FDA WARNING_LETTER - Ecig Vapor Juice Store - September 27, 2022

The FDA issued a Warning Letter to Ecig Vapor Juice Store on September 27, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Ecig Vapor Juice Store's "Rootbeer 0.3% 30ml e-liquid product" is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

This product lacks an FDA marketing authorization order, rendering it 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.

Ecig Vapor Juice Store's Premarket Tobacco Product Application (PMTA), STN PM0003266, submitted on September 10, 2020, received a Refuse To Accept determination on October 18, 2021, covering 55,159 products. The FDA states that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction.

The company must submit a written response within 15 working days detailing actions