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FDA Releases Updated Module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” for Tobacco Product Manufacturing Establishments

By Azim Chowdhury & LieAnn Van-Tull on November 24, 2020
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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.

New 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, chowdhury@khlaw.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).

Photo of Azim Chowdhury Azim Chowdhury

Azim Chowdhury is a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation. He is a Partner in Keller and Heckman’s nationally-ranked food and drug law practice.

Mr. Chowdhury advises domestic and foreign corporations in matters of…

Azim Chowdhury is a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation. He is a Partner in Keller and Heckman’s nationally-ranked food and drug law practice.

Mr. Chowdhury advises domestic and foreign corporations in matters of Food and Drug Administration (FDA) and international regulatory compliance. In particular, he has developed expertise in tobacco and vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the Tobacco and E-Vapor practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, distributors, retailers, suppliers and trade associations in matters of FDA, state and global regulatory compliance. He also assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in food-contact materials.

Mr. Chowdhury has authored and edited numerous articles and publications, including Tobacco Regulation and Compliance: An Essential Resource, FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer and Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. He is a frequent contributor to the Food and Drug Law Institute’s (FDLI) Update Magazine and has served on the Editorial Advisory Board of the Food and Drug Law Journal.  In addition, he has been interviewed in the U.S. News and World Reports Best Lawyers Edition (2016) and was named one of “10 Names to Know in the Vape World” in the October 2015 issue of Vape Magazine. Mr. Chowdhury received the 2018 National Law Review Go-To Thought Leadership Award for his consistent coverage of the emerging issues surrounding vaping and e-cigarettes on Keller and Heckman’s law blog, The Continuum of Risk.  As an industry leader, Mr. Chowdhury frequently speaks at industry conferences and events.

Mr. Chowdhury also has an active pro bono practice through Keller and Heckman’s Pro Bono Program, and has been featured in the Baltimore Sun for successfully obtaining asylum in the United States for a family who fled their home country of El Salvador because of violence they faced from an international gang.

Prior to entering private practice, he served as a judicial law clerk on the Court of Special Appeals of Maryland. Mr. Chowdhury received a B.A. and B.S. from Johns Hopkins University, a MBA from the University of Maryland Robert H. Smith School of Business, and a JD, cum laude, from the University of Maryland School of Law.

Education: Johns Hopkins University (B.A., B.S., 2003); University of Maryland Robert H. Smith School of Business (M.B.A., 2006); University of Maryland School of Law (J.D., 2006, cum laude).

Admissions: District of Columbia; Maryland

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Photo of LieAnn Van-Tull LieAnn Van-Tull

LieAnn Van-Tull practices in the area of food and drug law, as well as tobacco and e-vapor regulation. She advises domestic and foreign clients on compliance with global food and drug packaging requirements. Ms. Van-Tull also provides state and federal legislative counsel to…

LieAnn Van-Tull practices in the area of food and drug law, as well as tobacco and e-vapor regulation. She advises domestic and foreign clients on compliance with global food and drug packaging requirements. Ms. Van-Tull also provides state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers.

Prior to joining Keller and Heckman, Ms. Van-Tull served as regulatory counsel for the Food and Drug Administration (FDA). While at FDA, she was on the lead counsel team on enforcement actions against companies that produce electronic nicotine delivery systems. Ms. Van-Tull also developed policies and programs involving matters affecting the regulation of the tobacco industry. Ms. Van-Tull also has a background in chemistry.

Admitted to practice in Maryland only. Practice limited to matters before the FDA and matters ancillary thereto.

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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    The Continuum of Risk
  • Organization:
    Keller Heckman
  • Article: View Original Source

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