FDA WARNING_LETTER - Str8Vape, LLC - April 08, 2021

The FDA Center for Tobacco Products issued a Warning Letter to STR8VAPE after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, which are deemed tobacco products subject to FDA regulation. Specifically, STR8VAPE distributed the "STR8VAPE AMERICAN BLEND 3mg 70VG/30PG 30ML" e-liquid without the required premarket authorization. This product is classified as 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). The distribution of an adulterated/misbranded product (section 301(k)) and the failure to provide the required report (section 301(p)) constitute prohibited acts. STR8VAPE, a registered manufacturer with numerous listed products, must promptly address these violations and ensure compliance. A written response detailing corrective actions, including discontinuation dates for violative sales and a compliance plan, is required within 15 working days. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, or injunction.