As we predicted might happen in our recent article titled Maryland ruling – will this bring the PMTA deadline forward?, a Court for the District of Maryland has ordered that appropriate new tobacco products on the market in the US, as of August 8, 2016, must file a Premarket Tobacco Product Application (PMTA) by May 12, 2020. Here we provide an overview of the latest developments and offer advice to US companies in the Electronic Nicotine Delivery Systems (ENDS) market, who now face the challenge of this accelerated compliance deadline.
How ‘final’ is the new deadline?
On July 11, 2019 it was ordered that:
1. The FDA (Food and Drug Administration) shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming rule (“New Products”), applications for marketing orders must be filed within 10 months of the date of this Memorandum Opinion and Order;
2. New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion;
3. New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;
4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.
This decision could be appealed, however it’s considered unlikely. The public health groups who filed the lawsuit concerned have won in principal. Meanwhile, FDA achieved the revised 10-month deadline they requested (and avoided an even shorter 4-month deadline requested by the public health groups). So, in a sector which has previously seen significant levels of uncertainty, clarity has now been provided in the bitter-sweet form of a shortened deadline.
Why 10 months?
Well, it appears that a compromise may have been reached. The Memorandum Opinion states:
“Balancing the need to address the existing public health crisis among today’s youth, which both parties acknowledge, and the need to avoid creating an additional public health crisis if e-cigarette availability dropped so precipitously as to push users to combusted tobacco products, and considering both the FDA’s laudable efforts to guide the premarket approvals process and the Industry’s lack of effort to obtain approval without an imminent deadline, I will impose a ten-month deadline for submission and a one-year deadline for approval, as the FDA suggested.”
It’s clear that a generalized opinion appears to have been formed of the collective ENDS industry, which has been said to have apparently taken “every available dilatory measure to keep its products on the market without approval”. Many will feel this is an unfair representation of the sector, made up of mainly responsible companies who have been preparing for such a deadline for years. As the Memorandum of Opinion quotes “ENDS manufacturers have not just sat around. They have done what they can to prepare for the PMTA process..”.
So, what now?
Whatever your opinions about the latest ruling, now is not the time to ruminate and speculate – now is the time to proceed proactively to secure your future business continuity and success.
To add to the challenge, there’s no ‘one size fits all’ solution to the route ahead. As the Memorandum of Opinion comments “ENDS manufacturers come in different shapes and sizes, with vastly different levels of resources to devote to trying to anticipate what FDA would require”. However, if you haven’t already done so, it’s highly recommended that all ENDS companies planning to submit a PMTA, identify their most commercially important products, establish investment availability and secure a team of PMTA partners and advisors as soon as possible. In an industry where the number of specialist Contract Research Organizations (CROs) qualified to undertake the required studies is highly limited, the importance of the latter should not be under-estimated. Also, when time is restricted, having the right skills, experience and expertise on board is likely to be critical to your likelihood of success.
Is 10 months enough time?
In short, yes – however, prioritization is a word that will most likely be utilized a lot over the next 10 months. As we’d already predicted the deadline might be brought forward as a result of the Maryland Ruling, our team have already established what a 10 month strategy would look like. We’ve identified the studies that are likely to be essential for your business to achieve a validated PMTA submission. Hence our strategy involves focusing on these studies, and then supplementing your submission with additional data during the 12 month review period. This is the most appropriate approach to take, given that the total number of studies cannot effectively be completed within the next 10 months e.g. product stability assessments. An efficient approach will be required, based on sound scientific rationale and regulatory expertise.
We’ve got this.
Broughton are a Contract Research Organisation providing analytical, scientific and regulatory support to businesses in the e-cigarette sector. Our integrated project management team deliver the full PMTA process on your behalf, across all compliance areas, enabling you to increase the value of your business and advance a smoke-free future.
Information regarding our Accelerated PMTA strategy will be communicated on our website soon. Meanwhile, if you’re looking for assistance with selecting products, confirming costs, or prioritizing next steps for your business contact our team. Now is the time.