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WARNING LETTER

snushaven.com MARCS-CMS 724257 —


Delivery Method:
VIA Electronic Mail
Reference #:
RW2602396
Product:
Tobacco

Issuing Office:
Center for Tobacco Products

United States


February 27, 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://snushaven.com and determined that nicotine pouch products listed there are offered for sale or distribution to consumers 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 are intended for human consumption.1 Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. § 387a) and 21 C.F.R. § 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), it is unlawful for any retailer2 to sell a tobacco product to any person younger than 21 years of age.3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.

Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded

Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). FDA has determined that your Zyn - Apple Mint Mini (6mg) nicotine pouch product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA’s investigation of https://snushaven.com, a person younger than 21 years of age purchased Zyn - Apple Mint Mini (6mg) nicotine pouch product from your website.

Conclusion and Requested Action

It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments 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., and FDA’s implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.

Please be aware that the FD&C Act requires “new tobacco products” to have premarket authorization. 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. See Section 910(a) of the FD&C Act. 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.

You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA’s implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your 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 your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your 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 https://www.fda.gov.

Please note your reference number, RW2602396, 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/

John E. Verbeten
Director
Office of Compliance and Enforcement
Center for Tobacco Products

VIA Electronic Mail

cc:

Contact Privacy Inc. Customer 0169776921
snushaven.com@contactprivacy.com

Tucows Domains, Inc.
domainabuse@tucows.com

Shopify, Inc.
abuse@shopify.com

________________

1 Effective April 14, 2022, an amendment to the FD&C Act extends FDA’s regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.

2 The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. § 387(14)).

3 Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21.

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