[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Proposed Rules]
[Pages 11989-12029]
[FR Doc No: 2014-04385]

Vol. 79

Monday,

No. 41

March 3, 2014

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 101

Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed
at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments; Proposed Rule

Federal Register / Vol. 79 , No. 41 / Monday, March 3, 2014 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2004-N-0258 (Formerly Docket No. 2004N-0456)]
RIN 0910-AF23

Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One-Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend the definition of a single-serving container; require dual-column
labeling for certain containers; update and modify several reference
amounts customarily consumed (RACCs or reference amounts); add several
food products and food product categories to the reference amounts
customarily consumed per eating occasion for the general food supply;
amend the label serving size for breath mints; and make technical
amendments to various aspects of the serving size regulations. These
actions are being taken, in part, in response to recommendations of the
2003 FDA Obesity Working Group and FDA's recognition that portion sizes
have changed since the original serving size regulations were published
in 1993. This proposal also discusses six citizen petitions. The
intended effect of this rulemaking is to provide consumers with more
accurate and up-to-date information on serving sizes.

DATES: Submit either electronic or written comments on the proposed
rule by June 2, 2014. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by April 2, 2014, (see the
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2004-
N-0258 and/or RIN 0910-AF23, by any of the following methods, except
that comments on information collection issues under the Paperwork
Reduction Act of 1995 must be submitted to the Office of Information
and Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper 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. FDA-2004-N-0258 and Regulatory Information Number 0910-
AF23 for this rulemaking. All comments received may be posted without
change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this proposed rule.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this proposed rule,
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:  With regard to the proposed rule:
Cherisa Henderson, Center for Food Safety and Applied Nutrition (HFS-
830), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740,<PHONE_NUMBER><EMAIL_ADDRESS>    With regard to the information collection: Domini Bean, Office of
Information Management, Food and Drug Administration, 1350 Picard Dr.,
PI50-400T, Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
Proposed Rule
I. Background
    A. The Serving Size Regulations
    B. The Obesity Working Group
    C. The Advance Notice of Proposed Rulemaking
    1. Single-Serving Containers
    2. Updating the RACCs
    3. Comparison of Calories in Foods of Different Portion Sizes
    4. Overview of Comments on the Advance Notice of Proposed
Rulemaking
    D. Requests for Changes to Serving Size Requirements
    1. Requests To Modify and Establish Certain RACCs and Add
Products to Product Categories
    2. Adding Products to the List of Products for Each Product
Category
    3. Citizen Petitions
    a. Petition for Food and Beverages Sold in Single-Serving
Containers
    b. Petition for a New RACC for Fruitcake
    c. Petition for a New RACC for Yogurt
    d. Petition for a New RACC for Mint Wafers and Similar Candy
Products
    e. Petition for a New RACC for Certain Candies Weighing 20 g or
Less per Piece
    f. Petition for a New Product Category and New RACC for Small
Breath Mints Weighing 0.5 g or Less
    E. Technical Issues
II. The Proposed Rule
    A. Legal Authority/Statutory Directive
    B. Need for This Regulation
    C. Single-Serving Containers and Dual-Column Labeling
    1. Research Related to Single-Serving Containers and Dual-Column
Labeling
    a. Research on the Impact of Package and Portion Sizes on
Consumption
    b. Research on Consumer Use and Understanding of the Serving
Size Labeling
    c. Research on Dual-Column Labeling
    2. Single-Serving Containers
    a. Comments on the ANPRM Regarding Single-Serving Containers
    b. Proposed Amendments for Single-Serving Containers
    3. Dual-Column Labeling--Mandatory Listing of a Second Column of
Nutrient Values on the Nutrition Facts Label Based on the Entire
Container or Unit
    a. Comments on the ANPRM Regarding Dual-Column Labeling
    b. Proposed Amendments for Dual-Column Labeling
    D. Reference Amounts Customarily Consumed
    1. Research and Data Related to Updating, Modifying, and
Establishing RACCs
    2. Updating Existing RACCs
    a. Comments on the ANPRM Regarding Updating the Existing RACCs
    b. Methods Used To Update the Existing RACCs
    c. Proposed Amendments To Update the Existing RACCs
    3. Modifying and Establishing RACCs
    a. Methods Used To Modify Existing RACCs and Establish New RACCs
    b. Proposed Amendments To Modify Existing RACCS and Establish
New RACCs
    4. Products of Concern Listed in Consumer Comments--Agency
Request for Information
    5. Impact of Changes in RACCs on the Eligibility of Nutrient
Content Claims and Health Claims
    6. Request To Establish a New 25 g RACC for Candies Weighing 20
g or Less
    E. Establishing a New Serving Size for Breath Mints
    F. Comparison of Calories in Foods of Different Portion Sizes

