FDA WARNING_LETTER - Buyvapor.com LLC - September 01, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Johnson Tran regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products on the website https://www.buyvapor.com. The FDA determined that the ENDS products offered for sale are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation identified is the sale of "new tobacco products" without required premarket authorization. Specifically, the products "Cafe Racer – Motto Pods Tropical Tea (Blackberry Mango)," "Cafe Racer – Motto Pods Berry Ice," and "Cafe Racer – Motto Pods Tangerine Ice" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

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, injunction, and refusal of admission for imported products.