FDA WARNING_LETTER - Naturally Infused LLC - November 21, 2022

The FDA issued a Warning Letter to Naturally Infused on November 16, 2022, following a review of their websites (www.naturallyinfused.com, Instagram, and Facebook) in October 2022. The letter identifies multiple violations related to the marketing and sale of human and animal products containing CBD or Delta-8 THC.

The FDA determined that Naturally Infused's CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, D8 THC Infused coffees, and Delta-8 THC Gummies are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they contain unsafe food additives (CBD and Delta-8 THC are not approved food additives and are not GRAS). Introducing these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act.

Furthermore, the introduction of CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees into interstate commerce is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), as CBD is an active ingredient in an approved drug (Epidiolex) and has been subject to substantial clinical investigations.