FDA WARNING_LETTER - Luckys Vape & Smoke II - April 16, 2021

This FDA Warning Letter, dated April 16, 2021, addresses Lucky’s Vape & Smoke II for manufacturing and distributing e-liquid products, specifically "Lucky’s Vape Killa Cookie 6mg e-liquid," without required premarket authorization. The FDA determined that this product is a "new tobacco product" as 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 deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the absence of required notice or information under section 905(j). The letter states that manufacturing, selling, or distributing such products, or failing to provide required reports, constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Lucky’s Vape & Smoke II, a registered manufacturer with over 8,800 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions including civil money penalties, seizure