On June 24th, the U.S. Food and Drug Administration (FDA) stated in a declaration that registered tobacco product manufacturers must report to the FDA twice a year (on June 30th and December 31st) whether there are any changes in their tobacco product list.
If the manufacturer makes any of the following changes, it must be reported:
Any tobacco products for commercial distribution that were not previously included in the list have been introduced;
Cease the production, preparation, mixing or processing of any tobacco products for commercial distribution;
Resume the production, preparation, blending or processing of any tobacco products that were previously listed as discontinued;
Any major changes have been made to the previously submitted list information, such as names, labels, consumer information or advertising changes.
The information previously submitted to the FDA should not be resubmitted.
Updates can be submitted using the new “Next Generation Tobacco Registration and Listing Module (TRLM NG)”. If the applicant is unable to submit online using TRLM NG, the corresponding registration and list PDF forms (FDA Form 3741) or FDA Form 3741a can be mailed to the Document Control Center of the Tobacco Products Center (CTP).
For resources related to the submission of the product list, please visit the Tobacco Registration and Product List – Next Generation (TRLM NG) instructions page. Manufacturers can also read the registration and product list pages of domestic product enterprise owners and operators to learn more information.