Good Smokes LLC, d/b/a Vape N Vapor Warning Letter Details

Summary

Good Smiles LLC, d/b/a Vape N Vapor was warned for selling and distributing e-liquid products containing nicotine without proper FDA premarket authorization. The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements that mandate "new tobacco products" obtain a premarket authorization order before being legally marketed in the United States. The warning addressed the company's failure to recognize that e-liquid products containing nicotine from any source fall under FDA jurisdiction as tobacco products, particularly following the March 2022 legislative expansion of tobacco product definitions to include all nicotine-containing products.