FDA WARNING_LETTER - Kissy Vape - June 22, 2023

The FDA issued a Warning Letter on June 16, 2023, to Kissy Vape (kissyvape.com) for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA's review of the website found ENDS products, specifically "Elf Bar BC5000 Blue Razz Ice" and "Elf Bar BC5000 Tropical Rainbow Blast," being sold without the required premarket authorization.

Under sections 201(rr) and 901(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are defined as tobacco products subject to FDA jurisdiction, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022. New tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, require a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, or an exemption.

The identified Elf Bar products are considered new tobacco products as they were not marketed by the February 15, 2007, cutoff and lack the necessary FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act