NOAT Inc. – FDA Warning Letter

The FDA issued a Warning Letter to NOAT Inc., based in Long Island City, NY, on September 19, 2025, following a review of their website, which revealed the sale of nicotine pouch products in the U.S. The inspection identified that these products, specifically NOAT Spicy Melon 7mg and NOAT Spicy Lime 7mg, are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not marketed in the U.S. before February 15, 2007. These products lack the necessary premarket authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The regulatory framework requires that all new tobacco products must have a marketing authorization order to be legally marketed in the U.S. The FDA"s jurisdiction, as expanded by the Consolidated Appropriations Act, 2022, includes products containing nicotine from any source. NOAT Inc. is required to cease the violative sale and distribution of these products and submit a written response within 15 working days detailing corrective actions taken to comply with the FD&C Act. Failure to address these violations may lead to enforcement actions, including penalties or product seizure. NOAT Inc. must ensure all products and advertising comply with FDA regulations to avoid further regulatory actions.