Request for OMB Review

Supporting Statement for

An Experimental Study of Carbohydrate Content Claims on Food Labels

Submitted by

Consumer Studies Staff\
Office of Regulations and Policy

Center for Food Safety and Applied Nutrition

Food and Drug Administration

Department of Health and Human Services

Originally submitted: July, 2005

With revisions: October, 2005 and December, 2005

Supporting Statement for

An Experimental Study of Carbohydrate Content Claims on Food Labels

Submitted by

Food and Drug Administration

Center for Food Safety and Applied Nutrition

## A. JUSTIFICATION

> **1. [Circumstances Necessitating Information
> Collection]{.underline}**

The authority for FDA to collect the information for this experimental
study derives from the FDA Commissioner\'s authority, as specified in
section 903(d)(2) of the Food, Drug, and Cosmetic Act (the act) (21 USC
§ 393(d)(2)). (A copy of this statutory section is included as
attachment A.) The Nutrition Labeling and Education Act of 1990 (the
1990 amendments) (Pub. L. 101-535) amended the act. Section 403(r)(1)(A)
of the act (21 U.S.C. § 343(r)(1)(A)), added by the 1990 amendments,
states that a food is misbranded if it is a food intended for human
consumption which is offered for sale and for which a claim is made on
its label or labeling that expressly or implicitly characterizes the
level of any nutrient of the type required to be declared as part of
nutrition labeling, unless such claim uses terms defined in regulations
by FDA under section 403(r)(2)(A) of the act (21 U.S.C. § 343(r)(2)(A)).
(A copy of this statutory section is included as attachment B.)

In 1993, FDA published regulations that implemented the 1990 amendments.
Among these regulations, 21 CFR 101.13 sets forth general principles for
nutrient content claims (see 56 FR 60421, November 27, 1991; 58 FR 2302,
January 6, 1993). (A copy of this statutory section is included as
attachment C.) Other regulations in Subpart D of 21 CFR Part 101 define
specific nutrient content claims, such as "free," "low," \"reduced,\"
\"light,\" \"good source,\" \"high,\" and \"more\" for different
nutrients and calories and identify several synonyms for each of the
defined terms. In addition, 21 CFR 101.69 establishes the procedures and
requirements for petitioning the Agency to authorize nutrient content
claims. (A copy of this statutory section is included as attachment D.)

The Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub.
L. 105-115) amended section 403(r)(2) of the act by adding sections
403(r)(2)(G) and (H) (21 U.S.C. § 343(r)(2)(G) & (H)) to permit nutrient
content claims based on published authoritative statements by a
scientific body, when FDA is notified of such claim in accordance with
the requirements established in these sections (see attachment B)..

Current FDA regulations make no provision for the use of nutrient
content claims that characterize the level of carbohydrate in foods
because FDA has not defined, by regulation, terms for use in such
claims. Consumer and industry groups have petitioned the FDA to amend
existing food labeling regulations to define terms for use in nutrient
content claims characterizing the level of carbohydrate in foods.

2.  **[How, By Whom, Purpose of Collection]{.underline}**

The FDA has received six different petitions to define various
carbohydrate content claims for food labeling. This supporting statement
describes a proposed experimental study that would enhance the Agency's
understanding of consumer response to such claims and, therefore, assist
the Agency in responding to the petitions.

The information objectives for this proposed experimental study are to
evaluate carbohydrate content food label claims and disclosure
statements in terms of their effects on consumer understanding and
consumers' ability to make appropriate product judgments for healthy
dietary practices.

The label claims and statements that would be tested in the proposed
study include "low carb," "x grams net carbs," "carbconscious," and
"good source of carb." The study would also include no claim, control
labels. Where relevant, this study would test carbohydrate content
claims with and without the following disclosure statements on the front
panel: (1) "see nutrition information for fat content," (2) "see
nutrition information for sugar content," and (3) "not a low-calorie
food." Participants would be exposed to either one front panel or both a
front panel and corresponding Nutrition Facts Panel (sometimes
abbreviated, "NFP") for one of three products: a bread, a juice drink,
or a frozen dinner. The Nutrition Facts Panels would vary to create more
and less healthful product profiles. All participants would be asked the
same series of questions.

*Primary Hypotheses*

The following are the [primary]{.underline} hypotheses to be tested in
this experiment. Differences would be measured in the perceived amounts
of nutrients, likelihood of purchasing the product, ratings of the
healthfulness of the product, and likelihood of the product helping
someone to manage their weight (for the "low," "net" and "carbconscious"
claims) or the likelihood of the product helping someone to have more
energy (for the "good source" claims).

[Hypothesis 1]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "low carb," "net carb," or
"carbconscious" claim will evaluate products differently than those who
view the no claim, control label.

[Hypothesis 2]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "low carb" or "carbconscious" claim
with a fat or calorie disclosure will evaluate the product differently
than those who view the "low carb" or "carbconscious" claim without the
fat disclosure or calorie disclosure, respectively.

[Hypothesis 3]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "good source of carb" claim will
evaluate the product differently than those who view the no claim,
control label.

[Hypothesis 4]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "good source of carb" claim with a
sugar disclosure will evaluate the product differently than those who
view the "good source of carb" claim without the sugar disclosure.

[Hypothesis 5]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "low carb," "carbconscious"
or "net carb" claim with a *healthier low carb* NFP will evaluate the
product differently than those who view the same front panel with a
*less healthful low carb* NFP.

[Hypothesis 6]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "low carb" or "carbconscious"
claim with a fat or calorie disclosure and a *less healthful low carb*
NFP will evaluate the product differently than those who view a "low
carb" or "carbconscious" claim with a *less healthful low carb* NFP, but
without a fat or calorie disclosure, respectively.

[Hypothesis 7]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "low carb," "carbconscious,"
or "net carb" claim with a *healthier, low carb* NFP will evaluate the
product differently than those who view a no claim, control front panel
with a *healthier low carb* NFP.

[Hypothesis 8]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "good source of carb" claim
with a sugar disclosure and a *high carb* NFP will evaluate the product
differently than those who view a "good source of carb" claim with a
*high carb* NFP, but without a sugar disclosure.

[Hypothesis 9]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "good source of carb" claim
with *healthier high carb* NFP will evaluate the product differently
than those who view a "good source of carb" claim with a *less healthful
high* *carb* NFP.

