Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3030844110.
Violations1
Issue DateOct 9, 2024
Product TypeTobacco
StatusOpen
Letter Details
Firm
Blaze USA, LLC, d/b/a Blaze Wholesale
Location
Blaze USA, LLC, d/b/a Blaze Wholesale
1509 North Leg Road
Augusta , GA 30909
United States
FEI Number
3030844110
Country
United States
Issue Date
October 09, 2024
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Open
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.
Blaze USA, LLC, d/b/a Blaze Wholesale FDA Warning Letter, October 9, 2024