[Federal Register: April 20, 2005 (Volume 70, Number 75)]
[Notices]
[Page 20568-20570]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap05-66]
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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