Q1 2024 warning letter roundup with Asa Waldstein

Each quarter, I provide updates on notable FDA warning letters. 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.

Dietary supplement warning letters this quarter have been nearly nonexistent as FDA has been focusing on areas such as tobacco, Foreign Supplier Verification Program (FSVP) violations, companies selling ammonia smelling salts, and noncompliant OTC (over-the-counter) products such as those containing high amounts of lidocaine.

FTC disclosure enforcement

The Federal Trade Commission sent several warning letters last fall to influencers promoting the safety of aspartame and sugar but who were not disclosing their material connection properly. This enforcement action highlights how #Ad may no longer be a sufficient form of disclosure. For example, if the endorsement is made verbally, the disclosure should also be made verbally. Also, making visual disclosures can be especially challenging in Reels and Stories because "videos may have competing elements" that may not be visible on cell phones or when reposting. This is the first action highlighting the new endorsement guidelines and it will be an interesting and also challenging area to watch.

Contaminant testing warning letters

FDA has sent six warning letters this year because companies were not testing for common adulterants such as diethylene glycol (DEG) and ethylene glycol (EG) in glycerin products. This is in addition to the 36 similar warning letters in 2023. These warning letters are directed at companies primarily making OTC and other drugs, but supplement companies can learn from these letters. Ensuring ingredients like glycerin and ethanol are tested for these possible impurities is essential. It seems FDA requires drug companies to test each batch for these contaminants. However, testing each batch of incoming supplement ingredients like glycerin may be unnecessary if a company has verified the supplier and has SOPs (standard operating procedures) and documentation to support reduced adulterant testing. At the very least, testing annually or when changing vendors is a good idea.

Additional trends to keep a close eye on are:

Listing botanicals in the correct format: Minor labeling issues, such as incorrectly listing a plant's name, are not likely to attract a warning letter on their own. It does, however, signal to FDA that there may be other issues and will prompt them to look deeper. Recently, we've seen the continued trend of companies being cited for incorrectly listing a botanical ingredient's common name as referenced in the American Herbal Products Association’s (AHPA) Herbs of Commerce. These types of violations are not the primary reason for warning letters, but they are referenced when other, more serious offenses, such as disease claims or cGMP (current good manufacturing practices) issues, are cited. Another common warning letter citation is companies forgetting to add the plant part, such as "chamomile flower," in the Supplement Facts panel. This recent warning letter contains improper Form 483 responses, disease claims and botanical labeling issues. 

Inflammation claims: Words like "lowers inflammation" and "anti-inflammatory" were cited in 17 supplement-related warning letters last year. These statements carry some risk, but based on FDA enforcement trends, they seem unlikely to trigger a warning letter unless higher-risk words like "arthritis" or "cancer" are also present, with some exceptions. This warning letter exception is animal-related and "only" makes inflammation and anti-viral statements. Although risky, this is typically not enough to tip the scale into the warning letter category unless it's an animal product, as FDA has a lower "lenience" for claims made about animals compared to human products. As a reminder, all statements should be substantiated, and even if FDA does not cite disease words in warning letters, they may trigger Amazon delisting, National Advertising Division (NAD) cases, FTC action, or plaintiff’s attorney actions, especially if the claims are related to mobility claims in glucosamine products, as we observed with this Joint Juice lawsuit.

CBD update:

Q1 2024 was the first quarter since 2021 in which FDA did not mention CBD or delta-8 in warning letters. We've certainly seen enforcement activity in the cannabinoid space trend downwards in the past year, and the absence of warning letters in Q1 shows this trend is continuing. This is partially due to fewer CBD companies selling products than in the past, and those that remain in business likely have expertise in the nuances of marketing compliance. The exception to this is continued sales of delta-8 and other synthesized cannabinoids, and since many of these companies are making wild disease claims and also selling potentially dangerous products, I expect more FDA action to combat the prolific synthesized cannabinoid market.

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