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Establishment Registration and Product Listing for Tobacco Products

Comment period closed: closed 33 days ago (Sep 14, 2026).

Summary (from the Federal Register abstract)

The Food and Drug Administration (FDA, the Agency, or we) is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. Complete and accurate establishment registration and product listing information is important to accomplish statutory, regulatory, and public health objectives. Currently, 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, creating significant gaps in Agency information. This action, if finalized, would extend registration and listing requirements to include owners and operators of foreign establishments.

Document type
Proposed Rule
Federal Register document number
2026-13047
Published
Jun 29, 2026
Action
Proposed rule.
Docket
FDA-2025-N-7130
Comments posted on Regulations.gov (at last check)
250
RIN
0910-AH59
CFR parts
21 CFR 1108
DATES section (from the document)
Either electronic or written comments on the proposed rule must be submitted by September 14, 2026.
Topics (auto-tagged)
GMP / manufacturing Tobacco

Source: Federal Register API, document 2026-13047. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.