Tobacco Product Master Files (TPMF) are voluntary submissions to the FDA that contain trade secret and/or confidential commercial information about a tobacco product or component. TPMFs are a beneficial tool for manufacturers, component suppliers, ingredient suppliers, and researchers, and can assist the tobacco product submission process.
This program mutually benefits TPMF owners, who can reference their own master file rather than submitting the information separately for multiple submissions, and authorized parties who can reference scientific data and analyses that would otherwise be confidential, ultimately resulting in potential cost savings for all parties involved.
What is a TPMF?
A TPMF is a file submitted to the FDA that contains trade secret and/or confidential commercial information about a tobacco product that the owner does not want to share with other persons. However, the confidential information may be needed by other parties in preparing tobacco product submissions, such as:
- Premarket Tobacco Applications (PMTA)
- Substantial Equivalence Reports (SE)
- Modified Risk Tobacco Product (MRTP) Applications
- Request for Exemption from SE Requirements
- Grandfathered Submissions
- Investigational Tobacco Product Submissions
- Ingredient Listings
By having a TPMF on file with the FDA, a TPMF owner may allow an authorized party the right to reference the TPMF in support of a tobacco product submission to the FDA. If the authorized party is granted the right of reference, the FDA can access and review the confidential information as part of their submission, but the authorized party does not see or have access to the confidential information.
The FDA does not intend to conduct a scientific review of a TPMF at the time of its submission, and it will typically only be reviewed when appropriately referenced in a tobacco product submission. Establishing a TPMF with the FDA does not mean the data contained within has been validated by the FDA, and does not equate to any conclusion regarding its contents.
- 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 that information being shared to the customer.
- A laboratory establishes a TPMF containing protocols and methods to determine the quantities of Harmful and Potentially Harmful Constituents (HPHCs) for new and predicate tobacco products. The manufacturer of the new and predicate tobacco products submits an SE Report and references the TPMF, which allows the FDA to evaluate the levels of the HPHCs.
- An owner establishes a TPMF containing all of the design parameters for a predicate tobacco product. The TPMF also contains evidence to demonstrate the product was on the market as of February 15, 2007. The owner provides a manufacturer a right-of-reference to the TPMF, which allows the FDA to adequately characterize the predicate product and make a determination of predicate eligibility.
Why Use a TPMF?
The TPMF program benefits owners, who can reference their own master file rather than submitting the information separately for multiple submissions, and authorized parties who can reference scientific data and analysis that would otherwise be confidential — ultimately resulting in potential cost savings for all parties involved.
Owner of a TPMF
If a tobacco product manufacturer, supplier, or researcher has a TPMF on file at the FDA, the master file owner can reference the confidential information within that file in any future tobacco product submissions without the need to re-submit or duplicate each time. Additionally, by submitting a TPMF, an owner would be able to provide a service to existing or potential customers who intend to submit a submission to the FDA and may be interested in referencing the TPMF in support of that submission.
Authorized Third Parties
By obtaining authorization from a TPMF owner, an authorized party could reference data and analyses, such as extensive ingredient lists and constituent testing, that they otherwise would be required to develop themselves. This allows authorized parties access to confidential information without actually seeing the information.
FDA issued a guidance entitled "Tobacco Product Master Files: Guidance for Industry." The guidance provides recommendations to industry on submitting, establishing, and referencing a TPMF.