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  1. Premarket Tobacco Product Applications

FDA Tobacco Product Application Tips - Premarket Tobacco Product Applications

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Overview  

A premarket tobacco product application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A PMTA must provide scientific data that demonstrates permitting the marketing of a new tobacco product is appropriate for the protection of the public health.  

Applicants may have questions about the PMTA submission process, such as which forms are required and what information must be included on these required forms. Based on frequently identified issues, CTP has outlined the required forms and provided tips to help applicants correctly complete them.  

These tips do not cover all the information that may need to be provided in the forms. Please see each of the forms’ appendices for more detailed instructions. You can also find more information on application requirements on our Preparing and Submitting a PMTA page.  

If you have questions about your application or the status of your review, please reach out to your assigned Regulatory Health Project Manager (RHPM) as provided in FDA’s official communications regarding your application. You may also email AskCTP@fda.hhs.gov or call 1-877-287-1373 for additional support. 

Tips for Completing PMTA Form FDA 4057 

All PMTAs must be submitted using the most up-to-date version of Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission.

General Tip: Be sure to complete every field in the form, unless otherwise noted. Absence of required information may impede FDA ingestion and processing of your application. 

Applicant Identification

Applicant Identification

  • Provide the applicant’s name. You can enter a person’s name or an organization. 
  • Provide a complete address. 
  • Be sure your contact information is up to date so the project manager for your application can get in touch with you if needed.

Authorized Representative

  • Only complete this section if you are an applicant in the United States. Provide the authorized representative’s name, complete address, and contact information. 

Manufacturer Information

  • Only complete this section if the manufacturer is different from the applicant. If that’s the case, provide the organization name and a complete address. 

U.S. Agent Information

  • Only complete this section if you are an applicant outside the United States. Provide the U.S. agent’s name, complete address, and contact information. 

Submission Information

Certification Statements

  • Provide the correct certification statement(s) for the application type you are submitting. Certification statements for PMTAs are required by 21 CFR 1114.7(a) and described in 21 CFR 1114.7(m).
  • Complete all the fields for each relevant certification statement, including the name of the responsible official, such as the authorized representative or U.S. agent.
  • Make sure that each appropriate certification statement is signed by the responsible official. Please note that this signature is separate from any signature used on the electronic forms for eSubmitter and the CTP Portal.

Tips for Completing PMTA Amendment Form FDA 4057a

Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission is a required form for applicants submitting amendments and other general correspondence to FDA. In most circumstances, the agency can only consider PMTA amendments for pending applications that include required Form FDA 4057a.

General Tip: When submitting amendments for a PMTA, FDA will first review the required Form FDA 4057a. The submission will not be further reviewed if the required form or required content in the form is missing.  

Applicant Identification 

  • Fill out “Subsection A” so that the information matches the application you are amending.
  • If you are transferring ownership, you must indicate in “Subsection B” that you are including the following in the submission:
    • A notice stating that all of the former applicant's rights and responsibilities relating to the PMTA have been transferred to the new applicant. 
    • A notice stating the new applicant's commitment to agreements, promises, and conditions made by the former applicant and contained in the PMTA.
  • If you are adding, updating, replacing, or removing an applicant, authorized representative, point of contact, U.S. agent, or manufacturer, carefully read and follow the instructions under “Subsection C”. These instructions explain what demographic information is needed based on the change(s) being made.

Submission Information

  • Select “Amendment” under the “Type of Submission.”
  • Include the FDA submission tracking number (STN) assigned to the application you are amending. Watch this video for help finding your STN within the CTP Portal. 
  • Select the appropriate amendment response type (i.e., “Deficiency Letter,” “Unsolicited,” or “Other”). If selecting “Unsolicited” or “Other,” include a description under the “Submission Summary.”

Certification Statement

  • Complete the certification statement, as required by 21 CFR 1114.9(a) and described in 21 CFR 1114.7(m).
  • Complete all fields of the certification statement, including the name of the responsible official, such as the authorized representative or U.S. agent.
  • Make sure that the certification statement is signed by the responsible official. Please note that this signature is separate from any signature used on the electronic forms for eSubmitter and the CTP Portal.  

Tips for Completing PMTA Form FDA 4057b 

PMTA submissions should include the most up-to-date version of Form FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet. 

General Tip: Remember not to edit or change the spreadsheet. Making changes, like adding or removing columns or editing header text, for example, may prevent your information from loading in the system and affect FDA’s ability to review your submission.

Formatting 

  • Download the spreadsheet file and make sure to enable macros before you begin entering your data. 
  • Convert the file to an “.xlsx” format for submission. 
  • Do not convert the file to a PDF. 
  • Avoid using special characters (such as #, $, *) in the spreadsheet.
  • Do not copy and paste content into fields that have dropdown menus with response options for you to choose from. 
  • Some dropdown menus include “Other” as a response option. Only choose “Other” if the information you need to provide is not already listed as a response option.

Introduction Tab 

  • Remember to include only one product category and subcategory per spreadsheet. 
    • If you need to include more than one category and subcategory, prepare a separate Form FDA 4057b for each separate category and subcategory.
  • Complete all required fields, including the “Applicant Name,” “Product Category,” “Product Subcategory,” and “Application Type.” 
  • Click the “Enter Unique Product Properties” button to advance to the next tab. 
  • Use the “Reset” button if you need to clear all the fields on the “Introduction” tab. 
    • Clicking the “Reset” button will not delete previously entered information on the “Product” tab.   

Product Tab

  • Remember that clicking the “Enter Unique Product Properties” button on the “Introduction” tab will automatically update the form with the fields you need to complete on the “Product” tab based on the "Product Category” and “Subcategory” chosen on the “Introduction” tab. 
    • The form will automatically hide columns in the “Product” tab that do not apply to the "Product Category” and “Subcategory” information you provided on the “Introduction” tab.
    • Do not unhide hidden columns and add data to them. You can include additional information under the column labeled “Additional Properties.”  
  • Complete all required fields. 
  • Do not leave fields blank or insert “NA” or “N/A.”
  • The “TP Number” and “Additional Properties” fields are optional fields.
  • For fields that require numbers, provide a single value and do not list a range. 
  • Provide the information for each new tobacco product in a single row.
    • For example, a difference in nicotine concentration, e-liquid volume, or PG/VG would be a separate new tobacco product, and information on that product would need to be included in a different row. 
  • When you enter a numeric value, the units are required in a separate column. 
    • For example, if your product has an e-liquid volume of 5 milliliters: “5” should be entered in the “E-Liquid Volume” column and “millimeters” should be picked from the “E-Liquid Volume Units” dropdown response list.

Tips for Verifying PMTA Form FDA 4057b with Product Form Validator Tool 

PMTA submissions are required to include scientific data demonstrating the marketing of a new tobacco product is appropriate for the protection of public health. These data are submitted on the latest version of Form FDA 4057b “Premarket Tobacco Product Application Product Grouping Spreadsheet.”

General Tip: Use the Product Form Validator Tool to validate the data in Form FDA 4057b and confirm the form has been completed consistent with FDA requirements before submitting to FDA. Applicants are not required to use the tool, but using the tool can help reduce the time you spend reviewing, correcting, and resubmitting the form.

If you require detailed, step-by-step instruction and additional tips on navigating the tool, explore Validator Tool for PMTA Product Grouping Spreadsheet Download and Installation.

 
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