**Request for OMB Review**

**Supporting Document**

**0910-0565**

**Experimental Study of Health Claims on Food Packages**

Submitted by

Consumer Studies Team

Division of Market Studies

Office of Scientific Analysis and Support

Center for Food Safety and Applied Nutrition

Food and Drug Administration

Department of Health and Human Services

June, 2005

**Supporting Statement**

**EXPERIMENTAL STUDY OF HEALTH CLAIMS ON FOOD PACKAGES**

**SUBMITTED by**

**Food and Drug Administration**

The Food and Drug Administration (FDA) is submitting an Information
Collection Request for an experimental study to examine consumer
responses to health claims on labels of conventional foods. The proposed
study consists of two parts: (1) an Internet experiment with 1,080
consumers, and (2) a mall-intercept experiment with 1,080 consumers;
both experiments will use the same instrument to collect information.
Data from the study are needed to inform any policy initiative(s) that
the agency may undertake in the future to provide consumers information
to help them make informed food choices.

## **A. JUSTIFICATION**

**A1. Need for the Collection of Information**

The need for this collection of information derives from the agency\'s
objective to obtain current, timely, and policy-relevant consumer
information to carry out its statutory functions. The FDA Commissioner
is authorized to undertake this collection as specified in section
903(d)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
393(d)(2)) (Attachment A).

> As a public health agency, FDA helps consumers make informed dietary
> decisions by regulating nutrition information in food labels,
> initiating its own consumer education activities, and collaborating
> with public and private entities in conveying nutrition information to
> consumers. These activities are aimed at influencing consumer
> awareness, understanding and behaviors related to diet and nutrition
> and ultimately health outcomes of the Nation.
>
> To help consumers reduce their risk of disease and improve their
> health by making sound dietary decisions, on November 25, 2003 FDA
> issued an advance notice of proposed rulemaking (ANPRM) to request
> comments on various issues related to health claims on conventional
> food and dietary supplement labels (68 FR 66040). One of the issues
> that FDA raised in the ANPRM related to whether the wording of a
> health claim needs to refer to the substance (a component of food,
> e.g., a nutrient) that is the basis of the claim. (Hereinafter, the
> term "health claim" will refer only to a claim meeting the standard of
> significant scientific agreement or, in other words, an FDA-
> authorized claim.) For instance, in the example of the
> calcium-osteoporosis claim ("**Calcium may reduce the risk of
> osteoporosis***"*), FDA requires that the substance that is the basis
> of the claim (in this case, calcium) be included in the wording of the
> claim (21 CFR 101.72). The requirement that the substance be included
> in the wording of a health claim was motivated by the fact that most
> substances that are the subject of an authorized health claim are
> substances that, like calcium, can be found in a number of foods .
> Therefore, FDA has provided for health claims that refer to the common
> substance to assist consumers in their understanding of the nature of
> the diet-health relationship and, more importantly, to help consumers
> recognize that they can construct healthy diets by using a variety of
> foods that contain the substance.
>
> FDA requests comments on the usefulness of statements that expressly
> include the particular component of food (e.g., the nutrient) that is
> the basis for the claim (e.g., "**Calcium-rich foods, such as yogurt,
> may reduce the risk of osteoporosis**\'\') versus "food-specific"
> claims that do not include the food component (e.g., "**Yogurt may
> reduce the risk of osteoporosis.**\'\') How consumers respond to the
> two kinds of statements can suggest how the explicit mention of a food
> component in a claim affects dietary choices, which in turn informs
> any policy initiative(s) that FDA may undertake in the future to
> provide information to consumers to help them make informed food
> choices. FDA, however, lacks sufficient empirical evidence to
> understand how consumers are likely to react to the two different
> kinds of health claims, has not received any such evidence in comments
> to the ANPRM, and is not aware of any extant evidence.

# **A2. Purpose and Use of the Information**

**A2.1** [Purpose of Information]{.underline}

> The purpose of the proposed collection of information is to help
> enhance FDA's understanding of consumer responses to health claims and
> inform any policy initiative(s) that FDA may undertake in the future.
> The information will be used primarily to assess what differences, if
> any, the inclusion of the food component in a health claim makes in
> (1) consumer recognition of the food component underlying a
> diet-disease relationship; and (2) consumer recognition that, in
> addition to the food product that carries the claim, there are other
> foods from which they can obtain the food component. In addition, the
> Agency desires to understand whether the two types of health claim
> affect consumer attitudes toward a food.
>
> The [primary]{.underline} hypotheses to be tested using the collected
> data are:
>
> Hypothesis 1: Compared to not mentioning '(Substance)-rich foods, such
> as (food),' a [health claim]{.underline} including the phrase leads to
> a better recognition of the substance underlying a diet-disease
> relationship;
>
> Hypothesis 2: Compared to not mentioning '(Substance)-rich foods, such
> as (food),' a [health claim]{.underline} including the phrase leads to
> a better recognition that there are other food sources of the stated
> relationship.
>
> The [secondary]{.underline} hypothesis (Hypothesis 3) is: Compared to
> not mentioning '(Substance)-rich foods, such as (food),' a [health
> claim]{.underline} including the phrase leads to a more favorable
> attitude toward a product.

**A2.2** [Users and Use of Information]{.underline}

**A.2.2.1** *Information items*

The proposed collection of information is a controlled randomized
experimental study. The study will use a within-subjects factorial
design with participants randomly assigned to experimental conditions.

To accomplish the purpose of this study, as stated in A2.1 above, the
agency plans to ask study participants' cognitive reactions to mock food
labels as measures of dependent variables:

-   recognition of substances related to the health benefits,

-   recognition that there are other foods offering the health benefits,
    and

-   product attitudes.

> There are two independent variables, type of front-panel health
> message and type of diet-disease relationship. The independent
> variables will be manipulated and randomly assigned to study
> participants.
>
> Cognitive responses to labels can be influenced not only by labeling
> statements but also by prior knowledge of foods, substances, and
> diet-health relationships. Knowledge, in turn, can be influenced by
> product experience, personal involvement, and other health
> motivations. Therefore, to help isolate the effects of health messages
> on cognitive responses, the study plans to ask about other pertinent
> information (see B.2.1.2 and Appendix B for details).
>
> **A.2.2.2** **and A.2.2.3** *Users and use of the information*.
>
> The agency expects to use the information (1) to enrich the
> deliberations of any policy initiative(s) that the agency may
> undertake in the future to provide consumers information to help them
> make informed food choices, and (2) to identify needs for potential
> future research in related areas.

**A2.3** [Plan of Analysis]{.underline}

**A2.3.1 and A.2.3.2** *Purposes of analysis and analytical approach*.

> The purpose of analysis is to quantitatively summarize study results
> to satisfy the informational need. Commonly accepted statistical
> techniques for experimental data, such as descriptive statistics,
> analysis-of-variance (ANOVA), and regression will be used to analyze
> the information and produce quantitative results.

The agency proposes to conduct concurrently Internet interviews and
mall-intercept interviews using the same instrument (including stimuli)
and with same number of participants in each data collection mode. The
purpose is to explore cross-mode replicability or mode differences in
collected data. This agency and other public and private entities have
gradually migrated from conventional mall-intercept experiments to
Internet experiments, due to the latter's advantages in efficiency and
speed. Yet, there is a paucity of evidence on Internet experiment's
convergent validity, i.e., whether the two modes produce comparable
data, particularly evidence related to experiments focusing on food
labels.

> Holding everything else constant, several factors may be expected to
> cause mode differences. First of all, participants in Internet
> experiments often come from members of established consumer panels who
> (1) self-select themselves to be part of a study, i.e., volunteer to
> share their opinions for a given topic, (2) possess a certain degree
> of computer and Internet skills, and (3) are used to frequent
> interview requests. In contrast, participants in conventional
> mall-intercept interviews (1) are requested to, rather than volunteer
> to, share their opinions and do not participate in interviews unless
> invited and offered acceptable conditions for their participation, (2)
> do not necessarily possess the computer and Internet skills comparable
> to Internet consumer panelists, and (3) are not necessarily accustomed
> to interviews. Second, the Internet does not offer the interview
> administrator the same degree of control over an Internet interview
> environment as over a mall-intercept interview environment. There is
> limited ability for the administrator to ensure that all interviews
> are conducted using a consistent technical configuration (e.g.,
> download speed, screen size); that all interviews are completed; that
> all interviews are completed in one session without break-ups; or that
> participants do not consult any other sources in providing the
> information. In contrast, since mall-intercept interviews are
> conducted at central locations using the same computer equipment and
> with the presence of interviewers, there is a higher degree of actual
> and perceived control over the interview environment.
>
> Any one or both of these factors can lead to different levels of
> motivation and different interview experiences in tasks such as
> maneuvering a Web page or comprehension of visual materials. Such
> differences, in turn, can cause disparities in how participants derive
> and provide the requested information. In that the agency does not
> wish to compromise data quality for data collection efficiency and
> speed, the agency considers the proposed mode analysis a beneficial
> use of its resources toward obtaining reliable data from Internet
> experiments in this and future studies.

**A3. Use of Information Technology**

The proposed information collection plans to recruit and interview
participants via Internet. This mode of data collection will reduce
respondent burden. It also can mitigate potential human errors in
experiment administration. By pre-loading assignments of experimental
conditions and relevant materials (e.g., labels) on the system, it is
easier to control and verify data collection instrument and it requires
no involvement by any interviewer. This technology can record process
information, such as time spent on a screen, which can provide
additional insights of consumer responses without increasing participant
burden. The technology also facilitates efficient data collection.

#### **A4. Efforts to Avoid Duplication and Why Available Information Cannot be Used**

> The agency has not identified, in a thorough literature review and
> through contacts with knowledgeable researchers, any available
> information that could meet the agency\'s need.
>
> Nevertheless, the agency has located two experimental studies that
> examined consumer responses to health claims on food packages. These
> studies do not meet the agency's informational need but have been
> useful in developing ideas for the proposed information collection.
>
> Levy, Derby, and Roe (1997)[^1] investigated whether "short" health
> claims communicate positive attitudes about a product more effectively
> and communicate health information about the product more accurately
> than "long" health claims. A "short" health claim mentions diets, the
> substance, and the risk, e.g., "**A diet low in saturated fat,
> cholesterol and total fat may help reduce the risk of heart
> disease**." A "long" health claim, on the other hand, also mentions
> risk factors, e.g., "**Many factors, such as a family history of the
> disease, increased blood and LDL-cholesterol levels, high blood
> pressure, cigarette smoking, and being overweight, contribute to
> developing heart disease. A diet low in saturated fat, cholesterol and
> total fat may help reduce the risk of heart disease**." Overall, the
> study found few response differences attributable to the length of a
> health claim, though there were some variations between the tested
> diet-disease relationships (yogurt-calcium-osteoporosis, cereal-folic
> acid-neural tube defects, and lasagna-saturated fat/cholesterol/total
> fat-heart disease). This study, however, does not meet the agency's
> informational need for three main reasons. First, the study did not
> include food-specific health claims, e.g., "**Yogurt may reduce the
> risk of osteoporosis**," which is the focus of this proposed
> collection of information. Second, the health claims used in the study
> always mentioned the substance. Third, the study did not include all
> dependent measures proposed for this collection of information.
>
> Paul, Ink, and Geiger (1999)[^2] examined consumer responses to two
> variants of a health claim on Quaker Oats labels: a "short" claim,
> indicating that "**A diet high in oatmeal may help reduce the risk of
> heart disease,**" as compared with a "long" claim, indicating that
> "**Diets low in saturated fat and cholesterol and high in grains,
> fruits and vegetables that contain fiber, particularly soluble fiber,
> may reduce risk of heart disease, a condition associated with many
> factors**." The study found that the health benefit was more likely
> recognized in the "short" rather than the "long" claim. Nevertheless,
> the study was intended to compare a claim that mentions "oatmeal" and
> another that mentions "grains, fruits, and vegetables." Hence, the
> study does not meet the agency's informational need.

#### **A5. Methods to Minimize Burden on Small Business**

The collection of information will not involve small business.

**A6. Consequences to the Agency\'s Program or Policy Activities if the
Collection is not Conducted**

Without this collection of information, the agency will lack critical
input to inform any policy initiative(s) that it may undertake in the
future to provide consumers information to help them make informed food
choices.

**A7. Special Circumstances**

This collection of information fully complies with 5 CFR 1320.5. There
are no special circumstances.

**A.8 Public Comments and Consultation Outside the Agency**

In the **Federal Register** of December 10, 2004 (69 FR 71819), FDA
requested comments on the information collection. FDA received two
comments, both from the food industry.

> One comment supported consumer research to enhance health message
> communication as a means to help consumers make sound dietary
> decisions. The comment suggested that, to improve the quality of the
> study and analysis, the Agency should (1) lay out the objective(s) and
> analysis plan of the study, (2) consider asking about how helpful a
> health message is in helping consumers make food choices, (3) consider
> asking respondents to read the health message on the stimulus, and (4)
> consider increasing the sample size.
>
> The Agency agrees that objective, analysis plan, and pertinent
> measures are essential for ensuring the quality of the study. As
> suggested in the **Federal Register**, the study is designed primarily
> to help understand how well food-specific health claims communicate
> information compared to nutrient-specific health claims, and
> secondarily to help understand how well health messages that include
> the nutrient communicate information compared to other health messages
> that do not include the nutrient. The Agency has developed preliminary
> dependent measures and decision rules for analysis. In addition, the
> Agency has added questions on the helpfulness of the messages and used
> a technique to ensure that participants have noticed the health
> message on the stimulus.
>
> The Agency is not persuaded that the sample size needs to be
> increased. The Agency has carefully considered the sample size
> required for the study and consulted the relevant research. The Agency
> has determined that the planned sample size, 1,060 in total and
> approximately 360 per health claim condition (120 per diet-disease
> relationship x 3 diet-disease relationships), is sufficient to detect
> meaningful main effects of repeated-measures binary responses such as
> whether the responsible nutrient is recognized, and to detect
> interaction effects between diet-disease relationships and health
> message conditions.
>
> The other comment also recognizes the importance of consumer research.
> It asserts, however, that the proposed study should be abandoned for
> two reasons. First, by testing generic and hypothetical products,
> brands, and marketing contexts, the Agency is misconstruing its legal
> authority under the applicable First Amendment standards (i.e., the
> comment states that FDA needs to justify regulatory restrictions on
> the expression of any particular health claim by demonstrating alleged
> harms and showing that the restrictions would alleviate the harm). The
> comment asserts that, under such requirements, FDA's obligations are
> case-specific, i.e., targeted at a particular marketer with respect to
> a particular health claim expression. Second, the comment states that
> the impression consumers take away from a particular health claim
> cannot be evaluated in a scientifically valid or reliable manner
> through academic research that attempts to isolate the meaning of
> health claims from its context. The comment further asserts that even
> if valid findings are possible, they would have no validity or meaning
> under real world conditions. Hence, the comment argues that claims
> need to be tested on real product labels and in a real purchasing
> context.
>
> FDA disagrees with this comment. The Agency notes that the research
> approach mentioned in the comment, testing specific claims on specific
> products in specific contexts, would be appropriate if the Agency's
> only mission were to protect consumers from harms caused by deceptive
> product labeling, and if the objective of the study were to gather
> evidence on whether a labeling statement on a specific product
> marketed in a specific context could produce the alleged harm and the
> harm is material.
>
> In addition to protecting consumer health from harms caused by
> deceptive product labeling, however, the Agency's mission also calls
> for advancing consumer health by providing information about food
> products to help consumers improve their health and decrease the risk
> of contracting diseases by making sound dietary choices. The study was
> proposed with this mission in mind and therefore does not intend to
> and is not designed to demonstrate any harm attributable to any
> specific health messages on any specific products. As stated in the
> **Federal Register**, the study will hold back-panel information
> (e.g., nutrient contents) constant between front-panel conditions for
> a given food product. Furthermore, the nutrient contents of test
> products will meet current regulatory standards for various health
> messages. Therefore, by design, the study approach precludes any
> attempt to examine any potential harm as purported in the comment.
> Instead, the study approach is commonly used and accepted by
> researchers for the purpose of investigating communication efficacy of
> label stimuli.
>
> Health messages such as health claims are intended for all qualifying
> marketers and products, rather than certain specific marketers or
> products, to use. Hence, under the Agency's regulatory regime, the
> study does not intend to examine specific claims on specific products
> in specific contexts, as individual marketers would do. Rather, the
> study will attempt to illustrate possible consumer responses to
> different types of health messages that may be found on packages of
> various food products. Finally, the Agency notes that, despite the
> discordance between experimental contexts and the real world,
> experimental findings are widely recognized and accepted as the best
> available evidence to demonstrate communication efficacy.
>
> The agency has consulted with non-FDA experts about the proposed
> information collection and has conducted cognitive interviews to
> refine the proposed questionnaires. The agency has considered and,
> when appropriate, incorporated in the attached information collection
> instrument public comments, inputs from non-FDA experts, and
> refinements suggested by cognitive interviews.
>
> The following non-FDA experts were consulted:

1.  Dr. Joseph Alba

> Distinguished Professor of Marketing and Chairman
>
> Department of Marketing
>
> University of Florida
>
> Gainesville, FL 32611
>
> E-mail: <joe.alba@cba.ufl.edu>
>
> Phone: 352-392-0161

2.  Dr. Siva K. Balasubramanian

> Henry J. Rehn Professor of Marketing

College of Business Administration

Southern Illinois University

Carbondale, IL 62901-4629

> E-mail: <siva@cba.siu.edu>
>
> Phone: 618-453-7787

3\. Dr. Paula Fitzgerald Bone

> Professor of Marketing
>
> West Virginia University
>
> Morgantown, WV 26506-6025
>
> E-mail: paula.bone@mail.wvu.edu
>
> Phone: 304-293-7959

4\. Dr. Neal H. Hooker

> Assistant Professor
>
> Department of Agricultural, Environmental and Development Economics
>
> The Ohio State University
>
> Columbus, OH 43210-1067

E-mail: hooker.27@osu.edu 

> Phone: 614-292-3549

5\. Dr. Chris Janiszewski

> Faricy Professor of Marketing
>
> Department of Marketing
>
> University of Florida
>
> Gainesville, FL 32611
>
> E-mail: <chris.janiszewski@cba.ufl.edu>
>
> Phone: 352-392-0161

6\. Dr. Edward F. Vonesh

> Senior Baxter Research Scientist
>
> Statistics, Epidemiology and Surveillance
>
> Baxter Healthcare Corporation
>
> Round Lake, IL 60073
>
> E-mail: <Ed_Vonesh@baxter.com>
>
> Phone: 847-473-6514

**A.9 Payment to Participants**

> The Internet panel participants will not be paid specifically for this
> study. However, they are offered chances to win sweepstakes as part of
> the contractor's incentives for panel members. The mall participants
> will be paid \$5 in cash.

**A.10 Assurance of Confidentiality and Basis of Assurance**

Assurance of confidentiality of information will be provided to all
participants. A statement that \"the information will be kept
confidential\" will be read before each interview. Confidentiality will
be assured by using an independent contractor to collect the
information, by enacting procedures to prevent unauthorized access to
respondent data, and by preventing the public disclosure of the
responses of individual participants.

Identifying information will not be included on the data files delivered
to the agency. The data collection contractor has standard procedures
for assuring the confidentiality of survey respondents. All of the
contractor\'s employees sign a statement agreeing to maintain
confidentiality of data. The data will be collected in the interviews
will be maintained in an automated information system with access
restricted to authorized personnel. Names, addresses, and telephone
numbers will be retained only until validation and editing are complete;
such information will be stripped from the database before the data
files are sent to the agency.

All electronic data will be maintained in a manner that is consistent
with the Department of Health and Human Services ADP Systems Security
Policy as described in DHHS ADP Systems Manual, Part 6, chapters 6-30
and 6-35. All data will also be maintained in consistency with the FDA
Privacy Act System of Records #09-10-0009 (Special Studies and Surveys
on FDA Regulated Products).

**A.11 Sensitive Questions**

The collection of information does not include any questions of a
sensitive nature.

**A.12 Estimated Hour Burden of the Collection of Information**

> The estimated total hour burden of the collection of information is
> 1,287 hours (Table 1). Prior to the administration of the interview,
> the agency plans to conduct Internet pretests of the final
> questionnaires to minimize potential problems in administration of the
> interviews. The pretests, each lasting 30 minutes (0.5 hour), will be
> conducted with 60 participants. A contractor will send 9,000 e-mail
> invitations to recruit Internet participants. We assume 12 percent of
> those contacted will agree to participate in and complete the
> interviews (1,080 respondents). The interviews are expected to last 25
> minutes (0.4 hour). The contractor will be expected to approach 3,500
> mall visitors to obtain 1,080 participants in the mall interview. The
> mall interview is expected to last 30 minutes (0.5 hour). The
> annualized cost to all respondents for the hour burden for the
> collection of information is \$16,731 at \$13 per hour.

**Table 1. Estimated Hour Burden**

  ---------------- --------------- ------------ ------------- ------------ ----------
  **Activity**     **Number of     **Annual     **Total       **Hours per  **Total
                   Respondents**   Frequency    Annual        Response**   Hours**
                                   per          Responses**                
                                   Response**                              

  Pretest          60              1            60            0.5          30

  Internet         9,000           1            9,000         0.02         180
  Invitation                                                               

  Mall Invitation  3,500           1            3,500         0.03         105

  Internet         1,080           1            1,080         0.40         432
  Interview                                                                

  Mall Interview   1,080           1            1,080         0.50         540

  Total                                                                    1,287
  ---------------- --------------- ------------ ------------- ------------ ----------

**A.13 Estimated Cost Burden to Respondents Excluding Estimates Shown in
A.12 and A.14**

All respondent burden is reflected in A12.

**A.14 Estimated Cost to the Federal Government**

The estimated total cost to the Federal Government for this information
collection \$183,000. This includes the value of a contract with
Synovate to implement the collection of information and the value of
one-half of an Full-Time-Employee \[spell out FTE or use equivalent
information such as, 160 hours at a GS-12 level (160 hours x \$29/hour =
\$4,640\] to analyze the information.

**A.15 Program Changes or Adjustments**

There are no program changes or adjustments.

**A.16 Project Schedule and Plan for Analysis**

The planned schedule for the project is shown in Table 2.

**Table 2. Project Schedule**

  -------------------------------- --------------------------------------
  **Date**                         **Activity**

  Within 5 days after receipt of   Notification to contractor to proceed
  OMB approval of collection of    with data collection activities
  information                      

  Within 90 days after             Completion of data collection and
  notification to contractor       delivery of data by contractor

  Within 180 days after            Completion of preliminary analyses
  notification to contractor       

  Within 240 days after            Completion of final analyses
  notification to contractor       
  -------------------------------- --------------------------------------

**A.17 Displaying the OMB Approval Expiration Date**

No exemption is requested.

**A.18 Exceptions to the Certification Statement of OMB Form 83.I**

No exceptions are requested.

**B. COLLECTION OF INFORMATION EMPLOYING**

**STATISTICAL METHODS**

# **B1. Potential Participant Universe**

> The planned universe of this experimental study will be (1) adult
> members of a national Internet consumer panel for the Internet
> interview, and (2) adult visitors to mall six shopping malls for the
> mall interview. Panel members have previously opted-in to join the
> panel, agreed to answer periodic surveys on a variety of topics, and
> provided basic demographic and other background information.

**B2. Procedures for the Collection of Information**

**B2.1** [Statistical methodology for sampling and information
collection]{.underline}

**B.2.1.1** *Sampling methodology*

> The target Internet sample size is 1,080, selected from the Internet
> consumer panel per age, gender, and education distributions of the
> panel. Likewise, the target mall sample size is 1,080, selected from
> visitors to six shopping malls per age, gender, and education
> distributions in respective areas around the mall locations.
>
> **B.2.1.2** *Information collection methodology*
>
> All information will be collected via the Internet. All interviews
> will be self-administered by participants via an Internet link to the
> instrument.
>
> Several key features of the collection methodology are described
> below.

1.  [Experimental conditions]{.underline}. The experiment uses a 6
    (front-panel health claim/health message) x 3 (diet-disease
    relationships) within-subjects factorial design. The term "health
    message" refers to nutrient content claims, structure/function
    claims, and dietary guidance statements. Thus, there are 18
    experimental conditions (each condition is a combination of a
    front-panel condition and a diet-disease relationship).

    1.  The three diet-disease relationships to be included are: (a)
        yogurt-calcium-osteoporosis, (b) orange
        juice-potassium-hypertension, and (c) bread-"lysoton"-diabetes.
        Note that "lysoton" is a fictitious substance and (c) is a
        fictitious relationship. The study includes these three
        relationships solely for the purpose of covering varying levels
        of consumer familiarity with the foods, substances, and risks. A
        wider range of familiarity should help make the study findings
        more useful than if only one diet-disease relationship were
        examined. The agency emphasizes, however, that the choice of
        these experimental conditions does not in any way suggest or
        imply any new or impending change in regulatory actions
        regarding the use of health claims/messages or the scientific
        basis of these relationships.

    2.  The six front-panel health-claim/health-message conditions are:

-   a "food-specific" health claim, e.g., "Yogurt may reduce the risk of
    osteoporosis,"

-   a "substance-specific" health claim, e.g., "Calcium-rich foods, such
    as yogurt, may reduce the risk of osteoporosis,"

-   a nutrient content claim, e.g., "A good source of calcium,"

-   a structure/function claim, e.g., "Helps promote bone health," and

-   a dietary guidance statement, e.g., "Dairy products may reduce the
    risk of osteoporosis," and

-   no health claim/health message.

> Conditions other than the two health claims are included solely to
> enhance the ecological validity of the findings. The "no health
> claim/health message" condition is included to examine what consumers
> already know about nutrients or food sources, even when neither of
> them is mentioned on a label. Health messages are frequently found on
> food product packages and provide consumers various amounts of
> information about food products and their relationships to health.
> Whether consumer responses to these health messages are consistent
> with their responses to the two health claims will help generalize the
> findings An examination of response differences between health
> messages that mention (e.g., a nutrient content claim) or do not
> mention (e.g., a structure/ function claim) a nutrient or food source
> and between these health messages and the two health claims in
> question can help validate any effects observed between the two health
> claims. This validation will in turn enhance the external validity of
> the findings between the "food-specific" and "nutrient-specific"
> health claims. The agency emphasizes that the inclusion of examples of
> structure/function claims, nutrient content claims, and dietary
> guidance statements does not in any way suggest or imply any new or
> impending change in regulatory actions regarding these messages.
>
> All health-claim/health-message conditions, except for the no claim
> condition, will mention one or more components of a diet-disease
> relationship. For example, a nutrient content claim will mention a
> substance ("calcium") but not the corresponding food ("yogurt") or
> benefit ("osteoporosis") while a "substance-specific" health claim
> will mention all three components.
>
> All front panels will have a taste-related statement such as, "Rich,
> Natural Flavor," to mimic real labels.

