The U.S. Food and Drug Administration (FDA) recently released an updated module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” to its FDA Unified Registration and Listing (FURLS) Tobacco Registration and Listing Module (TRLM) (FURLS TRLM). TRLM NG was developed to better assist industry stakeholders submitting information and to improve system usability.
Section 905(b) of the Family Smoking Prevention and Tobacco Control Act requires the owners and operators of domestic establishments that manufacture, prepare, compound, or process finished tobacco products[i], including deemed tobacco products, to register with FDA and submit product listings. Here, the phrase “manufacture, preparation, compounding, or processing” includes repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product. U.S. tobacco product importers do not register with FDA unless they are also engaged in a manufacturing activity in the United States.
Registered tobacco manufacturers are required to register and/or renew annually with FDA by December 31 each year through TRLM NG module or by paper submission. Changes to product lists to reflect new products being manufactured, products no longer being manufactured, or changes to labeling/packaging, advertising, or consumer information, must be made twice each year – by June 30 and December 31. This means that any labels that have changed to include FDA’s required nicotine warning statement, for example, will need to be updated in TRLM NG. Paper submissions (i.e., FDA Form 3741 or Form 3741a) must be mailed to CTP’s Document Control Center.
The updated module, TRLM NG, provides the following substantive updates and improvements for industry:
- Users can manage multiple active and draft registrations in a single account (e., owner, operator, authorized third party, other roles/ registrations under one single account);
- Improved dashboard capabilities which include a summarized view of registration status and associated establishments;
- Resources provided to assist users through the listing process;
- Faster processing and loading speed for searching, filtering, and exporting products and material files listings;
- A single screen view of product actions with the option to add, edit, and upload, as well as make changes in bulk, to process requests at a faster rate; and
- Autoscaling capability to handle large data volumes and number of users.
As noted above, Users will need to register if they did not have a preexisting FURLS TRLM account and the following are applicable:
- Your tobacco manufacturing establishment (s) is located within the United States; and
- Your establishment (s) is involved with any of the listed operations: blending, manufacturing, labeling, relabeling, reconstituting/reconstituting tobacco, packaging, repackaging, saucing (or casing) storing, and testing.
Existing Users with a FURLS TRLM Account
On August 31, 2020 FDA sent transition emails to users that already had FURLS TRLM accounts. The transition email contained instructions for activating a user’s TRLM NG account and resetting their passwords. Users do not need to re-enter their registration and product listing information as data that has already been submitted to FDA has automatically transferred/migrated to TRLM NG. TRLM NG has the following roles within the updated system: Primary User and Additional User. These User roles are defined as:
Primary User – The User having the listed email, name, and phone number listed in FURLS TRLM. The Primary User account information will migrate from FURLS TRLM to TRLM NG and will need to create a TRLM NG password. This User account will receive the transition email that was sent on August 31, 2020.
Additional User – Any Additional Users will not be automatically listed in FURLS TRLM NG. Each Additional User will need to create their own TRLM NG account with their name, email, phone number and password to log into TRLM NG.
Primary Users will be the only user to have access to the registrations migrated from legacy TRLM (FURLS TRLM). The Primary User will be able to grant an Additional User access to a specific registration by entering the TRLM NG Username (email) and selecting a role for the User on the specific registration.
If a company cannot access its August 31, 2020 transition email, FDA has advised that the company may first want to check your “junk/spam’ folders. If you continue to have technical difficulties, please contact TRLM NG Helpdesk at CTP-TRLM-NG-Helpdesk@fda.hhs.gov.
For additional assistance, Users may also reference Tobacco Registration and Product Listing Next Generation (TRLM NG) Instructions, TRLM NG User Guide, TRLM NG Training Video, and TRLM NG Frequently Asked Questions (FAQs).
If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury (202.434.4230, email@example.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapr. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.
[i] Establishments that do not manufacture “finished” tobacco products should not register with FDA. FDA considers a tobacco product as finished if the tobacco product, including all components and parts, is sealed in a final packaging intended for consumer use (e.g., filters or filter tubs sold separately to consumers or part of kits).