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, 17010-17014 [05-6644]
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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?
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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.
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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.
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FDA is issuing this ANPRM in response
to recommendations of the Obesity
Working Group (OWG), which was
created by the Commissioner of FDA
(the Commissioner) to develop an action
plan to address the Nation’s obesity
problem. Comments on whether, and if
so, how to amend the agency’s serving
size regulations will inform any FDA
rulemaking that may result from this
ANPRM.
Submit written or electronic
comments by June 20, 2005.
ADDRESSES: You may submit comments,
identified by Docket No. 2004N–0456
and/or RIN number 0910–AF23, 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–0456 and/or
RIN number 0910–AF23 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, 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: Lori
LeGault, Center for Food Safety and
Applied Nutrition (HFS–840), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–1791.
SUPPLEMENTARY INFORMATION:
DATES:
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I. Background
A. The Serving Size 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.
Section 403(q)(1)(A)(i) of the act (21
U.S.C. 343(q)(1)(A)(i)) requires that most
foods under FDA’s jurisdiction bear
nutrition information based on a serving
size that reflects the amount of food
customarily consumed and is expressed
in a common household measure
appropriate to the food. The NLEA also
required that FDA issue regulations that
establish standards to define serving
size.
To implement the serving size
requirements of the NLEA, FDA
underwent extensive notice-andcomment rulemaking (56 FR 60394,
November 27, 1991 (the 1991 serving
size proposed rule); 58 FR 2229, January
6, 1993 (the serving size final rule); and
58 FR 44039, August 18, 1993 (the
serving size technical amendments)).
Consistent with the act, the serving size
regulations established a system to
define ‘‘serving size’’ that was
composed of two basic elements: (1)
Reference amounts customarily
consumed per eating occasion (reference
amounts or RACCs) for specific food
product categories; and (2) procedures
for determining serving sizes for use on
product labels derived from the
reference amounts. The second element
was necessary because the RACCs are
provided primarily in metric units
(based on data from nationwide food
consumption surveys that are expressed
in grams); however, the act requires that
serving sizes be expressed in common
household measures that are
appropriate to the particular food.
In § 101.9(b)(1) (21 CFR 101.9(b)(1)),
we defined the term ‘‘serving’’ or
‘‘serving size’’ to mean:
an amount of food customarily consumed
per eating occasion by persons 4 years of age
or older, which is expressed in a common
household measure that is appropriate to the
food. When the food is specially formulated
or processed for use by infants or by toddlers,
a serving or serving size means an amount of
food customarily consumed per eating
occasion by infants up to 12 months of age
or by children 1 through 3 years of age,
respectively.
In § 101.12(b) (21 CFR 101.12(b)), we
established RACCs (upon which label
serving sizes are to be determined) for
129 food product categories
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representing the general food supply
and 11 categories for infant and toddler
foods. The general principles and
factors that FDA considered in arriving
at the RACCs are described in
§ 101.12(a). Among these principles,
FDA sought to ensure that foods that
have similar dietary usage, product
characteristics, and customarily
consumed amounts have a uniform
reference amount so that consumers
could make nutritional comparisons of
like products in the marketplace.
The RACCs represent the amount of
food customarily consumed per eating
occasion for each product category, and
were derived primarily from data
obtained from the 1977–1978 and 1987–
1988 Nationwide Food Consumption
Surveys conducted by the U.S.
Department of Agriculture (58 FR 2229
at 2236–2237). We reviewed food
consumption data for the foods in each
product category and considered three
statistical estimates, i.e., the mean
(average), the median (50th percentile),
and the mode (most frequent value).
Following the procedures detailed in
the 1991 serving size proposed rule (56
FR 60394 at 60403–60406), we
determined the reference amount that
was most likely to represent the amount
customarily consumed for each product
category.
In § 101.9(b), we established
procedures for converting RACCs into
appropriate label serving sizes. Among
these provisions is § 101.9(b)(6), where
we defined the criteria for products to
be labeled as single-serving containers.
(See 58 FR 2229 at 2232–2235 for FDA’s
evaluation of comments.) Most products
packaged and sold individually that
contain less than 200 percent of the
applicable RACC must currently be
labeled as a single serving. An exception
to this rule occurs for products that
contain between 150 percent and 200
percent of the RACC and that have a
RACC of 100 grams (g) or 100 milliliters
(mL) or larger. In this case, the product
may be labeled as one or two servings,
at the manufacturer’s option.
For example, the RACC for carbonated
beverages is 240 mL (i.e., 8 fluid (fl)
ounces (oz)). Containers of carbonated
beverages that weigh 360 mL (i.e., 12 fl
oz, 150 percent of 240 mL) or less must
be labeled as a single serving.
Containers weighing between 360 mL
and 480 mL (i.e., 16 fl oz, 200 percent
of 240 mL) may be labeled as a single
serving or as ‘‘about 2’’ servings per
container (§ 101.9(b)(8)(i)).
