FDA WARNING_LETTER - Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape - June 24, 2021

The FDA issued a Warning Letter to Custom Vapors Inc d/b/a VIP Custom Vapors/Premier Vape for manufacturing and distributing an e-liquid product without required marketing authorization. The FDA determined that Premier Vape PURE TOBACCO 3ML 3MG e-liquid is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required notice or information under section 905(j). The manufacture, sale, and/or distribution of such a product constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Custom Vapors Inc, a registered manufacturer with over 2,900 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation dates of violative sales/distribution, and a plan for maintaining compliance.