FDA WARNING_LETTER - Vapor Outlet Inc d/b/a Union Hills Vape Shop - March 19, 2021

The FDA issued a Warning Letter to Little Town Vaping d/b/a Swamp Vapor New Iberia, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that the company's "UH Vape CTCM 120ml 3mg" e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product is being sold without the required premarket authorization, specifically an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, and is not otherwise exempt. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The company, a registered manufacturer with 864 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions