FDA WARNING_LETTER - VapeClub - April 21, 2020

The FDA issued a Warning Letter to Vladislav Igorevich Vassiliev of Vape Club Ltd. on April 13, 2020, following a review of the website https://www.vapeclub.co.uk. The review determined that electronic nicotine delivery system (ENDS) products were offered for sale or distribution to U.S. customers.

The FDA classifies ENDS products as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and regulation under section 901(b) and 21 C.F.R. § 1100.1. Effective August 8, 2016, ENDS, e-liquids, cigars, and pipe tobacco were deemed subject to regulation.

The primary violation identified is the sale of "new tobacco products" without required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified tobacco product marketed after this date, requiring a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, unless substantially equivalent or exempt.

Specifically, the products NS20 & NS10 Sour Apple Refresher E-Liquid Pods by Strapped, and NS20 & NS10 Pinkman E-Liquid