Companies in the Electronic Nicotine Delivery Systems (ENDS) sector in the US are required to submit a Premarket Tobacco Product Application (PMTA) 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 Nicotine Services is dedicated to helping businesses secure a future market share in this rapid-growth sector.
The final PMTA ruling 21 CFR Parts 1100, 1107, and 1114 [Docket No. FDA-2019-N-2854] details the requirements ENDs companies must meet, and the evidence that must be submitted to demonstrate compliance with the final ruling. We have summarized these requirements in our ‘What is a PMTA?’ article.
The process of seeking marketing authorization is extensive but can be broken down as follows:
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, human factors.
Detailed literature review on subject areas listed within (k)(1)
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. Find out more here.
Broughton Nicotine Services understand that compiling a regulatory submission requires substantial resource and specific expertise. We have drawn on our experience within all the key workstream areas to develop a simple pathway with the aim of achieving a successful PMTA submission.
Your assigned Project Manager will work with our team of scientific workstream lead experts to deliver your PMTA project through (i) Planning, (ii) Compilation and (iii) Submission.
Phase 1. Planning
Planning is an important first step. For regulatory submissions the planning 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 Planning 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 products currently on the market, your PMTA strategy will include recommendations regarding products most likely to achieve PMTA success.
For new products requiring pre-market approval before entering the US market, Phase 1 can also include tailored R&D activities for device, e-liquid 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.
Consultation and engagement with FDA can be an important activity of Planning. Our experienced Workstream Leads will create communication strategies to collaborate with FDA and the public health communities. We advise clients on the design and execution of studies that support regulatory submissions.
Phase 2. Compilation
This stage involves the extensive compilation of scientific data. Your assigned 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 a Chemistry, Manufacturing and Controls (CMC) evaluation, undertaken by our Contract Research Organization (CRO).
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 ENDS 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 Nicotine Services team generate submission-ready documents for this purpose and work closely with the FDA? submission lead to ensure dossiers are accepted on first submission.
Broughton Nicotine Services operate exclusively in the ENDS sector. Our team of scientific and regulatory experts, backed by our in-house, custom-built Contract Research Organisation (CRO) facility, understand your specific challenges and opportunities. With expertise across US and EU markets for tobacco-products, medical devices and pharmaceuticals, we are committed to working with you to increase the value of your business and advance a smoke-free future.
Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.