Moderator: Paul Cummings, General Manager, Smithers
 

Following the deadline for submission for PMTA in the US in September 2020, the market has altered as some companies have pulled out of the market or paused innovation while waiting for marketing approval from the FDA while others have filled perceived gaps in the sector. This presentation will look at the product mix of those applications which form the over 6m PMTA submissions currently being reviewed by the FDA and what this suggests about the future of the post-regulated market. In addition, it will look at trends which are in part caused by the regulatory uncertainty, from the growth of disposables and smaller pod devices, to the changing flavour preferences in response to increasing restrictions being imposed on flavoured products. It will also look at new alternatives to nicotine products such as heated tobacco, nicotine pouches and the cross-over with cannabis, and the impact this has on the vape market in the US.
 
Tim Phillips | Managing Director, ECigIntelligence

Panelists:

• David Ettinger – Partner, Keller & Heckman
• Eric Gu – Associate, Keller & Heckman
• Tim Phillips - Managing Director, EcigIntelligence
• Greg Conley – President, American Vaping Association

Moderator:

• Patricia Kovacevic, General Counsel and Chief Compliance Officer Consultant, Independent

Description
This panel will dive into a global discussion regarding the current ENDS Market – with special focus on the following markets:

• United States
• United Kingdom
• UAE
• China
• Australia
• Japan
• South Korea

The panelists will present different perspectives regarding challenges, regulations, and opportunities moving forward within the industry.
 

Moderator: Autumn Bernal, PhD, Founder & Principle, ToxCreative LLC

During the one-year period of September 9, 2020-2021, FDA took final action on over 6 million PMTAs for e-cigarettes.  Final actions included refuse to accept (RTA), refuse to file (RTF), and marketing denial order (MDO).  These actions provide insights into how FDA evaluates PMTAs for e-cigarettes.  It is important to understand what information is needed for a PMTA to be accepted and filed so that it can enter scientific review.  Once in scientific review, FDA focuses on whether marketing of an e-cigarette is appropriate for the protection of public health (APPH).  There are many factors that FDA weighs in evaluating an e‑cigarette PMTA to determine whether it is APPH or not.  Critically, FDA weighs the potential benefit of an e-cigarette to move smokers down the continuum of risk against the potential risk of an e-cigarette leading to youth use.  This presentation will discuss how FDA approaches our review of e-cigarette PMTAs.
Matt Holman | Director, Office of Science, FDA

Moderator: Paul Cummings, General Manager, Smithers

In order to keep their novel tobacco products on the market, hundreds of e-cigarette and e-liquid companies, big and small, submitted PMTAs to comply with a court-ordered September 9, 2020 deadline.   As of September 2021, the FDA issued marketing denial orders (MDOs) to 93% of these applications.  FDA focused the MDOs predominately on nontobacco and nonmenthol flavors.  The FDA stated the applications receiving MDOs “lacked sufficient evidence that these products have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.” 

Surprisingly, several companies received MDOs without ever receiving a deficiency letter or getting the opportunity to respond to a deficiency letter.  For many of these companies, tobacco and menthol flavored products are still pending a review.  As the FDA continues its review of the remaining products, some of companies may still receive deficiency letters for their tobacco and menthol e-cigarettes and e-liquids.  In this case, a deficiency letter is a gift. 

This Presentation will help you navigate the review process. We’ll explain how to read and interpret a deficiency letter and how to develop a response strategy. Don’t be caught unprepared, you don’t have to wait for that deficiency letter; we will outline what you can begin working on now. 
Willie McKinney Ph.D., DABT | CEO, McKinney Regulatory Science Advisors, LLC

• What types of data had (and hadn’t) companies submitted?
• What factors played into FDA thinking, and what were their expectations?
• What can we learn from the MDOs to inform future submissions?
• What about other products?

Additional Presenter:
Evan Richardson – Director, Regulatory Services, Synchrogenix

Following the receipt of a Marketing Order for their initial Electronic Nicotine Delivery Systems (ENDS) products, stakeholders will turn their attention towards the expansion of their product portfolios. Minimizing the costs – in time and money – to obtain a Marketing Order for these subsequent products will be a primary focus. Ultimately, stakeholders may find their testing, reporting, and Premarket Tobacco Product Application (PMTA) submission strategies evolve as their portfolios grow.
In this presentation, regulatory experts from Synchrogenix will discuss strategies to obtain PMTAs for similar products by leveraging the existing body of data to support the next round of PMTA submissions. Examples include the benefits of Tobacco Product Master Files (TPMFs), supplemental PMTAs, and bridging strategies. The usefulness of a forward-thinking and submission-focused approach in terms of study design, document preparation, and electronic Tobacco Technical Document (eTTD) structure will also be discussed.
Vivienne Tedesco-Ciavarra | Regulatory Services Manager, Synchrogenix

Moderator: Paul Cummings, General Manager, Smithers

Panelists:

• Eric Heyer – Partner, Thompson Hine
• Patricia Kovacevic, General Counsel and Chief Compliance Officer Consultant, Independent
• Chris Russell – Director of Russell Burnett Research and Consultancy Ltd
• Mark Anton – President, What A Smoke, LLC
• Greg Conley – President, American Vaping Association

This panel will discuss the Flavor Ban in the US and what it means for the future. A discussion about youth use, adult consumers, challenges in getting behind in technology and other areas from the rest of the world.