"Consumer Perceptions Related to Harmful and Potentially Harmful Constituents in Tobacco Products"; OMB Control No. 0910-0674

Pretesting of Tobacco Communications

HPHC focus group memo to OMB plus materials_0910_0674-010611

"Consumer Perceptions Related to Harmful and Potentially Harmful Constituents in Tobacco Products"; OMB Control No. 0910-0674

OMB: 0910-0674

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
Food and Drug Administration

____________________________________________________________________________________________________________________________

Memorandum
Date

January 10, 2011

From

PRA Specialist, Paperwork Reduction and Records Management Staff
Office of Information Management

Subject

Request for Approval of FDA Focus Group, “Consumer Perceptions Related to Harmful and
Potentially Harmful Constituents in Tobacco Products”; OMB Control No. 0910-0674

Human Resources and Housing Branch
Office of Information and Regulatory Affairs, OMB
Through: HHS Reports Clearance Officer ____________

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is seeking OMB
approval under the generic clearance 0910-0674 to conduct a set of focus groups, “Consumer
Perceptions Related to Harmful and Potentially Harmful Constituents in Tobacco Products”, to assess
consumer perceptions and knowledge with respect to harmful and potentially harmful (H/PH) tobacco
constituents, which will inform the Agency's efforts to implement the mandatory publicly available list
of H-PH constituents required by the Family Smoking Prevention and Tobacco Control Act (the
Tobacco Control Act).
Section 904 (d)(1) of the Tobacco Control Act states “Not later than 3 years after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary
shall publish in a format that is understandable and not misleading to a lay person, and place on public
display (in a manner determined by the Secretary) the list [of harmful and potentially harmful
constituents] established under subsection (e).”
In order to develop information that is understandable and not misleading, FDA must conduct research
to gain insight on consumer perceptions and knowledge with respect to harmful and potentially harmful
(H-PH) tobacco constituents.
The first stage of the research will consist of 16 focus groups representing a diverse population. The
focus groups will be conducted in areas of the United States with relatively high rates of smoking
(Metropolitan D.C, Nashville, TN, Baton Rouge, LA, and Miami FL). At least eight of the groups will
be comprised of young smokers: four groups between 13 and 17 years of age and four groups between
18 and 24 years of age. The remaining groups will consist of four groups between 25 and 34 years of
age and four groups between 35 and 65 years of age. The groups will be separated by gender. Groups
will also vary by race, income, and/or smoking status (e.g., regular users, occasional users, those
planning to quit, etc.). At least half of the groups will be comprised of smokers with lower literacy
levels.
The Contractor will recruit 12 individuals for each focus group discussion, with the expectation of
having 8 to 10 participants per group. The Contractor will contact potential respondents by telephone
and screen them for eligibility. Additionally, respondents will receive a reminder call and
confirmation letter before the groups convene. Each respondent will also receive a $75.00 cash
incentive for their time and participation.

For studies employing similar respondent selection criteria, the incidence of a successful completed
telephone screening has been found to be between 30-40%. The recruiter will require approximately
five minutes to complete the screening interview for a selected participant, and will require less time
to disqualify a potential respondent.
For the focus group with youth who are aged 13 to 17, the facility will first speak to an adult to
determine if he or she is the parent or guardian of an adolescent aged 13 to 17 who lives in the
household. If so, the recruiter will explain the study and ask permission to speak to the adolescent. If
permission is given, the recruiter will explain the study to the adolescent and screen him/her for
eligibility. The recruiter will speak to the parent/guardian again to tell him/her if the adolescent is
eligible. If eligible, the recruiter will ask the parent/guardian if the adolescent would be interested in
participating in the focus group. The recruiter will explain that the session will be videotaped and
will ask if this is okay. If it is, the recruiter will explain that it is preferred that the parent/guardian
accompanies his/her child to the session (a room for them to wait in will be provided) and will ask if
the parent/guardian will do so. If the parent/guardian says no, the recruiter will confirm that the
parent/guardian is giving permission for the adolescent to participate without their accompaniment.
A respondent screener, moderator’s guide, focus group packet, focus group stimuli (mock H-PH
tobacco constituent lists) and consent forms are attached in Appendices I, II, III, IV, V. The
contractor will recruit participants and facilitate discussions.
The time required for screening and participation will be 1.6 hours per participant. There will be a
total of no more than 192 participants in 16 groups, producing a total estimated maximum respondent
burden of 307.2 hours.
Table 1. Estimated Annual Reporting Burden for Selected Respondentsa
Number of

Annual

Total

Respondents

Frequency

Annual

Hours per

per

Responses

Response

192

1.6

Total Hours

Response
192

307.2

There are no capital costs or operating and maintenance costs associated with this collection
of information.

In order to meet the statutory deadline, FDA/CTP would like to begin the focus group research by
January 2011 and have all groups completed by April 2011. The data collected in these focus groups
will be used to inform the design of a follow-up qualitative-quantitative comprehension study and a
quantitative experimental survey to assess the ability of consumers to use and understand the publicly
available information on H-PH constituents. FDA/CTP plans to conduct the comprehension study in
July 2011 and the experiment in March 2012.
If you have any questions, please contact Jonna Capezzuto on 301.796.3794.

Attachments:

Appendix 1
Respondent Screener:
Consumer Knowledge and Perceptions of Harmful and
Potentially Harmful Tobacco Constituents
Recruiting Goals

Sixteen groups: (4) Washington DC, (4) Nashville, TN (4) Baton Rouge, LA, (4) Miami, FL
The groups will be segmented by level of education (6- less than HS ed., 6-HS ed. and 4-post
HS).
Mix of races and ethnicities.
All groups will be separated by gender.
Each group should be comprised of participants who have similar socioeconomic
backgrounds.
Age profile for each group should be as follows:
• 4 groups ages 13-17 (two group regular tobacco users, two occasional tobacco users);
these groups should be separated into middle school attendees and high school
attendees
• 4 groups ages 18-24 years of age (two groups regular tobacco users, two groups
occasional tobacco users)
• 4 groups ages 25-34 years of age (two groups of tobacco users, two groups planning
to quit tobacco use)
• 4 groups between 35-65 years of age (two groups tobacco users, two groups planning
to quit tobacco use)
All participants must be able to read, understand, and speak English.
Scientists, tobacco industry workers, and market researchers will be excluded.
All participants who normally wear corrective lenses, contacts, or glasses to read must have
them with them during the focus group.
Participants cannot have participated in a focus group or a similar study in the past 6 months.
12 recruits per group in order to get 8-12 to participate.
Participants will receive $75 incentives.
Each focus group will last approximately 90 minutes.
Upon consent, groups will be audio- and video-taped.
Obtain consent/assent.
The identity of the participants will remain confidential.
Groups at the Washington DC site will be observed by staff from the Food and Drug
Administration (FDA). FDA will travel to other sites if funding permits.
Participants do not have to answer any questions that they do not want to, but are encouraged
to participate.

Focus Groups Screener

Recruitment Script for Adults

Hello Mr. /Ms. __________________________________, my name is __________________ and I
would like to talk to you about a focus group study we plan to conduct for the U.S. Department of
Health and Human Services. We are recruiting people for an upcoming focus group in which
participants will be asked to share their thoughts and feelings about information regarding tobacco
products. Would you mind answering a few questions to see if you are able to participate in the
study?

Screening Questions
Q1.

Before I start, are you at least 18 years old?
[YES] Continue
[NO]
If no: Can I speak with someone at least 18 years old?
If no, when would be a good time to call back and speak with someone at
least 18 years old? SET UP CALL BACK TIME
Or, is there no one over 18 in the household? TERMINATE IF NO ONE
OVER 18

Q2. Have you participated in a focus group within the past 6 months?
[YES] TERMINATE
[NO] Continue
Q3. Do you currently smoke cigarettes?
[YES]
Do you smoke everyday or occasionally? ____everyday ____occasionally
[For those who smoke everyday] How many cigarettes do you smoke each day?
______
[NO] Continue
Q4. Do you use other tobacco products such as chewing tobacco, snuff, dip or snus?
[YES]
Do you use [state the tobacco product mentioned] every day or occasionally?
____everyday ____occasionally
[For those who use a tobacco product everyday] How many times a day do you use
[state the tobacco product mentioned]? _____
Focus Groups Screener

[NO] Continue
[If answers NO to both Q3 and Q4, TERMINATE]
Q5. How long have you been using tobacco products?

Less than 2 years
2-5 years
6-10 years
11-20 years
More than 20 years

Q6. Which of the following best describes your thinking about quitting tobacco use?

Planning to quit within the next month [assign to planning to quit group]
Thinking about quitting within the next 12 months [assign to planning to quit group]
I will quit someday but not within the next 12 months [assign to not planning to quit group]
I’m not interested in quitting [assign to not planning to quit group]

Demographic Questions
Q7. Are you male or female?

Male
Female

Q8. How old are you? ____________
If the person refuses to report age, then say “I understand you don't want to tell me your age.
Which of the following category of age are you in?”

18-24
25-34
35-49
50-65

Q9. What is the highest level of education you have completed?

Less than high school
High school (including GED)
Some college
College
Post graduate

Q10. What is your profession? ________________________________________

Focus Groups Screener

[TERMINATE if market researcher, scientist, or employed by the tobacco industry. Ask
directly if unsure based on response above.]
Q11. Are you of Hispanic or Latino origin?

Yes
No

Q12. What is your race? I am going to read several categories of race. You may choose one or
more categories as they apply. Are you…

White
Black or African American
Asian
Native Hawaiian or other Pacific Islander
American Indian or Alaska Native
Other

Q13. On a scale of 1-5, how comfortable are you understanding and speaking English? 1 is very
uncomfortable, 3 is somewhat comfortable, and 5 is very comfortable. ______________
[TERMINATE if 3 or lower]
Q14. On a scale of 1-5, how comfortable are you participating in a group discussion with
approximately 8-10 other adults? 1 is very uncomfortable, 3 is somewhat comfortable, and 5 is very
comfortable. _______________
[TERMINATE if 3 or lower]
Q15. Which of the following groups includes your total annual household income?

Under $20,000
$20,000-34,999
$35,000-59,999
$60,000-99,999
$100,000 or more

[Optional, participant may refuse to provide]
From what you told me it looks like you are eligible to participate in the study therefore we invite
you to meet with a group to discuss issues related to tobacco products with about 10 other people
who use tobacco products. The discussion will last no more than two hours, will be video- and
audio-taped, and observed by the focus group staff. Your participation and everything you say
during the discussion will remain confidential. You will receive $75 for participating. Additionally,
we will serve you snacks and beverages before the group discussion starts. Are you interested in
participating in this focus group?
[YES]
[NO]

Continue
TERMINATE

Focus Groups Screener

I’m glad that you will be able to join us! The focus group will take place on [Day], [Date], at [6:00
or 8:00 p.m.] at [site location]. If you normally wear corrective lenses, contacts, or glasses to read
please remember to have them with you during the focus group.
Will you be available to participate at this time?
[YES]
[NO]

Continue
TERMINATE

I would like to send you a confirmation letter and directions to the facility. In order to do so, could
you please tell me your mailing address (or fax number, e-mail address) and a phone number where
you can be reached:
Name:______________________________________
Address:__________________________________________________________
City:_______________________ State:_________ Zip:______________
Phone:_______________________
Email:_______________________
Date of focus group:__________________ Time:________________
We are only inviting a few people, so it is very important that you notify us as soon as possible if for
some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should
happen. We look forward to seeing you on [date] at [time].

Focus Groups Screener

Recruitment Script for Adolescents

Parent Introduction:
Hello Mr. /Ms. __________________________________, my name is __________________ and I
would like to talk to you about a focus group study we plan to conduct for the U.S. Department of
Health and Human Services. We are recruiting for an upcoming focus group in which participants
will be asked to share their thoughts and feelings about information regarding tobacco products. We
believe it is particularly important to talk with teens about this issue. Can we speak to
_______________ [teen’s name] to see if they are able to participate in the study? If he/she is able
to participate, we will need you to sign a consent form and have him/her bring it to the focus group.

Adolescent Introduction:
Hello __________________________________, my name is __________________. I’m with XXX
and we’re interested in talking to teens about tobacco products. We are planning to conduct
discussion groups with teens for the U.S. Department of Health and Human Services. Everything
you share in the group will be confidential—which means it will not be shared with anyone outside
of the group, including your parents. Would you mind answering a few questions to see if you are
able to participate in the study?

Screening Questions
Q1. Before I start, are you between ages 13 and 17?
[YES]
[NO]

Continue
TERMINATE

Q2. Have you participated in a focus group within the past 6 months?
[YES]
[NO]

TERMINATE
Continue

Q3. Do you currently smoke cigarettes?
[YES]
How many days in the past 30 days have you smoked? ____
[For those who smoke 20 or more days, assign to regular user group]
[NO] Continue

Q4. Do you use other tobacco products such as chewing tobacco, snuff, dip or snus?
Focus Groups Screener

[YES]
How many days in the past 30 days did you use a smokeless tobacco product? ____
[For those who used a smokeless tobacco product for 20 or more days, assign to
regular user group]
[If total days of tobacco use is 20 or more with combined cigarettes and
smokeless tobacco use, assign to regular user group]
[NO] Continue
[If answers NO to both Q3 and Q4, TERMINATE]
Q5. How long have you been using tobacco products?

Less than 1 year
1-2 years
3 or more years

Demographic Questions
Q6. Are you male or female?

Male
Female

Q7. How old are you? ___________________

Q8. What grade are you in?

7th grade
8th grade
9th grade
10th grade
11th grade
12th grade
No longer attending school
Other _____________________

Q10. [For those who report being in school] Are you in middle school or high school?
Middle School
High School

Focus Groups Screener

Q9. Are you of Hispanic or Latino origin?
Yes
No
Q10. What is your race? I am going to read several categories of race. You may choose one or
more categories as they apply. Are you…
White
Black or African American
Asian
Native Hawaiian or other Pacific Islander
American Indian or Alaska Native
Other
Q11. On a scale of 1-5, how comfortable are you understanding and speaking English? 1 is very
uncomfortable, 3 is somewhat comfortable, and 5 is very comfortable. ______________
[TERMINATE if 3 or lower]
Q12. On a scale of 1-5, how comfortable are you participating in a group discussion with
approximately 8-10 other people around your age? 1 is very uncomfortable, 3 is somewhat
comfortable, and 5 is very comfortable. _______________
[TERMINATE if 3 or lower]
From what you told me it looks like you are eligible to participate in the study. I would like to invite
you to join about 10 other teens who also use tobacco products in a group discussion. The
discussion will last no more than two hours, will be video- and audio-taped, and observed by the
focus group staff. As I said earlier, your participation and everything you say during the discussion
will remain confidential. You will receive $75 for participating. Additionally, we will serve you
snacks and beverages before the group discussion starts. Are you interested in participating in this
focus group?
[YES]
[NO]

Continue
TERMINATE

Because you are under age 18, we will need a parent or guardian’s permission for you to be in the
focus group. Will you be able to have a parent or a guardian sign a form giving you permission to
attend?
[YES]
[NO]

Continue
TERMINATE

You will need to bring the consent form I will send you with your parent or guardian’s signature
when you come to the focus group. If you don’t have this consent form, you won’t be able to
participate.
Focus Groups Screener

Continue
TERMINATE

Because you are under 18, you will need to get written permission from a parent or guardian in order to
participate in the focus group. I would also like to send you a confirmation letter and directions to the
facility. In order to do so, could you please tell me your mailing address (or fax number, e-mail address)
and a phone number where you can be reached:
Name:______________________________________
Address:__________________________________________________________
City:_______________________ State:_________ Zip:______________
Phone:_______________________
Email:_______________________
Date of focus group:__________________ Time:________________
We are only inviting a few people, so it is very important that you notify us as soon as possible if for
some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should
happen. We look forward to seeing you on [date] at [time]. If you use reading glasses, please bring
them with you to the focus group.

Focus Groups Screener

Informed Consent for Participation in a
Discussion Group
ICF Macro is conducting discussion groups on behalf of the U.S. Department of
Health and Human Services to better understand consumers’ thoughts and
knowledge about tobacco products. We have invited you to participate in a
discussion with other consumers to share your thoughts and knowledge about these
products.
If you consent to participate in the discussion, here are some things you should
know:
•

Your participation is totally voluntary.

•

Your name will not be used in any reports about this discussion group. We will
be taking notes during the discussion about what was said, but we will not
record who made the comments.

•

The discussion will be audio- and video-taped so that when we write our report
we can make sure we understand everything that was said.

•

There will be observers from the Food and Drug Administration and ICF Macro
in another room taking notes during this discussion.

•

Anything discussed during the group will be confidential

•

You will receive $75 for participating in the group.

•

You may discontinue participation at any time, either by leaving the discussion
group or not answering a question, without penalty or loss of benefits.

•

The discussion group will last approximately 90 minutes.

•

Any questions you have about the discussion groups will be answered before we
begin our discussion. Contact information is provided below for any questions
that arise after the discussion.

•

You will be provided with a copy of this form to take with you.

Contact information: If you have any concerns about your participation in this
discussion group or have any further questions about the project, contact Ms. Edith
Stevens at ICF Macro, telephone number (301) 572-0534.
Your signature below indicates that you understand the above and agree to
participate in this group.
Print your name:

_________________________ Date:

__________________

Signature:

_________________________ Witness: __________________

Informed Consent for Participation in a
Discussion Group
ADOLESCENT FOCUS GROUP

Please read this assent form carefully. Take time to ask as many questions as you want. If there are
any words or information you do not clearly understand, study personnel will be happy to explain
them to you. This assent form must be signed before you can participate in the focus group. Your
parent/guardian must also sign this form before you can participate.
INTRODUCTION
ICF Macro is conducting discussion groups on behalf of the U.S. Department of
Health and Human Services to better understand adolescents’ thoughts and knowledge
about tobacco products. We have invited you to participate in a discussion with other
adolescents to share your thoughts and knowledge about these products. Your part in
this study involves being in a focus group (discussion group). The focus group will be
guided by an adult who is trained to get your opinion and encourage everyone to take
part.
Your participation is entirely voluntary.
PURPOSE OF THE RESEARCH STUDY
The purpose of this study is to better understand adolescents’ thoughts and knowledge about
tobacco products.
INFORMATION ABOUT THE STUDY
This research involves 4 focus groups of about 6-10 adolescents each. If you agree, you will
participate in one focus group. This meeting will last about 2 hours. Group conversations will be
recorded, and notes will be taken. Only first names will be used to help protect your privacy.

YOUR ROLE IN THE STUDY
Participating in a research study can be an inconvenience to daily life. Please consider the study
time commitments and responsibilities when you are deciding whether or not you should
participate. These include:
•
•

Coming to the study site for the focus group at the planned time;
Providing truthful information about what you think about the usefulness of the materials for
yourself and other adolescents.

REIMBURSEMENT FOR STUDY PARTICIPATION
You will receive $75.00 in cash for your participation in the study. This will be given to you at the
end of the focus group session.
CONFIDENTIALITY
As part of this study, the study staff may record personal information about you that contains your
name and other personal identifiers. Transcripts of focus groups will only include your first name.
Subject’s Initials_________

The collection and submission of the information will be accomplished with strict adherence to
professional standards of confidentiality. Information from this study may be published in
professional journals or at scientific conferences, but your confidentiality will be respected and no
names will be used in any report or presentation.
RESEARCH QUESTIONS AND CONTACTS
You may freely ask questions about this assent form or the study now or at any time during the
study. If you have any questions about the research, or compensation, during this study you may
contact the study staff.
VOLUNTARY NATURE OF STUDY
Entering a research study is voluntary. Anyone who is asked to be in a research study may so no.
No one has to become a research subject. If you start a research study, you may stop at any time.
You do not need to give a reason. No health care professional can discriminate against you or treat
you differently if you choose not to be in a research study or later decide not to participate.
ASSENT STATEMENT BY PARTICIPANT 17 AND UNDER
I have read this assent form. I understand what I am being asked to do. My questions have been
answered and any words I did not understand have been explained to me. I agree to be in this
research study for the purposes listed above. I will receive a copy of this assent form for my
records.
___________________________
Print your name here if you want to be in this study
___________________________
____________________________
Sign your name here if you want to
Signature
be in this study

____________
Date

Subject’s Initials_________

CONSENT STATEMENT BY PARENT OR GUARDIAN
I have read this consent form. My questions have been answered. I agree to allow my child to be in
this research study for the purposes listed above. I will receive a copy of this consent form for my
records.
By signing this consent form I am not giving up any of my or my child’s legal rights. I also
understand that nothing in this consent is intended to change any applicable federal, state or local
laws regarding informed consent.
___________________________
Printed Name of Minor Research Subject (Child)
___________________________
Name of Guardian (Print)

____________________________
Signature

____________
Date

_____________________________ _____________________________ ____________
Name of Person Obtaining
Signature
Date
Informed Consent

Subject’s Initials_________

Moderator’s Guide:
Consumer Knowledge and Perceptions about Harmful and Potentially
Harmful Tobacco Constituents
-------------------------------------------------------------------------------------------------Opening Remarks – Introductions and Rules (5 minutes)
•
•
•
•
•

