Warning Letter Wednesday Posts

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 ...

Bashing competitors, even unnamed ones, can lead to competitor challenges. In this post, I review this National Advertising Division case where General Mills challenges television commercials by Welch’s Fruit Snacks. ...

This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing ...

FDA inspected this TCM manufacturing and product company earlier in the year, including looking at its product catalog and website. This led to GMP and disease claim citations. Let’s start ...