Tobacco Product Master File (TPMF)

Tobacco Product Master Files (TPMF) can be submitted to the FDA by any research laboratory, manufacturer, or individual voluntarily. TPMFs are a beneficial tool for manufacturers, component and ingredient suppliers, and researchers. Having the agency have access to a TPMF can assist with the tobacco product submission process.

Enthalpy Analytical has provided the FDA with our own tobacco product master file. Enthalpy’s TPMF references all of Enthalpy’s proprietary, in-house developed HPHC methods, validations, and standard operating procedures.

The TPMF is a truly beneficial tool for researchers and manufacturers alike. It allows owners to reference data for multiple submission types including: PMTA, SE, and MRTP submissions to the FDA. Authorized parties who have been granted authorization to reference a TPMF by the TPMF owner (Enthalpy) can reference TPMF data, analyses, ingredient lists, and constituent testing, in support of a tobacco product submission. The FDA can then access and review the trade secret and/or confidential information as part of the authorized party’s submission without that party seeing or accessing the TPMF owner’s confidential information. When a TPMF is established with FDA, it can be referenced by the TPMF owner and/or an authorized party through providing a letter of authorization.

If you would like authorization to reference Enthalpy’s tobacco product master file please email our team to get a Letter of Authorization (LOA) sent on your behalf for the agency to access Enthalpy’s TPMF.