US Premarket Tobacco Product Application (PMTA)

Broughton regulatory experts and scientists have been involved in several successful PMTA regulatory submissions and have a wealth of experience and insight to bring to your project.

In order to access the US market, companies are required to submit a Premarket Tobacco Product Application (PMTA) for NGPs to the US Food and Drugs Administration (FDA) for both new and currently marketed products. The applicant needs to prove marketing of a particular tobacco-containing product is appropriate for the protection of public health, and that their business can maintain records which demonstrate continued compliance with the original application.

The process of seeking approval for a set of products is extensive, with a range of scientific, analytical and regulatory support being required to achieve compliance. However, the potential return for businesses that take a pro-active and strategic approach to their PMTA is significant. Broughton is dedicated to helping businesses secure a future market share in this rapid-growth sector.

Your product is unique, your data is unique and your story should also be unique. Through our network of in-house and external consultants with deep industry experience and portfolio of client services, we can help you navigate the PMTA maze and ensure that your product moves from concept, through prototype all the way to regulatory submission. With our track record, experience, and comprehensive client services all backed by strong and professional project management, we can offer our clients a total solution to ensure that their product gains marketing authorization with FDA efficiently and smoothly.

Involved in PMTA
What's involved in a PMTA?
The final PMTA ruling  21 CFR Parts 1100,1107, and 1114 [Docket No. FDA-2019-N-2854] details the requirements companies must meet, and the evidence that must be submitted to demonstrate compliance with the final ruling. We have summarized these requirements in our 'A guide to PMTA?' brochure.
Product Formulation and Analysis
Manufacturing and Quality
Non-clinical studies
Human subject studies
Product Formulation and Analysis (Section (i))
Full disclosure of ingredients, materials, components, constituents (HPHCs), container closure system, formulation, nicotine formulation, product stability, design risks, principles of operation and product analysis.
Manufacturing and Quality (Section (j))
Full disclosure of manufacturing sites and their control processes, SOPs, design controls, employee training, management oversight, supply chain and its control/monitoring processes, complaint handling, non-conformance processes, corrective action processes, process validation, and finished product test procedures.
Health Risk Investigations (Non-Clinical and Clinical) (Section (k)(1)
Full study reports on health risks of product (constituent health effects, toxicological profile(s) of product(s) and ingredients/components, pharmacological profile of product(s), health risk of product(s), tobacco use behaviour studies, tobacco use initiation, perception studies, and human factors.

If you made a PMTA submission by September 9, 2020 to ensure your existing product could stay on the market, you may receive a Deficiency letter. Do you have the team in place ready for this stage? If not, now is the time to act.

Our 3-Phase Approach

Your assigned Project Manager will work with our team of scientific workstream lead experts to deliver your PMTA project through (i) Strategy Definition, (ii) Compilation and (iii) Submission.

3-Phase Approach
Phase 1. Strategy Definition

Strategy Definition is an important first step. For regulatory submissions, the Strategy Definition phase is where we build the project team, assess product and process readiness, create scientific strategies, mitigate risks and understand potential costs/timelines of your project before committing to the dossier compilation and submission.

During the Strategy Definition Phase we work with your team to understand your products, data and processes in order to compile a PMTA strategy and stakeholder Return on Investment (ROI) evaluation.

For new products requiring pre-market approval before entering the US market, Phase 1 includes tailored R&D activities for nicotine pouches, devices, e-liquids and e-liquid cartridges to optimize product design parameters through planned experimentation. Important scientific data is collated at this early stage to facilitate the regulatory strategy and scientific narrative across all workstreams.

Strategy Definition
Phase 2. Compilation

This stage involves the extensive compilation of scientific data. Your dedicated Project Manager will manage the full PMTA process on your behalf, liaising with experienced Workstream Leads in each of the 4 key compliance areas. Alternatively, companies with internal Workstream Leads can supplement their in-house capabilities with a tailored solution.

Manufacturing - Full disclosure of manufacturing sites and their control processes.

Product Formulation Analysis – Scientific product analysis and Chemistry Manufacturing and Controls (CMC) evaluation.

Health Investigation Non-clinical Studies – Detailed assessment of the toxicological and pharmacological profile of your products.

Health Investigation Human Subject Studies – Clinical studies undertaken with your specific products, in order to determine their potential impact on public health.

Studies undertaken in the 4 key compliance areas are highly inter-related - so timing and co-ordination of activities is critical to maximize synergies across the studies.

Scientific bridging strategies developed by our team of specialists will reduce the levels of testing and studies required in all areas, hence maximizing the cost-effectiveness of your PMTA.

Phase 3. Submission

The regulatory submission process consists of the collation, formatting and electronic publishing of the dossier to FDA. This dossier contains all scientific protocols, reports, line data, references, bridging strategies, clinical site information, manufacturing control and quality management system evidence, and supporting information. FDA has specific detailed requirements for the submission of dossiers. The Broughton team generate submission-ready documents for this purpose and submit them on your behalf.  

Tobacco Product Master Files

Under the FDA pathways for NGP marketing authorization, a Tobacco Product Master File (TPMF) can be a powerful tool in your dossier construction and filing strategy. This is a method by which you protect confidential information from any other partners in the manufacturing and testing of your product. In some cases, especially if you are filing for multiple products, a TPMF can store information that is common to all of your products ensuring that you do not have to repeat the same information. A TPMF has the added advantage in that it can be updated frequently, without any penalization to the timelines associated with the review of your application. However, once substantive scientific review of your dossier has commenced, updates to the TPMF cannot be made.

Have you received, or are anticipating receiving, a PMTA Deficiency Letter?

If you are anticipating a letter and require supplementary data to support your Premarket Tobacco Product Application Submission (PMTA), now is the time to act. Once a Deficiency letter is issued you will have 90 days to respond to Food and Drug Administration (FDA) – not a long time when you consider that your response is likely to require the generation and interpretation of data.

PMTA partners who understand your business

Our team of scientific and regulatory experts, backed by our in-house laboratory services, understand your specific challenges and opportunities. With expertise across global markets for tobacco-products, medical devices and pharmaceuticals, we are committed to working with you to increase the value of your business and create a smoke-free future.

Experienced approach

Industry-leading Workstream Leads with FDA consultation experience.

Integrated approach

Co-ordinated project management across all compliance areas.

Efficient approach

Scientific strategies that optimize cost-effectiveness and success.

Get Started on your PMTA Scientific Strategy Plan

Contact us to find out how we can help to drive your full PMTA program

PMTA strategy Plan


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