Mr. Pink Collections, LLC – FDA Warning Letter, Nov 25, 2019

On November 22, 2019, the FDA issued a Warning Letter to Mr. Hu regarding products sold on www.mrpinkcbd.com, www.facebook.com/MrPinkCBD/, www.instagram.com/mrpinkcbd/, and a YouTube video. The FDA determined that "CBD Oil Drops," "CBD Gummies," "CBD Vape Pen," and "Mr. Pink Natural CBD Oil for Pets" (also "Vegan Bacon Flavored Pet CBD Oil"), promoted as containing CBD, violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The "CBD Oil Drops," "CBD Gummies," and "CBD Vape Pen" are deemed unapproved new drugs under sections 505(a) and 301(d), and misbranded drugs under section 502(f)(1) of the FD&C Act, due to therapeutic claims establishing drug intent. These products are not generally recognized as safe and effective, and lack FDA approval or adequate directions for use. Furthermore, CBD products are excluded from the dietary supplement definition under section 201(ff) because CBD is an active ingredient in an approved drug (Epidiolex) and subject to substantial clinical investigations.

The "CBD Gummies" product, if marketed as a conventional human food, is prohibited under section 301(ll) as it contains a substance (CBD) that is an active ingredient in an approved drug and is not