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Electronic Submissions for Tobacco Products

The United States District Court has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.

FDA has compiled information and resources to assist with submission of premarket review applications.


On this page:


FDA recently reopened the comment period for the PMTA proposed rule to allow comment on an additional form that may assist industry and FDA in identifying products that may be eligible for submission as a group or bundled submission. The comment period has now closed but you can still view the proposed form. Please also view instructions on how to download the proposed form.

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. Learn more below about the electronic submission process, including recommended file formats and submission methods.

  • Electronic submission types
  • Process for electronically submitting information to CTP via the CTP Portal
  • Resources for Submitting Electronic Submissions to CTP

*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.


Electronic Submission Types

Submission Type Prepare Via Submit Via Additional Information
  • Tobacco health documents Sec. 904(a)(4)
  • Ingredient listing (TI) Sec. 904(a)(1)
  • Warning plans 
    (cigars and smokeless tobacco)
    OMB Control Numbers 0910-0768 and 0910-0671
  • Quantities of harmful and potentially harmful constituents (HPHCs) Sec. 904(a)(3)
    OMB Control Number 0910-0732
  • Apply to market a new tobacco product (SE Reports Sec. 905(j), EX REQ Sec. 905(j)(3), PMTA)
  • Modified Risk Tobacco Product (MRTP) application Sec. 911(g)(4)
  • Tobacco Product Master Files (TPMF)
  • Meeting requests
    OMB Control Number 0910-0731
  • Other correspondence related to regulatory requirements
  • New tobacco products submitted a Premarket Tobacco Application (PMTA), 910(b)
  • New tobacco product submitted with a request for exemption from substantial equivalence, 905(j)(3)
e-Submitter tool CTP Portal Requires prior request of an Industry Manager Account
 

User fee information

OMB Control Number 0910-0749

The burden time for this collection of information is estimated to average 4 hours per response, including the time to review instructions, search existing data sources, gather and the data needed, and complete and review the collection of information.

FDA Form 3852 Email TobaccoUserFees@fda.hhs.gov  
Pay user fees Invoice sent from FDA iReceivable system; ACH Wire Transfer; check  
Register establishment; submit list of products and product labeling/advertising  

Tobacco Registration and Listing Module of FDA’s Unified Registration and Listing Systems (FURLS)

If you are unable to submit online using FURLS, 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.

 
Tobacco product safety issues   Safety Reporting Portal Learn about the types of  problems that should be reported to FDA.
Comment on tobacco product rules, regulations, and guidance   Submit Comments on Tobacco Products Find current comment opportunities and respond.

Report a tobacco product violation

OMB Control Number 0910-0716

The burden time for this collection of information is estimated to average .25 minutes per response, including the time to review instructions, search existing data sources, gather and the data needed, and complete and review the collection of information.

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:

  • Tobacco Health Document HD 904(a)(4) Submission, Technical Working Specifications
    • If you are unable to submit online, mail submissions to CTP’s Document Control Center, using FDA Form 3743 (PDF).
      OMB Control Number 0910-0654

The burden time for this collection of information is estimated to average 50 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.

The burden time for this collection of information is estimated to average 3.75 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.

The burden time for this collection of information is estimated to average 36 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.


Contact CTP

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

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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