1.  Both the front and back panels of a label will be available for
    examination. The computer screen will show the front label with a
    button on the side to allow viewing of the back panel, if so
    desired. Since the study focuses on responses to health claims on
    the front panel, back panel information (e.g., nutrition profiles of
    a product) will be kept constant between front-panel conditions for
    a given food product. The stated levels of nutrients will meet
    stipulated general criteria on disqualifying levels for claims
    (e.g., the food must contain less than 13 g of fat per reference
    amount).

> 4\) All front panels will be full-color and patterned after existing
> labels in the market. The front label will identify the food but
> include no brand name.

2.  [Random assignment]{.underline}. Each participant will be randomly
    assigned to two experimental conditions (health message condition x
    diet-disease relationship combinations). No participant will see the
    same message condition or the same diet-disease relationship twice.
    For example, if a participant is asked first about orange
    juice-potassium-hypertension x nutrient content claim ("Food 1"),
    then he will not be asked about orange juice or nutrient content
    claim again in the second condition ("Food 2"). A participant will
    be administered the same two conditions in both the telephone
    interviews.

3.  [Key dependent measures]{.underline}. Three dependent measures will
    be collected in Phase 2 of the interview, one for each hypotheses
    stated in A.2.

> **Hypothesis 1**: Compared to not mentioning "(Substance)-rich foods,
> such as (food)," a health claim mentioning the phrase leads to a
> better recognition of the substance underlying a diet-disease
> relationship.
>
> **Dependent Measure 1**: (Question D6 in the questionnaire) "What
> nutrient in THIS \[FOOD\] would you say may help lower the risk of
> \[DISEASE\]? (*from a list)*.\] Recognition of the substance
> underlying a diet-disease relationship is established when the
> nutrient in question is selected. Hypothesis 1 will be examined in
> two-tailed tests of proportion between "substance-specific" and
> "food-specific" health claim conditions.
>
> **Hypothesis 2**: Compared to not mentioning "(Substance)-rich foods,
> such as (food)," a health claim mentioning the phrase leads to a
> better recognition that there are other food sources of the stated
> relationship; and
>
> **Dependent Measure 2**: (Question D7) "Would you say one can get
> \[NUTRIENT\] from any foods other than \[FOOD\]? Yes or no?\]
> Recognition of other food sources is established with an affirmative
> answer to the question. Hypothesis 2 will be examined in two-tailed
> tests of proportion between "substance-specific" and "food-specific"
> health claim conditions.
>
> **Hypothesis 3**: Compared to not mentioning "(Substance)-rich foods,
> such as (food)," a health claim mentioning the phrase leads to more
> favorable attitude toward a product.
>
> **Two Dependent Measure 3**: (Question D10) "On a six-point scale,
> where 6 means "very likely" and 1 means "very unlikely," how likely or
> unlikely would you say THIS \[FOOD\] is to help reduce the risk of
> \[DISEASE\]?" \[*Response: 1-6 Likert scale*.\] (Question D12)
> "Imagine that you are in a grocery store and thinking about getting
> some \[FOOD\] for yourself. Assume the \[FOOD\] you see here is
> comparable to other \[FOOD\]s on the shelf in terms of price, taste,
> flavor, and nutritive values. On a six-point scale, where 6 means
> "definitely would consider buying" and 1 means "definitely would not
> consider buying," how likely or unlikely would you consider buying
> THIS \[FOOD\] rather than another \[FOOD\]?" *\[Response: 1-6 Likert
> scale.\]* Hypothesis 3 will be examined in two-tailed tests of mean
> between "substance-specific" and "food-specific" health claim
> conditions.

4.  [Covariate measures]{.underline}. To help understand non-label
    factors that may relate to participants' responses to the dependent
    measures, the following information will be collected.

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1)  Prior knowledge of a diet-disease relationship:

    a.  (Question A2) perceived healthfulness of a food, (Section B in
        the Questionnaire) awareness of nutrients, awareness of
        diet-disease relationships, responsible nutrients, other food
        sources.

    b.  (Question A1) consumption frequency and (E1) purchase
        experience.

2)  Other motivational and personal characteristics:

    a.  (Question E3) purchase criteria, (C1) use of dietary
        supplements, (C2 and C3) special diets, (F1) any health
        problems, and (F2) perceived personal risk.

3)  BMI, perceived weight status, demographics.

> It is hypothesized that, recognition of a nutrient \[Hypothesis 1\],
> recognition of other food sources \[Hypothesis 2\], or product
> attitudes \[Hypothesis 3\] is less associated with the contents of a
> health claim (i.e., whether '(Substance)-rich foods, such as (food)'
> is mentioned) when there is a higher level of prior knowledge related
> to a given food product. This is because a higher level of prior
> knowledge, which may arise from more familiarity with a food, its
> health benefits, and source of the benefits (e.g., nutrients), is more
> likely to be associated with diminished usefulness of explicit
> mentions of product attributes (e.g., nutrient, benefit) in making
> inferences about the attributes or with weaker effectiveness of
> explicit mentions of a benefits or its source to persuade belief in
> the benefits.
>
> Prior knowledge, in turn, may be associated with one or both of the
> following two categories of variables: (a) more experience in purchase
> or consumption of a food, and (b) stronger motivation toward acquiring
> nutrition information or practicing a healthy lifestyle (such as
> health benefit being an important purchase criterion, being on one or
> more special diets or limiting certain nutrients, use of dietary
> supplements, or having suffered one or more diseases or perceiving
> oneself to be at risk for one or more diseases).