[Hypothesis 10:]{.underline} Among respondents who view the [front and
back]{.underline} labels, those who view a "good source of carb" claim
with a *healthier, high carb* NFP will evaluate the product differently
than those who view a no claim control with a *healthier, high carb*
NFP.

The proposed experimental study data would be collected via the Internet
from 9,360 members of a consumer panel maintained by the research firm
Synovate. Synovate's Internet panel consists of approximately 600,000
households that have agreed to participate in research studies conducted
through the Internet. Most households in the panel will respond to mail
or telephone surveys, as well as Internet surveys like this one.

Panel members are recruited by a variety of means designed to reflect
all segments of the population. They are required to have a computer
with Internet access. Typical panel members receive three or four
invitations per month to participate in research projects. Studies begin
with an e-mailed invitation to the sampled respondents.

Each panel member has provided demographic data for their household that
allows for the selection of samples that resemble closely the
distribution of the U.S. population on age, gender, education, and
race/ethnicity. Overall, the panel tends to under-represent minorities,
low income households, and the elderly.

For this proposed study, members of Synovate's consumer Internet panel
have been screened for diet status through brief questions included in a
quarterly multi-topic survey that Synovate emailed to all of its
Internet panel members. The over 173,000 people who responded to the
diet status screening questions would be eligible to be sampled for the
experiment.

Conventional statistical techniques for experimental data, such as
descriptive statistics, analysis of variance, and regression models
would be used to analyze the data. Covariates used in the analysis would
include diet status, age, race/ethnicity, gender, and education.

This proposed data collection would be one-time only. No successive
related data collections are planned.

3.  **[Consideration Given to Information Technology]{.underline}**

This proposed study would use the Internet for data collection. Members
of the sample, who are part of a consumer opinion panel, would receive
an invitation to participate in the experiment to their email address.
People who choose to participate would respond from their personal
computer at a time of their choosing. The respondents would view the
product labels and study questions on their computer screen and would
register their responses using their keyboard and mouse. The Internet
was selected as the means to collect data to minimize burden
cost-effectively.

4.  **[Identification of Information]{.underline}**

Before conceptualizing this proposed study, the Agency reviewed the
consumer research submitted by the petitioners, evaluated the literature
for relevant material, and conducted a series of focus groups. The data
submitted by the petitioners do not answer the questions of interest in
this study. A review of the literature indicated that there is no
directly comparable existing research on consumer understanding of
carbohydrate content claims. However, the more broad literature on
consumer response to nutrient content claims was used to inform the
study design, as were data from the Agency's focus groups.

Although both previous research on nutrient content claims and the focus
group data provide important context for this project, they do not
provide answers to the questions of interest in this experiment. To
directly apply existing consumer research on various nutrient content
claims to carbohydrate content claims is not appropriate. Total
carbohydrate claims may be understood differently by consumers than
other nutrient content claims about which there exists a body of
research for three reasons. First, carbohydrate content claims already
exist in the form of such claims as "sugar-free" and "good source of
fiber." Second, petitioners have requested authorization for both "low"
and "good source" claims for this one nutrient. No other nutrient is
authorized for both "low" and "good source" claims. The 2005 U.S.
Dietary Guidelines[^1] provide recommendations to consumers related to
components of carbohydrate to choose and other components of
carbohydrate to limit. It could be difficult for consumers to apply such
dietary guidance to total carbohydrate claims. For example, the 2005
Dietary Guidelines recommend that consumers choose fiber-rich produce
and whole grains often and that they limit foods with added sugar or
caloric sweeteners. Third, reaction to "net carbohydrate" and similar
statements has yet to be explored in existing research.

Several previous studies were used to inform the design of this
experiment. The results of a study by Roe, Levy and Derby[^2] suggest
that when a nutrient-content claim is available on the front panel,
consumers may not bother to read the Nutrition Facts Panel. This is of
particular interest relative to "net carbohydrate" statements, where the
information explaining the term may be found on a back panel. Taking
this research into consideration, this proposed experiment would have
some of the participants exposed only to the front panel and others
exposed also to the Nutrition Facts Panel. The Roe et al. study also
suggests that claims are associated with a "halo" effect, such that
participants perceive that attributes unrelated to the claim are
associated with the product. The proposed experiment is designed to help
understand whether carbohydrate claims are associated with
misattribution of health benefits. In this experiment, disclosure
statements would be used to understand whether such information could
redress misattribution.

Research by Garreston and Burton[^3] suggests that consumers have
greater trouble evaluating fiber information on food packages than they
do information on fat. Matching a fiber claim with an incongruous
Nutrition Facts Panel is less likely to affect trust in the claim than
matching a fat claim with incongruous Nutrition Facts. Manipulating
fiber is one way products could qualify for carbohydrate claims. "Net
carbohydrate" statements can be based on calculating total carbohydrate
minus fiber.

> During the summer of 2004, to assist in developing this study, the
> Agency conducted a series of focus groups to gauge consumer
> understanding of various carbohydrate content claims on food packages.
> Focus groups are guided discussions led by a trained moderator. This
> research method is often used to collect qualitative information on a
> specific topic. Focus groups results are not generalizable. These
> eight focus groups with American consumers, conducted in four U.S
> cities, produced some important findings about familiarity with and
> interest in various carbohydrate claims on food product labels. Major
> findings were:

-   Participants seemed misinformed about nutrients that fall into the
    > category of carbohydrate.

-   Participants appeared to think of carbohydrate in terms of
    > particular foods rather than a nutrient. They were quick to
    > suggest a distinction between "good carbs" (grains, fruits, and
    > vegetables) and what they called "bad carbs" (breads, rice, pasta,
    > and potatoes), which were also refered to among participants as
    > "white carbs."

-   Participants seemed unable to make meaningful distinctions between
    > various carbohydrate content claims.

-   Participants appeared split on their approach to nutrition. Some
    > tried to maintain a balanced daily diet that includes different
    > nutrients. Others specifically focused on calories or a select
    > nutrient when choosing foods.

-   Participants claimed to have seen "low carb" labels in stores,
    > however only a small handful said they currently look for,
    > purchase, or would purchase products making carbohydrate content
    > claims. [^4]

Based on the findings from the focus groups, there is uncertainty as to
how consumers might notice, evaluate, and use carbohydrate content
claims on food packages. The proposed experimental study would provide
quantitative data to help answer unresolved questions about consumer
reaction to carbohydrate content claims.

