FDA WARNING_LETTER - Daddy Burt Hemp Co - November 25, 2019

The FDA issued a Warning Letter to Daddy Burt Hemp after reviewing their website and social media in October 2019, identifying multiple violations related to their CBD products.

The FDA determined that Daddy Burt Hemp's "Full Spectrum CBD Oil," "Pure CBD Oil," "CBD Gummies," "Skin Rejuvenation CBD Lotion," and "Joint & Muscle Relief CBD Cream" are unapproved new drugs, sold in violation of sections 505(a) and 301(d) of the FD&C Act, and misbranded under section 502(f)(1) due to inadequate directions for use. The letter cites numerous therapeutic claims on the company's website and social media, establishing the products' intended use as drugs for conditions like anxiety, arthritis, autism, and pain. The FDA expressed particular concern about marketing these unapproved drugs for children.

Additionally, the "CBD Oil for Pets (250 mg Bacon Flavor)" was identified as an unapproved new animal drug, unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The FDA also stated that CBD products cannot be marketed as dietary supplements or animal food, as CBD is excluded from the dietary supplement definition and is not a GRAS (Generally Recognized As Safe) substance for animal food.

Daddy Burt Hemp must respond within fifteen working days, detailing corrective actions and prevention measures, or