FDA WARNING_LETTER - Shamrockshrooms.com - July 16, 2024

This Warning Letter, issued by the FDA and FTC, addresses Shamrock Shrooms for marketing Delta-8 THC products. The FDA reviewed the company's website (shamrockshrooms.com) in October 2023, February, March, and June 2024.

The FDA determined that Errlli Delta-8 THC Shark Gummies, Errlli Delta-8 THC Sour Brite Crawlers, and Errlli Delta-8 Sour Glowworms 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). Delta-8 THC is not approved as a food additive and is not generally recognized as safe (GRAS). Introducing adulterated food into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. 331(a). The FDA expressed concerns about Delta-8 THC's psychoactive effects, potential for harm, and the risk of accidental consumption by children due to candy-like forms and packaging mimicking well-known snack brands. From January 2021 to December 2023, FDA received over 300 adverse event reports related to Delta-8 THC products, with nearly half involving