Warning Letter Wednesday^® Posts

This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing ...

11 companies were cited for failing to provide FDA information on contaminant testing for glycerin, propylene glycol, and other ingredients. These ingredients are most commonly adulterated with diethylene glycol (DEG) ...

This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in ...

Claims about animal products were cited in today’s warning letter. Most statements involve customer testimonials with biomarkers such as “kidney values,” and “liver count,” and some other disease statements. Animal ...

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 ...