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Proposed rule

Establishment Registration and Product Listing for Tobacco Products

Built by the Tribune's code from the Federal Register. No AI wrote this page. Published in the Federal Register June 29, 2026. Document 2026-13047. Updated Nov. 9, 2026.

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What it would change

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 1108

Before this

No earlier Federal Register document under regulation identifier 0910-AH59 since Jan. 1, 2025.

What happens next and when

Either electronic or written comments on the proposed rule must be submitted by September 14, 2026.

The agency's dates, word for word.

Document number2026-13047
ActionProposed rule.
AgenciesHealth and Human Services Department; Food and Drug Administration
PublishedJune 29, 2026
Comments closeSept. 14, 2026
Regulation identifier (RIN)0910-AH59
DocketFDA-2025-N-7130
Significant (marked in the Federal Register)Yes

Source: the Federal Register (public domain). The document in the Federal Register