FDA Warning Letter to npouches.com (May 19, 2026) — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

FDA Warning Letter — Violations FDA cited at npouches.com

WARNING LETTER npouches.com MARCS-CMS 730125 — May 19, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Tobacco Recipient: npouches.com United States privacy@npouches.com info@npouches.com Issuing Office: Center for Tobacco Products United States Secondary Issuing Offices United States May 19, 2026 WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://npouches.com and determined that dissolvable tobacco products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including dissolvable tobacco products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)). New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded FDA has determined that you offer for sale or distribution to customers in the United States dissolvable tobacco products that lack a marketing authorization order, including: Hyde Nic Strips – Cool Mint 2mg. The tobacco product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, it is misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting this product was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)). Additional Considerations Children are at particular risk for ingesting oral tobacco products like dissolvable tobacco products with labeling, advertising, and/or design features that cause the product to imitate a food and/or edible products, particularly products that are typically marketed toward, and/or appealing to, children. Moreover, children are at particular risk because exposure to nicotine in a dissolvable product, even in relatively small amounts, could result in acute toxicity. FDA finds this unauthorized product particularly concerning because the product labeling, advertising, and/or design for the Hyde Nic Strips product (see Exhibit A) may be attractive to ch