    G. Technical Amendments
    1. Rounding Rules for Products That Have More Than Five Servings
and the Number of Servings Falls Exactly Between Two Values
    2. Options for When the Number of Servings per Container Varies
    3. Minor Corrections to General and Product Category Names
    4. Minor Changes to Footnotes
    5. Minor Changes to Table 1 in 21 CFR 101.12(b)
    6. Minor Changes to Table 2 in 21 CFR 101.12(b)
    7. Reference Amounts for Products That Require Further
Preparation
    8. Reference Amount for Combined Products Consisting of Two or
More Separate Foods That Are Packaged Together and Are Intended To
Be Eaten Together and That Have No Reference Amount for the Combined
Product
    9. Reference Amounts for Varieties or Assortments of Foods in
Gift Packages That Have No Appropriate Reference Amount
III. Proposed Effective and Compliance Dates
IV. Environmental Impact
V. Analysis of Impacts
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Comments
IX. References

Executive Summary

Purpose of the Proposed Rule

Need for the Proposed Rule
    Following the passage of the Nutrition Labeling and Education Act
(NLEA) of 1990 (Pub. L. 101-535), which added section 403(q) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q))
we issued various regulations related to serving size requirements (see
21 CFR 101.9 and 101.12). Since we established those regulations, there
have been developments that have compelled us to re-evaluate our
regulations on serving sizes and determine whether and what, if any,
revisions are needed to ensure that the Nutrition Facts label meets its
intended goal of helping consumers maintain healthy dietary practices.
Specifically, such developments include the availability of newer
consumption data; research showing that amounts of food consumed by the
American public have changed; and the availability of recent consumer
research on the use and understanding of the Nutrition Facts label.
    In consideration of these new developments, this rule proposes a
number of changes to our regulations in Sec. Sec.  101.9 and 101.12. In
consideration of the new consumption data, this rule proposes to amend
the reference amounts customarily consumed (RACCs) that are used to
determine serving sizes consistent with section 403(q)(1)(A)(i) of the
FD&C Act, which states that a serving size is an amount of food
customarily consumed. Additionally, in consideration of recent
consumption data, research on consumption, and research on consumer
understanding of the Nutrition Facts label, this rule proposes to amend
some of the required procedures used to determine serving sizes,
proposes to amend the definition of a single serving container, and
also proposes to require that certain containers of foods bear an
additional column of nutrition information to help consumers understand
the nutritional significance of consuming an entire container of
certain foods containing multiple servings. Overall, the proposals in
this rule are designed to ensure that serving sizes are based on
current consumption data, as well as to provide consumers with
information on the nutrition facts label, related to the serving size,
that will help them maintain healthy dietary practices.

Summary of the Legal Authority

    The NLEA amended the FD&C Act to provide FDA with the authority to
require nutrition labeling on most packaged foods regulated by the
Agency. Specifically, section 403(q)(1)(A)(i) of the FD&C Act requires,
with certain exceptions, that food that is intended for human
consumption and offered for sale bear nutrition information that
provides a serving size that reflects the amount of food customarily
consumed and is expressed in a common household measure that is
appropriate to the food, and is our primary legal authority to issue
the regulations in this proposed rule. Additionally, we are relying on
section 2(b)(1)(A) of NLEA, which states that requirements in
regulations issued under the authority of the NLEA, including serving
size requirements, shall be ``conveyed to the public in a manner which
enables the public to readily observe and comprehend such information
and to understand its relative significance in the context of a total
daily diet.'' Finally, we are also relying on the authorities in
sections 701(a), 403(a)(1), and 201(n) of the FD&C Act (21 U.S.C.
371(a), 343(a)(1), and 321(n)) for amendments in this proposed rule.
Under section 701(a) of the FD&C Act, we have authority to issue
regulations for the efficient enforcement of the FD&C Act. Under
section 403(a) of the FD&C Act, a food is deemed misbranded if its
labeling is deemed false or misleading in any particular. Additionally,
under section 201(n) of the FD&C Act, in determining whether or not a
food is misbranded because its labeling is misleading, we must take
into account not only representations made or suggested, but also the
extent to which the labeling fails to reveal facts that are material in
light of such representations or material with respect to consequences
that may result from the use of the food. All of these authorities
listed in this paragraph give us the authority to issue this proposed
rule related to serving size labeling.

