
[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Pages 57092-57094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0020]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study of 
Consumer Response to Health Claims and Disclaimers About the 
Relationship Between Selenium and Risk of Various Cancers

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 October 
17, 2012.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--New and 
title ``Experimental Study of Consumer Response to Health Claims and 
Disclaimers About the Relationship Between Selenium and Risk of Various 
Cancers.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

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 Consumer Response to Health Claims and 
Disclaimers About the Relationship Between Selenium and Risk of Various 
Cancers--(OMB Control Number 0910--New)

I. Background

    FDA regulates the labeling of food products under the Federal Food, 
Drug, and Cosmetic Act, as amended by the Nutrition Labeling and 
Education Act of 1990 (NLEA). NLEA regulations establish general 
requirements for voluntary health claims in food labeling; health 
claims are labeling statements that characterize the relationship 
between a food substance and a disease or health-related condition (21 
CFR 101.14(a)(1)). Under the petition process for new health claims (21 
CFR 101.70), the petitioner must submit the scientific evidence 
supporting a proposed health claim to FDA for review. If FDA determines 
that there is significant scientific agreement (SSA) among experts that 
the proposed health claim is supported by the totality of publicly 
available evidence, FDA issues a regulation authorizing the claim (21 
CFR 101.14(c) and (d)). Health claims must be ``complete, truthful, and 
not misleading'' (21 CFR 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'' (21 CFR 101.14(d)(2)(v)).
    In a court challenge to FDA's decision not to authorize four 
dietary supplement health claims that failed to meet the SSA standard, 
the U.S. Court of Appeals for the DC Circuit held that the First 
Amendment does not permit FDA to prohibit health claims that the Agency 
determines to be potentially misleading unless the Agency also 
reasonably determines that a disclaimer would not eliminate the 
potential deception (Pearson v. Shalala, 164 F.3d 650 (DC Cir. 1999)). 
Because the court also held that a health claim is not inherently 
misleading simply because the evidence supporting it does not reach the 
SSA level, the decision effectively requires FDA to permit health 
claims that are backed by credible scientific evidence unless the 
Agency can demonstrate that the claim would mislead consumers. In 
response to the court's decision, FDA issued guidance on an interim 
review process for health claims that do not meet the SSA standard for 
the issuance of a regulation authorizing the claim (Ref. 1). These 
claims, referred to as ``qualified health claims'' (QHCs), include a 
disclaimer or other qualifying language to distinguish them from claims 
that meet the SSA standard and to prevent consumers from being misled 
about the level of scientific evidence supporting the claim (Ref. 2). 
When FDA reviews a QHC petition and determines that the proposed claim 
is supported by credible evidence and that it can be qualified to 
prevent consumers from being misled, the Agency issues a letter stating 
its intent to exercise enforcement discretion for the use of the QHC in 
food labeling.
    In 2003, FDA issued a letter of enforcement discretion for two QHCs 
for dietary supplements containing selenium (Ref. 3):

    Claim 1: ``Selenium may reduce the risk of certain cancers. Some 
scientific evidence suggests that consumption of selenium may reduce 
the risk of certain forms of cancer. However, FDA has determined 
that this evidence is limited and not conclusive.''
    Claim 2: ``Selenium may produce anticarcinogenic effects in the 
body. Some scientific evidence suggests that consumption of selenium 
may produce anticarcinogenic effects in the body. However, FDA has 
determined that this evidence is limited and not conclusive.''

