By CBDINSTOCK MEDIA TEAM | September 23, 2026
A U.S. brand writes the specifications for a nicotine vape. A factory in Shenzhen builds it. Under the Food and Drug Administration’s reading of federal tobacco law, both would count as manufacturers: one as the specification developer, the other as a third-party manufacturer.
FDA uses nearly the same example in a proposal that would require covered foreign tobacco-product establishments to register and list their products before those products are imported or offered for import into the United States.
The comment period closed September 14. No final rule has been published, and no new foreign-registration deadline is in effect. If FDA finalizes the proposal, the product listing could tie a specific nicotine-vape SKU, and the establishment that made it, to records FDA already holds from premarket submissions.
The proposal would put foreign factories into the registration system
Domestic tobacco-product manufacturers already register their establishments and list their products. FDA’s June 29 proposal would prescribe a new 21 CFR Part 1108 and extend the process to covered foreign establishments.
A foreign owner or operator would have to register and submit product-listing information before a tobacco product made or processed at the establishment is imported or offered for import. Registration would be confirmed by December 31 each year, even when nothing changed. Product listings would be reviewed and updated—or confirmed unchanged—in June and December.
The proposed registration record would include the establishment, owner and operator, trade names, tobacco-related website addresses and an official correspondent. That correspondent would send the required information and serve as the liaison with FDA. The designation would not shift liability away from an owner, operator or another person.
Registered foreign establishments would also be subject to FDA inspection under section 905, as domestic registrants already are. FDA’s announcement says the rule would support on-site inspections abroad; the preamble says the agency currently inspects foreign tobacco establishments only to support premarket tobacco product application (PMTA) review.
FDA proposes that a future final rule take effect 60 days after it is published in the Federal Register.
Whoever writes the specification may count as a manufacturer
FDA’s proposed definition of “manufacturer” covers any person who manufactures, prepares, compounds or processes a tobacco product, including by repackaging or relabeling.
The agency states that this includes specification developers, third-party manufacturers (a category that covers contract manufacturers), bulk manufacturers, repackagers and relabelers. FDA also notes a specification developer’s establishment is the place where the specifications are developed.
In an OEM arrangement, that can mean two sites: a U.S. brand office that develops the specification and an overseas factory that performs contract manufacturing. The proposal would require a product listing to identify the operations or processes performed at an establishment, with specification development and contract manufacturing among FDA’s examples.
The proposal carves out common carriers moving product in the ordinary course, companies that make only non-tobacco raw materials used in a component or part, and operations making investigational products only. A supplier that makes a finished component, or a warehouse that relabels or repackages, is not within those carve-outs.
The listing looks like a regulated specification record
Proposed § 1108.24 would require each product listing to carry the registrant’s FDA registration number and the name of each establishment, so FDA can tell which of a registrant’s sites makes the product. It would also require the commercial name, product category and subcategory, packaging information, identifiers and—as applicable—technical properties.
The fields are not identical for every ENDS subcategory. FDA’s illustrative table assigns a closed e-cigarette a broader set of properties than an open device or an ENDS component. An open e-cigarette example includes length, diameter, e-liquid volume, nicotine source, wattage and battery capacity. The component example—FDA uses a coil—has a shorter set plus any additional property needed to identify it uniquely.
The proposed rule also calls for a UPC. When one is unavailable, the manufacturer would provide another industry identifier and identify its type, such as a SKU, item number or catalog number. It would also require an FDA-assigned Tobacco Product Number for an update to an earlier listing, plus any FDA-assigned Submission Tracking Number or Product Identification Number.
The practical question for hardware teams comes first: can the same SKU be described consistently in the factory’s specification system, the brand’s catalog, the packaging identifier and the premarket record?
FDA states that the identifying properties would support a 1:1 comparison linking products across submissions, including ingredient listings, harmful and potentially harmful constituent listings, and premarket orders. In the proposed system, a wattage or battery-capacity entry is one way the agency would tell one product from another.
FDA asked about supply-chain contacts but did not propose them
The notice also shows what FDA has not decided. The agency asked whether registrations should carry contact information for an establishment’s brand owners, direct accounts, importers and consignees, and specification developers.
None of those fields appears in the proposed text as a requirement. FDA only requested comment on them. Their presence in the notice shows the agency is considering a wider record.
FDA must review the public docket before deciding whether to issue, revise or abandon a final rule.
Registration would not authorize a product for sale
Proposed § 1108.20 states the distinction directly: registration and listing would not mean FDA agreed that an item is a tobacco product, and would not provide marketing authorization.
A new tobacco product that requires authorization under section 910 would still need an FDA marketing authorization order, such as a PMTA marketing granted order or a substantial-equivalence order. A registration number is not an approval, and a listing is not an authorization. Marketing that suggests otherwise would misstate what the system does.
Proposed § 1108.62 says a tobacco product is misbranded if it was made in an establishment not duly registered, including under section 905(h), or if it was left off a required product list. The foreign-establishment provisions are designed to help FDA determine whether imported products should be refused admission under section 801(a).
Empty universal hardware leaves an intended-use question
The rule would reach products that meet the federal tobacco-product definition, which covers products containing nicotine from any source, along with their components and parts. The proposed component definition covers software or assembled materials “intended or reasonably expected” to affect a tobacco product’s performance or characteristics, or to be used with or for the human consumption of a tobacco product. FDA states that definition is consistent with its 2023 registration guidance.
That makes universal hardware harder to classify from a label alone. An empty 510 cartridge marketed for cannabis oil is not automatically a nicotine ENDS product. A cannabis label does not settle the question on its own if the same SKU is also sold for, or reasonably expected to be used with, nicotine e-liquid.
The question is especially concrete at a dual-line factory that makes nicotine devices and cannabis-oil hardware on the same campus. Under the proposed definition, buildings on one campus under the same management would be one establishment; buildings under different management would register separately. The relevant facts can include who developed the specification, where each process occurs, how the SKU is labeled and sold, and how it is reasonably expected to be used.
The proposal itself says that listing a borderline item would not constitute an admission that it is a tobacco product. It also does not say that omitting an item settles the scope question. Businesses with dual-use facts need product-specific legal analysis rather than a category-wide answer.
What teams can verify while FDA reviews the docket
There is no filing to make under this proposal today. There are records that manufacturers, brands and importers can test before a final rule appears:
- Who developed the specification, and at which physical location?
- Which establishment performs assembly, filling, relabeling, repackaging or contract manufacturing?
- Does the SKU master hold the identifiers and subcategory-specific properties FDA listed?
- Do the catalog, website, packaging and import descriptions tell a consistent intended-use story?
- If a product has an FDA submission number, is it attached only to the exact configuration it covers?
Until the agency publishes a final rule, the June notice remains a proposal. The supply-chain contact fields FDA asked about and the uniquely identifying properties it sought comment on for ENDS can still change.
CBDINSTOCK is affiliated with ILEVA, a supplier of empty 510 cartridges and all-in-one hardware to cannabis-oil manufacturers and brands. This article reports and analyzes public records; it is not legal advice.
