FDA WARNING_LETTER - Secret City Vapor - July 14, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Secret City Vapors LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically citing Secret City Vapor POM POM 6MG 120ML e-liquid. These products are deemed tobacco products subject to FDA regulation. The FDA found that this e-liquid is a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under 21 U.S.C. § 387b(6)(A) and misbranded under 21 U.S.C. § 387c(a)(6) due to the failure to provide required notice under section 905(j). The letter also highlights prohibited acts under 21 U.S.C. § 331(k) for marketing adulterated/misbranded products and 21 U.S.C. § 331(p) for failing to provide required reports. The firm, a registered manufacturer with over 700 listed products, had a Premarket Tobacco Product Application for 581 products refused acceptance. Secret City Vapors LLC must respond within 15 working days detailing corrective actions, including discontinuing violative sales and a compliance plan, to avoid further regulatory action such as civil money penalties, seizure, or injunction.