FDA Warning Letter to Matesbrand.com for Nicotine Pouches

FDA Warning Letters

Filed March 20th, 2026

Detected March 25th, 2026

Summary

The FDA issued a warning letter to matesbrand.com for illegally marketing new tobacco products, specifically nicotine pouches, without required premarket authorization. The agency determined that the listed nicotine pouch products are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

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What changed

The U.S. Food and Drug Administration (FDA) has issued a warning letter to matesbrand.com, identifying nicotine pouch products offered for sale on their website as new tobacco products that lack the statutorily required premarket authorization. Specifically named are "Pouchmates Nicotine Pouches – Peach Smoothie" and "Pouchmates Nicotine Pouches – Strawberry Raspberry." The FDA asserts these products are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed before February 15, 2007, and do not have the necessary FDA marketing authorization orders or exemptions.

This warning letter signifies that matesbrand.com is marketing new tobacco products unlawfully and is subject to enforcement action at the FDA's discretion. The company is responsible for ensuring all tobacco products sold and distributed in the United States have the required premarket authorization. Failure to comply could result in further regulatory action. The FDA directs the recipient to its searchable database for a list of authorized tobacco products.

What to do next

Cease marketing all new tobacco products without premarket authorization.
Ensure all tobacco products sold and distributed have FDA marketing authorization.
Review the FDA's searchable tobacco products database for compliance.

Penalties

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.

Source document (simplified)

Delivery Method: VIA Electronic Mail Reference #: RW2602398 Product: Tobacco Recipient: matesbrand.com United States

hi@matesbrand.com Issuing Office: Center for Tobacco Products United States

March 20, 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://www.matesbrand.com and determined that nicotine pouch 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 nicotine pouch 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 nicotine pouch products that lack a marketing authorization order, including: Pouchmates Nicotine Pouches – Peach Smoothie and Pouchmates Nicotine Pouches – Strawberry Raspberry.

The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, they are 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 these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).

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, and 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 https://www.fda.gov.

Please note your reference number, RW2602398, 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 UPS and Electronic Mail

cc:

7D Holdings, LLC
7 Daze LLC
Attn: John Lau
1425 South Vineyard Avenue
Ontario, CA 91761

7D Holdings, LLC
8 The Green, Suite R
Dover, DE 19901

7 Daze LLC
Attn: John Lau
13170 Spring Street
Baldwin Park, CA 91706
info@7dazemfg.com

GoDaddy.com, LLC
abuse@godaddy.com

Shopify, Inc.
abuse@shopify.com