Key Points:
·Mandatory reporting frequency: June 30th and December 31st every year.
·Types of changes to report: new product launch, product discontinued or resumed, significant changes in product information.
Submission method:
·Preferred: Tobacco Registration and Listing Module for the Next Generation (TRLM NG) online system;
·Alternate option: Mail the FDA 3741/3741a form.
Prohibited actions: Do not submit duplicate information that has already been reported.
Target audience: All tobacco product manufacturers registered with the FDA.
On June 24, the U.S. Food and Drug Administration (FDA) stated that registered tobacco product manufacturers must report any changes in their tobacco product lists twice a year (June 30 and December 31) to the FDA.
Any changes made by the manufacturer must be reported.
·Introduced any tobacco products for commercial distribution that were not previously included on the list;
·Ceased production, preparation, blending, or processing of any tobacco products for commercial distribution;
·Resumed production, preparation, blending, or processing of any tobacco products previously listed as discontinued;
·Made significant changes to any previously submitted listing information, such as name, label, consumer information, or advertising changes.
·Information previously submitted to the FDA should not be resubmitted.
Updates can be submitted using the new Tobacco Registration and Listing Module Next Generation (TRLM NG). If applicants are unable to submit online using TRLM NG, they can mail the corresponding registration and listing PDF forms (FDA Form 3741 or FDA Form 3741a) to the Document Control Center at the Center for Tobacco Products (CTP).
For resources related to submitting a product list, please visit the Tobacco Registration and Listing - Next Generation (TRLM NG) information page. Manufacturers can also refer to the Registration and Product Listing page for domestic product owners and operators to learn more.
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