FDA Warning Letters

I like to think of suggestive words like “may” and “could” as the compliance version of “with all due respect.” If I say “with all due respect” to someone, it ...

Inflammation claims were cited in 17 supplement-related warning letters last year. Here, we’ll look at the lessons we can learn from these letters. Statements like “reduces inflammation” or “anti-inflammatory” are ...

Two weeks ago, FDA sent its 15th CBD and delta-8 warning letter of 2023. Although this seems like a high number, it was down from 34 last year. So why ...

For those still learning about FSMA, food labeling, nutrient content claims, and website marketing claims, reading this post and the entire warning letter is suggested. This letter is a lesson ...

Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes ...

There have been seven YouTube-related FDA warning letters this year, and I expect the trend to continue. This demonstrates that videos are marketing claims and are, therefore, fair game for ...

This company received a warning letter for claims made on its website and old social media posts. The oldest post cited in this letter is from 2016, which shows that ...

This warning letter is interesting. This is an ophthalmic drug warning letter, but the supplement and cosmetic industries can glean helpful information here. Here, I review these learning opportunities. Are ...

 FTC sent warning letters to two trade associations and 12 influencers for not disclosing material connection in their posts promoting the safety of aspartame and sugar. This shows that FTC ...

This company was inspected by FDA and received several common 483 violations, such as improper specifications and not having written procedures for cleaning and product returns. From my reading of ...

FDA has been paying close attention to probiotic products marketed to preterm infants recently, and this letter shows the continuing trend. There are ~100 searchable Warning Letter Wednesday posts here! You can ...

This warning letter is interesting as it details some of FDA’s thinking on test methods. Upon my initial reading of this letter, it seemed like FDA had an issue with ...