FDA WARNING_LETTER - Vaporistic Bayville - July 16, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to STR8VAPE after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically Vaporistic Nic 3.6 mg, without required marketing authorization. These e-liquids are considered 'new tobacco products' under the FD&C Act, subject to premarket authorization requirements effective August 8, 2016, as they were not commercially marketed before February 15, 2007. The FDA found that STR8VAPE's product lacks the necessary marketing order, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of a required notice under section 905(j). The letter also cites prohibited acts under sections 301(k) for holding adulterated/misbranded products for sale and 301(p) for failing to provide the required report. As a registered manufacturer with over 880 listed products, STR8VAPE is responsible for ensuring compliance. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance, to avoid potential regulatory actions like civil money penalties, seizure, or injunction.