Tobacco Product Establishment Registration and Product Listing
On this page:
- Requirements and Deadlines
- Who Must Register and Submit Tobacco Product Listings?
- When to Update Tobacco Product Listings
- How to Make Tobacco Product Establishment Registration and Product Listing Submissions
Requirements and Deadlines
Tobacco product establishment registration and product listing are two requirements under Section 905 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Establishment registration is the annual process by which owners or operators of domestic tobacco product establishments notify the FDA of their existence and operations.
Product listing is the biannual process by which those same establishments report the specific tobacco products they manufacture, including certain changes to those products' names, labeling, advertising, or distribution.
All domestic tobacco product establishments must meet the following annual and biannual deadlines:
| Requirement | Deadline | How to Submit |
|---|---|---|
| Annual Establishment Registration | December 31 | Online via Tobacco Registration and Listing Module – Next Generation (TRLM NG) or mail paper Form FDA 3741 (PDF – 2MB) |
| Biannual Product Listing | June 30 and December 31 | Online via Tobacco Registration and Listing Module – Next Generation (TRLM NG) or mail paper Form FDA 3741 (PDF – 2MB) and, if applicable, Form FDA 3741b (xlsx – 3MB). |
Who Must Register and Submit Tobacco Product Listings?
Owners or operators of domestic establishments that manufacture, prepare, compound, process, repackage, or relabel tobacco products are required to register and submit product listings.
New establishments must register and list tobacco products immediately upon first engaging in manufacturing of any tobacco product. Existing registrations must be renewed annually by December 31.
The product listing requirement applies to all tobacco products including cigarettes, smokeless tobacco products, e-liquids and other electronic nicotine delivery systems (ENDS) products, cigars, pipe and hookah tobacco, nicotine pouches, nicotine gels, roll-your-own tobacco, and dissolvable nicotine products.
When to Update Tobacco Product Listings
The product listing requirement pertains to updates, inactivations, and new listings. Only domestic establishments making certain changes are required to update their product listing information. Information previously submitted to the FDA should not be resubmitted. Establishments must update their product listing once during June and once during December if they have made any of the following changes:
- New product introduced: Commercial distribution of a tobacco product not previously listed.
- Product discontinued: Manufacturing of a previously listed product has ceased.
- Product resumed: Manufacturing of a product previously listed as discontinued has resumed.
- Product name change: The name of a listed product has changed.
- Labeling change: The labeling of a listed product has been updated (e.g., new health warnings, format changes, or required cigar warning statements).
- Advertising change: A material change has been made to advertising associated with a listed product.
- Consumer information change: Consumer information associated with a listed product has been updated.
- Other material changes: Any other change to previously submitted listing information that is required to be reported.
How to Make Tobacco Product Establishment Registration and Product Listing Submissions
The FDA strongly recommends submitting all establishment registrations and product listings electronically through the Tobacco Registration and Listing Module – Next Generation (TRLM NG).
TRLM NG streamlines data entry and facilitates efficient and timely submissions to the FDA. The electronic system provides an interactive template form and an automatic acknowledgement of FDA receipt. It also allows registrants to attach and track large numbers of material files for labeling, advertising, and consumer information submissions. The FDA encourages use of the Form FDA 3741b (xlsx – 3MB) spreadsheet for initial product list submissions or adding new products to existing product lists.
The TRLM NG Help Webpage shares useful information including a user guide, frequently asked questions, and training videos.
Manufacturers unable to submit electronically through TRLM NG may complete a paper Form FDA 3741 (PDF – 2MB) and mail it to CTP’s Document Control Center. Submissions must be received by the FDA no later than the June 30 or December 31 deadline. Legacy Forms FDA 3741 and 3741a were retired on Sept. 28, 2026 , and replaced by a single unified Form FDA 3741 for all tobacco product categories. For initial product listings or adding new products to existing product lists, Form FDA 3741b (xlsx – 3MB) can also be printed or saved to a USB flash drive or DVD and mailed to the FDA.
Email the FDA at CTPRegistrationandListing@fda.hhs.gov with any additional questions. If you are a small business, consider these two additional options:
For more information on how to comply with the FDA’s tobacco product regulations or for a list of upcoming tobacco product submission deadlines, please visit CTP’s manufacturing webpage.