Warning Letter Wednesday^® Posts

FDA just posted a group of ten warning letters about homeopathics and other unapproved products marketed for sexually transmitted infections (STIs) or their symptoms. Amazon and Walmart are among the ...

The National Advertising Division (NAD) recently reviewed claims made by a functional chocolate company. This case helps provide some more context to the question, “Can studies on individual ingredients support ...

Peptides!!! This company submitted two new dietary ingredient notifications (NDINs) for a peptide ingredient in its GLP-1 biomimetic supplement. In both responses, FDA raised safety objections, and according to the ...

I’ve seen a lot of dietary supplement manufacturing facilities in my life, and within a few minutes you can usually determine how seriously a company takes GMPs. In this warning ...

A few weeks ago, I wrote about a “#1 Best Selling Beets Brand” NAD case. This week, let’s look at “#1” claims in the animal-product world. This National Advertising Division ...

In the past couple of months, FTC recently sent warning letters to eight companies that appear to have misrepresented certain products as “Made in the USA (MUSA)” and “Made in ...

This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues. From warning letter. “Pages were removed from your logbook and ...

“#1 Best Selling Brand” is a bold statement to make. In this case, the National Advertising Division (NAD) helps clarify what this means and how to substantiate it. One of ...

I love puffery. In advertising, puffery is described as an exaggerated, boastful, or subjective promotional claim about a product or service that a reasonable consumer would not take as a ...

FDA inspected this supplement manufacturer and marketer in November 2025 and issued some 483s related to sanitation and GMP documentation issues. The company then sent four 483 responses to FDA ...

I often use this example to explain how FDA enforcement works. A single disease-type claim is unlikely to trigger a warning letter unless it is over the top. Instead, FDA ...

This dietary supplement company was inspected by FDA in November and issued 483s and several months later, the FDA reviewed its website and social media.  Online disease claims, along with ...