A proposed FDA rule would require foreign tobacco manufacturers to register facilities and report products marketed in the U.S. Photo credit: PxHere.
The US Food and Drug Administration (FDA) has proposed new regulations that would require foreign tobacco manufacturers to register their production facilities and list products sold in the US, extending requirements that currently apply only to domestic manufacturers.
The proposal aims to close what the agency describes as a regulatory gap that limits its ability to identify and oversee tobacco products manufactured overseas, particularly unauthorized imports.
Under the proposed rule, foreign companies that manufacture, prepare, compound, or process tobacco products for the US market would need to register their establishments with FDA and submit product listings. The rule would also establish standardized requirements covering the format, content, and procedures for registration and product reporting for both domestic and foreign manufacturers.
According to FDA, the additional information would help the agency identify illegal tobacco products entering the US market and support inspections of manufacturing facilities outside the country. The proposal forms part of FDA's broader effort to curb imports of unauthorized tobacco products, including e-cigarettes.
"All companies selling tobacco products in the United States should play by the same rules," said Bret Koplow, acting director of FDA's Center for Tobacco Products. "The FDA is working hard to close the gap between domestic and foreign companies, level the playing field for American businesses, and ensure that all manufacturers are held to the same standards."
If finalized, the rule would also require manufacturers to retain product labeling, advertising, and consumer information for at least four years after use. FDA said those records would help verify compliance with labeling and advertising requirements.
Manufacturers would also need to submit information that uniquely identifies each tobacco product, including its FDA submission tracking number, nicotine concentration and source, characterizing flavors, package sizes, package types, and product dimensions. For e-cigarettes, companies would additionally report technical specifications such as e-liquid volume, battery capacity, and wattage.
The proposal would require most submissions to take place electronically through FDA's online system. Manufacturers would review and update establishment registrations annually and product listings twice each year to keep agency records current.
Federal law already requires US tobacco manufacturers to register their facilities and list products with FDA. Foreign manufacturers, however, remain exempt unless the agency establishes those requirements through regulation. The proposed rule would implement that authority and place overseas producers under the same registration framework as their domestic counterparts.
FDA has opened the proposal for public comment through September 14, 2026.