Statement of Midwest Goods on FDA Civil Seizure Action

BENSENVILLE, 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.