    In 2007, FDA published a notice in the Federal Register (72 FR 
72738; December 21, 2007) (the 2007 notice) announcing the Agency's 
intent to reevaluate these two QHCs, among other health claims. One of 
the other health claims being reevaluated is the authorized health 
claim for dietary fat and cancer risk in Sec.  101.73 (21 CFR 101.73). 
The model health claims in Sec.  101.73(e) use language similar to the 
``certain cancers'' language used in Claim 1 for selenium, as they 
state that low-fat diets may reduce the risk of ``some cancers'' or 
``some types of cancers.'' The 2007 notice explained that, during FDA's 
reevaluation of the scientific evidence underlying these claims, the 
Agency also planned to consider whether the claims should be revised to 
replace generic references to ``certain cancers'' (or similar language) 
with the names of specific cancers (e.g., prostate cancer, breast 
cancer) because each type of cancer is a separate disease with 
different causes and risk factors (72 FR at 72740).
    In 2008, FDA received a petition requesting enforcement discretion 
for two additional QHCs similar to the ones for which FDA had issued a 
letter of enforcement discretion in 2003. The basic claim in the first 
sentence of each proposed QHC was the same as the claim in the first 
sentence of the corresponding 2003 QHC (``selenium may reduce the risk 
of certain cancers'' and ``selenium may produce anticarcinogenic 
effects in the body,'' respectively), but the 2008 petition

[[Page 57093]]

requested enforcement discretion for the use of the following 
disclaimer with each claim: ``Scientific evidence supporting this claim 
is convincing but not yet conclusive.'' The 2008 petition also 
requested enforcement discretion for a number of other QHCs about 
selenium and reduced risk of specific cancers. In 2009, FDA issued a 
response to the 2008 petition in which the Agency stated its intent to 
exercise enforcement discretion for QHCs about selenium and reduced 
risk of prostate, thyroid, and bladder cancers (Ref. 4). The Agency 
declined to exercise enforcement discretion for QHCs about selenium and 
several other site-specific cancers because there was no credible 
evidence that selenium reduces the risk of those cancers. The Agency 
also declined to exercise enforcement discretion for the two QHCs that 
were similar to the 2003 ``certain cancers'' and ``anticarcinogenic 
effects'' QHCs because it concluded that the proposed claims were 
misleading and could not be cured with a disclaimer.
    Several of the petitioners filed suit in the U.S. District Court 
for the District of Columbia, challenging FDA's 2009 petition response 
under the First Amendment. On cross-motions for summary judgment, the 
court ruled for the plaintiffs on the ``certain cancers'' and 
``anticarcinogenic effects'' claims, as well as three of the site-
specific cancer claims (Alliance for Natural Health v. Sebelius, 714 F. 
Supp. 2d 48 (D.D.C. 2010)). With respect to the ``certain cancers'' and 
``anticarcinogenic effects'' QHCs, the court found that FDA had failed 
to show with empirical evidence that the claims were misleading and 
could not be corrected with disclaimers. The court also concluded that 
the Agency's scientific decisions regarding three QHCs for site-
specific cancers were not supported by the record and remanded the case 
to FDA for reconsideration of those claims, along with the ``certain 
cancers'' and ``anticarcinogenic effects'' QHCs. FDA and the plaintiffs 
then reached a settlement whereby FDA agreed to exercise enforcement 
discretion for QHCs for selenium and reduced risk of bladder, prostate, 
colon, rectal, and thyroid cancers (Ref. 5). In lieu of the ``certain 
cancers'' and ``anticarcinogenic effects'' QHCs, plaintiffs agreed to 
accept a QHC that listed all five site-specific cancers.

