FDA WARNING_LETTER - Wise Guys Vapes - February 09, 2022

The FDA issued a Warning Letter to Wise Guys Vapes on February 9, 2022, after reviewing submissions and inspection records. The FDA determined that Wise Guys Vapes manufactures and distributes e-liquid products, specifically "Wise Guys Whitey Bulger 3mg e-liquid," which are deemed tobacco products under the FD&C Act.

The primary violation is that this e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction. Wise Guys Vapes must submit a written response within 15 working days detailing actions to address violations, including discontinuing sales/distribution and a plan for future compliance.