[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]
[DOCID:fr19oc05-19]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
behaviors.
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:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: 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:
<bullet> FAX: 301-827-6870.
<bullet> 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://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://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 FURTHER INFORMATION CONTACT:
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: .
SUPPLEMENTARY INFORMATION:
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://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://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
system.
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://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://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://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]
BILLING CODE 4160-01-S
Meeting Registration October 17, 2005
Tentative Agenda October 17, 2005