For products packaged and sold
individually that contain 200 percent or
more of the RACC, it is the
manufacturer’s option to label the
product as a single-serving container if
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the entire content of the package can
reasonably be consumed at a singleeating occasion. For example, the RACC
for muffins is 55 g. If a single large
muffin weighs 110 g (200 percent of 55
g), there are two options for the serving
size declaration: ‘‘1 muffin (110 g)’’ or
‘‘1/2 muffin (55 g).’’
B. The Report of the FDA Obesity
Working Group
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). 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.’’ To
address this issue, among other actions,
the OWG recommended that FDA
reexamine its regulations on serving
sizes by soliciting comment on the
following topics: (1) Whether to require
food packages that can reasonably be
consumed at one eating occasion to
declare the whole package as a single
serving; (2) which, if any, RACCs of
food categories need to be updated; and
(3) whether to provide for comparative
calorie claims for smaller portions of
identical foods.
II. Agency Request for Information
FDA’s research on consumers’ use of
the Nutrition Facts panel (NFP) has
indicated that consumers’ ability to
quickly read and understand the NFP is
an important factor in determining
whether consumers use the NFP and
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whether the NFP is helpful to them. In
focus groups, participants indicated that
they cared about nutrition and reported
using the NFP, but also said that they
did not want to spend a lot of time
reading labels and did not always
consider nutrition when deciding what
to eat. They were interested in calories,
but were also concerned about saturated
fat, total fat, cholesterol, carbohydrates,
and sodium. Most participant comments
indicated that they incorrectly thought a
serving size was a recommended
portion size, rather than a standardized
unit of measure. Some participants said
that typical serving sizes, as a
recommended portion, are unrealistic
and pointed out that some people need
to eat different amounts, depending on
their age, body type, and lifestyle. In the
2002 Health and Diet Survey (Ref. 2),
respondents were asked how they used
the NFP. The most common answers
were: (1) To see if the product was high
or low in a specific nutrient, (2) to
decide how much to eat, and (3) to help
in meal planning. To address these
issues, we request comments on the
following questions:
• How can FDA make serving size
information on the NFP easier for
consumers to use when deciding what
foods and how much of these foods they
should eat?
• Do consumers recognize the
differences between serving sizes on
food labels and servings recommended
in dietary guidance? If so, what do
consumers think the differences are?
What information on a label would help
make this distinction clearer? For
example, should the serving size and/or
servings per container on the food label
be made more prominent? If so, how?
• Are there some alternative, simpler
ways to help consumers determine their
nutrient intake based on what they eat?
If so, please describe. What are the
advantages and disadvantages of these
options?
A. Updating RACCs
The serving size is critical to nutrition
labeling since all of the information on
nutrient levels depends on the amount
of the product represented. Because
there is evidence that the U.S.
population is eating larger portion sizes
than they did in the 1970s and 1980s
(Refs. 3 through 6), the OWG
recommends that FDA determine
whether to update the RACCs, and if so,
how to update the RACCs. Changes to
the RACCs, in most instances, would
require changes to the serving size on
products, which in turn would require
changes to the nutrient values listed on
the nutrition label.
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Newer food consumption data are
available from the 1999–2000 and the
2001–2002 National Health and
Nutrition Examination Surveys
(NHANES) (Ref. 7), and these data
provide a more current indication of the
amount of food being consumed by
individuals. However, we do not want
consumers to confuse the serving size
on the food label (which is required by
the act to be based on the amount
customarily consumed) with an amount
that is recommended for consumption.
For example, if data show that
consumers are drinking larger amounts
of carbonated beverages and FDA
increases the RACC, which will likely
increase the serving size on the food
label, additional educational efforts may
be required to reinforce to consumers
that a larger serving size on the
container is not a ‘‘recommended’’
serving size.
We request comments on these issues
and specifically on the following
questions:
• How do recent food consumption
data, such as data from the 1999–2000
and 2001–2002 NHANES, factor into the
determination of which, if any, RACCs
need to be updated? Are there other
food consumption data sources that are
available or that could be provided to
the agency for our consideration?
• If we revise the RACCs, what
criteria should be used as the basis for
change? For example, would a
percentage (e.g., 20 percent, 25 percent,
or 30 percent) increase or decrease from
current RACCs be a valid rationale for
change?
• Would consumers think that an
increase in serving size on food labels
means more of the food should be
eaten? What additional education efforts
should be provided to consumers to
avoid such a conclusion?
• We previously stated in the
preamble to the serving size final rule
under part 101 (21 CFR part 101) (58 FR
2229 at 2235): ‘‘Section 403(q)(1)(A)(i)
of the act, which states that a serving
size is the amount customarily
consumed, effectively requires the use
of food consumption data as the primary
basis for determining serving sizes.’’
However, considering the issues raised
previously in this document, should the
agency reconsider its definition of
‘‘serving’’ and ‘‘serving size’’ or how the
agency interprets ‘‘customarily
consumed’’?
B. Single-Serving Containers
Several comments to the OWG docket
strongly opposed the practice of
individually packaged foods that appear
to be single-serving containers,
declaring two or more servings on the
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label—such as sodas and snack packs.
In addition, as noted in the OWG report,
FDA initiated eight focus groups around
the country and, among other questions,
asked consumers about serving size
information on small packages.
Examples of food labels were presented
for a 20 fl oz soda and an individually
packaged large muffin. In general, focus
group participants thought that having
multiple servings listed on the label for
these products was misleading and
confusing. Many participants did realize
that if the entire package of food is
eaten, the number of servings should be
multiplied by the amount of the nutrient
of interest; though some participants
were confused and made mistakes when
trying to calculate the total amount in
their heads.
To address this issue, we ask for
comments on the following questions:
• Should FDA initiate rulemaking to
require packages that can reasonably be
consumed at one eating occasion to
provide the nutrition information for the
entire package? If so, what criteria
should FDA use to determine which
multiserving products would require
nutrition information for the entire
package? Should it be based on the total
amount in the container, the type of
food, or something else?
• Should such products be required
to include an additional column within
the NFP to list the quantitative amounts
and % Daily Value for the entire
package, as well as the preexisting
columns listing the quantitative
amounts and % Daily Value for a
serving that is less than the entire
package (i.e., the serving size derived
from the RACC)? Alternatively, should
the nutrition information only be
declared for the entire package as a
single serving?
• If the nutrient amount per serving
size (derived from the RACC) and per
package were listed side-by-side in
separate columns, how would this affect
consumers’ ability to understand the
label?
The current cutoff criteria for single
serving containers (200 percent of the
RACC (or 150 percent for products that
have a RACC of 100 g or 100 mL or
larger)) does not appear to be
appropriate across the board for all food
categories. As previously noted in this
document, participants in focus groups
said they thought that having multiple
servings listed on the label of a 20 fl oz
soda (250 percent of the RACC) was
misleading and confusing.
• Should the current cutoff criteria to
define single-serving containers be
changed? Should criteria vary for
different types of products? Explain
why or why not. What criteria should be
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used to designate which package sizes
should be required to list nutrition
information for the entire package?
In addition to the three statistical
estimates previously mentioned in this
document (i.e., the mean, median, and
mode), food consumption surveys allow
calculation of intake estimates for
individuals who eat a greater amount of
food than average (e.g., those in the 90th
and 95th percentiles). Should package
sizes falling at these amounts (e.g., 90th
or 95th percentile), as reported from
nationwide food consumption surveys,
be used as cut points at or below which
nutrition information should be
included for the entire package? If so,
the RACC tables in § 101.12(b) would
have to be modified to include a column
for the amount specific to each product
category as a cut point for when a
product must be labeled as a singleserving container. Is this a viable
option? If not, how can single-serving
containers be defined?
New regulations can have indirect
effects, such as the repackaging of a
product by the manufacturer.
• If FDA requires that manufacturers
list the nutrient content for the entire
package for packages up to specified
sizes, are manufacturers likely to
repackage products in larger sizes to
avoid this requirement? If so, what are
the likely impacts of this repackaging?
• Conversely, manufacturers may
have an incentive to lower the size, and
therefore the total calories, of single
serving packages. Would this be an
option that manufacturers would
consider? If so, what would be the likely
consequences of this repackaging?
C. Comparison of Calories in Foods of
Different Portion Sizes
As noted in the OWG Report, the
Federal Trade Commission has
suggested that FDA consider ‘‘allowing
food marketers to make truthful, nonmisleading label claims comparing
foods of different portion sizes.’’ Our
current regulations for comparative
nutrient content claims, including
calorie claims, require that all such
comparisons be based on a uniform
amount of food, i.e., per RACC for
individual foods or per 100 g for meals
and main dishes. Consequently, the
current regulations (§ 101.60(b)) require
that comparisons reflect actual nutrient
differences in the same quantity of
similar foods (e.g., ‘‘Reduced calorie
chocolate ice cream, 25% fewer calories
than the leading brand of chocolate ice
cream. The leading brand contains 150
calories per 1/2 cup serving. Our ice
cream contains 100 calories per 1/2 cup
serving’’). The current regulations do
not permit claims that compare the
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amount of calories based on different
sized portions of the same food.
Nevertheless, as noted in the OWG
report, ‘‘using the food label to promote
consumption of smaller portions may
have merit [particularly] if consumers
understand that (1) the calorie reduction
is solely a function of the reduction in
portion size and (2) the smaller portion
size is actually less than what they
usually consume.’’ Thus, we solicit
comments regarding the appropriateness
of label claims based on the amount of
calories in a specified portion of a
product (i.e., the amount of food
specified by the claim, e.g., one 15 g
cookie) vs. claims based on the RACC
and specified in the labeled serving size
of a product (i.e., the amount specified
in the Nutrition Facts panel, e.g., two 15
g cookies). We ask for specific
comments on the following questions:
• Because all currently approved
comparative claims are based on the
difference in the amount of the nutrient
in a uniform amount of food such as per
RACC, or per 100 g, will it be confusing
to consumers to have claims made only
on the basis of the difference in the
amount of calories in two different
labeled servings (i.e., the serving size
specified in two different Nutrition
Facts panels, e.g., an 8 fl oz can vs. a
12 fl oz can of soda) or two different
portions (i.e., amounts specified by the
claim, e.g., one 15 g cookie vs. two 15
g cookies) of the same food? Explain
why or why not.
