Blaze USA, LLC, d/b/a Blaze Wholesale Warning Letter Details

Summary

Blaze USA, LLC, d/b/a Blaze Wholesale was cited for selling and distributing electronic nicotine delivery system (ENDS) products without obtaining required premarket authorization orders from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act's requirements for tobacco products, which extend to all products containing nicotine from any source following the 2022 legislative expansion of FDA jurisdiction. As a distributor of ENDS products, the company was required to ensure that these "new tobacco products" had FDA premarket approval before being legally marketed in the United States.