Two things changed in FDA's establishment registration and product listing system this year, and they have very different legal weight. One is a proposed rule published on June 29, 2026 that would, for the first time, require foreign establishments to register with FDA and list the products they send to the US. The other is a redesigned Form FDA 3741 that FDA launched on September 28, 2026, which every domestic manufacturer will use for the annual registration due by December 31.
The first is a proposal and creates no obligation until a final rule takes effect. The second is a form, live today, for requirements the statute already imposes. For a pouch or e-liquid manufacturer, and for the people who buy nicotine for one, the useful work is the same either way: know which sites in your supply chain would be caught, and know what data the form asks you to hold about each product. This post sets out what each change actually says, where the rule is silent about nicotine ingredient suppliers, and what to ask your suppliers before year end. Every source cited here was checked on October 1, 2026.
Two Changes With Two Different Legal Statuses
The proposal is titled "Establishment Registration and Product Listing for Tobacco Products" and appears at 91 FR 39168, Docket No. FDA-2025-N-7130. It would create a new 21 CFR Part 1108, and its comment period closed on September 14, 2026. As of October 1, 2026 the Federal Register lists no final rule under this RIN, 0910-AH59, so everything in the next section describes what FDA has proposed, not what the law requires.
Today the gap is real. In the proposal's own words, "only domestic owners and operators are required to register their establishments and list their tobacco products with FDA while foreign owners and operators are not subject to these requirements." The statute has always contemplated foreign registration, but section 905(h) of the FD&C Act makes it depend on regulations that FDA has not yet issued.
The form is different in kind. FDA's announcement says the redesigned Form FDA 3741 "now covers all regulated tobacco product categories," including oral nicotine products such as nicotine pouches, and that "the previous versions of Forms FDA 3741 and 3741a have been retired." Before it, pouch and e-cigarette makers filed on Form 3741a, which FDA describes as the form "for deemed tobacco products such as e-cigarettes and nicotine pouches." The redesign changes how domestic manufacturers file, not who has to.
What the Proposed Rule Would Require of Foreign Sites
Under the proposed rule, any foreign establishment that manufactures, prepares, compounds or processes a tobacco product imported or offered for import into the US would have to register and list it. The timing is strict: a foreign site would have to register "before any tobacco product manufactured, prepared, compounded, or processed at the establishment is imported or offered for import" (proposed 21 CFR 1108.22).
The definition of manufacturer is broad. The proposal names specification developers, third-party manufacturers (including contract manufacturers), bulk tobacco product manufacturers and repackagers or relabelers. Because specification developers are named alongside contract manufacturers, a US brand owner that has its pouches made abroad should expect the contract site to be covered, not only its own establishment.
The registration data is specific. The proposal would require:
- the establishment's name, physical address and contact details, plus its owner and operator
- an official correspondent who, for a foreign site, "shall facilitate communication among the foreign establishment, the government of such foreign country, and representatives of FDA"
- an FDA Establishment Identifier (FEI), which FDA assigns if the site has none, with a DUNS number optional
- every submission in English, and for any labeling, advertising or consumer information disseminated in the US in another language, an English translation with a signed certification that it is accurate
- for each listed product, a Universal Product Code or, if none exists, an alternative identifier such as a SKU
Two things are absent. The proposed text contains no requirement to appoint a US agent; it only allows an owner to authorize a third party to register on its behalf. It also does not require importer or consignee details. FDA only asks for comments on whether it should.
If the rule is finalized as proposed, it would take effect 60 days after the final rule publishes in the Federal Register. FDA's paperwork estimate in the proposal assumes 3,253 foreign tobacco establishments would file an initial registration. That figure is FDA's estimate across all tobacco products, not a count of nicotine suppliers, and the proposal does not break it down by product type.
Where Nicotine and Nicotine Salt Suppliers Fall Is Not Settled
This is the question an ingredient buyer actually needs answered, and the proposal does not answer it. Nowhere in the proposed rule does FDA say whether a facility that makes only nicotine, a nicotine salt or a nicotine concentrate for sale to other manufacturers must register. Three parts of the text pull in different directions.
First, the definition of a tobacco product reaches anything "containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)" (proposed 21 CFR 1108.3). Second, the proposal treats a "bulk tobacco product" as one that is not in final packaging but is otherwise suitable for consumer use, and its preamble gives bulk e-liquid as an example because it needs only packaging and labeling. A site that blends finished e-liquid in bulk for a US filler is therefore squarely inside the proposal.
Third, the proposal exempts "manufacturers of only raw materials, other than tobacco, used in manufacturing a component or part," and illustrates that with unprocessed acacia gum, titanium dioxide and acetate tow. None of those examples contains nicotine, so they say nothing about a nicotine supplier.
FDA's existing compliance policy adds a further layer. Its 2023 registration and listing guidance, which is nonbinding, says FDA does not "at this time, intend to enforce these requirements with respect to products that are sold or distributed solely for further manufacturing." The proposed rule neither repeats that policy nor withdraws it.
