Tobacco Products

March: A Public Workshop – Electronic Cigarettes and the Public Health

Electronic Cigarettes and the Public Health:
Second Public Workshop

March 9 and March 10, 2015
8:00 a.m. to 5:00 p.m.

The Marriott Inn and Conference Center
Potomac Ballroom
University of Maryland University College (UMUC)
3501 University Blvd. East
Hyattsville, Maryland  20783

Transcripts


Agenda and Webinar Information


Workshop Objective:

The purpose of this workshop is to gather scientific information and stimulate discussion among scientists about electronic cigarettes (e-cigarettes). This is the second in a series of three workshops intended to obtain information on e-cigarettes and the public health. The information presented and discussed during the workshop series is not intended to inform the Agency’s rulemaking  related to deeming additional tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule, 79 FR 23141, published April 25, 2014).  All comments regarding the proposed rule were to be submitted to the agency by August 8, 2014 (Docket No. FDA-N-0189).

If the deeming rule is finalized as proposed, e-cigarettes that are tobacco products would be subject to FDA regulation under the FD&C Act.  As stated in the proposed deeming rule, FDA “is aware of the recent significant increase in the prevalence in e-cigarette use” (79 FR 23152), and there is much to be learned about these relatively new entrants to the market.  These workshops are intended to better inform FDA about these products.  Should the agency move forward as proposed to regulate e-cigarettes, additional information about the products would assist the agency in carrying out its responsibilities under the law.  This would be true regardless of the details of any such final rule.   Accordingly, FDA is working to obtain such information now rather than waiting for the conclusion of the deeming rulemaking.

The focus of this workshop will be the impact of e-cigarettes on individual health. Topics to be addressed include, for example: (1) topography; (2) exposures and toxicological considerations; (3) pharmacokinetics and pharmacodynamics of nicotine exposure in users; (4) abuse liability and dependence; (5) short and long-term health effects in users; (6) considerations for high risk or vulnerable populations; and (7) human factors. A workshop focusing on product science, protective packaging, constituent labeling, and environmental impact was held in December 2014.  FDA intends to follow this second workshop with an additional workshop that will address the impact of e-cigarettes on the population, including discussions of product appeal (e.g., impact of advertising, marketing, flavorings, consumer perceptions), impact on nonusers (second and thirdhand exposures), and product labeling.


Who Should Attend this Workshop?

Scientific and medical experts; other interested participants from academia, public health organizations, federal, state and local government agencies; the tobacco industry; and other interested stakeholders.


Registration to Attend the Workshop: 

If you wish to attend the workshop in person or by Webcast, you must register by submitting either an electronic or written request no later than February 20, 2015.

Please submit electronic requests at https://www.surveymonkey.com/s/CTP-March-Workshop .  Persons without Internet access may send written requests for registration to Caryn Cohen (see Contact for Questions, below).  Requests for registration must include the prospective attendee’s name, title, affiliation, address, email address if available, and telephone number.  Registration is free and you may register to either attend in-person or view the live Webcast.  Both seating and viewership are limited, so early registration is recommended.  FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity.

For registrants with Internet access, confirmation of registration will be emailed to you no later than February 23, 2015.

Onsite registration may be allowed if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.


Archived Webcast and Transcripts

FDA will post the webcast along with complete transcripts on this website as soon as they are available.


Presenters and Panelists:

FDA is interested in gathering scientific information from individuals with a broad range of backgrounds on the scientific topics to be discussed at the workshop. We are inviting presenters and panelists to address information pertaining to the questions listed below:

Toxicological considerations: 

