Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Health Claims on Food Packages, 20568-20570 [05-7822]
Download as PDF
<![CDATA[
20568
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
VIII. Other Information
This and other CDC funding
opportunity announcements can be
found on the CDC Web site, Internet
address: https://www.cdc.gov. Click on
‘‘Funding’’ then ‘‘Grants and
Cooperative Agreements.’’
Dated: April 14, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–7888 Filed 4–19–05; 8:45 am]
BILLING CODE 4163–18–P
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.
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
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
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,
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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 frontpanel 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 dietdisease 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 dietdisease 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
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
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
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
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 foodspecific health claims communicate
information compared to nutrientspecific 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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
20569
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 repeatedmeasures 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
E:\FR\FM\20APN1.SGM
20APN1
20570
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
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 BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Pretest
Total Annual
Responses
Hours per
Response
60
1
60
Invitation
2,000
1
Interview, Phase 1
1,060
Interview, Phase 2
1,060
0.5
30
2,000
0.02
40
1
1,060
0.17
180
1
1,060
0.25
265
Total
1 There
Total Hours
515
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
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0470]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
For Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
DATES: Fax written comments on the
collection of information by May 20,
2005.
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
ADDRESSES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, rm.
4B–41, Rockville, MD 20857, 301–827–
1472.
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.
New Animal Drugs for Investigational
Use—21 CFR Part 511 (OMB Control
Number 0910–0117)—Extension
FDA has the responsibility under the
Federal Food, Drug, and Cosmetic Act
(the act), for approval of new animal
drugs. Section 512(j) of the act (21
U.S.C. 360b(j)), authorizes FDA to issue
regulations relating to the
investigational use of new animal drugs.
The regulations setting forth the
conditions for investigational use of
new animal drugs have been codified at
part 511 (21 CFR part 511). A sponsor
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20568-20570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7822]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Pretest 60 1 60 0.5 30
----------------------------------------------------------------------------------------------------------------
Invitation 2,000 1 2,000 0.02 40
----------------------------------------------------------------------------------------------------------------
Interview, Phase 1,060 1 1,060 0.17 180
1
----------------------------------------------------------------------------------------------------------------
Interview, Phase 1,060 1 1,060 0.25 265
2
----------------------------------------------------------------------------------------------------------------
Total 515
----------------------------------------------------------------------------------------------------------------
\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