Summary of the Major Provisions of the Proposed Rule

Single-Serving Containers and Dual-Column Labeling

    Over the last 20 years, evidence has accumulated demonstrating that
container sizes can influence the amount of food consumed. For
containers of certain sizes, consumers are likely to eat the entire
container in one sitting. For other container sizes, consumers may
consume the container in one sitting or may consume the container over
multiple sittings or share the container contents with other consumers.
To address containers that may be consumed in a single-eating occasion,
FDA is proposing that all containers, including containers of products
with large RACCs (i.e., products with RACCs of at least 100 grams (g)
or 100 milliliters (mL)), containing less than 200 percent of the RACC
be labeled as a single-serving container. To address containers that
may be consumed in one or more sittings, or shared, FDA is proposing
that containers that contain at least 200 percent and up to and
including 400 percent of the RACC be labeled with dual-column labels
that include a column of nutrition information within the Nutrition
Facts label that lists the quantitative amounts and percent Daily
Values (percent DVs) for the entire container, as well as the
preexisting required column listing the quantitative amounts and
percent DVs for a serving that is less than the entire container (i.e.,
the serving size derived from the RACC).

Changing the Reference Amounts Customarily Consumed (RACCs)

    FDA established RACCs in 1993 based, in part, on data from
Nationwide Food Consumption Surveys (1977-1978 and 1987-1988) conducted
by the U.S. Department of Agriculture (USDA). Over the last decade,
there has been general recognition that consumption patterns have
changed. To determine changes in serving sizes and whether the RACCs
should be updated, FDA has analyzed recent food consumption data

from the National Health and Nutrition Examination Surveys (NHANES)
(2003-2008 surveys).\1\ Generally, changes to the RACCs are proposed in
this rule if the NHANES median consumption data have increased or
decreased by at least 25 percent compared to the 1993 RACCs. However,
consistent with our regulations in Sec.  101.12(a), we are also
considering other factors, such as designating the same RACCs for
products with similar consumption data and similar dietary usage or
product characteristics.
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    \1\ Hereinafter referred to as the NHANES 2003-2008 surveys or
NHANES 2003-2008 consumption data, as applicable.
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    In addition, since the final rule on serving sizes published in
1993, we have received requests from manufacturers to modify, establish
and identify appropriate product categories within the tables in Sec.
101.12(b), and change the serving size for various food products. Using
the data currently available to us, we are also addressing these
requests in this proposed rule.

Technical Amendments

    We have been alerted to a number of technical amendments that
should be made to the serving size regulations in Sec. Sec.  101.9 and
101.12. This rule proposes a number of technical amendments to help
clarify the serving size requirements in these regulations.

Effective Date

    We are proposing an effective date of 60 days after the date of the
final rule's publication in the Federal Register with a compliance date
2 years after the effective date.

Costs and Benefits

    We have developed one comprehensive preliminary regulatory impact
analysis (PRIA) that presents the benefits and costs of this proposed
rule as well as the proposed rule entitled ``Food Labeling: Revision of
the Nutrition and Supplement Facts Labels''. The PRIA analyzes the
costs and benefits of both the major changes proposed by the rules
(i.e., those proposals that would require the manufacturer to undertake
a re-design of their label), as well as the minor changes proposed by
the rules (i.e., those proposals that would not require a label re-
design). The cumulative impact of these two nutrition labeling
proposals, assuming a two-year compliance period and taken as a whole,
is shown in the following table.

               Summary of Costs and Benefits Over 20 Years
                         [In billions of 2011 $]
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                                                                 Net
                                     Benefits      Costs       benefits
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Present Value (PV):
    3%...........................        $31.4         $2.3        $29.1
    7%...........................         21.1          2.3         18.8
Annualized (3% PV Amount):
    3%...........................          2.0          0.2          1.8
Annualized (7% PV Amount):
    7%...........................          1.9          0.2          1.7
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Notes: Compliance period is 24 months. Costs include relabeling and
  reformulation costs, which are one-time costs, as well as
  recordkeeping costs, which recur. Present values of relabeling and
  reformulation costs are equivalent at 3 or 7 percent because we
  conservatively assume that these one-time costs are incurred upon
  publication of the rule instead of at the end of the compliance
  period. Recordkeeping costs, because of their recurring nature, differ
  by discount rate; however, such costs comprise a very small percentage
  of total costs.

