[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Notices]
[Page 63802-63804]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no03-47]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0509]
Agency Emergency Processing Under Office of Management and Budget
Review; Experimental Study of Health Claim Disclaimers on Foods
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 emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information is an experimental study of health claims on food product
labels to evaluate the communication effectiveness of various possible
labeling statements (i.e., disclaimers) to convey differing levels of
scientific support for health claims. The study examines the
communication effectiveness of disclaimers in realistic label use
situations for a range of health claims and associated food products
that may bear such health claims.
DATES: Fax written comments on the collection of information by
December 10, 2003. FDA is requesting approval of this emergency
processing by December 10, 2003.
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 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: FDA is requesting emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The information is critical
to the agency's mission of regulating food labeling. Currently FDA is
operating under interim procedures for reviewing qualified health
claims on conventional foods and dietary supplements (``Guidance for
Industry and FDA: Interim Procedures for Qualified Health Claims in the
Labeling of Conventional Human Food and Human Dietary Supplements,''
that published in the Federal Register of July 10, 2003 (68 FR 41387-
41390)). This interim approach was necessitated by various developments
since the passage of the Nutrition Labeling and Education Act (NLEA),
including successful legal challenges based on the First Amendment. The
interim procedures provide guidance to industry regarding how the
agency will respond to qualified health claims until the agency can
promulgate notice-and-comment rulemaking. However, guidance documents
do not establish legally enforceable responsibilities and are intended
only as recommendations.
The interim procedures strain the agency's limited resources for
reviewing qualified health claims. Qualified health claims greatly
increase the number of potential health claims and as a result the
agency anticipates a far greater number of health claim petitions. The
agency included criteria for prioritizing petitions in order to
maximize the public health benefit of its interim qualified health
claim procedure, which will necessitate delays for some petitions. The
interim guidance also creates uncertainty for industry, since qualified
health claims are permitted through a letter of enforcement discretion,
and are not authorized through a regulation. This is likely to inhibit
some companies from submitting petitions during the interim period. FDA
prefers that this interim period be as short as possible.
Consumer data are important to the development of new regulations
for health claims. A central consideration in the development of a new
regulatory framework for qualified health claims is the importance of
ensuring that such claims can be made in a way that is not misleading
to consumers. The agency recognizes that it is unknown whether
consumers can distinguish between differing levels of scientific
support and there are no consumer data currently available to assess
the effectiveness of wording options proposed for conveying the
different levels. The interim guidance relies on limited prior
experience under a temporary policy of enforcement discretion, using ad
hoc health claim disclaimers.
Given the uncertainties and constraints inherent with interim
guidance and the absence of relevant consumer data to address questions
raised by the new approaches to health
[[Page 63803]]
claims under consideration, we are seeking emergency approval of the
proposed study in order to provide needed consumer data in time to
assist the agency in developing new regulations for qualified health
claims.
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 Claim Disclaimers on Foods
FDA is requesting OMB approval of an experimental study of health
claims and disclaimers on food labels to help the Center for Food
Safety and Applied Nutrition formulate decisions and policies affecting
labeling requirements for qualified health claims. Several possible
approaches to implementing this qualified health claim scheme that
differ in terms of the specific language and form of disclaimers used
to convey level of scientific certainty are evaluated in terms of the
ability of the proposed approach to accurately convey the actual level
of scientific uncertainty for the stated claim.
The recent report of the FDA Task Force (Consumer Health
Information for Better Nutrition Initiative Task Force Final Report,
July 10, 2003) describes a four-level rating scheme for evaluating
petitioned claims (consisting of unqualified claims that meet the
standard of significant scientific agreement as defined by NLEA and
three levels of qualified claims supported by decreasing levels of
scientific evidence). The proposed consumer research is designed to
test approaches to conveying levels of scientific uncertainty through
the use of disclaimers that are linked to this four-level rating scheme
for petitioned health claims.
