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FDA/CTP to hold workshop on exploding e-cigarettes

From: FDA/Center for Tobacco Products

April 19-20, 2017
8:30 a.m.-4:30 p.m.

Food and Drug Administration (FDA)
Center for Tobacco Products (CTP)
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-000

Workshop Objective

FDA/CTP is hosting a science-based public workshop to gather information and stimulate discussion on batteries used in electronic nicotine delivery systems (ENDS), including electronic cigarettes. In particular, CTP seeks to gather information about battery safety concerns (e.g., overheating, fire, explosion, other modes of failure), risk mitigation, and design parameters related to ENDS. Additionally, information related to the communication from tobacco product manufacturers or importers to distributors, wholesalers, retailers, consumers, and the general public on battery-related safety concerns with the use of ENDS products will also be collected.

Who Should Attend this Workshop?

Scientific and medical experts; ENDS manufacturers, importers, distributors, wholesalers, and retailers; manufacturers of batteries for ENDS and other consumer products; federal, state, and local government agencies; and other interested stakeholders, such as academic researchers and public health organizations.

Registration to Attend or View Live Webcast of 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 March 17, 2017.

Please submit electronic request to register onlinedisclaimer icon. Persons without Internet access may send written requests for registration to Dhanya John (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 March 21, 2017. Onsite registration may be allowed if space is available. If registration reaches maximum capacity, FDA will post a notice closing registration on our Public Meetings & Conferences page.

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/CTP is interested in gathering scientific information about ENDS battery safety concerns from individuals with a broad range of backgrounds on the various ENDS battery-related topics to be discussed at the workshop. We are inviting presenters and panelists to provide insight into ENDS battery-related safety events as well as address the questions listed below.

A. Current ENDS Design and Associated Risks

  1. In general, what factors (e.g., integrated safety circuit design, user device modifications, mismatches between devices and batteries and/or chargers, changes in components or suppliers, poorly designed batteries, stacking batteries, type of battery, battery environment) contribute to ENDS failure? Which of these factors, if any, contribute to a failure that can result in ENDS overheating, fire, explosion, or other mode of failure?
  2. What types of ENDS are more likely to experience a battery-related safety concern (e.g., overheating, fire, explosion) and why? What are the relative risks of overheating, fire, and explosion with different ENDS that are currently marketed? How many incidents of ENDS explosions have occurred, and what were the characteristics (e.g., user-modifiable ENDS versus disposable ENDS; battery type and configuration) of the products that have exploded? What failure analysis, if any, exists for known cases of ENDS explosions?
  3. What types of batteries are used in ENDS? What types of safety features are currently being used in ENDS and ENDS batteries? What percentage of ENDS batteries have safety features that might prevent ENDS overheating, fire, explosion, or other mode of failure?
  4. ENDS battery failures may occur while the battery is charging with power supplies that were not provided by the manufacturer or importer (e.g., USB connections). How do features of the battery charging process (e.g., type of charger, device–charger compatibility) influence the potential for ENDS overheating, fire, explosion, or other mode of failure?

B. ENDS Design for Risk Control

  1. What types of ENDS design and battery features (e.g., maximum number of puffs on an aerosolizing apparatus, battery replacement schedule) might prevent or reduce the incidence of overheating, fire, explosion, or other mode of failure?
  2. What types of ENDS design changes might reduce safety hazards associated with USB-based charging? What additional strategies are available to mitigate risks associated with ENDS battery charging?
  3. In addition to overheating, fire, and explosion, what other battery concerns need to be considered (e.g., corrosion, release of battery components through leakage, volatilization, leaching) to protect ENDS users and non-users?

