On June 26, 2026, the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), announced a proposed rule titled “Establishment Registration and Product Listing for Tobacco Products” that, if finalized, would require foreign tobacco product manufacturing establishments to register with FDA and list tobacco products manufactured for import into the United States. FDA is positioning the proposal as a significant tool to identify unauthorized imported tobacco products, including electronic nicotine delivery system (ENDS) products, and to conduct inspections of foreign manufacturing facilities. Comments on the proposed rule are due September 14, 2026.
The proposal would add a new 21 C.F.R. Part 1108 governing registration of tobacco product establishments and listing of tobacco products in commercial distribution. The rule would prescribe the format, content, and procedures for registration and product listing for both domestic and foreign establishments that manufacture, prepare, compound, or process tobacco products subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Statutory Background: Why a Rulemaking Was Needed
Section 905 of the FD&C Act has long required U.S. domestic tobacco product establishments to register with FDA. Specifically, Section 905(b) requires every person who owns or operates an establishment “in any State” engaged in the manufacture, preparation, compounding, or processing of tobacco products to register annually with FDA. Section 905(i) separately requires registrants to file a list of all tobacco products being manufactured, prepared, compounded, or processed for commercial distribution, and to report certain changes in June and December of each year.
Foreign establishments, however, are treated differently under the statute. Section 905(h) provides that a foreign establishment engaged in the manufacture, preparation, compounding, or processing of tobacco products “shall register” under Section 905 under regulations promulgated by the Secretary. Those regulations must require foreign establishments to provide the information required by Section 905(i) and include provisions ensuring that adequate and effective means are available for FDA to determine whether imported tobacco products should be refused admission under Section 801(a).
That statutory structure created a notable distinction: domestic registration obligations were self-executing, while foreign establishment registration depended on FDA issuing implementing regulations. FDA acknowledges in the proposed rule that because it has not yet issued such regulations, foreign owners and operators are not currently required to register their establishments or list tobacco products imported or offered for import into the United States. FDA states that this discrepancy creates gaps in the Agency’s information about products and establishments.
What the Proposed Rule Would Require
If finalized, the proposed rule would require owners or operators of establishments—domestic or foreign—engaged in the manufacture, preparation, compounding, or processing of tobacco products to register with FDA. FDA would expressly include specification developers, third-party manufacturers, bulk tobacco product manufacturers, repackagers, and relabelers within the scope of entities engaged in manufacturing for purposes of the rule. The proposal also includes limited exceptions for certain investigational-use tobacco products, manufacturers only of non-tobacco raw materials used in components or parts, common carriers acting in the ordinary course, and certain foreign-trade-zone products exported without further distribution in the United States.
If finalized as proposed and once effective, an owner or operator of a foreign establishment would have to register and submit tobacco product listing information before any tobacco product manufactured, prepared, compounded, or processed at that establishment is imported or offered for import into the United States. Domestic establishments would be required to register and submit product listing information within five business days of first engaging in covered operations. Thereafter, each covered owner or operator would be required to submit annual establishment registration by December 31 and, in June and December of each year, review, update as needed, or confirm that there have been no changes to its tobacco product listing information on file with FDA.
FDA is proposing that registration and listing information generally be submitted electronically through FDA’s tobacco product registration and listing system (see Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions | FDA), unless FDA grants a waiver. The submission would include establishment information, owner and operator information, the designated official correspondent, trade names, tobacco-related website addresses, Registration Identification Number (RGID), FDA Establishment Identifier (FEI), and other identifying information.
Product listing information would be extensive. For each listed tobacco product, manufacturers would need to provide brand and subbrand names, product category and subcategory, package type, characterizing flavor, and, as applicable, nicotine source, product quantity, portion size, dimensions, filter ventilation percentage, e-liquid volume, nicotine concentration, PG/VG values, wattage, battery capacity, UPC or other industry product identifier, FDA Submission Tracking Numbers (STNs), FDA Product Identification Numbers, and the operations performed at the establishment.
