Weight Loss Claims Trigger FDA Product Testing

This company was making weight loss claims, leading to FDA purchasing and testing their product. Sibutramine was found, but surprisingly, the company is still selling the product. I find this confusing and look to FDA to help remove these dangerous products from the market.

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🔷FDA reviewed the company’s website last December, and sometime after that, purchased and tested a product, which ended up containing the drug sibutramine. On February 8th of this year, FDA issued a public notification that this product contained a hidden drug ingredient.

🔹According to the warning letter, the company refused to recall the product. After finding the drug-spiked ingredient and issuing the public notification, I find it strange that the company didn’t comply with this request. At this point, do you think the FDA could/should have elevated this to a seizure or injunction? I don’t believe many drug-spiked products are in the market, but when the FDA finds them, I would like them removed in haste.

🔷Aside from the presence of the drug-spiked ingredient FDA also cited several “disease-type” claims. The claims in this letter, such as “burns fat,” “weight loss,” and “Lose 20 pounds in 20 days,” are not normally seen in warning letters unless ingredients like sibutramine are mentioned. This leads me to think FDA is scanning for these trigger words before testing the ingredients. Also, statements like these are more common in FTC and plaintiff attorney complaints. FTC’s “gut check” document on weight loss claims is worth a read.

🔷This company is lucky FDA didn’t dig any deeper into its website. I ran Apex Compliance on their site and found numerous “Alzheimer’s” and “virus and flu infection” statements.

🔷The moral of the story here is that if you are selling weight loss (or sexual health) products, ensure you are testing for undisclosed drug-spiked ingredients. Amazon already requires an annual test for this, but testing each product lot is not a bad idea.

Read the full letter here. 

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.