[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Notices]
[Pages 4329-4332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1692]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study entitled ``Experimental Study of 
Consumer Response to Health Claims and Disclaimers About the 
Relationship Between Selenium and Risk of Various Cancers.''

DATES: Submit either electronic or written comments on the collection 
of information by March 27, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, 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 Consumer Response to Health Claims and 
Disclaimers About the Relationship Between Selenium and Risk of Various 
Cancers--(OMB Control Number 0910--NEW)

I. Background

    The Food and Drug Administration (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

[[Page 4330]]

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)-(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 D.C. 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 (D.C. 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; Dec. 21, 2007) announcing the Agency's intent to reevaluate 
these two QHCs, among other health claims (the 2007 notice). One of the 
other health claims being reevaluated is the authorized health claim 
for dietary fat and cancer risk in 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 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 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

[[Page 4331]]

supporting a claim (Ref. 6 through 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,'' 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total  annual   Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener..              72               1              72  0.083 hr. (5                   6
                                                                                 minutes).
Cognitive interview...........               9               1               9  1 hr. (60                      9
                                                                                 minutes).
Pretest invitation............             240               1             240  0.033 hr. (2                   8
                                                                                 minutes).
Pretest.......................              60               1              60  0.167 hr. (10                 10
                                                                                 minutes).
Survey invitation.............          50,000               1          50,000  0.033 hr. (2               1,650
                                                                                 minutes).
Survey........................           1,200               1           1,200  0.167 hr. (10                200
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,883
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(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/

[[Page 4332]]

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 Studies 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: January 20, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1692 Filed 1-26-12; 8:45 a.m.]
BILLING CODE 4160-01-P