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

From: 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).

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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.

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