FDA WARNING_LETTER - Life Leaf Medical CBD Center - July 16, 2024

The FDA and FTC issued a Warning Letter to Lifeleaf Medical, LLC, after reviewing their website, www.lifeleafmedical.com, in November 2023, and January, March, April, and June 2024. The letter states that the company is taking orders for products represented as containing Delta-8 THC, specifically Delta-8 THC Nerd Ropes, Stoneos Delta-8 Cookies, and Delta-8 Cereal Treats.

The FDA determined these products are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(i), because they contain an unsafe food additive. Introducing adulterated food into interstate commerce is a prohibited act under section 301(a) of the Act, 21 U.S.C. 331(a). Delta-8 THC is not approved as a food additive, nor is it generally recognized as safe (GRAS) for use in conventional foods. The FDA has serious concerns about Delta-8 THC products, including lack of safety evaluation, adverse event reports, psychoactive effects, and potential appeal to children due to packaging mimicking well-known snack brands.

The FTC also cited the company for unfair or deceptive marketing practices under Section 5 of the FTC Act. The products' appearance and packaging