5.  **[Small Businesses]{.underline}**

No small businesses would be involved in this data collection.

6.  **[Less Frequent Information Collection]{.underline}**

The proposed data collection is one-time only. There are no plans for
successive data collections relative to carbohydrate content claims on
foods labels.

7.  **[Information Collection Circumstances]{.underline}**

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

8.  **[Consultations with Persons Outside FDA]{.underline}**

The 60-day public comment notice was published in the Federal Register
on April 8, 2005, Volume 70, Number 67 (Docket No 2005N-0120). (A copy
of the 60-day Federal Register notice is included as attachment E.) FDA
received eight comments on this proposed data collection. The first
comment is from a citizen; the second is from National Starch Food
Innovation; the third is from The Sugar Association; the fourth is from
the American Dietetic Association; the fifth is from the Grocery
Manufacturers of America; the sixth is one combined comment from the
Grain Foods Foundation, Wheat Foods Council, North American Millers'
Association, and the American Bakers Association; and both the seventh
and eighth comments are from the Calorie Control Council.

The first comment is related to the validity of the methodology and
assumptions used by FDA. The comment indicated that the sample size for
the study is 150,000 households and that this sample is too large.

The sample for this study is not households and it is not 150,000
(150,000 is the number of respondents originally estimated to reply to
the screener). The sample size for the study is 9,360 consumers. In the
study design originally planned, the sample size was justified by the
proposed subgroup analyses. In the revised design, which does not
include subgroup analyses, the sample size is justified by a smaller
estimated effect size. Overall, the sample size is a reflection of the
number of conditions, the number of products, and a power analysis.

The experimental conditions in the study design include claims contained
in the carbohydrate petitions and claims already found in the
marketplace. These experimental conditions are required to test the
study hypotheses. A wide variety of food products could be eligible for
carbohydrate content claims. The Agency, therefore, believes that it is
important to include different types of products in the study to make
certain that the cause-effect relationships found are not
product-specific. The sample size per condition per product is 180
respondents. This figure is based on (1) 0.05 alpha, (2) 0.80 power, (3)
two-tailed mean tests, and (4) an estimated effect size between small
and medium, roughly 0.30. Based on this figure, the total sample size
required for the analysis is 9,360 (the product of multiplying 180 by
each condition and relevant product (see section B1 of this Supporting
Statement).

The second comment addresses ways to enhance the quality, utility, and
clarity of the information to be collected. The comment argues that the
term total carbohydrate should be changed to exclude fiber. The change
suggested by the comment would make testing a "net carbohydrate"
statement unnecessary. The commenter would like this proposed data
collection to include a condition in which total carbohydrate is defined
with fiber excluded.

The Agency's goal for this proposed data collection is to better
understand how consumers perceive a variety of front panel carbohydrate
content claims and related statements. Testing consumer response to new
definitions for total carbohydrate on the Nutrition Facts Panel is
outside the scope of this data collection.

The third comment is related to whether this study would have practical
utility and also poses questions and offers ways to enhance the quality,
utility, and clarity of the information to be collected. The comment
states that there is no evidence that carbohydrate should be restricted
and therefore no need to amend current regulations to allow carbohydrate
content claims on food labels. The comment argues that, by extension,
there is no need for the proposed data collection.

The Agency disagrees that the study should not be undertaken. FDA has
received petitions asking the Agency to amend existing regulations to
permit carbohydrate content claims on food labels. This proposed data
collection would be used to enhance the Agency's understanding of
consumer response to such claims and, therefore, provide context for the
Agency's response to the petitions.

The third comment also addresses four methodological issues. (1) The
comment argues that respondents should evaluate several aspects of the
products included in the study and that respondents should evaluate the
test products relative to similar products. (2) This comment questions
whether the study can demonstrate whether consumers making real-life
nutrition decisions would review the Nutrition Facts information when
the front panel includes a carbohydrate content claim. (3) The comment
argues that understanding consumer response to qualifying information on
the front panel is important because products may be reformulated to
meet guidelines for a carbohydrate content claim. The reformulated
products may make substitutions, like removing sugar and adding fat. The
comment argues that equally prominent information related to
modifications is important to ensure consumers are not misled. The
comment suggests a statement such as "Reduced carbohydrate, \_\_% fewer
calories, \_\_% more fat." (4) The comment suggests that the study
should evaluate consumer response to carbohydrate content claims based
on modifications to serving size.

In response to the methodological issues raised in the third comment:
(1) The proposed study questions do ask respondents to evaluate several
aspects of the test product and to consider the test product relative to
another, similar product. (2) Several design features will help the
Agency understand whether consumers might take into consideration
information that is not part of the front panel. The proposed data
collection is designed to evaluate the response to carbohydrate content
claims with consumers who only have access to the front panel compared
to responses to the same questions from consumers who have access to
both the front panel and the full Nutrition Facts information. Among
test conditions, the product profiles presented on the Nutrition Facts
Panel will vary. Some respondents will see a product with a carbohydrate
content claim on the front and Nutrition Facts information for a more
healthful product. Others will see the same package design, with the
same claim, but the Nutrition Facts information will be for a less
healthful product. (3) The proposed study is designed to evaluate
consumer response to claims when the front panel also includes a
disclosure statement and when it does not include such a statement. The
statements included in the study would be "see nutrition information for
fat content," "see nutrition information for sugar content," and "not a
low-calorie food." These statements will appear on the test labels with
the prominence defined in regulation (21 CFR 101.13(h)(4)(i)) (see
attachment C). (4) Modifications to serving size do not drive consumer
understanding of the claims themselves and are outside the scope of this
data collection.

The fourth comment expresses agreement with the objectives and research
questions associated with this data collection. The comment then
addresses ways to enhance the utility of the information collected. The
comment requests that FDA's consumer research on labeling issues be more
general, rather than focused on one nutrient. The comment also suggests
that consumer research include in-person observation in actual-use
settings.

FDA believes that it is necessary for this study to focus on
carbohydrate claims, rather than on labeling issues in general, in order
to best inform the Agency about how consumers may react to these content
claims on food labels. Total carbohydrate claims are unique from other
nutrient content claims for two reasons. First, petitioners have
requested authorization for both "low" and "good source" claims for
total carbohydrate. Currently, no nutrient is authorized for both "low"
and "good source" claims. Second, the 2005 U.S. Dietary Guidelines[^5]
provide recommendations to consumers related to types of carbohydrate to
choose and other types of carbohydrate to limit. For example, the
Guidelines recommend that consumers choose fiber-rich produce and whole
grains often and that they limit foods with added sugar or caloric
sweeteners. Although FDA has not authorized nutrient content claims for
total carbohydrates, consumers already find claims for certain types of
carbohydrate in the marketplace, such as "sugar-free" and "good source
of fiber." To gather meaningful data, the sample for this study, the
foods included as stimuli, and the label claims must be specific to the
issues surrounding carbohydrate content labeling. Many questions
included in the study protocol, however, may be appropriate for other
labeling studies.

Conducting this study in-person in actual-use settings would not be
practical and poses methodological challenges. Consumers use labels
while shopping, at home, and in other settings. Collecting data in these
settings with an adequate sample for the proposed analysis would
increase the costs of the study and increase respondent burden. In
addition, consumers may alter their typical behavior when being tracked
by a data collector while shopping or being watched in their home as
they prepare foods. The methodology proposed for this study is
appropriate for meeting the research objective of evaluating how
consumers react to different labeling alternatives for carbohydrate
content claims. The study design and performance tasks selected will
require consumers to make judgments based on content claims and other
nutrition facts. The statistical analysis of the data will determine
whether carbohydrate labeling options provide consumers with the
information needed to make accurate decisions.

The fifth comment addresses ways to enhance the quality, utility, and
clarity of the information to be collected. The comment suggests that
the questions included in the protocol be straightforward and specific.
The comment expresses concern about using terms like "healthier" or
"more desirable." The comment recommends that the study labels include
disclosure statements for fat only when the nutrition profile of the
product would require such a statement under the current regulations.
The comment disagrees with the testing of a sugar disclosure due to the
lack of a daily value for sugar on which to base such a statement. The
comment also expresses support for testing carbohydrate content claims
with a "not a low-calorie food" disclosure, but considers a declaration
of calories per serving or "see nutrition information for calorie
content" better options to emphasize the importance of calories.
Finally, the comment requests that the Agency make available the
definitions of the carbohydrate claims prior to conducting this study.

The Agency agrees that the questions should be straightforward and
specific and designed them with those objectives in the forefront. The
terms "healthier" and "more desirable" are not included among the study
questions. Use of a fat content disclosure statement in this study will
be consistent with current regulations (CFR 101.13(h)(1)) (see
attachment C). The sugar disclosure used in this proposed study would
accompany a "good source of carb" claim. In the study, the disclosure
would appear on a product with "good source of carb" on the front panel
and information in the Nutrition Facts box that indicates that most of
the carbohydrate in the product is sugars. The goal of this test is to
better understand how consumers react to a "good source of carb" claim
on a product high in sugar and low in other carbohydrates. The Agency
disagrees with the comment's suggestion to test a declaration of
calories per serving or "see nutrition information for calorie content"
in lieu of "not a low calorie food." The Agency considers the statement
"not a low calorie food" to be an appropriate, explicit statement to
make consumers more aware of calories. The disclosure "not a low calorie
food" is currently seen by consumers in the marketplace when
"sugar-free" claims are made on products that are not low calorie. The
experimental study looks at ranges of carbohydrate content levels for
the products to explore differences in consumer reaction.

The sixth comment argues that the study methods are sound and suggests
ways to enhance quality, utility, and clarity of the information to be
collected. The comment suggests substituting the soda and frozen dinner
stimuli with pasta, cereal, orange juice or any fruit. The comment does
not offer a reason for these preferences. The comment also proposes
testing white bread and whole grain bread as separate products.

In the revised study design, the soda is replaced by a juice drink. The
three products proposed for this study were selected to understand
whether consumer perception of carbohydrate content claims varies when
the claim is on a label for a traditionally high-carbohydrate staple
(bread), a beverage (juice drink), and a complete meal (frozen dinner).
The Agency does not agree that any of the specific substitutions
suggested in the comment would improve the study. The label for the
bread does not indicate whether it is white, wheat, or another grain.
Consumers will view a label claim on the front panel for bread labeled
simply "home-style." Some of the respondents who view the Nutrition
Facts Panel for the bread will see a higher-fiber, lower-fat bread,
while others see a lower-fiber, higher-fat bread. The analysis will
evaluate the differences in perception of the claims when the nutrient
profile suggests a more healthful versus a less healthful product.

The seventh comment and eighth comments address the quality, utility,
and clarity of the information to be collected. The comments request
that this data collection test changes to the carbohydrate section of
the Nutrition Facts Panel. One of these comments requests that fiber and
sugar alcohols be listed separately from other carbohydrates. The other
of the comments proposes moving carbohydrates with reduced caloric value
from the carbohydrate listing on the Nutrition Facts Panel and adding a
listing called "low calorie ingredients," which would include the
subheadings listings "fiber" and "other."

Evaluating any proposed changes to the Nutrition Facts Panel is outside
the scope of this data collection. This data collection is designed to
evaluate consumer understanding of carbohydrate claims on the front
panel.

The 30-day Federal Register notice published on August 17, 2005 (Volume
70, Number 158). FDA received one comment to the 30-day Federal Register
notice from Kraft Foods Global, Inc.

The comment questions why the Agency is conducting consumer research on
an issue that is a matter of nutritional science. This study is not
designed to challenge nutritional science, but rather to help the Agency
evaluate consumer understanding of the science-based claims, with and
without disclosure statements.

The comment argues that since nutrient content claims are "direct
objective statements about the level of nutrient in food relative to an
authoritative reference value," the Agency should not explore whether
carbohydrate claims convey any meaning beyond the food's carbohydrate
value. The Agency believes that it is important to understand whether
claims on food packages are confusing or misleading to consumers.
Consumers may not interpret statements based in science as they were
intended. Research, such as that by Roe, Levy, and Derby described
earlier in this Supporting Statement, shows that claims may have "halo"
effects that lead consumers to misattribute health benefits with a
claim. The proposed experiment is designed to help understand whether
carbohydrate claims are associated with misattribution of health
benefits. In this experiment, disclosure statements would be used to
understand whether such information could redress misattribution of
benefits. This understanding is not intended to challenge nutritional
science, but rather to provide the Agency with more complete information
to assess the effect of carbohydrate content claims on food labels.

