Twice every year – by June 30 and Dec. 31 – registered tobacco product manufacturers are required to report to the U.S. Food and Drug Administration their tobacco product listings if they have made certain changes, the FDA reminded in a statement.
If a manufacturer made any of the following changes, they must be reported:
- Introduced any tobacco products for commercial distribution that were not included in a previous listing;
- Discontinued manufacturing, preparation, compounding, or processing any tobacco products for commercial distribution;
- Resumed manufacturing, preparation, compounding, or processing any tobacco products previously listed as discontinued; or
- Made any required or voluntary material change to any listing information previously submitted, such as a name, labeling, consumer information, or advertisement changes.
Information previously submitted to FDA should not be resubmitted.
Updates can be submitted using the new “Tobacco Registration and Listing Module Next Generation (TRLM NG).” If you are unable to submit online using TRLM NG, you can mail the appropriate Registration & Listing PDF form (FDA Form 3741) or, for deemed establishments, (FDA Form 3741a) to CTP’s Document Control Center.
For resources on product listing submissions, go to the Tobacco Registration and Product Listing – Next Generation (TRLM NG) Instructions page. Manufacturers can also read the Registration and Product Listing for Owners and Operators of Domestic Product Establishments page for more information.
