[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Notices]               
[Page 48423-48426]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0120]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study of 
Carbohydrate Content Claims on Food Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 16, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Experimental Study of Carbohydrate Content Claims on Food Labels

    The authority for FDA to collect the information for this 
experimental study derives from the Commissioner of Food and Drugs' 
authority, as specified in section 903(d)(2) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)).
    The Nutrition Labeling and Education Act of 1990 (Public Law 101-
535) amended the act. Section 403(r)(1)(A) of the act (21 U.S.C. 
343(r)(1)(A)) was added under these amendments. This section 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.
    In 1993, FDA published regulations that implemented the 1990 
amendments. Among these regulations, Sec.  101.13 (21 CFR 101.13) sets 
forth general principles for nutrient content claims (see 56 FR 60421, 
November 27, 1991, and 58 FR 2302, January 6, 1993). Other regulations 
in subpart D of part 101 (21 CFR part 101, subpart D) 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, Sec.  101.69 (21 CFR 101.69) establishes 
the procedures and requirements for petitioning the agency to authorize 
nutrient content claims.
    The Food and Drug Administration Modernization Act of 1997 (Public 
Law 105-115) amended section 403(r)(2) of the act by adding sections 
403(r)(2)(G) and (r)(2)(H) to permit nutrient content claims based on 
published authoritative statements by a scientific body when FDA is 
notified of such claims in accordance with the requirements established 
in these sections.
    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. FDA has been petitioned to amend existing food labeling 
regulations to define terms for use in nutrient content claims 
characterizing the level of carbohydrate in foods.

[[Page 48424]]

    The purpose of this proposed data collection is to help enhance 
FDA's understanding of consumer response to carbohydrate content claims 
on food labels. More specifically, this experimental study will help 
answer the following research questions:
    1. Does the presence of a given front panel carbohydrate content 
claim suggest to consumers that the product is lower or higher in total 
carbohydrate, calories, and other nutrients (i.e., total fat, fiber, 
and protein) than the same product without the claim or with a 
different claim?
    2. Does the presence of a given front panel carbohydrate content 
claim suggest to consumers who do not view the Nutrition Facts panel 
that the food is healthier or otherwise more desirable than the same 
product without the claim or with a different claim?
    3. Does the presence of a front panel carbohydrate content claim 
suggest to consumers that the product is healthier than the same 
product without a claim or with a different claim despite information 
to the contrary available on the Nutrition Facts panel?
    4. Do disclosure statements help consumers to draw appropriate 
conclusions about products with carbohydrate content claims on the 
front panel?
    The label claims that would be tested in the proposed study include 
``carb-free,'' ``low carb,'' ``x g net carbs,'' ``carbconscious,'' 
``good source of carb,'' and ``excellent source of carb.'' The study 
would also include control labels (labels not bearing a claim). Where 
relevant, this study would test carbohydrate content 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.''
    Participants would see mock food label images for one of the 
following three products: (1) A loaf of bread, (2) a can of soda, and 
(3) a frozen entree. Three products were selected to understand whether 
consumer perception of carbohydrate content claims changes when the 
food is a traditionally high-carbohydrate, ubiquitous staple (bread), a 
beverage (soda), or a complete meal (frozen entree).
    Half of the participants would see only a front panel with a 
carbohydrate content claim or a control label not bearing a claim. The 
other half of the participants would see both the front panel and the 
back panel, which includes the Nutrition Facts information. In the 
Nutrition Facts panel for the bread and frozen entree, the calorie, 
fat, and fiber content would vary to create more and less healthful 
product profiles. Total carbohydrate content would also vary. On the 
Nutrition Facts panel for the soda, the sugar content, and therefore 
total carbohydrate content and calories, would vary.
    The proposed experimental study would be conducted online via the 
Internet. The sample would be drawn from an existing consumer opinion 
panel developed and maintained by the research firm Synovate. 
Synovate's Internet panel consists of 600,000 households that have 
agreed to participate in research studies conducted through the 
Internet.
    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. 
Periodically, Synovate gives incentives of small monetary value to 
panel members for their participation. Studies begin with an e-mailed 
invitation to the sampled respondents.
    For this proposed study, Synovate's Internet panel would be 
screened for diet status. Twenty-five percent of the households in the 
Internet panel (150,000 households) are expected to respond to the 
screening questions. Based on information gathered from the screening 
process, a sample would be drawn to allow for 2,500 participants in 
each of 4 groups: (1) Diabetic consumers, (2) consumers who try to eat 
a diet low in carbohydrate (but who are not diabetic), (3) consumers 
who try to eat a diet high in carbohydrate, and (4) consumers who are 
not part of any of the preceding three groups. Assignment to a 
condition would be random within each of the four groups of consumers. 
Of the members of the Internet panel who respond to the screening 
questions and are selected for the study (18,200 panel members), 55 
percent (10,000 panel members) are expected to participate in the 
experiment.
    In the Federal Register of April 8, 2005 (70 FR 18032), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received eight comments on this proposed 
data collection. The first comment was from a citizen; the second was 
from National Starch Food Innovation; the third was from The Sugar 
Association; the fourth was from the American Dietetic Association; the 
fifth was from the Grocery Manufacturers of America; the sixth was 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 were 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. 
The sample size for the study is 10,000 consumers. FDA needs this 
sample size to conduct sub-analyses within four different groups: 
Consumers who are diabetic, nondiabetics who are limiting their 
carbohydrates, consumers who are trying to consume foods high in 
carbohydrate, and consumers in none of the previous categories. To 
identify an adequate number of consumers from each of these groups for 
meaningful sub-analyses, FDA will need to screen the full Synovate 
Internet panel, but will not be using the full panel for the study 
itself. The screening will be conducted in the context of a quarterly 
multi-topic survey that Synovate e-mails to all of its Internet panel 
members. This data collection proposes to include three very brief diet 
status screening questions on one of Synovate's multi-topic surveys. 
These questions would take no more than 36 seconds to complete. Based 
on Synovate's previous experience with this panel, 150,000 panel 
members should reply to the screening questions. The sample for this 
proposed data collection would be drawn from the estimated 150,000 
responses to the screening questions. The sample would include roughly 
18,000 consumers, of which FDA projects that 10,000 will complete the 
study.
    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.

[[Page 48425]]

    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 as 
follows: (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;'' and (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 the following will occur: (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)); (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 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

[[Page 48426]]

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 (21 CFR 101.13(h)(1)). 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.
    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 (soda), and a complete meal 
(frozen dinner). The agency does not agree that any of the 
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.
    FDA estimates the burden of the collection of information as 
follows:

                                                     TABLE 1.--Estimated Annual Reporting Burden\1\
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                                                  No. of       Annual Frequency per       Total Annual
                  Activity                     Respondents           Response              Responses             Hours per Response        Total Hours
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Cognitive Interviews                                      9                      1                      9                0.5                          5
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Pretest                                                 150                      1                    150                0.17                        26
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Screener                                            150,000                      1                150,000                0.01                     1,500
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Experiment                                           10,000                      1                 10,000                0.12                     1,200
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Total                                        ...............  .....................  .....................  ...........................           2,731
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\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 30 minutes 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 approximately 10 minutes to 
complete.
    The screener would be sent via the Internet to the entire 600,000-
household Internet panel, of which 25 percent (150,000 households) are 
predicted to respond. The brief screener is predicted to take each 
respondent 36 seconds to complete.
    The experiment would be conducted with 10,000 panel members. The 
experiment is predicted to take each respondent approximately 7 minutes 
to complete.

    Dated: August 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16242 Filed 8-16-05; 8:45 am]

BILLING CODE 4160-01-S