[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20568-20570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0486]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by May 20, 
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 written 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 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 raised in the ANPRM related to 
whether the wording of a health claim needs to refer to the substance 
(a component of food, e.g., a 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, in other 
words, an FDA- authorized claim.) For instance, in the example of the 
calcium-osteoporosis claim (``Calcium may reduce the risk of 
osteoporosis''), FDA currently requires that the substance that is the 
basis of the claim (in this case, calcium) be included in the wording 
of the claim (21 CFR 101.72). The requirement that the substance in a 
health claim be included in the wording of the claim was motivated by 
FDA's experience that most substances that are the subject of an 
authorized health claim are, like calcium, substances that can be found 
in a number of foods. Therefore, FDA requires that health claims refer 
to the common substance to assist consumers in their understanding of 
the nature of the diet-health relationship and, more importantly, to 
help 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 such statements (e.g., 
``Calcium-rich foods, such as yogurt, may reduce the risk of 
osteoporosis'') versus ``food-specific'' claims that do not specify the 
food component (e.g., ``Yogurt may reduce the risk of osteoporosis''). 
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.
    The purpose of the proposed collection of information is to enhance 
FDA's understanding of consumer responses to health claims and inform 
any policy initiative(s) that FDA may undertake in the future. The 
information will be used to assess what differences, if any, the 
inclusion of the food component in a health claim makes in the 
following areas: (1) Consumer recognition of the food component 
underlying a diet-disease relationship; (2) 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 (3) consumer 
perceptions of, and attitudes toward, the food.
    The proposed collection of information is a controlled randomized 
experimental study. The study will use a 6 x 3 within-subjects design 
(6 front-panel health claims/health messages x 3 diet-disease 
relationships), with participants randomly assigned to experimental 
conditions. 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 term ``health message'' refers to nutrient content claims, 
structure/function claims, and dietary guidance statements. Prior 
knowledge of foods, components of food (e.g., nutrients), and risks 
will be measured; such 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 201(n) and 403(a)(1) of the act (21 U.S.C. 321(n) and 
343(a)(1)).
    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

[[Page 20569]]

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 or impending 
change in regulatory actions regarding these messages.
    The study proposes to include three examples of diet-disease 
relationships: (1) Yogurt-calcium-osteoporosis, (2) orange juice-
potassium-hypertension, and (3) bread-``lysoton''-diabetes. Lysoton is 
a fictitious substance; this fictitious relationship is included for 
test purposes only. The study includes these particular relationships 
solely for the purpose of covering varying levels of consumer 
familiarity with the foods, nutrients, and risks and to enhance the 
usefulness of the study findings. We emphasize that the choice to use 
these particular diet-disease relationships in this study does not in 
any way suggest or imply any new or impending change in regulatory 
actions regarding the use of these health claims/health messages or the 
scientific basis of these relationships.
    The planned universe of this experimental study is members of an 
Internet consumer panel, all of them are adults (18 years or older). 
The study will use a two-phase data collection methodology. Phase 1 is 
an Internet interview to ask about prior knowledge. Phase 2 is another 
Internet interview of the same individuals to elicit responses to 
experimental conditions. The two interviews will be administered at 
least a week apart. 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.
    Target sample size of the study is 1,060 participants who complete 
both interviews. Participants will be randomly assigned to the same 2 
of the 18 experimental conditions in both interviews. 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 
interview. 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:
    1. Responses to the experimental conditions such as perceived 
health benefits, substances related to the benefits, other food sources 
that may offer the same benefits;
    2. Prior knowledge of diet-disease relationships;
    3. Food purchase and consumption experience;
    4. Interest in food and food purchase decisions;
    5. Use of dietary supplements, special diets, and health status; 
and
    6. Demographic characteristics.
    In the Federal Register of December 10, 2004 (69 FR 71819), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received two comments, both from the food 
industry.
    One comment supported consumer research to enhance health message 
communication as a means to help consumers make sound dietary 
decisions. The comment suggested that to improve the quality of the 
study and analysis the agency should lay out the objective(s) and 
analysis plan of the study, consider asking about how helpful a health 
message is in helping consumers make food choices, consider asking 
respondents to read the health message on the stimulus, and consider 
increasing the sample size.
    The agency agrees that objective, analysis plan, and pertinent 
measures are essential for ensuring the quality of the study. As 
suggested in the 60-day notice, the study is designed primarily to help 
understand how well food-specific health claims communicate information 
compared to nutrient-specific health claims, and secondarily to help 
understand how well health messages that include the nutrient 
communicate information compared to other health messages that do not 
include the nutrient. The agency has developed preliminary dependent 
measures and decision rules for analysis. In addition, the agency has 
added questions on the helpfulness of the messages and used a technique 
to ensure that participants have noticed the health message on the 
stimulus.
    The agency is not persuaded that the sample size needs to be 
increased. The agency has carefully considered the sample size required 
for the study and consulted the relevant research. The agency has 
determined that the planned sample size, 1,060 in total and 
approximately 360 per health claim condition (120 per diet-disease 
relationship x 3 diet-disease relationships), is sufficient to detect 
meaningful main effects of repeated-measures binary responses, such as 
whether the responsible nutrient is recognized, and to detect 
interaction effects between diet-disease relationships and health 
message conditions.
    The other comment also recognizes the importance of consumer 
research. It asserts, however, that the proposed study should be 
abandoned for two reasons. First, by testing generic and hypothetical 
products, brands, and marketing contexts, the agency is misconstruing 
its legal authority under the applicable First Amendment standards 
(i.e., the comment states that FDA needs to justify regulatory 
restrictions on the expression of any particular health claim by 
demonstrating alleged harms and showing that the restrictions would 
alleviate the harm). The comment asserts that, under such requirements, 
FDA's obligations are case-specific, i.e., targeted at a particular 
marketer with respect to a particular health claim expression. Second, 
the comment states that the impression consumers take away from a 
particular health claim cannot be evaluated in a scientifically valid 
or reliable manner through academic research that attempts to isolate 
the meaning of health claims from its context. The comment further 
asserts that even if valid findings are possible, they would have no 
validity or meaning under real world conditions. Hence, the comment 
argues that claims need to be tested on real product labels and in a 
real purchasing context.
    FDA disagrees with this comment. The agency notes that the research 
approach mentioned in the comment, testing specific claims on specific 
products in specific contexts, would be appropriate if the agency's 
only mission were to protect consumers from harms caused by deceptive 
product labeling, and if the objective of the study were to