The proposed rule would also require owners and operators to maintain a historical file containing consumer information, labeling, and advertisements for all listed tobacco products. Such materials would need to be retained while in use and, once discontinued, for at least four years after final dissemination. FDA also proposes recordkeeping requirements for certain free sample distribution information for smokeless tobacco products.
Foreign Establishments and FDA Inspections
The most critical consequence of the proposed rule is that registered foreign establishments would become subject to FDA inspection under Sections 905(g) and 905(h) of the FD&C Act. FDA notes that it currently inspects foreign tobacco product establishments only to support PMTA review under 21 C.F.R. § 1114.27. The proposed rule would therefore significantly expand FDA’s ability to inspect foreign manufacturing facilities outside the PMTA context.
The proposed foreign establishment provisions also track Section 905(h) in that registration would depend on adequate and effective means being available, by arrangement with the relevant foreign government or otherwise, to allow FDA to determine whether tobacco products manufactured at the foreign establishment should be refused admission if imported or offered for import into the United States.
Registration Would Not Equal Marketing Authorization
Importantly, registration and product listing would not constitute FDA authorization to market a tobacco product. The proposed rule states that registration and listing do not denote FDA marketing authorization. Listed products that are subject to Sections 905 and 910 of the FD&C Act are not authorized for legal sale or distribution in the United States unless they have an FDA marketing authorization order in effect.
The proposed rule would also codify misbranding consequences. FDA proposes that a tobacco product manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 905—or not included in a required product list—would be deemed misbranded. The rule would also prohibit representations suggesting that registration, listing, or possession of a registration number means FDA approval, marketing authorization, or that a listed product is safe or less harmful.
Relationship to FDA’s Still-Unfinalized TPMP Rule
This proposed rule should also be read against the backdrop of FDA’s 2023 proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP). As we previously discussed, FDA’s TPMP proposal would establish good manufacturing practice-style requirements for domestic and foreign manufacturers of finished and bulk tobacco products, but that rule did not implement FDA’s authority under Section 905(h) to require foreign establishment registration and product listing. More than three years later, FDA still has not finalized the TPMP rule.
If both rules are eventually finalized, foreign tobacco product manufacturers may face two complementary regulatory regimes: (1) TPMP requirements governing manufacturing practices and (2) Part 1108 requirements governing registration, product listing, product identification, labeling and advertising records, and inspection readiness. In that sense, the new proposed Part 1108 rule may become the infrastructure FDA needs to identify who is manufacturing tobacco products for the U.S. market, where those products are manufactured, and which products should be prioritized for inspection or import enforcement.
Key Takeaways for Industry
Foreign manufacturers, U.S. importers, brand owners, and contract manufacturers should begin evaluating how the proposed rule would apply to their supply chains. In particular, companies should identify all foreign establishments that manufacture, prepare, compound, process, repackage, relabel, or otherwise handle tobacco products, including ENDS and oral nicotine pouches, imported or offered for import into the United States. They should also assess whether product data systems can capture the level of product-specific information FDA proposes to require, including SKU-level product identifiers, STNs, nicotine source and concentration, flavors, e-liquid volume, wattage, battery capacity, and related product attributes.
Companies should also begin reviewing whether their labeling, advertising, and consumer information files are complete and organized in a manner that would satisfy the proposed historical file requirements. FDA’s proposal would require retention of materials not only currently in use, but also discontinued materials for at least four years after final dissemination.
Finally, stakeholders should consider submitting comments. FDA is specifically seeking feedback on whether to require additional information, including direct account information, importer and consignee information, and brand owner contact information. These issues could have significant implications for foreign manufacturers, U.S. importers, distributors, and brand owners whose products are manufactured through contract or multi-party supply chain arrangements.
The proposed rule has been a long time coming. Congress created a pathway for FDA to require foreign tobacco manufacturing establishment registration in Section 905(h), and FDA has finally proposed the implementing regulations necessary to make that requirement operative. If finalized, this rule would close that gap and materially expand FDA’s visibility into, and oversight of, foreign-manufactured tobacco products, including products containing nicotine from any source, entering the U.S. market.