2019 ENDS US Agenda

Smithers is pleased to announce the ENDS US 2019 Agenda:

Day One | December 10

Registration & Exhibit Hall Opens

  1. Registration & Exhibit Hall Opens

  2. Opening Remarks

    Conference Producer: Starla Ford

Session I: Understanding the Regulatory Landscape

In this session, we will explore current and ongoing considerations for the ENDS marketplace

  1. Keynote Presentation To Be Confirmed!

  2. The View from The Ground – The Impact of Ongoing Regulatory Changes

    Schell Hammel | Owner & President of Vapor Bar

    Schelle Hammel will discuss challenges at the Municipal, state and federal level including the upcoming FDA deeming regulations date change, and what all that looks like from the ground level – i.e. Manufacturer and Vape Shop Owner.

  3. Presentation To Be Confirmed - PMTA Contentions

  4. Ongoing Litigation – Updates & Debrief

    Stacy L. Ehrlich | Partner of Kleinfeld Kaplan & Becker LLP

    Are you finding it difficult to keep up with all of the lawsuits against FDA relating to the deeming rule and PMTAs? This session will walk you through all of the significant legal challenges and explain in simple terms the current status and the potential implications of each case. 

  5. Networking & Coffee Break

Session II: Global Perspectives - Understanding Standards Development and Public Health Perceptions

This session will take a closer look at the standards and public health perceptions beyond the United States and around the globe

  1. Examining the bigger picture: global update on ENDS science and regulation

    Ian Fearon | Consultant of whatIF? Consulting Limited

    Outside of the US, we are seeing many developments in regulation and scientific knowledge, both positive and negative. This presentation will provide an overview of:

    • The global regulatory environment for ENDS and impacts on availability and marketing
    • Worldwide responses to US developments
    • Scientific studies supporting a role for ENDS in tobacco harm reduction
    • A future perspective; what are we likely to see in the future?
  2. The History & Challenges Faced by the CORESTA EVAP Sub-Group in Developing Standards for E-cigarettes

    Eduardo Berea | Board Member of CORESTA and EVAP Group

    CORESTA is an international association dedicated to collaborative scientific work on tobacco and its derived products. 29 Working groups cover crop breeding to consumer behaviour, agricultural guidelines to toxicology assessment, sustainability to analytical method development for combustible and next generation products. In the EVAP Group, formed in 2013, over 45 organizations, e-cig. and e-liquid producers, academia, regulators, equipment suppliers and laboratories develop standardized methods for e-cigarettes. In 2014, after publishing documents on product definitions and terms to support harmonisation of nomenclature, the group standardized the generation and collection of e-cigarette aerosols (2015), which was the basis for ISO 20768. In 2017, the group produced a method for the routine determination of PG, VG, water, and nicotine in the aerosol of e-cigarettes, subsequently developed into ISO 20714. To support these methods, a guidance document was published on collection strategies for a wide range of e-cig. types and another for the generation of aerosol samples under intense puffing conditions. EVAP’s current work focuses on analysis of target compounds in e-liquid and aerosol through collaborative studies on methods for the analysis of carbonyl compounds and metals. This presentation will review the history and challenges faced when developing standardized methods, as well as key learnings and current discussion within the group.

  3. Presentation Pending Approval

  4. Lunch & Networking Break

Session III: Working “Smart”, Not Hard - An Examination of PMTA Testing Strategies

This session will take a deeper dive into maintaining regulatory compliance, including "smart" testing strategies to fulfill PMTA requirements

  1. Presentation To Be Confirmed

  2. In Vitro Testing of Vape Products: An Overview of the Methods Often Used in Preparing FDA Premarket Tobacco Product Applications

    Jeff Ballin, PhD | Study Director/Principal Investigator of Battelle

    To create, modify or market an electronic nicotine delivery system (ENDS), e-cigarette, e-juice, vape juice or vape flavor ingredients, manufacturers must comply with the newly released FDA tobacco regulations and pursue Premarket Tobacco Product Application (PMTA) testing. A vape shop or ENDS retail business that prepares or mixes combinations of flavors, liquid nicotine or e-liquids for direct consumer use in ENDS meets the definition of a tobacco manufacturer and is therefore subject to PMTAs. The PMTA Final Guidance recommends a full assessment of the toxicological and pharmacological profiles of the new tobacco product, including ENDS and e-liquids. FDA supports minimizing animal inhalation toxicology studies and is increasingly encouraging applicants to rely more on “in vitro” studies to evaluate the genotoxic potential of the ENDS in comparison to other tobacco products. An overview of the in vitro toxicology methods, which are commonly applied in PMTAs, and what the assays say about the safety of a product will be discussed. In vitro testing is complex, and manufacturers should have a strategy for the in vitro work before pursuing a PMTA. This presentation offers insights that inform the in vitro testing portion of the application package to the FDA.

  3. A Quick and Effective Approach to Determining if a Product Would Likely Receive PMTA Authorization

    Derek Beauchamp | Senior Technical Director of Analytical Sciences of Avomeen Analytical Service

    With the final guidance and due dates established by the FDA, E-liquid and ENDS device manufacturers are determining which products to complete PMTAs for. Most companies are choosing their best selling products to put through a PMTA initially, while others are selecting products that have a higher likelihood of being granted a PMTA authorization. Deformulation will allow an e-liquid manufacturer to understand if there any ingredients present in the formulation that are of concern and would likely result in an unsuccessful PMTA application. For a fraction of the cost of a PMTA, manufacturers can gather relevant and pertinent information about the likelihood of a being approved for a PMTA. Performing R&D activities to deformulate and understand what is in the product formulation is a valuable strategy when evaluating product viability for PMTA authorization. Deformulation of a product, also known as “chemical reverse engineering”, is the process of analytically breaking down a material or product’s formulation to separate and determine the specific identity and exact quantity of both its major and minor constituent components. This process can be vital to a wide range of scenarios such as identifying hazardous components in consumer products, determining potential patent infringement, or improving competitive positioning of existing or new product(s).

  4. Networking & Coffee Break

Session IV: Vapor and Flavors – Is There a Path Forward?

  1. Presentation Pending Approval

  2. Application of a multi-layer systems toxicology framework for in vitro assessment of the biological effects of Classic Tobacco e-liquid and its corresponding aerosol using an e-cigarette device with MESH™ technology

    Nikolai Ivanov, Ph.D. | Global Head of Biomarker & Biosensor Research of Philip Morris International R&D Innovation Cube

    We previously proposed a systems toxicology framework for in vitro assessment of e-liquids. The framework starts with the first layer aimed at screening the potential toxicity of e-liquids, followed by the second layer aimed at investigating the toxicity-related mechanism of e-liquids, and finally the third layer aimed at evaluating the toxicity-related mechanism of the corresponding aerosols. In this work, we applied this framework to assess the impact of the e-liquid MESH Classic Tobacco and its aerosol compared with that of cigarette smoke (CS) from the 3R4F reference cigarette. The results showed that the cytotoxicity of the MESH Classic Tobacco liquid was similar to the Base liquid but lower than 3R4F CS TPM at comparable nicotine concentrations. Relative to 3R4F CS exposure, MESH Classic Tobacco aerosol exposure did not cause tissue damage and elicited lower changes in the mRNA, microRNA, and protein markers. In the context of tobacco harm reduction strategy, the framework is suitable to assess the potential reduced impact of electronic cigarette aerosol relative to CS.

  3. A Crazy Ride – ENDS Compliance and What We Can Expect

    Chris Howard | VP, General Counsel and Chief Compliance Officer of E-Alternative Solutions (EAS)

    Chris Howard, Vice President, General Counsel and Chief Compliance Officer of E-Alternative Solutions, LLC will discuss FDA compliance – how we got where we are and where the industry might be headed.  Chris will discuss the Deeming Rule and the torturous path the industry has been on since 2016 specifically focusing on flavored ENDS products and the PMTA process.  More specifically, he will provide insights on how the proposed federal flavor ban came about – the perceptions and realities that lead the industry to this place – and what we might expect in the future.  On PMTAs, Chris will discuss the Maryland Court decision implementing a 10-month compliance period, what this means for the industry and how this deadline might play out.  Finally, Chris will provide some insights on these issues impacts and where the industry may be headed from here.

