Twisted Vapors – FDA Warning Letter, Feb 17, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Twisted Vapors on February 17, 2022, after reviewing submissions and inspection records. The FDA determined Twisted Vapors manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of Twisted Vapors Banana 30ml, 30 PG, 70 VG, 3mg nic e-liquid without the required premarket marketing authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

Twisted Vapors, a registered manufacturer with over 9,700 listed products, is advised that all new tobacco products without premarket authorization are marketed unlawfully and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within