Whole Leaf Organics, LLC – FDA Warning Letter, Sep 30, 2019

The FDA issued a Warning Letter to Whole Leaf Organics after a September 2019 website review, identifying several CBD-containing products ("CBD-EX," "CBD MAX 1000 mg," "CBD-RX," "CBD Defend," "CBD Enflame") marketed for human and animal use. For human use, these products are deemed unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a), 331(d)), as claims establish drug intent and they lack general recognition of safety and effectiveness. They are also misbranded drugs under section 502(f)(1) (21 U.S.C. 352(f)(1)) due to inadequate directions for use. Furthermore, they cannot be dietary supplements, as CBD is excluded from the dietary supplement definition under section 201(ff) (21 U.S.C. 321(ff)) due to its status as an active ingredient in an approved drug or subject to substantial clinical investigations. For animal use, the products are unapproved new animal drugs, unsafe under section 512(a) (21 U.S.C. 360b(a)), and adulterated under section 501(a)(5) (21 U.S.C. 351(a)(5)), lacking FDA approval. Marketing CBD products as animal food is a prohibited act under section 301(ll) (21 U.S.C. 331(ll)). CBD is not Generally Recognized As Safe (GRAS) for animal food (21 CFR 570.30), making animal food containing it an unsafe food additive and thus adulterated under sections 409 and 402(a)(2)(C)(i) of the FD&C Act. Whole Leaf Organics must respond in writing within fifteen working days, detailing corrective actions and documentation. Failure to comply may result in legal action, including seizure and injunction.