Welcome and thank you for participating
Conducting focus group on behalf of the U.S. Department of Health and Human Services
Would like to learn more about what you know and want to know about tobacco products
Speak freely and openly—no right or wrong answers
Encourage everyone to participate but you do not have to answer any questions you don’t
want to
• Ok to disagree with each other, but must remain respectful
• Try to speak one at a time
• Everything said is completely confidential and will not be reported in connection with
names or other identifying information
• Will begin audio recording after introductions
• Audio recordings will be transcribed for analysis purposes but will not include names or
other identifying information
• Please do not look through or write on packets in front of you until instructed to do so; do
not write your name on the packet
• Group will last no more than two hours
• For the purposes of time, may need to end parts of the discussion before everyone has had
a chance to speak—will allow time at the end for final thoughts and questions
• Please silence cell phones; if you must take a call, please step out of the room
• Restrooms are located XX
• Questions?
-------------------------------------------------------------------------------------------------Ice Breaker (5 minutes)
Let’s go around the room and introduce ourselves. Please tell me your first name, and a little bit
about yourself, like what you would be doing right now if you weren’t here with us.
--------------------------------------------------------------------------------------------------1. Tobacco products introduction (15 minutes)
As you may know, we brought you here tonight because you use tobacco products. We would
like to hear your thoughts about these products. Let’s start by going around the room and having
everyone tell us how long you have been using tobacco. Keep in mind that when we talk about
tobacco products tonight, we are referring to cigarettes, chewing tobacco, snuff, dip, snus.
How many of you know that the Food and Drug Administration (FDA) regulates tobacco
products? [Get a tally of number of hands that go up]
What comes to mind when you hear that the FDA regulates tobacco? What do you think this
means?
What do you think this means FDA will be doing to regulate tobacco products?
1

Do you think FDA regulating tobacco products will affect you? If so, how?
How important do you think it is for the FDA to regulate tobacco products? Why?
As of June 2009, the FDA was given authority to regulate tobacco products. This includes
developing new health warnings and providing people with information on the chemicals found
in tobacco products.
2. General knowledge about H-PH constituents found in tobacco products (15 minutes)
What do you know about the tobacco product you use? Do you think about what may be in your
tobacco products? Or do you think about what gets inside your body when you use your tobacco
product?
[Allow for discussion. If needed prompt group to discuss the chemicals that may be in their
products]
In front of you is a packet. This packet is something that we will be using during this group to let
you write down some of the thoughts you might have tonight. Please do not write your name on
the packets. I will let you know when to open them and when you should turn to the next page.
Go ahead and open to the first page. As you can see this first page asks you the question “How
important do you think it is for you to know about the chemicals that are in your tobacco
product(s)?” Please mark the response that matches how you feel. [Likert scale of 1-5 (1=not at
all important, 5=very important)]
Ask participants to discuss their answers and why they chose them.
Now turn to page 2 in your packet and mark your response to the question “How important do
you think it is for you to know how each of these chemicals affects your body?” [Likert scale of
1-5 (1=not at all important, 5=very important)]
Ask participants to discuss their answers and why they chose them.
How many of you know or have heard something about chemicals in tobacco products and
smoke? [Get a tally of number of hands that go up]
What comes to mind when you think about these chemicals?
What are these chemicals? [Record on board]
Are there any others you can think of?
How many do you think there are in one cigarette?
What do you think these chemicals do to your body? [Ask about the specific chemicals the
participants mentioned]

Where did you learn about the chemicals in tobacco products? How about their effect on the
body?
3.

Use of Information (10 minutes)

Some of you said it was important for you to know what chemicals are in your tobacco products.
If you wanted to know more about what is in your tobacco products, where would you look?
Why?
Have you ever searched for this type of information before?
If so…
• Where did you look?
• What made you search for this information?
• How did you know where to look for the information?
• What did you do with the information? [PROBE: decision-making, behavior
change]
If not…
• If you knew this information was available, would you be interested in looking at it?
• What would prompt you to look for this information?
• Where do you think this information would be found?
• What do you think you would do with the information? [PROBE: decision-making,
behavior change]
4. Test HPHC list (20 minutes)
Now we’re going to take some time to look at a list of some of the chemicals found in tobacco
products. As you are looking at this list, please write down any thoughts that come to mind on
page 3 in your packet.
[Pass out a copy of the list created for testing purposes only. Give participants a few minutes to
review and record.]
Does anyone want to share what they wrote down? What does this list make you think? How
does it make you feel? Does it make you want to do anything with it?
What do you think the purpose of this list is?
Does this list mean anything to you? What does this information mean to you?
What do you notice as you look at this list? [PROBE: order, headers, numbers listed below]

Order:
Do you think the chemicals are listed in any particular order? Why do you think this?

Do you think the health conditions along the top are listed in any particular order? Why
do you think this?
How should a list like this to be ordered?
Headers:
What do the headers mean?
Do you find the headers useful?
Is this the type of information you expected to see?
What other headers or types of information would you find useful?
What do the health condition headers mean to you (cancer, lung…)?
What does the header “amount per cigarette” mean to you?
Numbers:
What do the numbers on this list tell you?
Are the numbers meaningful?
Are the numbers useful?
Why do you think that there is often two numbers listed?
Why do you think some chemicals may only have one number?
What comes to mind when you see a high number versus a low number?
Do the symbols (mg, µg, ng) after the number tell you anything?
Do you think listing the amount in the chemical is necessary? Why? Why not?
General:
What types of chemicals do you think are on this list and why?
What information do you find the most useful on this list? Why?
What information do you find the least useful on this list? Why?
Is there anything about this list that surprises you? What and Why?
What would help you understand this list better? [PROBE: instructions]

If you could change the way the list looks or the information it shows, how would you change it?
[PROBE: reasons why participants would make the changes they suggest]
If there was a list like this for your tobacco product, how likely is it that you would look for it?
Turn to page 4 in your packet and mark your response [Likert scale of 1-5]
Ask participants to discuss their answers and why they chose them.
Imagine this is a list for your brand of cigarettes or smokeless tobacco. What does this make you
think about…
1) your brand?
2) your smoking?
3) other brands of tobacco products?
5. Multiple HPHC test lists of tobacco products (15 minutes)
Now we’re going to take a look at lists for a few different tobacco products--we’ll refer to them
as Brand X, Brand Y, and Brand Z. We want to know what you are thinking about when you
look at a list of chemicals from different tobacco products. I want you to look at these lists and
hear your reactions. Flip to page 5 in your packet and write down words or phrases that come to
mind.
[Pass out a copy of the three lists created for testing purposes only. Give participants a few
minutes to review.]
What comes to mind when you look at these lists?
How are these lists similar and how are they different?
What do these similarities and differences mean to you?
If Brand X was your brand, would having these other lists make you think differently about your
brand? How so? What does this make you think of the other two brands?
What if I tell you Brand Z is a type of chewing tobacco? Now what do you think about these
products? [PROBE: impact on tobacco use, impression of brands, product safety]
Impression of brands:
How do you think Brand Z compares to the other two brands?
If you do not use chewing tobacco, does seeing this list make you think differently about
your own brand? Why or why not?
If you use chewing tobacco, what does this make you think about your brand?

Impact on tobacco use:
5

If you do not use chewing tobacco, does seeing this list make you think differently about
the type of tobacco product you use?
If you use chewing tobacco, what does seeing this list make you think about your own
tobacco use?
Product safety:
Does one brand appear to be safer than another? If so, what makes you think this?
Do you think you would look at lists of different tobacco products other than your own brand?
Why?
6. Publication and Dissemination (10 minutes)
Now that you’ve had a chance to look at examples of these lists of chemicals…
Who would you expect to put these lists out? Why?
Where would you expect to see lists like these? [PROBE: website]
What would come to mind if you saw these lists posted on an FDA website?
7. Debrief/Closing (5 minutes)
Under the Family Smoking Prevention and Tobacco Control Act, the FDA is required to develop
a list of “harmful and potentially harmful constituents” found in tobacco products by brand and
sub-brand. For example, consumers will be able to be able to find a list of these chemicals for
every brand of cigarette and smokeless tobacco.
Tobacco companies will be responsible for providing the list to FDA, who will then make it
available to consumers.
FDA is making this list available to let consumers know which harmful chemicals are in their
tobacco products.
Knowing this, is there anything else you would like FDA to keep in mind as they develop this list
and make it available to the public?
Do you have any questions before we conclude?
FDA wants to remind you that all tobacco is harmful and encourages you to consider quitting.
For more information, there are brochures available as you leave.
Thank you for participating in today’s discussion. As a token of our appreciation for your time,
you will each receive $75. Please pick up your incentive from XX as you leave.

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