5.  [Other information]{.underline}. The study plans to ask participants
    to (1) assess the level of a non-featured nutrient in a product
    (e.g., dietary fiber in bread), and (2) indicate what information
    item(s) on the label (e.g., front label, % Daily Value) they used to
    decide the answers (Questions D25 and D26). In addition, for the
    Internet sample, the study plans to collect information on modem
    speed to investigate any potential effects on label response by
    download speed. In both the Internet and the mall studies, the study
    will also collect information on whether participants select to look
    at the back panel of a label while responding to label questions.

6.  [Procedures]{.underline}.

    1.  The same instrument will be used for both the Internet and the
        mall-intercept interview. All participants will be provided an
        Internet link to the instrument.

    2.  The instrument (see Appendix B for details) will be administered
        in two phases. Phase 1 collects information on prior knowledge
        of foods and diet-disease relationships, as described in 4.1)
        above, use of dietary supplements, and special diets. Phase 2
        presents food labels and collects information on label responses
        (the dependent measures, as described in 3 above, and other
        information such as food purchase experience, use of food label
        (as described in 5 above), and other information.

    3.  It is estimated that Phase 1 will take no more than 8 minutes to
        complete and Phase 2 no more than 15 minutes, respectively.

    4.  In the Internet study, Phase 2 will be administered
        approximately two weeks after Phase 1 to minimize potential
        confounding effects of Phase 1, which asks a given participant
        the same foods. In the mall-intercept study, Phase 2 will follow
        Phase 1 and be separated from Phase 1 by a 5-minute filler task
        (see Appendix b for details) to minimize potential effects of
        Phase 1.

    5.  The mall-intercept study will be administered at six mall
        interview facilities in various locations in the contiguous
        United States. The planned locations are Albany, NY; Charlotte,
        NC; Dallas, TX; Los Angeles, CA; Bloomington, MN; and Plymouth
        Meeting, PA. The agency selects these locations to reflect
        diversities in demographics such as race, age, and education.
        Actual study locations will be determined upon receipt of
        clearance of this data collection and conditional on facility
        availability and other relevant factors.

**B2.3** [Degree of accuracy needed for the purpose described in the
justification]{.underline}

> The planned sample size for main effects is 360 per health claim
> condition (120 per diet-disease relationship x 3 diet-disease
> relationships). This size is conservatively expected to identify
> differences with an odds ratio of at least 2 (e.g., 0.5 vs 0.3), even
> if there is no correlation between the repeated measures.[^3]
>
> We base this expectation on the following requirement, design
> parameters and assumptions.

-   Requirement: the sample size should be sufficient to detect a small
    effect size between the two [health claim]{.underline} conditions
    (whether a substance is mentioned or not) with α = 0.05 and β = 0.2.

-   Design parameters: (1) repeated dependent measures, (2) key
    dependent measures (Measures 1 and 2) are binary (yes or no), (3)
    each of the two health claim conditions will be randomly assigned
    with an equal size of approximately 360 participants pooled over
    three diet-disease relationships (120/relationship x 3
    relationships).

-   Conservative assumptions: (1) 70% of participants in each label
    conditions recognize the diet-disease relationship and are asked
    Dependent Measures 1 and 2, (2) there is no correlation between
    dependent measures.

> The planned sample size may also render adequate power to test
> interactions between health claim conditions (whether a substance is
> mentioned or not) and diet-disease conditions.

**B2.4** [Use of specialized sampling procedures]{.underline}

No specialized sampling procedures are required.

**B2.5** [Use of periodic data collection cycles to reduce
burden]{.underline}

This is a one-time data collection.

#### **B3. Methods to Maximize Participation**

> The agency will implement the following procedures to maximize
> participation.

1.  Cognitive interviews and pretests will be conducted to help improve
    understandability of the interview questions, to reduce participant
    burden, and to enhance interview administration.

2.  The contractor's Internet invitation, as well as its Internet
    reminder, will state the sponsor of the study (the FDA) and purpose
    of study to encourage participation. Mall recruiters will also state
    the sponsor and purpose of study before screening begins.

3.  The contractor will provide a toll-free number of prospective
    participants to inquire about the authenticity of the interview and
    other questions.

4.  All interviews and sample assignment will be monitored and problems
    solved by supervisors daily throughout the course of the collection
    of information.

**B4**. **Tests of Procedures or Methods**

The agency will have its contractor pretest the instrument with 60
individuals after OMB approval of the collection of information. The
pretests will serve to address any unforeseen problems in administration
of the interview.

**B5. Individuals Involved in Statistical Consultation and Information
Collection**

The contractor, Synovate, will collect the information on behalf of the
FDA as a task order under the Quick-Turn-Around Research Services
contract. Leigh Seaver, Ph.D., is the Senior Study Director for
Synovate, telephone (703)790-9099. Analysis of the information will be
conducted primarily by staff on the Consumer Studies Team, Division of
Market Studies, CFSAN, FDA, and coordinated by Chung-Tung Jordan Lin,
PhD, telephone (301)436-1831.

