Warning Letter Wednesday Posts

Making biomarker claims about dietary supplements has some risks, and here I explore enforcement trends to be aware of. In recent years, the FDA has increased scrutiny of biomarker-related claims, ...

Using clinical study citations can be a crucial part of product marketing. If the study citations are from well-powered studies using competent and reliable scientific evidence, they can bolster the ...

Do you have product reviews on your website? In general, FDA is “hands off” with true 3rd party, non-curated, non-compensated honest reviews unless they have been endorsed. Here are some ...

FDA sent three warning letters this week to companies selling drug-spiked ingredients like diclofenac and methocarbamol. This is a short Warning Letter Wednesday as I am writing this from holiday ...

This warning letter shows us where the line is between allowable cosmetic claims, the “not really okay structure-function claims, and disease claims. In this letter, the disease claims tipped the ...

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 ...