Tobacco Product Master File

Simplifying Regulatory Submissions

TPMFs streamline and simplify the regulatory product application process and may reduce associated costs. The TPMF is a truly beneficial tool for researchers and manufacturers alike. When McKinney Specialty Labs grants you access to our master file, we enable you to reference data, analyses, ingredient lists, and constituent testing, that can support multiple tobacco product FDA submissions.

The FDA can then access and review the information in our TPMF in support of your applications. Once FDA has determined that the information in the TPMF is acceptable, referencing our TPMF in your application can streamline the FDA review process.

If you would like authorization to reference McKinney Specialty Lab’s tobacco product master file, please email our team to receive a Letter of Authorization (LOA).