CBD American Shaman, LLC – FDA Warning Letter, Nov 16, 2022

On November 16, 2022, the FDA issued a Warning Letter to CBD American Shaman, following an October 2022 review of their website and social media. The FDA determined the company was illegally marketing unapproved and misbranded CBD products for human and animal consumption.

Key violations include: - **Adulterated Human Foods:** Products like CBD Suckers, Hard Candies, Cookies, Sparkling Tea/Water, Coffee, and Honey are deemed adulterated under 21 U.S.C. 342(a)(2)(C)(i) because they contain CBD, an unsafe food additive not approved for use in conventional foods and not generally recognized as safe (GRAS). The letter notes particular concern for products appealing to children. - **Prohibited Act (301(ll)):** Introducing these CBD-containing foods into interstate commerce is prohibited under 21 U.S.C. 331(ll) because CBD is an active ingredient in an approved drug (Epidiolex) and has been subject to substantial clinical investigations. - **Unapproved and Misbranded Human Drug:** "CBD + ZINC OXIDE Sunscreen" is an unapproved new drug under 21 U.S.C. 355(a) and misbranded under 21 U.S.C. 352(ee). It does not conform to OTC monograph requirements for sun