FDA Warning Letters

FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here. Sign up for the ...

This warning letter resulted from a GMP inspection and label review. Several labeling errors are cited in this letter, which are excellent learning lessons. FDA has clear requirements for nutrient content claims ...

FDA has issued two drug-spiked product warning letters this year! This is the type of action I appreciate seeing the FDA do, as this small number of bad actors in ...

The first “supplement” warning letter of 2023 belongs to a CBD company. 2022 was the year of the CBD warning letter, and FDA enforcement in this area appears to be ...

Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, ...

This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not ...

This warning letter cites claims made in the “About Us” section of the company’s website. Usually, when “About Us” claims are mentioned in warning letters, there is some hyperlinking to ...

If a company engages with a post on its social media wall, this is considered “endorsing the testimonial” and is marketing. It has been quite a while since we have ...

This is a story of a small tea company that was cited for making risky disease claims on its website. The company probably didn’t realize they were breaking the rules, ...

Social media engagement is back in warning letters! It has been some time since FDA cited “Liking” a post as an endorsement of the “testimonial.” One of the companies was ...

CBD-related FDA warning letters are up over 420% this year, and this recent batch of five warning letters has some excellent learning opportunities. The biggest news is one of these ...

Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim ...