Minutes of the Aug. 15, 2013 Joint Meeting of the Risk Communication and Tobacco Products Scientific Advisory Committees
FDA Office of the Commissioner / Office of Planning
Risk Communication Staff
FDA White Oak Campus, Bldg. 31,
Conference Center (Rm. 1503)
Silver Spring, MD
The Risk Communication Advisory Committee (RCAC) and the Tobacco Products Scientific Advisory Committee (TPSAC) met on Thursday, August 15, 2013. Prior to the meeting, committee members and invited guests were provided copies of the background material from the FDA and the submissions from the public. The RCAC Acting Chair, William Hallman, Ph.D. called the meeting to order at 9:00 a.m. EST and welcomed the members of the committee and audience to the meeting. The conflict of interest statement was read into the record by the Designated Federal Official, Luis G. Bravo. There were approximately 100 persons in attendance and 6 speakers for the Open Public Hearing session.
On August 15, 2013, the Joint committees convened to discuss and provide comments on the results of the FDA consumer research “Experimental Study on the Public Display of Lists and Harmful and Potential Harmful Tobacco Constituents” [OMB Control No. 0910-0736] to assess the impact of HPHC information on consumer perceptions and comprehension, and how to effectively communicate information about the HPHCs of tobacco products to the general public. FDA presented to the Committees some of the legal requirements related to harmful and potentially harmful constituents (HPHCs), lessons learned from other displays of HPHC information, and findings from FDA’s first round of research.
RCAC Members Present (Voting)
William Hallman, Ph.D., Acting Chair
Vicki S, Freimuth, Ph.D.
Kala Paul, M.D.
Carolyn J. Strickland, Ph.D., R.N.
Temporary Members (Voting)
Madeline Lawson, M.S.
Betsy Sleath, Ph.D.
Monique Turner, Ph.D.
Michael S. Wolf, Ph.D., M.P.H.
RCAC Industry Representative Members Present (Non-voting)
Lars-Erik Rutqvist, M.D., Ph.D. (Representative of Scientific Affairs Swedish Match)
TPSAC Members (Voting)
Jonathan M. Samet, M.D., M.S. (Chair)
Warren K. Bickel, Ph.D.
Mark Stuart Clanton, M.D., M.P.H.
Joanna Cohen, Ph.D.
Thomas E. Eissenberg, Ph.D.
Patricia Nez Henderson, M.P.H., M.D. (Representative of the General Public)
Philip P. Huang, M.D., M.P.H. (Employee of a state or local government or of the Federal Government)
Suchitra Krishnan-Sarin, Ph.D.
TPSAC Industry Representative Members Present (Non-voting)
Jonathan Daniel Heck, Ph.D., DABT (Representative of the tobacco manufacturing industry)
Hampton H. Henton (Representative of the interests of tobacco growers)
David M. Johnson, Ph.D. (Representative for the interest of small business tobacco manufacturing industry)
TPSAC Ex Officio Members Present (Non-voting)
Mirjana Djordjevic, Ph.D.
Douglas Tipperman, MSW
Timothy McAfee, Ph.D., M.P.H.
FDA Participants at the table (Non-voting)
Ji Sun Lee, J.D.
David L. Ashley, Ph.D.
Conrad Choiniere, Ph.D.
Carolyn Dresler, M.D., M.P.A.
Mitch Zeller, J.D.
Designated Federal Official
Luis G. Bravo
The agenda on August 15, 2013 was as follows:
Call to Order
William K. Hallman, Ph.D.
Introduction of the Committee Members
Conflict of Interest Statement
Luis G. Bravo
FDA Welcome and Update
Ji Sun Lee, J.D.
Overview of the Tobacco Products Scientific Committee (TPSAC)
Jonathan Samet, M.D., MS
Harmful and Potentially Harmful Constituents
Conrad Choiniere, Ph.D.
FDA Research Conducted in Support of the Development of an HPHC List for Public Display
Greta Tessman, MA
FDA Experimental Study of the Public Display of Lists of HPHCs: Study Design
Sarah Johnson, Ph.D.
FDA Experimental Study of the Public Display of Lists of HPHCs: Analysis and Results
David Portnoy, Ph.D., MPH
Communicating About Harmful and Potentially Harmful Constituents and Tobacco Smoke: Potential Opportunities and Challenges
Tesfa Alexander, Ph.D.
Open Public Hearing
Mike Ogden, Ph. D., RAI Services Company
Questions to Committee
Conrad Choiniere, Ph.D.
William K. Hallman, Ph.D.
Risk Communication Advisory Committee Meeting
The purpose of the meeting as described by Dr. Conrad Choiniere’ s opening presentation was to discuss the FDA’s requirement to publish information about harmful and potentially harmful constituents in tobacco and/or its smoke. The specific goal was to establish a list of harmful and potentially harmful constituents, including smoke constituents of each tobacco product by brand; and publish for public display the information in a format that is understandable and not misleading.
Summary of Presentations and Discussions
Dr. Choiniere provided a definition of harmful and potentially harmful constituents (HPHC) and how the list of 93 HPHCs was developed. He also explained how the FDA published draft guidance on the initial list, identifying and proposing the enforcement of 20 HPHCs that have well-established testing methods, and laboratory capacity for manufacturers to test for the 20 HPHCs. The goal is to eventually receive information on the full list from manufacturers. Dr. Choiniere also addressed the following questions: How will the public respond to the HPHC information? What does the HPHCs list convey to the public? Will the public understand the technical information such as chemical names, units of measurement and significance of quantities which vary amongst the chemicals? He also shared that FDA is required to conduct periodic research to ensure that the list is not misleading the public and report those results to Congress by April 2015.
