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Project Information

Project Information


Review of the Health Effects of Electronic Nicotine Delivery Systems (ENDS)


Project Scope:


An ad hoc committee under the auspices of the
Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine shall be convened to evaluate the available evidence of the health effects related to the use of electronic nicotine delivery systems (ENDS) and identify future federally funded research needs. As part of its work, the committee will conduct a comprehensive and systematic assessment and review of the literature.  The literature review shall include analysis of data on both short and long-term health effects in:


--users of ENDS, including health effects associated with the use of the full range of these devices (e.g., "cig-a-likes," tank systems, mods);

--vulnerable populations of users (e.g., youth, pregnant women, individuals with underlying medical conditions (e.g., heart disease, pulmonary disease));

--nonusers of ENDS exposed to secondhand and thirdhand aerosol generated by use of these devices.

The committee's report will document the findings and provide a list of recommendations for future research. The list of research needs to inform FDA and ENDS regulation will be prioritized with respect to:

--research to gather information of most importance for the regulation of ENDS to protect the population health;

--research that should be a priority for federal funding.

Status: Completed

PIN: HMD-BPH-16-02

Project Duration (months): 18 month(s)

RSO: Stratton, Kathleen

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 02/16/2017

David L. Eaton - (Chair)
David Eaton is the dean and vice provost of the Graduate School at the University of Washington and professor of Environmental and Occupational Health Sciences and of Public Health Genetics. Dr. Eaton’s research has focused on the metabolism of drugs and environmental carcinogens. He is interested in determining how useful animal toxicity testing data are to predicting human response, as well as understanding how individuals may differ in their susceptibility to cancer-causing chemicals. He served as president of the Society of Toxicology, as vice-president of the Toxicology Education Foundation, and on the Board of Trustees of the Academy of Toxicological Sciences, of which he is an Elected Fellow. He previously served on seven committees convened by the National Academies of Sciences, Engineering, and Medicine on a variety of environmental health topics. Dr. Eaton received his Ph.D. in pharmacology from the University of Kansas Medical Center. He is an elected member of the National Academy of Medicine.
Anthony Alberg
Anthony Alberg is the Blatt Ness Endowed Chair in Oncology, Professor of Public Health Sciences, and the Associate Director of Population Sciences of the Hollings Cancer Center at the Medical University of South Carolina. Dr. Alberg is an epidemiologist whose research focuses on non-melanoma skin cancer, cigarette smoking, health effects of secondhand smoke, etiology of tobacco-associated malignancies, and tobacco prevention and control. He currently serves on the Cancer Screening and Prevention Editorial Board of NCI’s Physician Data Query, as the Chair-Elect of the Cancer Prevention Committee of the American Society of Clinical Oncology and has served as editor for the Epidemiology Section of the American College of Chest Physician’s Lung Cancer Guidelines II and III, associate editor of the American Journal of Epidemiology, and has been a contributing author to two US Surgeon General’s Reports on the Health Consequences of Smoking. In South Carolina, he is a member of the state’s Cancer Control Advisory Committee (CCAC) and chair of the CCAC’s Cancer Surveillance Committee. He has previously served on the National Academies committee addressing the health implications of raising the minimum age for purchasing tobacco products. Dr. Alberg received his M.P.H. from Yale University School of Medicine and his Ph.D. from the Johns Hopkins University Bloomberg School of Public Health.
Maciej Goniewicz
Maciej Goniewicz is an associate professor of Oncology at the Department of Health Behavior, Roswell Park Cancer Institute in Buffalo, NY. Dr. Goniewicz’s primary research area is in nicotine pharmacology, with a focus on nicotine dependence and smoking cessation. He has research experience in smoking cessation behavioral treatment, pharmacotherapy, and pharmacokinetics in both clinical and community-based settings. His current research is focused on new nicotine-containing products and alternative forms of tobacco. These studies include the laboratory evaluation of the products, pharmacological and toxicological assessment, surveys among their users, and their potential application in harm reduction and smoking cessation. Dr. Goniewiez received his Pharm.D. and Ph.D. in Toxicology and Pharmacology from the Medical University of Silesia, Poland.
