Tobacco Product Master Files Ease CTP Submission Process

The U.S. Food and Drug Administration is encouraging the creation of tobacco product master files (TPMFs). TPMFs are voluntary submissions to the FDA that contain trade secret and/or confidential commercial information about a tobacco product that the owner does not want to share with others. Once a TPMF is submitted, the TPMF owner can allow authorized parties the right to reference the owner’s TPMF in support of their own tobacco product submission to the FDA.

For example, a flavor supplier could submit a TPMF to the FDA that contains the full listing of ingredients and composition information of different flavors. The flavor supplier could then grant a customer 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, the FDA will also review the confidential TPMF ingredient and composition information, without sharing that information with the customer.

Submissions that may reference a TPMF include premarket tobacco applications, substantial equivalence reports, modified risk tobacco product applications, requests for exemption from substantial equivalence requirements, grandfathered submissions, investigational tobacco product submissions, and ingredient listings.

This program mutually benefits TPMF owners and authorized parties. TPMF owners can reference their own master file rather than submitting the information contained in the TPMF separately for multiple submissions. Authorized parties can reference scientific data and analysis that would otherwise be confidential or potentially difficult to develop themselves. Ultimately, TPMFs result in potential cost savings for all parties involved.

The FDA does not intend to conduct a scientific review of a TPMF at the time of its establishment, and establishment of a TPMF does not equate to a conclusion regarding its contents. The FDA typically reviews the TPMF when appropriately referenced in a submission to the agency’s Center for Tobacco Products.

In May 2016, the FDA published a Tobacco Product Master File (TPMF) Guidance, which outlines recommendations for how to submit, and what information to include, in a TPMF. Visit our website for more information.