FDA WARNING_LETTER - Smoke and Vape Inc d/b/a Backdoor Smoke Shop - February 18, 2025

On February 14, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Smoke and Vape Inc d/b/a Backdoor Smoke Shop in Hopkins, MN, for selling and distributing unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined that the company markets "new tobacco products" without the required premarket authorization, which renders them adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the product "Pod Juice OXBAR MAGIC MAZE 2.0 ZODIAC EDITION BLUE SLUSHY ICE 5%" was identified as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This violates section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) for adulteration and section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) for misbranding due to the absence of required notice under section 905(j).

The letter emphasizes that all new tobacco products, including those containing nicotine from any source (as per the Consolidated Appropriations Act, 2022), must comply with the