Warning Letter Wednesday Posts

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 ...

Celebration! Today is 250 consecutive weeks of this Warning Letter Wednesday® post! Before we get into this week’s post, I think some reflection is in order. I started writing about ...

WLW# 249 If I list “Magnesium Glycinate Gummies 200 mg per serving,” does a reasonable consumer think there is 200mg of elemental magnesium in each serving? This recent NAD case ...

This is a bizarre one. It involves a functional mushroom and herbal company that received a warning letter for claims made in clinical study and other citations in the “Newspaper” ...

Greetings from SupplySide Connect! If you are attending, please stop by booth #723 and say hello. We have some fun WLW stickers/pins for you! From my perspective, men’s fertility supplements ...

There have been only four eBay-related warning letters in recent years, and two of them occurred this week. This shows that even platforms like eBay, Etsy, or Pinterest are being reviewed ...

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 ...