Warning Letter Wednesday^® Posts

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 ...

5 years of WLW posts! I appreciate you! For five years, every week, I’ve written this newsletter. We plan our Tuesday dinners around this post, as we always know that ...

FDA just issued a batch of 10 warning letters to companies selling the drug ketamine online. I am still surprised when I see drugs openly sold via standard e-commerce, and ...

The warning letter covers manufacturing equipment flaws, theoretical yields, incomplete 483 responses, missing product specifications, and other issues. Fun reminders of the importance of GMP compliance. First, the manufacturing equipment ...

Today’s WLW mentions claims in TikTok Shop, another Amazon letter, and a “disease-oriented” warning letter that does not include high-risk disease claims. Oye vey! When I read this next warning ...

Any product marketed online is “fair game” for FDA enforcement. In this warning letter, a dietary supplement company was cited for making disease claims. Let’s see what we can learn. ...

Everyone uses AI, and in many cases it is wonderful. However, this warning letter highlights that using AI is not a shortcut for quality and reinforces the “trust but verify ...

It is important to respond to FDA 483 requests before they lead to a warning letter. In this example, the company was inspected and issued a 483 by FDA in ...

Many products sprayed into the nose are considered OTC drugs, which allow companies to make designated claims about them. This also requires nasal OTC drugs to follow strict monographs. These ...

This warning letter is an example of how online ingredient/product education crosses the line into disease-claim marketing. There are numerous examples such as this. From warning letter. “… contains six ...

I love it when warning letters reveal how interconnected marketing can be. In this example, FDA cites a social media post that discusses and links to a blog on the ...