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Preparing a Premarket Tobacco Product Application (PMTA) to obtain a Food and Drug Administration Marketing Order can be overwhelming, even for experienced filers. Following recent changes to regulation, many manufacturers of synthetic nicotine products are now exploring their PMTA prospects, and for new operators, getting their first introduction to a complex and time-consuming project.
Breaking a PMTA project down into its constituent parts for preparation makes the endeavor much more manageable; fortunately, PMTA regulations (namely 21 U.S.C. Part 1114) provide prospective filers with the necessary constituent parts of a successful PMTA. Tackling the preparation of a PMTA in stages is likely the best approach for smaller manufacturers or those who are new to PMTA filings.
First, the regulations governing PMTA require that all PMTAs include a cover letter, table of contents, a comprehensive index, and completed PMTA’s must be submitted in formats approved by FDA. Next, the regulations provide a ready-made basic table of contents by listing all components required to be included in a PMTA filing. These include:
1. General information – including the applicant’s information and contact details, any authorized agents or other representatives and their contact details, as well as basic details of the new tobacco product (category, subcategory, and product quantity/flavor details)
2. New tobacco product descriptive information
3. Product samples
4. Labeling and details of proposed marketing plans
5. Statement of compliance with 21 CFR part 25 (this will be in the form of an Environmental Assessment)
6. Summary
7. Product formulation
8. Manufacturing information: including good manufacturing practices, quality controls and procedures, and manufacturing compliance standards
9. Scientific studies and analyses, and health risk information
a. Including the manufacturer’s own study or studies to demonstrate the new product is Appropriate for the Protection of Public Health
10. Studies and data about effects on the population as a whole, including propensity for abuse, youth initiation, and similar considerations
11. Certification statement
The above reflects the basic structure of a PMTA – the minimum required content for FDA review. Beyond these basic components, individual filings will likely include any number of additional sections, sub-sections, appendices, and of course, reference to a variety of scientific studies and data. Each point above is further elaborated within the relevant sections of the regulation.
Additionally, filers should be aware that, since passage of FDA’s PMTA Final Rule, there are now required forms to be included in submissions. While there is certainly not a one-size-fits-all approach to PMTA, the above basic requirements are an excellent way to organize and approach your PMTA to make the project manageable.
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