FDA WARNING_LETTER - Fly High Smoke Shop - February 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Anouar Taffani regarding electronic nicotine delivery system (ENDS) products sold on flyhighhempco.com. The FDA determined these products are "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source.

The violations identified are that the products Elf Bar BC5000 Blue Razz Lemon Disposable Vape, Cali Plus Disposable Vape 1500 Puffs Frozen Peach Lemonade, and Lava Plus 2600 Puffs Disposable Vape Cherry Banana are "new tobacco products" that lack required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and are not exempt from marketing authorization. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided under section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales and a plan for future compliance. Failure to comply may result in regulatory actions such