[Federal Register Volume 71, Number 98 (Monday, May 22, 2006)]
[Notices]
[Pages 29340-29342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7692]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0097]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study of 
Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids, 
Monounsaturated Fatty Acids From Olive Oil, and Green Tea

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 (the PRA).

DATES: Fax written comments on the collection of information by June 
21, 2006.

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: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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 Qualified Health Claims: Consumer Inferences 
About Omega-3 Fatty Acids, Monounsaturated Fatty Acids From Olive Oil, 
and Green Tea

    FDA regulates health claims in the labeling of food products under 
the Nutrition Labeling and Education Act of 1990 (NLEA). NLEA 
regulations establish general requirements for health claims in food 
labeling. A manufacturer is required to provide a description of the 
scientific evidence supporting a proposed health claim to FDA for 
review before the claim may appear in labeling (Sec. Sec.  101.14(c) 
and (d),

[[Page 29341]]

101.70 (21 CFR 101.14(c) and (d), 101.70)). If FDA determines that 
there is significant scientific agreement among experts that the 
proposed health claim is supported by the totality of publicly 
available evidence, FDA issues a regulation authorizing the claim. 
Health claims must be ``complete, truthful, and not misleading'' 
(Sec. 101.14(d)(2)(iii)) and must ``enable the public to comprehend the 
information provided and to understand the relative significance of 
such information in the context of a total daily diet'' (Sec.  101.14 
(d)(2)(v)).
    In 2003, an FDA Task Force on Consumer Health Information for 
Better Nutrition issued a report that provided guidance on an interim 
review process for health claims that do not meet the significant 
scientific agreement (SSA) standard for the issuance of a regulation 
authorizing the claim. These claims, referred to as ``qualified health 
claims,'' are evaluated according to an interim evidence-based ranking 
system for scientific data and include a disclaimer or other qualifying 
language to distinguish them from claims that meet the SSA standard. 
The report also identified the need for consumer research to examine 
ways to communicate the level of scientific support associated with 
qualified health claims.
    In the fall of 2004, FDA issued letters of enforcement discretion 
for two qualified health claims about the relationship between risk of 
coronary heart disease and consumption of monounsaturated fatty acids 
from olive oil and omega-3 fatty acids, respectively. The qualified 
health claims appear below:
    1. Limited and not conclusive scientific evidence suggests that 
eating about 2 tablespoons (23 grams) of olive oil daily may reduce the 
risk of coronary heart disease due to the monounsaturated fat in olive 
oil. To achieve this possible benefit, olive oil is to replace a 
similar amount of saturated fat and not increase the total number of 
calories you eat in a day. One serving of this product [Name of food] 
contains [x] grams of olive oil.
    2. Supportive but not conclusive research shows that consumption of 
EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart 
disease. One serving of [name of food] provides [x] grams of EPA and 
DHA omega-3 fatty acids. [See nutrition information for total fat, 
saturated fat and cholesterol content.]
    In June 2005, FDA issued a letter of enforcement discretion for two 
qualified health claims about the relationship between risk of breast 
and prostate cancers and consumption of green tea. The qualified claims 
appear below:
    1. Two studies do not show that drinking green tea reduces the risk 
of breast cancer in women, but one weaker, more limited study suggests 
that drinking green tea may reduce this risk. Based on these studies, 
FDA concludes that it is highly unlikely that green tea reduces the 
risk of breast cancer.
    2. One weak and limited study does not show that drinking green tea 
reduces the risk of prostate cancer, but another weak and limited study 
suggests that drinking green tea may reduce this risk. Based on the 
studies, FDA concludes that it is highly unlikely that green tea 
reduces the risk of prostate cancer.
    In November 2005, FDA released the results of a prior study of 
qualified health claims to assess the effectiveness of claim language 
and grading schemes for conveying the level of scientific evidence 
supporting the claim. The study showed that report card schemes helped 
consumers distinguish between various levels of scientific support. 
However, the report card scheme inadvertently conveyed other nutrient 
and product attributes to consumers. In particular, report card schemes 
resulted in ``halo effects'' and other misperceptions concerning the 
general healthfulness and quality of the product. In addition, the 
study showed that consumers attributed higher levels of scientific 
support to certain qualified health claims bearing a grade of ``B'' 
than to non-graded claims that meet FDA's standard of ``SSA''. Thus, 
the study proposed here will further explore the report card grading 
scheme by modifying it in two ways. First, the study will test the 
ability of grade disclaimers to correct for some of the misperceptions 
created by report card schemes observed in the earlier study. Second, 
the study will include SSA claims as ``A'' grade claims within the 
report card grade scheme.
    The study proposed here is part of an ongoing effort by FDA to 
collect data concerning qualified health claims and their impact on 
consumer perceptions and behavior. Previous FDA studies have examined 
hypothetical qualified health claims to evaluate ways to communicate 
the strength of scientific evidence supporting a claim. This study will 
examine four qualified health claims and two SSA claims to evaluate 
whether consumers comprehend the information in the claim and whether 
consumers understand the relative significance of the information in 
the context of a total diet. In addition, the study will broaden FDA's 
understanding about how consumers interpret qualified health claims, 
particularly as they pertain to the level of scientific evidence 
conveyed by the message and to any differences there may be between 
qualified health claims on dietary supplements versus foods.
    The experimental study data will be collected using participants of 
an Internet panel. Participation in the experimental study is 
voluntary.
    In the Federal Register of March 30, 2005 (70 FR 16291), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. At that time, the experimental study was titled 
``Experimental Study of Qualified Health Claims: Consumer Inferences 
about Omega-3 Fatty Acids and Monounsaturated Fatty Acids from Olive 
Oil.'' Previously, it did not include the two qualified health claims 
for green tea or the two SSA health claims, and the study also did not 
include further exploration of the report card grading scheme for 
health claims. The study is now renamed to indicate the inclusion of 
the green tea claims. Burden estimates have also been adjusted to 
account for the increase in respondents necessary to make these changes 
in the study.
    FDA received four letters in response to the notice, each 
containing one or more comments. One of the letters and portions of 
another letter contained comments that were not responsive to the four 
PRA questions for which comments were requested. One of these comments 
was about the presence of monounsaturated fatty acids in oils other 
than olive oil, while the others raised legal issues outside the scope 
of the PRA. These comments will not be addressed in this document, 
which is intended to summarize and respond to comments about PRA 
issues. The comments that addressed the four PRA questions and our 
responses follow.
    One comment expressed concern that the proposed collection of 
information is unnecessary for the proper performance of the agency's 
functions and that the information will have no practical utility. The 
comment asserted that the information to be collected will be 
inadequate for the agency to assess whether consumer confusion will 
arise from the claims.
    FDA disagrees. The study is part of an ongoing effort by FDA to 
collect data concerning the communications effects of qualified health 
claims on consumer perceptions and judgments. The purpose of the study 
is to assess how some claim language compares to other claim language 
in conveying information to consumers. The study

