Warning Letter Wednesday^® Posts

The NAD+ battles continue. In this National Advertising Division (NAD) competitor challenge case, several claims were challenged, and because the defending company did not properly respond to NAD with a compliance ...

I’m sometimes asked about “what are the risks and best practices” when company officials appear on podcasts discussing ingredients, products, and diseases. This warning letter involves a prescription cancer drug’s ...

Pet food is big business, which means competitors sometimes challenge each other’s claims at the National Advertising Division (NAD). In this case, a competitor challenged claims in three video ads ...

Clinical study parameters can turn a dietary supplement study into a drug study in FDA’s view, triggering Investigational New Drug (IND) requirements. In one FDA Bioresearch Monitoring investigation, a study ...

This is a cautionary tale about a skincare company that relied on a third-party app score and before-and-after images, leading to NAD scrutiny. This company highlights a third-party app that ...

This is a story about a homeopathic manufacturer that was cited for several GMP issues, and about a discarded “sticky note” containing an out-of-trend result that was not properly investigated. ...

A nicotine and caffeine drink company was cited for making disease claims and for selling a “new tobacco product.” I’ve seen a lot of weird products, but a nicotine caffeine ...

This is a precautionary tale on how to correctly set up a product testing program, run a quality management system, and how to avoid a warning letter. A bee pollen ...

There seem to be three major issues in this dietary supplement warning letter. Inadequate product specifications, lack of documentation, and incomplete 483 responses. Let’s see what we can learn. Inadequate ...

Comparing pricing to other companies can lead to issues if not substantiated. One retail grocery chain was challenged through the National Advertising Division (NAD) competitor challenge process. They were claiming ...

Anxiety claims continue to attract FDA warning letter attention. In 2025, there were ten “supplement-related” anxiety warning letters. Let’s see what we can learn. Animal “supplements” were mentioned in 50% of ...

This one is a shocker! I’ve been reading warning letters for years, but I’ve never seen one this bad with rodent, pest, and cat issues. In May, the Kentucky Department ...