FDA WARNING_LETTER - Vapor-Saloon, LLC - August 08, 2022

The FDA issued a Warning Letter to Vapor-Saloon, LLC on August 8, 2022, following a review of submissions and inspection records. The FDA determined that Vapor-Saloon manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act, requiring compliance with specific regulations.

The core violation is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid products Elysium 3mg 120ml, Dragonlily 6mg 120ml, BLUEBONNET 3mg 120ml, and Caribou 3mg 60ml were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

Vapor-Saloon's Premarket Tobacco Product Application (PMTA), STN PM0003867, submitted on September 10, 2020, received a Refuse To File determination on April 7, 2022, covering 447 products. The FDA emphasizes that all new tobacco products on the