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17008 Federal Register / Vol. 70, No.

63 / Monday, April 4, 2005 / Proposed Rules

DEPARTMENT OF HEALTH AND comments and additional information (§ 101.9(d)(1)(iv)). The nutrition labeling
HUMAN SERVICES on the rulemaking process, see the final rule also provides that information
‘‘Comments’’ heading of the on ‘‘Calories’’ and ‘‘Calories from fat’’ in
Food and Drug Administration SUPPLEMENTARY INFORMATION section of the NFP must follow the heading
this document. ‘‘Amount Per Serving’’ and be declared
21 CFR Part 101 Docket: For access to the docket to in one line with enough space to clearly
read background documents or differentiate between ‘‘Calories’’ and
[Docket No. 2004N–0463]
comments received, go to http:// ‘‘Calories from fat’’ unless ‘‘Calories
RIN 0910–AF22 www.fda.gov/ohrms/dockets/ from saturated fat’’ is voluntarily
default.htm and insert the docket declared, in which case they should
Food Labeling; Prominence of Calories number, found in brackets in the appear in a column, with ‘‘Calories’’ at
AGENCY: Food and Drug Administration, heading of this document, into the the top, followed by ‘‘Calories from fat’’
HHS. ‘‘Search’’ box and follow the prompts and ‘‘Calories from saturated fat’’
and/or go to the Division of Dockets (§ 101.9(d)(5)). Exceptions to some of
ACTION:Advance notice of proposed
Management, 5630 Fishers Lane, rm. these provisions are provided for foods
rulemaking.
1061, Rockville, MD 20852. that contain two or more separately
SUMMARY: The Food and Drug FOR FURTHER INFORMATION CONTACT: packaged foods that are intended to be
Administration (FDA) is issuing this Jillonne Kevala, Center for Food Safety eaten individually (§ 101.9(d)(13)),
advance notice of proposed rulemaking and Applied Nutrition (HFS–830), Food foods that contain insignificant amounts
(ANPRM) to request comment on and Drug Administration, 5100 Paint of seven or more of certain specified
whether to amend certain provisions of Branch Pkwy., College Park, MD 20740– nutrients (§ 101.9(f)), foods intended for
the agency’s nutrition labeling 3835, 301–436–1450. infants and children less than 2 years of
regulations to give more prominence to SUPPLEMENTARY INFORMATION: age (§ 101.9(j)(5)), dietary supplements
calories on food labels. FDA is issuing (§ 101.9(j)(6)), and foods in small and
I. Background intermediate-sized packages
this ANPRM in response to
recommendations of the Obesity A. Nutrition Labeling Regulations (§ 101.9(j)(13)).
Working Group (OWG), which was The Federal Food, Drug, and Cosmetic B. The Report of FDA’s OWG
created by the Commissioner of Food Act (the act) as amended by the In August 2003, the Commissioner
and Drugs (the Commissioner) to Nutrition Labeling and Education Act of created the OWG and charged it to
develop an action plan to address the 1990 (NLEA) (Public Law 101–535), develop an action plan covering the
Nation’s obesity problem. Comments on together with FDA’s implementing critical dimensions of the obesity
whether and, if so, how to give greater regulations, established mandatory problem in America to help consumers
emphasis to calories on the nutrition nutrition labeling for packaged foods to lead healthier lives through better
label will inform any FDA rulemaking enable consumers to make more nutrition. The OWG was composed of
that may result from this ANPRM. informed and healthier food product professionals across FDA who provided
