A PMTA (Premarket Tobacco Product Application) is a regulatory requirement for companies operating in the Electronic Nicotine Delivery Systems (ENDS) market who sell their products in the US. This article explains what’s involved in a PMTA, who this applies to and when, the potential benefits of a successful application and how to get started.
Does my ENDS business need a PMTA?
PMTAs are a requirement of the US Food and Drug Administration (FDA), who require companies to demonstrate that marketing of a particular tobacco-containing product is appropriate for the protection of public health. As ENDS products are tobacco-derived, nicotine-containing products, the requirement for a PMTA relates to this sector.
Whether your business produces e-liquids, aerosolizing apparatus or combined ENDS products – this applies to you. In some cases this requirement also applies to retailers, as our guide to the latest guidance issued by FDA on requirements for US vape shops explains. And, despite the word ‘Premarket’ in the name - this doesn’t just relate to new products being brought onto the market. It applies to existing products you intend to continue selling too.
What does a PMTA involve?
Full requirements are outlined in Final PMTA Guidance issued by the FDA. In summary, a PMTA is an extensive process which involves undertaking scientific studies and analysis in 3 key compliance areas:
1. Product analysis and manufacturing studies – Scientific product analysis and an evaluation of your manufacturing controls.
2. Non-clinical studies – Detailed assessment of the toxicological and pharmacological profile of your products.
3. Human subject studies – Clinical studies undertaken with your products, to determine their potential impact on public health.
These studies are detailed in a major product dossier submitted to the FDA. One PMTA submission typically relates to an application for a number of different products/SKUs (stock keeping units). Start to finish the process has a projected timescale of at least 10 months to achieve a validated submission.
Is there a deadline for PMTA?
PMTAs need to be submitted for new and/or existing products by May 12, 2020 to remain on the market after that date. Given the project timescale for studies and submission, you are advised to start planning your PMTA strategy as soon as possible.
How do I start my PMTA?
A PMTA will require significant commitment in terms of time and investment. Before you jump straight in, we suggest carrying out initial pre-studies to determine which of your existing products have the highest likelihood of success and identify any new product development needs. This information will then enable you to plan your full PMTA application more effectively, seek funding if required and understand the potential ROI of your PMTA.
Will a PMTA be worth it?
Do you intend to sell ENDS products in the US after May 2020? Or, are you preparing an ENDS business for sale? If the answer to either of these is yes, then PMTA is most likely already high on your priority list.
The size of the North American e-cigarette and vaping market is projected to reach USD 20 billion by 2025*. Due to the significant investment levels required for PMTA, it’s also likely that the number of companies in this growing market will reduce. So, the potential opportunity for businesses committed to this sector is clear.
PMTA partners for your business
Broughton offer a team of scientific and regulatory experts to manage the full PMTA process on your behalf. We’ll generate and compile the data you require, consult with the FDA, and submit your PMTA.
Your ENDS business is not generic, so neither is our approach. We’ll develop a strategy aligned with the specific requirements of your products and your business. Book a meeting with us today to discuss how you can get started.
*E-cigarette & Vaping - Global Market Size, Share & Trends Analysis (2018-2025) - ResearchAndMarkets.com