Tobacco Product Master Files: What Are They and How Could They Benefit You?

Posted on September 6, 2017 by FDA Voice

By: Mitch Zeller, J.D.

In a bid to help streamline and simplify the tobacco product application process and potentially reduce the associated costs, FDA is encouraging the creation and use of tobacco product master files (TPMFs).

Mitch Zeller, J.D., Director of FDA's Center for Tobacco Products

TPMFs are voluntary submissions to FDA that typically contain trade secrets and/or confidential commercial information about a tobacco product that the owner does not want to publicly share with others. But this information may be referenced by other parties in preparing tobacco submissions if the TPMF owner grants those other parties a right of reference.

Here’s how TPMFs are designed to work. Once a master file is submitted, anyone interested in referencing that file as part of their own submission may request a letter of authorization from the TPMF owner. If the request is granted, FDA reviewers will be able to access and review non-public information in the TPMF according to the authorization in the course of reviewing the submission, even if that information is not available to the authorized party.

For example, a flavor supplier might submit a TPMF to FDA that contains the full listing of ingredients and composition information of different flavors. The flavor supplier could then grant a customer, for example, an e-cigarette manufacturer, the right to reference the TPMF to support the customer’s premarket application for an e-cigarette that uses the supplier’s flavors. When reviewing the premarket application, FDA would also review ingredient and composition information in the TPMF, which may otherwise be confidential, without that information being shared with the customer.

Tobacco Product Master Files: What Are They and How Could They Benefit You?

TPMFs can be mutually beneficial for both file owners and parties authorized to reference the files in their own applications—ultimately resulting in potential cost savings for all parties involved. For TPMF owners, allowing FDA to keep certain information on file can reduce administrative work for the company and the need to resubmit this data for future applications, thus easing the application burden. Additionally, when a TPMF owner grants another entity access to a master file, it enables the authorized party to reference scientific data and analyses in the file that otherwise could be costly and time-consuming to obtain if the party, itself, needed to produce the information.

By filing TPMFs with FDA, owners gain the ability to expand existing customer relationships and to foster new ones while also keeping the owner’s information confidential.

Tobacco product submissions that may reference a TPMF include:

Premarket tobacco applications
Substantial equivalence reports
Modified risk tobacco product applications
Request for exemption from substantial equivalence requirements
Grandfathered submissions
Investigational tobacco product submissions
Ingredient listings

There are many ways TPMFs can be used in different types of applications. For instance, a lab could create a TPMF that contains protocols and methods for measuring levels of harmful and potentially harmful constituents (HPHCs) in tobacco products. An authorized manufacturer that used the lab’s services to generate HPHC data for, e.g., a substantial equivalence report could reference the lab’s TPMF in its submission to FDA, helping FDA evaluate HPHCs in its tobacco products.

FDA does not intend to conduct scientific review of a TPMF until the TPMF is referenced in a submission.

To learn more about the many benefits of becoming a TPMF owner, see “Tobacco Product Master Files: Guidance for Industry.” Contact us at ASKCTP@fda.hhs.gov or 1-877-CTP-1373 (1-877-287-1373).We will present a webinar on TPMFs soon, so stay tuned and sign up for email updates.

Mitch Zeller, J.D., is the Director of FDA’s Center for Tobacco Products