FDA WARNING_LETTER - Earthly Hemps - July 16, 2024
Discuss this record with AI
The FDA and FTC issued a Warning Letter to Robert Waring regarding products sold on earthlyhemps.com. The FDA reviewed the website in November 2023, January 2024, and March 2024, and the FTC in June 2024.
The FDA determined that Dr. Blaze THC Delta-8 Slushers, Doweedos Delta-8 Chips, and Delta-8 Weedos 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, Delta-8 THC. Introducing adulterated food into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. 331(a). Delta-8 THC is not approved as a food additive and is not generally recognized as safe (GRAS) for use in conventional foods. The FDA expressed serious concerns about Delta-8 THC products, including lack of safety evaluation, adverse event reports, psychoactive effects, manufacturing processes, and appeal to children. The products in question mimic well-known snack brands, increasing the risk of accidental consumption by children.
The FTC also cited unfair or deceptive marketing practices under Section 5 of the FTC Act. The products' packaging
ID · f64f4f51-49dc-49f6-acaa-86ecf38a8c54
Full citation text and observation details available on the Dashboard.