The comment suggests that the Agency develop specific "decision
criteria" for the results of the study. Consumer research does not set
policy, but rather helps to inform policy. Data from this study would
help to inform the Agency's response to the carbohydrate content claim
petitions. These data would be used in conjunction with data from many
other sources. The results from this experiment are designed to help the
Agency understand whether there are different consumer effects for
different signals.

The comment proposed that all consumers have access to the Nutrition
Facts Panel to "more closely approximate real-life conditions." The
Agency disagrees that this proposal would better emulate shopping or
food use conditions. Research suggests that many consumers do not look
at the Nutrition Facts Panel when they shop for foods. However, when
asked direct questions about a product's nutritional value, these same
consumers may look at the Panel, if it were available. The study is
designed to capture the understanding of consumers who do and do not
evaluate the Nutrition Facts Panel when shopping and using foods. By
comparing the front-panel only conditions to conditions that include the
Nutrition Facts, the Agency will better understand whether the Nutrition
Facts could help to redress any possible confusion or misattribution
associated with the claim.

The comment disagrees with the Agency's use of a "good source" claim
with a "see nutrition information for sugar content" disclosure. The
Agency was including this high sugar product with a "good source" claim
to better understand the boundaries for any possible misattribution
effects of the claim. The Agency is interested in understanding the
effect of sugar disclosures, for which there is no precedent.

However, the comment's concern over the condition has made the Agency
decide to use a juice drink in the study, rather than soda. Juice drinks
can be high in sugar, but unlike soda, may include other nutrients than
sugars.

9.  **[Payment or Gift]{.underline}**

Members of Synovate's Internet panel will not be paid specifically for
their participation in this study. However, as part of the firm's
incentive to recruit and maintain membership, panelists are offered
rewards by the firm for their general participation in surveys sent out
by the panel. The reward takes the form of entries into the panel's
monthly sweepstakes. Each time a member completes a study, the
individual is automatically entered into the current month's drawing to
win one of the following cash prizes: one cash prize of \$1000, 10
prizes of \$100, 15 prizes of \$50, 30 prizes of \$25, and 150 prizes of
\$10.

 

10. **[Confidentiality Provisions]{.underline}**

All respondents would be provided with the assurance of confidentiality.
The experiment would include information explaining to respondents that
their information will be kept confidential. An independent contractor
for the FDA would collect these data and would not provide FDA
identifying information on the respondents.

The contractor, Synovate, has procedures in place to prevent
unauthorized access to respondent information. The firm stores members'
personal identifiable information on separate servers from survey
response data, uses firewalls to secure its servers, maintains audit
records of log-ins, file accesses and other security incidents, and
conducts its work in a high security building.

Synovate reassesses security protocols each month. Access to all data
collected by Synovate is limited to the internal Chief Privacy Officer
and designated staff members only. Synovate staff members are trained in
their privacy policy. Each staff person who requires access to system
data must sign a confidentiality agreement each year.

All electronic data would be maintained in a manner which 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 would also be maintained in consistency with the FDA
Privacy Act System of Records #09-10-0009 (Special Studies and Surveys
on FDA Regulated Products).

11. **[Privacy]{.underline}**

This data collection would not include sensitive questions. The complete
list of questions is attached in attachment F.

12. **[Burden of Information Collection]{.underline}**

The total annual estimated burden imposed by this collection of
information is 2,888 hours for this one-time collection (Table 1).

Table 1. Estimated Annual Reporting Burden^1^

  ------------ ------------- ----------- ------------- ----------- -----------
  Activity     No. of        Annual      Total Annual  Hours per   Total Hours
               Respondents   Frequency   Responses     Response    
                             per                                   
                             Response                              

  Cognitive    9             1           9             1           9
  interviews                                                       

  Pretest      150           1           150           0.17        26

  Screener     173,000       1           173,000       0.01        1,730

  Experiment   9,360         1           9,360         0.12        1,123

  Total                                                            2,888
  ------------ ------------- ----------- ------------- ----------- -----------

^1^There are no capital costs or operating and maintenance costs
associated with this collection of information.

These estimates are based on FDA's experience with previous consumer
studies. The cognitive interviews are designed to ensure that the
questions are worded as clearly as possible to consumers. The cognitive
interviews would take each respondent no more than an hour to complete.
The pretest of the final questionnaire is designed to minimize potential
problems in the administration of the interviews. The pretest is
predicted to take each respondent 10 minutes to complete.

The screener was administered to the entire 600,000 Internet panel, with
over 173,000 responses. To include diet status as a covariate, the
screener was designed to identify respondents who are diabetic,
non-diabetics who are limiting their carbohydrates, those who are trying
to consume foods high in carbohydrate, and consumers in none of the
previous categories. The screener was estimated to take respondents 36
seconds to complete.

The experiment would be conducted with 9,360 panel members. The
experiment is predicted to take each respondent seven minutes to
complete.

13. **[Costs to Respondents]{.underline}**

There are no costs to respondents.

14. **[Costs to Federal Government]{.underline}**

The estimated cost to the federal government is \$200,000. This includes
the costs paid to the contractor to program the study, draw the sample,
collect the data, and create a database of the results. This cost also
includes FDA staff time to design and manage the study, to analyze the
resultant data, and to draft a report.

15. **[Reason for Change\
    ]{.underline}**This is a new data collection.

16. **[Statistical Reporting]{.underline}**

Conventional statistical techniques for experimental data, such as
descriptive statistics, analysis of variance, and regression models
would be used to analyze the data. Covariates used in the analysis would
include diet status, age, race/ethnicity, gender, and education.

> Table 2 outlines the time plan for data collection and analysis.

Table 2. Project Schedule for the Carbohydrate Content Claim Experiment

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

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

  Within 45 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 and
  notification to contractor       report
  -------------------------------- --------------------------------------

The Agency anticipates disseminating the results of the study after the
final analyses of the data are completed, reviewed, and cleared. The
exact timing and nature of any such dissemination has not been
determined, but may include presentations and articles at trade and
academic conferences, publications, and Internet posting. 

17. **[Display of OMB Approval Date\
    ]{.underline}**\
    No exemption is requested.

18. **[Exceptions to "Certification for Paperwork Reduction Act
    Submissions"\
    ]{.underline}** No exceptions are requested.