Our reading, and it is only a reading: the status of an upstream nicotine producer under a final rule is open, and a buyer should not plan on either answer. What is not open is that the finished-product manufacturer, and any foreign contract site making a finished or bulk product for it, would be covered. That is where the mapping work starts. If you have not yet traced your nicotine back to the site that made it, our guide to nicotine traceability from seed to shipment covers the documents that make that possible.
What the Consolidated Form 3741 Asks For on December 31
For domestic manufacturers nothing about the deadlines has changed. FDA's registration and listing page gives December 31 for annual establishment registration and June 30 and December 31 for product listing updates, and says submissions "must be received by the FDA no later than" those dates. The underlying duty comes from section 905 of the FD&C Act, not from the form.
What changes is the paperwork. FDA says previously submitted registrations and listings "remain in TRLM NG," manufacturers do not have to resubmit their entire registration, and the system "will provide prompts for updating existing registration and product listing information to align with the new Form FDA 3741." For a registrant already in TRLM NG, the December 31, 2026 annual registration is therefore the first one completed on the new form.
The product section of the redesigned Form FDA 3741 says every listed product must have a UPC, a category and subcategory, package type, characterizing flavor, a way to quantify the product, a nicotine source and, where applicable, a nicotine concentration. The Form FDA 3741b product spreadsheet turns those into columns. For our audience, three of them matter:
- Intent of Use, with the options "Consumer Use" and "For Further Manufacturing" (Form FDA 3741b)
- Nicotine Source, with the options tobacco-derived (TDN), non-tobacco (NTN), both or none (Form FDA 3741b)
- Product Subcategory, which now includes "Nicotine Pouch" under oral nicotine products (Form FDA 3741b)
Neither form asks for an ingredient list or the name of an ingredient supplier. Ingredient listing is a separate submission, and the proposed rule states that ingredient listing under Form FDA 3742 is not part of it. The nicotine source field is the one place where your choice of nicotine shows up directly in a listing, so the source declared on your supplier's documentation has to match what you file.
What to Ask Your Suppliers Before Year End
None of the following is a legal requirement for your supplier today. Each item maps to a field on the live Form FDA 3741 or in the proposed rule, which is why it is worth having on file before a final rule arrives rather than after.
- Every manufacturing site, by address and owner. The proposal treats an establishment as one place of business under one ownership at one general physical location, so plants at different addresses are separate establishments, and so are buildings on one site run by different owners.
- Owner and operator, if they differ. Both the form and the proposal ask for each separately.
- FEI and DUNS numbers, if any. An FEI is assigned by FDA, so a supplier that has never dealt with FDA will not have one.
- Which operations each site performs. The form's own list includes contract manufacturing, co-packing, e-liquid production, e-liquid filling and testing.
- Whether the material is sold for further manufacturing or is a bulk product. The proposal's bulk tobacco product definition and the 2023 guidance's policy on products sold solely for further manufacturing both turn on that distinction.
- The nicotine source classification. Tobacco-derived or non-tobacco, matching the certificate of analysis.
- A named official correspondent. The proposal would require every registrant to designate one, and because all submissions would have to be in English, a foreign site needs someone who can handle FDA correspondence in English.
One caution when you read the answers. A registration is not an endorsement, and the form itself states that registration "does not denote FDA authorization for the marketing of tobacco products." Under the proposed rule, presenting a registered establishment as FDA-approved would itself be misbranding. Failing to register or list where the law requires it is also misbranding under section 903(a)(6) of the FD&C Act, which is why the finished-product manufacturer cannot leave these questions to the supplier.
Our post on FDA's enforcement priorities guidance covers the documentation questions that sit alongside these. If you are reviewing nicotine suppliers against this list, you can request documentation or a quote for the grade you are qualifying and ask for these answers alongside it.
Frequently Asked Questions
Do foreign nicotine pouch manufacturers have to register with FDA today?
No. Foreign establishments are not currently required to register or list, because section 905(h) of the FD&C Act makes their registration depend on regulations FDA has not yet finalized. FDA's proposed rule of June 29, 2026 would change that, but it is still a proposal.
When would FDA's foreign establishment registration rule take effect?
Only after FDA publishes a final rule, which had not happened as of October 1, 2026. The proposal says a final rule would take effect 60 days after it publishes in the Federal Register, and that a foreign site would have to register before its products are imported or offered for import.
Would a supplier that only makes nicotine or nicotine salts have to register?
The proposed rule does not say. It covers bulk products such as bulk e-liquid, and its exemption for raw materials uses examples that contain no nicotine. FDA's 2023 guidance says FDA does not currently intend to enforce registration for products sold solely for further manufacturing, and the proposal neither repeats nor withdraws that policy.
What changed on Form FDA 3741 for the December 31, 2026 registration?
One form now covers every tobacco product category. FDA retired Form 3741a, which pouch and e-liquid makers used before, when it launched the redesigned Form FDA 3741 on September 28, 2026. Existing data stays in TRLM NG, and the system prompts registrants to update it rather than resubmit everything.