FDA WARNING_LETTER - athleticnicotine.com - April 29, 2025

On April 10, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding nicotine pouch products sold on athleticnicotine.com. The FDA determined that "Athletic Nicotine FLV. 01" and "Athletic Nicotine FLV. 02" are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded jurisdiction to products containing nicotine from any source.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. 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 lack of required notice or information under section 905(j).

The letter states that marketing these products without authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The recipient must submit a written response within 15 working days detailing actions taken to address violations, including discontinu