FDA WARNING_LETTER - TNT Vapors - June 30, 2021

The FDA issued a Warning Letter to TNT Vapors for manufacturing and distributing e-liquid products, specifically "TNT Betty 3mg e-liquid," without the required premarket authorization. Under the FD&C Act, e-liquids are deemed tobacco products subject to FDA regulation. The "TNT Betty 3mg e-liquid" is considered 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 makes 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 sale or distribution of such products is a prohibited act under sections 301(k) and 301(p). TNT Vapors must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.