The U.S. Food and Drug Administration has issued a proposed rule that would require foreign tobacco product manufacturers to register their establishments and list their products with the agency, closing a regulatory gap that currently exempts them from requirements that domestic manufacturers must meet.

Under the proposed rule, titled "Establishment Registration and Product Listing for Tobacco Products," foreign and domestic establishments that manufacture, prepare, compound, or process tobacco products would be subject to the same registration and listing requirements. Manufacturers would also be required to submit product details including nicotine concentration, characterizing flavors, package sizes, and, for e-cigarettes, specifications such as e-liquid volume, battery capacity, and wattage.

The rule would additionally require all manufacturers to maintain product labeling, advertising, and consumer information records for at least four years after their use, and to submit information electronically in most cases. Establishment registrations would need to be reviewed and updated annually, and product listings twice a year.

"All companies selling tobacco products in the United States should play by the same rules," said Bret Koplow, Ph.D., J.D., Acting Director of the FDA's Center for Tobacco Products.

The FDA said the rule, if finalized, would expand its ability to conduct on-site inspections of foreign manufacturing facilities and identify unauthorized tobacco products, including e-cigarettes, before they reach U.S. consumers. The agency noted it has previously conducted seizures of unauthorized e-cigarettes manufactured abroad.

The proposed rule is open for public comment through Sept. 14, 2026, at Regulations.gov.