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Notice

Electronic Cigarettes and the Public Health; Public Workshop

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA), Center for Tobacco Products, is announcing a public workshop to obtain information on electronic cigarettes and the public health. The workshop will include presentations and panel discussions about the current state of the science, and will focus on product science, packaging, constituent labeling, and environmental impacts. FDA intends to follow this workshop with two additional electronic cigarette workshops, with one on individual health effects and one on population health effects.

Dates and Times: The public workshop will be held on December 10, 2014, from 8 a.m. to 5 p.m. and on December 11, 2014, from 8:30 a.m. to 3:30 p.m. Individuals who wish to attend the public workshop must register by November 25, 2014.

Location: The public workshop will be held at the FDA White Oak Conference Center, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking, transportation, security, and information regarding special accommodations due to a disability, please refer to http://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm.

Contact Person: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email: workshop.CTPOS@fda.hhs.gov.

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 https://www.surveymonkey.com/​s/​CTP-December-Workshop. Persons without Internet access may send written requests for registration to Caryn Cohen (see Contact Person). 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, Start Printed Page 55816FDA will post a notice closing registration at http://www.fda.gov/​TobaccoProducts/​NewsEvents/​ucm238308.htm. If you need special accommodations due to a disability, please contact Caryn Cohen (see Contact Person) no later than December 3, 2014.

Presenters and Panelists: FDA is interested in gathering scientific information from individuals with a broad range of perspectives on technical topics to be discussed at the workshop. 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 workshop.CTPOS@fda.hhs.gov by November 4, 2014.

Oral Presentations by Members of the Public: This workshop includes a public comment session. Persons wishing to present during the public comment session must make this request at the time of registration and should identify the topic they wish to address from among those topics under consideration, which are identified in section II. FDA will do its best to accommodate requests to present. FDA urges individuals and organizations with common interests to consolidate or coordinate their comments, and request a single time for a joint presentation. For those requesters with Internet access, Caryn Cohen (see Contact Person) will email you regarding your request to speak by November 26, 2014.

Transcripts: A transcript of the proceedings will be available after the workshop at http://www.fda.gov/​TobaccoProducts/​NewsEvents/​ucm238308.htm as soon as the official transcript is finalized. It will also be posted to the docket at http://www.regulations.gov once the docket is opened.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing a public workshop to gather scientific information and stimulate discussion among scientists about electronic cigarettes (e-cigarettes). The focus of this workshop will be product science (specifically device designs and characteristics, and e-liquid and aerosol constituents), product packaging, constituent labeling, and environmental impact. FDA intends to follow this workshop with two additional workshops that will address other scientific topics related to e-cigarettes, including: (1) The impact of e-cigarettes on individual health, including clinical pharmacology, topography, abuse liability, dependence, and health effects and (2) the impact of e-cigarettes on the population, including discussions of product appeal (e.g., impact of advertising, marketing, flavorings, consumer perceptions) and product safety labeling.

On April 25, 2014, FDA published a proposed rule to extend its tobacco product authorities to additional products that meet the statutory definition of “tobacco product” (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; 79 FR 23141, April 25, 2014, Docket No. FDA-2014-N-0189) (proposed deeming rule). If the proposed 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 23141 at 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.

Participants should note that this workshop is not intended to inform the Agency's deeming rulemaking. All comments regarding the proposed deeming rule were to be submitted to the Agency by August 8, 2014 (Docket No. FDA-2014-N-0189). As such, the scope of this workshop is limited to the topics presented in Section II.

At the start of this first workshop in this series, FDA will announce via a Federal Register notice the establishment of a docket for submission of written comments. 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.

II. Topics for Discussion

The public workshop will include presentations and panel discussion regarding e-cigarettes and the public health, specifically relating to the products themselves. Topics to be addressed include, for example: (1) Product science (including design, chemistry, and toxicology); packaging, labeling, and environmental impact assessments; (2) potential risks and benefits of product characteristics; (3) strategies to mitigate risk to users; (4) methods for evaluating product performance, constituents, stability, etc.; and (5) potential risks to the environment. Additional information related to workshop presentations and discussion topics, including specific questions to be addressed at the workshop, can be found at http://www.fda.gov/​TobaccoProducts/​NewsEvents/​ucm238308.htm.

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Dated: September 11, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-22122 Filed 9-16-14; 8:45 am]

BILLING CODE 4164-01-P