FDA WARNING_LETTER - Dr. Smoke, LLC aka Dr. S, LLC - July 05, 2023

The FDA and FTC issued a Warning Letter to DrSmoke.com after reviewing their website in December 2022 and June 2023, identifying the sale of human products containing Delta-8 THC, specifically "Cheetos Crunchy Flamin’ Hot THC Infused Chips" and "Doritos Nacho Cheese THC Infused Chips."

The FDA determined these products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because Delta-8 THC is an unsafe food additive. It is not approved, nor is there a basis for it to be Generally Recognized As Safe (GRAS) for use in conventional foods. Introducing adulterated food into interstate commerce is prohibited by section 301(a) of the FD&C Act, 21 U.S.C. 331(a). The FDA expressed serious concerns about Delta-8 THC products, including lack of evaluation/approval, adverse event reports, psychoactive effects, manufacturing processes, and appeal to children.

The FTC cited Section 5 of the FTC Act, prohibiting unfair or deceptive marketing practices. The products' packaging mimics well-known snack brands, making them appealing to children and increasing the risk of accidental ingestion, which has led to numerous adverse events.

DrSmoke.com must notify the FDA within fifteen