By Timothy S. Donahue

Top Takeaways:

• Registration proposed: FDA would require foreign tobacco manufacturers to register facilities and list products, aligning with requirements already imposed on U.S. companies.
• Closing an enforcement gap: The proposal aims to improve oversight of imported products, including unauthorized disposable e-cigarettes.
• More product disclosure: Manufacturers would have to report the nicotine source, flavors, and product specifications, and maintain marketing records for four years.

The U.S. Food and Drug Administration has proposed a rule that, for the first time, would require foreign tobacco product manufacturers to register their facilities and list their products with the agency. The move aims to strengthen oversight of imported tobacco products and help curb the flow of unauthorized e-cigarettes into the United States.

If finalized, the rule would subject foreign manufacturers to many of the same registration and product listing requirements that already apply to domestic tobacco companies, closing what the FDA describes as a longstanding regulatory gap, according to the agency.

“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.”

The proposed rule, “Establishment Registration and Product Listing for Tobacco Products,” would require domestic and foreign establishments that manufacture, prepare, compound, or process tobacco products intended for the U.S. market to register with the FDA and submit detailed product listings.

While domestic manufacturers have long been required to register their facilities under federal law, foreign manufacturers have not been subject to the same requirements unless the FDA issues implementing regulations. The proposal would establish those requirements for the first time.

The proposal follows a series of high-profile enforcement actions against unauthorized disposable e-cigarettes manufactured overseas, including record seizures at U.S. ports and increased collaboration between the FDA and Customs and Border Protection. The agency has repeatedly identified foreign manufacturers—particularly those supplying unauthorized disposable products—as a major enforcement priority.

FDA said the expanded registration system would give the agency a more complete picture of tobacco products manufactured for sale in the United States, allowing regulators to identify illegal products more quickly and conduct inspections at overseas manufacturing facilities.

The proposal is particularly significant for the e-cigarette market, where nearly all authorized and unauthorized disposable products entering the United States are manufactured overseas.

“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,” the agency said.

Under the proposal, manufacturers would also be required to submit substantially more detailed information for each product, including nicotine concentration, nicotine source, characterizing flavors, package type and size, and FDA Submission Tracking Numbers.

For e-cigarettes, companies would also report specifications such as e-liquid volume, battery capacity, and wattage.

The rule would also require manufacturers to maintain records of labeling, advertising, and consumer information for at least four years after use, allowing the FDA to more readily assess compliance with marketing and labeling requirements, including unauthorized modified-risk claims or marketing that appeals to youth.

Most submissions would be required to be submitted electronically through FDA’s online registration system. Manufacturers would also need to review facility registrations annually and update product listings twice a year.

If adopted, the rule would give the agency greater visibility into foreign manufacturing operations before products reach U.S. consumers and provide FDA with additional inspection and surveillance tools to identify unauthorized tobacco products earlier in the supply chain.

The proposed rule is open for public comment through Sept. 14, after which FDA will review submissions before determining whether to issue a final regulation.