Key Points
- Import enforcement: FDA’s proposed rule could strengthen oversight of unauthorized imported e-cigarettes and the foreign supply chains behind them.
- Foreign manufacturers: Chinese OEM/ODM factories, specification developers, brand owners and certain component-related companies may need to reassess their regulatory roles.
- Not market authorization: Establishment registration and product listing would not make unauthorized ENDS products legal in the U.S. market.
- Data readiness: Companies should prepare product-level data, including SKU information, nicotine source, product specifications, identifiers and FDA submission status.
- Timeline: The rule remains proposed, with public comments due Sept. 14, 2026, but manufacturers and distributors should not wait for a final rule to begin preparing.
2Firsts
June 29, 2026
A proposed FDA rule requiring foreign tobacco manufacturers to register establishments and list products could give the agency greater visibility into unauthorized imported e-cigarettes and the supply chains behind them, Keller and Heckman LLP partner Azim Chowdhury told 2Firsts.
Chowdhury, a Washington, D.C.-based attorney who focuses on FDA tobacco and vapor regulation, said the proposal should not be viewed as a routine filing requirement, but as part of FDA’s import enforcement, inspection and market surveillance strategy.
The U.S. Food and Drug Administration announced the proposed rule on June 26. The proposal, titled “Establishment Registration and Product Listing for Tobacco Products,” would extend registration and product listing obligations to foreign establishments that manufacture, prepare, compound or process tobacco products for import or offer for import into the United States.
FDA said the proposal would help identify illegal foreign tobacco products, including unauthorized e-cigarettes, and support on-site inspections of manufacturing facilities outside the United States.
Closing a Regulatory Gap
Chowdhury traced the gap to Section 905 of the Tobacco Control Act. The provision already requires U.S. domestic tobacco product manufacturing establishments to register with FDA and list their products, while Section 905(h) contemplated foreign-establishment registration only under regulations issued by FDA.
Because FDA had not issued those implementing regulations, foreign tobacco product manufacturers were not subject to the same registration and product listing obligations as domestic manufacturers.
“The proposed rule is best understood as FDA finally moving to close a gap that has existed since Congress enacted the Tobacco Control Act,” Chowdhury said.
For overseas manufacturers, including Chinese e-cigarette manufacturers and supply-chain companies, the proposal could mark a shift in how FDA sees foreign-made products entering the U.S. market. Rather than focusing only on imported products or U.S.-facing brands, the proposal would give the agency clearer information about the establishments and entities behind those products.
An Enforcement-Oriented Proposal
The enforcement context is central to the proposal, Chowdhury said. FDA has been increasingly focused on imported unauthorized electronic nicotine delivery system products, including disposable ENDS, amid broader concerns over the agency’s limited visibility into who manufactures those products, where they are made and which specific products are being imported.
“In that sense, this is not just a paperwork rule. It is an import enforcement, inspection, and market surveillance rule,” Chowdhury said.
According to Chowdhury, FDA wants a more complete database of foreign manufacturers and the products they make for the U.S. market, so that products found at the border or in the marketplace can be connected back to specific establishments.
That could matter for both U.S. distributors and foreign suppliers. If finalized, the rule could make supplier identity, establishment registration, product listing status, product identifiers and FDA marketing authorization information more important in commercial due diligence.
Chowdhury also noted that FDA has not yet finalized its separate Tobacco Product Manufacturing Practice rule, which was proposed in March 2023. FDA’s current rules page continues to list that TPMP rule as proposed, while separately listing the new registration and listing proposal dated June 29, 2026.
Registration Does Not Equal Authorization
Addressing parallels to FDA’s existing registration and listing frameworks, including the drug framework under 21 CFR Part 207, Chowdhury said the comparison is fair, particularly with respect to drugs.
FDA states in the proposal that parts of the tobacco rule are consistent with the drug establishment registration and listing framework in 21 CFR Part 207, including initial registration timing for foreign establishments and the principle that domestic and foreign establishments should be subject to similar registration and listing requirements.
But Chowdhury cautioned against over-reading the comparison. Part 207 applies to drugs. The closer medical device analogue is 21 CFR Part 807, under which device establishments register annually and list devices. The device framework also includes U.S. agent requirements for foreign establishments, while the tobacco proposal uses an “official correspondent” concept to facilitate communications with FDA and potentially coordinate matters involving foreign inspections.