Adam Leventhal
Adam Leventhal is an associate professor of preventive medicine and psychology at the University of Southern California. Dr. Leventhal is a clinical psychologist who conducts longitudinal cohort research, laboratory studies, and clinical trials. Major foci of his work include adolescent and young adult substance use; comorbidity between psychiatric disorders and addiction; e-cigarette use and tobacco regulatory science; addiction psychopharmacology and genetics; and addiction among populations subject to health disparities (e.g., African Americans, women). He directs the University of Southern California Health, Emotion, & Addiction Laboratory (USC-HEAL), a multidisciplinary team of scholars, staff, and students that supports scientific and educational activities in the health promotion and disease prevention field. Dr. Leventhal received his M.A. in psychology and Ph.D. in clinical psychology from the University of Houston.
Jose E. Manautou
José E. Manautou is a professor of Pharmacology & Toxicology and interim chair of the Department of Pharmaceutical Sciences at the University of Connecticut School of Pharmacy. Dr. Manautou’s research interests include target organ toxicity, hepatic detoxification and disposition mechanisms, and hepatotoxicants and interference affecting susceptibility to chemical injury. He is a former Councilor of the Society of Toxicology and of the society's Mechanisms Specialty Section. He previously served on a committee of the National Academies addressing health risks of trichloroethylene. Dr. Manautou received his Ph.D. in Pharmacology and Toxicology from Purdue University School of Pharmacy.
Sharon McGrath-Morrow
Sharon McGrath-Morrow is a professor in the Department of Pediatrics at the Johns Hopkins School of Medicine with a joint appointment in the Department of Environmental Health Sciences at the Bloomberg School of Public Health. Dr. McGrath-Morrow is also the Johns Hopkins Pediatric Pulmonary Fellowship Director, a fellow of the American Academy of Pediatrics and a member of the American Academy of Pediatric Tobacco Consortium. She is a pediatric pulmonologist and clinician scientist who runs a translational laboratory modeling neonatal lung injury. Her research interests include understanding the neonatal immune response to acute lung injury, respiratory outcomes in preterm infants with chronic lung disease and the impact of secondhand and thirdhand smoke on postnatal lung growth and adult lung function. Dr. McGrath-Morrow received her M.D. from the University of Virginia.
David Mendez
David Mendez is an associate professor in the Department of Health Management and Policy at the University of Michigan, School of Public Health. His research focuses on the application of mathematical/computational models for public health policy, particularly in the field of tobacco control. He has conducted research on the impact of tobacco control policies on smoking prevalence and health outcomes. He has also been involved in research to evaluate policies regarding residential radon and the uptake of the HPV vaccine. He is currently engaged in a study to evaluate the impact of peer pressure on smoking uptake among teenagers using systems dynamics and agent-based models. He served on a prior committee of the National Academies assessing agent-based modeling in tobacco control. Dr. Mendez received his M.S. in applied statistics, M.S. in operations research/systems science and Ph.D. in management science from Michigan State University.
Richard Miech
Richard Miech is a research professor at the Survey Research Center, Institute for Social Research, University of Michigan. Previously Dr. Miech had been a professor and department chair in the Department of Health and Behavioral Sciences at the University of Colorado Denver. His work focuses on trends in substance use, with an emphasis on disentangling how these trends vary by age, historical period, and birth cohort membership. His research interests also include the causes and consequences of substance use over the life course. Dr. Miech received his M.A. and Ph.D. in sociology from the University of North Carolina at Chapel Hill and a M.P.H. from Johns Hopkins University.
Ana Navas-Acien
