Tobacco Product Master File Commonly-Asked Questions

April 15, 2024

As a part of an ongoing effort to describe specific elements of the application process to CTP and introduce strategic considerations for application development, here is a quick overview of the tobacco product master file (TPMF) process.

What is a tobacco product master file?

A TPMF is a confidential submission to the FDA that contains detailed information about a tobacco product, its manufacturing process, and other relevant data. It allows the TPMF owner to authorize other parties to rely on the information in the TPMF without disclosing it to them.

Who can create a TPMF?

Any person or entity involved in the manufacturing, distribution, or marketing of a tobacco product can create a TPMF.

What information should be included in a TPMF?

A TPMF should include comprehensive information about the tobacco product, such as its composition, manufacturing process, quality control procedures, and any relevant scientific studies or data.

How can others use a TPMF?

Once authorized by the TPMF owner, other parties can reference the information in the TPMF to support their own submissions to the FDA without having direct access to the confidential information contained in the TPMF.

Are TPMFs mandatory for all tobacco products?

No, TPMFs are not mandatory for all tobacco products. However, they can be a useful tool for streamlining the regulatory process and protecting confidential information.

How do I establish a TPMF?

To establish a TPMF, you should follow the guidelines provided by the FDA, which include preparing a comprehensive submission that meets the requirements outlined in the guidance document.

Can I update or modify a TPMF?

Yes, TPMFs can be updated or modified as needed. It is important to keep the information in the TPMF accurate and up to date.

How long does it take for the FDA to review a TPMF?

The FDA does not provide a specific timeline for reviewing TPMFs. The review process can vary depending on the complexity of the submission and the workload of the FDA.

Are TPMFs subject to FDA inspections?

Yes, TPMFs are subject to FDA inspections. The FDA may conduct inspections to verify the accuracy and completeness of the information provided in the TPMF.

Can I withdraw a TPMF?

Yes, you can withdraw a TPMF submission if needed. However, it is important to consult with the FDA and follow their guidelines for the withdrawal process.