KOI CBD LLC – FDA Warning Letter, Nov 25, 2019

The FDA issued a Warning Letter to KOI CBD following a September 2019 review of their website, koicbd.com, identifying multiple violations related to products containing cannabidiol (CBD). The company's "CBD HEALING BALM," "CBD VAPE OIL," "FULL SPECTRUM CBD TINCTURE," "KOI LOTION," "KOI CBD Gummies," and "KOI CBD Infused Shot" are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act due to therapeutic claims, and misbranded under section 502(f)(1) for lacking adequate directions for use. The "KOI CBD Infused Shot" is also cited for not meeting the dietary supplement definition under section 201(ff) as CBD is excluded. Furthermore, "KOI CBD Gummies" marketed as a conventional human food, and any CBD-containing animal food, are considered adulterated under section 402(a)(2)(C)(i) and their introduction into interstate commerce is a prohibited act under section 301(ll) because CBD is an unapproved food additive and not Generally Recognized As Safe (GRAS). Similarly, "KOI Naturals CBD Spray for Pets" and "KOI CBD Soft Chews" are unapproved new animal drugs, unsafe under section 512(a) and adulterated under section 501(a)(5). The FDA requires prompt corrective action within fifteen working days, including a written response detailing steps taken to prevent recurrence, or face potential legal action such as seizure and injunction.