Ana Navas-Acien is a professor of Environmental Health Sciences at Columbia University Mailman School of Public Health. Dr. Navas-Acien’s research investigates the long-term health effects of widespread environmental exposures (arsenic and other metals, tobacco smoke, air pollution), their interactions with genetic and epigenetic variants, and effective interventions for reducing involuntary environmental exposures. For more than 10 years, she has been working on environment-related research in population-based cohort studies such as the Strong Heart Study, a study of cardiovascular disease and its risk factors in American Indian communities, and the Multi-Ethnic Study of Atherosclerosis (MESA), a study of cardiovascular, metabolic and lung disease in urban settings across the US. She has served on National Academies committees addressing inorganic arsenic and the scientific capabilities of the U.S. Environmental Protection Agency. Dr. Navas-Acien received her M.D. from the University of Granada, M.P.H. from the National School of Health, Madrid, Spain, and Ph.D. from Johns Hopkins University.
Kent E. Pinkerton
Kent Pinkerton is a professor in the Department of Pediatrics in the School of Medicine and the Department of Anatomy, Physiology, and Cell Biology in the School of Veterinary Medicine at the University of California, Davis. Dr. Pinkerton also serves as director of the University's Center for Health and the Environment. Dr. Pinkerton’s research interests focus on the health effects of environmental air pollutants on lung structure and function, the interaction of gases and airborne particles within specific sites and cell populations of the lungs in acute and chronic lung injury, and the effects of environmental tobacco smoke on lung growth and development. Prior to 2008, he received research support from Phillip Morris and has collaborated with other researchers who received research support from Phillip Morris. He previously served on committees of the National Academies related to estimating mortality risk reduction from decreasing tropospheric ozone exposure, formaldehyde risk assessment, and particulate matter surveillance. Dr. Pinkerton received his Ph.D. in pathology from Duke University.
Nancy A. Rigotti
Nancy Rigotti is a Professor of Medicine at Harvard Medical School and Associate Chief of the Division of General Internal Medicine at Massachusetts General Hospital. Dr. Rigotti has pioneered research on interventions to reduce smoking prevalence and the burden of tobacco-related morbidity and mortality. A general internist, her clinical research focuses on developing and disseminating interventions for smoking cessation within primary care practices and inpatient settings. She founded and directs the MGH Tobacco Research and Treatment Center. She is a Past President of the Society of General Internal Medicine and a Past President of the Society for Research in Nicotine and Tobacco. She was a Scientific Editor of the 1989 Surgeon General’s Report on Tobacco, a comprehensive review that provided scientific support for policymaking and she was a Deputy Editor of Nicotine & Tobacco Research. Dr. Rigotti received her M.D. from Harvard Medical School.
David A. Savitz
David A. Savitz is Vice President for Research at Brown University and Professor of Epidemiology in the Brown University School of Public Health, with a joint appointment in Obstetrics and Gynecology in the Alpert Medical School. His epidemiological research has addressed a wide range of many important public health issues including environmental hazards in the workplace and community, reproductive health outcomes, and environmental influences on cancer. He has done extensive work on health effects of nonionizing radiation, pesticides, drinking water treatment by-products, and perfluorinated compounds. He was the president of the Society for Epidemiologic Research and the Society for Pediatric and Perinatal Epidemiologic Research and North American Regional Councilor for the International Epidemiological Association. He was compensated by Best Practice Management Inc. through an unrestricted grant from Star Scientific to chair a panel discussion and author a 2006 summary paper on the public health implications of smokeless tobacco use as a harm reduction strategy. Dr. Savitz received his Master’s degree in Preventive Medicine from Ohio State University and Ph.D. in Epidemiology from the University of Pittsburgh Graduate School of Public Health. He is an elected member of the National Academy of Medicine.
Gideon St.Helen
Gideon St.Helen is an assistant professor of Medicine, Division of Clinical Pharmacology, Dept. of Medicine, at the University of California, San Francisco. The focus of his research program is the utility and evaluation of biological markers of tobacco use and exposure for epidemiology, risk assessment, product regulation, and identification of susceptibility factors. Dr. St.Helen received his Ph.D. in toxicology from the University of Georgia.

