FDA WARNING_LETTER - Brew City Juice, LLC - August 04, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Brew City Juice, LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically "No Name Blue Moon 3mg 60ml" and "Brew City Blue Razz 3mg 60ml," which are deemed tobacco products subject to FDA regulation. These products are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice under section 905(j). The letter also cites prohibited acts under section 301(k) for handling adulterated/misbranded products and section 301(p) for failing to provide required reports. Brew City Juice, a registered manufacturer with over 140 listed products, must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.