Lessons From Inflammation Warning Letters

Inflammation claims were cited in 17 supplement-related warning letters last year. Here, we’ll look at the lessons we can learn from these letters.

Statements like “reduces inflammation” or “anti-inflammatory” are disease claims, but they are not likely to attract a warning letter on their own.

• 47% of the inflammation claim warning letters (8 of 17) cited in 2023 warning letters include the word arthritis.

• 53% of these warning letters (9 of 17) include the word “cancer.”

Here are some key takeaways.

All 17 warning letters include high-risk claims like arthritis, cancer, or Monkeypox, with one exception. 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 warning letter category unless it’s an animal product, as FDA has a lower “tolerance” for claims made about animals compared to human products.

Although making inflammation claims carries some risk, they are unlikely to be the sole reason for a warning letter. This includes claims made on posts or platforms different from the inflammation claim. This demonstrates how FDA looks at disease claim enforcement. They look at the 10,000-foot view of a company’s online persona and piece together claims from areas like blogs and socials for one big picture of non-compliance. This shows that compliance is not done in a vacuum, and taking a holistic approach to compliance is important. This is one of the approaches we take at my regulatory consulting company, Supplement Advisory Group. Contact me to talk about your consulting needs.

41% of these warning letters involve claims on social media. This is a friendly reminder that even very old social media posts are considered active marketing.

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.