[Federal Register: October 19, 2005 (Volume 70, Number 201)]
[Proposed Rules]               
[Page 60749-60751]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 101

[Docket No. 2005N-0413]

Assessing Consumer Perceptions of Health Claims; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Assessing Consumer Perceptions of Health Claims.'' 
The meeting will present research assessing consumers' reactions to 
health claims and will address the implications of these studies for 
future research designed to evaluate consumer understanding of health 
claims and the effect of health claims on consumer perceptions and 

DATES: The public meeting will be held on Thursday, November 17, 2005, 
from 9 a.m. to 4:30 p.m. All of those attending the meeting must 
register by November 10, 2005. See section III of this document for 
details on how to register. Submit written or electronic comments, 
including all relevant data

[[Page 60750]]

and information, related to the focus of the public meeting by January 
17, 2006.

ADDRESSES: The public meeting will be held at the Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, Harley W. 
Wiley Auditorium, 5100 Paint Branch Pkwy., College Park, MD 20740.
    You may submit comments, identified by Docket No. 2005N-0413, by 
any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
, including any personal information provided. For detailed 

instructions on submitting comments, see the ``Comments'' heading of 
the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

    For general questions about the meeting, to register, to request 
permission to speak at the meeting, or to request onsite parking: 
Marion V. Allen, Center for Food Safety and Applied Nutrition (HFS-32), 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 301-436-1584, FAX: 301-436-2371, e-mail: 

    For technical questions: Steven L. Bradbard, Center for Food Safety 
and Applied Nutrition (HFS-727), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1826, FAX: 301-436-
1826, e-mail: steve.bradbard@fda.hhs.gov.


I. Background

    Health claims are statements used on food labels or in food 
labeling that describe a relationship between a food or component of 
food and reduction in the risk of a disease or health-related condition 
(21 U.S.C. 343(r)(1)(B); Sec.  101.14(a)(1) and (a)(2) (21 CFR 
101.14(a)(1) and (a)(2)). The 1993 regulations for health claims (Sec.  
101.14) adopted the congressionally mandated standard of significant 
scientific agreement (SSA) in the Nutrition Labeling and Education Act 
of 1990 (Public Law 101-538). This standard limits authorized health 
claims in food labeling to those dietary substance/disease 
relationships where, based on the totality of publicly available 
scientific evidence, there is significant scientific agreement among 
qualified experts that the claim is supported by such evidence. 
However, the approach of deciding whether a claim was misleading or not 
based on FDA's evaluation of whether the scientific evidence met the 
significant scientific agreement standard was overturned in court on 
first amendment grounds (see Pearson v. Shalala, 164 F.3d 650 (D.C. 
Cir. 1999) (Pearson decision)).
    The Pearson decision rejected FDA's approach in part because the 
agency did not meet its burden under the First Amendment of justifying 
a restriction on health claims that do not meet the SSA standard. The 
court criticized FDA's approach for not considering the possibility 
that disclaimers about the quality of science underlying claims that 
did not meet the SSA standard (``qualified health claims'') could 
remedy any potential harm. Following the Pearson decision and 
subsequent related cases, including Whitaker v. Thompson, 248 F. Supp. 
2d 1 (D.D.C. 2002) (finding a ``credible evidence'' standard as the 
appropriate standard for FDA to apply in evaluating qualified health 
claims), FDA revised its process for reviewing qualified health claim 
petitions. FDA considers the use of qualified health claims when such 
claims are supported by credible scientific evidence and accurately 
communicate the level of scientific support for the claim. FDA 
instituted an interim system for communicating qualified health claims 
in food and dietary supplement labeling based on a four level system to 
classify health claim petitions in terms of the strength of science 
supporting the claim (``Guidance for Industry and FDA: Interim 
Evidence-Based Ranking System for Scientific Data'' (68 FR 41387, July 
11, 2003); ``Guidance for Industry and FDA: Interim Procedures for 
Qualified Health Claims in the Labeling of Conventional Human Food and 
Human Dietary Supplements'' (68 FR 41387)). At the same time it 
instituted this interim system, FDA developed a consumer studies 
research agenda designed to identify the most effective ways to best 
present scientifically based, truthful and nonmisleading information to 
consumers and to identify the kinds of information known to be 
misleading to consumers. See ``Consumer Studies Research Agenda--
Improving Consumer Understanding and Product Competition on the Health 
Consequences of Dietary Choices,'' Attachment D to the Report of the 
FDA Task Force on Consumer Health Information for Better Nutrition 
(July 10, 2003), available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~dms/nuttftoc.html#memo
 (last accessed September 30, 2005).