II. Purpose and Methodology of Proposed Study

    The objective of FDA's proposed study is to collect quantitative 
data to examine consumer interpretations of two dietary supplement 
labeling claims, ``selenium may reduce the risk of certain cancers'' 
and ``selenium may produce anticarcinogenic effects in the body,'' with 
and without various disclaimers. Previous studies conducted by FDA and 
others have examined consumer understanding of hypothetical QHCs and 
QHCs that are the subject of a letter of enforcement discretion. The 
primary goal of the previous studies was to evaluate ways to 
communicate the strength of scientific evidence supporting a claim 
(Refs. 6 to 9). None of these studies, however, has investigated 
whether labeling claims using phrases such as ``certain cancers'' and 
``anticarcinogenic effects'' may mislead consumers into having 
unjustified perceptions about the effects of a dietary supplement or 
food and how such misperceptions may affect behavioral intentions. The 
Agency therefore proposes to use selenium QHCs in this case study to 
examine consumer reactions to health claims using those phrases, with 
and without various disclaimers.
    Specifically, the study plans to examine: (1) Whether one or both 
of the selenium claims quoted in this document would lead consumers to 
have the impression that selenium reduces the risk of all forms of 
cancer (``cancer in general''); (2) whether one or both of these claims 
would lead consumers to have the impression that selenium reduces the 
risk of a cancer for which there is no credible evidence of risk 
reduction, and, if so, whether a disclaimer specifying the names of the 
cancers for which there is such evidence (bladder, prostate, colon, 
rectal, and thyroid cancers) can communicate to consumers that the 
claimed risk reduction effect is only for the named cancers; (3) 
whether the ``anticarcinogenic effects'' claim would lead consumers to 
believe that selenium not only reduces the risk of cancer, but also 
treats or completely prevents cancer; (4) whether various disclaimer 
options for the two claims would correct potential consumer 
misperceptions about the nature of the relationship between selenium 
and various cancers or the scope of the claims; and (5) whether either 
of the claims leads consumers to have other erroneous perceptions, such 
as that all cancers are alike.
    The proposed study will use a Web-based survey to collect 
information from approximately 1,200 adults, including 800 men who are 
55 years or older and 400 women who are 50 years or older, who belong 
to online consumer panels maintained by a contractor. Data provided by 
the nationally representative Health Information National Trends Survey 
(HINTS; Ref. 10) suggest that individuals in the age groups proposed 
for this study have a higher overall prevalence of cancer in general, 
and a higher prevalence of most of the specific cancers that are the 
subject of an existing QHC for selenium (see list in I. Background 
section), but do not systematically differ from individuals in other 
age groups with respect to their patterns of cancer-related 
perceptions. By targeting participants in this age range and with these 
characteristics, the study is expected to maximize efficient use of the 
limited resources allocated to the project by yielding a greater amount 
of information pertinent to people who are more likely to take a 
selenium supplement. To that end, the study will aim for increased 
representation of potential selenium users by targeting a sample that 
includes at least 400 participants who have taken a selenium supplement 
at least once. Because the rate of selenium use in the general 
population is estimated to be low overall, but somewhat higher among 
men than women (Refs. 11 and 12), the sample will consist of a greater 
proportion of men. In addition, the screening process for the online 
consumer panel will limit female participants to those who report being 
married, and women enrolled in the study will be asked to provide 
information about their spouses' use of selenium in addition to their 
own.
    On a computer screen, participants will view a label image and 
answer questions about their perceptions and behavioral intentions in 
response to the label they view. Each participant will be randomly 
assigned to an experimental condition in which he or she will view one 
of the following: (a) A selenium product label containing no claim; (b) 
a selenium product label containing the claim that ``selenium may 
reduce the risk of certain cancers''; (c) a selenium product label 
containing the claim that ``selenium may produce anticarcinogenic 
effects in the body''; (d) a selenium product label containing one of 
the claims from (b) or (c) plus a selected disclaimer statement. To 
help understand the data, the study will also collect information on 
each participant's background, including, but not limited to, health 
status, race/ethnicity, education, and income.
    The proposed study is part of FDA's continuing effort to enable 
consumers to make informed dietary choices and eat healthful diets. 
Results of this case study will be used to further the Agency's 
understanding of how consumers may interpret ``certain cancers'' and 
``anticarcinogenic effects,''

