The Haunted Vapor Room – FDA Warning Letter, Jul 5, 2023

The FDA and FTC issued a Warning Letter to Mrs. Barton regarding products sold on www.njvaporroom.com, specifically those containing Delta-8 THC. The FDA determined that products like "Rope 500mg Delta-8 Nerds Candy" and "Medicated Dope Rope Bites" are adulterated under section 402(a)(2)(C)(i) of the FD&C Act because they contain an unsafe food additive, Delta-8 THC. This substance is not approved as a food additive, nor is it generally recognized as safe (GRAS). Introducing adulterated food into interstate commerce is prohibited by section 301(a) of the FD&C Act.

The FDA expressed serious concerns about Delta-8 THC products, citing lack of evaluation/approval, adverse event reports, psychoactive effects, manufacturing process concerns, and appeal to children. The FTC also found the marketing of these products, particularly their resemblance to conventional candies and snack foods, to be unfair or deceptive under Section 5 of the FTC Act, posing an unwarranted health and safety risk, especially to children.

The letter requires Mrs. Barton to notify the FDA in writing within fifteen working days of the specific steps taken to address these violations, including preventing recurrence. Similarly, the FTC requires notification within 15 working days regarding actions taken to cease marketing edible Delta-8 THC products that imitate conventional foods appealing to children. Failure to comply may result in legal action,