Committee Membership Roster Comments

Original Committee Posted 12/29/2016.
Dr. Adam Leventhal added as a committee member 2/15/2017.

Events



Location:

J. Erik Jonsson Woods Hole Center
314 Quissett Ave.
Woods Hole, Massachusetts
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Alexis Wojtowicz
Contact Email:  awojtowicz@nas.edu
Contact Phone:  (202) 334-2779

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Dave Eaton (chair)
Anthony Alberg (via teleconference)
Maciej Goniewicz
Adam Leventhal
Jose Manautou
Sharon McGrath-Morrow
David Mendez
Ana Navas-Acien
Kent Pinkerton
Nancy Rigotti
David Savitz
Gideon St.Helen

The following topics were discussed in the closed sessions:

• Continued discussion and review of chapter drafts
• Continued development work plan and report outline

The following materials (written documents) were made available to the committee in the closed sessions:

• Study timeline and statement of task
• Selected bibliographies on patterns of use and psychosocial factors/correlates of use
• Chapter drafts
• Bibliography of screened studies that meet inclusion criteria from updates of the literature search on the health effects of ENDS

Date of posting of Closed Session Summary:
September 05, 2017
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Alexis Wojtowicz
Contact Email:  awojtowicz@nas.edu
Contact Phone:  (202) 334-2779

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Dave Eaton (Chair)
Anthony Alberg
Maciej Goniewicz
Adam Leventhal (by teleconference)
Jose Manautou
Sharon McGrath-Morrow
David Mendez
Richard Miech
Ana Navas-Acien
Kent Pinkterton
Nancy Rigotti
David Savitz
Gideon St.Helen


The following topics were discussed in the closed sessions:

• Continued discussion of working groups, information needs, and data gathering methods
• Continued development work plan and report outline
• Reviewed sections of chapter drafts

The following materials (written documents) were made available to the committee in the closed sessions:

• Study timeline and statement of task
• Table of articles on human health effects of ENDS use in human populations
• Selected bibliographies on patterns of use and psychosocial factors/correlates of use
• Chapter drafts
• Bibliography of screened studies that meet inclusion criteria from updates of the literature search on the health effects of ENDS

Date of posting of Closed Session Summary:
July 05, 2017
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Alexis Wojtowicz
Contact Email:  awojtowicz@nas.edu
Contact Phone:  (202) 334-2779

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Eaton (chair)
Anthony Alberg
Maciej Goniewicz
Adam Leventhal
Jose Manautou
Sharon McGrath-Morrow
David Mendez
Richard Miech
Ana Navas-Acien (via teleconference April 24th and 25th)
Kent Pinkerton
Nancy Rigotti (April 24th only)
David Savitz
Gideon St.Helen

The following topics were discussed in the closed sessions:

• Continued discussion of working groups, information needs, and data gathering methods
• Continued development work plan and report outline
• Reviewed project timeline
• Deliberated areas of further research and need for input from other experts

The following materials (written documents) were made available to the committee in the closed sessions:

• Study timeline and statement of task
• Working group assignments
• Table of articles on human health effects of ENDS use in human populations
• Selected bibliographies on patterns of use and psychosocial factors/correlates of use
• Bibliography of screened studies that meet inclusion criteria from updates of the literature search on the health effects of ENDS

Date of posting of Closed Session Summary:
May 08, 2017
Publication(s) resulting from the event:

-


Location:

National Academy of Sciences Building
2101 Constitution Ave NW, Washington, DC 20418
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Alexis Wojtowicz
Contact Email:  awojtowicz@nas.edu
Contact Phone:  -

Agenda
This is a draft agenda and subject to change.

