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 children and youth by imitating breath strips (see Exhibit B). Exposure to oral tobacco products containing 2–3 mg of nicotine or more per product unit likely presents a serious risk of severe acute toxicity, including seizures and potentially life-threatening outcomes, in children under 6 years old. Further, the unauthorized product’s labeling, advertising, and/or design may be attractive to youth because the labeling, advertising, and/or design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the product is a tobacco product or be confused with an everyday object and accidently ingested by young children. Any labeling, advertising, and/or design features that could entice youth to initiate or maintain use of tobacco products are of concern to FDA.  Sales of such unauthorized tobacco products are prohibited, and FDA is concerned that your actions could encourage unlawful sales and maintain or increase youth use. Conclusion and Requested Actions FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization.  All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco. It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq. or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, or 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.  However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act.  Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission. The violations discussed in this letter do not necessarily constitute an exhaustive list.  You should take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act. Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.  If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  This letter notifies you of our findings and provides you with an opportunity to address them.  You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov. Please note your reference number, RW2602421, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address: DPAL-WL Response, Office of Compliance and Enforcement FDA Center for Tobacco Products c/o Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov. Sincerely, /S/ Ele Ibarra-Pratt Acting Director Office of Compliance and Enforcement Center for Tobacco Products VIA Electronic Mail cc: GoDaddy.com, LLC abuse@godaddy.com Shopify, Inc abuse@shopify.com Content current as of: 05/20/2026 Regulated Product(s) Tobacco