FDA Warning Letter to Prilla.com for Unapproved Nicotine Pouch Products
Summary
FDA's Center for Tobacco Products issued a Warning Letter to Prilla.com (Las Vegas, NV) for marketing new tobacco products—specifically VITO Watermelon 6mg and VITO Mango Fusion 6mg nicotine pouches—without required premarket authorization under Section 910 of the FD&C Act. FDA determined these products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6). The letter requests a written response within 15 working days describing corrective actions, including dates of discontinued sale and compliance plans. Failure to comply may result in civil money penalties, seizure, and/or injunction.
“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: VITO Watermelon 6mg and VITO Mango Fusion 6mg.”
Tobacco product distributors and retailers should audit their product portfolios to confirm each item has required FDA marketing authorization. Nicotine pouch products have been a focus of FDA enforcement activity; products without authorization may be detained at import or subject to domestic enforcement including civil money penalties, seizure, and injunctions regardless of whether the seller believes products are otherwise compliant.
About this source
FDA Warning Letters are public notifications to firms the agency believes are significantly violating FDA regulations. Common triggers include Current Good Manufacturing Practice violations, unauthorized drug claims, substandard clinical trial conduct, unapproved marketing, and tobacco sales to minors. Letters require a written response within 15 working days. Around 75 letters land each month across drug manufacturers, medical device makers, tobacco retailers, and dietary supplement companies. Watch this if you run a regulated manufacturing operation, advise on FDA compliance, defend companies in enforcement matters, or track quality-system failures that precede recall events. GovPing publishes each letter with the recipient, agency division, and cited violations.
What changed
FDA's Center for Tobacco Products determined that Prilla.com markets nicotine pouch products (VITO Watermelon 6mg and VITO Mango Fusion 6mg) without required premarket authorization orders under Section 910(c)(1)(A)(i) of the FD&C Act. These products are classified as new tobacco products because they were not commercially marketed in the US as of February 15, 2007. The products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6). Any firm marketing new tobacco products without statutorily required premarket authorization is marketing unlawfully and is subject to enforcement action at FDA's discretion. Parties should review all tobacco products in their portfolio to confirm each has either an FDA marketing authorization order in effect, an approved substantial equivalence order, or a valid exemption under Section 905(j)(3).
What to do next
- Submit a written response within 15 working days describing actions to address violations and bring products into compliance, including dates of discontinued sale and distribution
Archived snapshot
Mar 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Delivery Method: VIA UPS and Electronic Mail Reference #: RW2602397 Product: Tobacco Recipient: prilla.com/us 1408 South Main Street
Las Vegas, NV 89104
United States
contact@prilla.com info@prilla.com accessibility@prilla.com Issuing Office: Center for Tobacco Products United States
March 6, 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://prilla.com/us and determined that the 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: VITO Watermelon 6mg and VITO Mango Fusion 6mg.
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, RW2602397, 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:
Name.com, Inc.
abuse@name.com
Cloudflare, Inc.
abuse@cloudflare.com
PRILLA, INC.
Attn: CORPORATION SERVICE COMPANY
251 Little Falls Drive
Wilmington, DE 19808
PRILLA, INC.
Attn: Thomas H Thorelli
70 West Madison Street, Suite 5750
Chicago, IL 60602
PRILLA, INC.
Attn: INCORP SERVICES, INC.
9107 West Russell Road, Suite 100
Las Vegas, NV 89148
PRILLA, INC.
Attn: Andreas Gustafsson
150N Michigan Ave, Ste 1950
Chicago, IL 60601
PRILLA, INC.
Attn: INCORP SERVICES, INC.
101 E. 9th Ave., Ste. 12-B
Anchorage, AK 99501
- ## Content current as of:
03/17/2026
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