Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape
4192 Union Road
Buffalo , NY 14225
United States
bloodinklifelove@gmail.comIssued Jun 23, 2021Center for Tobacco Products
Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape
4192 Union Road
Buffalo , NY 14225
United States
bloodinklifelove@gmail.com
FEI Number
N/A
Country
United States
Issue Date
June 23, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
September 20, 2024
Summary
Custom Vapors Inc, operating as VIP Custom Vapors and Premier Vape, manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, classified as tobacco products under the Family Smoking Prevention and Tobacco Control Act, were deemed subject to FDA regulation as of August 8, 2016, and required marketing authorization orders before commercial distribution. The inspection and submission review revealed that the company failed to secure this mandatory premarket approval before offering its products for sale in the United States.
Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape FDA Warning Letter, June 23, 2021