From Interdiction to Registration: FDA Proposes Mandatory Registration for Foreign Tobacco Manufacturers

On June 26, 2026, the FDA announced that it had submitted a proposed rule to the Federal Register; it was published on June 29 (91 FR 39168, Docket No. FDA-2025-N-7130) under the title "Establishment Registration and Product Listing for Tobacco Products" (proposed 21 CFR Part 1108).

If finalized, the rule would close a structural gap of more than a decade within the existing legal framework. At present only domestic tobacco product manufacturers must register with the FDA and submit product listings; foreign manufacturers — including those exporting large volumes of e-cigarette product into the United States through various channels — are not subject to equivalent obligations until the FDA brings them within its reach by formal rulemaking. That regulatory gap is among the structural reasons so much unauthorized e-cigarette product reaches the U.S. market.

Bret Koplow, Acting Director of the FDA's Center for Tobacco Products, summarized the policy in a sentence: "All companies selling tobacco products in the United States should play by the same rules." As a matter of enforcement logic, the rule is a systematic upgrade of the FDA's regulatory approach to foreign illegal product, following the enforcement priorities guidance and flavored authorization policy of early May and the NYTS youth survey data of late June. The direction has not changed; the toolkit has moved from interdiction at the port to registration at the source.

This is a general overview and does not constitute legal advice on any particular matter.

I. The Proposed Rule

1. Who Must Register: Brand Owners and Contract Manufacturers Alike

The rule reaches owners and operators of all establishments, domestic and foreign, engaged in the "manufacture, preparation, compounding, or processing" of tobacco products. Notably, it defines "manufacturer" broadly, expressly bringing the following within the registration obligation:

• Specification developers — the brand owner or development entity that holds the product design specifications and directs the contract manufacturer;
• Third-party manufacturers — the contract factories that perform physical production for a brand owner or specification developer;
• Bulk tobacco product manufacturers — including factories producing e-liquid not in final packaging; and
• Repackagers and relabelers.

In other words, even a factory that is not the brand owner and performs only contract manufacturing must register its establishment with the FDA independently. The brand owner's and the contract manufacturer's obligations run in parallel; neither substitutes for the other.

2. What Must Be Reported: Down to Nicotine Source and E-Liquid Volume

The rule would require registrants to submit uniquely identifying information for each product manufactured. For e-cigarette products, the technical parameters that must be reported include:

• nicotine concentration and source (tobacco-derived or non-tobacco nicotine, TDN/NTN);
• characterizing flavors (menthol, tobacco, cherry, wintergreen, and so on);
• e-liquid volume, battery capacity, and wattage;
• propylene glycol to vegetable glycerin ratio (PG/VG); and
• packaging type, units per package, and the like.

Registrants must also review and update establishment registration information annually (by December 31 each year); update product listings semiannually (June and December); and retain historical records of product labeling, advertising materials, and consumer information for not less than four years.

3. Legal Consequence: Unregistered Means Misbranded, and Refusable at the Border

The rule would bring "manufactured in an establishment not duly registered" within the statutory definition of misbranding. Under existing law, a misbranded tobacco product may be refused entry and detained at a U.S. port. Once the rule takes effect, therefore, any tobacco product from a foreign establishment that has not registered would face automatic refusal at importation, without waiting for the FDA to establish a violation case by case.

4. Inspection Authority Extended to Foreign Establishments

Under the current regime, FDA inspection of foreign establishments is limited to supporting PMTA review — a passively triggered mechanism. Under §§ 905(g) and (h) of the FD&C Act, registered establishments are subject to FDA inspection; once the rule is finalized, the FDA would have clear statutory authority to schedule and conduct inspections of registered foreign establishments on its own initiative, extending the regulatory perspective systematically from the product level to the source of production.

5. Comment Period Closes September 14, 2026

The proposed rule is in its public comment period. Any organization or individual may submit written comments through regulations.gov by September 14, 2026 (Docket No. FDA-2025-N-7130). The FDA will consider the comments in deciding whether and how to revise and finalize the rule.

II. Reading the Signals: Three Practical Trends

1. From Interdiction After the Fact to Registration at the Source

For several years, the FDA's tools against foreign illegal vape product have been principally port detention and warning letters to retailers, distributors, and importers — essentially a reactive mechanism. Its limitations are evident: lacking systematic knowledge of the large population of foreign manufacturers, the FDA could only respond case by case, at high resource cost and limited coverage, with illegal product often entering faster than it could be seized.

The core value of the proposed rule is that it would build a structural, comprehensive registry of foreign manufacturers. Once finalized, every foreign manufacturer exporting tobacco product to the United States would have to report its identity, establishment address, and product technical parameters — from which the FDA would assemble a searchable, traceable, continuously updated global tobacco manufacturer registry.

Part of the reason so many manufacturers have operated at the regulatory margin for so long is that the FDA has lacked a systematic tool to make them visible. That gap would be closed: which factories are exporting to the United States, and whether their reported technical parameters match the product actually in circulation, would no longer be a blind spot.

2. "Specification Developer" Locks In Brand Owner and Contract Manufacturer Liability Together

The typical structure of the vape supply chain today is that the brand company (brand owner / specification developer) handles product design and specification development, while the OEM factory handles physical production. In past regulatory practice, some contract factories argued that they merely produce to a customer's requirements and that the brand owner bears the principal compliance obligation.

The proposed rule breaks that logic expressly: the brand owner, as specification developer, must register its development establishment; the contract factory, as third-party manufacturer, must register its production establishment independently; and the two sets of registration and listing obligations run in parallel without substitution. Even a small or mid-sized contract manufacturer therefore cannot avoid registration on the theory that the product is not its own and compliance belongs to the brand.

For Chinese companies the practical implication is this: if your factory is currently contract-manufacturing e-cigarette product for export to the United States, then regardless of whether the brand owner is a Chinese company, once the product enters the U.S. market your factory must register separately with the FDA after the rule takes effect. Supply chains with multiple outsourced production stages will need to work through each participant's registration obligation layer by layer.

3. Registration Information Becomes Public — in Effect, a Compliance Whitelist

Under proposed § 1108.60, all establishment registration and product listing information would be published on the FDA's website and available to anyone. The implications should not be underestimated.

For U.S. importers, distributors, and retailers, that means a verifiable compliance whitelist. Product from an unregistered establishment, or a lot whose technical parameters do not match the registration, would no longer require case-by-case FDA verification — importers, distributors, and retailers could check the public database directly. A U.S. buyer intent on compliance can make "registered with the FDA" a supplier screening criterion, so that a factory may lose its U.S. orders well before any enforcement action reaches it.

More significantly, the product-level technical parameters the rule would require — characterizing flavor, nicotine source, e-liquid volume, battery capacity — would form a publicly searchable product characteristics database. When U.S. Customs and Border Protection examines imported goods at the port, it can compare the actual parameters against the registered information: any lot inconsistent with what was reported would face additional exposure to a misbranding finding at the specification level. For companies accustomed to using reported parameters to obscure the actual product, that automated comparison would systematically compress the room to operate.

Closing

The signal in this proposed rule is not complicated: the regulator is building a full registry system for the foreign supply side of the U.S. vape market. Manufacturers that have operated outside that system — brand owners and contract manufacturers alike — would face clear registration obligations and clear consequences for non-compliance once it takes effect. This is not a final warning before tightening; it is the opening signal of a new regulatory era.

References: U.S. Food and Drug Administration, "FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health" (June 26, 2026); Federal Register, "Establishment Registration and Product Listing for Tobacco Products," 91 FR 39168, Docket No. FDA-2025-N-7130 (June 29, 2026).

This article addresses general legal questions only and does not constitute legal advice on any specific matter.