Warning Letter Wednesday^® Posts

FDA recently sent a group of herpes-support product warning letters. This one caught my eye since FDA used secondary marketing, such as imagery and website claims to further support their ...

Amanita mushrooms are great to look at in nature, but do they have a place in dietary supplements? Let’s see what we can learn. FDA recently issued a warning letter ...

A baby monitor company challenging another makes for an interesting compliance discussion. This National Advertising Division (NAD) case includes popularity, safety, wellness, and parental sleep claims. Even though this is ...

FDA just posted a group of ten warning letters about homeopathics and other unapproved products marketed for sexually transmitted infections (STIs) or their symptoms. Amazon and Walmart are among the ...

The National Advertising Division (NAD) recently reviewed claims made by a functional chocolate company. This case helps provide some more context to the question, “Can studies on individual ingredients support ...

Peptides!!! This company submitted two new dietary ingredient notifications (NDINs) for a peptide ingredient in its GLP-1 biomimetic supplement. In both responses, FDA raised safety objections, and according to the ...

I’ve seen a lot of dietary supplement manufacturing facilities in my life, and within a few minutes you can usually determine how seriously a company takes GMPs. In this warning ...

A few weeks ago, I wrote about a “#1 Best Selling Beets Brand” NAD case. This week, let’s look at “#1” claims in the animal-product world. This National Advertising Division ...

In the past couple of months, FTC recently sent warning letters to eight companies that appear to have misrepresented certain products as “Made in the USA (MUSA)” and “Made in ...

This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues. From warning letter. “Pages were removed from your logbook and ...

“#1 Best Selling Brand” is a bold statement to make. In this case, the National Advertising Division (NAD) helps clarify what this means and how to substantiate it. One of ...

I love puffery. In advertising, puffery is described as an exaggerated, boastful, or subjective promotional claim about a product or service that a reasonable consumer would not take as a ...