A Puzzling “Disease Claim” Letter Without High-Risk Claims

Today’s WLW mentions claims in TikTok Shop, another Amazon letter, and a “disease-oriented” warning letter that does not include high-risk disease claims. Oye vey!

When I read this next warning letter, I thought to myself, “Why did FDA issue this letter?” The reason for this is that there are no high-risk disease claims, GMP issues, or serious product category mismatches (e.g., cosmetics masquerading as drugs). To be fair, only one of the three capsule products was labeled as a dietary supplement, while the others lacked an SFP or a “Supplement” statement of identity. Still, the claims don’t seem too out of bounds.

From warning letter. “Based on a review of your website, … are drugs under … because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.”

From warning letter. “Helps increase testosterone levels”

Asa comments: This is from the dietary supplement product. I ask: is this really worth mentioning in a warning letter? Of course, “Supports balanced testosterone levels” would have been lower risk, but this seems like an odd use of FDA resources.

From warning letter. “An authentic powder booster Ayurvedic Medicine useful in physical & sexual weakness which improves libido, vigour & vitality, sexual power. Keeps you always healthy, energetic & gives you total satisfaction of married life.”

From warning letter. “For Stamina & Excitement” and “Make Love Longer than ever”

Asa comments: These are all the unauthorized claims referenced in the warning letter. That’s it! I admit they are cringy, but are they really disease or unallowable structure-function claims?

TikTok Shop: I was so excited to see this as it may signal that FDA is starting to look at claims on TikTok. Woohoo!

From warning letter. “On your TikTok shop page …Treatment for Prostatitis Symptom Relief”

Asa Comments: This is another cosmetic product marketed with disease-type claims. There are several other similar cosmetic warning letters in this group of letters, most making medium+ risky claims. Now is the time to tighten up all topical product listings!

Amazon received yet another warning letter, which was FBA, meaning Amazon actually handles the product. As I wrote previously, if a company doesn’t actually handle the product, such as on a marketplace where the sellers ship the product, there seems to be a lower real-world risk of a warning letter.

In this instance, it appears that Amazon handled the product. As we know, distributors are responsible for the products they sell. The Amazon warning letter involves a cosmetic product making OTC-topical claims related to balanitis. These types of claims are easy pickings for FDA, as marketing claims turn them into drugs. I admit, balanitis is not a high-risk disease-type claim, but I feel like this letter may have put Amazon on notice about topical products on their platform being marketed for OTC-monograph-style claims. A good rule is that words ending in “itis,” which means “inflammation of,” are disease claims and do not belong on a supplement or cosmetic.