    FDA (Ref. 1) and others (Refs. 2 and 3) have conducted research to 
assess consumers' responses to health claims. Some of this research has 
studied consumers' reactions to qualifying language that is similar to 
that found in FDA's interim system for communicating the level of 
scientific support for health claims. This research provides important 
information about consumers' judgments about the level of scientific 
support for health claims, and reports the effects of health claims on 
consumers' perceptions of the substance-disease relationship, product 
healthfulness, product quality and safety, and purchase intent.

II. Purpose and Scope of the Meeting

    FDA is holding this public meeting to discuss the findings from its 
own and other research that examines consumers' reactions to health 
claims, including those claims supported by SSA and those that are 
qualified, on conventional foods and dietary supplements. The

[[Page 60751]]

meeting also will allow attendees an opportunity to provide comments to 
FDA about the implications of the available research for further 
consumer studies that may be needed or that are already underway by 
other parties to assess consumer understanding of health claims and the 
effect of health claims on consumer perceptions and behaviors. FDA is 
also interested in hearing from commenters their views regarding 
schemes or signals, other than those already studied, that may, 
consistent with the first amendment, effectively communicate to 
consumers the level of scientific support for health claims, without 
leading consumers to make erroneous inferences about the claimed 
substance-disease relationship and/or other product characteristics. 
FDA anticipates that this meeting will also include comments from 
attendees about alternative research methods to empirically assess 
consumer understanding of health claims and the effect of health claims 
on consumer perceptions and behaviors. FDA intends to consider all 
pertinent information from this public meeting in any rulemaking 
related to alternatives for regulating qualified health claims in the 
labeling of conventional human foods and dietary supplements (see 68 FR 
66040, November 25, 2003).

III. Registration

    Please submit your registration information (including name, title, 
firm name (if applicable), address, telephone, FAX (if available), by 
November 10, 2005. We encourage you to register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~comm/register.html
 or by FAX to Marion V. Allen at 

301-436-2605. Space is limited and registration will be closed when 
maximum seating capacity is reached. Please also specify whether you 
need onsite parking when you register. We also will accept 
registrations onsite, if space is available.
    If you need special accommodations due to a disability, please 
contact Marion V. Allen (see FOR FURTHER INFORMATION CONTACT) no later 
than November 10, 2005.
    If you wish to make a presentation, indicate your request when 
registering and submit the following information by November 10, 2005: 
(1) A brief written statement about the general nature of the views you 
wish to present and (2) the names of any copresenters who must also 
register to attend. The amount of time allowed for each oral 
presentation at the public meeting will be limited (e.g., 5 minutes 
each), and will depend in part upon the number of persons who request 
to speak. Individuals and organizations that do not preregister to make 
a presentation may be given an opportunity to speak if time permits.
    Persons preregistered or wishing to register onsite should check in 
between 7:30 and 8:30 a.m. Because the meeting will be held in a 
Federal building, meeting participants must present photo 
identification and plan adequate time to pass through the security 

IV. Comments

    In addition to attending or presenting oral comments at the 
meeting, interested persons may submit to the Division of Dockets 
Management (see ADDRESSES) written or electronic comments related to 
the focus of this public meeting. All relevant data and information 
should be submitted with the written comments. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Meeting Transcript

    A transcript will be made of the meeting's proceedings. You may 
request a copy in writing from FDA's Freedom of Information Office 
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, 
Rockville, MD 20857, approximately 30 working days after the public 
meeting at a cost of 10 cents per page. The transcript of public 
meeting and all comments submitted will be available for public 
examination at the Division of Dockets Management (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www. fda. gov/ ohrms/ dockets/ default. htm.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSESS) and may be viewed 
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the 
Web site address, but we are not responsible for subsequent changes to 
the Web site after this document publishes in the Federal Register.)

    1. Derby, B.M. and A.S. Levy, ``Working Paper: Effects of 
Strength of Science Disclaimers on the Communication Impact of 
Health Claims,'' Working Paper No. 1, FDA, Center for Food Safety 
and Applied Nutrition (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/OHRMS/dockets/dockets/03N0496/03N-0496-rpt0001.pdf
), September 2005.

    2. France, K.R. and P.F. Bone, ``Policy Maker's Paradigms and 
Evidence from Consumer Interpretations of Dietary Supplement 
Labels,'' Journal of Consumer Affairs, Volume 39, No. 1, Copyright 
2005 by the American Council on Consumer Interests, 2005.
    3. Qualified Health Claims Consumer Research Project Executive 
Summary, International Food Information Council Foundation (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ific.org/research/qualhealthclaimsres.cfm
), March 2005.

    Dated: October 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20969 Filed 10-17-05; 10:49 am]