[Federal Register: December 10, 2004 (Volume 69, Number 237)]
[Notices]               
[Page 71819-71821]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de04-74]                         


[[Page 71819]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0486]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Health Claims on Food Packages

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 an experimental study to assess consumer 
responses to health claims on labels of conventional foods. Although 
the focus of the study is on consumer responses to health claims, the 
study also looks at their responses to other health messages to help 
enhance the external validity of the findings.

DATES: Submit written or electronic comments on the collection of 
information by February 8, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
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 Health Claims on Food Packages

    The authority for FDA to collect the information derives from the 
FDA Commissioner's 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)).
    To help consumers reduce their risk of disease and improve their 
health by making sound dietary decisions, in the Federal Register of 
November 25, 2003 (68 FR 66040), FDA issued an advance notice of 
proposed rulemaking (ANPRM) to request comments on various issues 
related to health claims on conventional food and dietary supplement 
labels. One of the issues that FDA has raised in the ANPRM relates to 
whether the wording of a health claim needs to refer to the substance 
(a component of food, e.g., nutrient) that is the basis of the claim. 
(Hereinafter, the term ``health claim'' will refer only to a claim 
meeting the standard of significant scientific agreement or, put 
another way, an FDA- authorized claim.) For instance, in the example of 
the calcium-osteoporosis claim (``Calcium may reduce the risk of 
osteoporosis''), FDA requires that the substance that is the basis of 
the claim (i.e., calcium) be included in the wording of the claim (21 
CFR 101.72). The requirement of including the substance in a health 
claim was motivated by FDA's experience that most substances that are 
the subject of an authorized health claim are substances that can be 
found in a number of foods (e.g., calcium) or spread throughout the 
food supply (e.g., saturated fat). Therefore, FDA has provided for 
health claims that include reference to the common substance to assist 
consumers in their understanding of the nature of the diet-health 
relationship, and more importantly so that consumers recognize that 
they can construct healthy diets by using a variety of foods that 
contain the substance.
    FDA requests comments on the usefulness of statements that 
expressly include the particular component of food (e.g., nutrient) 
that is the basis for the claim (e.g., ``Calcium-rich foods, such as 
yogurt, may reduce the risk of osteoporosis'') versus ``food-specific'' 
claims that do not include the food component (e.g., ``Yogurt may 
reduce the risk of osteoporosis'' (68 FR 66040 at 66047). How consumers 
respond to the two kinds of statements can suggest how the explicit 
mention of a food component in a claim affects dietary choices, which 
in turn informs any policy initiative(s) that FDA may undertake in the 
future to provide information to consumers to help them make informed 
food choices. FDA, however, lacks sufficient empirical evidence to 
understand how consumers are likely to react to the two different kinds 
of health claims, has not received any such evidence in comments on the 
ANPRM, and is not aware of any existent evidence.
    The purpose of the proposed collection of information is to help 
enhance FDA's understanding of consumer responses to health claims and 
inform any policy initiative(s) that FDA may undertake in the future to 
provide consumers information to help them make informed food choices. 
The information will be used to assess what differences, if any, the 
inclusion of the food component in a health claim makes in consumer 
recognition of the food component underlying a diet-disease 
relationship; consumer recognition that, in addition to the food 
product that carries the claim, there are other foods from which they 
can obtain the food component; and consumer perceptions of, and 
attitudes toward, a food.
    The proposed collection of information is a controlled randomized 
experimental study. The study will use a 6 x 3 x 2 within-subjects 
design (6 front-panel health-claims/health messages x 3 diet-disease 
relationships x 2 prior knowledge) with participants randomly assigned 
to experimental conditions. The term ``health message'' refers to 
nutrient content claims,

[[Page 71820]]

