The U.S. Food and Drug Administration (FDA) today (May 22) announced the seizure of nearly 2 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. “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.”
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, 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, while some products were also seized for Intellectual Property Rights 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.
