FDA Warning Letters

Amazon compliance still needs improving Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites. You may be ...

Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons ...

Be nice to FDA investigators & follow inspection SOPs GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves ...

This is one of the cringiest Warning Letter Wednesday posts I’ve ever written. Wow! This company received a warning letter for making claims that it is better than Ozempic, has ...

Functional mushroom products are undergoing a renaissance, and FDA is paying close attention to how these products are tested and manufactured. This is likely because of the mass recall and ...

The fruit snack wars are on! A few months ago, I wrote about General Mills challenging television commercials by Welch’s Fruit Snacks (PIM’s). In the commercials, chef Gordon Ramsay throws ...

Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts ...

Disclosing material connections is an important part of influencer and ambassador marketing, including when customers receive free products and post about them. Drunk Elephant, a well-known skincare brand, was recently ...

Do you ever see products and think to yourself, “This can’t be safe” or “What regulatory category does that fall into?” After reading this recent warning letter that was issued ...

There are so many important GMP lessons in this warning letter. Let’s see what we can learn. Botanical identification methods:  When developing botanical specifications, ensuring they are complete is essential. In ...

Helping you understand the fine line between education and product marketing is one of the reasons I love writing Warning Letter Wednesday. We continue to see well intentioned companies perhaps ...

In this warning letter, the company engaged with “third-party” reviews on its website, which turned them into marketing. If product reviews are collected and displayed on a website, the agencies ...