**Appendix A 21 USC 393**

**Sec. 393. Food and Drug Administration**

> \(a\) In general\
> There is established in the Department of Health and Human Services
> the Food and Drug Administration (hereinafter in this section referred
> to as the \'\'Administration\'\').
>
> \(b\) Mission\
> The Administration shall -
>
> o (1) promote the public health by promptly and efficiently\
> reviewing clinical research and taking appropriate action on the\
> marketing of regulated products in a timely manner;
>
> o (2) with respect to such products, protect the public health by\
> ensuring that -
>
> \(A\) foods are safe, wholesome, sanitary, and properly\
> labeled;
>
> \(B\) human and veterinary drugs are safe and effective;
>
> \(C\) there is reasonable assurance of the safety and\
> effectiveness of devices intended for human use;
>
> \(D\) cosmetics are safe and properly labeled; and\
> (E) public health and safety are protected from electronic\
> product radiation;
>
> o (3) participate through appropriate processes with\
> representatives of other countries to reduce the burden of\
> regulation, harmonize regulatory requirements, and achieve\
> appropriate reciprocal arrangements; and\
> (4) as determined to be appropriate by the Secretary, carry out\
> paragraphs (1) through (3) in consultation with experts in\
> science, medicine, and public health, and in cooperation with\
> consumers, users, manufacturers, importers, packers,\
> distributors, and retailers of regulated products.
>
> \(c\) Interagency collaboration\
> The Secretary shall implement programs and policies that will foster
> collaboration between the Administration, the National Institutes of
> Health, and other science-based Federal agencies, to enhance the
> scientific and technical expertise available to the Secretary in the
> conduct of the duties of the Secretary with respect to the
> development, clinical investigation, evaluation, and postmarket
> monitoring of emerging medical therapies, including complementary
> therapies, and advances in nutrition and food science.
>
> \(d\) Commissioner
>
> o (1) Appointment\
> There shall be in the Administration a Commissioner of Food and\
> Drugs (hereinafter in this section referred to as the\
> \'\'Commissioner\'\') who shall be appointed by the President by and\
> with the advice and consent of the Senate.
>
> o (2) General powers\
> The Secretary, through the Commissioner, shall be responsible\
> for executing this chapter and for -
>
> \(A\) providing overall direction to the Food and Drug\
> Administration and establishing and implementing general\
> policies respecting the management and operation of programs\
> and activities of the Food and Drug Administration;
>
> \(B\) coordinating and overseeing the operation of all\
> administrative entities within the Administration;
>
> \(C\) research relating to foods, drugs, cosmetics, and devices\
> in carrying out this chapter;
>
> \(D\) conducting educational and public information programs\
> relating to the responsibilities of the Food and Drug\
> Administration; and\
> (E) performing such other functions as the Secretary may\
> prescribe.
>
> \(e\) Technical and scientific review groups\
> The Secretary through the Commissioner of Food and Drugs may, without
> regard to the provisions of title 5 governing appointments in the
> competitive service and without regard to the provisions of chapter
> [51]{.underline} and subchapter III of chapter 53 of such title
> relating to classification and General Schedule pay rates, establish
> such technical and scientific review groups as are needed to carry out
> the functions of the Administration, including functions under this
> chapter, and appoint and pay the members of such groups, except that
> officers and employees of the United States shall not receive
> additional compensation for service as members of such groups.
>
> \(f\) Agency plan for statutory compliance
>
> o (1) In general\
> Not later than 1 year after November 21, 1997, the Secretary,\
> after consultation with appropriate scientific and academic\
> experts, health care professionals, representatives of patient\
> and consumer advocacy groups, and the regulated industry, shall\
> develop and publish in the Federal Register a plan bringing the\
> Secretary into compliance with each of the obligations of the\
> Secretary under this chapter. The Secretary shall review the\
> plan biannually and shall revise the plan as necessary, in\
> consultation with such persons.
>
> o (2) Objectives of agency plan\
> The plan required by paragraph (1) shall establish objectives\
> and mechanisms to achieve such objectives, including objectives\
> related to -
>
> \(A\) maximizing the availability and clarity of information\
> about the process for review of applications and submissions\
> (including petitions, notifications, and any other similar\
> forms of request) made under this chapter;
>
> \(B\) maximizing the availability and clarity of information\
> for consumers and patients concerning new products;
>
> \(C\) implementing inspection and postmarket monitoring\
> provisions of this chapter;
>
> \(D\) ensuring access to the scientific and technical expertise\
> needed by the Secretary to meet obligations described in\
> paragraph (1);
>
> \(E\) establishing mechanisms, by July 1, 1999, for meeting the\
> time periods specified in this chapter for the review of all\
> applications and submissions described in subparagraph (A) and\
> submitted after November 21, 1997; and\
> (F) eliminating backlogs in the review of applications and\
> submissions described in subparagraph (A), by January 1, 2000.
>
> \(g\) Annual report\
> The Secretary shall annually prepare and publish in the Federal
> Register and solicit public comment on a report that -
>
> o (1) provides detailed statistical information on the\
> performance of the Secretary under the plan described in\
> subsection (f) of this section;
>
> o (2) compares such performance of the Secretary with the\
> objectives of the plan and with the statutory obligations of the\
> Secretary; and\
> (3) identifies any regulatory policy that has a significant\
> negative impact on compliance with any objective of the plan or\
> any statutory obligation and sets forth any proposed revision to\
> any such regulatory policy.

**Appendix B Information Collection Instrument**

**(See a separate document)**

[^1]: Levy, A.S., Derby, B.M., and Roe, B.E. 1997. "Consumer Impacts of
    Health Claims: An Experimental Study." Available at
    <http://vm.cfsan.fda.gov/~dms/hclm-rpt.html>. Accessed October 22,
    2004.

[^2]: Paul, G. L.; Ink, S. L.; and Geiger, C. J. 1999. "The Quaker Oats
    health claim: a case study." *Journal of Nutraceuticals, Functional
    & Medical Foods* *, 1 (4): 5-32*

[^3]: Lipsitz, S.R., Fitzmaurice, G.M. 1994. "Sample size for repeated
    measures studies with binary responses." Statistics in Medicine 13:
    1233-9.