Chowdhury said registration and listing are foundational tools FDA uses across regulated product categories to understand who is making regulated products, where they are made and what products are in commercial distribution. But tobacco products are not evaluated under the same standard as drugs or medical devices. Drugs and devices are generally assessed under a “safe and effective” standard, while new tobacco products are regulated under a population-level public health standard, known as “appropriate for the protection of the public health,” or APPH.
The distinction is especially important for ENDS companies: registration and listing do not equal marketing authorization.
“A foreign ENDS manufacturer could register and list a product, but if the product lacks the required FDA marketing authorization, registration does not cure that problem,” Chowdhury said.
In that situation, listing could give FDA more visibility into unauthorized products and the supply chains behind them, he added.
Lessons From Chinese Medical Device Compliance
Chowdhury said Chinese e-cigarette manufacturers can draw lessons from Chinese medical device companies’ experience with FDA registration, listing, inspections and U.S. compliance obligations.
A central lesson is that FDA registration should not be treated as a certificate of approval or a market access license. Chinese medical device companies have long had to understand that FDA establishment registration and device listing do not, by themselves, mean that a device is approved, cleared or otherwise legally marketable in the United States. The tobacco proposal adopts the same principle.
Registration and listing also become part of an ongoing compliance system rather than a one-time form. FDA relies on such information for inspections, postmarket surveillance, recalls and other regulatory programs.
Drawing parallels to FDA-regulated medical device and drug sectors, Chowdhury said foreign companies selling into the U.S. market should be prepared for FDA communications, document requests, English-language records or translations, and potentially on-site inspections.
The proposal would require foreign establishments to designate an official correspondent to help facilitate communications among the establishment, the foreign government and FDA. FDA also ties foreign registration to adequate and effective means to determine whether products should be refused entry, including document review, photographs, samples, labeling and other information.
Role clarity will also be important. Chinese ENDS companies often operate through OEM, ODM, private-label, brand-owner, trading-company and distributor structures. Chowdhury said FDA will not look only at the brand on the package. It will ask who owns or operates the establishment, who developed the specifications, who manufactured, compounded, processed, repackaged or relabeled the product, and which product identifiers and FDA submission tracking numbers apply.
The proposed rule expressly includes specification developers, third-party manufacturers and bulk manufacturers within the manufacturing framework.
Timeline and Preparations
The immediate date to watch is the comment deadline. FDA says comments are due Sept. 14, 2026. After that, FDA must review comments and issue a final rule before any new requirements become legally operative.
Chowdhury said there is no guaranteed timeline for a final rule. It could take a year or more, depending on the volume and substance of comments. The final rule could also differ from the proposal, and legal challenges could arise later.
Still, he said foreign manufacturers and U.S. distributors should not wait until a final rule is published to begin preparing.
If the final rule follows the proposal, companies may need to collect establishment information, designate responsible contacts, gather product-specific data, assemble labeling and advertising records, and coordinate with U.S. importers within a short period. FDA also proposes annual registration by Dec. 31 and product listing updates in June and December.
For Chinese e-cigarette supply-chain companies, Chowdhury advised starting with a regulatory mapping exercise. Companies should identify each entity in the chain and determine whether it acts as an owner, operator, OEM manufacturer, ODM manufacturer, specification developer, brand owner, repacker, relabeler, importer, distributor or component supplier.
Companies should also build product data files for each SKU or product configuration intended for the U.S. market, including brand and subbrand, product category, package type, characterizing flavor, nicotine source and concentration, e-liquid volume, PG/VG values, wattage, battery capacity, product identifiers, FDA submission tracking numbers and the operations performed at each establishment.
They should also audit their U.S. market authorization status. Registration and listing would not make an unauthorized ENDS product legal. For products subject to premarket tobacco product application requirements, companies still need to determine whether there is an FDA marketing authorization order or another valid marketing pathway.
For U.S. distributors, the proposal could make supplier qualification a more formal part of regulatory risk management. Chowdhury said distributors should require foreign suppliers to identify the responsible establishment, confirm who will submit registration and product listing information, provide product identifiers, disclose applicable PMTA or other FDA submission status, and agree contractually to cooperate with FDA communications, records requests and inspections.
Component suppliers should not assume they are automatically outside the rule. Some raw material suppliers may be exempt, but companies involved in components, parts, specification development, repackaging, relabeling or finished-product activities need a more careful analysis.
If finalized, the proposal would make the foreign ENDS supply chain more visible to FDA and U.S. enforcement authorities.
FDA is accepting public comments on the proposal through Sept. 14, 2026. The rule has not been finalized.
2Firsts will continue to follow the rulemaking process and its implications for global ENDS manufacturers, brand owners, importers and distributors.
Cover image generated by AI.
