Little Town Vaping d/b/a Swamp Vapor New Iberia – FDA Warning Letter, Mar 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 marketing authorization. The company's e-liquid products, specifically "SWAMP VAPOR heavenly berry 0.6% nicotine 30ml," are deemed tobacco products under the FD&C Act.

The violation stems from the product being a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or exemption. 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 absence of a required notice or information under section 905(j). Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

The firm is a registered manufacturer with 640 listed products. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales and distribution, and a plan for future compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction.