← REGULATORY CHANGES
FEDERAL REGISTER · PROPOSED RULEJune 29, 2026PROPOSED — NOT IN FORCE

Establishment Registration and Product Listing for Tobacco Products

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE
PROPOSED EFFECTIVE—
COMMENTS CLOSESep 14, 2026 · closed
APPLIES TO · SPEQ TAGNot tagged
Document type
Proposed Rule
Agency
Health and Human Services Department
Published
June 29, 2026
Comments close
September 14, 2026
Document number
2026-13047
CFR references
21 CFR 1108
Docket
FDA-2025-N-7130
RIN
0910-AH59
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.

Abstract as published in the Federal Register.

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