On Sept. 4, 2025, the Trump Administration released its Spring 2025 Unified Regulatory Agenda. The document details the Administration’s regulatory plans and recent actions across the federal government in 2025. At the U.S. Food and Drug Administration (FDA), the agenda lists plans to propose regulations to prescribe the format, content and procedures for establishment registration and tobacco product listing. This Establishment Registration and Product Listing for Tobacco Products proposed rule will cover registration and listing requirements for both domestic and foreign manufacturers of tobacco products. The proposed rule defines who would be required to register and list, when they would be required to register and list, and how they would be required to register and list. It is expected to be published in May of 2026.

FDA also lists the Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products final rule will be published in October 2025. This final rule would amend 21 CFR 1.79 to add a requirement that an import filer submit the FDA premarket application number at the time of entry in the Automated Commercial Environment (ACE), operated by U.S. Customs and Border Protection, for an Electronic Nicotine Delivery Systems (ENDS) product. According to FDA, “This rule, if finalized, will allow FDA to more effectively and efficiently determine the marketing authorization status of ENDS products offered for import, and thereby enforce the premarket authorization requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act. By reducing the time spent on import entry review, this rule, if finalized, will produce cost savings for FDA. Import filers of ENDS products will face costs to learn the rule and to retrieve pre-market application numbers and enter them into ACE.”