• If a claim is made based only on the
difference in the amount of calories in
two different serving sizes or portions of
the same food, what words should be
used to ensure that consumers
understand that comparisons are made
only on this basis (i.e., the difference in
the amount of product) and that there is
not a difference based on product
reformulation, e.g., ‘‘the caloric savings
is based on a smaller than normal
portion?’’
• Should the size of the compared
servings, portions, or packages be part of
the claim (e.g., ‘‘this 8 fl oz bottle of
juice has 33 percent fewer calories than
our 12 fl oz bottle’’)? Explain why or
why not.
• Should these types of claims be
limited to products that are identical
except for the specified serving or
portion size?
• Will such claims be misleading if
the claim is based on the number of
calories that are in an amount of food
other than what is specified in the
Nutrition Facts panel (e.g., claims based
on half a ‘‘labeled serving’’—one cookie,
compared to the amount specified in the
Nutrition Facts panel—two cookies)?
E:\FR\FM\04APP1.SGM
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17014
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Proposed Rules
• Should this claim be limited to
single-serving containers, or is it
appropriate on multi-serving packages?
Explain why or why not.
• If claims are permitted on multiserving packages, should these claims
be limited to products that have
portioned pieces, such as cookies or
slices of bread, or should they be
allowed on products that are not portion
controlled, such as pies or bulk sodas?
For example, might this claim be
extended to ‘‘bulk’’ products such as
pizza suggesting that if you cut a smaller
slice, you will get a caloric savings?
• What comparative terms are
appropriate? Because ‘‘reduced’’ has
always been used to signal some type of
reformulation (i.e., special processing,
alteration, formulation, or reformulation
to lower the nutrient content), is it
appropriate to use the term ‘‘reduced’’
on products that have not been so
altered? Is ‘‘less than,’’ which has been
used more broadly to signal differences
in nutrient levels derived through a
variety of means, a more appropriate
term?
• Currently all comparative calorie
claims are limited to reductions of at
least 25 percent. Should these
comparisons (e.g., reduced or fewer
calories) continue to be limited to
reductions of at least 25 percent, and if
not, what justification is there that a
smaller reduction of calories would be
meaningful and significant? Please
provide data.
• What other requirements may be
necessary to ensure that the claim is not
confusing or misleading to consumers?
• If manufacturers are permitted to
make such label comparisons of
different portion sizes of food, what is
the likely change in the distribution of
package sizes that will become available
to consumers?
• What other labeling changes, if any,
would encourage a broader range of
package sizes?
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 regulations 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
respond to the changes in label serving
sizes or package sizes. We will use the
information from comments to help
determine ways to estimate the possible
consumer responses to various changes.
VerDate jul<14>2003
15:01 Apr 01, 2005
Jkt 205001
The comments will also contribute to
our estimates of the effects of regulatory
options on small entities.
IV. References
Dated: March 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6644 Filed 4–1–05; 8:45 am]
BILLING CODE 4160–01–S
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. FDA has verified the
Web site addresses but is not
responsible for subsequent changes to
the Web sites after this document
publishes in the Federal Register.
1. Report of the Working Group on Obesity,
‘‘Calories Count’’ (Internet address: https://
www.cfsan.fda.gov/~dms/owg-toc.html),
March 12, 2004.
2. Food and Drug Administration, Center
for Food Safety and Applied Nutrition, ‘‘2002
Health and Diet Survey—Preliminary
Topline Frequencies (Weighted),’’ March
2004.
3. U.S. Department of Health and Human
Services, National Institutes of Health,
National Heart, Lung, and Blood Institute,
‘‘Portion Distortion! Do You Know How Food
Portions Have Changed in 20 Years?’’
(Internet address: https://hin.nhlbi.nih.gov/
portion/index.htm).
4. Young, L. R. and M. Nestle, ‘‘Expanding
Portion Sizes in the U.S. Marketplace:
Implications for Nutrition Counseling,’’
Journal of the American Dietetic Association,
Vol. 103, No. 2, pp. 231–234, February 2003.
5. Smiciklas-Wright, H., D. C. Mitchell, S.
J. Mickle, J. D. Goldman, A. Cook, ‘‘Foods
Commonly Eaten in the United States, 1989–
1991 and 1994–1996, Are Portion Sizes
Changing?’’ Journal of the American Dietetic
Association, Vol. 103, No. 1, pp. 41–47,
January 2003.
6. Nielsen, S. J. and B. M. Popkin,
‘‘Patterns and Trends in Food Portion Sizes,
1977–1998,’’ Journal of the American
Medical Association, Vol. 289, No. 4, pp.
450–453, January 22/29, 2003.
7. U.S. Department of Health and Human
Services, National Center for Health
Statistics, NHANES 1999–2000 Data Files
(Internet address: https://www.cdc.gov/nchs/
about/major/nhanes/NHANES99_00.htm)
and NHANES 2001–2002 Data Files (Internet
address: https://www.cdc.gov/nchs/about/
major/nhanes/nhanes01–02.htm).
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.
PO 00000
Frm 00048
Fmt 4702
Sfmt 4702
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 913
[Docket No. IL–103–FOR]
Illinois Regulatory Program
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Proposed rule; public comment
period and opportunity for public
hearing on proposed amendment.
