Warning Letter Wednesday Posts

Homeopathic products continue to be targeted by FDA. In this group of five warning letters FDA reinforced their position that homeopathics are drugs and must follow drug rules, including FDA ...

I’m sometimes asked what types of herbal products are safe and good to purchase. A first step is to ensure the company is not making extreme disease claims about its products, as ...

FDA issued a warning letter to an online marketplace that sells international products, including Korean skincare and miscellaneous household items, for distributing motion sickness patches that contained undisclosed drug ingredients. ...

“Buzzwords” or “trigger words” in marketing are one of the reasons companies receive warning letters. In today’s Warning Letter Wednesday, let’s explore some issues to avoid. From warning letter. “[P]owerful ...

I am often asked if third-party product reviews are considered marketing, and the answer is “it depends.”  Here are some best practices and considerations when soliciting and using third-party reviews. ...

NAD+ products are big business, and some product claims were challenged by a competitor in this National Advertising Division case. There are some great learning opportunities. Label claims: This is interesting. ...

A company specializing in homeopathic nasal swabs for children received a warning letter due to a series of issues. Let’s see what we can learn. I was inspired to write ...

GMP violations such as identity and other specifications continue to be cited in warning letters. Testing suitability and Incomplete 483 responses: Most companies can “walk back” or address 483s before ...

Dietary supplement labeling can be confusing, but I’ll run through some key issues from a recent warning letter today. Address or Phone Number From warning letter.  “The label fails to ...

There are some interesting learning opportunities in this warning letter. Let’s explore. FDA does not like homeopathics. This company sells homeopathic oral care products like mouth gel and mouth wash. ...

When is a product that is labeled as a “dietary supplement” not a supplement? The answer is “When it is represented as a conventional food,” along with a few other ...

This warning letter is a great teaching lesson of what not to do. Here are some extreme examples where the company crossed the compliance line by discussing the benefits of ...