Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Carbohydrate Content Claims on Food Labels, 48423-48426 [05-16242]
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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Notices
Status: Meeting is open to the public,
limited only by the space available.
Background: NIOSH has been
conducting an occupational
epidemiologic research program
addressing potential long term health
effects of working in the Department of
Energy (DOE) nuclear weapons complex
under a series of Memoranda of
Understanding (MOUs) with DOE.
Establishment of this research program
began following recommendations of a
Secretarial Panel for the Evaluation of
Epidemiologic Research Activities
(SPEERA) for the U.S. Department of
Energy in 1990. Input from various
stakeholders has been sought since the
program’s inception including
organized labor, current and former
workers, DOE site management and
contractors, DOE headquarters,
academic research partners, the
occupational safety and health
community, various governmental
agencies, and the general public. A
document entitled: Agenda for HHS
Public Health Activities (For Fiscal
Years 2005–2010) at U.S. Department of
Energy Sites is accessible at https://
www.cdc.gov/niosh/pdfs/hhsdoe_2005–
2010–2.pdf and includes information on
completed, ongoing, and proposed
occupational epidemiologic research
activities under the DOE–DHHS MOU.
Purpose: This meeting will provide an
overview of recently completed work
conducted under the MOU, outline
ongoing research activities, summarize
findings and follow-up from a NIOSH
public meeting held July 2004
addressing chronic lymphocytic
leukemia radiogenic research, and
discuss plans for future research.
Attendees will have opportunities for
questions and oral commentary on this
NIOSH research program. Stakeholder
feedback and the opportunity to update
stakeholders on this research program
are two primary objectives of the
meeting. Written comments will be
accepted at the meeting and may also be
sent to the address for the NIOSH
Health-Related Energy Research Branch
below.
The agenda for this meeting is
currently being developed. Stakeholders
interested in attending may request
additional information from the contact
person identified below. Written
comments may also be submitted to the
address below until November 1, 2005.
Contact Person for More Information:
Ms. Patty Gudlewski may be contacted
at 513–841–4419 or by e-mail at
PGudlewski@cdc.gov.
Addresses: Written requests for
meeting information may be sent to Ms.
P. Gudlewski; NIOSH–HERB; Mailstop
R–44; 4676 Columbia Parkway;
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Cincinnati, OH 45226. Written
comments should be sent to the
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same NIOSH mailing address or may be
e-mailed to him at SAhrenholz@cdc.gov.
The Director, Management Analysis
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the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: August 10, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–16257 Filed 8–16–05; 8:45 am]
BILLING CODE 4163–18–P
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.
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
PO 00000
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48423
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,
§ 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, § 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.
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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Notices
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 ‘‘carbfree,’’ ‘‘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,
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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
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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 subanalyses, 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 multitopic 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.
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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Notices
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, ll% fewer calories,
ll% 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
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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
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48425
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
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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Notices
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, lowerfat 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 BURDEN1
Activity
No. of Respondents
Cognitive Interviews
Annual Frequency per
Response
Total Annual Responses
Hours per Response
9
1
9
150
1
150,000
10,000
Pretest
Screener
Experiment
Total Hours
0.5
5
150
0.17
26
1
150,000
0.01
1,500
1
10,000
0.12
1,200
Total
1There
2,731
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
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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
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005C–0302, 2005C–0303, and
2005C–0304]
CIBA Vision Corp.; Filing of Color
Additive Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that CIBA Vision Corp. has filed three
petitions proposing that the color
additive regulations be amended to
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]]>Agencies
[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Notices]
[Pages 48423-48426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16242]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual
Activity Respondents Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive Interviews 9 1 9 0.5 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 150 1 150 0.17 26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener 150,000 1 150,000 0.01 1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experiment 10,000 1 10,000 0.12 1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ............... ..................... ..................... ........................... 2,731
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