AGENCY:
SUMMARY: We, the Office of Surface
Mining Reclamation and Enforcement
(OSM), are announcing receipt of a
proposed amendment to the Illinois
regulatory program (Illinois program)
under the Surface Mining Control and
Reclamation Act of 1977 (SMCRA or the
Act). Illinois proposes to revise its
regulations about revegetation success
standards, to update statutory citations,
to correct regulatory citations, and to
clarify language in various provisions.
Illinois intends to revise its program to
clarify ambiguities and to improve
operational efficiency.
This document gives the times and
locations that the Illinois program and
proposed amendment to that program
are available for your inspection, the
comment period during which you may
submit written comments on the
amendment, and the procedures that we
will follow for the public hearing, if one
is requested.
DATES: We will accept written
comments on this amendment until 4
p.m., e.s.t., May 4, 2005. If requested,
we will hold a public hearing on the
amendment on April 29, 2005. We will
accept requests to speak at a hearing
until 4 p.m., e.s.t. on April 19, 2005.
ADDRESSES: You may submit comments,
identified by Docket No. IL–103–FOR,
by any of the following methods:
• E-mail: IFOMAIL@osmre.gov.
Include Docket No. IL–103–FOR in the
subject line of the message.
• Mail/Hand Delivery: Andrew R.
Gilmore, Chief, Alton Field Division—
Indianapolis Area Office, Office of
Surface Mining Reclamation and
Enforcement, Minton-Capehart Federal
Building, 575 North Pennsylvania
Street, Room 301, Indianapolis, Indiana
46204
E:\FR\FM\04APP1.SGM
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Agencies
[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Proposed Rules]
[Pages 17010-17014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6644]
-----------------------------------------------------------------------
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.
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
concerning serving size.
[[Page 17011]]
FDA is issuing this ANPRM in response to recommendations of the Obesity
Working Group (OWG), which was created by the Commissioner of FDA (the
Commissioner) to develop an action plan to address the Nation's obesity
problem. Comments on whether, and if so, how to amend the agency's
serving size regulations 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-0456
and/or RIN number 0910-AF23, 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-
0456 and/or RIN number 0910-AF23 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, 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: Lori LeGault, Center for Food Safety
and Applied Nutrition (HFS-840), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1791.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Serving Size 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. Section 403(q)(1)(A)(i) of the act (21 U.S.C.
343(q)(1)(A)(i)) requires that most foods under FDA's jurisdiction bear
nutrition information based on a serving size that reflects the amount
of food customarily consumed and is expressed in a common household
measure appropriate to the food. The NLEA also required that FDA issue
regulations that establish standards to define serving size.
To implement the serving size requirements of the NLEA, FDA
underwent extensive notice-and-comment rulemaking (56 FR 60394,
November 27, 1991 (the 1991 serving size proposed rule); 58 FR 2229,
January 6, 1993 (the serving size final rule); and 58 FR 44039, August
18, 1993 (the serving size technical amendments)). Consistent with the
act, the serving size regulations established a system to define
``serving size'' that was composed of two basic elements: (1) Reference
amounts customarily consumed per eating occasion (reference amounts or
RACCs) for specific food product categories; and (2) procedures for
determining serving sizes for use on product labels derived from the
reference amounts. The second element was necessary because the RACCs
are provided primarily in metric units (based on data from nationwide
food consumption surveys that are expressed in grams); however, the act
requires that serving sizes be expressed in common household measures
that are appropriate to the particular food.
In Sec. 101.9(b)(1) (21 CFR 101.9(b)(1)), we defined the term
``serving'' or ``serving size'' to mean:
an amount of food customarily consumed per eating occasion by
persons 4 years of age or older, which is expressed in a common
household measure that is appropriate to the food. When the food is
specially formulated or processed for use by infants or by toddlers,
a serving or serving size means an amount of food customarily
consumed per eating occasion by infants up to 12 months of age or by
children 1 through 3 years of age, respectively.
In Sec. 101.12(b) (21 CFR 101.12(b)), we established RACCs (upon
which label serving sizes are to be determined) for 129 food product
categories representing the general food supply and 11 categories for
infant and toddler foods. The general principles and factors that FDA
considered in arriving at the RACCs are described in Sec. 101.12(a).
Among these principles, FDA sought to ensure that foods that have
similar dietary usage, product characteristics, and customarily
consumed amounts have a uniform reference amount so that consumers
could make nutritional comparisons of like products in the marketplace.
The RACCs represent the amount of food customarily consumed per
eating occasion for each product category, and were derived primarily
from data obtained from the 1977-1978 and 1987-1988 Nationwide Food
Consumption Surveys conducted by the U.S. Department of Agriculture (58
FR 2229 at 2236-2237). We reviewed food consumption data for the foods
in each product category and considered three statistical estimates,
i.e., the mean (average), the median (50th percentile), and the mode
(most frequent value). Following the procedures detailed in the 1991
serving size proposed rule (56 FR 60394 at 60403-60406), we determined
the reference amount that was most likely to represent the amount
customarily consumed for each product category.
