FDA Warning Letters

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 ...

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. ...