[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Page 18032-18034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 
    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 
    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 
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                         No. of        Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
Cognitive                          9                  1                  9               0.5                   5

[[Page 18034]]

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

    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 
    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]