Vapor Lounge, LLC – FDA Warning Letter, Apr 21, 2022

The FDA issued a Warning Letter to Vapor Lounge LLC on April 21, 2022, following a review of submissions and inspection records. The FDA determined that Vapor Lounge LLC manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of "new tobacco products" without the required premarket authorization. Specifically, the Vapor Lounge Grape Ape 3mg 60ml e-liquid product was cited as a new tobacco product not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order. This renders the product 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 information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The letter notes that Vapor Lounge LLC is a registered manufacturer with over 150 products listed with the FDA. A Premarket Tobacco Product Application (STN PM0003899) covering 204 products was submitted but received a Refuse To Accept determination on November 2, 2021