FDA WARNING_LETTER - snusme.com - April 29, 2025

The FDA Center for Tobacco Products issued a Warning Letter on April 18, 2025, to the entity operating snusme.com, following a review that identified nicotine pouch products offered for sale or distribution in the United States. These products, including "Zyn Red Fruits Slim" and "Zyn Violet Licorice Slim Strong," are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuation of sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. Imported products appearing adulterated/misbranded