zombieland llc – FDA Warning Letter, Jan 26, 2023

The FDA issued a Warning Letter to Zombieland, LLC d/b/a Mafia Street Vapor Company on January 26, 2023, based on a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the manufacturing, sale, and/or distribution of Mafia Street Vapor Company Razzle 3 nicotine e-liquid product without the required premarket authorization. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA has not received a marketing authorization application for the listed product. Failure to comply with the FD&C Act and its implementing regulations (21 C.F.R. Parts 1140, 11