[[Page 57094]]

phrases that appear in a number of health claims that are authorized by 
regulation, as well as in some QHCs for which the Agency has issued a 
letter of enforcement discretion. Results of the study will not be used 
to develop population estimates.
    In the Federal Register of January 27, 2012 (77 FR 4329), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received one comment that dealt 
with topics outside the scope of the proposed collection of information 
described in the 60-day notice. Therefore, the comment is not addressed 
here.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    No. of
           Activity                 No. of       responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener..             350               1             350  0.083 (5                      29
                                                                                 minutes).
Cognitive interview...........               9               1               9  1 hour..........               9
Pretest invitation............           1,700               1           1,700  0.033 (2                      56
                                                                                 minutes).
Pretest.......................              60               1              60  0.167 (10                     10
                                                                                 minutes).
Survey invitation.............          45,000               1          45,000  0.033 (2                   1,485
                                                                                 minutes).
Survey........................           1,200               1           1,200  0.167 (10                    200
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,789
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This burden estimate is 94 hours lower than the estimate published 
in the 60-day notice and includes 23 more hours for the cognitive 
interview screener, 48 more hours for the pretest invitation, and 165 
fewer hours for the survey invitation. These estimates were adjusted to 
better reflect the anticipated effort required to recruit, conduct 
cognitive interviews, pretest, and survey participants with the desired 
characteristics. FDA's burden estimate is based on prior experience 
with research that is similar to this proposed study.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

    1. U.S. Food and Drug Administration, ``Guidance for Industry: 
Interim Procedures for Qualified Health Claims in the Labeling of 
Conventional Human Foods and Human Dietary Supplements,'' 2003, 
available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053832.htm.
    2. U.S. Food and Drug Administration, ``Guidance for Industry: 
Evidence-Based Review System for the Scientific Evaluation of Health 
Claims,'' 2009, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm073332.htm.
    3. U.S. Food and Drug Administration, ``Selenium and Certain 
Cancers (Qualified Health Claim: Final Decision Letter) (Docket No. 
02P-0457),'' 2003, available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072780.htm.
    4. U.S. Food and Drug Administration, ``Selenium and a Reduced 
Risk of Site-Specific Cancers (FDA-2008-Q-04323),'' 2009, available 
at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm168527.htm.
    5. U.S. Food and Drug Administration, ``Settlement Reached for 
Qualified Health Claims Relating Selenium to Reduced Risk of 
Prostate, Colon, Rectal, Bladder, and Thyroid Cancers,'' 2011, 
available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm256940.htm.
    6. Derby, B.M. and A.S. Levy, ``Effects of Strength of Science 
Disclaimers on the Communication Impacts of Health Claims,'' 2005, 
available at http://www.fda.gov/OHRMS/dockets/dockets/03N0496/03N-0496-rpt0001.pdf.
    7. Choini[egrave]re, C. and L. Verrill, ``Experimental Study of 
Qualified Health Claims: Consumer Inferences About Monounsaturated 
Fatty Acids From Olive Oil, EPA and DHA Omega-3 Fatty Acids, and 
Green Tea,'' 2009, available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm207549.htm.
    8. Hooker, N.H. and R. Teratanavat, ``Dissecting Qualified 
Health Claims: Evidence From Experimental Studies,'' Critical 
Reviews in Food Science and Nutrition, vol. 48, pp. 160-176, 2008.
    9. Kapsak, W.R., D. Schmidt, N.M. Childs, et al., ``Consumer 
Perceptions of Graded, Graphic and Text Label Presentations for 
Qualified Health Claims,'' Critical Reviews in Food Science and 
Nutrition, vol. 48, pp. 248-256, 2008.
    10. National Cancer Institute, ``Health Information National 
Trends Survey,'' 2007, available at http://hints.cancer.gov/.
    11. Bailey, R.L., J.J. Gahche, C.V. Lentino, et al., ``Dietary 
Supplement Use in the United States, 2003-2006,'' Journal of 
Nutrition, vol. 141, pp. 261-266, 2011.
    12. Radimer, K., B. Bindewald, J. Hughes, et al., ``Dietary 
Supplement Use by US Adults: Data From the National Health and 
Nutrition Examination Survey, 1999-2000,'' American Journal of 
Epidemiology, vol. 160, pp. 339-349, 2004.

    Dated: September 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22795 Filed 9-14-12; 8:45 am]
BILLING CODE 4160-01-P


