Food Labeling; Prominence of Calories, 17008-17010 [05-6643]
Download as PDF
17008
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004N–0463]
RIN 0910–AF22
Food Labeling; Prominence of Calories
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
advance notice of proposed rulemaking
(ANPRM) to request comment on
whether to amend certain provisions of
the agency’s nutrition labeling
regulations to give more prominence to
calories on food labels. FDA is issuing
this ANPRM in response to
recommendations of the Obesity
Working Group (OWG), which was
created by the Commissioner of Food
and Drugs (the Commissioner) to
develop an action plan to address the
Nation’s obesity problem. Comments on
whether and, if so, how to give greater
emphasis to calories on the nutrition
label will inform any FDA rulemaking
that may result from this ANPRM.
DATES: Submit written or electronic
comments by June 20, 2005.
ADDRESSES: You may submit comments,
identified by Docket No. 2004N–0463
and/or RIN number 0910–AF22, by any
of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
• E-mail: fdadockets@oc.fda.gov.
Include Docket No. 2004N–0463 and/or
RIN number 0910–AF22 in the subject
line of your e-mail message.
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier [for
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
Docket No. or Regulatory Information
Number (RIN) for this rulemaking. All
comments received will be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
detailed instructions on submitting
VerDate jul<14>2003
15:01 Apr 01, 2005
Jkt 205001
comments and additional information
on the rulemaking process, see the
‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jillonne Kevala, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1450.
SUPPLEMENTARY INFORMATION:
I. Background
A. Nutrition Labeling Regulations
The Federal Food, Drug, and Cosmetic
Act (the act) as amended by the
Nutrition Labeling and Education Act of
1990 (NLEA) (Public Law 101–535),
together with FDA’s implementing
regulations, established mandatory
nutrition labeling for packaged foods to
enable consumers to make more
informed and healthier food product
choices in the context of their daily diet.
The cornerstone of the NLEA is the
requirement that packaged foods bear a
Nutrition Facts Panel (NFP), which
provides product-specific information
on serving size, calories, and nutrient
content. FDA’s final regulations
establishing nutrition labeling were
published in 1993 (58 FR 2079, January
6, 1993) (the nutrition labeling final
rule).
With respect to calorie information,
FDA’s nutrition labeling final rule
requires the listing of total calories and
calories from fat, with the exception that
‘‘Calories from fat’’ information is not
required on products that contain less
than 0.5 gram of fat in a serving
(§ 101.9(c)(1)(ii). When ‘‘Calories from
fat’’ is not listed, the statement ‘‘Not a
significant source of calories from fat’’
must be placed at the bottom of the
nutrition label (§ 101.9(c)(1)(ii) (21 CFR
101.9(c)(1)(ii))). In addition,
manufacturers may voluntarily list
calories from saturated fat
(§ 101.9(c)(1)(iii)).
The nutrition labeling final rule
specifies the format and content for the
listing of calories in the NFP and
provides that ‘‘Calories’’ must be in a
type size no smaller than 8 point
(§ 101.9(d)(1)(iii)) and be highlighted
PO 00000
Frm 00042
Fmt 4702
Sfmt 4702
(§ 101.9(d)(1)(iv)). The nutrition labeling
final rule also provides that information
on ‘‘Calories’’ and ‘‘Calories from fat’’ in
the NFP must follow the heading
‘‘Amount Per Serving’’ and be declared
in one line with enough space to clearly
differentiate between ‘‘Calories’’ and
‘‘Calories from fat’’ unless ‘‘Calories
from saturated fat’’ is voluntarily
declared, in which case they should
appear in a column, with ‘‘Calories’’ at
the top, followed by ‘‘Calories from fat’’
and ‘‘Calories from saturated fat’’
(§ 101.9(d)(5)). Exceptions to some of
these provisions are provided for foods
that contain two or more separately
packaged foods that are intended to be
eaten individually (§ 101.9(d)(13)),
foods that contain insignificant amounts
of seven or more of certain specified
nutrients (§ 101.9(f)), foods intended for
infants and children less than 2 years of
age (§ 101.9(j)(5)), dietary supplements
(§ 101.9(j)(6)), and foods in small and
intermediate-sized packages
(§ 101.9(j)(13)).