## B. Collections of Information Employing Statistical Methods 

**1. [Potential Respondent Universe and Sampling
Selection]{.underline}**

The universe for this experimental study is members of the Synovate
Internet panel. Synovate's Internet panel consists of 600,000 households
that are recruited by a variety of means to reflect all segments of the
U.S. population and have agreed to participate in Internet research
studies. Typical panel members receive three or four invitations per
month to participate in research projects.

The 600,000 panel members were emailed a screener, as part of a regular
Synovate omnibus study, to collect information on diet status. By
separating the screener questions from the experiment rather than
combining them, respondents should be less focused on their diets and
carbohydrate issues when answering the study questions.

The 9,360 participant sample for this study would be drawn from the pool
of over 173,000 panel members for whom we have information on diet
status from the screener. Quotas will be used so that the overall sample
is in proportion to the U.S. adult population on age, gender, education,
race/ethnicity, and diabetes status. Because there are no national
estimates for carbohydrate consumption behavior, quotas for high-and
low-carbohydrate diet status would be in proportion to the panelists
responding to the screener.

The Agency does not intend to generate nationally or locally
representative results or precise estimates of population parameters
from this study. The sample used is a convenience sample, rather than a
probability sample. Despite the attempt to match between the study's
sample and known population characteristics, matching is used solely to
produce samples with a reasonable degree of diversity in key demographic
characteristics. Furthermore, no legitimate weights can be constructed
from non-probability samples such as the one used here. Hence, the
Agency does not construe this sample or the results generated from this
sample as nationally or locally representative. Rather, the strength of
the experimental study lies in its internal validity, on which
meaningful estimates of differences across conditions can be produced
and generalized.

The sample size for this study is a reflection of the number of
conditions, the number of products proposed for the study, and the
assumptions described in the power analysis below. The experimental
conditions in the study design include claims contained in the
carbohydrate petitions and claims already found in the marketplace.

These experimental conditions are required to test the study hypotheses
described in section A2. These hypotheses reflect the information needed
by the Agency to respond to the carbohydrate content claim petitions.
The 2005 Dietary Guidelines highlight components of carbohydrate that
consumers should include in their diet and those that they should limit.
If authorized, carbohydrate content claims could appear on products that
are high or low in the carbohydrates consumers are encouraged to choose
(e.g., fiber) or those consumers are encouraged to limit (e.g., added
sugars). The Agency, therefore, believes that it is important to
understand consumer reaction to claims on products with more and less
healthful nutrition profiles.

In addition, the Agency believes that it is important to evaluate how
consumers react to carbohydrate claims in the absence of other nutrition
information, and also to assess how the availability of additional
nutrition information affects consumers' judgments and inferences about
the claim and the product. For each of the carbohydrate content claims
tested, some respondents will see the front panel only, while others
will see the front panel and the nutrition facts.

The Agency is also interested in whether disclosure statements that
accompany a front panel claim affect consumers' judgments about the
claim. This study tests three different disclosures for sugars, fat, or
calorie content.

A very wide variety of food products could be eligible for carbohydrate
content claims. The Agency, therefore, believes that it is important to
include different types of products in the study to make certain that
the cause-effect relationships found are not product-specific. This
study will thus evaluate consumers' reactions to carbohydrate content
claims for three different types of products.

*Power*

To test the hypotheses identified in section A2, the following
assumptions were made in deriving the sample size: (1) 0.05 alpha and
0.80 power, (2) two-tailed mean tests, and (3) an effect size between
small and medium, roughly 0.30. Based on these assumptions, the per
group sample size needed to detect a difference should be 180[^6]^.^ The
table below describes the study conditions (label(s) which respondents
would view), the number of products relevant to the condition, and the
total number of respondents needed for each condition (180 multiplied by
the number of products, one to three, relevant to the condition).

*[Groups Products 180 x products]{.underline}*

1.  Low carb front (180x) x3 products =540

2.  Net carb front x2 products =360

3.  CarbConscious front x3 products =540

4.  No claim front x3 products =540

5.  Low carb w/ disclosure front x3 products =540

6.  CarbConscious w/ disclosure front x3 products =540

7.  Good Source front x3 products =540

8.  Good Source w/ disclosure front x1 product =180

9.  Low carb front w/ healthier low carb NFP x2 products =360

10. CarbConscious front w/ healthier low carb NFP x2 products =360

11. Net carb front w/ healthier low carb NFP x2 products =360

12. Low carb front w/ less healthful low carb NFP x3 products =540

13. CarbConscious front w/ less healthful low carb NFP x3 products =540

14. Net carb front w/ less healthful low carb NFP x1 products =180

15. Low carb front w/ disclosure w/ less healthful low carb NFP x3
    products =540

16. CarbConscious front w/disclosure w/less healthful low carb NFPx3
    products =540

17. No claim front with healthier low carb NFP x3 products =540

18. No claim front with healthier high carb NFP x3 products =540

19. Good Source front w/ less healthful high carb NFP x3 products =540

20. Good Source front w/ disclosure w/ high carb NFP x1 products =180

21. Good Source front w/ healthier high carb NFP x2 products =360

> **TOTAL SAMPLE SIZE 9,360**

Below please find a list of the alternative hypotheses for the study
followed by a table indicating which condition is included in the study
to test which hypothesis or hypotheses.

[Hypothesis 1]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "low carb," "net carb," or
"carbconscious" claim will evaluate products differently than those who
view the no claim, control label.

[Hypothesis 2]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "low carb" or "carbconscious" claim
with a fat or calorie disclosure will evaluate the product differently
than those who view the "low carb" or "carbconscious" claim without the
fat disclosure or calorie disclosure, respectively.

[Hypothesis 3]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "good source of carb" claim will
evaluate the product differently than those who view the no claim,
control label.

[Hypothesis 4]{.underline}: Among respondents who see the [front panel
only]{.underline}, those who see a "good source of carb" claim with a
sugar disclosure will evaluate the product differently than those who
view the "good source of carb" claim without the sugar disclosure.

[Hypothesis 5]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "low carb," "carbconscious"
or "net carb" claim with a *healthier low carb* Nutrition Facts Panel
(NFP) will evaluate the product differently than those who view the same
front panel with a *less healthful low carb* NFP.

[Hypothesis 6]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "low carb" or "carbconscious"
claim with a fat disclosure and a *less healthful low carb* NFP will
evaluate the product differently than those who view a "low carb" or
"carbconscious" claim with a *less healthful low carb NFP*, but without
a fat disclosure.

