Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing; Request for Comments, 39815-39818 [E7-14046]
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Federal Register / Vol. 72, No. 139 / Friday, July 20, 2007 / Notices
scheduled between approximately 11:15
a.m. and 11:45 p.m. and between
approximately 3:30 p.m. and 4 p.m. on
August 16, 2007. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 31, 2007. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 1, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Pearline K. Muckelvene at least
7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–14088 Filed 7–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Cardiovascular
and Renal Drugs Advisory Committee
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and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 11, 2007, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD, 301–
977–8900.
Contact Person: Mimi Phan, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
Mimi.Phan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 3014512533
or 3014512535. Please call the
Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
updated information on the risks and
benefits of erythropoeisis-stimulating
agents (ARANESP, Amgen, Inc.,
EPOGEN, Amgen, Inc., and PROCRIT,
Amgen, Inc.) when used in the
treatment of anemia due to chronic
renal failure. This discussion follows a
March 9, 2007, FDA Public Health
Advisory regarding the use of these
agents (https://www.fda.gov/cder/drug/
advisory/RHE2007.htm).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
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submissions may be made to the contact
person on or before August 27, 2007.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 17, 2007. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 20, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Mimi Phan at
301–827–7001, at least 7 days in
advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–14086 Filed 7–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0277]
Food Labeling: Use of Symbols to
Communicate Nutrition Information,
Consideration of Consumer Studies
and Nutritional Criteria; Public
Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public hearing concerning the use of
symbols to communicate nutrition
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Federal Register / Vol. 72, No. 139 / Friday, July 20, 2007 / Notices
information on food labels. The purpose
of the hearing is for FDA to solicit
information and comments from
interested persons about programs
currently in use regarding the use of
symbols to communicate nutrition
information on food labels.
DATES: The public hearing will be held
on September 10 and 11, 2007, from 9
a.m. to 5 p.m. See section V of this
document for additional dates
associated with registration and
participation in the hearing. Submit
written or electronic comments (i.e.,
submissions other than notices of
participation and written material
associated with an oral presentation) by
November 12, 2007. The administrative
record of the hearing will remain open
until November 12, 2007.
ADDRESSES: Public hearing. The public
hearing will be held at The Inn &
Conference Center by Marriott,
University of Maryland, University
College, 3501 University Blvd. E.,
Adelphi, Maryland 20783.
Registration and notice of
participation and written material
associated with an oral presentation.
Submit electronic requests to register
and notices of participation for the
hearing to https://www.cfsan.fda.gov/
register.html. We encourage you to use
this method to submit notices of
participation, if possible. Submit
written requests to register and notices
of participation, and written material
associated with an oral presentation to:
Kathy Houston, Z-Tech Corp., 1803
Research Blvd., suite 301, Rockville, MD
20850, 301–251–4976, FAX: 301–315–
2801, or e-mail: khouston@ztechcorp.com.
Comments. Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. For
additional information on submitting
comments, see section VI in this
document.
FOR FURTHER INFORMATION CONTACT: To
submit an oral or written notice of
participation by phone, by fax, or by email, or to submit written material
associated with an oral presentation by
fax or by e-mail: Kathy Houston, Z-Tech
Corp., 1803 Research Blvd., suite 301,
Rockville, MD 20850.
For all other questions about the
hearing or if you need special
accommodations due to a disability:
Juanita Yates, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 301–436–1731, e-mail:
Juanita.Yates@fda.hhs.gov.
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SUPPLEMENTARY INFORMATION:
I. Background
In the United States, the Nutrition
Labeling and Education Act of 1990 (the
1990 amendments) (Public Law 101–
535) amended the Federal Food, Drug,
and Cosmetic Act (the act) to require
nutrition labeling on the labels of
packaged foods to enable consumers to
make more informed and healthier food
choices in the context of their daily diet.
In 1993, FDA established regulations
that implemented the 1990
amendments, including provisions
concerning the use of claims on the
label or in labeling of a food. Among
these regulations, the agency set forth
general principles for nutrient content
claims (21 CFR 101.13), which are
claims that characterize the level of a
nutrient in a food (e.g., ‘‘low fat,’’ ‘‘good
source of fiber’’), and for health claims
(21 CFR 101.14), which are claims that
characterize the relationship of a food
substance to a disease or health-related
condition (e.g., ‘‘calcium may reduce
the risk of osteoporosis’’).