B. The Report of FDA’s OWG
In August 2003, the Commissioner
created the OWG and charged it to
develop an action plan covering the
critical dimensions of the obesity
problem in America to help consumers
lead healthier lives through better
nutrition. The OWG was composed of
professionals across FDA who provided
a range of expertise in areas such as
food labels; communication and
education efforts; the role of industry
and restaurants; and therapeutic
interventions for obesity. The OWG met
eight times and received briefings from
several invited experts from other
government agencies. In addition, the
OWG held one public meeting, one
workshop, two round table discussions
(one with health professionals/
academicians, and one with consumer
groups), and solicited comments on
obesity-related issues, directing them to
a docket established in July 2003
(Docket No. 2003N–0338) (referred to in
this ANPRM as ‘‘the Obesity docket’’).
The final report issued by the OWG
centered on the scientific fact that
weight control is primarily a function of
the balance of calories eaten and
calories expended; and therefore,
focused on a ‘‘calories count’’ emphasis
for FDA actions (Ref. 1).
A principal aspect of the
Commissioner’s charge was for the
OWG to ‘‘develop an approach for
enhancing and improving the food label
to assist consumers in preventing
weight gain and reducing obesity.’’ After
considering the legal requirements
concerning food labeling and the
limited data on consumer familiarity
E:\FR\FM\04APP1.SGM
04APP1
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Proposed Rules
with, and use of, food label information
(described in section I.C of this
document), the OWG recommended that
FDA: (1) Develop options for revising or
adding caloric and other nutritional
information on food packaging, (2)
obtain information on the effectiveness
of these options in affecting consumer
understanding and behavior relevant to
caloric intake, and (3) evaluate this
information to make evidence-based
decisions on which options to pursue.
This ANPRM will focus only on the
OWG recommendations pertaining to
giving more prominence to calories.
C. Data Concerning the NFP and Calorie
Information
The OWG reviewed research
conducted by FDA and others,
described more fully in ‘‘Calories
Count’’ (Ref. 1), that shows that most
consumers are familiar with the
nutrition information on food labels and
that they use this information primarily
for evaluating the nutrition quality of
specific food products. However, the
percentage of consumers who use the
NFP information productively for
weight management purposes is low
(Ref. 1). In addition, the OWG also
reviewed results of focus group research
conducted by FDA in November and
December 2003 to provide, among other
things, preliminary information on the
participants’ attitudes and behaviors
towards nutrition information on food
labels. In this research, among other
things, FDA asked participants
questions aimed at determining
consumer attitudes and behaviors
towards changes in the presentation of
calorie information in the NFP and
calorie information on the front label of
food packages.
Participants in FDA focus groups
cared about nutrition labeling and
reported using the NFP. While many
participants said they were interested in
calories, many also pointed to multiple
concerns that went beyond the labeling
of calories such as the level of saturated
fat, total fat, cholesterol, carbohydrates
and sodium (Ref. 1).
In terms of calorie-related variations
in the NFP, the focus groups tested
participant understanding of several
food label designs, including one
similar to the current NFP but with
some modifications. These included a
relatively larger font size for the calories
line, a %DV (daily value) for calories,
and removal of the listing for ‘‘Calories
from fat.’’ Many of the participants in
these studies did not comment on the
changes in the label until they were
pointed out to them (Ref. 1).
Focus group participants were also
shown a design that included a
VerDate jul<14>2003
15:01 Apr 01, 2005
Jkt 205001
‘‘starburst’’ with the amount of calories
per serving placed on the front of the
label (i.e., the principal display panel
(PDP)), as a way to give greater
prominence to calories. The
respondents felt that this design was
misleading, i.e., that the manufacturer
was trying to indicate that the entire
product (as opposed to a single serving)
had fewer calories than it actually had.
Other groups were shown a design that
included a white square with the
amount of calories for the entire
package. The responses of those shown
this white square design were mixed
(Ref. 1).
Findings from focus group research
yield only qualitative data and should
not be viewed as nationally
representative of consumers’ views.
Quantitative experimental data are
necessary to make reliable and verifiable
conclusions of consumers’ views.
However, focus group research can shed
some interesting light on the complex
issues covered by the OWG and are
useful for identifying quantitative
research needs.
In addition to the literature review
and focus group research described
more fully in Ref. 1, we have also
reviewed the written and public
comments submitted to the Obesity
docket. Several of these comments
suggested that FDA develop ways to
emphasize calories on the food label. In
particular, these comments suggested
that the label should focus less on fat
and more on calories and overall diet,
and that calories should be listed on the
front, or on the PDP of the package in
clear, bold lettering. Other comments
noted that research should be conducted
to determine whether the current calorie
listing is meaningful to consumers. We
agree with the comments that more
research is needed, and that the
highlighted comments are important
considerations. However, before
recommending changes to the food
label, the agency wants to develop a
better understanding of how consumers
currently use calorie information on the
NFP, and then assess whether the NFP
requires modification to be effective in
facilitating positive dietary change (Ref.
1).
D. Recommendations From the OWG
Concerning Calorie Labeling
Based on information presented to
and gathered by the OWG, its Report
observed that, despite evidence of a
positive correlation between label use
and certain positive dietary choices
(e.g., selection of lower sodium or lower
fat content foods), the trend towards
obesity has accelerated over the last
decade (Ref. 1). The OWG hypothesized
PO 00000
Frm 00043
Fmt 4702
Sfmt 4702
17009
that consumers may not take advantage
of the available information on the food
label to control their weight, may not
appreciate how the information could
be used for weight management
purposes, or may find it to hard to apply
the available information to such
purposes (Ref. 1). Therefore, the OWG
recommended that FDA issue an
ANPRM to solicit public comments on
how to give more prominence to
calories on the food label. Possible
changes suggested by the OWG were as
follows: (1) Increasing the font size for
calories; (2) providing for a %DV for
calories; and (3) eliminating the
‘‘Calories from fat’’ listing, as this may
take the emphasis away from the listing
of ‘‘Calories’’ (Ref. 1).
II. Agency Request for Information
The ability to determine the caloric
content of packaged foods is critical for
consumers, especially consumers who
are trying to control total caloric intake
and manage their weight. While the
current NFP does allow consumers to
determine the caloric content of
packaged foods, it may be, as suggested
by the OWG Report, that modifying the
food label to give more emphasis to
calorie information would benefit
consumers in weight control and
maintenance. To help the agency
determine which regulatory options
provide consumers with information
that is most useful in weight control and
weight management, and for any future
analysis of benefits and costs associated
with those regulatory options, we
request comments and available data on
the following questions.
A. Questions Concerning Prominence of
Calorie Information on Food Labels
• Would consumer awareness of the
caloric content of packaged foods be
increased by amending nutrition
labeling regulations to give more
prominence to the declaration of
calories per serving? Why or why not?
• How would a more prominent
listing of calorie information change the
way consumers use the NFP in deciding
what to eat?
• What methods could be considered
for increasing prominence? For
example, should the font size be
increased for the listing of ‘‘Calories’’
from the current requirement of 8-point
type, and/or should extra bold type or
a different style of type be used?
• Would providing for a %DV
disclosure for total calories assist
consumers in understanding the caloric
content of the packaged food in the
context of a 2,000 calorie diet? Why or
why not?
E:\FR\FM\04APP1.SGM
04APP1
17010
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Proposed Rules
B. Questions Concerning ‘‘Calories From
Fat’’
D. Questions About Reformulation of
Foods Or Redesign of Packaging
Section 403(q)(1)(C)(ii) of the act (21
U.S.C. 343) states that total calories from
fat must be declared on the food label,
unless the Secretary [of Health and
Human Services] determines that the
listing is not necessary to assist
consumers in maintaining healthy
dietary practices. When the nutrition
labeling final rule was published in
1993, the Dietary Guidelines for
Americans (1990) recommended that
diets be low in fat (Ref. 2). The current
Dietary Guidelines for Americans (2005)
recommends that diets be moderate in
fat with most fats coming from
polyunsaturated and monounsaturated
fatty acids (Ref. 3). Moreover, the
current Dietary Guidelines for
Americans recommends maintaining
body weight in a healthy range by
balancing those calories consumed from
foods and beverages with those calories
expended. Based on the information in
the previous sentences, we request
comments and data on the following
questions:
• What data is there on how
consumers use the listing of ‘‘Calories
from fat?’’
• How does the listing ‘‘Calories from
fat’’ adjacent to ‘‘Calories’’ affect
consumers’ focus on the total calories of
a food?
• What are the advantages or
disadvantages of eliminating the listing
for ‘‘Calories from fat’’ from the
nutrition label?
• What data would be needed to
determine whether the listing of
‘‘Calories from fat’’ is or is not necessary
to assist consumers in maintaining
healthy dietary practices?
Changing the regulations on calorie
labeling may have an effect on what
producers offer for sale. FDA has no
prior information about whether new
requirements for calorie labeling would
simply change the way currently
existing foods are packaged, or if the
new requirements would change the
formulation of foods offered for sale. In
light of this information:
• Would the display of caloric
content per package on PDPs encourage
more competition based on the caloric
content of packages and, if so, how?
• If the calorie content per serving
were required to be more prominently
displayed on the NFP, would it
encourage more competition based on
the calorie content of the food? Would
the result be products reformulated to
have fewer calories per serving, for
example greater use of no calorie
sweeteners? Would it result in any
repackaging of products offered? How
would this option change the kinds of
products offered?
• If the calorie content per package
were required to be prominently
displayed on the PDP, would it
encourage more competition based on
the calorie content of the food? Would
the result be repackaging of products
into smaller units, for example
repackaging cookies into 100 calorie
packages? Would there be any incentive
to reformulate under this option? How
would this option change the kinds of
products offered?
• Are you aware of any research,
consumer or industry-based, that can
assist the agency to answer any of the
previous questions?
C. Questions About Use of Calorie
Information on Food Labels
Based on preliminary results from
focus group research, discussed in this
ANPRM, we request comments and data
on the following questions:
• Is calorie content used to determine
how much of a given food to eat, or to
determine which foods, out of a range
of similar products, to eat? Why or why
not?
• If calorie labeling affects decisions
on whether to eat a food and on how
much to eat, how would the effects of
the following requirements differ:
A requirement to display the number
of calories per serving on the PDP or
A requirement to increase the
prominence of the calories per serving
in the NFP?
• What do consumers currently think
the calories on packaged foods
represent?
VerDate jul<14>2003
15:01 Apr 01, 2005
Jkt 205001
III. Future Analysis of Benefits and
Costs
If the agency proposes regulatory
changes based on the initiatives
outlined in this ANPRM, we will
estimate the costs of labeling changes
and other potential costs (such as the
costs of reformulating products) should
the regulation create incentives for new
products. The comments on this
ANPRM may identify other costs as
well. The benefits of the regulatory
options depend on how consumers and
producers respond to the changes in
calorie labeling. We will use the
information from comments to help
determine ways to estimate the possible
consumer responses to various changes.
The comments will also contribute to
our estimates of the effects of regulatory
options on small entities.
