FDA WARNING_LETTER - Little Town Vaping d/b/a Swamp Vapor Lafayette - March 16, 2021

The FDA issued a Warning Letter to Little Town Vaping d/b/a Swamp Vapor for manufacturing and distributing e-liquid products without required premarket authorization. The FDA determined that their "SWAMP VAPOR Cowboy 0.3% NIC 30ML" e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

This product lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and is not exempt. Consequently, it is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j). The failure to provide such a report is a prohibited act under section 301(p).

The company, a registered manufacturer with 640 listed products, must ensure compliance with the FD&C Act. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/distribution, and a plan for maintaining compliance.