FDA WARNING_LETTER - nicshop.com - April 29, 2025

The FDA's Center for Tobacco Products issued a Warning Letter on April 18, 2025, to Nicshop.com, based on a review of their website. The FDA determined that Nicshop.com offers nicotine pouch products for sale or distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The violations identified are that four specific nicotine pouch products—Zyn nicotine pouches, Apple Mint (Slim); Zyn nicotine pouches, Cool Frost (Slim); Zyn nicotine pouches, Espressino (mini dry); and Wyn nicotine pouches, Banana Chill—are "new tobacco products" that lack the required premarket authorization order. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.