Tuesday, 2/21/2017
8:45 Welcome and Opening Remarks
David Eaton, committee chair
Understanding Vaping: Who, What, and Why
9:00 User and Retailer Perspective
Spike Babaian, VapeNY
9:20 Insights from qualitative research
Jennifer Alexander, RTI
9:40 Patterns of Use and Disparities
Daniel Giovenco, Mailman School of Public Health
10:00 Role of Flavorings in Sensory Perceptions of ENDS
Paul Wise, Monell Center
10:20 Panel Discussion and Q&A
10:45 Break
Systematic Reviews: Methodology and Lessons Learned
11:00 Integrating in vitro and in vivo data
Jon Samet, USC (remotely)
11:20 Human Health Effects
Allison Glasser and Ray Niaura, Truth Initiative
11:40 Discussion and Q&A

Noon Lunch Available in Cafeteria (lower level)
Preclinical and Clinical Testing of ENDS
1:00 AEMSA Standards
Lou Ritter, American E-Liquid Manufacturing Standards Association
1:15 Key variables important in assessing ENDS Devices:
John Bellinger, Evolv Inc
1:35 Key variables important in assessing e-Liquids:
Kurt Kistler, Pennsylvania State University, Brandywine
1:55 Clinical Studies in ENDS Users
James Murphy, British American Tobacco
2:15 Particle Deposition
Kirsten Koehler, Johns Hopkins Bloomberg School of Public Health
2:35 In Vitro models available for testing of ENDS
Holger Behrsing, Institute for In Vitro Sciences, Inc
2:55 Results from in vitro assays
Marianna Gaca, British American Tobacco
3:15 Panel Discussion and Q&A
3:45 Break
Use of Population Dynamic Models to Understand the Population Health Effects of ENDS: Data Gaps and Uncertainties
4:00 Population Dynamic Modeling
Eric Vugrin, Sandia National Labs
4:20 Panel Discussion
Annette Bachand (Environ), Rafael Meza (U. Michigan) and David Levy (Georgetown)
5:00 Public Comment
5:15 Adjourn

Wednesday, 2/22
9:30-10:00 AM Virtual session: Human studies of ENDS exposures: functional changes in airway resistance and inflammatory cytokine profiles after human ENDS exposures
Session end time subject to change
Pam Dalton (Monell Center)


Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Eaton (Chair)
Anthony Alberg
Maciej Goniewicz
Adam Leventhal
Jose Manautou
Sharon McGrath-Morrow
David Mendez
Richard Miech
Ana Navas-Acien
Kent Pinkerton
Nancy Rigotti
Gideon St.Helen

The following topics were discussed in the closed sessions:

• Completed the committee conflict of interest and bias discussion for new committee member
• Discussed statement of task and previous day presentations
• Continued discussion of working groups, information needs, and data gathering methods
• Developed preliminary work plan and rough report outline
• Reviewed project timeline
• Deliberated areas of further research and need for input from other experts



The following materials (written documents) were made available to the committee in the closed sessions:

• Study timeline and statement of task
• Handouts of presentation slides
• Preliminary working group assignments and systematic review overview


Date of posting of Closed Session Summary:
March 10, 2017
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Alexis Wojtowicz
Contact Email:  awojtowicz@nas.edu
Contact Phone:  -

Agenda
January 23, 2017

CLOSED SESSION - 08:00 AM - 10:00 AM

OPEN SESSION - 10:00 AM – 11:00 AM

10:00 AM Discussion of Charge

Welcome, David Eaton, Chair

Center for Tobacco Products, Speaker TBD

11:00 AM - Adjourn

BEGIN CLOSED SESSION - 11:00 AM

January 24, 2017 - CLOSED SESSION
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Eaton (Chair)
Anthony Alberg
Maciej Goniewicz
Sharon McGrath-Morrow
David Mendez
Richard Miech
Ana Navas-Acien
Kent Pinkerton
Nancy Rigotti
David Savitz
Gideon St.Helen

The following topics were discussed in the closed sessions:

• Completed orientation on the HMD consensus study process
• Completed the committee conflict of interest and bias discussion for those present
• Discussed statement of task
• Identified working groups, information needs, and data gathering methods
• Developed preliminary work plan and rough report outline
• Reviewed project timeline
• Deliberated topics and panels for March public workshop


The following materials (written documents) were made available to the committee in the closed sessions:

• Study timeline
• Handouts of presentation slides
• Preliminary report draft
• Working group assignments

Date of posting of Closed Session Summary:
February 07, 2017
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office