In Sec. 101.9(b), we established procedures for converting RACCs
into appropriate label serving sizes. Among these provisions is Sec.
101.9(b)(6), where we defined the criteria for products to be labeled
as single-serving containers. (See 58 FR 2229 at 2232-2235 for FDA's
evaluation of comments.) Most products packaged and sold individually
that contain less than 200 percent of the applicable RACC must
currently be labeled as a single serving. An exception to this rule
occurs for products that contain between 150 percent and 200 percent of
the RACC and that have a RACC of 100 grams (g) or 100 milliliters (mL)
or larger. In this case, the product may be labeled as one or two
servings, at the manufacturer's option.
For example, the RACC for carbonated beverages is 240 mL (i.e., 8
fluid (fl) ounces (oz)). Containers of carbonated beverages that weigh
360 mL (i.e., 12 fl oz, 150 percent of 240 mL) or less must be labeled
as a single serving. Containers weighing between 360 mL and 480 mL
(i.e., 16 fl oz, 200 percent of 240 mL) may be labeled as a single
serving or as ``about 2'' servings per container (Sec.
101.9(b)(8)(i)).
For products packaged and sold individually that contain 200
percent or more of the RACC, it is the manufacturer's option to label
the product as a single-serving container if
[[Page 17012]]
the entire content of the package can reasonably be consumed at a
single-eating occasion. For example, the RACC for muffins is 55 g. If a
single large muffin weighs 110 g (200 percent of 55 g), there are two
options for the serving size declaration: ``1 muffin (110 g)'' or ``1/2
muffin (55 g).''
B. The Report of the FDA Obesity Working Group
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). 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.'' To
address this issue, among other actions, the OWG recommended that FDA
reexamine its regulations on serving sizes by soliciting comment on the
following topics: (1) Whether to require food packages that can
reasonably be consumed at one eating occasion to declare the whole
package as a single serving; (2) which, if any, RACCs of food
categories need to be updated; and (3) whether to provide for
comparative calorie claims for smaller portions of identical foods.
II. Agency Request for Information
FDA's research on consumers' use of the Nutrition Facts panel (NFP)
has indicated that consumers' ability to quickly read and understand
the NFP is an important factor in determining whether consumers use the
NFP and whether the NFP is helpful to them. In focus groups,
participants indicated that they cared about nutrition and reported
using the NFP, but also said that they did not want to spend a lot of
time reading labels and did not always consider nutrition when deciding
what to eat. They were interested in calories, but were also concerned
about saturated fat, total fat, cholesterol, carbohydrates, and sodium.
Most participant comments indicated that they incorrectly thought a
serving size was a recommended portion size, rather than a standardized
unit of measure. Some participants said that typical serving sizes, as
a recommended portion, are unrealistic and pointed out that some people
need to eat different amounts, depending on their age, body type, and
lifestyle. In the 2002 Health and Diet Survey (Ref. 2), respondents
were asked how they used the NFP. The most common answers were: (1) To
see if the product was high or low in a specific nutrient, (2) to
decide how much to eat, and (3) to help in meal planning. To address
these issues, we request comments on the following questions:
How can FDA make serving size information on the NFP
easier for consumers to use when deciding what foods and how much of
these foods they should eat?
Do consumers recognize the differences between serving
sizes on food labels and servings recommended in dietary guidance? If
so, what do consumers think the differences are? What information on a
label would help make this distinction clearer? For example, should the
serving size and/or servings per container on the food label be made
more prominent? If so, how?
Are there some alternative, simpler ways to help consumers
determine their nutrient intake based on what they eat? If so, please
describe. What are the advantages and disadvantages of these options?
A. Updating RACCs
The serving size is critical to nutrition labeling since all of the
information on nutrient levels depends on the amount of the product
represented. Because there is evidence that the U.S. population is
eating larger portion sizes than they did in the 1970s and 1980s (Refs.
3 through 6), the OWG recommends that FDA determine whether to update
the RACCs, and if so, how to update the RACCs. Changes to the RACCs, in
most instances, would require changes to the serving size on products,
which in turn would require changes to the nutrient values listed on
the nutrition label.
Newer food consumption data are available from the 1999-2000 and
the 2001-2002 National Health and Nutrition Examination Surveys
(NHANES) (Ref. 7), and these data provide a more current indication of
the amount of food being consumed by individuals. However, we do not
want consumers to confuse the serving size on the food label (which is
required by the act to be based on the amount customarily consumed)
with an amount that is recommended for consumption. For example, if
data show that consumers are drinking larger amounts of carbonated
beverages and FDA increases the RACC, which will likely increase the
serving size on the food label, additional educational efforts may be
required to reinforce to consumers that a larger serving size on the
container is not a ``recommended'' serving size.
We request comments on these issues and specifically on the
following questions:
How do recent food consumption data, such as data from the
1999-2000 and 2001-2002 NHANES, factor into the determination of which,
if any, RACCs need to be updated? Are there other food consumption data
sources that are available or that could be provided to the agency for
our consideration?
If we revise the RACCs, what criteria should be used as
the basis for change? For example, would a percentage (e.g., 20
percent, 25 percent, or 30 percent) increase or decrease from current
RACCs be a valid rationale for change?
