The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million – the largest-ever seizure of this kind. The seizures were part of a joint federal operation in Chicago to examine incoming shipments and prevent illegal e-cigarettes from entering the country.

Almost all the illegal shipments uncovered by the operation originated in China. 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.

“We will never allow foreign actors to threaten the health of America’s children,” said HHS Secretary Robert F. Kennedy, Jr. “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.”

“The FDA and our federal partners are taking strong actions to shore up America’s borders and stop the flow of illegal vaping products into our country,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Americans – especially our children – should not be using potentially dangerous, addicting products that have been snuck into the U.S. If a product has not been authorized by the FDA, CBP will seize, detain or destroy it.”

This enforcement action is part of the FDA’s broader aggressive strategy against childhood vaping. Additional activities include ending the practice of “port shopping,” by which illegal products repeatedly try to enter the United States; addressing the distribution networks of illegal e-cigarette products; educating parents about dangers of vaping; and working with store owners nationwide to prevent the sale of illegal products.

The seizures represent coordinated compliance and enforcement efforts by multiple federal agencies working together to stop the distribution and sale of illegal e-cigarettes. Prior to this operation, the joint FDA and CBP team conducted investigative work to identify potentially non-compliant incoming shipments. The team was also able to successfully improve the efficiency of the review and processing, building off previous operations.

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.

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. 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. To find a list of tobacco products that may be legally marketed and sold in the U.S., visit the FDA’s Searchable Tobacco Products Database.

In addition to the product seizures, the FDA contacted 37 importers and import entry filers regarding their actions. These firms were responsible for importing these illegal e-cigarettes and were advised that it is a federal crime to make false statements or entries to the U.S. government. The FDA reminded the firms of their responsibility to ensure the products they import comply with U.S. requirements and that their import entries must contain complete and accurate information moving forward. The FDA requested the firms to respond to the letters within 30 days with the requested information.

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