The US FDA requires all registered tobacco manufacturers to submit product inventory change reports before June 30 and December 31, including new product launches, discontinuation of production, resumption of production, and major changes in product information. Paper forms can be submitted online or by mail through the next generation Tobacco Registration and Listing Module (TRLM NG) system.
Key points:
- Mandatory reporting frequency: June 30 and December 31 every year;
- Types of changes to be reported: new product launch, product discontinuation or resumption of production, major changes in product information
Submission method:
- Preferred: Next Generation Tobacco Registration and Listing Module (TRLM NG) online system;
- Alternative: Mailing FDA 3741/3741a form
Prohibitions: Do not submit the reported information repeatedly - Applicable to: All tobacco product manufacturers registered with the FDA
On June 24, the U.S. Food and Drug Administration (FDA) stated in a statement that registered tobacco product manufacturers must report to the FDA twice a year (June 30 and December 31) if there are certain changes in their tobacco product lists.
If a manufacturer makes any of the following changes, it must report:
- Introduced any tobacco product for commercial distribution that was not previously listed;
- Cessed the production, preparation, mixing or processing of any tobacco product for commercial distribution;
- Resumed the production, preparation, mixing or processing of any tobacco product previously listed as discontinued;
- Made significant changes to any previously submitted listing information, such as name, labeling, 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 Product Listing Module – Next Generation (TRLM NG). If applicants are unable to submit online using TRLM NG, they can mail the appropriate Registration and Product Listing PDF form (FDA Form 3741) or FDA Form 3741a to the Document Control Center at the Center for Tobacco Products (CTP).
For resources on product listing submissions, visit the Tobacco Registration and Product Listing – Next Generation (TRLM NG) Instructions page. Manufacturers can also read the Registration and Product Listing for Domestic Product Establishment Owners and Operators page for more information.
