# Establishment Registration and Product Listing for Tobacco Products

**Action Urgency Score:** 45/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Proposed rule. |
| Published | 2026-06-29 |
| Comments close | 2026-09-14 |
| Significant | Yes (EO 12866) |
| CFR parts | 21 CFR 1108 |
| Summary | 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 info |
| Document number | 2026-13047 |

## Why this score
- Significant rule under EO 12866.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/06/29/2026-13047/establishment-registration-and-product-listing-for-tobacco-products). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.