Warning Letter Wednesday Posts

Top 10 weirdest and cringiest warning letters I’ve ever seen. FDA issued a warning letter to a company selling an essential oil-looking nasal diffuser for Alzheimer’s treatment, dementia, and other ...

In an ongoing saga of the dental care and teeth whitening industry, a large company’s “gum detoxify” and other claims were challenged by a competitor in this National Advertising Division ...

There has been a recent enforcement trend where having an unallowable ingredient in a product can result in a warning letter, even if no disease claims or GMP violations are ...

This is one of the only occurrences I’ve seen where “third-party” website product reviews were cited in a warning letter. There are, however, a few caveats and key takeaways. Let’s ...

Four years of Warning Letter Wednesday posts! I am so grateful for your support! When I started writing this post, I had no idea it would turn into this! I’ve ...

This warning letter involves a nut butter company that was making implied and express cancer claims on its website and product labels. This is an extreme example of what not ...

A dietary supplement company conducting a clinical study was investigated by FDA’s Bioresearch Monitoring Program and found violations. According to FDA “this program includes inspections designed to evaluate the conduct ...

Where is the line between needing an ingredient study or a full product study for substantiation? This National Advertising Division (NAD) case explores the nuances of reasonable consumer interpretation of ...

Dietary supplement manufacturing and marketing issues are all cited in this warning letter. This feels like a trip way back in time when GMP regulations and compliance for “supplements” were ...

Investigating customer complaints and reporting serious adverse events (SAERs) is a cornerstone of dietary supplement safety and compliance. In this warning letter, a supplement company that makes products for young ...

This may be the oddest response to an FDA batch product record request.  From warning letter. “recipes and procedures have been followed for decades. Though not in writing, they have ...

This warning letter has numerous examples of what not to do when labeling supplements. Here’s what we can learn. Incorrect statement of identity: The statement of identity is one of ...