Review of 2025 “Anxiety” Warning Letters
Animal & kratom products are a big focus
Anxiety claims continue to attract FDA warning letter attention. In 2025, there were ten “supplement-related” anxiety warning letters. Let’s see what we can learn.
Animal “supplements” were mentioned in 50% of the letters. FDA seems to have a lower tolerance for claims made about animal products, so even statements like “separation anxiety” can lead to an animal-related warning letter, where this is typically not “enough” to tip the scale to a human warning letter. This is likely due to the lack of a formal regulatory structure for animal supplements, but at least groups like the National Animal Supplement Council (NASC) are helping to bridge the compliance gap.
50% of the letters also included the word “depression.” This shows that “anxiety and depression” are a one-two punch of disease claim non-compliance.
70% of the warning letters also mention claims on social media, indicating that the FDA is still scanning social channels for disease claims. Apex Compliance® can now scan entire authenticated business Instagram and Facebook accounts for risky keywords and give you an actionable report of where the words occur, how to potentially fix the issues, and more. It is an official Meta API that “only” took nine months to get approved. I’m quite proud of this feature.
60% included claims made about kratom and CBD products. If you sell these products, now is the time to review your marketing to ensure there are no “hidden” regulatory landmines.
If substantiated, here are some possible lower-risk alternatives to “anxiety”.
- “Occasional anxiety” has never been mentioned in any warning letters that I can find. This is likely because being anxious occasionally is closer to a normal, non-disease-related event, whereas “anxiety” on its own may be related to a disease such as generalized anxiety disorder.
- Happy mood support
- Supporting a positive state of mind
- # Smiles for days
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