A. Use of Nutrition Symbols on Food
Labels in the United States.
In recent years, domestic
manufacturers and retailers have begun
to include symbols that indicate
nutritional quality on the label or in
labeling of a food. Symbol programs
have been instituted by companies to
promote their products and provide
consumers with easily understandable
nutrition information to aid them in
their food purchases. Various food
manufacturers, grocery stores, trade
organizations, and health organizations
have developed, or are currently
developing, symbols and icons that
indicate specific nutritional attributes of
food products. Although each symbol
intends to indicate that the food product
bearing the symbol is a healthful choice,
each symbol program has different
nutrient requirements. The selected
nutrients and the nutrient levels
required for eligibility vary among the
different symbol programs in use. With
the increasingly widespread availability
of these symbols from manufacturers,
retailers, and third party organizations,
it is possible that eligible food products
could bear multiple nutrition symbols.
B. Use of Nutrition Symbols on Food
Labels in Other Countries
A few countries around the world
have already instituted voluntary
labeling systems for governmentdesigned front-label1 nutrition symbols.
1As used in this notice, the term ‘‘front label’’
means the part of the label that is most likely to be
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These symbol systems vary in their
format. Some systems have detailed
graphic illustrations that indicate the
content of a number of selected
nutrients, while others simply present a
single icon indicating that a food is
healthful (with further information
available elsewhere, such as in booklets
and web sites). Also in use
internationally are industry-designed
nutrition symbol systems that are
available for use in countries that do not
have a government-designed symbol
program or, in certain countries, that
exist as alternatives to the governmentdesigned symbols.
II. Purpose and Scope of the Hearing
The purpose of the hearing is for FDA
to solicit information and comments
from interested persons about programs
currently in use regarding the use of
symbols to communicate nutrition
information on food labels.
This notice describes the scope of the
hearing. We invite information and
comment on the issues and questions in
section III of this document. If you are
interested in this hearing or this subject,
you may address as many of the
following questions as you wish. We do
not expect you to address all questions.
When possible, please provide scientific
information and data in support of your
comments. In addition, to the extent
possible, please provide as specific
information as is feasible about the
estimated costs and benefits associated
with your responses (e.g., the costs and
benefits of current practices and/or the
cost and benefits of any
recommendations you may make).
III. Issues and Questions for Discussion
The following issues and questions
will be discussed at the public hearing:
Issue 1: There are many food label
nutrition symbol programs currently in
the domestic and international
marketplace. Each system uses different
nutrition criteria and requirements
regarding eligibility for use. The agency
would like information on the food
products that bear nutrition symbols
and the nutrient requirements for those
symbols.
Question 1. In what product
categories are nutrition symbols used
(e.g., packaged foods, fresh produce,
meat/poultry, seafood)?
Question 2. Which symbols are
nutrient specific, and which are
summary symbols based on multiple
nutrients?
displayed, presented, shown, or examined under
customary conditions of display for retail sale. In
the United States, the front label is known as the
principal display panel (21 CFR 1.1).
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Question 3. What are the nutritional
criteria, including calories, included in
a symbol system and how were those
particular nutritional criteria chosen for
inclusion?
Question 4. What nutrient thresholds
and/or algorithms are used to determine
if a food product may display a nutrient
specific or summary symbol?
Question 5. Are nutrition symbols
presented together with front label
nutrition claims such as ‘‘low fat’’ or
‘‘good source of calcium’’ and, if so, to
what extent and for what types of
claims?
Question 6. Are there programs to
educate consumers to understand the
nutrition symbols or is all information
contained in the symbols? When
education programs are available, how
are they presented?
Issue 2: The presence of nutrition
symbols could affect the food
purchasing decisions of consumers.
Symbols could help consumers make
food choices, but it is also possible that
symbols could introduce confusion
when making decisions. The agency
would like information on consumer
research that supported the
development of these programs and
research that illustrates how these
programs are understood and utilized by
consumers.
Question 7. What are consumer
attitudes toward nutrition symbols?
Question 8. What are consumer
attitudes toward products or brands that
carry a nutrition symbol compared to
other products or brands in the same
product category (e.g., cereals) and in
other categories that do not carry such
a symbol?
Question 9. What are consumer
interpretations of symbol-carrying
products or brands in terms of their
overall healthfulness, specific health
benefits, featured nutrition attributes,
nonfeatured nutrition attributes, quality,
safety, and any other non-nutrition
attributes?
Question 10. What is consumer
perception of the presence of multiple
and different nutrition symbols on front
labels of different brands in a given
product category, e.g., cereals?
Question 11. What is consumer
interpretation of the co-existence on the
food label of symbols and/or other
nutrition messages, when present, and
quantitative nutrition information (e.g.,
the Nutrition Facts label that appears on
foods in the United States)?
Question 12. What is consumer
interpretation of the co-existence of
front-label nutrition symbols and
nutrition symbols present on the tags of
supermarket shelves, when available?
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Question 13. When do consumers use
nutrition symbols and what do they use
them for?
Question 14. Do nutrition symbols on
food labels direct consumers toward
purchase of foods that bear them and, if
so, to what extent?
Question 15. Do symbols affect the
nutritional quality of the total diet of
consumers who use the symbols and, if
so, to what extent?
Issue 3: The availability of a nutrition
symbol for use on the food label could
have an impact on costs for both
industry and for consumers. The agency
would like information on possible
economic impacts.
Question 16. To what extent, if any,
have products been developed or reformulated to qualify them for a given
nutrition symbol?
Question 17. What are the costs
associated with product development,
re-formulation, or both?
Question 18. What are the costs
associated with putting symbols on
packages?
Question 19. What, if any, are the
price differences between symbolcarrying products and other products
within the same category?
Question 20. Has inclusion of
nutrition symbols on the labels of food
products affected the sales of those
products?
IV. Notice of Hearing Under 21 CFR
Part 15
By delegation from the Commissioner
of Food and Drugs (the Commissioner)
(Staff Manual Guide 1410.21 paragraph
1.f. (5)), the Assistant Commissioner for
Policy finds that it is in the public
interest to permit persons to present
information and views at a public
hearing regarding the use of symbols to
communicate nutrition information on
food labels and is announcing that the
public hearing will be held in
accordance with part 15 (21 CFR part
15). The presiding officer will be the
Commissioner or his designee. The
presiding officer will be accompanied
by a panel of FDA employees with
relevant expertise.
Persons who wish to participate in the
hearing (either by making a presentation
or as a member of the audience) must
file a notice of participation (see DATES,
ADDRESSES, FOR FURTHER INFORMATION
CONTACT, and section V of this
document). By delegation from the
Commissioner (Staff Manual Guide
1410.21 paragraph 1.f. (5)), the Assistant
Commissioner for Policy has
determined under § 15.20(c) that
advance submissions of oral
presentations are necessary for the panel
to formulate useful questions to be
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posed at the hearing under § 15.30(e),
and that the submission of a
comprehensive outline or summary is
an acceptable alternative to the
submission of the full text of the oral
presentation. For efficiency, we request
that individuals and organizations with
common interests consolidate their
requests for oral presentation and
request time for a joint presentation
through a single representative. After
reviewing the notices of participation
and accompanying information, we will
schedule each oral presentation and
notify each participant of the time
allotted to the presenter and the
approximate time that the presentation
is scheduled to begin. If time permits,
we may allow interested persons who
attend the hearing but did not submit a
notice of participation in advance to
make an oral presentation at the
conclusion of the hearing. The hearing
schedule will be available at the
hearing.
After the hearing, the schedule and a
list of participants will be placed on file
in the Division of Dockets Management
(see ADDRESSES) under the docket
number listed in brackets in the heading
of this notice.
To ensure timely handling of any
mailed notices of participation, written
material associated with presentations,
or comments, any outer envelope
should be clearly marked with the
docket number listed in brackets in the
heading of this notice along with the
statement ‘‘Food Labeling: Use of
Symbols to Communicate Nutrition
Information, Consideration of Consumer
Studies and Nutritional Criteria; Public
Hearing.’’
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation.