DATES: Submit written or electronic choices in the context of their daily diet. a range of expertise in areas such as
comments by June 20, 2005. The cornerstone of the NLEA is the food labels; communication and
ADDRESSES: You may submit comments, requirement that packaged foods bear a education efforts; the role of industry
identified by Docket No. 2004N–0463 Nutrition Facts Panel (NFP), which and restaurants; and therapeutic
and/or RIN number 0910–AF22, by any provides product-specific information interventions for obesity. The OWG met
of the following methods: on serving size, calories, and nutrient eight times and received briefings from
• Federal eRulemaking Portal: http:// content. FDA’s final regulations several invited experts from other
www.regulations.gov. Follow the establishing nutrition labeling were government agencies. In addition, the
instructions for submitting comments. published in 1993 (58 FR 2079, January OWG held one public meeting, one
• Agency Web site: http:// 6, 1993) (the nutrition labeling final workshop, two round table discussions
www.fda.gov/dockets/ecomments. rule). (one with health professionals/
Follow the instructions for submitting With respect to calorie information, academicians, and one with consumer
comments on the agency Web site. FDA’s nutrition labeling final rule groups), and solicited comments on
• E-mail: fdadockets@oc.fda.gov. requires the listing of total calories and obesity-related issues, directing them to
Include Docket No. 2004N–0463 and/or calories from fat, with the exception that a docket established in July 2003
RIN number 0910–AF22 in the subject ‘‘Calories from fat’’ information is not (Docket No. 2003N–0338) (referred to in
line of your e-mail message. required on products that contain less this ANPRM as ‘‘the Obesity docket’’).
• Fax: 301–827–6870. than 0.5 gram of fat in a serving The final report issued by the OWG
• Mail/Hand delivery/Courier [for (§ 101.9(c)(1)(ii). When ‘‘Calories from centered on the scientific fact that
paper, disk, or CD–ROM submissions]: fat’’ is not listed, the statement ‘‘Not a weight control is primarily a function of
Division of Dockets Management (HFA– significant source of calories from fat’’ the balance of calories eaten and
305), Food and Drug Administration, must be placed at the bottom of the calories expended; and therefore,
5630 Fishers Lane, rm. 1061, Rockville, nutrition label (§ 101.9(c)(1)(ii) (21 CFR focused on a ‘‘calories count’’ emphasis
MD 20852. 101.9(c)(1)(ii))). In addition, for FDA actions (Ref. 1).
Instructions: All submissions received manufacturers may voluntarily list A principal aspect of the
must include the agency name and calories from saturated fat Commissioner’s charge was for the
Docket No. or Regulatory Information (§ 101.9(c)(1)(iii)). OWG to ‘‘develop an approach for
Number (RIN) for this rulemaking. All The nutrition labeling final rule enhancing and improving the food label
comments received will be posted specifies the format and content for the to assist consumers in preventing
without change to http://www.fda.gov/ listing of calories in the NFP and weight gain and reducing obesity.’’ After
ohrms/dockets/default.htm, including provides that ‘‘Calories’’ must be in a considering the legal requirements
any personal information provided. For type size no smaller than 8 point concerning food labeling and the
detailed instructions on submitting (§ 101.9(d)(1)(iii)) and be highlighted limited data on consumer familiarity

