The U.S. Food and Drug Administration on Sept. 28 launched a redesigned Form FDA 3741 that consolidates establishment registration and product listing submissions for all regulated tobacco product categories, including cigarettes, e-cigarettes, smokeless tobacco, heated tobacco products, and oral nicotine products such as nicotine pouches. The change replaces two previously separate forms, Form FDA 3741 and Form FDA 3741a, and is intended to simplify the process for manufacturers by eliminating the need to determine which form applies to different product categories.
The redesigned form includes a submission checklist that directs manufacturers to the sections relevant to their filing and allows companies updating existing registrations to change specific information without resubmitting unchanged sections. The FDA is also encouraging manufacturers to use the new Form FDA 3741b spreadsheet for initial product-list submissions or additions to existing product lists. Domestic tobacco product manufacturers must submit annual establishment registrations by Dec. 31, while product listings are due June 30 and Dec. 31 when manufacturers have made certain changes to their products or manufacturing operations.
The FDA said manufacturers should submit the redesigned Form FDA 3741 electronically through its Tobacco Registration and Listing Module Next Generation (TRLM NG) system, although paper submissions remain available for companies unable to file electronically. Existing registrations and product listings will remain in TRLM NG, and manufacturers do not need to resubmit their entire registration because of the change. The previous versions of Forms FDA 3741 and 3741a have been retired, with existing TRLM NG users receiving prompts to update registration and product-listing information using the new format.
