Establishment Registration and Product Listing for Tobacco Products Preliminary Regulatory Impact Analysis (Proposed Rule)

This proposed rule prescribes 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.

While the specific benefits are difficult to quantify, having complete and accurate tobacco product establishment registration and product listing information for both domestic and foreign establishments can help FDA accomplish several important statutory, regulatory, and public health objectives. We quantify costs to be incurred by both domestic and foreign establishments from the time used to enter and submit their registration and tobacco product listing information and also from the time it takes for their managers to accompany FDA inspections. The 20-year annualized total costs to domestic and foreign establishments and FDA range from $6.80 million to $26.55 million at a 7 percent discount rate, with a primary estimate of $15.57 million. 

Regulatory Impact Analysis 

Establishment Registration and Product Listing for Tobacco Products Preliminary Regulatory Impact Analysis (Proposed Rule) – PRIA (PDF 578 KB) 

Federal Register: 91 FR 39168
Publication Date: 06/29/2026 
Docket: FDA-2025-N-7130