Nicfixed, LLC d/b/a Good Karma Vapor Warning Letter Details

Summary

Nicfixed, LLC d/b/a Good Karma Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, which are electronic nicotine delivery systems deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act effective August 8, 2016, violated section 910 of the Federal Food, Drug, and Cosmetic Act by being marketed without the necessary marketing authorization order. The FDA determined that these products qualified as "new tobacco products" requiring premarket approval before commercial distribution in the United States.