FDA Updates Tobacco Product Establishment Registration and Product Listing Form to Increase Efficiency
Sept. 29, 2026
On Sept. 28, the U.S. Food and Drug Administration (FDA) launched a redesigned form that streamlines industry submissions for tobacco product establishment registration and product listing. As part of the agency’s ongoing efforts to increase efficiency and improve regulatory processes, the FDA consolidated two previously separate forms for different categories of tobacco products into a single form.
By Dec. 31 of each year, all domestic tobacco product manufacturers are required to submit their annual establishment registration with the FDA. Twice each year—by June 30 and Dec. 31—those same manufacturers are required to submit their product listings if they have made certain changes.
To make these submissions, manufacturers previously were required to use Form FDA 3741 (PDF – 2MB) for certain tobacco products such as cigarettes and smokeless tobacco and Form FDA 3741a for deemed tobacco products such as e-cigarettes and nicotine pouches. The redesigned Form FDA 3741 (PDF – 2MB) now covers all regulated tobacco product categories, including cigarettes, e-cigarettes, smokeless tobacco, heated tobacco products, and oral nicotine products, such as nicotine pouches. This update simplifies the process for manufacturers by eliminating the need to determine the applicable form or completing separate submissions for different types of tobacco products.
The updated Form FDA 3741 also features a submission checklist that guides users through only the sections relevant to their submission, making the process faster and more efficient. For manufacturers who need to update existing registrations, the redesigned form allows users to update specific types of information without resubmitting unchanged sections. The FDA also encourages use of a new Form FDA 3741b (XLSX – 3MB) for initial product list submissions or adding new products to existing product lists.
The FDA strongly encourages all establishments to submit the redesigned form electronically through the Tobacco Registration and Listing Module Next Generation (TRLM NG) system. Electronic submission is the fastest, most efficient way to register establishments and list tobacco products. Manufacturers unable to submit electronically through TRLM NG may complete a paper version of the updated Form FDA 3741 and mail it to CTP’s Document Control Center. Form FDA 3741b can also be printed or saved to a USB flash drive or DVD and mailed to the FDA.
Previously submitted registrations and product listings remain in TRLM NG. Manufacturers are not required to resubmit their entire registration as a result of this change and will use the redesigned form when completing their annual registration. For existing TRLM NG users, the system will provide prompts for updating existing registration and product listing information to align with the new Form FDA 3741. The previous versions of Forms FDA 3741 and 3741a have been retired.