According to public records, the case centers on Midwest Goods, Inc., also known as Midwest Distribution, based in Bensenville, Illinois. The enforcement action was carried out by the Food and Drug Administration (FDA) with assistance from the U.S. Marshals. Authorities targeted and seized more than 75 brands of bottled e-liquids intended for use in refillable, open-system electronic nicotine delivery systems. Some of the products were reportedly manufactured in the United States, while others came from overseas, with several accounts noting that many originated from China. The FDA maintains that a large portion of these products either lacked the required premarket authorization or were otherwise not legally marketable under current federal law.
The legal justification for the seizure is tied to the Premarket Tobacco Product Application (PMTA) requirements. Under U.S. law, new tobacco products — including e-liquids — must have FDA authorization before they can be legally sold. Products without authorization may be seized. In fact, the FDA had already issued a warning letter to Midwest Goods in January 2025, citing distribution of products that lacked authorization and classifying some items as adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act. Officials have also alleged that certain products seized were “illicit vaping products,” including flavored options thought to appeal to youth.
The scale of the enforcement was significant. Reports indicate that at least 600,000 units were seized from the Midwest Goods facility. This operation appears to be part of a broader, multistate effort targeting multiple distributors and retailers. In response, Midwest Goods has stated that it is cooperating with authorities. The company contends that many of the seized products already had PMTAs submitted, some as far back as the original September 2020 deadline, and that those applications remain pending. Midwest also notes that the FDA had previously inspected its facility in August, removed certain products at its request, and was aware of ongoing discussions about compliance.
A civil case has since been filed in the Northern District of Illinois, under the title United States of America v. Midwest Goods, Inc. d/b/a Midwest Distribution and Midwest Illinois, et al. (Case No. 1:25-cv-10928). While the case docket itself is available, the full text of the seizure warrant has not been made public. In many civil seizure cases, warrant affidavits — which outline probable cause — are sealed or redacted, particularly in the early stages, which may explain why such details remain unavailable.
The seizure was executed under a civil seizure warrant, which authorizes the government to confiscate property alleged to be in violation of the law. Unlike a criminal search warrant, it does not require an indictment beforehand. The legal authority stems from statutes within the Federal Food, Drug, and Cosmetic Act governing tobacco and e-liquid products, along with related laws addressing misbranded or unauthorized tobacco products.
Statement of Midwest Goods on FDA Civil Seizure ActionBENSENVILLE, Ill.--(BUSINESS WIRE)--This morning, Food and Drug Administration agents and U.S. marshals executed a civil seizure warrant at our facilities. Midwest Goods is fully cooperating with the authorities as they conduct this court-authorized activity.
The vast majority of the products listed on the warrant are over 75 brands of bottled e-liquids for use in refillable, open-system electronic nicotine delivery system (“ENDS”) devices. These bottled e-liquids are manufactured by U.S. companies here in the United States that employ hundreds, if not thousands, of U.S. workers. Many of these products, to our understanding, have premarket tobacco product applications that are among the hundreds of thousands of applications that have been pending with FDA for years, even though the relevant provision of the Food, Drug and Cosmetic Act requires FDA to make determinations on such applications within 180 days of their submission. These e-liquid products include products for which the applications have been pending since the original deadline of September 9, 2020—over five years ago. To our understanding, prior to today’s enforcement action, FDA has allowed most, if not all, of these products to be marketed and sold while these premarket applications remain pending. It is the availability of these far less harmful products that have pushed U.S. cigarette smoking rates to record lows in recent years. And the CDC’s 2023 National Youth Tobacco Survey found that fewer than 6% of youth that use ENDS products use devices compatible with bottled e-liquids.
Midwest has always attempted to work cooperatively with FDA. After a recent FDA inspection in August, we advised FDA that we had removed from our product catalog and inventory several ENDS products about which FDA inspectors had inquired. We also offered to remove other ENDS products from our product catalog if FDA was concerned about our continuing to offer them for sale. FDA acknowledged receipt of our correspondence, but did not request that we stop selling any other products.
We find FDA’s actions particularly troubling given reports earlier this week that FDA plans to expedite within a matter of months reviews of several tobacco products manufactured by Big Tobacco companies, including, to our understanding, products with applications submitted years after some of the products FDA is seizing from our warehouse, as well as other reports that Big Tobacco is now actively marketing its own disposable ENDS products that lack premarket authorization. Nevertheless, Midwest intends to continue to cooperate with federal authorities and, if necessary, to vindicate our rights in court.
Contacts
Mr. Sande Shamash
sande.s@midwestgoods.com"
A copy of the warning letter sent to Midwest in Jan 2025.
- Delivery Method:
- VIA UPS and Electronic Mail
- Reference #:
- ER2401093
- Product:
- Tobacco
- Recipient:
- Midwest Goods Inc., d/b/a Midwest Distribution and Midwest Distribution Illinois
-
1001 Foster Avenue Bensenville, IL 60106United States
- Issuing Office:
- Center for Tobacco Products
-
United States
January 08, 2025
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and determined that Midwest Goods Inc., d/b/a Midwest Distribution and Midwest Distribution Illinois sells and/or distributes e-liquid products 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 e-liquid 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.
Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA’s jurisdiction to products “containing nicotine from any source,” not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of “tobacco product” under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) to include products containing nicotine from any source. Tobacco products, including e-liquid products, containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
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 the following e-liquid products that lack a marketing authorization order: MR FOG BUBBLE GANG BLUE RASPBERRY 100mL 12mg/mL.
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 an FDA marketing authorization order 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.
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 products that received marketing granted orders, please visit our website: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders#PMTAView%20all%20marketing%20granted.
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 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, ER2401093, in your response and direct your response to the following address:
DEM-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"