Would consumers think that an increase in serving size on
food labels means more of the food should be eaten? What additional
education efforts should be provided to consumers to avoid such a
conclusion?
We previously stated in the preamble to the serving size
final rule under part 101 (21 CFR part 101) (58 FR 2229 at 2235):
``Section 403(q)(1)(A)(i) of the act, which states that a serving size
is the amount customarily consumed, effectively requires the use of
food consumption data as the primary basis for determining serving
sizes.'' However, considering the issues raised previously in this
document, should the agency reconsider its definition of ``serving''
and ``serving size'' or how the agency interprets ``customarily
consumed''?
B. Single-Serving Containers
Several comments to the OWG docket strongly opposed the practice of
individually packaged foods that appear to be single-serving
containers, declaring two or more servings on the
[[Page 17013]]
label--such as sodas and snack packs. In addition, as noted in the OWG
report, FDA initiated eight focus groups around the country and, among
other questions, asked consumers about serving size information on
small packages. Examples of food labels were presented for a 20 fl oz
soda and an individually packaged large muffin. In general, focus group
participants thought that having multiple servings listed on the label
for these products was misleading and confusing. Many participants did
realize that if the entire package of food is eaten, the number of
servings should be multiplied by the amount of the nutrient of
interest; though some participants were confused and made mistakes when
trying to calculate the total amount in their heads.
To address this issue, we ask for comments on the following
questions:
Should FDA initiate rulemaking to require packages that
can reasonably be consumed at one eating occasion to provide the
nutrition information for the entire package? If so, what criteria
should FDA use to determine which multiserving products would require
nutrition information for the entire package? Should it be based on the
total amount in the container, the type of food, or something else?
Should such products be required to include an additional
column within the NFP to list the quantitative amounts and % Daily
Value for the entire package, as well as the preexisting columns
listing the quantitative amounts and % Daily Value for a serving that
is less than the entire package (i.e., the serving size derived from
the RACC)? Alternatively, should the nutrition information only be
declared for the entire package as a single serving?
If the nutrient amount per serving size (derived from the
RACC) and per package were listed side-by-side in separate columns, how
would this affect consumers' ability to understand the label?
The current cutoff criteria for single serving containers (200
percent of the RACC (or 150 percent for products that have a RACC of
100 g or 100 mL or larger)) does not appear to be appropriate across
the board for all food categories. As previously noted in this
document, participants in focus groups said they thought that having
multiple servings listed on the label of a 20 fl oz soda (250 percent
of the RACC) was misleading and confusing.
Should the current cutoff criteria to define single-
serving containers be changed? Should criteria vary for different types
of products? Explain why or why not. What criteria should be used to
designate which package sizes should be required to list nutrition
information for the entire package?
In addition to the three statistical estimates previously mentioned
in this document (i.e., the mean, median, and mode), food consumption
surveys allow calculation of intake estimates for individuals who eat a
greater amount of food than average (e.g., those in the 90th and 95th
percentiles). Should package sizes falling at these amounts (e.g., 90th
or 95th percentile), as reported from nationwide food consumption
surveys, be used as cut points at or below which nutrition information
should be included for the entire package? If so, the RACC tables in
Sec. 101.12(b) would have to be modified to include a column for the
amount specific to each product category as a cut point for when a
product must be labeled as a single-serving container. Is this a viable
option? If not, how can single-serving containers be defined?
New regulations can have indirect effects, such as the repackaging
of a product by the manufacturer.
If FDA requires that manufacturers list the nutrient
content for the entire package for packages up to specified sizes, are
manufacturers likely to repackage products in larger sizes to avoid
this requirement? If so, what are the likely impacts of this
repackaging?
Conversely, manufacturers may have an incentive to lower
the size, and therefore the total calories, of single serving packages.
Would this be an option that manufacturers would consider? If so, what
would be the likely consequences of this repackaging?
C. Comparison of Calories in Foods of Different Portion Sizes
As noted in the OWG Report, the Federal Trade Commission has
suggested that FDA consider ``allowing food marketers to make truthful,
non-misleading label claims comparing foods of different portion
sizes.'' Our current regulations for comparative nutrient content
claims, including calorie claims, require that all such comparisons be
based on a uniform amount of food, i.e., per RACC for individual foods
or per 100 g for meals and main dishes. Consequently, the current
regulations (Sec. 101.60(b)) require that comparisons reflect actual
nutrient differences in the same quantity of similar foods (e.g.,
``Reduced calorie chocolate ice cream, 25% fewer calories than the
leading brand of chocolate ice cream. The leading brand contains 150
calories per 1/2 cup serving. Our ice cream contains 100 calories per
1/2 cup serving''). The current regulations do not permit claims that
compare the amount of calories based on different sized portions of the
same food.
