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Data / Federal rules / 2026-13047

Establishment Registration and Product Listing for Tobacco Products

The Food and Drug Administration published this proposed rule in the Federal Register on June 29, 2026. Comments closed on September 14, 2026.

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What the agency says

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.

Key facts

Document number
2026-13047
Type
Proposed rule
Action
Proposed rule
Agency
Health and Human Services Department; Food and Drug Administration
Published
June 29, 2026
Comments due
September 14, 2026
Dates
Either electronic or written comments on the proposed rule must be submitted by September 14, 2026.
Docket
Docket No. FDA-2025-N-7130
Regulation ID (RIN)
0910-AH59
Code of Federal Regulations
21 CFR 1108
Significant
Yes, under Executive Order 12866
Pages
36

The document on federalregister.gov PDF

Other documents from the Food and Drug Administration

Everything from the Food and Drug Administration · Published in June 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.