FDA Warning Letters

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 ...

FDA purchased and tested “dietary supplement” products from an online retailer that was selling products in the US. FDA discovered some of the products to contain drug spiked ingredients such ...

Puffery is one of my favorite types of advertising principles to discuss. It is considered to be “exaggerated, blustering, or boastful statement or general claim that could only be understood ...

Making claims about the aggregated number of five-star reviews is quite common. In this NAD case, one of the challenged claims, “210,000+ 5-Star Reviews of Rascals Products,” was found not ...

Homeopathic products continue to be targeted by FDA. In this group of five warning letters FDA reinforced their position that homeopathics are drugs and must follow drug rules, including FDA ...