FDA WARNING_LETTER - Master Sales LLC - September 10, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Master Sales LLC on September 5, 2024, based on a review of inspection records. The letter states that Master Sales LLC manufactures, sells, and/or distributes hookah products, which are defined as tobacco products under section 201(rr) of the FD&C Act. These products are subject to FDA jurisdiction and must comply with the FD&C Act and its implementing regulations.

A key violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the product "NU Tobacco Strong Mint 250g" is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Master Sales LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales and a plan for maintaining compliance.