FDA Warning Letters

When is a product that is labeled as a “dietary supplement” not a supplement? The answer is “When it is represented as a conventional food,” along with a few other ...

This warning letter is a great teaching lesson of what not to do. Here are some extreme examples where the company crossed the compliance line by discussing the benefits of ...

FDA issued seven warning letters to companies that were selling non-compliant ophthalmic products. These are products that are added to the eyes like moisturizing drops. FDA takes their safety very ...

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 ...