  1. How can toxicological evaluations of the short and long-term effects of e-cigarettes in users be approached?
  2. What are the potential roles of nonclinical models (e.g., in silico, in vitro, and in vivo) and human clinical studies? 
  3. What in vitro and in vivo models can be utilized for comparing toxicity between tobacco products?
  4. What panel of biomarkers of exposure and toxicity in animal studies can be used to evaluate the toxicity of short and long-term e-cigarette use?
  5. What panels of biomarkers of exposure and toxicity allow for cross-species comparisons (i.e., between animals and humans)? What are the limitations of scaling from animal to human studies?
  6. What panel of biomarkers of exposure and toxicity could be useful for monitoring exposure and toxicity in humans across different tobacco products?
  7. Where are aerosols delivered or deposited in humans?
  8. What methods most effectively measure aerosol delivery/deposition/absorption?
  9. What is the impact of local and systemic exposure (of e-liquid and aerosol)?
  10. What aerosol constituents (e.g., chemicals, toxicants, flavorants, other additives) are delivered to users? Are there differences in delivery of aerosol constituents between new and experienced users? 
  11. What are the levels of aerosol constituents delivered to the experienced user?
  12. How do levels of toxicant exposure compare to those in users of other tobacco or nicotine containing products (e.g., traditional cigarettes, other combusted tobacco products, smokeless tobacco, nicotine replacement therapy)? 
  13. What are the toxicological concerns associated with long-term inhalation of aerosols containing propylene glycol, glycerin and flavorings?
  14. What is known about the toxicities of inhaled flavorings? Are some inhaled flavorings more toxic than others?
  15. What strategies can be used to evaluate the potential toxicity of inhaled flavorings in humans?
  16. What strategies can be used to demonstrate that an individual flavor ingredient additive does not increase the inherent toxicity of the e-liquid and aerosol?

Topography

  1. How are e-cigarettes used in terms of actual use patterns (frequency of use) and topography (number of puffs per session, puff volume, puff duration, velocity)?
  2. How can e-cigarette topography be evaluated to accurately capture user  behaviors?
  3. What factors impact e-cigarette topography?  For example, how is topography affected by the type of device, reason(s) for use, or user subpopulation (e.g., polytobacco users, experienced users, youth)?
  4. What strategies can be used to quantitate e-cigarette use? How can quantitative measures of e-cigarette use be compared to the use of other tobacco or nicotine containing products?

Clinical Pharmacology and Abuse Liability:

  1.  What are the pharmacokinetics and the pharmacodynamic effects of nicotine delivered via e-cigarettes?
  2. How do the pharmacokinetic and pharmacodynamic properties of e-cigarettes differ in specific subpopulations (e.g., experienced users, naive users, dual users, youth)?
  3. To what extent do e-cigarettes deliver nicotine via pulmonary absorption?
  4. What are the primary subjective effects associated with e-cigarette use?
  5. How do the subjective effects associated with e-cigarette use differ in specific subpopulations (e.g., experienced users, naive users, dual users, youth)?
  6. What are the reinforcing effects of e-cigarettes? How do these compare to traditional cigarettes in smokers as well as to other combusted products, smokeless tobacco or nicotine replacement therapy?
  7. What measures or methods can be used for assessing the reinforcing effects of e-cigarettes in users?
  8. Are there ways that flavorings may enhance the abuse liability of e-cigarettes?
  9. What non-nicotine constituents in e-cigarette aerosols may contribute to e-cigarette use and dependence?
  10. What unique abuse liability risks may exist for e-cigarette users in specific subpopulations (e.g., former smokers, youth, polytobacco users)?
  11. What is the impact of e-cigarette use on nicotine addiction (e.g., how may  e-cigarette use increase, support or decrease nicotine addiction)?
  12. What strategies can be used to evaluate the potential for an e-cigarette withdrawal syndrome?  What strategies can be used to characterize e-cigarette withdrawal?
  13. What are the characteristics of e-cigarettes that may affect uptake and use by nonusers, former smokers, and youth?

Health Effects in Users:

  1. What are the known short and long-term health effects of e-cigarettes in experienced users?  What are potential other short and long-term health effects of e-cigarettes in users that should be evaluated?
  2. What are the potential short and long-term health effects of inhaling humectants (e.g., propylene glycol, glycerin), flavorings and other e-liquid additives?
  3. What strategies can be used to evaluate the short and long-term health effects of e-cigarettes in users?
  4. What biomarkers and clinical endpoints can be used to assess the impact of e-cigarettes on user health?
  5. What evidence is available that e-cigarettes promote current smokers to completely switching as compared to continuing dual or polytobacco use? What data are available that indicate the characteristics of e-cigarettes that may enhance the potential for complete switching and how do these characteristics compare to approved cessation aids?

