Smithers Rapra is pleased to announce the ENDS US 2017 Agenda:
Lucia Regan | Conference Producer, Smithers Rapra
The FDA recently released news on a long term plan for lower nicotine levels in tobacco products including ENDS and E-Cigs. You will have the opportunity to hear from the FDA Director of CTP and regulatory specialists in this segment.
Mitch Zeller, J.D. | Director, Center for Tobacco Products of FDA
The U.S. FDA recently announced its new "comprehensive regulatory plan to shift trajectory of tobacco-related disease, death" that refocuses the Agency's implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA's new strategy aims to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes. While the FDA has indicated that its long-term plan, among other things, is to potentially lower nicotine in cigarettes to non-addictive levels. It also made major changes to its compliance policy for recently "deemed" tobacco products that immediately impacts manufacturers of e-vapor, e-liquid, cigars, hookah, and pipe tobacco products. FDA Center for Tobacco Product Director Mitch Zeller will discuss FDA’s new comprehensive regulatory plan and the importance of various stakeholders working together.
Azim Chowdhury | Partner of Keller and Heckman LLP
Azim Chowdhury, Partner at Keller & Heckman LLP, will review the Tobacco Control Act requirements, deadlines and challenges that apply to e-cigarettes and vapor products, including: product registration, ingredient listing, health document submissions, labeling regulations, and Premarket Tobacco Application requirements.
David Graham | Chief Impact Officer of NJOY
This presentation will explore how ENDS regulation has multiple options ranging from idealistic to simplistic, and how the right balance needs to be struck to allow continued innovation in the interests of public health.
This session will be focusing on the way regulations impact the growth possibilities of the e-cigarettes industry in the market. It will also discuss the perspectives on managing current compliance, challenges and best practices.
Patricia I. Kovacevic | General Counsel and Chief Compliance Officer of Nicopure Labs LLC
This talk focuses attention on reviewing the latest developments in the regulatory landscape and the interest in working on harm reduction, specifically what does it mean for the industry and how to work together to provide safer products.
Dr. Ian M. Fearon | Principal Scientist and Head of Clinical Research of British American Tobacco
Large, multinational tobacco companies have invested heavily in developing e-cigarettes, as well as in fundamental research supporting the harm reduction potential of this technology. This panel session will examine the motives behind tobacco industry research and seek to explore whether their involvement is beneficial or detrimental to the category and the to the vaping industry as a whole.
Brittani Cushman | Vice President of External Affairs of Turning Point Brands, Inc.
This presentation will continue the discussion on how regulations could impact the ENDS industry and the distribution chain of products. In the coming years, companies and retailers will have to put their products under rigorous scrutiny given the newly proposed regulations and protocols they must comply with. It will be an interesting trajectory to follow because there is no doubt that E-Cigarettes and ENDS products are gaining space in the current market.
E-Cigarettes are not new in the industry but in recent years have gained notoriety for the capacity of technological development and research that open new possibilities and alternatives. Electronic Delivery Systems have emerged as an online leader in popularity among smoking alternatives in the U.S. and Canada. This session will evaluate health and legal implications. It will also review the historic landscape and current situation of e-cigarettes.
Jose Luis Murillo | Vice President Regulatory Affairs of Altria Client Services LLC
This session will emphasize the importance of tobacco harm reduction for public health, and discuss tobacco harm reduction in light of the FDA's newly announced plan to regulate tobacco and nicotine. Joe will also highlight work that remains to be done and talk about Altria's efforts to advance a harm-reduction strategy.
We have the opportunity to hear the science behind the polemic statement that promotes the use of electronic nicotine delivery systems and Non nicotine delivery systems as an effective and less harmful alternative to traditional tobacco and nicotine use. The panel will discuss what recent studies have been done and their findings.
John Bellinger | Co-Owner of Evolv
Product innovation drives towards increasing safety and health concerns from the manufactures to the consumer, guided by regulatory frame in an attempt to create a better product with a lower risk for the end consumer.
With the open dissemination in social network of information we are seeing new small producers of e-cigarettes as well as accessory producers participating in the market. These growths show the need for more information and follow-up to the right protocols that will guarantee public safety in the products for the final consumer.
Dr. Daniel Norwood | Executive Partner of SCIO Analytical & Senior Consultant at Smithers Rapra
This talk will review the process of approval and testing that new components and parts have to follow in order to be commercialized in the market. More than 460 different e-cigarettes brands are currently on the market such as: e-cigs, vapes, vape pens, etc.
Charles Ducker, Ph.D. | Principal Chemist/Group Leader of Eurofins Medical Device Testing
Eurofins is a worldwide leader in the analytical testing of new devices and will share their experience in navigating the regulatory water with these new nicotine delivery systems. The FDA extended their regulatory authority in 2016 to include all ENDS. Their current draft guidance for ENDS, published in May of 2016, indicates the need for extractables and leachables (E&L) data. Since the route of administration is through inhalation, ENDS are considered high risk based on the FDA’s E&L risk matrix. In order to satisfy the safety concerns of the regulatory agencies, manufacturers must perform an E&L evaluation to demonstrate that the device will not introduce harmful chemicals due to the storage and use of the product. Since the FDA has not offered guidance specific to the setup of E&L studies for ENDS, it is necessary to design a relevant study based on the intended use. A typical E&L study would include a reflux extraction coupled with a simulation study to look at real time storage and use conditions. This would be followed by a two pronged stability studies where both the liquid drug product and the vapor it produces would be tested on the shelf life of the product.
Glenn J. Myatt, Ph.D. | Chief Scientific Officer of Leadscope
This session is dedicated to presenting different case studies from pharmaceuticals and manufacturers to analyze diverse points of view, closing the conversation with a Q&A session for sharing experiences and ideas.
Tim Phillips | Managing Director of ECigIntelligence
Co-presented by Amy Madl and Autumn Bernal of Cardno ChemRisk
Dr. Fearon will be presenting the process for data acquisition in clinical studies for e-cigarettes and ENDS. His experience involves GCP compliant human studies examining the effects of novel nicotine and tobacco products and biological effects.
Christopher Russell | Senior Research Fellow, Behavioural Studies of Tobacco and Nicotine Use of Centre for Substance Use Research (CSUR)
This talk will complete the block on case studies, specifically focusing on the investigation and findings done on post-consumer experiences. When a clinical study for E-Cigarettes is required what are the important topics to take into account health wise and what are the findings.
We will bring presentations on the media impact, scientific advancements in research and innovations with the intention to take a panoramic view and discuss next steps in the Electronic Nicotine Delivery Systems and E-Cigarettes field.
Chris Howard | Vice President, General Counsel and Chief Compliance Officer of E-Alternative Solutions, LLC
This talk will cover how regulatory restrictions and media make it difficult for consumers to obtain accurate information about ENDS risks and benefits. Today we have all kinds of information in our hands as we grow more conscious about what we use and consume. Health information is fundamental for a product to get into the market, but what happens when the information is not available or the regulatory framework is not clear? This topic is very important since misjudgement and fear takes over the consumer perception and affects the industry in negative ways.
Linda Crumpler | Business Development Director of Cerulean
In the ENDS market the pace of new product development has been striking and regulation has followed this explosion of new products. Increasingly data on composition, construction, emissions and the consequences of these emissions has to be submitted to allow continued sales. The conflict presented by this fast evolving market landscape is that information requirements are separated from the methods of generating raw test data. It is clear that new methods of testing need to be developed. These can be informed by burnt down tobacco testing but should not slavishly follow the same methods if a more appropriate method can be developed for the ENDS industry. Two novel methods of testing are discussed. The first one that casts a new spotlight on in vitro exposure testing that is designed around ENDS products. The second method offers the prospect of real time chemical analysis of ENDS vapors. The key issue of validity of results and instrumental artifacts are discussed in depth as is where these new ideas can take us for the future when HNB products are considered.
Dr. Daniel Norwood and Members of the Advisory Board
After a journey of extensive information, exchange of knowledge, studies and ideas, everyone will gather together to see what comes next and the future outlook for ENDS and E-Cigarettes.