compliant, clinical citations should be appropriately placed — ideally within a bibliography or as part of a balanced scientific discussion — and should not be excessively showcased.

CBD update:

Surprisingly, FDA did not send any CBD or delta-8 warning letters in the first half of this year, but its Q3 enforcement brisky increased. This quarter had nine FDA letters that were predominantly focused on delta-8 THC products marketed in formats that are favorable to children. This is a serious problem, and I'm glad to see some FDA action here. Delta-8 may have its place in commerce, but keeping it away from children is something we can agree on. Here, FDA explains how a delta-8 product mimics a common candy.

FDA and FTC have previously sent similar warning letters, which I write about here.

Follow Warning Letter Wednesday for weekly updates on interesting warning letters.