Tobacco Products

August - Biomarkers of Tobacco Exposure: A Public Workshop

Biomarkers of Tobacco Exposure: A Public Workshop

August 3 and 4, 2015
8:30 a.m. to 5:00 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 20993-0002 

Workshop Objective:

This workshop is designed to open the discussion on how to identify and implement the use of biomarkers for the purpose of tobacco product regulation, including product reviews and rules development. The purpose of the workshop is to gather information on identifying potential biomarkers that may be currently appropriate for regulatory use as well as identify biomarkers for which more data is required, but may be implemented for use in the near future.  Further, the workshop is a forum for discussing a framework for developing a scientifically robust and transparent process for biomarker selection, establishing appropriate evidentiary standards or criteria for utilization by the FDA, and identifying areas of research which may help move the field forward. 

The objectives of this workshop are to gather information on potential strategies and criteria for evaluating biomarkers of tobacco exposure and to start identifying biomarkers of tobacco exposure which could be useful in tobacco product regulation.

Workshop Agenda:

Link to the agenda

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 July 10, 2015.

Please submit electronic requests at 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 July 15, 2015.

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:

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: 
Session 1: Strategies for Identifying Potential Biomarkers for CTP Regulatory Use

  1. How do biomarkers fit into risk assessment for chemical exposure?
  2. How have other regulatory agencies selected biomarkers for regulatory use?  Can the frameworks and processes they have used serve as potential models for CTP?  Why or why not?
  3. What are some challenges and lessons learned from previous efforts to qualify or validate biomarkers for regulatory purposes?
  4. What characteristics can be considered when evaluating biomarkers of tobacco exposure?

Session 2: Biomarkers of Exposure and Relationship with Disease Risk

  1. Which (if any) biomarkers of tobacco exposure are predictive of future disease risk in humans?
  2. What types of studies or evidence are useful for establishing the predictive validity (change in a biomarker is associated with change in disease risk) of tobacco exposure biomarkers in humans?  
  3. What are the main challenges to evaluating the association between biomarkers of tobacco exposure and disease risk in human population studies?
  4. What evidence from nonclinical studies is useful for regulatory purposes if evidence from human studies is lacking?

Session 3: Identifying Biomarkers of Tobacco Exposure for CTP Regulatory Use

  1. What biomarkers of tobacco exposure are currently well established with respect to analytical validation, tobacco product use and/or disease risk?
  2. What biomarkers of tobacco exposure hold promise but are still in development?
  3. What is the relationship between actual HPHC (Harmful and Potentially Harmful Constituents) exposure and the biomarkers of exposure as measured in the user?
  4. Is there a set of biomarkers of tobacco exposure could currently be used as a proxy for a comprehensive evaluation of exposure to HPHCs?
  5. What biomarkers of exposure might be useful to compare HPHC exposure in the user to exposures in in vitro and in vivo toxicology studies?
  6. What are the limitations in the use of biomarkers of exposure?
  7. What are the next steps to furthering the development and validation of biomarkers?
  8. What analytic methods are used to measure biomarkers of tobacco exposure?
  9. What biological samples (e.g., urine, saliva, blood) are appropriate for tobacco exposure biomarker analysis?  
  10. Are reference standards available? If not, how is the quality and reliability of tobacco biomarker testing monitored and evaluated?

Session 4: Biomarkers of Exposure in Smokeless Tobacco and Electronic Nicotine Delivery Systems (ENDS)

  1. What are the most relevant biomarkers of exposure in exclusive users of smokeless tobacco and ENDS?   
  2. Are there exposures associated with use of smokeless tobacco and ENDS that may not be present in cigarette smokers?  If so, are there biomarkers for these exposures that are currently established or in development?
  3. What studies have been conducted comparing levels and types of biomarkers of exposure in exclusive users of smokeless tobacco and ENDS with non-users or other tobacco user groups?
  4. Are there product design features (e.g. variable voltage) that might alter levels and types of biomarkers of exposure in product users? 

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 by June 12, 2015.

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 Biomarkers of Tobacco Exposure

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 August 4, 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 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 July 15, 2015.

Key Dates:

  • Deadline for Requests to Serve as a Presenter or Panelist:  June 12, 2015
  • Registration Deadline:  July 10, 2015
  • Deadline for Requests to Speak During Public Comment Session:  July 10, 2015
  • Date successful registrants will receive registration confirmation: July 15, 2015

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:

Dhanya John, J.D.
Office of Science
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue, Building 75
Silver Spring, Maryland 20993-0002
Telephone: 1-877-287-1373 (choose Option 5),
FAX: 301-595-1138

Page Last Updated: 10/20/2015
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