  4. Panel Discussion – Are flavors going to be viable moving forward?

  5. Closing Remarks

  6. Evening Welcome Reception

Day Two | December 11

Exhibit Hall Opens

  1. Opening Remarks

    Conference Producer: Starla Ford

Session V: Public Health Concerns and Societal Perception - Communicating Sound Science

  1. Communicating with Public Health Associations: avoiding pitfalls and finding ways to speak credibly

    Cheryl K. Olson, Sc.D. | Health Behavior Consultant of -

    The narrative around vaping, initially so full of hope and promise, has taken a wrong turn. Industry and public health people can seem like mistrusting, warring tribes. How can we open up cracks in hardening misperceptions and start real conversations?  To start, replace the “Big Tobacco” image with human faces and stories, explain the reasoning and motivations that led you to work with modified-risk products, and use qualitative research to guide new conversations. 

  2. Presentation To Be Confirmed

  3. Presentation Pending Approval

  4. Networking & Coffee Break

Session VI: Health Risk Assessments and Behavioral Testing Strategies

  1. Rates and Predictors of Past 30-Day Abstinence from Cigarette Smoking in a Cohort of Adult Established Smokers Who Used a JUUL Vaporizer for Twelve Months

    Christopher Russell Ph.D. | Deputy Director of Centre for Substance Use Research (CSUR)

    Assessing the effect of JUUL vapor products on adult smokers’ use of conventional tobacco cigarettes can help inform the potential population health impact of these products. Methods: Participants were 15,456 adult established current smokers in the United States recruited at their first purchase of a JUUL Starter Kit in a retail or e-commerce store. Online surveys assessed past 30-day use of conventional cigarettes, JUUL vapor products, and other vapor products at 3, 6 and 12 months after this first JUUL purchase. Results: Past 30-day point prevalence abstinence from cigarette smoking at 12 months was 32.3% in the intent-to-treat (ITT) sample, and 58.6% among respondents to the 12-months survey (n=8,511). Consecutive past 30-day smoking abstinence outcomes at 3, 6 and 12 months were reported by 15.1% of the ITT sample and 39.1% of respondents to all surveys (n=5,963). Odds for reporting past 30-day smoking abstinence at 12 months were significantly higher among past 30-day primary users of Mint or Mango flavored JUULpods, exclusive users of JUULpods in characterizing flavors, and daily users of the JUUL vaporizer. Conclusions: Around 15% of a large cohort of adult new users of a JUUL vaporizer were past 30-day abstinent from cigarette smoking at 3, 6 and 12 months after their first JUUL purchase. Primary use of JUULpods in characterizing flavors appeared to be important to adult smokers’ chances of having completely switched to using a JUUL at 12 month

  2. How to Apply Human Factors Studies to Address PMTA Guidelines

    T. Grant Leffingwell | Senior Research Scientist, Human Factors of Battelle

    PMTA guidance states that human factors considerations and analyses should include studies that identify normal use and foreseeable misuse by product users and nonusers in different environments. The guidance recommends that manufacturers first identify use-related hazards and risks associated with use errors, and subsequently identify risk controls to ensure the minimization of harms and adverse experiences. While the guidance offers good insight, it does not prescribe how companies should go about acquiring this information. Addressing these considerations requires expertise that goes beyond just typical preference-based market research for consumer and business purposes. Human factors activities include a variety of comprehensive analyses along with controlled, scientific studies of people interacting with and using the product. The focus of these activities is to evaluate the safety, risk, and usability associated with the product and its use. These activities are necessary in order to be compliant with the guidance. This presentation will describe different types of human factors activities and how they align to the information recommended in the PMTA guidance. Topics to be addressed include: user and use environment research, task analyses, normal use and foreseeable misuse risk analyses (including failure modes and effects analysis or uFMEAs), formative usability and label comprehension studies, and human factors validation studies.