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (part
10 (21 CFR part 10, subpart C)). Under
§ 10.205, representatives of the
electronic media may be permitted,
subject to the procedures and
limitations in § 10.206, to videotape,
film, or otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b). For additional information
about transcripts, see section VII in this
document.
Any handicapped persons requiring
special accommodations to attend the
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hearing should direct those needs to the
appropriate contact person (see FOR
FURTHER INFORMATION CONTACT).
To the extent that the conditions for
the hearing, as described in this
document, conflict with any provisions
set out in part 15, this notice acts as a
waiver of these provisions as specified
in §§ 10.19 and 15.30(h). In particular,
§ 15.21(a) states that the notice of
hearing will provide persons an
opportunity to file a written notice of
participation with the Division of
Dockets Management within a specified
period of time. If the public interest
requires, e.g., if a hearing is to be
conducted within a short period of time,
the notice may name a specific FDA
employee and telephone number to
whom an oral notice of participation
may be given. If the public interest
requires, the notice may also provide for
submitting notices of participation at
the time of the hearing. In this
document, the conditions for the
hearing specify that notices of
participation be submitted
electronically to an agency Web site, to
a contact person who will accept notices
of participation by mail, telephone, fax,
or e-mail, or in person on the day of the
hearing (as space permits). In addition,
the conditions for the hearing specify
that written material associated with an
oral presentation be provided to a
contact person (who will accept it by
mail, fax, or e-mail) rather than to the
Division of Dockets Management. We
are using these procedures to facilitate
the exchange of information between
participants and the agency. By
delegation from the Commissioner (Staff
Manual Guide 1410.21 paragraph 1.f.
(5)), the Assistant Commissioner for
Policy finds under § 10.19 that no
participant will be prejudiced, the ends
of justice will thereby be served, and the
action is in accordance with law if
notices of participation are submitted by
the procedures listed in this notice
rather than to the Division of Dockets
Management.
V. How to Participate in the Hearing
Registration by submission of a notice
of participation is necessary to ensure
participation and will be accepted on a
first-come, first-served basis. The notice
of participation may be submitted
electronically, orally, or by fax, mail, or
e-mail (see ADDRESSES and FOR FURTHER
INFORMATION CONTACT). We encourage
you to submit your notice of
participation electronically. A single
copy of any notice of participation is
sufficient.
The notice of participation must
include your name, title, business
affiliation (if applicable), address,
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telephone number, fax number (if
available), and e-mail address (if
available). If you wish to request an
opportunity to make an oral
presentation during the open public
comment period of the hearing, your
notice of participation also must include
the title of your presentation, the
sponsor of the oral presentation (e.g.,
the organization paying travel expenses
or fees), if any; and the approximate
amount of time requested for the
presentation. Presentations will be
limited to the questions and subject
matter identified in section III of this
document, and, depending on the
number of requests received, we may be
obliged to limit the time allotted for
each presentation (e.g., 5 minutes each).
Under § 15.20(c), if you request an
opportunity to make an oral
presentation, you must submit your
presentation (either as the full text of
the presentation, or as a comprehensive
outline or summary). You may submit
your presentation by e-mail, fax, or
mail. A single copy of your presentation
is sufficient. See ADDRESSES and FOR
FURTHER INFORMATION CONTACT for
information on where to send your
presentation.
Persons who wish to request an
opportunity to make an oral
presentation at the hearing must submit
a notice of participation by August 24,
2007, and also must submit either the
full text of the oral presentation, or a
comprehensive outline or summary of
the oral presentation, by August 31,
2007. All other persons wishing to
attend the hearing must submit a notice
of participation by August 31, 2007.
Persons requiring special
accommodations due to a disability
must submit a notice of participation by
August 31, 2007, and should inform the
contact person of their request (see FOR
FURTHER INFORMATION CONTACT).
Individuals who request an opportunity
to make an oral presentation will be
notified of the scheduled time for their
presentation prior to the hearing.
We also will accept notices of
participation onsite on a first come, first
served basis; however, the anticipated
maximum seating capacity is 75 to 100,
and registration will be closed when the
maximum seating capacity is reached.
Requests for an opportunity to make a
presentation from individuals or
organizations that did not make such a
request in advance may be granted if
time permits.
Persons who submit a notice of
participation in advance of the hearing
should check in at the on-site
registration desk between 8:30 and 9
a.m. Persons who wish to submit a
notice of participation onsite may do so
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at the registration desk between 8:30
and 9 a.m. on either day of the hearing.
We encourage all participants to attend
the entire hearing.
All submissions and comments
received may be posted without change
to https://www.fda.gov/ohrms/dockets/
default.htm, including any personal
information provided.
VI. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments for consideration at or after
the hearing in addition to, or in place of,
a request for an opportunity to make an
oral presentation (see section V of this
document). Submit two paper copies of
any written comments, except that
individuals may submit one copy.
Comments are to be identified with the
agency name and 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.
VII. Transcripts
Transcripts of the hearing will be
available for review at the Division of
Dockets Management (see ADDRESSES)
and on the Internet at https://
www.fda.gov/ohrms/
docketsapproximately 30 days after the
hearing. You may place orders for
copies of the transcript through the
Freedom of Information Office (HFI–35),
Food and Drug Administration, 5600
Fishers lane, rm. 6–30, Rockville, MD
20857, at a cost of 10 cents per page.
Dated: July 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–14046 Filed 7–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food Safety and Defense . . . Be ALERT;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Atlanta
District and Southeast Regional Office
(SER), in collaboration with Georgia
Food Safety and Defense Task Force,
and the Metro Environmental Health
Directors Food Service Advisory
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]]>Agencies
[Federal Register Volume 72, Number 139 (Friday, July 20, 2007)]
[Notices]
[Pages 39815-39818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0277]
Food Labeling: Use of Symbols to Communicate Nutrition
Information, Consideration of Consumer Studies and Nutritional
Criteria; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing concerning the use of symbols to communicate nutrition
[[Page 39816]]
information on food labels. The purpose of the hearing is for FDA to
solicit information and comments from interested persons about programs
currently in use regarding the use of symbols to communicate nutrition
information on food labels.
DATES: The public hearing will be held on September 10 and 11, 2007,
from 9 a.m. to 5 p.m. See section V of this document for additional
dates associated with registration and participation in the hearing.
Submit written or electronic comments (i.e., submissions other than
notices of participation and written material associated with an oral
presentation) by November 12, 2007. The administrative record of the
hearing will remain open until November 12, 2007.
ADDRESSES: Public hearing. The public hearing will be held at The Inn &
Conference Center by Marriott, University of Maryland, University
College, 3501 University Blvd. E., Adelphi, Maryland 20783.
Registration and notice of participation and written material
associated with an oral presentation. Submit electronic requests to
register and notices of participation for the hearing to https://
www.cfsan.fda.gov/register.html. We encourage you to use this method to
submit notices of participation, if possible. Submit written requests
to register and notices of participation, and written material
associated with an oral presentation to: Kathy Houston, Z-Tech Corp.,
1803 Research Blvd., suite 301, Rockville, MD 20850, 301-251-4976, FAX:
301-315-2801, or e-mail: khouston@z-techcorp.com.
Comments. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. For additional information on submitting
comments, see section VI in this document.
FOR FURTHER INFORMATION CONTACT: To submit an oral or written notice of
participation by phone, by fax, or by e-mail, or to submit written
material associated with an oral presentation by fax or by e-mail:
Kathy Houston, Z-Tech Corp., 1803 Research Blvd., suite 301, Rockville,
MD 20850.
For all other questions about the hearing or if you need special
accommodations due to a disability: Juanita Yates, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 301-436-
1731, e-mail: Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the United States, the Nutrition Labeling and Education Act of
1990 (the 1990 amendments) (Public Law 101-535) amended the Federal
Food, Drug, and Cosmetic Act (the act) to require nutrition labeling on
the labels of packaged foods to enable consumers to make more informed
and healthier food choices in the context of their daily diet. In 1993,
FDA established regulations that implemented the 1990 amendments,
including provisions concerning the use of claims on the label or in
labeling of a food. Among these regulations, the agency set forth
general principles for nutrient content claims (21 CFR 101.13), which
are claims that characterize the level of a nutrient in a food (e.g.,
``low fat,'' ``good source of fiber''), and for health claims (21 CFR
101.14), which are claims that characterize the relationship of a food
substance to a disease or health-related condition (e.g., ``calcium may
reduce the risk of osteoporosis'').
A. Use of Nutrition Symbols on Food Labels in the United States.
In recent years, domestic manufacturers and retailers have begun to
include symbols that indicate nutritional quality on the label or in
labeling of a food. Symbol programs have been instituted by companies
to promote their products and provide consumers with easily
understandable nutrition information to aid them in their food
purchases. Various food manufacturers, grocery stores, trade
organizations, and health organizations have developed, or are
currently developing, symbols and icons that indicate specific
nutritional attributes of food products. Although each symbol intends
to indicate that the food product bearing the symbol is a healthful
choice, each symbol program has different nutrient requirements. The
selected nutrients and the nutrient levels required for eligibility
vary among the different symbol programs in use. With the increasingly
widespread availability of these symbols from manufacturers, retailers,
and third party organizations, it is possible that eligible food
products could bear multiple nutrition symbols.
B. Use of Nutrition Symbols on Food Labels in Other Countries
A few countries around the world have already instituted voluntary
labeling systems for government-designed front-label\1\ nutrition
symbols. These symbol systems vary in their format. Some systems have
detailed graphic illustrations that indicate the content of a number of
selected nutrients, while others simply present a single icon
indicating that a food is healthful (with further information available
elsewhere, such as in booklets and web sites). Also in use
internationally are industry-designed nutrition symbol systems that are
available for use in countries that do not have a government-designed
symbol program or, in certain countries, that exist as alternatives to
the government-designed symbols.
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\1\As used in this notice, the term ``front label'' means the
part of the label that is most likely to be displayed, presented,
shown, or examined under customary conditions of display for retail
sale. In the United States, the front label is known as the
principal display panel (21 CFR 1.1).
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II. Purpose and Scope of the Hearing
The purpose of the hearing is for FDA to solicit information and
comments from interested persons about programs currently in use
regarding the use of symbols to communicate nutrition information on
food labels.
This notice describes the scope of the hearing. We invite
information and comment on the issues and questions in section III of
this document. If you are interested in this hearing or this subject,
you may address as many of the following questions as you wish. We do
not expect you to address all questions. When possible, please provide
scientific information and data in support of your comments. In
addition, to the extent possible, please provide as specific
information as is feasible about the estimated costs and benefits
associated with your responses (e.g., the costs and benefits of current
practices and/or the cost and benefits of any recommendations you may
make).
III. Issues and Questions for Discussion
The following issues and questions will be discussed at the public
hearing:
Issue 1: There are many food label nutrition symbol programs
currently in the domestic and international marketplace. Each system
uses different nutrition criteria and requirements regarding
eligibility for use. The agency would like information on the food
products that bear nutrition symbols and the nutrient requirements for
those symbols.
Question 1. In what product categories are nutrition symbols used
(e.g., packaged foods, fresh produce, meat/poultry, seafood)?
Question 2. Which symbols are nutrient specific, and which are
summary symbols based on multiple nutrients?
[[Page 39817]]
Question 3. What are the nutritional criteria, including calories,
included in a symbol system and how were those particular nutritional
criteria chosen for inclusion?
Question 4. What nutrient thresholds and/or algorithms are used to
determine if a food product may display a nutrient specific or summary
symbol?
Question 5. Are nutrition symbols presented together with front
label nutrition claims such as ``low fat'' or ``good source of
calcium'' and, if so, to what extent and for what types of claims?
Question 6. Are there programs to educate consumers to understand
the nutrition symbols or is all information contained in the symbols?
When education programs are available, how are they presented?
Issue 2: The presence of nutrition symbols could affect the food
purchasing decisions of consumers. Symbols could help consumers make
food choices, but it is also possible that symbols could introduce
confusion when making decisions. The agency would like information on
consumer research that supported the development of these programs and
research that illustrates how these programs are understood and
utilized by consumers.
Question 7. What are consumer attitudes toward nutrition symbols?
Question 8. What are consumer attitudes toward products or brands
that carry a nutrition symbol compared to other products or brands in
the same product category (e.g., cereals) and in other categories that
do not carry such a symbol?
Question 9. What are consumer interpretations of symbol-carrying
products or brands in terms of their overall healthfulness, specific
health benefits, featured nutrition attributes, nonfeatured nutrition
attributes, quality, safety, and any other non-nutrition attributes?
Question 10. What is consumer perception of the presence of
multiple and different nutrition symbols on front labels of different
brands in a given product category, e.g., cereals?
Question 11. What is consumer interpretation of the co-existence on
the food label of symbols and/or other nutrition messages, when
present, and quantitative nutrition information (e.g., the Nutrition
Facts label that appears on foods in the United States)?
Question 12. What is consumer interpretation of the co-existence of
front-label nutrition symbols and nutrition symbols present on the tags
of supermarket shelves, when available?
Question 13. When do consumers use nutrition symbols and what do
they use them for?
Question 14. Do nutrition symbols on food labels direct consumers
toward purchase of foods that bear them and, if so, to what extent?
Question 15. Do symbols affect the nutritional quality of the total
diet of consumers who use the symbols and, if so, to what extent?
Issue 3: The availability of a nutrition symbol for use on the food
label could have an impact on costs for both industry and for
consumers. The agency would like information on possible economic
impacts.
Question 16. To what extent, if any, have products been developed
or re-formulated to qualify them for a given nutrition symbol?
Question 17. What are the costs associated with product
development, re-formulation, or both?
Question 18. What are the costs associated with putting symbols on
packages?
Question 19. What, if any, are the price differences between
symbol-carrying products and other products within the same category?
Question 20. Has inclusion of nutrition symbols on the labels of
food products affected the sales of those products?
IV. Notice of Hearing Under 21 CFR Part 15
By delegation from the Commissioner of Food and Drugs (the
Commissioner) (Staff Manual Guide 1410.21 paragraph 1.f. (5)), the
Assistant Commissioner for Policy finds that it is in the public
interest to permit persons to present information and views at a public
hearing regarding the use of symbols to communicate nutrition
information on food labels and is announcing that the public hearing
will be held in accordance with part 15 (21 CFR part 15). The presiding
officer will be the Commissioner or his designee. The presiding officer
will be accompanied by a panel of FDA employees with relevant
expertise.
Persons who wish to participate in the hearing (either by making a
presentation or as a member of the audience) must file a notice of
participation (see DATES, ADDRESSES, FOR FURTHER INFORMATION CONTACT,
and section V of this document). By delegation from the Commissioner
(Staff Manual Guide 1410.21 paragraph 1.f. (5)), the Assistant
Commissioner for Policy has determined under Sec. 15.20(c) that
advance submissions of oral presentations are necessary for the panel
to formulate useful questions to be posed at the hearing under Sec.
15.30(e), and that the submission of a comprehensive outline or summary
is an acceptable alternative to the submission of the full text of the
oral presentation. For efficiency, we request that individuals and
organizations with common interests consolidate their requests for oral
presentation and request time for a joint presentation through a single
representative. After reviewing the notices of participation and
accompanying information, we will schedule each oral presentation and
notify each participant of the time allotted to the presenter and the
approximate time that the presentation is scheduled to begin. If time
permits, we may allow interested persons who attend the hearing but did
not submit a notice of participation in advance to make an oral
presentation at the conclusion of the hearing. The hearing schedule
will be available at the hearing.
After the hearing, the schedule and a list of participants will be
placed on file in the Division of Dockets Management (see ADDRESSES)
under the docket number listed in brackets in the heading of this
notice.
To ensure timely handling of any mailed notices of participation,
written material associated with presentations, or comments, any outer
envelope should be clearly marked with the docket number listed in
brackets in the heading of this notice along with the statement ``Food
Labeling: Use of Symbols to Communicate Nutrition Information,
Consideration of Consumer Studies and Nutritional Criteria; Public
Hearing.''
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
the procedures and limitations in Sec. 10.206, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec. 15.30(b). For additional information about
transcripts, see section VII in this document.
Any handicapped persons requiring special accommodations to attend
the
[[Page 39818]]
hearing should direct those needs to the appropriate contact person
(see FOR FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this document, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec. Sec.
