WASHINGTON, D.C. — The U.S. Food and Drug Administration has proposed requiring foreign tobacco manufacturers to register their facilities and disclose detailed product information, a move aimed at strengthening enforcement against unauthorized e-cigarettes and other tobacco products entering the United States.
The proposed rule would close a regulatory gap that currently requires domestic tobacco manufacturers to register with the FDA and list their products, while foreign manufacturers are generally exempt from those requirements.
If finalized, the regulation would require both domestic and foreign establishments that manufacture, prepare, compound or process tobacco products to register with the agency and submit product listings.
The proposal comes as the FDA intensifies efforts to curb the importation and sale of unauthorized e-cigarettes, many of which are manufactured overseas and marketed in flavors that regulators contend appeal to young people.
“All companies selling tobacco products in the United States should play by the same rules,” Bret Koplow, acting director of the FDA’s Center for Tobacco Products, stated.
The agency indicated that expanded registration and reporting requirements would give regulators a more complete picture of products manufactured for sale in the U.S. market and improve the FDA’s ability to identify and inspect foreign facilities.
The proposal also would require manufacturers to retain labeling, advertising and consumer information records for at least four years after their use, allowing regulators to verify compliance with marketing restrictions and investigate unauthorized health claims.
Manufacturers would also have to provide detailed product information, including nicotine concentration, flavor characteristics, package sizes and product dimensions.
For e-cigarettes, the requirements would extend to specifications such as e-liquid volume, battery capacity and wattage.
Most submissions would be required electronically through the FDA’s online system. Manufacturers also would need to update establishment registrations annually and refresh product listings twice each year.
“If finalized, this proposed rule would strengthen the FDA’s ability to enforce against illegal foreign tobacco products that may threaten the health and safety of Americans, including youth,” Koplow stated.
The proposal represents another step in the FDA’s broader campaign to increase oversight of the vaping market and prevent unauthorized products from reaching U.S. consumers.
The proposed rule, titled “Establishment Registration and Product Listing for Tobacco Products,” is open for public comment through Sept. 14, 2026, on Regulations.gov.
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