[Federal Register: July 20, 2007 (Volume 72, Number 139)]
[Notices]
[Page 39815-39818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy07-65]
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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.
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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
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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 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided.
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
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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