Warning Letter Wednesday^® Posts

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 ...

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 ...