10.19 and 15.30(h). In particular, Sec. 15.21(a) states that the
notice of hearing will provide persons an opportunity to file a written
notice of participation with the Division of Dockets Management within
a specified period of time. If the public interest requires, e.g., if a
hearing is to be conducted within a short period of time, the notice
may name a specific FDA employee and telephone number to whom an oral
notice of participation may be given. If the public interest requires,
the notice may also provide for submitting notices of participation at
the time of the hearing. In this document, the conditions for the
hearing specify that notices of participation be submitted
electronically to an agency Web site, to a contact person who will
accept notices of participation by mail, telephone, fax, or e-mail, or
in person on the day of the hearing (as space permits). In addition,
the conditions for the hearing specify that written material associated
with an oral presentation be provided to a contact person (who will
accept it by mail, fax, or e-mail) rather than to the Division of
Dockets Management. We are using these procedures to facilitate the
exchange of information between participants and the agency. By
delegation from the Commissioner (Staff Manual Guide 1410.21 paragraph
1.f. (5)), the Assistant Commissioner for Policy finds under Sec.
10.19 that no participant will be prejudiced, the ends of justice will
thereby be served, and the action is in accordance with law if notices
of participation are submitted by the procedures listed in this notice
rather than to the Division of Dockets Management.
V. How to Participate in the Hearing
Registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. The notice of participation may be submitted
electronically, orally, or by fax, mail, or e-mail (see ADDRESSES and
FOR FURTHER INFORMATION CONTACT). We encourage you to submit your
notice of participation electronically. A single copy of any notice of
participation is sufficient.
The notice of participation must include your name, title, business
affiliation (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available). If you wish to request
an opportunity to make an oral presentation during the open public
comment period of the hearing, your notice of participation also must
include the title of your presentation, the sponsor of the oral
presentation (e.g., the organization paying travel expenses or fees),
if any; and the approximate amount of time requested for the
presentation. Presentations will be limited to the questions and
subject matter identified in section III of this document, and,
depending on the number of requests received, we may be obliged to
limit the time allotted for each presentation (e.g., 5 minutes each).
Under Sec. 15.20(c), if you request an opportunity to make an oral
presentation, you must submit your presentation (either as the full
text of the presentation, or as a comprehensive outline or summary).
You may submit your presentation by e-mail, fax, or mail. A single copy
of your presentation is sufficient. See ADDRESSES and FOR FURTHER
INFORMATION CONTACT for information on where to send your presentation.
Persons who wish to request an opportunity to make an oral
presentation at the hearing must submit a notice of participation by
August 24, 2007, and also must submit either the full text of the oral
presentation, or a comprehensive outline or summary of the oral
presentation, by August 31, 2007. All other persons wishing to attend
the hearing must submit a notice of participation by August 31, 2007.
Persons requiring special accommodations due to a disability must
submit a notice of participation by August 31, 2007, and should inform
the contact person of their request (see FOR FURTHER INFORMATION
CONTACT). Individuals who request an opportunity to make an oral
presentation will be notified of the scheduled time for their
presentation prior to the hearing.
We also will accept notices of participation onsite on a first
come, first served basis; however, the anticipated maximum seating
capacity is 75 to 100, and registration will be closed when the maximum
seating capacity is reached. Requests for an opportunity to make a
presentation from individuals or organizations that did not make such a
request in advance may be granted if time permits.
Persons who submit a notice of participation in advance of the
hearing should check in at the on-site registration desk between 8:30
and 9 a.m. Persons who wish to submit a notice of participation onsite
may do so at the registration desk between 8:30 and 9 a.m. on either
day of the hearing. We encourage all participants to attend the entire
hearing.
All submissions and comments received may be posted without change
to https://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided.
VI. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments for consideration at or
after the hearing in addition to, or in place of, a request for an
opportunity to make an oral presentation (see section V of this
document). Submit two paper copies of any written comments, except that
individuals may submit one copy. Comments are to be identified with the
agency name and 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.
VII. Transcripts
Transcripts of the hearing will be available for review at the
Division of Dockets Management (see ADDRESSES) and on the Internet at
https://www.fda.gov/ohrms/docketsapproximately 30 days after the
hearing. You may place orders for copies of the transcript through the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents
per page.
Dated: July 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14046 Filed 7-19-07; 8:45 am]
BILLING CODE 4160-01-S