[Hypothesis 7]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "low carb," "carbconscious,"
or "net carb" claim with a *healthier, low carb* NFP will evaluate the
product differently than those who view a no claim, control front panel
with a *healthier low carb* NFP.

[Hypothesis 8]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "good source of carb" claim
with a sugar disclosure and a *high carb* NFP will evaluate the product
differently than those who view a "good source of carb" claim with a
*high carb* NFP, but without a sugar disclosure

[Hypothesis 9]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "good source of carb" claim
with *healthier high carb* NFP will evaluate the product differently
than those who view a "good source of carb" claim with a *less healthful
high* *carb* NFP.

[Hypothesis 10]{.underline}: Among respondents who view the [front and
back]{.underline} labels, those who view a "good source of carb" claim
with a *healthier, high carb* NFP will evaluate the product differently
than those who view a no claim control with a *healthier, high carb*
NFP.

The 21 conditions for the study are necessary to address the 10
hypotheses described above.

*[Groups Hypothesis number(s)]{.underline}*

1.  Low carb front 1 and 2

2.  Net carb front 1

3.  CarbConscious front 1 and 2

4.  No claim front 1 and 3

5.  Low carb w/ disclosure front 2

6.  CarbConscious w/ disclosure front 2

7.  Good Source front 3 and 4

8.  Good Source w/ disclosure front 4

9.  Low carb front w/ healthier low carb NFP 5 and 7

10. CarbConscious front w/ healthier low carb NFP 5 and 7

11. Net carb front w/ healthier low carb NFP 5 and 7

12. Low carb front w/ less healthful low carb NFP 5 and 6

13. CarbConscious front w/ less healthful low carb NFP 5 and 6

14. Net carb front w/ less healthful low carb NFP 5

15. Low carb front w/ disclosure w/ less healthful low carb 6

16. CarbConscious front w/disclosure w/less healthful low carb NFP 6

17. No claim front with healthier low carb NFP 7

18. No claim front with healthier high carb NFP 10

19. Good Source front w/ less healthful high carb NFP 8 and 9

20. Good Source front w/ disclosure w/ high carb NFP 8

21. Good Source front w/ healthful high carb NFP 9 and 10

**2. [Procedures for the Collection of Information]{.underline}**

The key dependent measures collected in the experiment to test each
hypothesis stated in sections A2 and B1 are (1) purchase intent (Q1);
(2) overall healthfulness (Q2); (3) appropriateness for a given
objective (Q3); and (4) perceived level of nutrients (Q4).

Purchase intent: Q1. If you were shopping for \[FILL BREAD/A JUICE
DRINK/A FROZEN BEEF DINNER\], how likely would you be to purchase this
\[FILL BREAD/JUICE DRINK/FROZEN BEEF DINNER\]?

Overall healthfulness: Q2. If you were going to \[FILL EAT BREAD/HAVE A
JUICE DRINK/EAT A FROZEN BEEF DINNER\], how healthy of a choice would
this \[FILL BREAD/JUICE DRINK/FROZEN BEEF DINNER\] be?

Appropriateness for a given objective: Q3. Based on what you see on this
label, how likely is it that \[FILL EATING THIS BREAD/HAVING THIS JUICE
DRINK/EATING THIS FROZEN BEEF DINNER\] as a regular part of one's diet
would help someone \[FILL manage their weight, strengthen their bones,
have more energy for sports\]?

Perceived level of nutrients: Q4. Based on what you see on this label,
how high or low do you consider this \[FILL BREAD/JUICE DRINK/FROZEN
BEEF DINNER\] to be in each of the following nutrients? Calories, Total
Fat, Total Carbohydrate, Sugars, Fiber, Protein.

Each of the dependent measures will be used to test each of the
hypotheses. Subjects across all of the conditions will be asked to
answer all of these questions. For all of the alternative hypotheses in
the study, differences are expected in the likelihood of purchasing the
product, ratings of healthfulness of the product, measures of the
nutrients, and the likelihood of helping someone to manage their weight
and have more energy for sports, in the case of low and high
carbohydrate claims, respectively.

Covariates will be used to account for differences in responses related
to the characteristics of the respondent. To help understand non-label
factors that may relate to participants' responses to the dependent
measures, the following information has been or will be collected.

> a\. Interest in nutrition information (Q5).
>
> Q5. When you buy a food product for the **FIRST TIME**, how often do
> you read the nutrition facts label that lists ingredients and provides
> nutrition information?
>
> b\. Purchase experience (Q6).

Q6. How often do you buy \[FILL WITH THE PRODUCT RESPONDENT SAW\]?

c\. Consumption experience (Q7).

Q7. How often do you \[EAT BREAD/HAVE JUICE DRINKS/EAT FROZEN DINNERS\]

d.  Diabetes status (Screener1)

Screener1: Have you been diagnosed with any type of diabetes?

e.  Carbohydrate consumption behavior (Screener2)

> Screener2: In the past 30 days have you....?
>
> Tried to **limit** the amount of carbohydrate you eat
>
> Tried to choose foods that are **low** in carbohydrate
>
> Tried to **increase** the amount of carbohydrate you eat
>
> Tried to choose foods that are **high** in carbohydrate
>
> None of the above
>
> f\. Demographics, age, race/ethnicity, gender, education (panel
> enrollment demographic questionnaire).

It is hypothesized that: (1) Respondents who are interested in nutrition
or who are diabetic are more likely to respond to the content of
nutrition profile, when available (e.g. judge a more healthful profile
more favorably). (2) In the absence of nutrition information,
respondents who buy and consume the product regularly are more likely to
indicate that they would purchase the product and rate it as healthful.
(3) Respondents who have recently limited carbohydrate or chosen foods
low in carbohydrate are more likely to rate the products with a low
carbohydrate or a carbconscious claim favorably, while respondents who
try to increase carbohydrate or choose foods high in carbohydrate are
more likely to rate these products unfavorably.

All information would be collected via the Internet. The three products
in this experiment are (1) a loaf of bread, (2) bottled juice drink, and
(3) a frozen beef dinner. These products were selected to understand
whether consumer perception of carbohydrate content claims varies when
the claim is on a label for a traditionally high-carbohydrate and
ubiquitous staple (bread), a beverage (juice drink), and a complete meal
(frozen dinner).