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Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Proposed Rules 17009

with, and use of, food label information ‘‘starburst’’ with the amount of calories that consumers may not take advantage
(described in section I.C of this per serving placed on the front of the of the available information on the food
document), the OWG recommended that label (i.e., the principal display panel label to control their weight, may not
FDA: (1) Develop options for revising or (PDP)), as a way to give greater appreciate how the information could
adding caloric and other nutritional prominence to calories. The be used for weight management
information on food packaging, (2) respondents felt that this design was purposes, or may find it to hard to apply
obtain information on the effectiveness misleading, i.e., that the manufacturer the available information to such
of these options in affecting consumer was trying to indicate that the entire purposes (Ref. 1). Therefore, the OWG
understanding and behavior relevant to product (as opposed to a single serving) recommended that FDA issue an
caloric intake, and (3) evaluate this had fewer calories than it actually had. ANPRM to solicit public comments on
information to make evidence-based Other groups were shown a design that how to give more prominence to
decisions on which options to pursue. included a white square with the calories on the food label. Possible
This ANPRM will focus only on the amount of calories for the entire changes suggested by the OWG were as
OWG recommendations pertaining to package. The responses of those shown follows: (1) Increasing the font size for
giving more prominence to calories. this white square design were mixed calories; (2) providing for a %DV for
(Ref. 1). calories; and (3) eliminating the
C. Data Concerning the NFP and Calorie Findings from focus group research
Information ‘‘Calories from fat’’ listing, as this may
yield only qualitative data and should take the emphasis away from the listing
The OWG reviewed research not be viewed as nationally of ‘‘Calories’’ (Ref. 1).
conducted by FDA and others, representative of consumers’ views.
described more fully in ‘‘Calories Quantitative experimental data are II. Agency Request for Information
Count’’ (Ref. 1), that shows that most necessary to make reliable and verifiable The ability to determine the caloric
consumers are familiar with the conclusions of consumers’ views. content of packaged foods is critical for
nutrition information on food labels and However, focus group research can shed consumers, especially consumers who
that they use this information primarily some interesting light on the complex are trying to control total caloric intake
for evaluating the nutrition quality of issues covered by the OWG and are and manage their weight. While the
specific food products. However, the useful for identifying quantitative current NFP does allow consumers to
percentage of consumers who use the research needs. determine the caloric content of
NFP information productively for In addition to the literature review packaged foods, it may be, as suggested
weight management purposes is low and focus group research described by the OWG Report, that modifying the
(Ref. 1). In addition, the OWG also more fully in Ref. 1, we have also food label to give more emphasis to
reviewed results of focus group research reviewed the written and public calorie information would benefit
conducted by FDA in November and comments submitted to the Obesity consumers in weight control and
December 2003 to provide, among other docket. Several of these comments maintenance. To help the agency
things, preliminary information on the suggested that FDA develop ways to
determine which regulatory options
participants’ attitudes and behaviors emphasize calories on the food label. In
provide consumers with information
towards nutrition information on food particular, these comments suggested
that is most useful in weight control and
labels. In this research, among other that the label should focus less on fat
weight management, and for any future
things, FDA asked participants and more on calories and overall diet,
analysis of benefits and costs associated
questions aimed at determining and that calories should be listed on the
with those regulatory options, we
consumer attitudes and behaviors front, or on the PDP of the package in
request comments and available data on
towards changes in the presentation of clear, bold lettering. Other comments
the following questions.
calorie information in the NFP and noted that research should be conducted
calorie information on the front label of to determine whether the current calorie A. Questions Concerning Prominence of
food packages. listing is meaningful to consumers. We Calorie Information on Food Labels
Participants in FDA focus groups agree with the comments that more
cared about nutrition labeling and research is needed, and that the • Would consumer awareness of the
reported using the NFP. While many highlighted comments are important caloric content of packaged foods be
participants said they were interested in considerations. However, before increased by amending nutrition
calories, many also pointed to multiple recommending changes to the food labeling regulations to give more
concerns that went beyond the labeling label, the agency wants to develop a prominence to the declaration of
of calories such as the level of saturated better understanding of how consumers calories per serving? Why or why not?
fat, total fat, cholesterol, carbohydrates currently use calorie information on the • How would a more prominent
and sodium (Ref. 1). NFP, and then assess whether the NFP listing of calorie information change the
In terms of calorie-related variations requires modification to be effective in way consumers use the NFP in deciding
in the NFP, the focus groups tested facilitating positive dietary change (Ref. what to eat?
participant understanding of several 1). • What methods could be considered
food label designs, including one for increasing prominence? For
similar to the current NFP but with D. Recommendations From the OWG example, should the font size be
some modifications. These included a Concerning Calorie Labeling increased for the listing of ‘‘Calories’’
relatively larger font size for the calories Based on information presented to from the current requirement of 8-point
line, a %DV (daily value) for calories, and gathered by the OWG, its Report type, and/or should extra bold type or
and removal of the listing for ‘‘Calories observed that, despite evidence of a a different style of type be used?
from fat.’’ Many of the participants in positive correlation between label use • Would providing for a %DV
these studies did not comment on the and certain positive dietary choices disclosure for total calories assist
changes in the label until they were (e.g., selection of lower sodium or lower consumers in understanding the caloric
pointed out to them (Ref. 1). fat content foods), the trend towards content of the packaged food in the
Focus group participants were also obesity has accelerated over the last context of a 2,000 calorie diet? Why or
shown a design that included a decade (Ref. 1). The OWG hypothesized why not?

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17010 Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Proposed Rules

