[Federal Register: April 4, 2005 (Volume 70, Number 63)]
[Proposed Rules]
[Page 17008-17010]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap05-24]


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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.

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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: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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
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. 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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

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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?

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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, (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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