FDA WARNING_LETTER - Pure Vape - August 25, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Purevape.com after reviewing its website and determining that the company offers electronic nicotine delivery system (ENDS) products, specifically Juul Pods – Mint, for sale in the U.S. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007. The FDA found that Purevape.com is selling these ENDS products without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). The letter emphasizes the company's responsibility to ensure compliance with all applicable provisions of the FD&C Act and FDA regulations. Purevape.com is required to immediately correct these violations, discontinue the sale and distribution of the non-compliant products, and submit a written response within 15 working days detailing corrective actions and a plan for future compliance. Failure to address these violations may lead to further regulatory action, including detention and refusal of admission for imported products.