• Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants.  It is naturally occurring at very low levels in hemp and can be synthetically manufactured by chemical conversion of cannabidiol (CBD) extracted from hemp.  We have discussed a September 14, 2021 consumer update, “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC,” that was issued by FDA after an uptick in adverse event reports, findings of Delta-8 THC products marketed to children, and contamination concerns from potentially unsafe manufacturing methods.  FDA’s first warning letters for products labeled as containing Delta-8 THC were announced on May 4, 2022, as discussed here. 

• On July 5, 2023, in a coordinated effort with the Federal Trade Commission (FTC), FDA announced the issuance of six warning letters for adulterated food violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and unfair or deceptive marketing violations of the FTC Act related to adding Delta-8 THC to conventional foods.  The products at issue in the new warning letters are candy (e.g., sour worms and gummy bears), chips, cookies, and other snack foods that FDA says intentionally mimic well-known snack food brands (i.e., Doritos, Oreos, Cheetos, Jolly Rancher, and Nerds) by using similar brand names, logos, or pictures on packaging that consumers, especially children, may confuse with traditional snack foods.  FDA is also concerned that adults could unintentionally consume these products or take a higher dose than expected and suffer serious consequences, and notes this risk is especially dangerous for those who are driving, working, or have other responsibilities. 

• All Delta-8 THC products at issue were found by the agencies’ review of the companies’ websites where customers could place orders for the products.  Safety concerns raised by FDA and FTC suggest that enforcement against these kinds of products containing Delta-8 THC will remain a priority.  Keller and Heckman will continue to monitor and report on regulatory developments related to cannabis-derived ingredients.