Smoke and Vape Company, LLC d/b/a Smoke and Vape Co. Warning Letter Details

Summary

Smoke and Vape Company, LLC was cited for offering electronic nicotine delivery system (ENDS) products for sale through their website without required FDA premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company's products contained nicotine from any source and fell under FDA's expanded tobacco product jurisdiction following the 2022 Consolidated Appropriations Act amendment, requiring compliance with FDA regulations for "new tobacco products." The FDA determined these ENDS products were being distributed to customers in the United States without the legally mandated premarket authorization order needed for marketing such tobacco products.