Freeman and Biddy, LLC d/b/a Freedom Vapes Warning Letter Details

Summary

Freeman and Biddy, LLC d/b/a Freedom Vapes manufactured and distributed e-liquid tobacco products without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction since August 2016, were determined to be "new tobacco products" requiring FDA premarket approval before commercial distribution in the United States. The FDA found the products to be adulterated and misbranded based on the lack of required premarket authorization documentation.