FDA Foreign Vape Registration Rule Comments Close

The public comment window on the U.S. Food and Drug Administration's proposed establishment registration and product listing rule closed at 11:59 p.m. Eastern on September 14, 2026. It is a piece of rulemaking that lands on the supply chain rather than on any single premarket application, and for e-liquid brands, contract manufacturers and importers it is worth understanding in detail.

What the proposed rule would require

FDA announced the proposal on June 26, 2026, and published it in the Federal Register on June 29 under docket number FDA-2025-N-7130. Titled "Establishment Registration and Product Listing for Tobacco Products," it would add a new 21 CFR Part 1108.

Domestic tobacco product manufacturers are already required by statute, at 21 U.S.C. 387e, to register their establishments and list their products with FDA. To date the agency has administered those obligations through guidance rather than formal regulation. The same statute provides for registration and listing by foreign establishments, but only to the extent FDA issues regulations requiring it — and the agency never has. The proposal would codify the domestic requirements as regulation and extend them to foreign establishments for the first time.

"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, in the agency's announcement. "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."

Who counts as a manufacturer

The rule defines an establishment as a place of business under one ownership at one general physical location that is engaged in the manufacture, preparation, compounding or processing of a tobacco product. Registration would reach specification developers, third-party manufacturers, bulk tobacco product manufacturers, and repackagers and relabelers.

That list is the sentence brands should read twice. A company that designs a product and contracts the production out is a specification developer, and the obligation attaches to it directly — outsourcing production does not move the registration duty onto the manufacturer alone.

Foreign owners and operators would have to register and submit listing information before offering a product for import. As a condition of registration, a foreign establishment would need to designate an agent who resides or maintains a place of business in the United States, agree to permit on-site FDA inspections, and provide the name and address of each known importer. The requirements would also apply to foreign establishments operating inside U.S. foreign trade zones.

One clarification matters here: registration and product listing are not marketing authorization. A product subject to premarket review remains unauthorized unless and until a marketing order is in effect, regardless of whether its maker is registered.

The product listing is where the detail lives

For each listed product, a manufacturer would report brand and sub-brand names, product category and subcategory, package type, characterizing flavor, source of nicotine and nicotine concentration, product quantity, portion size, dimensions, a UPC or other industry identifier, and the FDA-assigned Submission Tracking Number. For ENDS products specifically, the listing would also carry e-liquid volume, propylene glycol and vegetable glycerin values, wattage and battery capacity.

Several of those fields go beyond what current guidance asks of domestic manufacturers, which does not require the STN, nicotine source and concentration, characterizing flavor, or ENDS technical specifications. Linking each listing to its STN is the mechanism that matters: it lets FDA cross-reference what is listed as being on the market against its own database of premarket submissions.

Submissions would be made electronically through FDA's Tobacco Registration and Listing Module Next Generation system. Registrations would be renewed annually by December 31, and product listings reviewed and updated twice a year. Separately, manufacturers would have to retain labeling, advertising and consumer information records for each listed product while in use and for at least four years after use is discontinued.

What FDA estimates it would cost

The agency's preliminary regulatory impact analysis puts 20-year annualized total costs — across domestic establishments, foreign establishments and FDA itself — at between $6.80 million and $26.55 million at a 7 percent discount rate, with a primary estimate of $15.57 million.

The distribution is the interesting part. FDA's primary estimate assigns $0.013 million to domestic establishments, or 0.1 percent of total costs, and $0.37 million to foreign establishments, or 2.4 percent. The agency itself accounts for the remaining 97.5 percent. On FDA's own numbers, the incremental burden on an individual manufacturer is administrative rather than capital: it is recordkeeping and data hygiene, not new equipment.

What happens next

More than 200 comments had been posted to the docket as the window closed. FDA will review them as part of the rulemaking process before deciding whether to issue a final rule. Nothing in the proposal is binding today, and the agency has not committed to a timeline or to a final text.

The practical preparation is the same either way, because most of it is good manufacturing discipline regardless of what the final rule says. Brands should be able to answer, per SKU: which STN covers it, what its characterizing flavor is as it would be described to a regulator, what the nicotine source and concentration are, what the PG/VG ratio and fill volume are, and where the labeling and advertising history for that SKU is stored. Companies that already keep that information in a structured, per-SKU form have very little work to do. Companies that keep it in scattered spreadsheets and supplier emails have more.

Where Nova Manufacturing fits

Nova Manufacturing is a U.S. contract e-liquid manufacturer. We build standardized formulations with documented ingredient sourcing, run batch documentation on every production line, and produce to GMP-quality standards — which means the per-SKU data this proposal would ask for already exists in our records rather than having to be reconstructed after the fact.

If you are evaluating what a registration and listing regime would mean for your catalog, or you want a manufacturing partner whose documentation is built to be handed to a regulator, get in touch with our team to talk through your product line.