FDA WARNING_LETTER - usaheatproduct.store - April 29, 2025

On April 18, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to the operator of usaheatproduct.store, identifying that nicotine pouch products were offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction, and require compliance with the FD&C Act.

The FDA determined that "Zyn Icy Blackcurrant Slim 11mg" and "Velo Mini Purple Grape 6mg" are new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products 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 premarket authorization or notice under section 905(j).

The letter mandates prompt action to address these violations and bring the products into compliance. The recipient must submit a written response within 15 working days, detailing actions taken, including discontinuation dates of violative sales and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as