GN Tobacco Sweden AB d/b/a White Fox USA – FDA Warning Letter, Sep 27, 2022

The FDA issued a Warning Letter to Ashot Movsisyan on September 22, 2022, following a review of the website https://whitefoxusa.com. The FDA determined that nicotine pouch products, specifically "Siberia - 80 Degree White Dry" and "White Fox - One Paw Nicotine Pouches," are manufactured and offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include products containing nicotine from any source.

The identified violations are that these nicotine pouch products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notices or information were not provided under section 905(j).

Although the firm submitted Premarket Tobacco Product Applications (PMTAs) for 16 products, the products cited in this Warning Letter were not included in those applications. The FDA requires a