I. Background

A. The Serving Size Regulations

    On November 8, 1990, the Nutrition Labeling and Education Act (the
NLEA) was signed into law (Pub. L. 101-535). The NLEA amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), and 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 FD&C Act (21 U.S.C. 343(q)(1)(A)(i))
requires that most foods under FDA's jurisdiction bear nutrition
information that provides a serving size that reflects the amount of
food customarily consumed per eating occasion and is expressed in a
common household measure appropriate to the food. Section 2(b)(1)(B) of
the NLEA also required that we issue regulations that establish
standards to define serving size.
    To implement the serving size requirements of the NLEA, FDA
conducted notice-and-comment rulemaking (56 FR 60394, November 27, 1991
(the 1991 serving size proposed rule), and 58 FR 2229, January 6, 1993
(the 1993 serving size final rule)). FDA also published technical
amendments to the 1993 serving size final rule on August 18, 1993 (58
FR 44039) (the 1993 technical amendments). Consistent with the FD&C
Act, the serving size regulations established standards to define
``serving size'' that are composed of two basic elements: (1) Reference
amounts customarily consumed (RACCs or reference amounts) per eating
occasion for specific food product categories; and (2) procedures for
determining serving sizes for use on product labels derived from the
RACCs. The second element was necessary because the RACCs are provided
primarily in metric units (based on data from national food consumption
surveys that are expressed in grams); however, the FD&C Act requires
that serving sizes be expressed in common household measures that are
appropriate to the particular food.
    Section 101.9(b)(1) (Sec.  101.9(b)(1)) defines 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.
    Section 101.12(a) (Sec.  101.12(a)) describes the general
principles and factors that we considered in arriving at the RACCs.
Among these principles, we sought to ensure that foods that have
similar dietary usage, product

characteristics, and customarily consumed amounts have a uniform
reference amount customarily consumed (RACC or reference amount) so
that consumers could make nutritional comparisons of similar products
in the marketplace. In Sec.  101.12(b), we established RACCs (upon
which label serving sizes are to be determined) for 129 product
categories representing the general food supply and 11 product
categories of foods for infants and children 1 through 3 years of age.
    The current 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 (NFCS) conducted by the U.S.
Department of Agriculture (USDA) (58 FR 2229 at 2236-2237). We reviewed
food consumption data for the foods in each product category and
considered three statistical estimates: The mean (average), the median
(50th percentile), and the mode (the most frequent value). For the 1993
serving size final rule we followed the procedures discussed in the
1991 serving size proposed rule (56 FR 60394 at 60403-60406) and the
general principles discussed in Sec.  101.12, and determined the RACC
that was most likely to represent the amount customarily consumed for
each product category.
    Section 101.9(b) establishes procedures for converting RACCs into
appropriate label serving sizes. Section 101.9(b)(6) defines the
criteria for products to be labeled as single-serving containers.
Generally, products packaged and sold individually that contain less
than 200 percent of the applicable RACC must currently be labeled as
one serving. An exception to this rule occurs for products that contain
more than 150 but less than 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 discretion. For example, the RACC for carbonated
beverages is 240 mL (i.e., 8 fluid (fl) ounces (oz)). Containers of
carbonated beverages that are 360 mL (i.e., 12 fl oz, 150 percent of
240 mL) or less must be labeled as a single serving. Containers of
carbonated beverages weighing more than 360 mL and less than 480 mL
(i.e., more than 12 fl oz, 150 percent of 240 mL, and less than 16 fl
oz, 200 percent of 240 mL) may be labeled as ``1 serving'' or as ``2
servings'' per container. For products packaged and sold individually
that contain 200 percent or more of the RACC, the manufacturer may
currently label the product as a single-serving if the entire content
of the container can reasonably be consumed at a single-eating occasion
(Sec.  101.9(b)(6)).
    Under Sec.  101.9(b)(11), manufacturers must provide a second
column of nutrition information for products that are promoted on the
label, labeling, or advertising for a use that differs in quantity from
the RACC by 200 percent or greater from the use upon which the
reference amount was based (e.g., liquid cream substitutes promoted for
use with breakfast cereals). The second column of nutrition information
is based on the amount customarily consumed in the promoted use.
    Manufacturers may also voluntarily provide a second column of
nutrition information per 100g or 100 mL, or per 1 oz or 1 fl oz of the
food as ``packaged'' or ``purchased'' (Sec.  101.9(b)(10)(i)) and per
cup popped for popcorn in a multi-serving container (Sec.
101.9(b)(10)(iii)). Additionally, manufacturers may voluntarily provide
a second column of nutrition information on the Nutrition Facts label
per one unit if the serving size of a product in discrete units in a
multi-serving container is more than one unit (Sec.  101.9(b)(10)(ii)).
For example, the RACC for muffins is currently 55 g. Under Sec.
101.9(b)(10)(ii), if three muffins in a multi-serving container of six
muffins weigh 18 g each, there are two options for the serving size
declaration: (1) A label showing the serving size as ``3 muffins (55
g),'' with the Nutrition Facts label listing nutrition information per
serving (i.e., 3 muffins); or (2) a label with the Nutrition Facts
label listing again the nutrition information per serving (i.e., 3
muffins), but also with an additional column listing the nutrition
information per ``1 muffin (18 g),'' which would be less than one
serving.
    Dual-column labeling may also be used to present nutrition
information for two or more forms of the same food (e.g., both ``as
purchased'' and ``as prepared'') under Sec.  101.9(e). Additionally, if
a food is commonly combined with other ingredients or is cooked or
otherwise prepared before eating, under certain circumstances an
additional column may be used to declare nutrition information on the
basis of the food as ``consumed'' (Sec.  101.9(h)(4)). For example a
dry ready-to-eat cereal may be described with one set of Percent Daily
Values for the cereal as sold per ounce, and may use another for the
cereal with milk (e.g., per ounce of cereal plus 1/2 cup of vitamin D
fortified skim milk).

