Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments, 60749-60751 [05-20969]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Proposed Rules
for providing oral and/or written
comments at the meeting.
We will ask for public comments on
our proposed rules after a presentation
of an overview of SSA’s Comprehensive
Work Opportunity Initiative. This
discussion will be followed by a brief
overview of the Ticket NPRM followed
by an opportunity to offer comment on
the following areas: (1) State
participation and beneficiary choice; (2)
employment network payment systems;
(3) ticket eligibility for beneficiaries
whose conditions may improve; (4)
eligibility for more than one ticket per
period of eligibility; (5) the definition of
‘‘using a ticket’’ and timely progress; (6)
the evidence requirements for
employment network payment; and (7)
availability of phase 1 milestone
payments in conjunction with
vocational rehabilitation
reimbursement.
The third and final phase of the
meeting will start with an overview of
SSA’s Demonstration Projects and will
be followed by an opportunity to
comment on any of the Demonstration
Projects or SSA Work Incentives.
For each issue and as time allows, we
will give each individual the
opportunity to provide oral comments
within a specified amount of time (e.g.,
approximately two minutes).
Microphones will be stationed at
convenient points in the meeting room.
We will ask individuals wanting to
provide comments to us to form a line
behind each microphone and approach
the microphone in turn. We will ask
that each speaker, before delivering his
or her remarks, identify themselves by
full name, address, and telephone
number. For those individuals
representing organizations, we will
request that they identify themselves by
full name, state the name of the
organization and the capacity in which
they represent the organization, and
give the organization’s address and
telephone number. Each individual will
then state his/her comments regarding
the area/issue open for comment. Each
individual’s remarks will be recorded
and later transcribed and entered into
the rulemaking record as written
comments.
We anticipate allotting a period of
time to receive oral comments on each
area/issue, with a short break between
each such period. At times announced
during the meeting, and at the end of
each meeting, we will accept written
comments from individuals wishing to
give us comments in writing.
VerDate Aug<31>2005
15:04 Oct 18, 2005
Jkt 208001
What Will SSA Do With the Comments
It Receives on the NPRM?
The transcript of the oral comments
on the NPRM given to us at the town
hall meetings and any written
comments we receive at the meetings,
together with the written comments that
we receive in the manner prescribed in
the NPRM during the 90-day comment
period, will become a part of the
rulemaking record for making changes
to the regulations for the Ticket to Work
program. The 90-day comment period
ends on December 29, 2005. We will
consider all of these comments in
developing the final rules for the Ticket
to Work program. We will summarize
the public comments we received on the
NPRM and respond to the major
comments in the preamble to our final
regulations.
We will post the written comments
we receive during the 90-day comment
period, including the transcript of the
oral comments presented at the town
hall meetings, on our Internet site at
https://policy.ssa.gov/pnpublic.nsf/
LawsRegs. You may also make
arrangements to inspect the comments
as explained in the ‘‘How do I provide
comments on the NPRM if I do not go
to a town hall meeting?’’ section of this
notice.
What Are the Tentative Sites and Dates
for Other Town Hall Meetings?
The tentative sites and approximate
dates for additional town hall meetings
are as follows:
Miami, Florida: November 16, 2005
from 9 a.m.–12 p.m.
Hartford, Connecticut: December 6,
2005 from 9 a.m.–12 p.m.
Des Moines, Iowa: December 14, 2005
from 9 a.m.–12 p.m.
When we have more information
about these additional town hall
meetings, we will publish that
information in a notice(s) in the Federal
Register at a time nearer to the event(s).
Seating may be limited at these
meetings.
How Do I Provide Comments on the
NPRM if I Do Not Go to a Town Hall
Meeting?
You may give us your written
comments by: using our Internet site
facility (i.e., Social Security Online) at
https://policy.ssa.gov/pnpublic.nsf/
LawsRegs or the Federal eRulemaking
Portal at https://www.regulations.gov; email to regulations@ssa.gov; telefax to
(410) 966–2830; or letter to the
Commissioner of Social Security, P.O.
Box 17703, Baltimore, MD 21235–7703.
You may also deliver them to the Office
of Regulations, Social Security
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
60749
Administration, 107 Altmeyer Building,
6401 Security Boulevard, Baltimore, MD
21235–6401, between the hours of 8
a.m. and 4:30 p.m. on regular business
days. To be sure your comments are
considered, we must receive them by
December 29, 2005.
We post the comments on our Internet
site at https://policy.ssa.gov/
pnpublic.nsf/LawsRegs. You may also
inspect the comments on regular
business days by making arrangements
with the following contact person: Greg
Zwitch, SSA Regulations Officer, Social
Security Administration, 107 Altmeyer
Building, 6401 Security Boulevard,
Baltimore, MD 21235–6401, e-mail
regulations@ssa.gov, or telephone (410)
965–1887 or TTY (410) 966–5609.
Authority: Sec. 1148 of the Social Security
Act (42 U.S.C. 1320b–19); sec. 101(e), Pub. L.
106–170, 113 Stat. 1860, 1877 (42 U.S.C.
1320b–19 note).
Dated: October 14, 2005.
Martin H. Gerry,
Deputy Commissioner for Disability and
Income Security Programs.
[FR Doc. 05–20972 Filed 10–18–05; 8:45 am]
BILLING CODE 4191–02–U
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.
Notice of public meeting;
request for comments.
ACTION:
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
E:\FR\FM\19OCP1.SGM
19OCP1
60750
Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Proposed Rules
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
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 email. 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 https://
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 https://
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
VerDate Aug<31>2005
15:04 Oct 18, 2005
Jkt 208001
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:
marion.allen@fda.hhs.gov.
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.
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);
§ 101.14(a)(1) and (a)(2) (21 CFR
101.14(a)(1) and (a)(2)). The 1993
regulations for health claims (§ 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
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
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 https://
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
E:\FR\FM\19OCP1.SGM
19OCP1
Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Proposed Rules
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 https://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
VerDate Aug<31>2005
15:04 Oct 18, 2005
Jkt 208001
60751
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.
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 (https://www.ific.org/research/
qualhealthclaimsres.cfm), March 2005.
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.
Dated: October 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20969 Filed 10–17–05; 10:49
am]
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 https://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
(https://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
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 133
[Docket No. 2000P–0586 (formerly Docket
No. 00P–0586)]
Cheeses and Related Cheese
Products; Proposal to Permit the Use
of Ultrafiltered Milk
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
SUMMARY: The Food and Drug
Administration (FDA) is proposing to
amend its regulations to provide for the
use of fluid ultrafiltered milk (UF) in the
manufacture of standardized cheeses
and related cheese products. This action
responds principally to two citizen
petitions: One submitted by the
American Dairy Products Institute
(ADPI) and another submitted jointly by
the National Cheese Institute (NCI), the
Grocery Manufacturers of America, Inc.
(GMA), and the National Food
Processors Association (NFPA). FDA
tentatively concludes that this action
will promote honesty and fair dealing in
the interest of consumers and, to the
extent practicable, will achieve
consistency with existing international
standards of identity for cheeses and
related cheese products.
DATES: Submit comments by January 17,
2006.
ADDRESSES: You may submit comments,
identified by Docket No. 2000P–0586,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
E:\FR\FM\19OCP1.SGM
19OCP1
]]>Agencies
[Federal Register Volume 70, Number 201 (Wednesday, October 19, 2005)]
[Proposed Rules]
[Pages 60749-60751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20969]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://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 https://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 https://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:
marion.allen@fda.hhs.gov.
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.
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 https://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 https://
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 https://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 (https://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 (https://
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
