July 1, 2026

In a new proposed rule, released on June 26, 2026, the FDA proposes to extend establishment registration and product listing requirements to foreign tobacco product manufacturers for the first time. 

The rule, titled "Establishment Registration and Product Listing for Tobacco Products," would close a long-standing regulatory gap that has left foreign manufacturers outside the registration system that domestic manufacturers have long operated under since 2009. 

Under the proposed rule, foreign tobacco product manufacturers will now need to adhere to the same establishment registration and device listing requirements as US-based manufacturers. Additionally, registered foreign establishments would become subject to FDA inspection under sections 905(g) and (h) of the FD&C Act. FDA currently inspects foreign establishments only in connection with premarket tobacco product applications (PMTAs); this rule would broaden that authority to any registered foreign establishment. 

The rule also clarifies who qualifies as a "manufacturer," for both domestic and foreign entities. If a brand owner designs product specifications and hands them to a contract manufacturer for production, both parties would be considered manufacturers and required to register. 

FDA states the rule is intended to improve its ability to identify tobacco products and the establishments producing them, and to support enforcement against noncompliant products, including those lacking required premarket authorization. 

Key takeaways for manufacturers and brand owners: 

  • Foreign establishments that manufacture, prepare, compound, or process tobacco products would become subject to the same registration and product listing requirements currently imposed only on domestic manufacturers. 
  • All manufacturers would be required to submit detailed product identification data, including FDA-assigned Submission Tracking Numbers, nicotine concentration and source, characterizing flavors, package sizes and types, and product dimensions. 
  • For e-cigarettes specifically, manufacturers would also need to disclose e-liquid volume, battery capacity, and wattage. 
  • Establishment registrations would require annual renewal by December 31; product listings would need to be reviewed and updated twice per year, in June and December. 
  • Manufacturers would be required to retain a historical file of labeling, advertising, and consumer information for 4 years. 
  • Manufacturers distributing free samples of smokeless tobacco products would be required to maintain detailed records of those distributions for 4 years. 
  • The proposed rule notably borrows structurally from FDA's existing drug establishment registration framework under 21 CFR Part 207, including timing standards and provisions for parent/affiliate registration. 
  • The public comment period runs for 75 days following the rule's publication in the Federal Register. Comments may be submitted at Regulations.gov under Docket No. FDA-2025-N-7130 until September 14, 2026. 

For brands relying on foreign manufacturers, this rule could materially affect existing operations and in-progress PMTAs. Companies should assess now whether their manufacturing and supply chain relationships would trigger registration obligations under the rule's expanded definitions. 

If your operations involve foreign-manufactured tobacco products, or if you have questions about how this rule may affect your registration and listing obligations, contact Accorto. The comment period remains open, and there is still time to submit input directly on the rulemaking. 

 

Full Press Release (FDA.gov)

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, the 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." 

About Accorto Regulatory Solutions

Accorto Regulatory Solutions, LLC is a U.S.-based regulatory consulting firm specializing in FDA regulatory strategy, application development, and compliance support for FDA-regulated products. Accorto works with companies at all stages of growth, from early-stage and startup organizations to established international manufacturers entering or expanding within the U.S. market. With experience across emerging and mature regulatory environments, Accorto helps clients translate regulatory requirements into practical, scalable solutions that support product development, market entry, and long-term compliance.