north carolina hemp exchange, llc – FDA Warning Letter, Jul 5, 2023

The FDA and FTC issued a Warning Letter to NC Hemp Shoppe for marketing Delta-8 THC products as human foods. Websites www.nchempshoppe.com and https://www.yelp.com/biz/nc-hemp-shoppe-raleigh were reviewed in December 2022 and June 2023.

The products Stoner Patch Delta-8 Gummies Watermelon 500mg, Stoneo Oreo Cookies Delta-8 THC, Delta-8 THC Flamin Hot Cheetos, and Stoney Patch 500mg are deemed 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 an unsafe food additive (Delta-8 THC). Introducing adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C 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). The FDA has 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 mimic well-known snack brands, increasing the risk of accidental ingestion by children.

The FTC