Electronic Submissions for Tobacco Products

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Electronic Submission Types
Process for Electronically Submitting Information to CTP via CTP Portal Next Generation
Resources for Submitting Electronic Submissions to CTP
Contact CTP Electronic Submissions Team

TThe FDA’s Center for Tobacco Products has several processes in place for manufacturers and other industry to submit regulatory information and correspondence about tobacco products using electronic methods. For the most user-friendly and efficient application submission process, CTP recommends using CTP Portal Next Generation (CTP Portal NextGen) to create, prepare, and submit Premarket Tobacco Product Application (PMTA), Tobacco Substantial Equivalence Report (SE), and Amendment and General Correspondence submissions using the web-based forms.

Applicants also have the option to use the FDA e-Submitter tool to package files and information, and then transmit those files via CTP Portal NextGen.
Submission types that do not use CTP Portal NextGen, but can still be submitted electronically, include:

User fees
Establishment registration
Product listing
Safety reporting**

Filing submissions electronically assists FDA with the receipt, processing, review and archiving process for tobacco products.

^**The^{Safety Reporting Portal}^{(SRP) is a secure web-based system that streamlines the submission of individual adverse experiences (health problems) and product problems involving tobacco products. The SRP does not accept submissions formatted in any computer language (such as xml or html).}

Electronic Submission Types Submitted via CTP Portal NextGen

Electronic submission of the following submission types can be prepared using the e-Submitter tool and submitted via CTP Portal NextGen, or PMTA and SE submissions can be prepared and submitted using CTP Portal. Please note that submission requires a prior request of an Industry Account Manager account.

NOTE: FDA encourages applicants to use the PMTA and SE web-based forms directly within CTP Portal NextGen for the most user-friendly and efficient application submission process. By Nov. 14, 2026, applicants should use the web-based forms in CTP Portal NextGen for PMTA and SE submissions (applicants may submit PDF versions if unable to submit online). After Nov.14, 2026, eSubmitter will no longer be available for PMTA and SE submissions.

Submission Type	OMB Control Number(s)
Tobacco health documents Sec. 904(a)(4)	0910-0654
Ingredient listing (TI) Sec. 904(a)(1)	0910-0650
Warning plans (Smokeless Tobacco and Cigars)	0910-0671 0910-0768
Quantities of harmful and potentially harmful constituents (HPHCs) Sec. 904(a)(3)	0910-0732
Apply to market a new tobacco product* Substantial Equivalence (SE) Reports Sec. 905(j), Form FDA 3965 – SE Report Submission Form FDA 3965a – SE Report Amendment and General Correspondence Submission (formerly Form FDA 3964) Premarket Tobacco Product Application (PMTA) Sec. 910(b) Form FDA 4057 – PMTA Submission Form FDA 4057a – PMTA Amendment and General Correspondence Submission *If applicants do not use the latest version of the forms or do not complete them properly, FDA generally intends to refuse to accept the application.	0910-0673 0910-0768 0910-0879
Modified Risk Tobacco Product (MRTP) application Sec. 911(g)(4)	N/A
Tobacco Product Master Files (TPMF)	N/A
Meeting requests	0910-0731
Other correspondence related to regulatory requirements	N/A
	0910-0768 0910-0879 0910-0684
Pre-Existing Tobacco Products	0910-0775
Additional Submission Types	OMB Control Number(s)	Prepare Via	Submit Via	Additional Information
User fee information	0910-0749	FDA Form 3852	Email: TobaccoUserFees @fda.hhs.gov

Pay user fees	N/A	Invoice sent from FDA	iReceivable system; ACH Wire Transfer; check

Register establishment; submit list of products and product labeling/advertising	0910-0312 0910-0650		Tobacco Registration and Product Listing Module - Next Generation (TRLM NG) If you are unable to submit online using TRLM NG, please mail the appropriate Registration & Listing PDF form (Form FDA 3741 or, for deemed establishments, Form FDA 3741a) documents to CTP's Document Control Center.

Report a tobacco product adverse experience or product problem	0910-0291		Safety Reporting Portal	Learn about the types of problems that should be reported to FDA.

Comment on tobacco product rules, regulations, and guidance	N/A		Submit Comments on Tobacco Regulatory Activities	Find current comment opportunities and respond.

Report a tobacco product violation	0910-0716	Electronic form	Report Potential Tobacco Product Violation	If unable to submit online, mail the paper form.

See all timelines and guidance for regulatory submissions made by manufacturers, distributors and importers.

Process for Electronically Submitting Information to CTP via CTP Portal Next Generation

Process for electronically submitting PMTA and SE information to CTP via CTP Portal NextGen:

Use CTP Portal NextGen to create a new draft submission package.
Identify your submission type and select the appropriate web form.
Prepare the submission package electronically in CTP Portal NextGen by completing the web form and uploading required and supporting documentation.
When complete, use the Review and Submit page to ensure all required information is provided in the web form and click submit when ready.

Process for submission types other than PMTA and SE Reports, such as Exemption Requests, Harmful and Potentially Harmful Constituents reports, and Tobacco Product Ingredient Listings:

Prepare submission electronically using FDA’s eSubmitter tool.
Work with CTP to plan and submit a test or practice submission to CTP to identify any challenges or issues prior to full submission.
See CTP’s eSubmitter Submission Checklist and Technical Working Instructions for help preparing your electronic submission. People with disabilities having problems accessing the PDF may call 1-877-CTP-1373 for assistance.
Submit final files via CTP Portal NextGen. (Request for an Industry Account Manager (IAM) account.)

Resources for Submitting Electronic Submissions to CTP

General resources for using e-Submitter and CTP Portal NextGen:

Overview of the Electronic Submissions Process for Industry: Contains basic information about the documents and data needed to successfully create an electronic submission.
Electronic Submission File Formats and Specifications: Provides greater detail about file types and electronic submission standards available for tobacco product submissions. Includes detailed outline of the submission table of contents and detailed instructions for completing Form FDA 3965b and 4057b.
FAQs and Common Errors and Questions that Delay Submission Processing: Contains more information about electronic submissions to CTP, including confidentiality and trade secret policies as well as links to additional relevant FDA guidance documents.
Submitting documents via CTP Portal NextGen
Refer to the CTP Portal NextGen help page for frequently asked questions, tips for submitting, and video and user guides.

Contact CTP Electronic Submissions Team

Contact the CTP electronic submissions team with any additional questions regarding electronic submissions.

The Electronic Submissions Help Desk can assist with technical questions prior to submission of an application. Once an application has been submitted, it will follow the regulatory process and receive an appropriate determination following our policies. We encourage applicants to know the various electronic requirements and to contact the help desk with questions prior to submission.

If you have any questions regarding a submitted application, email AskCTP@fda.hhs.gov or call 1-877-287-1373.

For questions other than electronic submissions, contact the product's manufacturer or contact us.

If you are unable to submit online, mail submissions to CTP's Document Control Center.