Considerations for Health Effects in Specific User Populations:

  1. What populations of users may be at lower or higher risk of adverse effects related to e-cigarette use?
  2. What factors could be considered in the evaluation of risk in vulnerable populations?
  3. What are the health effects in dual users (i.e., users of e-cigarettes and traditional cigarettes or other combusted products)?
  4. What unique issues could be considered in the evaluation of the short and long-term health effects in users of e-cigarettes in combination with traditional cigarettes, other combusted products, and smokeless tobacco?
  5. What unique health effects may be of concern for users with underlying disease (e.g., chronic obstructive pulmonary disease, cardiovascular disease, diabetes mellitus, cancers, mental health disorders)?  
  6. What unique health effects may be of concern in youth e-cigarette users?
  7. How can health risks associated with youth initiation and ongoing use be evaluated?
  8. What are the short and long-term health effects of e-cigarette use during pregnancy?  What is the impact of e-cigarette use during pregnancy on the pregnant woman and on the fetus?
  9. How can the short and long-term effects of e-cigarette use during pregnancy be evaluated?

Human Factors:

  1. What adverse events have been associated with e-cigarette use in users?
  2. How are e-cigarette products modified by users and what are the inherent risks or consequences of the various modifications?
  3. What strategies can be used to mitigate risks related to human factors?
  4. What information do consumers need to adequately understand the product and mitigate risk?
  5. What strategies could be considered to effectively communicate information about the product, especially user risks?
  6. What labeling strategies could be considered? 

To be considered to serve as a presenter, please provide the following:

  • A brief abstract for each presentation. The abstract should identify the specific topic(s) to be addressed and the amount of time requested.
  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.

Panelists will discuss their scientific knowledge on the questions and presentations. To be considered to serve as a panelist, please provide the following:

  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.

If you are interested in serving as a presenter or panelist, please submit the above information, along with the topic on which you would like to speak, to workshop.CTPOS@fda.hhs.gov by January 22, 2015.


FDA Invites Public Comments on E-Cigarettes and the Public Health 

To present oral comments at the workshop:

For those attending the workshop in person, FDA will hold a public comment session on the above listed topics on March 10, 2015 during which comments from the public will be accepted. If you would like to present during the public comment session, please indicate this at the time of registration (at https://www.surveymonkey.com/s/CTP-March-Workshop) and provide the specific topic of your presentation. FDA will do its best to accommodate requests to speak.  Individuals and organizations with common interests are urged to consolidate or coordinate their remarks and request time for a joint presentation.  FDA will determine the amount of time allotted to each speaker and provide instructions to speakers ahead of the meeting.

Requesters with Internet access will receive an email regarding your request to speak during the public comment period by February 23, 2015.

Docket for submitting public written comments:

At the start of the first workshop in this series, FDA announced via a Federal Register notice the opening of a docket for submission of written comments regarding all three workshops (see Establishment of a Public Docket; Electronic Cigarettes and the Public Health Workshop, Docket No. FDA-2014-N-1936, http://www.gpo.gov/fdsys/pkg/FR-2014-12-02/pdf/2014-28261.pdf).  Regardless of attendance at the public workshops, interested persons are invited to submit comments to the docket.  Comments submitted to the docket will not be added to other dockets, such as the docket for the proposed rule deeming additional tobacco products subject to the FD&C Act.


Key Dates:
  • Deadline for Requests to Serve as a Presenter or Panelist:  January 22, 2015
  • Registration Deadline:  February 20, 2015
  • Deadline for Requests to Speak During Public Comment Session:  February 20, 2015

Special Accommodations:

If you need special accommodations because of disability, please contact Caryn Cohen (see Contact for Questions) no later than March 2, 2015.
Contact for Questions:

Caryn Cohen
Office of Science
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue, Building 75
Silver Spring, MD 20993
Telephone: 1-877-287-1373 (choose Option 5),
FAX: 240-276-3655
e-mail:  Workshop.CTPOS@fda.hhs.gov

Page Last Updated: 04/24/2015
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