Ms. Gretta Tessman presented findings from FDAs focus groups about consumer knowledge and perceptions of HPHCs. She presented examples of how constituents have been made available to the public in other contexts; findings from literature; findings from the FDA conducted focus groups in March 2011; and prototype list as a result of the formative research process. Ms. Tessman explained that findings have shown that consumers have limited knowledge of awareness of chemicals in tobacco products. Focus group findings showed that participants understood using tobacco could cause many health problems, but they believed that tobacco products contained fewer than 50 chemicals. Furthermore, participants found the chemical names, amounts and units of measure confusing.
Dr. Sarah Johnson introduced the committee to the experimental study that was conducted on the public display of lists of quantities of HPHCs, particularly describing the purpose, aims and design of the study. There were two goals of this study: examining the impact of augmenting the lists of HPHCs with supplemental information, and the second goal was to examine the impact of presenting a list of HPHCs when some constituent quantities are available and others are not.
Dr. David Portnoy introduced the committee to the results and top line analysis of the study that was included a little over 3500 participants. The first analysis focused on the research question: Does augmenting the lists of HPHCs with supplemental information improve comprehension of the lists? Results showed that for each product type, participants that viewed a list that was augmented with supplemental information had higher comprehension scores when compared to those that viewed a list that was not augmented with supplemental information. Secondly, results showed that exposure to any HPHC list, compared to the no-exposure control group, were associated with both higher comprehension scores as well as higher harm perceptions.
Dr. Tesfa Alexander presented on a study to aid in the evaluation of the issues related to public education of HPHCs; with additional background information, to address the question of: “What strategies might FDA use in public understanding of HPHCs?” Environmental scans conducted of internet content and community programs show that numerous health organizations provide constituent information. From all of the study information captured, there are 5 areas identified for potential HPHC education; 1) Increase public awareness and understanding of the presence of HPHCs in all regulated tobacco products; 2) Increase public awareness and understanding of the origins of HPHCs; 3) Increase public awareness and understanding of the health effects associated with HPHCs; 4) FDA to increase public understanding of how HPHCs are measured in tobacco products and tobacco smoke; and 5) FDA to increase public understanding of HPHC brand and sub-brand quantities.
Following the presentations, FDA presenters addressed clarifying questions from the committee like:
- Were stimuli questions based on actual data, or were they just examples for people to react to?
- When you developed these stimuli and materials, did you pick up on any differential response or input from the adolescent focus groups?
- Why the segregation between cigarettes and roll-your-own, since roll-your-own are cigarettes, why is the differentiation made?
- What constitutes comprehension for the study?
- What is the point? What are we driving at? If basically people do not perceive a difference between harm perception between, say, a cigarette and smokeless, wouldn’t that be important information to understand?
- In terms of the big picture, can you tell us why you did what you did? Why did you test what you did, augmented by what, what information was included and why you thought to include, augmented by what and why?
- In terms of measurement, what does it mean? What do the scales mean? What does a one-point or two-point difference – even though its statistically significant or marginally, what does it mean in terms of its practical significance?
- Looking at your comprehension scores, what would you target as an acceptable comprehension level?
- Was any consideration given into looking at other ways to reach out to a broader segment of the population other than the internet panels? Similarly, was there any advice or counsel received from those who are culturally sensitive to ensure that you had a good representation in your study?
- Have you thought about defining what being misled is, perhaps define the proportion of individuals before and after the intervention who is misled, and whether that proportion increases with the different lists presented here?
- A key concept presented is that consumers don’t understand that the harmful constituents are actually part of the tobacco product and produced through burning the tobacco product. Why is that a key concept for people to understand, as opposed to simply understanding that the chemicals are in the product itself?
- It has been stated that FDA is focused on public education initiatives. Is that basically a concept, or have you given any thought to the direction that might take?
Questions to the Committee
- Section 904(d) of the FD&C Act directs FDA to publish and place on public display a list of HPHCs in each tobacco product by brand and by quantity in each brand and sub-brand in a format that is understandable and not misleading to a lay person. What potentially important communication objectives for the HPHC list should FDA consider when fulfilling its statutory obligation?
- How could FDA assess whether the publication of the list of HPHCs in tobacco products by brand and by quantity in each brand and sub-brand is in a format that is “understandable and not misleading to a lay person”?
- What method(s) and outcome(s) could be used to assess whether HPHC lists are understandable to a lay person?
- Does the Committee recommend that the HPHC list meet a predetermined threshold level for a particular outcome or set of outcomes? If so, what criteria could FDA use to set the threshold level? Does the Committee recommend that an understandable HPHC list meet the same threshold level for all populations (e.g., youth at high risk for initiating, youth tobacco users, adult tobacco users, those with low health literacy)? If not, how should the levels be determined?
- What method(s) and outcome(s) could be used to assess whether HPHC lists are not misleading to a lay person?
- Does the Committee recommend that an HPHC list that is not misleading meet some predetermined threshold level for a particular outcome or set of outcomes? If so, what criteria could FDA use to set the threshold level? Does the Committee recommend that an HPHC list that is not misleading meet the same threshold level for all populations (e.g., youth at high risk for initiating, youth tobacco users, adult tobacco users, those with low health literacy)? If not, how could the levels be determined?
- What additional research could FDA conduct to inform the development of the format and assess the impact of the public display of the list of HPHCs in tobacco products by brand and by quantity in each brand and sub-brand?
- What strategies might FDA use in a public education effort aimed at a deeper public understanding of HPHCs?
- What should be the primary objectives of any FDA HPHC public education materials?
- How might educational materials linked to the HPHC list be designed to enhance public understanding?
In closing, Dr. Hallman thanked the committees, the FDA staff and public attendees for their participation. The FDA thanked the Committees for their comments and discussion.
Please see the verbatim transcript for details of the discussion
The meeting was adjourned at 4:53 p.m.