Social media engagement is back in warning letters! It has been some time since FDA cited “Liking” a post as an endorsement of the “testimonial.” One of the companies was ...

CBD-related FDA warning letters are up over 420% this year, and this recent batch of five warning letters has some excellent learning opportunities. The biggest news is one of these ...

Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim ...

This warning letter has numerous labeling teaching opportunities, which is really exciting! I don’t think any of these violations would attract a warning letter on their own, but altogether they ...

Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs. The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal ...

This company was cited for making immunity and Covid support claims, which remain top of mind for the authorities. There is never a suitable time to discuss Covid support claims ...

There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to ...

Warning Letter Wednesday focuses on label violations that helped lead to a warning letter. These are basic but important reminders. This company was inspected by FDA when they collected product ...

This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA ...

The warning letter has a unique “we offer the following comment” section. FDA references bitter orange extract (Citrus aurantium) as an ingredient in the Supplement Fact Panel. It then refers ...

Anxiety claims enforcement continues to be top of mind for the FDA. In this Warning Letter Wednesday I compare 2022 anxiety claims enforcement with the same time last year. I ...

Small herb company cited for elderberry-oriented disease claims. This is a good reminder there is no such thing as “too small to be on the FDA’s radar.” Claims in the ...