The U.S. Food and Drug Administration proposed a rule requiring foreign tobacco product manufacturers to register their manufacturing facilities and list the tobacco products they sell in the U.S., closing a regulatory gap that currently exempts overseas manufacturers from requirements already imposed on domestic companies. The agency said the proposal would strengthen its ability to identify and take action against illegal tobacco products—particularly unauthorized disposable e-cigarettes—and create a more level playing field for U.S. manufacturers.
If finalized, the rule would require both foreign and domestic manufacturers to register their establishments, submit detailed product information, and update registrations annually and product listings twice a year. Foreign facilities would also become subject to FDA inspections, giving the agency greater oversight of products before they enter the U.S. market. Manufacturers would also be required to maintain records of labeling, advertising, and consumer information for at least four years.
According to the FDA, the proposal would improve enforcement by providing more comprehensive information on tobacco products manufactured for the U.S. market and expanding oversight of foreign producers. Acting Center for Tobacco Products Director Bret Koplow said the rule would help ensure all companies selling tobacco products in the U.S. operate under the same standards while strengthening the agency’s ability to keep illegal products out of the marketplace. Public comments will be accepted through Sept. 14.
