A dietary supplement company conducting a clinical study was investigated by FDA’s Bioresearch Monitoring Program and found violations. According to FDA “this program includes inspections designed to evaluate the conduct ...

Where is the line between needing an ingredient study or a full product study for substantiation? This National Advertising Division (NAD) case explores the nuances of reasonable consumer interpretation of ...

Dietary supplement manufacturing and marketing issues are all cited in this warning letter. This feels like a trip way back in time when GMP regulations and compliance for “supplements” were ...

Investigating customer complaints and reporting serious adverse events (SAERs) is a cornerstone of dietary supplement safety and compliance. In this warning letter, a supplement company that makes products for young ...

This may be the oddest response to an FDA batch product record request.  From warning letter. “recipes and procedures have been followed for decades. Though not in writing, they have ...

This warning letter has numerous examples of what not to do when labeling supplements. Here’s what we can learn. Incorrect statement of identity: The statement of identity is one of ...

Shocking warning letter! After writing this post for over 200 weeks, I am rarely surprised. However, this warning letter highlights some truly audacious and potentially extremely unsafe THC and mushroom ...

Comparing supplements to drugs is a great way to irritate FDA and attract a warning letter. In today’s Warning Letter Wednesday, I am exploring Criterion #6, “Claims to be a ...

FDA cited a company for marketing sulbutiamine, an unallowable ingredient in their dietary supplement. This is different than the standard “drug-spiked” warning letter, where companies were hiding sildenafil and diclofenac ...

FDA has a low tolerance for animal product disease claims, especially when they include CBD. FDA recently issued three warning letters to companies marketing their CBD products as safe solutions ...

200 weeks of writing this weekly post. Wow, what a journey it’s been! Finding my voice on LinkedIn and beyond was not easy. I didn’t want to create drama and ...

Calling out the differences between your product and competitor products is permitted, but “poking the bear” often leads to competitor challenges. This NAD case involves a well-known mattress company challenging ...