[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Notices]
[Page 18032-18034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0120]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a consumer experimental study of
carbohydrate content claims on food labels.
DATES: Submit written or electronic comments on the collection of
information by June 7, 2005.
ADDRESSES: Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Submit written comments on the collection of information to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 18033]]
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 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.
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 three
products: (1) A loaf of bread, (2) a can of soda, and (3) a frozen
entr[eacute]e. 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 entr[eacute]e).
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 entr[eacute]e, 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
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Cognitive 9 1 9 0.5 5
interviews
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[[Page 18034]]
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: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7026 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S