Tobacco Products

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

Electronic Cigarettes and the Public Health:
A Public Workshop

June 1 and 2, 2015
8:00 a.m. to 5:00 p.m.
The Marriott Inn and Conference Center
Chesapeake Ballroom Salons A&B
University of Maryland University College (UMUC)
3501 University Blvd. East
Hyattsville, Maryland  20783


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 final 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 Chapter IX of 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 population health. Topics to be addressed include, for example: (1) prevalence and patterns of use; (2) impacts on the use of  current tobacco products; (3) uptake of e-cigarette use by non-users of tobacco products; (4) health effects of e-cigarettes in non-users: and (5) knowledge, attitudes, beliefs, and perceptions about e-cigarette products.  A workshop in December 2014 focused on e-cigarette product science, product packaging, constituent labeling, and environmental impact; and a workshop in March 2015 focused on the impact on e-cigarettes on individual health.


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 May 20, 2015.
 
Please submit electronic requests at https://www.surveymonkey.com/s/CTP-June-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 May 25, 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 the pertinent information and provide insight into methods to better answer the questions listed below: 
 
Prevalence and Patterns of Use 

  1. What is the prevalence of e-cigarette ever use, current use, and established use in the U.S.?
    1. What is the prevalence of e-cigarette use among population subgroups, such as youth and young adults?
    2. What proportion of e-cigarette users are current tobacco users, including cigarette smokers?
    3. What proportion of e-cigarette users are former tobacco users, including cigarette smokers?
    4. What proportion of e-cigarette users are never tobacco users, including never cigarette smokers?
  2. 2. What are the reasons individuals try e-cigarettes?
    1. Do these reasons differ by subgroups, specifically youth, young adults, or adults?
  3. What proportion of youth and young adult e-cigarette users would not have otherwise initiated tobacco product use?
  4. What proportion of youth and young adult e-cigarette users would have otherwise initiated use of combusted tobacco products?
  5. Where and how are youth and young adults getting e-cigarettes?
  6. What proportion of e-cigarette users is modifying the devices and not using the products as intended by the manufacturer?
  7. What types of e-cigarette devices are being used (e.g., “cigalike” devices vs. “tank” systems) and by whom? How do patterns of use differ among users of different device types?
  8. What is the volume of e-cigarette retail sales by type of sales route, including online sales, specialty retail (“vape”) shops, and traditional outlets? What are the product attributes of products sold via these routes? What proportion of sales is accounted for by products using tobacco flavors, menthol or other flavors? What types of non-tobacco or menthol flavors are most frequently sold?
  9. How do different types of marketing and messages about e-cigarettes influence experimentation with e-cigarettes?
  10. Does the use of products with tobacco flavors, menthol or other flavors differ by age group (specifically for youth and young adults versus older adults) and tobacco use history? 

Impacts on the Use of Current Tobacco Products

  1. How does e-cigarette use affect use of other tobacco products among current tobacco product users, including current cigarette smokers?
    1. Do cigarette smokers who initiate e-cigarette use eventually reduce or completely quit cigarette use?
    2. What proportion of cigarette smokers who use e-cigarettes and who quit smoking continue to use e-cigarettes after quitting (and for how long)?
    3. Is there evidence of changes in cigarette smoking frequency among dual e-cigarette and cigarette users? 
  2. What product features make an e-cigarette more or less appealing to current tobacco users, including cigarette smokers who want to quit?
  3. How do flavors affect the appeal and use of e-cigarettes among current tobacco users, including current cigarette smokers?
  4. What role do flavors in e-cigarettes have on experimentation and trajectory to established e-cigarette use among current tobacco users, including current cigarette smokers?
    1. Does the presence of flavors have an impact on dual use of e-cigarettes and cigarettes?
    2. Does the presence of flavors have an impact on complete switching from cigarettes to e-cigarettes? 

