Warning Letter Wednesday Posts

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 ...

SARMs (selective androgen receptor modulators) are potentially dangerous, and FDA issued six SARM-related warning letters in December. Warning letters sometimes come in groups like this, which is a clear message ...

As we close out this year, taking a pause and reflecting is a good thing. This WLW marks my 232nd consecutive weekly WLW post! When I mentioned this number the ...

FTC just sent 10 warning letters to companies alleging potential violations of its Consumer Review Rule, a “shot across the bow” that warns all companies that product reviews are important ...