Nevertheless, as noted in the OWG report, ``using the food label to
promote consumption of smaller portions may have merit [particularly]
if consumers understand that (1) the calorie reduction is solely a
function of the reduction in portion size and (2) the smaller portion
size is actually less than what they usually consume.'' Thus, we
solicit comments regarding the appropriateness of label claims based on
the amount of calories in a specified portion of a product (i.e., the
amount of food specified by the claim, e.g., one 15 g cookie) vs.
claims based on the RACC and specified in the labeled serving size of a
product (i.e., the amount specified in the Nutrition Facts panel, e.g.,
two 15 g cookies). We ask for specific comments on the following
questions:
Because all currently approved comparative claims are
based on the difference in the amount of the nutrient in a uniform
amount of food such as per RACC, or per 100 g, will it be confusing to
consumers to have claims made only on the basis of the difference in
the amount of calories in two different labeled servings (i.e., the
serving size specified in two different Nutrition Facts panels, e.g.,
an 8 fl oz can vs. a 12 fl oz can of soda) or two different portions
(i.e., amounts specified by the claim, e.g., one 15 g cookie vs. two 15
g cookies) of the same food? Explain why or why not.
If a claim is made based only on the difference in the
amount of calories in two different serving sizes or portions of the
same food, what words should be used to ensure that consumers
understand that comparisons are made only on this basis (i.e., the
difference in the amount of product) and that there is not a difference
based on product reformulation, e.g., ``the caloric savings is based on
a smaller than normal portion?''
Should the size of the compared servings, portions, or
packages be part of the claim (e.g., ``this 8 fl oz bottle of juice has
33 percent fewer calories than our 12 fl oz bottle'')? Explain why or
why not.
Should these types of claims be limited to products that
are identical except for the specified serving or portion size?
Will such claims be misleading if the claim is based on
the number of calories that are in an amount of food other than what is
specified in the Nutrition Facts panel (e.g., claims based on half a
``labeled serving''--one cookie, compared to the amount specified in
the Nutrition Facts panel--two cookies)?
[[Page 17014]]
Should this claim be limited to single-serving containers,
or is it appropriate on multi-serving packages? Explain why or why not.
If claims are permitted on multi-serving packages, should
these claims be limited to products that have portioned pieces, such as
cookies or slices of bread, or should they be allowed on products that
are not portion controlled, such as pies or bulk sodas? For example,
might this claim be extended to ``bulk'' products such as pizza
suggesting that if you cut a smaller slice, you will get a caloric
savings?
What comparative terms are appropriate? Because
``reduced'' has always been used to signal some type of reformulation
(i.e., special processing, alteration, formulation, or reformulation to
lower the nutrient content), is it appropriate to use the term
``reduced'' on products that have not been so altered? Is ``less
than,'' which has been used more broadly to signal differences in
nutrient levels derived through a variety of means, a more appropriate
term?
Currently all comparative calorie claims are limited to
reductions of at least 25 percent. Should these comparisons (e.g.,
reduced or fewer calories) continue to be limited to reductions of at
least 25 percent, and if not, what justification is there that a
smaller reduction of calories would be meaningful and significant?
Please provide data.
What other requirements may be necessary to ensure that
the claim is not confusing or misleading to consumers?
If manufacturers are permitted to make such label
comparisons of different portion sizes of food, what is the likely
change in the distribution of package sizes that will become available
to consumers?
What other labeling changes, if any, would encourage a
broader range of package sizes?
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 regulations 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 respond to the changes in
label serving sizes or package sizes. 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 by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses but is not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register.
1. Report of the Working Group on Obesity, ``Calories Count''
(Internet address: https://www.cfsan.fda.gov/dms/owg-toc.html), March
12, 2004.
2. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, ``2002 Health and Diet Survey--Preliminary
Topline Frequencies (Weighted),'' March 2004.
3. U.S. Department of Health and Human Services, National
Institutes of Health, National Heart, Lung, and Blood Institute,
``Portion Distortion! Do You Know How Food Portions Have Changed in
20 Years?'' (Internet address: https://hin.nhlbi.nih.gov/portion/
index.htm).
4. Young, L. R. and M. Nestle, ``Expanding Portion Sizes in the
U.S. Marketplace: Implications for Nutrition Counseling,'' Journal
of the American Dietetic Association, Vol. 103, No. 2, pp. 231-234,
February 2003.
5. Smiciklas-Wright, H., D. C. Mitchell, S. J. Mickle, J. D.
Goldman, A. Cook, ``Foods Commonly Eaten in the United States, 1989-
1991 and 1994-1996, Are Portion Sizes Changing?'' Journal of the
American Dietetic Association, Vol. 103, No. 1, pp. 41-47, January
2003.
6. Nielsen, S. J. and B. M. Popkin, ``Patterns and Trends in
Food Portion Sizes, 1977-1998,'' Journal of the American Medical
Association, Vol. 289, No. 4, pp. 450-453, January 22/29, 2003.
7. U.S. Department of Health and Human Services, National Center
for Health Statistics, NHANES 1999-2000 Data Files (Internet
address: https://www.cdc.gov/nchs/about/major/nhanes/NHANES99_
00.htm) and NHANES 2001-2002 Data Files (Internet address: https://
www.cdc.gov/nchs/about/major/nhanes/nhanes01-02.htm).
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. 05-6644 Filed 4-1-05; 8:45 am]
BILLING CODE 4160-01-S