B. Questions Concerning ‘‘Calories From D. Questions About Reformulation of IV. References


Fat’’ Foods Or Redesign of Packaging The following references have been
Section 403(q)(1)(C)(ii) of the act (21 Changing the regulations on calorie placed on display in the Division of
U.S.C. 343) states that total calories from labeling may have an effect on what Dockets Management (see ADDRESSES)
fat must be declared on the food label, producers offer for sale. FDA has no and may be seen between 9 a.m. and 4
unless the Secretary [of Health and prior information about whether new p.m., Monday through Friday.
Human Services] determines that the 1. Report of the Obesity Working Group,
requirements for calorie labeling would ‘‘Calories Count,’’ March 12, 2004, (http://
listing is not necessary to assist simply change the way currently
consumers in maintaining healthy www.cfsan.fda.gov/~dms/owg-toc.html).
existing foods are packaged, or if the 2. U.S. Department of Agriculture and U.S.
dietary practices. When the nutrition new requirements would change the Department of Health and Human Services,
labeling final rule was published in formulation of foods offered for sale. In ‘‘Dietary Guidelines for Americans,’’ 3d ed.,
1993, the Dietary Guidelines for light of this information: pp. 14–15, 1990.
Americans (1990) recommended that 3. U.S. Department of Agriculture and U.S.
diets be low in fat (Ref. 2). The current • Would the display of caloric Department of Health and Human Services,
Dietary Guidelines for Americans (2005) content per package on PDPs encourage ‘‘Dietary Guidelines for Americans 2005,’’
recommends that diets be moderate in more competition based on the caloric pp. vii-viii, 2005.
fat with most fats coming from content of packages and, if so, how?
V. Comments
polyunsaturated and monounsaturated • If the calorie content per serving
were required to be more prominently Interested persons may submit to the
fatty acids (Ref. 3). Moreover, the
displayed on the NFP, would it Division of Dockets Management (see
current Dietary Guidelines for
ADDRESSES) written or electronic
Americans recommends maintaining encourage more competition based on
the calorie content of the food? Would comments regarding this document.
body weight in a healthy range by
the result be products reformulated to Submit a single copy of electronic
balancing those calories consumed from
have fewer calories per serving, for comments or two paper copies of any
foods and beverages with those calories
example greater use of no calorie mailed comments, except that
expended. Based on the information in
sweeteners? Would it result in any individuals may submit one paper copy.
the previous sentences, we request
repackaging of products offered? How Comments are to be identified with the
comments and data on the following
would this option change the kinds of docket number found in brackets in the
questions:
heading of this document. Received
• What data is there on how products offered?
comments may be seen in the Division
consumers use the listing of ‘‘Calories • If the calorie content per package of Dockets Management between 9 a.m.
from fat?’’ were required to be prominently
• How does the listing ‘‘Calories from and 4 p.m., Monday through Friday.
displayed on the PDP, would it
fat’’ adjacent to ‘‘Calories’’ affect Dated: March 25, 2005.
encourage more competition based on
consumers’ focus on the total calories of the calorie content of the food? Would Jeffrey Shuren,
a food? the result be repackaging of products Assistant Commissioner for Policy.
• What are the advantages or into smaller units, for example [FR Doc. 05–6643 Filed 4–1–05; 8:45 am]
disadvantages of eliminating the listing repackaging cookies into 100 calorie BILLING CODE 4160–01–S
for ‘‘Calories from fat’’ from the packages? Would there be any incentive
nutrition label? to reformulate under this option? How
• What data would be needed to would this option change the kinds of DEPARTMENT OF HEALTH AND
determine whether the listing of products offered? HUMAN SERVICES
‘‘Calories from fat’’ is or is not necessary
to assist consumers in maintaining • Are you aware of any research, Food and Drug Administration
healthy dietary practices? consumer or industry-based, that can
assist the agency to answer any of the 21 CFR Part 101
C. Questions About Use of Calorie previous questions?
Information on Food Labels [Docket No. 2004N–0456]
III. Future Analysis of Benefits and
Based on preliminary results from Costs RIN 0910–AF23
focus group research, discussed in this
ANPRM, we request comments and data If the agency proposes regulatory Food Labeling: Serving Sizes of
on the following questions: changes based on the initiatives Products That Can Reasonably Be
• Is calorie content used to determine outlined in this ANPRM, we will Consumed At One Eating Occasion;
how much of a given food to eat, or to estimate the costs of labeling changes Updating of Reference Amounts
determine which foods, out of a range and other potential costs (such as the Customarily Consumed; Approaches
of similar products, to eat? Why or why costs of reformulating products) should for Recommending Smaller Portion
not? the regulation create incentives for new Sizes
• If calorie labeling affects decisions products. The comments on this AGENCY: Food and Drug Administration,
on whether to eat a food and on how ANPRM may identify other costs as HHS.
much to eat, how would the effects of well. The benefits of the regulatory ACTION:Advance notice of proposed
the following requirements differ: options depend on how consumers and rulemaking.
A requirement to display the number producers respond to the changes in
of calories per serving on the PDP or calorie labeling. We will use the SUMMARY: The Food and Drug
A requirement to increase the information from comments to help Administration (FDA) is issuing this
prominence of the calories per serving determine ways to estimate the possible advance notice of proposed rulemaking
in the NFP? consumer responses to various changes. (ANPRM) to request comment on
• What do consumers currently think The comments will also contribute to whether to amend certain provisions of
the calories on packaged foods our estimates of the effects of regulatory the agency’s nutrition labeling
represent? options on small entities. regulations concerning serving size.

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