Warning Letter Wednesday Posts

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 ...

Navigating allowable and off-limits claims can be confusing. Fortunately, the FDA offers a helpful resource, The “Small Entity Compliance Guide on Structure/Function Claims” which includes a Q&A format outlining 10 ...

This warning letter involves claims made about a topical OTC menthol product. OTC products must follow monographs. These are essentially recipe books that guide the ingredients, dosages, labeling, and claims ...

I often talk about disease claims attracting warning letters, but it can be difficult to know where the line is between allowable structure-function claims and off-limits health claims. Thankfully, the ...

A look at the manufacturing and quality process GMP is basically a series of quality processes, such as holding, verifying, and then releasing. This is true for incoming raw materials ...

Everyone loves free products, but influencers who receive free products and post about them must disclose this material connection. In a recent National Advertising Division monitoring case, a large publicly ...

Injectable CBD? The first CBD warning letter of the year is an odd one. The company was cited for selling injectable CBD products and making disease claims on its website ...