FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
June 26, 2026
Dear International Colleague,
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and conduct on-site inspections abroad.
Domestic tobacco product manufacturers are currently required under federal law to 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. This proposed regulation would implement this requirement, closing this regulatory gap. With a more complete picture of the products manufactured for sale to American consumers and where they come from, FDA can better protect public health and more efficiently identify and take action on unauthorized tobacco products such as e-cigarettes that are imported and illegally sold in the U.S.
Under the proposed rule, titled “Establishment Registration and Product Listing for Tobacco Products,” the FDA would 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.
“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 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.”
The FDA has existing authority to enforce against illegal tobacco products and has taken action on products manufactured abroad, including recent record-breaking seizures of unauthorized e-cigarettes. If finalized, this proposed rule would significantly expand the agency’s knowledge of tobacco products manufactured abroad for import into the U.S. and allow the agency to be more proactive.
The proactive establishment registration, systematic inspections, and product surveillance included in this proposed regulation would give the FDA significantly more tools to identify and act against illegal foreign tobacco products. For unauthorized e-cigarettes, many of which are manufactured outside the U.S., this is a critical step forward for protecting public health.
“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,” Dr. Koplow added. “By inspecting foreign manufacturing facilities, we can verify compliance at the source and stop illegal products before they reach American consumers.”
The rule, if finalized, would also require all manufacturers to maintain product labeling, advertising, and consumer information records for at least four years after their use. The FDA could then more easily verify compliance with labeling and advertising requirements and ensure that products are not marketed in ways that, for example, appeal to youth or make unauthorized health claims.
Additionally, this rule would require all manufacturers to provide information to uniquely identify each tobacco product, including products’ FDA-assigned Submission Tracking Number, nicotine concentration and source, characterizing flavors, package sizes and types, and product dimensions. For e-cigarettes, manufacturers would also need to provide specifications such as e-liquid volume, battery capacity, and wattage.
To streamline and increase efficiency, in most cases manufacturers would be required to submit information electronically through the FDA’s online system, enabling them to register more quickly. They would also be required to review and update their establishment registrations annually and their product listings twice a year to ensure the agency has current information.
The proposed rule is available for public comment. Submit your comments by Sept. 14, 2026, at Regulations.gov. The agency will review all comments as part of the rulemaking process.
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