FDA WARNING_LETTER - matesbrand.com - March 01, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to matesbrand.com on March 20, 2026, following a review of its website, which revealed the marketing of unauthorized nicotine pouch products. The FDA"s Center for Tobacco Products determined that matesbrand.com was offering "new tobacco products," specifically "Pouchmates Nicotine Pouches – Peach Smoothie" and "Pouchmates Nicotine Pouches – Strawberry Raspberry," for sale or distribution in the United States without the required premarket authorization.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), tobacco products commercially marketed after February 15, 2007, generally require specific FDA marketing orders. The absence of such authorization renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

matesbrand.com is required to immediately cease the sale and distribution of these unauthorized tobacco products. The company must submit a written response to the FDA within 15 working days, detailing the specific actions taken to address these violations, including the dates on which the violative sales were discontinued, and outlining a comprehensive plan for maintaining future compliance with the FD&C Act and its implementing regulations. Failure to comply may lead to further regulatory enforcement actions.