FDA WARNING_LETTER - Rock Drummer Vapors LLC - August 22, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Rock Drummer Vapors LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically "Morning Wood 6mg 30ml e-liquid," which are deemed tobacco products. The FDA found 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 the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 letter also cites prohibited acts under sections 301(k) for marketing adulterated/misbranded products and 301(p) for failing to provide required reports. Rock Drummer Vapors LLC must submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.