FDA Warning Letters

FDA recently issued its first kratom warning letter of the year to a company making opioid withdrawal and support claims. So far this year FDA has been quiet on kratom ...

FDA and FTC recently sent six joint warning letters to companies selling delta 8 products that were favorable to children. Thank you, FDA and FTC! These warning letters highlight some ...

There have been three YouTube-related supplement warning letters this year, which shows FDA is not slowing down with this enforcement trend. Since this is a US holiday, I will keep ...

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 ...

Today’s post highlights common mistakes made by a small herbal company. Looking at their mistakes can help show others what not to do. I am not picking on this company ...

In the eyes of FDA, discussing product ingredients is a marketing claim, even if there is no direct cross-linking to a product page or shopping cart. This is a common ...

I usually write about FDA warning letters, but today I will highlight a recent National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, ...

Comparing a supplement product to a drug is a quick way to attract FDA attention. In this warning letter, the company compared turmeric, an ingredient in their product, to the ...

Even very small companies that market online can attract an FDA warning letter. I am still surprised when I hear companies saying they are not big enough to be on ...

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 ...

The timeline of the FDA interaction is notable. The company was inspected last August, then FDA reviewed their website in October and November, then reviewed it again in March 2023. ...

The product in this warning letter contains hordenine HCL, which FDA does not consider a dietary ingredient. Adding this into a supplement makes it an adulterated product which is a ...