On June 29, 2026, the Food and Drug Administration (FDA) issued a notice of proposed rulemaking (NPRM), “Establishment Registration and Product Listing for Tobacco Products,” intended to close gaps in registration and listing requirements between domestic and foreign tobacco product manufacturers.
If finalized, the rule would require foreign tobacco product manufacturers that export products to the United States to register with the FDA and submit detailed information about the products intended for the United States market that they manufacture. Among other requirements, companies would need to provide the FDA with administrative and identifying information for the establishment and uniquely identifying information, including any relevant tobacco product number (TP#) for each tobacco product manufactured at the establishment and intended to be marketed in the United States. They would also need to maintain a historical file containing copies of consumer information, labeling, and advertisements for products on the product list.
Because the FDA only inspects tobacco establishments required to register or establishments with products under premarket review, companies newly required to register would face routine inspections under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Why the FDA Says the Rule Is Needed
The proposal reflects the FDA’s efforts to address what the agency describes as major gaps in its understanding of the tobacco marketplace. Under the FD&C Act, owners and operators of domestic tobacco product manufacturing establishments must register their establishments and submit product listings to the FDA. Section 905(h) requires the FDA to issue regulations before those requirements apply to owners of foreign establishments that manufacture tobacco products.
The FDA says the absence of registration requirements for foreign manufacturers has limited its ability to identify products entering the United States, monitor manufacturers, and take enforcement action against unauthorized tobacco products.
Who Would Be Covered
The rule would apply to any domestic or foreign owner or operator of an establishment engaged in the “manufacture, preparation, compounding, or processing of a tobacco product.” Covered entities would include third-party manufacturers, repackagers or relabelers, specification developers, bulk tobacco product manufacturers, and establishments that manufacture free samples of smokeless tobacco.
Owners or operators of new domestic establishments would have to register with the FDA within five business days of beginning operations. Foreign establishments would have to register before any tobacco product is imported or offered for import into the United States.
Foreign establishments would be subject to FDA inspection under Sections 905(g) and 905(h) of the FD&C Act because all registered establishments are subject to inspection. Currently, the FDA inspects foreign establishments only as part of premarket tobacco product application (PMTA) review.
Practical Implications for Industry
Although the proposal applies broadly across the tobacco industry, its practical impact is likely to be felt most by foreign manufacturers, electronic nicotine delivery systems (ENDS) companies, contract manufacturers, and U.S. importers. Companies should begin evaluating how the proposed rule could impact their international supply chains and whether they have systems capable of capturing the product-specific information the FDA proposes to require.
Enforcement Implications
The proposal offers insight into the FDA’s enforcement priorities. Throughout the NPRM, the agency emphasizes the importance of identifying unauthorized tobacco products, monitoring imported products, and strengthening compliance with premarket authorization requirements.
The proposal appears designed not only to improve the FDA’s visibility into the marketplace but also to facilitate more efficient enforcement against products the agency believes are being marketed unlawfully. As the FDA notes in the NPRM, and consistent with the FD&C Act, failing to provide required information to the FDA is a prohibited act, as is the introduction into interstate commerce of misbranded or adulterated products, the receipt of such products, or the adulteration or misbranding of products in interstate commerce.
Products from facilities that fail to appropriately register or list products, or products lacking required premarket authorization, are adulterated or misbranded. If finalized, the proposed rule would allow the FDA to pursue regulatory action—including civil money penalties, seizure, and injunction—against companies marketing, or attempting to market, tobacco products from unregistered facilities or products that are not properly listed. That is already the case for facilities currently required to register and list.
Once all products on the market must come from registered facilities and be listed, as the proposal would require, the FDA’s ability to take enforcement action against products from unregistered facilities or products not on product lists would be greatly simplified. Those products would be, as a matter of law, not legally marketed, allowing the FDA to take enforcement action without first assessing whether the product is new or has appropriate premarket authorization.
The FDA could also focus its surveillance and review on the marketing status of products listed by registered companies. For listed tobacco products that lack required premarket authorization, the FDA can, and likely will, review the products’ regulatory status and take action based on the failure to obtain appropriate authorization.
By reducing the burden on the FDA to identify and act against tobacco products marketed without appropriate premarket authorization, the rule, if finalized, could allow the FDA to devote additional resources to violations that are less clear-cut or harder to detect, such as products misleadingly marketed to minors or manufactured under insanitary conditions.
Next Steps
Interested parties may submit comments on the proposed rule to Docket No. FDA-2025-N-7130. Alston & Bird is following this issue closely and can assist clients in evaluating regulatory strategies and engaging with the FDA.
If you have any questions, or would like additional information, please contact one of the attorneys on our FDA: Drug & Device team.
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