Tim Phillips will give an overview of the US vape and novel nicotine market as it continues to evolve, including:

• Key attributes of the current US market and comparisons to other global markets, the growth in disposables and the impact of a changing regulatory landscape
• Growth in disposables, the changing types of hardware products in the market, and how consumers and retailers treat these products
• What role does synthetic nicotine continue to play in the ENDS market in the US, and how will it evolve?
• Flavours are still an important part of the US market, how has this changed and what is the current position given the limited flavours approved through PMTA to date?
• Other nicotine products such as nicotine pouches have been growing rapidly in the US, and we expect heated tobacco to launch nationwide shortly - how will consumers use these products, and to what extent will multi-use of various novel nicotine products affect the growth of ENDS products ahead?
• What does the future hold for this sector? and how will the US market look over the next few years?

Tim Phillips | Managing Director, ECigIntelligence

The ENDS sector continues to develop and innovate so that it can move into new ventures and opportunities in line with technological and societal changes. This panel looks to explore the views and thoughts of participants for opportunities (and threats) for the sector.
 
Moderator: Tony Abboud, President, Strategic Government Solutions, Inc. and Executive Director, Vapor Technology Association

Panelists:

• Tim Phillips, Managing Director, EcigIntelligence
• Aimee Knight, Toxicology Manager, British American Tobacco
• Kevin Burd, CEO, Chemular Inc.
• Martin Steinbauer, Co-Founder, SMOOD

Despite the plain wording and explicit limitations of its Congressional mandate on vaping, FDA’s makeshift approach to the PMTA process has been a shape-shifting chimera. Even the agency’s own friends and leaders lament a punch-drunk progression that staggered from the concealed “Bundling & Bracketing” memo to the intransigent “Fatal Flaw” formula — with delays, post-facto rule shifts, double-talk, and secrecy marking the path. The only certainty throughout has been an incessant and unethical political pressure applied behind the scenes and the result is millions of market denials to 99 percent of applicants and 100 percent of flavors besides tobacco. How can responsible companies ever hope to complete a regulatory steeplechase so lethally rigged? Can the agency muster the integrity to recognize that flavors play an essential role for countless aspiring quitters of cigarettes or will it watch helplessly as black marketeers swamp the space? And what of ordinary consumers counting on their government to provide a reliable, accessible marketplace with the varieties we know can diminish deaths from smoking?
Amanda Wheeler | President, American Vapor Manufacturers Association

In this presentation, we will review the regulatory landscape facing ENDS Companies in the U.S. and offer a practical guide for compliance with the myriad of evolving regulations.
Dov Seewald | President & CEO, Seewald Consulting

Dr. Cecil will briefly discuss the review processes that CTP has followed for the past several years for PMTA reviews.  As part of that discussion, he will share common errors that have resulted in negative order letters.  These will be generic observations across millions of products, but represent the consistent issues seen in many applications.
Todd Cecil | Deputy Director, FDA

Abstract and Speaker TBD!

This panel will start with a presentation by Azim Chowdhury giving a detailed looked at current MDO and litigation updates and discussion points that are important for everyone to be aware of. It will finish out with a look at the current landscape, and an open discussion with the panelists on what should be expected based on the presentation points and more.
 
Presenter and Moderator: Azim Chowdhury, Partner, Keller & Heckman
 
Panelists:

• Patricia Kovacevic, General Counsel and Chief Compliance Officer Consultant, Independent
• Ben Haas, Partner, Latham & Watkins LLP
• Paul Blair, VP of Government Affairs, Turning Point Brands

 
More panelists to come!
Azim Chowdhury | Partner, Keller & Heckman

The best available evidence suggests that substitution of e‑cigarettes for tobacco smoking has the potential to prevent almost all the harm caused by smoking. Increased rates of e‑cigarette use in the population have been shown to be associated with significant increases in rates of smoking cessation at the population level, and adult smokers who use e‑cigarettes are more likely to attempt to quit smoking and more likely to succeed in quitting than smokers who don’t use e‑cigarettes. Yet, despite e-cigarettes’ harm reduction potential and demonstrated efficacy for helping people to quit smoking, around one in five U.S. adult smokers have never used an e-cigarette, and in recent years both the uptake of e‑cigarettes and the decline of smoking prevalence have slowed. Consequently, an opportunity to reduce harm to millions more adult smokers is under threat. This presentation will discuss the public health consequences of e‑cigarette regulatory and policy measures that have weakened or removed factors that historically have been key to smokers’ capabilities, opportunities, and motivation to try and continue vaping in place of smoking. In particular, this presentation will discuss how the substitutability of vaping for smoking, and the associated health gains to adult smokers, are being diminished by:

• Bans, restrictions, and denials of marketing authorizations for non‑tobacco flavored e‑liquids, which reduce the sensorial/experiential appeal of vaping.
• Tax increases on the cost of vaping products, which reduce the affordability of vaping and the cost‑saving associated with switching.
• Exposure to misinformation about e‑cigarettes and misleading coverage of e‑cigarette research studies, which increase smokers’ uncertainty about, and misperceptions of, the relative harms of vaping and smoking.

Christopher Russell, Ph.D | Director, Russell Burnett Research and Consultancy Limited

This panel will discuss the reasons why approximately 1‑in‑5 U.S. adult smokers have never tried using an e‑cigarette, and what can be done within the current regulatory framework to persuade, incentivize, and support millions more smokers to try vaping in place of smoking. The panel will discuss how best to increase uptake of e‑cigarettes and drive switching among subgroups of smokers who are at the highest and most imminent risk of developing or dying from smoking‑related diseases, and how best to divert young adult smokers out of smoking before smoking‑related harm has accumulated. Lastly, the panel will discuss how a mass migration from smoking to vaping among adults can be facilitated and impeded by the vaping industry, individual vapers and consumer/trade organizations, the FDA, NGOs, and researchers.


Moderator: Christopher Russell, Ph.D., Director, Russell Burnett Research and Consultancy Ltd.

 Panelists:
 

• Cheryl Olson, Owner, Cheryl K. Olson Sc.D, LLC
• Vicki Crowder, President & Co-Founder, Custom Technologies, Inc.
• Georgios (Yoryos) Alevizopoulos, MD, PharmD, PHD, DFP, Co-Founder and Executive Director, GEAM Advisors P.C.
• Neil McKeganey, Ph.D., Director, CSURES
• Ray Niaura, Interim Chair of the Department of Epidemiology, Professor of Social and Behavior Sciences, New York University

 
More panelists to come!
 
Christopher Russell, Ph.D | Director, Russell Burnett Research and Consultancy Limited