FDA proposes new rule for foreign tobacco makers selling in US

The Food and Drug Administration moved to close a long-standing enforcement gap on June 26, proposing a rule that would require foreign tobacco makers to register their establishments and list the products they sell in the United States. The agency said the change is meant to give regulators a clearer picture of what is being made for American consumers, where it is coming from, and how to move faster against unauthorized products that reach the market, especially youth-appealing e-cigarettes.

The proposal, titled Establishment Registration and Product Listing for Tobacco Products and listed in the federal regulatory agenda as RIN 0910-AH59, would prescribe the format, content and procedures for registration and product listing for domestic and foreign establishments that manufacture, prepare, compound or process tobacco products. Domestic manufacturers already have to register with the FDA and list their products, but foreign manufacturers do not face the same requirement unless the agency specifically orders it through regulation. That gap, the FDA said, has made it harder to identify illegal imports and harder to conduct on-site inspections abroad.

The agency’s case for the rule comes against the backdrop of major enforcement actions targeting unauthorized e-cigarettes. The U.S. Department of Health and Human Services and U.S. Customs and Border Protection said they seized 4.7 million unauthorized e-cigarettes worth an estimated $86.5 million in Chicago, calling it the largest seizure of its kind and saying almost all of the shipments came from China. The FDA later said a separate Chicago operation seized nearly 2 million unauthorized e-cigarette units with an estimated retail value of $33.8 million. Those seizures have underscored how products can move through the import system before regulators have a full accounting of who made them and whether they were authorized for sale.

Bret Koplow, the acting director of the FDA’s Center for Tobacco Products, framed the proposal as a matter of basic fairness and public health. “All companies selling tobacco products in the United States should play by the same rules,” he said. The agency said the added reporting would help it level the playing field for American businesses and hold manufacturers to the same standards, while expanding its surveillance and inspection toolkit.

FDA materials also show how the system now works for companies already under the agency’s reach. Registered tobacco establishments must resubmit their registrations annually by Dec. 31, and certain product-listing changes must be filed twice a year, in June and December, through the Tobacco Registration and Listing Module Next Generation, known as TRLM NG. The Federal Register notice for the proposed rule is scheduled for June 29, 2026, setting up a process that could make foreign registration a core compliance requirement for companies shipping into the U.S. market.