Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
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 (
In 2003, FDA issued a letter of enforcement discretion for two QHCs for dietary supplements containing selenium (Ref. 3):
In 2007, FDA published a notice in the
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
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 (
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,”
FDA estimates the burden of this collection of information as follows:
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.
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
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
2. U.S. Food and Drug Administration, “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims,” 2009, available at
3. U.S. Food and Drug Administration, “Selenium and Certain Cancers (Qualified Health Claim: Final Decision Letter) (Docket No. 02P-0457),” 2003, available at
4. U.S. Food and Drug Administration, “Selenium and a Reduced Risk of Site-Specific Cancers (FDA-2008-Q-04323),” 2009, available at
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
6. Derby, B.M. and A.S. Levy, “Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims,” 2005, available at
7. Choinière, 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
8. Hooker, N.H. and R. Teratanavat, “Dissecting Qualified Health Claims: Evidence From Experimental Studies,”
9. Kapsak, W.R., D. Schmidt, N.M. Childs, et al., “Consumer Perceptions of Graded, Graphic and Text Label Presentations for Qualified Health Claims,”
10. National Cancer Institute, “Health Information National Trends Survey,” 2007, available at
11. Bailey, R.L., J.J. Gahche, C.V. Lentino, et al., “Dietary Supplement Use in the United States, 2003-2006,”
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,”