Anxiety Claims Enforcement Review

Anxiety claims enforcement continues to be top of mind for the FDA. In this #WarningLetterWednesday I compare 2022 anxiety claims enforcement with the same time last year. I found some interesting data points that help us understand where the FDA is finding risky items. These learning tools can alert companies where to look for risky keywords that may be lurking on company websites and social media.

Here are some key takeaways:

27% of this year’s warning letters mention claims made in hashtags compared with 20% in the same period last year. This shows that hashtags are indeed marketing claims and can tip the scale into the warning letter category if they are non-compliant. Here is my “Hashtags Are Marketing Claims” video. 

Warning letters citing blogs and anxiety claims more than doubled (63%) over the same period last year (30%). It is now common to see a several-year-old blog mentioned in a warning letter; a good reminder to ensure all blogs, including the old ones, are compliant. Here is my “Best Practices for Reducing Risk in Blogs” post.

Social media enforcement continues to be a trend to watch. This is exemplified by the 63% anxiety claims number this year compared to 40% in the same period last year.

The two most drastic changes this year were with CBD and animal anxiety claims.

72% of this year’s letters mention CBD, up from just 16% in the same period last year. This shows the FDA’s increasing intolerance of companies marketing CBD with disease claims. There has never been a riskier time to market CBD products; I go into detail about this here.

This year, animal and anxiety warning letters increased from 10% to 45%. I write about this enforcement trend here.

The one-two punch of both “anxiety” and “depression” is mentioned in about ¾ all of the 2021/22 anxiety warning letters.

There have been 22 anxiety-related FDA warning letters this year compared to 30 in the same period last year. I was a little surprised by the low number this year.

It is worth noting that “occasional anxiety” was mentioned zero times in these warning letters. The key takeaway is that focusing on life occurrences such as “occasional anxiety” or “occasional inflammation” may be a lower-risk marketing strategy.

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.