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Using eSubmitter to Prepare Tobacco Product Submissions

Please Note: FDA posted four updated forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting Jan. 2, 2026, applicants must use these forms in their PMTA and SE Report submissions. 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. The following forms are available for download on FDA’s website: 

  • Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
  • Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
  • Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
  • Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)

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Update to Latest eSubmitter Version for Tobacco Product Submissions

FDA updates eSubmitter submission templates monthly, usually in the first or second week of the month. Using updated templates for your submission helps ensure the latest fields are used and the structure of each submission can be received and processed by the FDA.

  • For new submissions, eSubmitter will automatically provide the newest template.
  • To update a previous submission, use the “Save As” option, and eSubmitter will load the newer template.

Can’t see the newest eSubmitter updates? 

Since November 2017, when CTP extended the ingredient listing deadline, FDA has updated eSubmitter to address feedback from industry, including allowing:

  • alpha numeric tobacco product (TP) numbers
  • attachment of.xlsx format Excel files

Prepare Tobacco Product Submissions to Submit Online:

Download the eSubmitter software to package regulatory documents into an electronic submission package to send to the Center for Tobacco Products (CTP), including:

  • Listing of Ingredients in Tobacco Products (Sections 904(a)(1) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
  • Tobacco Health Documents (Sections 904(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
  • Reporting Harmful and Potentially Harmful Constituents (Sections 904(a)(3) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
  • Product Applications (Premarket Tobacco Applications (PMTA), Substantial Equivalence (SE), Exemption from Substantial Equivalence, Tobacco Product Master Files (TPMF), Modified Risk Tobacco Products (MRTP))

Note: FDA encourages applicants to create, prepare, and submit Premarket Tobacco Product Application (PMTA), Tobacco Substantial Equivalence (SE) Report, and Amendment and General Correspondence submissions using the web-based forms available in CTP Portal Next Generation (CTP Portal NextGen). Login to CTP Portal NextGen to access the web-based forms, including for step-by-step instructions and a more efficient, integrated experience.

Format Electronic Submissions via eSubmitter

  1. Follow the character limits for the file path and file name. The character limits are: 
    • File path: 200 characters with spaces maximum, including folder and subfolder names, such as: C:\FredsFiles\SubmissionFolder987\AmendmentFolder5\ToxSection\ToxData\toxdatefile678.xpt|
      *Avoid subfolders when possible. Fewer folders within your submission will help keep all related files together and in one place.
    • File name: 50 characters maximum, such as toxdatefile123.xpt.
      *Assign unique file names to ALL files throughout the submission so no filenames are repeated twice.
  2. Avoid special characters, including spaces, or foreign language characters in file paths or file names. 
    • Examples of non-accepted filename characters:
      • Spaces. Use an underscore “_” or hyphen “-” instead of spaces in file names.
      •  /, \, @, %, <,>, “, ?, |, :, ;
      • Non-English characters, such as ä,é,î,ð,ñ,ü,æ
  3. Save files as standard file types. FDA accepts many different file types or file formats, including many common file types for ingredient listing, such as *.xpt, xls, xlsx, , csv, txt, , html, xml, , rtf, and others.
    • Data sets: FDA recommends SAS Transport file format (*.xpt) or Comma Separated Values file format (*.csv) for data sets when possible even if such data are displayed as tables in the narrative PDF documents.
    • Text: FDA recommends PDF format.
    • Proprietary software: If a proprietary software is used and FDA does not have the software, the files can’t be opened.  
  4. Break up submissions of more than 2GB in size and cross-reference. Additionally, for files larger than 2GB:
  5. Create a Cover Letter (optional) to attach to your main application document that outlines the organizational structure and includes the number of eSubmitter packages and files you  will transmit. 
    • Send it to your CTP point of contact (regulatory health project manager) in advance of your submission so FDA knows how many files or eSubmitter packages to expect.
    • *Consider using “open file” hyperlinks in table-of-contents-style list within the cover letter referencing additional documents within the submission. Where possible, bookmark across files and folders to referenced points wherever possible.  
  6. Read additional materials to assist with electronic submissions. FDA’s Center for Tobacco Products has created several reference documents to assist users with the electronic submissions process:

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