FDA’s Center for Tobacco Products steps up enforcement efforts of illicit e-cigarettes

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After a few months of relative quiet from the Food and Drug Administration's Center for Tobacco Products (CTP), a recent hearing and interview provide some insight into the White House administration’s focus on illicit vapor product enforcement.

“We are going to wipe out the illicit vapes off the market,” said Department of Health and Human Services Secretary Robert F. Kennedy, Jr. at a recent U.S. Senate Committee Hearing regarding the FDA’s Center for Tobacco Products (CTP) operations. 

“Chinese smugglers are laughing at us and we are going to stop it,” said Marty Makary, commissioner of the FDA during a television interview in response to a question about the flood of illicit vapor products coming from China. 

Further, there is now new leadership at the CTP as Makary announced that Bret Koplow will be temporarily filling the role of director at CTP. Koplow has worked in various roles for the FDA since 2011, including most recently as senior counselor to the FDA commissioner. 

In late May, the FDA, in collaboration with U.S. Customs and Border Protection (CPB), announced the seizure of unauthorized vapor products in Chicago with an estimated retail value of $33.8 million. During this operation, the team uncovered shipments of various illegal vapor products, almost all of which originated in China. 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. 

Also, for the first time, the FDA sent import informational letters to 24 tobacco importers and entry filers responsible for importing these illegal e-cigarettes. The letters advised 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 advised the firms to ensure their import entries contain complete and accurate information moving forward and that 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.

With this heightened prioritization of enforcement on illicit vapor products, Kennedy has also cited the lack of vapor product PMTA approvals, which has created a vacuum that has been filled by illicit vapor products. With these recent statements and actions, the FDA is taking positive steps to provide more regulatory clarity around vapor products.

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