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Tobacco Products

A Public Workshop – Electronic Cigarettes and the Public Health


Electronic Cigarettes and the Public Health: A Public Workshop 

We would like to thank those of you who attended the workshop in person or viewed the live webcast.  The archived webcast and verbatim transcript will be posted here as soon as they become available.  Information about upcoming CTP workshops will be posted on our “Meetings and Conference” page as dates, times and locations are finalized. 


December 10, 2014
8:00 a.m. to 5:00 p.m. 

December 11, 2014
8:00 a.m. to 3:30 p.m.

FDA White Oak Conference Center
Building 31, Room 1503, Section A
10903 New Hampshire Avenue
Silver Spring, MD 20993 



December 10th Links:

December 11th Links:


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 first of a planned series of 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 first workshop will be product science (specifically device designs and characteristics, and e-liquid and aerosol constituents), product packaging, constituent labeling and environmental impact. Future workshops will address the individual health and population health effects of e-cigarettes.


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 November 25, 2014.

Please submit electronic requests at  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 those registrants with Internet access, confirmation of registration will be emailed to you no later than November 26, 2014

Onsite registration may be allowed if space is available.  If registration reaches maximum capacity, FDA will post a notice closing registration at


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:

CTP believes it is important to gather scientific information from individuals with a broad range of perspectives on the technical topics to be discussed at the workshop.  We are inviting presenters and panelists to address the questions listed below: 

Device Design and Design Characteristics:

  1. What are the potential risks associated with different device characteristics (e.g., disposable versus refillable tanks and cartridges, variable voltage capabilities, coil resistance, interchangeable parts)?
  2. How can products be manipulated by users?  Are there hazards associated with certain manipulations?
  3. What are the significant design characteristics of e-cigarettes that modify the delivery of nicotine and other constituents to users?
  4. What are the potential material hazards (e.g., leaching, metal particle deposition) associated with e-cigarettes?  Do these hazards change with product aging or storage conditions?
  5. What are the information collecting capabilities of current devices? Can the function of the devices be modified by a 3rd party or software communications? What are the potential benefits and concerns associated with software, data collection and electronic communications in e-cigarettes?
  6. What currently available design or product standards (e.g., battery standards) are relevant to e-cigarettes?  
  7. What methods exist for evaluating e-cigarette performance? How does an individual product’s performance change over time? 

E-Liquid and Aerosol Constituents:

  1.  What is the chemical composition of e-liquids?
  2. When several ingredients can serve the same function, what are the reasons for preferring or avoiding a specific ingredient (e.g., propylene glycol vs. glycerin)?
  3. What is the stability of e-liquids? How do storage conditions and packaging affect e-liquid composition?
  4. What methods can be used to evaluate the constituent in e-liquids?
  5. How are impurities and contaminants (including e-liquid ingredients and potential microbial contaminants) identified and controlled?
  6. What are the identities, quantities and origins of the chemical constituents of the e-cigarette aerosols inhaled and exhaled aerosols by users?
  7. What methods exist to measure chemicals in aerosols (including particle size distribution)? 
  8. What aerosol-generating regimens exist for e-cigarettes?  What validation of aerosol-generating regimens has been carried out?
  9. How do aerosol constituent yields vary puff-by-puff?
  10. Are there particular ingredients in e-liquids that increase the toxicant levels in the aerosol? Are there alternative e-liquid ingredients (i.e., USP Grade) that are considered to produce lower levels of toxicants in the aerosol than some widely used ingredients? What are the potential toxicological risks associated with flavorings?
  11. Which e-liquid and aerosol constituents, toxicants, and impurities are or can be routinely evaluated? How can impurities, contaminants and toxicants in e-liquids and aerosols be identified and controlled?
  12. Given that the e-liquids and aerosols contain varying mixtures of toxicants, what comparative toxicity evaluations could be conducted between different e-cigarette products?

Device Design, E-Liquid and Aerosol Interactions:

  1. What design features are potential sources of risk?
    1. Do interchangeable parts increase product risk? (Address potential to modify or tamper with devices and associated risks.)
    2. Are refillable systems more risky to users compared to closed systems?  More risky to nonusers?  (Address potential use as “not intended”, e.g., “dripping”, use with marijuana waxes/oils.)
    3. Are some refillable systems, such as dual tank systems, more risky than others?
    4. Are there maximum temperatures that should not be exceeded for product components, such as surfaces, materials, batteries and heating elements?
    5. Is there a maximum power/wattage for heating e-liquids?
  2. What design features and manufacturing standards/tolerances are needed to minimize or mitigate risk to users and nonusers, especially risk of explosion, leaking of e-liquids, increased toxicant exposure (i.e., chemicals, metals, leachables)?
  3. What design features may alter the abuse liability of e-cigarettes (e.g., user electronic adjustments, constituent delivery modification)?
  4. What are the quantitative and qualitative relationships between the chemical contents in e-liquids (e.g., nicotine, humectants, flavorings) and chemical constituents in aerosols inhaled by users?
  5. What are the determinants of the quantitative and qualitative relationships between the chemical content in e-liquids and chemical constituents in delivered aerosols (e.g., device design effects on delivered aerosol particle characteristics including the impact of varied voltage and differences in coil resistance)?

Packaging and Constituent Labeling:

  1. Are there e-cigarette and e-liquid packaging characteristics (including design, size, product quantity) that minimize or eliminate risks (e.g., accidental exposures to e-liquids, choking) to both users and nonusers – especially young children?
  2. Do chemical constituents, product hazards, and expiration dates appear on e-cigarette and e-liquid labels?

Environmental Impact:

  1. How can the environmental impact of manufacturing e-cigarettes be compared to that of traditional cigarettes?
  2. Given that tobacco plants are the source of nicotine in e-liquids, what is the impact of manufacturing e-liquids, especially with increasing e-cigarette market volume, on the cultivation of tobacco plants?  Will land be converted to support the market growth of e-cigarettes?
  3. How are e-cigarettes, especially non-reusable products, disposed?  Are they recycled or are they disposed as regular trash? 
  4. Do e-cigarettes have components that are considered hazardous waste?
  5. Are disposal instructions for other products relevant to e-cigarettes?
  6. Are there ways to reduce the environmental waste and pollution from e-cigarette use?

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 sit on a panel to discuss their scientific knowledge on the questions and presentations in each session. 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 by November 4, 2014.


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 an open comment session on the above listed topics on December 11, 2014 from approxmately 8:45 a.m. to 9:45 a.m., during which comments from the public will be accepted. If you would like to speak during the open comment session, please indicate this at the time of registration 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. You may request an opportunity to present during the open comment session when you register for the workshop at

Persons registered to give public comments must check in at the registration table by 8:30 a.m. on December 11, 2014, in order to keep their time to speak. 

Docket for submitting public written comments:

At the start of the workshop, FDA will announce via a Federal Register notice the establishment of a docket for submission of written comments about the topics to be addressed at the workshops.  Regardless of attendance at the public workshops, interested persons will be invited to submit comments to the docket.  The forthcoming Federal Register notice will provide information on how to submit comments.

Please note that this docket will only pertain to this workshop.  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 (published April 25, 2014).


Key Dates:

Registration Deadline:  November 25, 2014
Deadline for Requests to Speak
During Open Comment Session:  November 25, 2014

Deadline for Requests to Serve
as a Presenter or Panelist:   November 4, 2014

Special Accommodations:

If you need special accommodations because of disability, please contact Caryn Cohen (see Contact for Questions) no later than December 3, 2014.
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


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