Little Town Vaping d/b/a Swamp Vapor Warning Letter Details

Summary

Little Town Vaping d/b/a Swamp Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of section 910 of the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as electronic nicotine delivery systems under the August 8, 2016 deeming rule, were being offered for sale or distribution in the United States without the necessary marketing authorization orders that the FDA requires for all new tobacco products.