The need for this collection of
information derives from the Food and Drug Administration's (FDA's)
regulation of 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, i.e., statements in food
labeling 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), petitioners must submit 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)). Prior research has not investigated how
consumers interpret labeling claims using phrases such as "certain
cancers" and "anticarcinogenic effects," or whether qualifiers,
such as a listing of site-specific cancers, would eliminate
potential deception. The agency therefore proposes an experimental
study to examine consumer reactions to health claims using those
phrases, with and without various disclaimers. The objective of
this 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.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.