Company Selling Adulterated Product Leads To Additional Product Testing
Test “sketchy” products for adulterants
This warning letter includes drug-spiked products, disease claims, and CBD. It shines a light on how a small, potentially unscrupulous company can tarnish the supplement industry's reputation.
Sign up here to have Warning Letter Wednesday delivered to your inbox. You can also search older posts here by keyword, which is a useful resource for your regulatory, marketing, and executive team.
🔷The order of events in this warning letter is interesting. FDA tested this company's product in April and found the presence of the undisclosed drugs Diclofenac, Dexamethasone, and Methocarbamol before posting the warning letter this week. I am unsure exactly how the process works, but I would prefer FDA act quicker to help remove these types of products from the market. This brings up the Mandatory Product Listing question; if FDA has all of that information, what will they do with it?
🔹In the past, I've seen FDA purchase and test products in the sketchy weight loss and male enhancement categories who were also making disease claims, but FDA testing joint health products is less common. One exception is a warning letter from last October which I write about here. What probably tipped off FDA is this company also sells a product that was part of an FDA consumer warning due to it containing Diclofenac, which is an NSAID. This likely led to FDA looking at the website, seeing the disease claims, and testing the other products.
🔹See the FDA consumer warning about this product.
🔷To top off several other issues, one of the products cited in this letter contains CBD. This is the first CBD-related warning letter this quarter which is surprising. As a data point during Q2 last year, there were 11 CBD-related warning letters. We are all aware that the CBD market has contracted, but some companies are still making over-the-top disease claims, especially in the Delta 8 market.
🔷There are several disease claims cited in this letter. In addition to these claims, I am sure the Bob Marley estate would take issue with potential trademark infringement.
👉From warning letter. "On the product labeling for "Bob Marley CannaKing" "REDUCES ANXIETY" "FIGHTS CANCER" "PARKINSON" "GLAUCOMA"" =
Read the full warning letter, including the dangers of these undisclosed drugs.
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.