structure/function claims, and dietary guidance statements. Prior 
knowledge of foods, components of food (e.g., nutrients), and risks 
will be measured and not manipulated; prior knowledge will serve as 
covariates in the analysis. There are two independent variables, type 
of front-panel health-claim/health message and type of diet-disease 
relationship. Health-claim/health-message conditions include the 
following items:
    1. A ``food-specific'' health claim, e.g., ``Yogurt may reduce the 
risk of osteoporosis;''
    2. A ``nutrient-specific'' health claim, e.g., ``Calcium-rich 
foods, such as yogurt, may reduce the risk of osteoporosis;''
    3. A nutrient content claim, e.g., ``A good source of calcium;''
    4. A structure/function claim, e.g., ``Helps promote bone health;''
    5. A dietary guidance statement, e.g., ``Dairy products may reduce 
the risk of osteoporosis;'' and
    6. No health claim/health message.
Claims on food labels must be truthful and nonmisleading as required 
under sections 403(a)(1) and 201(n) of the act.
    Health messages other than the two health claims are included 
solely for methodological purposes. The ``no health claim/health 
message'' condition is included to examine what consumers already know 
about nutrients or food sources, even when neither of them is mentioned 
on a label. Health messages are frequently found on food product 
packages and provide consumers various amounts of information about 
food products and their relationships to health. Whether consumer 
responses to these health messages are consistent with their responses 
to the two health claims will help generalize the findings. An 
examination of response differences between health messages that 
mention (e.g., a nutrient content claim) or do not mention (e.g., a 
structure/function claim) a nutrient or food source, and between these 
health messages and the two health claims in question can help validate 
any effects observed between the two health claims. This validation 
will in turn enhance the external validity of the findings between the 
``food-specific'' and ``nutrient-specific'' health claims. We 
emphasize, however, that the inclusion of examples of structure/
function claims, nutrient content claims, and dietary guidance 
statements does not in any way suggest or imply any new, impending, or 
change in regulatory actions regarding these messages.
    The study proposes to include the following three examples of diet-
disease relationships: (1) Yogurt-calcium-osteoporosis, (2) orange 
juice-potassium-hypertension, and (3) olive oil-monounsaturated fatty 
acid-heart disease. The study includes these three relationships solely 
for the purpose of covering varying levels of consumer familiarity with 
the foods, nutrients, and risks, so the study findings may be more 
useful than if only one diet-disease relationship were examined. We 
reiterate that the choices do not in any way suggest or imply any new, 
impending, or change in regulatory actions regarding the use of these 
health claims/health messages or the scientific basis of these 
relationships. In total, the study will examine 18 experimental 
conditions (6 front-panel health-claim/health message conditions x 3 
diet-disease relationships), each condition is a combination of a 
front-panel condition and a diet-disease relationship.
    The planned universe of this experimental study is 
noninstitutionalized adults 18 and older who reside in households with 
telephones in the contiguous United States and within a 10-mile radius 
of each of six selected mall interview facilities in various locations. 
The study will use a two-phase data collection methodology. Phase 1 is 
a random-digit dialing telephone interview, using the GENESYS sampling 
system, to recruit participants and to ask about prior knowledge as 
well as demographic characteristics. Phase 2 is a computer-assisted, 
self-administered interview (CASAI) to elicit responses to experimental 
conditions. A contractor will administer the CASAI at mall interview 
facilities separately from the telephone interview and on a different 
date after the telephone interview of the same participants. An 
understanding of the influences of prior knowledge on consumer 
responses will help reveal factors associated with differential 
responses and extend the usefulness of the findings to similar messages 
about other diet-disease relationships. It is necessary to collect 
prior knowledge information before and separately from collecting 
responses to health claims and health messages to minimize demand and 
confounding effects between prior knowledge and message responses. 
Hence, the study proposes to obtain prior knowledge in the telephone 
interview. To minimize unnecessary confounding by external factors, it 
is essential that all participants are able to look at the stimuli 
(i.e., labels) and stimuli are presented consistently and uniformly to 
all participants. The CASAI offers the advantage of consistent and 
uniform presentation of label images.
    Target sample size of the study is 1,060 participants who complete 
both the telephone interview and the CASAI. Participants will be 
randomly assigned to the same 2 of the 18 experimental conditions in 
both the telephone interview and the CASAI. Each of the two conditions 
includes a different diet-disease relationship and a different front-
panel condition. Presentation order of the conditions will be counter-
balanced within the sample. All front panels will be full-color and 
patterned after existing labels in the market. Both the front and back 
panels of a label will be available during the CASAI. Back panel 
information (e.g., nutrient contents) will be kept constant between 
front-panel conditions for a given food product.
    The following key information is to be collected:
     Responses to the experimental conditions such as perceived 
health benefits, substances related to the benefits, other food sources 
that may offer the same benefits;
     Prior knowledge of diet-disease relationships;
     Food purchase and consumption experience;

     Interest in food and food purchase decisions;
     Use of dietary supplements, special diets, and health 
status; and
     Demographic characteristics.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                Annual
         Activity              No. of        Frequency per    Total Annual   Hours  per Response    Total Hours
                             Respondents       Response         Responses
----------------------------------------------------------------------------------------------------------------
Pretest                                27                 1              27               2.4                 65
----------------------------------------------------------------------------------------------------------------

[[Page 71821]]


Screener                            4,500                 1           4,500               0.02                90
----------------------------------------------------------------------------------------------------------------
Interview                           1,060                 1           1,060               2.4              2,544
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      2,699
----------------------------------------------------------------------------------------------------------------
\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. Prior to the administration of the experiment, the 
agency plans to conduct a pretest of the final questionnaires to 
minimize potential problems in administration of the interviews. The 
pretest will be conducted in up to three waves, each with nine 
participants. The agency will use a screener to select an eligible 
adult in each household to participate in the study. Each pretest, as 
well as actual interview, is expected to last no more than a total of 
2.4 hours (10 minutes for the telephone interview, 15 minutes for the 
CASAI, and 2 hours for traveling time to and from the CASAI location).
    The anticipated sample size per condition is approximately 120. 
This sample size is expected to identify small to medium effects with a 
power of 0.8 and at the .05 significance level.

    Dated: December 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-27119 Filed 12-9-04; 8:45 am]

BILLING CODE 4160-01-S