FDA WARNING_LETTER - Atomic Vapor - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Atomic Vapor, identifying that their e-liquid product, ATOMIC VAPOR Tsunami 6mg, is being manufactured and distributed without the required premarket authorization. Under section 201(rr) of the FD&C Act, e-liquid products are classified as tobacco products subject to FDA jurisdiction.

The ATOMIC VAPOR Tsunami 6mg e-liquid product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. Consequently, it requires a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or an exemption. Since no such authorization or exemption is in effect, 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).

The FDA considers new tobacco products marketed without premarket authorization unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Atomic Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant