United Tobacco Vapor Group, Inc. d/b/a Premium Vapes – FDA Warning Letter, Mar 10, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Raymund Story regarding the website http://www.premium-vapes.com. The FDA determined that the website offers Electronic Nicotine Delivery System (ENDS) products, specifically Premium Vapes Grape Refill Cartridge, Premium Vapes Orange Refill Cartridge, and Premium Vapes Strawberry Refill Cartridge, for sale or distribution in the United States.

These ENDS products are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The products lack the required marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Furthermore, the failure to provide a required report under section 905(j) is a prohibited act under section 301(p).

The letter mandates prompt corrective actions, including discontinuing the violative labeling, advertising, sale, and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, seizure