FDA WARNING_LETTER - Brew City Juice LLC - September 06, 2022

The FDA issued a Warning Letter to Brew City Juice, LLC on August 4, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products "No Name Blue Moon 3mg 60ml" and "Brew City Blue Razz 3mg 60ml" were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices or information.

Prohibited acts include the sale of adulterated or misbranded tobacco products (section 301(k)) and the failure to provide required reports (section 301(p)). The company is a registered manufacturer with over 140 listed products.

Brew City Juice, LLC must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale/distribution of non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory