Warning Letter Wednesday^® Posts

Even lower-risk statements can lead to scrutiny, as we see in this National Advertising Division (NAD) case. I do not consider any of the claims NAD cited to be high ...

This copacker didn’t have most of the basic GMP structure required for handling and distributing dietary supplements, and based on my reading of the letter FDA gave them plenty of ...

This company was making claims about virus and flu prevention on its website and social media accounts, which led to a warning letter. Here are some of the high-risk claims ...

Manufacturing supplements is not easy. I was a supplement manufacturing & marketing executive for 15 years before starting my regulatory marketing compliance company, and implementing continuous improvement into our Quality Management System ...

Products like Doweedos Delta-8 Edible Chips were cited in yesterday’s joint FDA/FTC warning letters. There were actually six warning letters sent in this enforcement action group, but for some reason, ...

This is a cautionary tale of how quality control, food safety oversight, and sanitation, even at one of the world’s largest companies, can go wrong. Salmonella was discovered at one ...

Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic. Full disclosure: I like NAD, and their cases ...

I love educating about enforcement trends and regulatory marketing compliance, and I’ve been writing this weekly post for almost three years. I have two small companies in the dietary supplement ...

This company received a warning letter for selling tianeptine—a substance deemed dangerous and inappropriate for dietary supplements according to FDA. Read more about FDA’s position here. In January FDA inspected this ...

Nutrient content claims can lead to litigation and are often cited in warning letters, although they are not typically the primary reason for a letter. Following all the rules can ...

Videos must disclose material connections when making sponsored content. Here, we learn more about when material connection is needed and what constitutes disclosure, especially when children’s advertising is involved. In ...

This NAD case shows that making “clinically proven” claims attracts the highest level of scrutiny. The National Advertising Division (NAD) has been paying close attention to skincare marketing claims, and ...