FDA WARNING_LETTER - VapeSourcing - April 27, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Vapesourcing.com after reviewing its website and identifying the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products, specifically the VooPoo Rota 340mAh Pod System Kit, to U.S. customers. As a "new tobacco product" not commercially marketed before February 15, 2007, this ENDS product requires premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act, which it lacks. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failing to provide required notice or information under section 905(j). Furthermore, the failure to submit a required report under section 905(j) constitutes a prohibited act under section 301(p). FDA expressed particular concern over the product's design, which imitates a fidget spinner, increasing its appeal to youth and potentially encouraging unlawful sales. Vapesourcing.com is required to promptly correct these violations, discontinue all violative activities, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to civil money penalties, product seizure, injunctions, and refusal of admission for imported products.