- For Immediate Release:
The U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which occurred in February of this year in collaboration with U.S. Customs and Border Protection (CBP), were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country.
During this operation, the team uncovered shipments of various illegal e-cigarette products, almost all of which originated in China and were intended for shipment to various U.S. states. FDA and CBP personnel determined that, in an apparent attempt to evade duties and the review of products for import safety concerns, many of these unauthorized e-cigarette shipments contained vague product descriptions with incorrect values. Upon examining shipments, the team found several brands of unauthorized e-cigarettes, including Snoopy Smoke, Raz, and others.
“The FDA, working with our federal partners, can and will do more to stop the illegal importation and distribution of e-cigarette products in the United States,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Seizures of illegal e-cigarettes keep products that haven’t been authorized by the FDA out of the United States and out of the hands of our nation’s youth.”
These seizures are another example of coordinated compliance and enforcement actions across federal agencies to curb the distribution and sale of illegal e-cigarettes. In the lead up to this operation, the joint FDA and CBP team identified potentially violative incoming shipments and completed other investigative work. The team was also able to successfully implement several new internal efficiencies and procedures building off previous operations.
“We continue to see an increased number of shipments of vaping related products packaged and mislabeled to avoid detection,” said Bret Koplow, Ph.D., J.D., Acting Director of the FDA’s Center for Tobacco Products. “However, we have been successful at preventing these shipments from entering the U.S. supply chain – despite efforts to conceal the true identity of these unauthorized e-cigarette products.”
Most shipments violated the FDA’s Federal Food, Drug, and Cosmetic Act (FD&C Act), while some products were also seized for Intellectual Property Rights (IPR) violations for unauthorized use of protected trademarks. All of the 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 United States.
Standard practice for products forfeited to the government include disposing of the products in accordance with the law. In the case of unauthorized new tobacco products, including e-cigarettes, that generally means they will be destroyed.
FDA also sent, for the first time, import informational letters to 24 tobacco importers and entry filers responsible for importing these illegal e-cigarettes. The letters advise the recipients that it is a federal crime to make false statements or entries to the U.S. government, and the FDA seeks information on the steps they have taken to ensure compliance with applicable federal tobacco laws and regulations. Specifically, the letters advise the firms to ensure their import entries contain complete and accurate information moving forward. Failure to do so may also be viewed as an intentional attempt to circumvent the FDA’s review of the shipment. Firms are requested to respond to the letters within 30 days with the requested information.
FDA and CBP are members of a federal task force focused on e-cigarette enforcement. Previous FDA-CBP joint actions include the seizure of $18 million of illegal e-cigarettes at a cargo examination site in Los Angeles International Airport in 2023, seizure of $7 million of illegal e-cigarettes at a warehouse in Miami, and operations in Chicago announced in June and October of 2024 resulting in the seizure of illegal e-cigarettes valued at more than $77 million.
In addition to product seizures, the FDA has issued over 750 warning letters to firms for manufacturing, selling, or distributing unauthorized new tobacco products. It has also issued more than 800 warning letters to retailers for selling these products and filed civil money penalty complaints against 87 manufacturers and over 175 retailers for their distribution or sale.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