  3. The Product Use and Behavior (PUB) Instrument: A Novel Approach to Assessing ENDS Use and Topography

    Dr. Jeffrey S. Smith | Master Scientist- Clinical Studies Division of Reynolds American Inc. (RAI)

    The use of electronic nicotine delivery systems (ENDS) has increased dramatically over the last decade. However, during this same period of time, there has been little empirical evidence to describe how consumers use these new products. One reason for this scarcity of data is that techniques and approaches used to collect topography (puff) characteristics have yet to catch up with the changes in format and function of new ENDS products. RAI Services Company has developed a new approach that will assess ENDS topography use characteristics in both controlled (in-clinic) and naturalistic (ambulatory) environments.

    The Product Use and Behavior (PUB) instrument records the periods of product activation over a continuous period of use with limited impact on how the consumer interacts with the ENDS product. This new approach provides data on puff duration, inter-puff interval, total number of puffs, battery characteristics (voltage/current), and orientation of the ENDS product during use, as well as how these characteristics vary across use sessions in the form of cumulative use patterns over time.

    The analysis of the voluminous amount of data generated by the PUB instrument requires novel approaches to evaluation of time-series data in an unbiased manner. Additionally, data captured by the PUB instrument may also be used to estimate mouth level exposure (eMLE) per puff, per session and over product use periods.

    The PUB instrument produces data that provides additional insights into how consumers interact with, and use, ENDS products.

  4. Lunch & Networking Break

Session VII: New Products and Emerging Technology: HNB, CBD, and More

  1. A Close Look at Heated Tobacco: How the Category Has Developed Internationally and How It Could Affect the US market

    Stavroula Anastasopoulou | Senior Market Analyst of ECigIntelligence

    ECigintelligence will share estimates of the impact of the US vape crisis on Europe and the global vape market. We will provide a summary of the HT category development globally after which we´ll share results from recent surveys which show if IQOS has the chance to capitalise on the vape crisis in the US.

  2. Temperature sensing and control solutions for ENDS

    Viren Pathare | Vice President & General Manager of Heraeus Nexensos USA

    Temperature sensing and control are THE key to harm reduction in Electronic Nicotine Delivery Systems (ENDS). In THPs (tobacco heating products) and HNBs (heat not burn) products, controlled heating enables flavor and aerosol transport while preventing combustion; the major cause of harmful and potentially harmful (HPHC) chemicals. In liquid based ENDS temperature control is the key to avoiding the ‘dry wick’ phenomenon; the major cause of HPHCs.

    Heraeus Nexensos is the world leader in platinum resistance temperature detectors (RTDs). We have worked with major ENDS manufacturers to develop temperature sensors and heaters for potentially reduced risk products (PRRPs).

    This presentation will describe the use of RTDs and Pt heaters in ENDS and describe many new thermal management options available for designers for harm reduction. Platinum RTDs are best suited for critical temperature measurement because of their higher precision over the full temperature range (ambient – 300°C and more). The other advantage is the low signal drift of platinum elements which provides high reliability over thousands of heating cycles.

  3. Pathways to Cannabis/CBD legalization and FDA regulation of the industry

    Patricia I. Kovacevic | Global Legal & Regulatory Strategist of Regulation Strategy

    Flavored nicotine vaping products have come under scrutiny, as have vaping products containing THC and other substances. CDC and FDA have proclaimed an "epidemic”, however, the CBD and cannabis industries rightfully continue to expect pathways to legalization at federal level. Drawing upon FDA's experience with inhaled nicotine products, what will the pathway to legalization look like and what is FDA's current and anticipated regulatory approach to CBD/cannabis products, in particular vaping products? What should a responsible CBD/cannabis company undertake proactively to mitigate regulatory and litigation risk?

  4. Presentation Pending Approval - New Vapor/Heat-Not-Burn Technology

  5. Presentation To Be Confirmed

  6. Closing Remarks and Farewell Advisory Board