[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: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: 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://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://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, (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