On June 29, 2026, the U.S. Food and Drug Administration (FDA) published a notice of proposed rulemaking (NPRM) titled “Establishment Registration and Product Listing for Tobacco Products,” which would, for the first time, require foreign tobacco product manufacturers to register their manufacturing establishments and list their products with the agency. Domestic manufacturers are already subject to these registration and listing requirements; foreign manufacturers are not. This regulation, if finalized, would close that gap.
Background
The Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, requires owners and operators of domestic establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products to register their establishments with FDA and submit a list of the products that they produce or help to produce. See 21 U.S.C. § 387e. These obligations are imposed by the statute itself and are currently carried out pursuant to agency guidance rather than formal regulations.
The FDCA also provides for establishment registration and product listing by foreign establishments, but only to the extent that FDA promulgates relevant regulations. However, FDA has not issued such regulations, and foreign manufacturers have not been required to register their establishments or list their products. This proposed rule would codify the existing domestic requirements as formal regulations and extend them to foreign establishments for the first time.
Who Must Register and Submit Lists of Products?
Registration of establishments would be required for owners and operators of both domestic and foreign establishments “engaged in the manufacture, preparation, compounding, or processing of a tobacco product.” Additionally, this registration requirement applies to “specification developers, third-party manufacturers, bulk tobacco product manufacturers, and repackagers/relabelers.” As used here, an “establishment” is “a place of business, under one ownership at one general physical location,” engaged in the operations for which registration is required.
Foreign owners or operators would be required to register and submit product listing information before offering for import or importing any product manufactured at the establishment. As a condition of registration, a foreign establishment must also designate an agent who resides or maintains a place of business in the U.S. and must agree to permit FDA to conduct on-site inspections of the establishment. The proposed rule would also apply to foreign establishments operating within foreign trade zones in the U.S. Importantly, registration and product listing do not constitute marketing authorization; products subject to the premarket review requirements remain unauthorized unless and until a marketing authorization is in effect.
What Information Is Required for Registration?
For each establishment, the owner or operator would need to provide the name and full address of the establishment, the name and places of business of the owner or operator, all trade names used by the establishment, and, in the case of a partnership, the name of each partner. Foreign establishments would additionally need to provide the name and contact information of their designated U.S. agent and the name and address of each known importer. The proposed rule would require all registration submissions to be made electronically through FDA’s Tobacco Registration and Listing Module Next Generation system; under the current guidance for domestic manufacturers, electronic submission is recommended, but paper submissions are accepted. Registrations would need to be renewed annually by December 31.
The registration requirements under the proposed rule largely mirror what the current guidance already requires of domestic manufacturers. For existing domestic registrants, the primary difference will be the procedure stemming from the codification of these requirements as formal regulations and the shift to mandatory electronic filing.
What Information Is Required for Product Listing?
For each listed product, manufacturers would need to provide brand and sub-brand names, the product category and subcategory, the package type, characterizing flavor, source of nicotine and concentration, product quantity, portion size, dimensions, UPC or other industry identifiers, and the FDA-assigned submission tracking number (STN). For electronic nicotine delivery system (ENDS) products specifically, the manufacturer would also need to provide the volume of e-liquid, propylene glycol/vegetable glycerin values, wattage, and battery capacity. These listings would need to be reviewed and updated twice a year.
The product listing requirements under the proposed rule go beyond what the current guidance requires of domestic manufacturers. The current guidance does not require manufacturers to report STNs, nicotine source and concentration, characterizing flavors, or ENDS-specific technical specifications as part of their product listings. By linking each listed product to its STN, FDA can cross-reference product listings against its database of premarket submissions to identify products on the market without authorization. In addition, each owner and operator of a manufacturing facility would need to maintain historical records of consumer information, labeling, and advertisements for each listed product, retained while in use and for at least four years after use is discontinued.
Why It Matters
The proposed rulemaking is significant because it would codify the domestic establishment registration and product listing requirements as formal regulations and extend their application to foreign manufacturers for the first time. In the context of FDA’s ongoing efforts to combat the spread of illicit products, this proposed rule could provide the agency with increased visibility regarding the manufacturing of such products outside the U.S.
The comment period is open through September 14, 2026. If you have questions about the implications of the proposed rule as it pertains to your business, our team is happy to assist.