FDA WARNING_LETTER - Trekker Vapors LLP - July 23, 2021

The FDA issued a Warning Letter to Trekker Vapors LLP for manufacturing and distributing e-liquid products without required marketing authorization. As of August 8, 2016, e-liquids are deemed tobacco products subject to FDA regulation, requiring premarket authorization for "new tobacco products" not commercially marketed before February 15, 2007. Trekker Vapors LLP was found to be selling multiple e-liquid products, including Back Country, Coldwater, and Fireside, which are new tobacco products lacking the necessary FDA marketing authorization orders. Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the failure to provide required notices under section 905(j). The firm's actions constitute prohibited acts under sections 301(k) (holding adulterated/misbranded products for sale) and 301(p) (failure to provide required reports) of the FD&C Act. The FDA noted that Trekker Vapors is a registered manufacturer with over 100 listed products, highlighting a significant compliance issue. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.