FDA Warning Letters

This Warning Letter Wednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims. Other lessons here are: From Warning Letter: “Ayurveda has ...

Today’s Warning Letter Wednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications. The company submitted ...

The FDA issued ten warning letters to companies selling products with New Dietary Ingredients (NDIs) and other impermissible ingredients such as hordenine HCl. I see these ingredients in two categories. ...

This CBD Warning Letter Wednesday is a great teaching case as it cites many of the common mistakes we talk about each week. Here is what we can learn: Most ...

Website product tags and metatags continue to attract FDA attention in warning letters. This year three warning letters mention product tags or “category” tags. These tags help people find products ...

This year, there have been five warning letters that include claims made in blogs, and the line between what is allowable and what is a claim continues to shrink. It ...

It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This ...

Today’s Warning Letter Wednesday reminds us that the FDA considers old social media posts and hashtags marketing claims.  Six-year-old social media posts, uncompliant hashtags, and product tags are mentioned in ...

Seven CBD companies cited for implied COVID claims in this Warning Letter Wednesday. These are the first CBD-related warning letters after the announcement of the COVID and acidic cannabinoid introductory ...

Online company fined $4.2 million for blocking negative product reviews. The FTC alleges the company blocked product reviews with less than four stars. This is considered deceptive marketing and clearly ...

I got carried away writing this WLW post. Check out my blog for the detailed discussion. We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool ...

Claims made in product catalogs are considered marketing. This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to ...