The Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) and Customs and Border Protection (CBP), seized 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million.
The raids were carried out in Arizona, Florida, Georgia, Illinois, New Jersey and North Carolina, the agencies announced Wednesday. They said this was the largest-ever seizure of this kind.
The seizures were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country, HHS said in a statement.
U.S. Attorney General Pam Bondi, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary held a press conference Wednesday in the Chicago suburb of Bensenville at the Illinois seizure site.
“Earlier today, pursuant to search warrants issued by federal courts, U.S. Marshals began seizing hundreds of thousands of units of illicit vaping products at locations across the United States, including here at Midwest Goods in this suburb of Chicago,” Bondi said at the press conference. “Many of these products were smuggled in from China circumventing regulations.”
Bondi added that “additional seizures today have been made this morning at five other retailers and four other distributors in North Carolina, Arizona, New Jersey, Georgia and Florida.”
HHS said the FDA and CBP personnel determined that many of these shipments contained vague and misleading product descriptions with incorrect values, in an apparent attempt to evade duties and the review of products for import safety concerns.
“All e-cigarette products seized in this operation lacked the mandatory premarket authorization orders from the FDA and therefore cannot be legally marketed or distributed in the U.S.,” HHS said in a statement.
“We will never allow foreign actors to threaten the health of America’s children,” the health secretary said. “Today we took decisive action to protect kids from illegal vape products. Thank you to President Trump and Attorney General Bondi for their leadership in helping us shut down this black market.”
Midwest Goods statement
When reached for comment, Bensenville, Illinois-based Midwest Goods, one of Illinois’ largest e-cigarette distributors and a business targeted in the raid, issued the following statement to CSP Daily News.
“This morning, Food and Drug Administration agents and U.S. Marshals executed a civil seizure warrant at our facilities. Midwest 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 that 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 with 180 days of their submission."
Midwest Goods said that prior to Wednesday's enforcement action, the FDA has allowed most, if not all, of these products to be marketed or sold while the PMTAs remain pending.
“Midwest has always attempted to work cooperatively with FDA," its statement read. "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.
The company added that it found the 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."
The FDA plans to start a pilot program to fast-track nicotine pouch authorizations, according to Reuters, citing meeting transcripts seen by the news outlet. The program aims to finish the review of nicotine pouches from Philip Morris International (PMI), Stamford, Connecticut; Altria, Richmond, Virginia; Reynolds American, Winston-Salem, North Carolina; and Turning Point Brands, Louisville, Kentucky, by December, Reuters reported.
Vapor Technology Association calls action “reckless”
Tony Abboud, executive director of the Vapor Technology Association, said in statement that “American-made vaping products—produced by companies that have fully complied with the FDA’s own guidance and the PMTA process—are now being seized nationwide. For more than five years, VTA has warned the agency of flaws in its regulatory system, yet the FDA refuses to engage with stakeholders—an irresponsible course of action that now threatens the bankruptcy of hundreds of thousands of small businesses nationwide."
Abboud said that in Illinois alone, the vape industry produces an economic output of over $544 million and supports 2,666 jobs. The vaping industry currently contributes more than $17 billion annually to the U.S. economy, Abboud said.
“The consequences of this reckless course of action cannot be overstated. This is not only an assault on public health—it is an assault on American workers, small businesses, and the tax base that supports our communities,” he said. “The actions of HHS and the DOJ are detrimental to the state, local, and federal economies, and they must reverse course immediately.”
In total this year, the FDA and CBP have stopped more than 6 million unauthorized e-cigarettes worth over $120 million from entering the country, HHS said.
To date, the FDA has authorized 39 e-cigarette products and devices. These are the only e-cigarette products that can be legally marketed and sold in the U.S.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.