Smoke and Vape Inc d/b/a Backdoor Smoke Shop Warning Letter Details

Summary

Smoke and Vape Inc d/b/a Backdoor Smoke Shop was cited for selling electronic nicotine delivery system (ENDS) products without complying with FDA tobacco product regulations under the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket authorization orders for these tobacco products, which are subject to FDA jurisdiction as products containing nicotine from any source following the 2022 legislative expansion of FDA's tobacco authority. The inspection determined the retailer was distributing these products without the legally mandated premarket approval necessary for commercial marketing in the United States.