Premarket Tobacco Product Application (PMTA) submissions are required to include scientific data demonstrating that the marketing of a new tobacco product is appropriate for the protection of public health. This data is submitted on the latest version of Form FDA 4057b “Premarket Tobacco Product Application Product Grouping Spreadsheet.”
The Product Form Validator Tool can help validate the data in Form FDA 4057b “Premarket Tobacco Product Application Product Grouping Spreadsheet” 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 applicants spend reviewing, correcting, and resubmitting the form.
While the tool is designed to help applicants navigate the PMTA submission process, successful validation using the tool does not guarantee that an application contains all elements required for acceptance.
- Windows (64-bit system)
- Microsoft Excel
- Adobe Acrobat Reader
- Java v8 or greater
- 100 MB of disk space
Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard. For step-by-step instruction on installing and using the tool, download the User Guide below.
- Download Product Form Validator Tool Software (64-bit compatible)
- Note where you saved it on your computer.
- Extract or unzip the file, which prepares the file for installation.
- Run the file for immediate access to the tool.
- Download User Guide
Persons with disabilities having problems accessing the PDF files may call 1-877-CTP-1373 for assistance.
Using the tool
- Only one form can be validated at a time.
- After accessing the tool, locate and select the form to be validated. The form to be validated must be the latest version of Form FDA 4057b, which has a file extension of .xls or .xlsx.
- If an error shows at this point, you should troubleshoot by verifying the file extension.
- Once the data has successfully passed validation, you must save the completion certificate. This is important because the tool will remove the previous certificate when you begin validating a different FDA Form 4057b.
- If the data fails validation, an Issue Report can be created to help solve inconsistencies such as incorrect or missing data. Be sure to carefully review the Issue Report to correct the data and then revalidate the data to obtain a completion certificate.
- Remember to attach a copy of your completion certificate for each validated file when you are ready to submit your PMTA.
Reporting tool problems
- If you identify a problem with the tool, contact our Help Desk. Using the Application Log is the best way for our Help Desk to find a solution.
- Before contacting the Help Desk, make sure you navigate to and click the “Application Logs” text at the bottom right corner of the tool. This allows you to save a copy of the Application Log into a folder you chose.
- Please email this log as an attachment to reach our Help Desk at ctpeSub@fda.hhs.gov.