The Food and Drug Administration (FDA) proposed a rule on Friday that would require foreign tobacco product manufacturers to register their manufacturing establishments and list their products with the agency.
The proposed ruling would bring them under requirements that already apply to domestic manufacturers, the FDA said.
“All companies selling tobacco products in the United States should play by the same rules,” Bret Koplow, acting FDA Center for Tobacco Products Director, said in a statement.
Under the proposed rule, titled “Establishment Registration and Product Listing for Tobacco Products,” the FDA will prescribe the format, content and procedures for establishment registration and tobacco product listing. This would include both foreign and domestic establishments that manufacture, prepare, compound or process tobacco products, the agency said.
The rule would improve the FDA's ability to identify unauthorized tobacco products, including e-cigarettes, that are imported and illegally sold in the United States, the statement said.
Under federal law, domestic tobacco manufacturers must register their establishments and list their products with the FDA. In contrast, foreign tobacco product manufacturers are not subject to these requirements unless and until the FDA mandates their registration and product listing through regulation, the FDA said.
“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,” Koplow said.
The proposed rule would also require manufacturers to maintain records related to product labeling, advertising and consumer information for at least four years after use. Manufacturers would be required to submit identifying information for each tobacco product, including nicotine concentration, nicotine source, characterizing flavors, package size and product dimensions. Manufacturers of e-cigarettes would also have to provide information such as e-liquid volume, batter capacity and wattage.
“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 added. “By inspecting foreign manufacturing facilities, we can verify compliance at the source and stop illegal products before they reach American consumers.”
To streamline and increase efficiency, in most cases manufacturers would be required to submit information electronically through the agency’s online system, enabling them to register more quickly, the FDA said.
Manufactures would be required to update establishment registrations annually and product listing twice a year.
The proposed rule has been published for public comment through Sept. 14, before the FDA decides whether to issue a final rule.
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