Forty percent of the participants (3,780) would see only a front panel
with one of the carbohydrate content claims or a no claim, control
label. The remaining participants would see both a front panel and
corresponding Nutrition Facts Panel. For those with a condition that
includes nutrition information, both the front and Nutrition Facts Panel
would be shown side by side on the screen to respondents before they
answer any questions.

On the Nutrition Facts Panel for the bread and frozen dinner,
carbohydrate would be held constant at two levels, while the calories,
fat, and fiber content vary to create more and less healthful product
profiles. On the Nutrition Facts Panel for the juice drink, the sugar
content, and therefore calories and total carbohydrate content, would
vary. For example, one group of respondents would see the bread with a
"low carb" claim on the front panel and the nutrition facts would
indicate the product is low in total fat, saturated fat, and calories.
Another group of respondents would see the exact same front panel, but
the nutrition facts would indicate that the product is substantially
higher in calories, total fat, and saturated fat. Comparisons between
groups would help the Agency understand the extent of the possible
misattribution of health benefits.

The carbohydrate content claims and carbohydrate-related statements that
would be tested in the proposed study include "low carb," "x grams net
carbs," "carbconscious," and "good source of carb." The value of "net
carb" will be calculated as total carbohydrate less fiber and sugar
alcohols. The appropriate Nutrition Facts will include information on
this calculation in a "carb facts" box. Where relevant, this study would
test claims with and without the following disclosure statements: (1)
"see nutrition information for fat content"; (2) "see nutrition
information for sugar content"; and (3) "not a low-calorie food."

FDA has several regulations in part 101 (21 CFR part 101) that apply to
the use of disclosures. See § 101.13(h)(1) for disclosures on total fat,
saturated fat, cholesterol and sodium; § 101.62(c) for disclosures
related specifically to total fat and cholesterol on products with a
saturated fat content claim; and § 101.60(c)(1)(iii)(B) and §
101.60(c)(2)(v) for a calorie disclosure used with a sugar-free claim.

If consumers are misled by carbohydrate content claims on food labels,
the Agency would like to know whether disclosure statements could help
to redress this problem. The disclosure statements for this study are
appropriate to the products that might bear carbohydrate content claims.
The fat disclosure statement or the "not a low-calorie food" statement,
for example, may be necessary in light of the fact that low-carbohydrate
foods are sometimes marketed for weight-loss. Consumers might select
low-carbohydrate foods for this objective. However, these foods may be
higher in calories due to a higher fat content resulting from a
manufacturer's reformulation of a food. (While carbohydrates have four
calories per gram, fat has nine calories per gram.) Also,
low-carbohydrate foods tend to be higher in fat, naturally.

The sugar disclosure information in the study would be useful to
determine, if "good source" claims are permitted, whether these claims
should be required to be accompanied by a disclosure to alert consumers
to the sugar content in that food. The issue of disclosures and
disqualifying amounts for sugar on products bearing a "good source" of
carbohydrate content claim is a key issue of disagreement in the
petitions that FDA has received. A sugar disclosure does not currently
appear on packages. The Agency is concerned that foods that would be
eligible to bear "good source" claims based on total carbohydrate
content could include those foods that are high in added sugars, which
would be contrary to current dietary recommendations to limit the intake
of added sugars.

**3. [Methods to maximize response rates and to deal with issues of
non-response]{.underline}**

This experimental study would use an existing Internet panel to draw a
sample. The panel includes people who have expressed interest in sharing
their opinions via the Internet and do so regularly. The expected
participation rate for the Internet panel is 55 percent when responding
to a specific study. To help ensure that the participation rate is as
high as possible, the Agency will:

-   Design an experimental protocol that minimizes burden (short in
    length, clearly written, and with appealing graphics);

-   Test the draft protocol in cognitive interviews and pretests to
    ensure that the protocol does minimize burden and refine the
    protocol as appropriate;

-   Administer the experiment over the Internet, allowing respondents to
    answer questions at a time and location of their choosing;

-   Administer the experiment to individuals who have expressed interest
    in participating in Internet studies;

-   Email a reminder to the respondents who do not complete the protocol
    four days after the original invitation to participate is sent;

-   Provide contact information on where to get help for respondents who
    may have questions as they complete the experiment.

**4. [Test Procedures]{.underline}**

A series of up to nine cognitive interviews would be conducted in three
waves. At the end of each the first two waves, any necessary refinements
to the questions would be made and tested in the successive wave.
Cognitive interviews would help ensure that the questions are as clear
and as minimally burdensome as possible.

Pretests of the questionnaire would be conducted prior to the main
experimental study. The 150 pretest participants would be drawn from the
sample population, Synovate's Internet Panel. The pretest would be
completed in at most three waves of 50 interviews. Like the cognitive
interview schedule, any refinements identified in one wave would be made
and tested in the next. The pretest would help ensure that any potential
problems in sample selection, administration, and data collection are
addressed before the experiment is in the field.

**5. [Individuals Involved in Statistical Consultation and Information
Collection]{.underline}**

The contractor, Synovate, would 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 would be
conducted primarily by staff on the Consumer Studies Staff, Division of
Social Science, Office of Regulations and Policy, CFSAN, FDA, and
coordinated by Judith Labiner-Wolfe, PhD, telephone (301) 436-2443.

[^1]: U.S. Department of Health and Human Services and U.S. Department
    of Agriculture (January 12, 2005), *Dietary Guidelines for Americans
    2005*.

[^2]: Roe, Brian, Alan S. Levy, and Brenda M. Derby, (1999), "The Impact
    of Health Claims on Consumer Search and Product Evaluation Outcomes:
    Results from FDA Experimental Data, *Journal of Public Policy and
    Marketing*, 18 (Spring), 89-105.

[^3]: Garreston, Judith A., and Scot Burton (2000), "Effects of
    Nutrition Facts Panel Values, Nutrition Claims, and Health Claims on
    Consumer Attitudes, Perceptions of Disease-Related Risks and Trust,"
    *Journal of Public Policy and Marketing*, 19 (Fall), 213-227.

[^4]: FDA (August 26, 2005). "Carbohydrate Labeling Focus Group Internal
    Report." Unpublished draft.

[^5]: \[1\] U.S. Department of Health and Human Services and U.S.
    Department of Agriculture (January 12, 2005), *Dietary Guidelines
    for Americans 2005*.

[^6]: Cohen, Jacob (1988). Statistical Power Analysis for the Behavioral
    Sciences, Second Edition. Hillsdale, NJ: Lawrence Erlbaum
    Associates.