0 Tobacco Registration and Product Listing Updates Updates CENTER FOR TOBACCO PRODUCTS

CENTER FOR TOBACCO PRODUCTS

Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy.

Office of Compliance and Enforcement

TOBACCO REGISTRATION AND PRODUCT LISTING UPDATES
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• Overview of Section 905 of the FD&C Act

• (New) Tobacco Registration and Listing Module Next Generation (TRLM NG) system

• Who must register their establishments?

• When to register and when to update an establishment’s registration and product listing in 

TRLM NG?

• Types Of Updates To Include In Biannual Updates - 905(i)

• How to update an establishment’s registration and product listing?

AGENDA
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• Section 905(a)(1) Manufacture, Preparation, Compounding, or Processing. The term 

'manufacture, preparation, compounding, or processing' shall include repackaging or 

otherwise changing the container, wrapper, or labeling of any tobacco product package in 

furtherance of the distribution of the tobacco product from the original place of 

manufacture to the person who makes final delivery or sale to the ultimate consumer or 

user. 

• Section 905(b) requires owners and operators of establishments in any U.S. state or 

territory (or D.C.) engaged in the manufacturing, preparing, compounding, or processing of 

a tobacco product to register on or before December 31st of each year.

• Section 905(i)(3) of the Act requires that any changes in the product list be submitted 

biannually, once during June and once during December. 

SECTION 905 OF THE FD&C ACT
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THE NEW TRLM NG SYSTEM
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Industry Users can:

• Review guidance on FDA registration and product listing requirements;

• Register establishments, products, and material files with the FDA; and 

• Update registration information annually and product listing changes biannually to 

comply with statutory requirements.

How to access TRLM NG: 

• https://trlm-ng-industry.fda.gov

THE NEW TRLM NG SYSTEM
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• Every person who owns or operates any domestic establishment engaged in 

manufacturing, preparing, compounding, or processing regulated tobacco products must 

register under section 905(b) of the FD&C Act, and every registrant must file a list of its 

regulated tobacco products in accordance with section 905(i) of the FD&C Act. 

• An owner or operator may authorize a third-party agent to register their establishment 

and submit product listing information on its behalf. Establishment registration and 

product listing requirements currently apply only to those persons who own or operate 

domestic establishments engaged in manufacturing, preparing, compounding, or 

processing tobacco products; an importer who does not own or operate such an 

establishment is not subject to the requirements of section 905(b) or section 905(i) of 

the FD&C Act. 

WHO MUST REGISTER
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• A domestic establishment must register when it first engages in the manufacturing of a 

tobacco product.

• We request that a firm update its registration when it no longer engages in the 

manufacture, preparation, compounding, or processing of a tobacco product or tobacco 

products, including repackaging and relabeling of tobacco products.

• For example:

– Out of business;

– Now solely a retail establishment; or

– An importer who is not conducting manufacturing activities outlined in 905(a)(1).

– Brand owner who is not conducting manufacturing activities outlined in 905(a)(1).

WHEN TO REGISTER AND WHEN TO UPDATE AN ESTABLISHMENT’S 

REGISTRATION AND PRODUCT LISTING IN TRLM NG?
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• A tobacco product is introduced into commercial distribution that was not included in a 

previous product list.

• A manufactured tobacco product is discontinued from commercial distribution since the 

last report.

• A tobacco product was marked as discontinued in a previous report, and manufacturing 

and commercial distribution of the product has since resumed.

• Any material change in any information previously submitted.

TYPES OF UPDATES TO INCLUDE IN BIANNUAL UPDATES - 905(i)
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• Electronic submission system: TRLM NG

– Link to TRLM NG: https://trlm-ng-industry.fda.gov

• Paper submission: FDA Form 3741 and 3741(a)

HOW TO UPDATE A REGISTRATION AND PRODUCT LISTING 
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• Registration and Product Listing for Owners and Operators of Domestic Tobacco 

Product Establishments:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registrationand-product-listing-owners-and-operators-domestic-tobacco-product-establishments.

• The “Need help” page: https://trlm-ng-industry.fda.gov/help

• For Registration and Listing questions: CTPRegistrationandListing@fda.hhs.gov

• Webinar: Registration And Product Listing Requirements For Domestic Establishments

HELPFUL RESOURCES
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THANK YOU

If you have any TRLM NG questions, you can contact us at:

E-Mail: AskCTP@fda.hhs.gov

Phone: 1-877-CTP-1373

For other questions, technical assistance, or guidance finding the right resources, 

you can contact the Office of Small Business Assistance (OSBA) at: 

E-mail: SmallBiz.Tobacco@fda.hhs.gov

Phone: 1-877-287-1373 (Monday-Friday, 9:00 a.m. - 4:00 p.m. ET)

Mail: FDA/CTP Office of Compliance and Enforcement

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