GLP-1 Product Receives Warning Letter

This is one of the cringiest Warning Letter Wednesday posts I've ever written. Wow!

This company received a warning letter for making claims that it is better than Ozempic, has FDA approval, does not require a prescription, has no side effects, and is clinically proven in "clinical trials and was approved by the Food and Drug Administration last year."

This is the first GLP-1-related "supplement" FDA warning letter. Interestingly, it came in a group of five letters; the other four were companies selling semaglutide (generic Ozempic) labeled as "RESEARCH USE ONLY," but FDA cites their secondary marketing claims as proof of the intended weight loss use. Good detective work FDA!

This warning letter is a great study of how implied and express claims cross the compliance limits, such as with the before and after pictures, statements like "Only active GLP-1 is effective GLP-1," and "FDA approved" statements.

Here is my opinion on some of the information I've gathered.

• It is unclear what the ingredients in the product are, but they are marketed as natural and side-effect-free.

• The product is not labeled as a supplement, but it lists "Clinically Proven" and "Metabolism boost drops for weight management" on the label.

• The before and after pictures are super cringy and likely violate FTC regulations against deceptive marketing.

• The product reviews feel doctored, and the entire vibe of the website seems like an AI-generated experiment. It gave me the heebie-jeebies, and I expect the FTC would have a field day with this site.

• There are other "supplements" for sale on the website, such as THC gummies and weight loss gummies, that are making claims related to anxiety reduction (thanks to Apex Compliance for helping me find these).

• And much more

FDA also cites this company for making "FDA-approved" claims. As we know, supplements are FDA-regulated but not "approved."

• From warning letter. "webpage for ...includes the image of a blue circle with the claim, "FDA APPROVED" along with the statement,. . . was approved by the Food and Drug Administration last year."

Implied GLP-1 statements are cited but they’re probably not the primary reason for this warning letter.

• From warning letter. “The Science of GLP-1 . . . The effectiveness of … lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period.”

Bashing companies is not my style, as I believe in a "rising tide" and educational approach, as many companies who receive warning letters may not know any better, but this company's marketing feels calculated and intentional.

Read the full warning letter here.

DATE ORIGINALLY POSTED: 12/18/24

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.