[[Page 29342]]

uses an experimental design to assess consumer reactions to health 
claim language intended to convey both the potential health benefits 
and the level of scientific support for the health claim.
    The comment also suggested that the information will not be useful 
if it is the agency's intent to alter or restrict the wording of 
qualified health claims because, according to the comment, consumers 
have the right to receive truthful information, regardless of whether 
they understand that information.
    FDA disagrees. The agency has a responsibility to ensure that 
disclaimers and other qualifying language intended to prevent consumer 
deception are effective in serving that purpose. The study is designed 
to evaluate whether certain variants of the qualified health claims are 
more effective than others at conveying to consumers the potential 
health benefits and the level of scientific support for the health 
claim. FDA expects this study to be useful in determining language that 
effectively conveys this information to consumers.
    The comment suggested that there might be ways to improve the 
quality or utility of the information collection, yet did not offer 
specific recommendations to modify the study and analysis. In 
particular, the comment expressed concern that an Internet survey 
cannot be used to measure consumer confusion.
    FDA responds that the experimental study that is the basis of this 
information collection request is an Internet-based experiment, not an 
Internet survey. The experimental study is intended to assess the 
communication effects, in a large sample of study participants, of both 
existing health claim language that appears on dietary supplements and 
conventional food products and variants of such language. The study is 
not intended to measure consumer confusion per se.
    One comment recommended that, to help maximize the quality, utility 
and accuracy of the data to be collected in the study, FDA should test 
the qualified claim language exactly as stated in the Federal Register 
notice published March 30, 2005.
    FDA agrees. The experimental study will test the qualified claim 
language exactly as it appears in the notice, in addition to variants 
of the claim language.
    A comment urged FDA to takes steps to ensure that using electronic 
data collection is reliable and verifiable for the study.
    FDA is confident that the methodology is reliable and verifiable 
for this type of study. FDA will closely monitor the contractor that 
implements the experiment to ensure the validity and accuracy of the 
collected data.
    Another comment supported FDA's efforts to understand consumer 
responses to food and dietary supplement labels, but expressed concern 
that FDA has not supplied sufficient information to evaluate whether 
the estimated burden of the proposed collection is accurate.
    FDA believes that the estimate of burden is accurate because the 
estimate is based on past experience with Internet panel experiments 
similar in complexity and duration to the one proposed here. The study 
protocol will be available for public viewing when this 30-day notice 
is published. FDA has followed the procedures for public notice and 
comment about this information collection set out in the PRA (44 U.S.C. 
3501-3520) and OMB regulations (5 CFR part 1320).

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                     Annual Frequency per
 No. of Respondents        Response          Total Annual Responses    Hours per Response        Total Hours
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30 (pre-test)                           1                         30                   .16                     5
7,440 (experiment)                      1                      7,440                   .16                 1,191
TOTAL                ....................  .........................  ....................                 1,196
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7692 Filed 5-19-06; 8:45 am]
BILLING CODE 4160-01-S