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Session I: Market Updates + Current Trends
< Session Description >
Moderator: Paul Cummings, General Manager, Smithers
The US vape market: disposables, new nicotine alternatives, and changing trends in a post-PMTA landscape
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
PANEL: Global ENDS Market Discussion
  • David Ettinger – Partner, Keller & Heckman
  • Eric Gu – Associate, Keller & Heckman
  • Tim Phillips - Managing Director, EcigIntelligence
  • Greg Conley – President, American Vaping Association
  • Patricia Kovacevic, General Counsel and Chief Compliance Officer Consultant, Independent
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.
Networking Break
Session II: Understanding the Regulatory Landscape
< Session Description >
Moderator: Autumn Bernal, PhD, Founder & Principle, ToxCreative LLC
What You Should Know About FDA Regulation of E-Cigarettes
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
Lunch Break
Session III: Premarket Tobacco Applications: A Helpful Guide
< Session Description >
Moderator: Paul Cummings, General Manager, Smithers
The FDA gifted you a PMTA deficiency letter … what now?
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
A Scientific Assessment of Marketing Denial Orders (MDOs)
  • 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?
Don’t Reinvent the Wheel: How to Expand Your Product Portfolio the Smart Way
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
Session IV: ENDS + Efficacy
< Session Description >
Moderator: Paul Cummings, General Manager, Smithers
Panel: A Breakdown of the Flavor Ban + The Challenges that it Brings
  • 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.
Closing Remarks
Session V: Tobacco Harm Reduction – Diverging Perspectives
< Session Description >
Moderator: Sarah Cooney, Head of Scientific Collaboration and Communication, British America Tobacco
PANEL: ENDs + Public Health Coming Together
  • Ray Niaura – Interim Chair of the Department of Epidemiology – Professor of Social and Behavior Sciences, New York University
  • Charles Gardner – President, INNCO
  • Jim Solyst – Principal, JMS Scientific Engagement
  • Sarah Cooney, Head of Scientific Collaboration and Communication, British America Tobacco
Networking Break
Session VI: The Future of ENDs
< Session Description >
Moderator: Autumn Bernal, PhD, Founder & Principle, ToxCreative LLC
Recycling and how ENDS will need to become sustainable for future generations.
Presented by Bidi Vapor and their quest to create a sustainable ENDS future for the Bidi Stick.
Russell Quick | QRx Digital’s CEO and the contracted Global Marketing Director , Bidi Vapor
Synthetic Nicotine – How FDA Could Regulate This Growing Segment of the Vape Industry
FDA’s regulation of nicotine, prior to the Tobacco Control Act, goes back decades. With the passage of the TCA, FDA was granted new authority to regulate products that contain tobacco-derived nicotine as tobacco products. But what authority might FDA have over non-tobacco derived or “synthetic” nicotine? As more companies seek alternatives to tobacco-derived substances, the synthetic nicotine market has exploded in recent months. This presentation discusses the potential legal ramifications and what companies in this space need to be aware of.
Azim Chowdhury | Partner, Keller & Heckman
PANEL: A Look into the Future Landscape
  • Peter Beckett – Co-Founder and Director of Strategy,
  • Monica Schick – Senior Consultant, North Guide Solutions
  • Amanda Wheeler – President, American Vapor Manufacturers Association
  • Ian Fearon – Director, Whatif Consulting
  • Chris Allen - Chief Scientific Officer, Broughton Nicotine Services
  • Autumn Bernal, PhD, Founder & Principle, ToxCreative LLC
  • Discuss new products, technology, and the expansion of the market landscape
  • Potential opportunities and growth as we move the market further
  • Expand on challenges within the market, i.e. flavor ban, regulations, etc.
  • Bring to the forefront any big conversations or discussions that were seen within the workshop
Closing Remarks and Farewell