Uptake of E-cigarette Use by Non-Users of Tobacco Products

  1. How does e-cigarette use affect use of other tobacco products among never and former tobacco product users?
    1. How does use of e-cigarettes relate to transition to use of other tobacco products, including combustible products?
    2. What proportion of non-smoking youth and young adults who experiment with e-cigarettes as their first tobacco product progress to regular e-cigarette use and to use of combustible tobacco products?
    3. What proportion of youth and young adults report curiosity and susceptibility to e-cigarettes? How does e-cigarette curiosity/susceptibility  compare to curiosity/susceptibility to conventional cigarettes or other tobacco products?
    4. What factors influence whether experimentation with e-cigarettes leads to regular e-cigarette use?  To use of combustible tobacco products?
    5. What proportion of former cigarette smokers who initiate e-cigarette use relapse to conventional cigarette smoking?
    6. What factors influence whether e-cigarette use causes former smokers to relapse to cigarette smoking? To switch completely to e-cigarette use vs. dual use e-cigarettes and cigarettes?
  2. What product features make an e-cigarette more or less appealing to non-users of tobacco, including youth and young adults?
  3. How do flavors affect the appeal and use of e-cigarettes among non-users of tobacco, including youth and young adults?
  4. What role do flavors in e-cigarettes have on experimentation and trajectory to established use among never and former users of tobacco?
    1. How does this differ by subgroups, specifically youth, young adults or adults?
  5. How do flavors affect the appeal and use of e-cigarettes among never and former cigarette smokers?
  6. What product features make an e-cigarette more or less appealing to former cigarette smokers?

Health Effects of E-Cigarettes in Non-Users:

  1. What chemicals/toxicants are potentially delivered to nonusers who are exposed to e-cigarette aerosols?
  2. How do exhaled aerosol properties impact potential secondhand and thirdhand exposures?
  3. How far can aerosols travel in a confined environment to impact nonusers?
  4. What are the potential impacts of e-cigarette use on the levels of particulate matter and chemicals/toxicants from the e-cigarette in enclosed spaces such as cars, homes, office settings, and public buildings?
  5. What are the potential short- and long-term health risks, including cancer and non-cancer-related illnesses, of secondhand exposure to e-cigarette aerosols?
  6. What are the potential short- and long-term health risks, including cancer and non-cancer-related illnesses, of thirdhand exposure to e-cigarette aerosols?
  7. What other risks are associated with e-cigarette exposures in nonusers (e.g., overheating and explosion resulting in burn injuries)?
  8. What are the potential hazards associated with inadvertent exposure to e-cigarettes by young children (e.g., accidental dermal exposure or oral ingestion of liquid nicotine, choking on e-cigarette components, e-cigarette inhalation)?
  9. How can information about the health effects of e-cigarettes be best communicated to nonusers?

Attitudes, Beliefs, and Product Perceptions

  1. What beliefs and perceptions do e-cigarette users and non-users have about the risks of e-cigarettes compared to the risks of other tobacco products (both combustible and noncombustible), NRT, and cessation? How do beliefs and perceptions vary across subgroups by age and by e-cigarette and other tobacco use?
  2. What effect, if any, do e-cigarette use and marketing have on social norms related to conventional cigarette smoking?
  3. What beliefs and perceptions do e-cigarette users have  about e-liquid contents, nicotine amount/concentration, and flavorings?
  4. How are e-liquid ingredients, HPHCs, and nicotine levels communicated to consumers?
  5. How do different types of marketing and messages about e-cigarettes impact beliefs and perceptions?
  6. How does information communicated to consumers via e-cigarette and e-liquid product labels, labeling, and marketing (including advertising) influence attitudes, beliefs, product perceptions, and behaviors?

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 April 3, 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 June 2, 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 https://www.surveymonkey.com/s/CTP-June-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 May 25, 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:  April 3, 2015
  • Registration Deadline:  May 20, 2015
  • Deadline for Requests to Speak During Public Comment Session:  May 20, 2015
  • Date successful registrants will receive registration confirmation: May 25, 2015  

Special Accommodations:

If you need special accommodations because of disability, please contact Caryn Cohen (see Contact for Questions) at least seven days before the meeting. 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: 07/28/2015
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