The proposed study is intended to evaluate the effectiveness of
several possible options for communicating the strength of scientific
evidence for a given health claim across a range of health claims of
varying scientific certainty. The evidence should provide empirical
support for possible policy decisions about the need for disclaimers to
minimize consumers' misunderstanding and misapplication of qualified
health claims and the optimal language and the form such disclaimers
should take. The impact of disclaimers is examined across a range of
measures that capture what is conveyed about the state of scientific
certainty for the claim as well as the impact of the qualified health
claim on attributions about the food product that displays the claim.
FDA will conduct an experimental study using shopping mall
intercept samples. The mall intercept methodology allows controlled
presentation of visual materials, experimental manipulation of study
materials, and the random assignment of participants to experimental
conditions. The experimental manipulation of label conditions and
random assignment to conditions allows for statistical estimates of the
effects of different approaches to conveying level of scientific
support and allows quantitative comparisons of the effectiveness of
different forms and wording options for health claim disclaimers.
Random assignment ensures that mean differences between conditions can
be tested using established techniques such as analysis of variance and
multiple regression analysis to yield statistically valid estimates of
effect size.
The study design is based on the controlled presentation of
realistic product labels that carry health claims for four nutrient/
disease health claims. The four health claims that are tested vary in
terms of the degree of scientific evidence underlying the health claim.
Label conditions consist of different forms and specific wordings for
disclaimers that accompany the nutrient/disease health claim as well as
various control conditions that assess how consumers view the product
and the scientific evidence in the absence of an explicit health claim
on the product label.
Participants will be recruited using standard mall intercept
methods, implemented in 6 geographically dispersed shopping malls.
Participants are adults, aged 18 and older who do half or more of the
grocery shopping for their household. Each site will have the same
number of replicates of the experimental design that include all
counterbalancing factors.
Four different schemes for communicating strength of science are
tested: Point-Counterpoint (claim, followed by disclaimer), Embedded
language (disclaimer first), Report Card (A-D letter ratings) and
Graphic (graphic device to illustrate the rating scheme). Each scheme
adopts the four-level strength of science ranking system described in
the Interim Guidance.
The study includes four control conditions, representing important
types of label statements and label users that constitute benchmarks
for assessing the direction and magnitude of effects due to
communications about the strength of scientific evidence for the health
claims: (1) ``Tombstone'' control with no nutrient content or health
claim, (2) nutrient content claim, but no health claim, (3) ``full
information control'' in which the participant is provided with a
summary of the scientific evidence for the claim prior to observing
food labels and (4) expert controls, based on separate information
gathered from nutrition experts knowledgeable about the diet-disease
relationship.
The key measures for this study are the perceived strength of
science for the claim that is conveyed by the label condition and
product perception questions about the labeled food product (expected
health benefits, perceived nutrition ratings) that identify the
practical impact of the product label.
FDA will use the information from this study to guide the
development of regulatory policy options related to qualified health
claims. The agency acknowledges the lack of empirical data about how
consumers understand and respond to statements they see in product
labeling. The information gathered in this study can be used by the
agency to assess likely consumer responses to various options for
qualifying health claims based on varied levels of scientific evidence.
FDA estimates the burden of this collection of information as
follows:
[[Page 63804]]
Table 1--Estimated Annual Reporting Burden\1\
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Annual Frequency
Number of [chyph]per Total Annual Hours per Total Hours
[chyph]Respondents Response [chyph]Responses [chyph]Response
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1,920 1 1,920 .30 576
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The approaches and wording options for qualified health claims of
central interest to the agency requires a complex experimental design.
To ensure adequate power to identify differences, the minimum cell size
is 60 participants. This will be sufficient to identify small to medium
effects (i.e., r =.15 to .30) for all main effects and first order
interactions with power = (1 - beta), well in excess of .80 at the .05
significance level.
Dated: November 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28196 Filed 11-7-03; 8:45 am]
BILLING CODE 4160-01-S