C. Battery Concerns Related to ENDS Failures

  1. What failure mechanisms have been identified in other battery-powered products (e.g., laptops, cell phones, hoverboards) that could be addressed in ENDS?
  2. How does the configuration of batteries (e.g., cylindrical, pouch shaped) influence the risk of an ENDS battery-related safety concern (e.g., overheating, fire, explosion, other mode of failure)?
  3. What alternatives to batteries (e.g., alternative chemistries) could be considered for use in ENDS to reduce the risk of ENDS battery-related safety concerns (e.g., overheating, fire, explosion, other mode of failure)?
  4. What alternative heating sources (i.e., non-coil heating sources) could be considered for use in ENDS to reduce the risk of ENDS battery-related safety concerns (e.g., overheating, fire, explosion, other mode of failure)?
  5. How does lifetime battery performance affect ENDS and the function of ENDS components and parts? How do battery performance and patterns of use (e.g., temperature control device versus single voltage device) predict or correlate to the likelihood of ENDS overheating, fire, explosion, or other mode of failure?
  6. What existing battery standards may apply to ENDS batteries to reduce the risk of ENDS overheating, fire, explosion, or other mode of failure?
  7. How can ENDS products be engineered so that even upon battery failure, the aerosolizing apparatus may help protect against ENDS battery-related safety concerns (e.g., overheating, fire, explosion, other mode of failure) to mitigate injury and property damage (e.g., ventilation holes in mod casing)?

D. Non-Battery Concerns Related to ENDS Failures

  1. Aside from the battery, are there any properties or characteristics of ENDS (e.g., materials, ingredients, design, composition, heating source, other features), including ENDS components and parts (e.g., e-liquids), that contribute to ENDS overheating, fire, explosion, or other mode of failure?

E. Communication to Consumers and the General Public

  1. What battery-related safety information (e.g., replacement frequency, maximum lifetime, proper battery charging procedures, warnings about overheating, fire, explosion, or other mode of failure) do ENDS manufacturers and importers communicate to retailers, distributors, wholesalers, consumers, and the general public? What battery-related safety information do retailers communicate to consumers and the general public?
  2. In what format (e.g., instruction manual, labels) do ENDS manufacturers, importers, or retailers communicate battery-related safety information (e.g., replacement frequency, maximum lifetime, proper battery charging procedures, warnings about overheating, fire, explosion, or other mode of failure) to consumers and the general public?
  3. How can the potential risks associated with ENDS batteries be communicated effectively (e.g., via labeling, instructions for use, warnings) to consumers and the general public?
  4. What information, if any, exists about consumer understanding of ENDS use instructions, proper charging, storage procedures, and warnings?
  5. What information currently is, or could be, communicated by tobacco product manufacturers, importers, distributers, wholesalers, and retailers to consumers and the general public about safe handling and storage conditions of ENDS products and batteries?

If you are interested in serving as a presenter or panelist, please submit the following information found in the paragraph directly below, along with the topic on which you would like to speak, to workshop.CTPOS@fda.hhs.gov by February 17, 2017.

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 the scientific presentations and questions listed above. To be considered 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.

FDA Invites Public Comments on Battery Safety Concerns in ENDS

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 April 20, 2017, 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 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 and who have submitted a working email address will receive an email regarding your request to speak during the public comment period by March 21, 2017.

Docket for submitting public written comments:

FDA has announced via a Federal Register notice the establishment of a docket for submission of written comments in conjunction with the public workshop to gather information about batteries used in ENDS, including electronic cigarettes (see “Battery Safety Concerns in Electronic Nicotine Delivery Systems (ENDS); Invitation to Meet with FDA; Public Workshop; Establishment of a Public Docket; Request for Comments,” Docket No. FDA-2016-N-4232). Regardless of attendance at the public workshops, interested persons are invited to submit comments, research, data, and other information to the docket. The Federal Register notice provides detailed information on how to submit comments (Docket No. FDA-2016-N-4232).

Key Dates

  • Deadline for Requests to Serve as a Presenter or Panelist: February 17, 2017
  • Registration Deadline: March 17, 2017
  • Deadline for Requests to Speak During Public Comment Session: March 17, 2017
  • Date Successful Registrants will Receive Registration Confirmation and date requests to present oral comments will be acknowledged: March 21, 2017

Special Accommodations

If you need special accommodations because of disability, please contact Dhanya John (see Contact for Questions) at least seven days before the meeting.

Contact for Questions

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