[[Page 20570]]

gather evidence on whether a labeling statement on a specific product 
marketed in a specific context could produce the alleged harm and the 
harm is material.
    In addition to protecting consumer health from harms caused by 
deceptive product labeling, however, the agency's mission also calls 
for advancing consumer health by providing information about food 
products to help consumers improve their health and decrease the risk 
of contracting diseases by making sound dietary choices. The study was 
proposed with this mission in mind and, therefore, neither intends, nor 
is designed to demonstrate any harm attributable to any specific health 
messages on any specific products. As stated in the 60-day notice, the 
study will hold back-panel information (e.g., nutrient contents) 
constant between front-panel conditions for a given food product. 
Furthermore, the nutrient contents of test products will meet current 
regulatory standards for various health messages. Therefore, by design, 
the study approach precludes any attempt to examine any potential harm 
as purported in the comment. Instead, the study approach is commonly 
used and accepted by researchers for the purpose of investigating 
communication efficacy of label stimuli.
    Health messages such as health claims are intended for use by all 
qualifying marketers and in all qualifying products, rather than 
certain specific marketers or products. Hence, under the agency's 
regulatory regime, the study does not intend to examine specific claims 
on specific products in specific contexts, as individual marketers 
would do. Rather, the study will attempt to illustrate possible 
consumer responses to different types of health messages that may be 
found on packages of various food products. Finally, the agency notes 
that, despite the discordance between experimental contexts and the 
real world, experimental findings are widely recognized and accepted as 
the best available evidence to demonstrate communication efficacy.
    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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Pretest                           60                  1                 60               0.5                  30
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Invitation                     2,000                  1              2,000               0.02                 40
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Interview, Phase               1,060                  1              1,060               0.17                180
 1
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Interview, Phase               1,060                  1              1,060               0.25                265
 2
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Total                                                                                                        515
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Prior to the administration of the interview, the agency plans to 
conduct pretests of the final questionnaires to minimize potential 
problems in administration of the interviews. The pretests, each 
lasting 30 minutes (0.5 hours), will be conducted in up to 3 waves, 
each with 20 participants. A contractor will send 2,000 e-mail 
invitations to recruit participants. We assume 50 percent of those 
contacted will agree to participate in the interviews (1,060 
respondents). The interviews are expected to last 10 minutes (0.17 
hours) and 15 minutes (0.25 hours) for phase 1 and phase 2, 
respectively.
    The planned sample size per condition is approximately 120. The 
agency expects small main effects. Therefore, the planned sample size 
should yield a power of 0.8 at the 0.05 significance level.

    Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7822 Filed 4-19-05; 8:45 am]
BILLING CODE 4160-01-S