FDA WARNING_LETTER - Vapor E-Cigarette, L.L.C. - December 15, 2022

The FDA issued a Warning Letter to Vapor E-Cigarette, L.L.C. for manufacturing and distributing e-liquid products, specifically "vapor’s BREW e-liquid," without required marketing authorization. These products are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source, due to a March 15, 2022, legislative amendment.

The "vapor’s BREW e-liquid" product is deemed 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 renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided under section 905(j).

The FDA states that manufacturing, selling, or distributing such products without authorization constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.