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Electronic Submissions for Tobacco Products

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The 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 most submissions to CTP, including meeting requests and correspondence, manufacturers may use the FDA e-Submitter tool to package files and information, and then transmit those files via the CTP Portal.* Submission types that do not use the CTP Portal, but can still be submitted electronically, include user fees, establishment registration, product listing, and safety reporting.**

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

*The CTP Portal provides more functionality than the existing FDA Electronic Submissions Gateway, or ESG, WebTrader tool. CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you can still use it to submit documents to CTP. NOTE: FDA is releasing CTP Portal Next Generation (NG)—an enhanced web portal for electronically sending tobacco product submissions to the FDA—in early 2025. Learn more about the new CTP Portal NG.
**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

 

Submission Type OMB Control Number(s) Prepare Via Submit Via Additional Information
Tobacco health documents Sec. 904(a)(4) 0910-0654

 

 

 

 

 

 

 

 

 

 

 

 

e-Submitter tool

 

 

 

 

 

 

 

 

 

 

 

 

CTP Portal

 

 

 

 

 

 

 

 

 

 

 

 

Requires prior request of an Industry Manager Account
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  

  • SE Reports Sec. 905(j),  EX REQ
  • Sec. 905(j)(3),  
  • PMTA

0910-0673 

0910-0684 

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
New tobacco products submitted a Premarket Tobacco Application (PMTA), Sec. 910(b)  0910-0768
0910-0879 
New tobacco product submitted with a request for exemption from substantial equivalence, Sec. 905(j)(3)  0910-0684 
Pre-Existing Tobacco Products 0910-0775
         

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 (FDA Form 3741 or, for deemed establishments, FDA Form 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 the CTP Portal

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

Resources for Submitting Electronic Submissions to CTP

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

More information about specific submission types:

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 your submitted application, you may 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.

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