PO 00000
Frm 00044
Fmt 4702
Sfmt 4702
IV. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen between 9 a.m. and 4
p.m., Monday through Friday.
1. Report of the Obesity Working Group,
‘‘Calories Count,’’ March 12, 2004, (https://
www.cfsan.fda.gov/~dms/owg-toc.html).
2. U.S. Department of Agriculture and U.S.
Department of Health and Human Services,
‘‘Dietary Guidelines for Americans,’’ 3d ed.,
pp. 14–15, 1990.
3. U.S. Department of Agriculture and U.S.
Department of Health and Human Services,
‘‘Dietary Guidelines for Americans 2005,’’
pp. vii-viii, 2005.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6643 Filed 4–1–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004N–0456]
RIN 0910–AF23
Food Labeling: Serving Sizes of
Products That Can Reasonably Be
Consumed At One Eating Occasion;
Updating of Reference Amounts
Customarily Consumed; Approaches
for Recommending Smaller Portion
Sizes
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
advance notice of proposed rulemaking
(ANPRM) to request comment on
whether to amend certain provisions of
the agency’s nutrition labeling
regulations concerning serving size.
E:\FR\FM\04APP1.SGM
04APP1
Agencies
[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Proposed Rules]
[Pages 17008-17010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6643]
[[Page 17008]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004N-0463]
RIN 0910-AF22
Food Labeling; Prominence of Calories
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing this advance
notice of proposed rulemaking (ANPRM) to request comment on whether to
amend certain provisions of the agency's nutrition labeling regulations
to give more prominence to calories on food labels. FDA is issuing this
ANPRM in response to recommendations of the Obesity Working Group
(OWG), which was created by the Commissioner of Food and Drugs (the
Commissioner) to develop an action plan to address the Nation's obesity
problem. Comments on whether and, if so, how to give greater emphasis
to calories on the nutrition label will inform any FDA rulemaking that
may result from this ANPRM.
DATES: Submit written or electronic comments by June 20, 2005.
ADDRESSES: You may submit comments, identified by Docket No. 2004N-0463
and/or RIN number 0910-AF22, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0463 and/or RIN number 0910-AF22 in the subject line of your e-mail
message.
Fax: 301-827-6870.
Mail/Hand delivery/Courier [for paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
https://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.
SUPPLEMENTARY INFORMATION:
I. Background
A. Nutrition Labeling Regulations
The Federal Food, Drug, and Cosmetic Act (the act) as amended by
the Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law
101-535), together with FDA's implementing regulations, established
mandatory nutrition labeling for packaged foods to enable consumers to
make more informed and healthier food product choices in the context of
their daily diet. The cornerstone of the NLEA is the requirement that
packaged foods bear a Nutrition Facts Panel (NFP), which provides
product-specific information on serving size, calories, and nutrient
content. FDA's final regulations establishing nutrition labeling were
published in 1993 (58 FR 2079, January 6, 1993) (the nutrition labeling
final rule).
With respect to calorie information, FDA's nutrition labeling final
rule requires the listing of total calories and calories from fat, with
the exception that ``Calories from fat'' information is not required on
products that contain less than 0.5 gram of fat in a serving (Sec.
101.9(c)(1)(ii). When ``Calories from fat'' is not listed, the
statement ``Not a significant source of calories from fat'' must be
placed at the bottom of the nutrition label (Sec. 101.9(c)(1)(ii) (21
CFR 101.9(c)(1)(ii))). In addition, manufacturers may voluntarily list
calories from saturated fat (Sec. 101.9(c)(1)(iii)).
The nutrition labeling final rule specifies the format and content
for the listing of calories in the NFP and provides that ``Calories''
must be in a type size no smaller than 8 point (Sec. 101.9(d)(1)(iii))
and be highlighted (Sec. 101.9(d)(1)(iv)). The nutrition labeling
final rule also provides that information on ``Calories'' and
``Calories from fat'' in the NFP must follow the heading ``Amount Per
Serving'' and be declared in one line with enough space to clearly
differentiate between ``Calories'' and ``Calories from fat'' unless
``Calories from saturated fat'' is voluntarily declared, in which case
they should appear in a column, with ``Calories'' at the top, followed
by ``Calories from fat'' and ``Calories from saturated fat'' (Sec.
101.9(d)(5)). Exceptions to some of these provisions are provided for
foods that contain two or more separately packaged foods that are
intended to be eaten individually (Sec. 101.9(d)(13)), foods that
contain insignificant amounts of seven or more of certain specified
nutrients (Sec. 101.9(f)), foods intended for infants and children
less than 2 years of age (Sec. 101.9(j)(5)), dietary supplements
(Sec. 101.9(j)(6)), and foods in small and intermediate-sized packages
(Sec. 101.9(j)(13)).
B. The Report of FDA's OWG
In August 2003, the Commissioner created the OWG and charged it to
develop an action plan covering the critical dimensions of the obesity
problem in America to help consumers lead healthier lives through
better nutrition. The OWG was composed of professionals across FDA who
provided a range of expertise in areas such as food labels;
communication and education efforts; the role of industry and
restaurants; and therapeutic interventions for obesity. The OWG met
eight times and received briefings from several invited experts from
other government agencies. In addition, the OWG held one public
meeting, one workshop, two round table discussions (one with health
professionals/academicians, and one with consumer groups), and
solicited comments on obesity-related issues, directing them to a
docket established in July 2003 (Docket No. 2003N-0338) (referred to in
this ANPRM as ``the Obesity docket''). The final report issued by the
OWG centered on the scientific fact that weight control is primarily a
function of the balance of calories eaten and calories expended; and
therefore, focused on a ``calories count'' emphasis for FDA actions
(Ref. 1).
A principal aspect of the Commissioner's charge was for the OWG to
``develop an approach for enhancing and improving the food label to
assist consumers in preventing weight gain and reducing obesity.''
After considering the legal requirements concerning food labeling and
the limited data on consumer familiarity
[[Page 17009]]
with, and use of, food label information (described in section I.C of
this document), the OWG recommended that FDA: (1) Develop options for
revising or adding caloric and other nutritional information on food
packaging, (2) obtain information on the effectiveness of these options
in affecting consumer understanding and behavior relevant to caloric
intake, and (3) evaluate this information to make evidence-based
decisions on which options to pursue. This ANPRM will focus only on the
OWG recommendations pertaining to giving more prominence to calories.
C. Data Concerning the NFP and Calorie Information
The OWG reviewed research conducted by FDA and others, described
more fully in ``Calories Count'' (Ref. 1), that shows that most
consumers are familiar with the nutrition information on food labels
and that they use this information primarily for evaluating the
nutrition quality of specific food products. However, the percentage of
consumers who use the NFP information productively for weight
management purposes is low (Ref. 1). In addition, the OWG also reviewed
results of focus group research conducted by FDA in November and
December 2003 to provide, among other things, preliminary information
on the participants' attitudes and behaviors towards nutrition
information on food labels. In this research, among other things, FDA
asked participants questions aimed at determining consumer attitudes
and behaviors towards changes in the presentation of calorie
information in the NFP and calorie information on the front label of
food packages.
Participants in FDA focus groups cared about nutrition labeling and
reported using the NFP. While many participants said they were
interested in calories, many also pointed to multiple concerns that
went beyond the labeling of calories such as the level of saturated
fat, total fat, cholesterol, carbohydrates and sodium (Ref. 1).
In terms of calorie-related variations in the NFP, the focus groups
tested participant understanding of several food label designs,
including one similar to the current NFP but with some modifications.
These included a relatively larger font size for the calories line, a
%DV (daily value) for calories, and removal of the listing for
``Calories from fat.'' Many of the participants in these studies did
not comment on the changes in the label until they were pointed out to
them (Ref. 1).
Focus group participants were also shown a design that included a
``starburst'' with the amount of calories per serving placed on the
front of the label (i.e., the principal display panel (PDP)), as a way
to give greater prominence to calories. The respondents felt that this
design was misleading, i.e., that the manufacturer was trying to
indicate that the entire product (as opposed to a single serving) had
fewer calories than it actually had. Other groups were shown a design
that included a white square with the amount of calories for the entire
package. The responses of those shown this white square design were
mixed (Ref. 1).
Findings from focus group research yield only qualitative data and
should not be viewed as nationally representative of consumers' views.
Quantitative experimental data are necessary to make reliable and
verifiable conclusions of consumers' views. However, focus group
research can shed some interesting light on the complex issues covered
by the OWG and are useful for identifying quantitative research needs.
In addition to the literature review and focus group research
described more fully in Ref. 1, we have also reviewed the written and
public comments submitted to the Obesity docket. Several of these
comments suggested that FDA develop ways to emphasize calories on the
food label. In particular, these comments suggested that the label
should focus less on fat and more on calories and overall diet, and
that calories should be listed on the front, or on the PDP of the
package in clear, bold lettering. Other comments noted that research
should be conducted to determine whether the current calorie listing is
meaningful to consumers. We agree with the comments that more research
is needed, and that the highlighted comments are important
considerations. However, before recommending changes to the food label,
the agency wants to develop a better understanding of how consumers
currently use calorie information on the NFP, and then assess whether
the NFP requires modification to be effective in facilitating positive
dietary change (Ref. 1).
D. Recommendations From the OWG Concerning Calorie Labeling
Based on information presented to and gathered by the OWG, its
Report observed that, despite evidence of a positive correlation
between label use and certain positive dietary choices (e.g., selection
of lower sodium or lower fat content foods), the trend towards obesity
has accelerated over the last decade (Ref. 1). The OWG hypothesized
that consumers may not take advantage of the available information on
the food label to control their weight, may not appreciate how the
information could be used for weight management purposes, or may find
it to hard to apply the available information to such purposes (Ref.
1). Therefore, the OWG recommended that FDA issue an ANPRM to solicit
public comments on how to give more prominence to calories on the food
label. Possible changes suggested by the OWG were as follows: (1)
Increasing the font size for calories; (2) providing for a %DV for
calories; and (3) eliminating the ``Calories from fat'' listing, as
this may take the emphasis away from the listing of ``Calories'' (Ref.
1).
II. Agency Request for Information
The ability to determine the caloric content of packaged foods is
critical for consumers, especially consumers who are trying to control
total caloric intake and manage their weight. While the current NFP
does allow consumers to determine the caloric content of packaged
foods, it may be, as suggested by the OWG Report, that modifying the
food label to give more emphasis to calorie information would benefit
consumers in weight control and maintenance. To help the agency
determine which regulatory options provide consumers with information
that is most useful in weight control and weight management, and for
any future analysis of benefits and costs associated with those
regulatory options, we request comments and available data on the
following questions.
A. Questions Concerning Prominence of Calorie Information on Food
Labels
Would consumer awareness of the caloric content of
packaged foods be increased by amending nutrition labeling regulations
to give more prominence to the declaration of calories per serving? Why
or why not?
How would a more prominent listing of calorie information
change the way consumers use the NFP in deciding what to eat?
What methods could be considered for increasing
prominence? For example, should the font size be increased for the
listing of ``Calories'' from the current requirement of 8-point type,
and/or should extra bold type or a different style of type be used?
Would providing for a %DV disclosure for total calories
assist consumers in understanding the caloric content of the packaged
food in the context of a 2,000 calorie diet? Why or why not?
[[Page 17010]]
B. Questions Concerning ``Calories From Fat''
Section 403(q)(1)(C)(ii) of the act (21 U.S.C. 343) states that
total calories from fat must be declared on the food label, unless the
Secretary [of Health and Human Services] determines that the listing is
not necessary to assist consumers in maintaining healthy dietary
practices. When the nutrition labeling final rule was published in
1993, the Dietary Guidelines for Americans (1990) recommended that
diets be low in fat (Ref. 2). The current Dietary Guidelines for
Americans (2005) recommends that diets be moderate in fat with most
fats coming from polyunsaturated and monounsaturated fatty acids (Ref.
3). Moreover, the current Dietary Guidelines for Americans recommends
maintaining body weight in a healthy range by balancing those calories
consumed from foods and beverages with those calories expended. Based
on the information in the previous sentences, we request comments and
data on the following questions:
What data is there on how consumers use the listing of
``Calories from fat?''
How does the listing ``Calories from fat'' adjacent to
``Calories'' affect consumers' focus on the total calories of a food?
What are the advantages or disadvantages of eliminating
the listing for ``Calories from fat'' from the nutrition label?
What data would be needed to determine whether the listing
of ``Calories from fat'' is or is not necessary to assist consumers in
maintaining healthy dietary practices?
C. Questions About Use of Calorie Information on Food Labels
Based on preliminary results from focus group research, discussed
in this ANPRM, we request comments and data on the following questions:
Is calorie content used to determine how much of a given
food to eat, or to determine which foods, out of a range of similar
products, to eat? Why or why not?
If calorie labeling affects decisions on whether to eat a
food and on how much to eat, how would the effects of the following
requirements differ:
A requirement to display the number of calories per serving on the
PDP or
A requirement to increase the prominence of the calories per
serving in the NFP?
What do consumers currently think the calories on packaged
foods represent?
D. Questions About Reformulation of Foods Or Redesign of Packaging
Changing the regulations on calorie labeling may have an effect on
what producers offer for sale. FDA has no prior information about
whether new requirements for calorie labeling would simply change the
way currently existing foods are packaged, or if the new requirements
would change the formulation of foods offered for sale. In light of
this information:
Would the display of caloric content per package on PDPs
encourage more competition based on the caloric content of packages
and, if so, how?
If the calorie content per serving were required to be
more prominently displayed on the NFP, would it encourage more
competition based on the calorie content of the food? Would the result
be products reformulated to have fewer calories per serving, for
example greater use of no calorie sweeteners? Would it result in any
repackaging of products offered? How would this option change the kinds
of products offered?
If the calorie content per package were required to be
prominently displayed on the PDP, would it encourage more competition
based on the calorie content of the food? Would the result be
repackaging of products into smaller units, for example repackaging
cookies into 100 calorie packages? Would there be any incentive to
reformulate under this option? How would this option change the kinds
of products offered?
Are you aware of any research, consumer or industry-based,
that can assist the agency to answer any of the previous questions?
III. Future Analysis of Benefits and Costs
If the agency proposes regulatory changes based on the initiatives
outlined in this ANPRM, we will estimate the costs of labeling changes
and other potential costs (such as the costs of reformulating products)
should the regulation create incentives for new products. The comments
on this ANPRM may identify other costs as well. The benefits of the
regulatory options depend on how consumers and producers respond to the
changes in calorie labeling. We will use the information from comments
to help determine ways to estimate the possible consumer responses to
various changes. The comments will also contribute to our estimates of
the effects of regulatory options on small entities.
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m., Monday through Friday.
1. Report of the Obesity Working Group, ``Calories Count,''
March 12, 2004, (https://www.cfsan.fda.gov/dms/owg-toc.html).
2. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Dietary Guidelines for Americans,'' 3d ed.,
pp. 14-15, 1990.
3. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Dietary Guidelines for Americans 2005,'' pp.
vii-viii, 2005.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6643 Filed 4-1-05; 8:45 am]
BILLING CODE 4160-01-S