[Federal Register Volume 72, Number 139 (Friday, July 20, 2007)]
[Notices]
[Pages 39815-39818]
From the Federal Register Online via the Government Publishing 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 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: techcorp.com">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://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: [email protected].

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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 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://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