B. The Obesity Working Group

    In August 2003, the Commissioner of Food and Drugs created the
Obesity Working Group (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. A docket was established in July of 2003
(Docket No. FDA-2003-N-0161 (formerly Docket No. 2003N-0338)) (the
``Obesity docket'') to accept comments on obesity-related issues. The
OWG's final report entitled ``Calories Count'' (the ``Calories Count''
report) 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 help
consumers prevent weight gain and reduce obesity. To address this
issue, among other actions, the OWG recommended that we reexamine our
serving size regulations by inviting comment on: (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.

C. The Advance Notice of Proposed Rulemaking

    On April 4, 2005, we published an advance notice of proposed
rulemaking (ANPRM) (70 FR 17010) entitled ``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.'' The ANPRM was
published in response to the ``Calories Count'' report. The ANPRM
focused on the following topics, which are also discussed in this
proposed rule: (1) Single-serving containers and dual-column labeling;
(2) updating the RACCs; and (3) calorie comparison claims. We used the
three topics of the ANPRM to structure this proposed rule.

1. Single-Serving Containers
    The ANPRM invited comment on topics that originated, in large part,
from the OWG's activities. Several comments submitted to the Obesity
docket strongly opposed the practice of individually packaged foods
that appear to be single-serving containers, declaring two or more
servings on the label--such as certain sodas and snack packages. In
2003, we initiated eight focus groups around the country and showed
them examples of labels of a 20 fl oz soda and an individually packaged
large muffin. Focus group participants thought these products should be
labeled as single-serving products (Ref. 1). Many participants (though
not all) did understand 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 made mistakes when
trying to calculate the total amount of nutrients (Ref. 2) To address
problems identified from focus groups, the ANPRM discussed amending the
definition of a single-serving container in Sec.  101.9(b)(6) and
providing an additional column in the Nutrition Facts label that would
list the nutrition information for the entire package in addition to a
column listing multiple servings for the package (70 FR 17010 at
17012).
    In the 1993 serving size final rule, we used the mean, median, and
mode from food consumption surveys to determine the RACCs. In addition
to these three statistical estimates (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). Because estimates can be
calculated for individuals that eat a greater amount of food than
average, in the ANPRM, we invited comment on whether the 90th and 95th
percentiles could be used to determine the cutoff points at or below
which nutrition information should be provided for the entire package
(70 FR 17010 at 17013).
    We also sought comment in the ANPRM on the potential effects of
requiring that manufacturers list the nutrient content for the entire
package for certain package sizes (70 FR 17010 at 17013).
2. Updating the RACCs
    Because there is evidence that the U.S. population is eating larger
portion sizes than it did in the 1970s and 1980s (Refs. 3, 4, 5, and
6), the OWG recommended that FDA determine whether to update the RACCs,
and, if so, how to update the RACCs. The ANPRM recognized that 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 Facts label (70 FR 17010 at 17012).
    Even if consumers are consuming larger amounts, we do not want
consumers to confuse the serving size on the food label (which the FD&C
Act requires to be based on the amount customarily consumed) with an
amount that dietary guidance documents, such as the Dietary Guidelines
for Americans (Ref. 7), recommend for consumption. For example, if data
show that consumers are drinking larger amounts of carbonated
beverages, and we increase the RACC for such beverages, which will
likely increase the amount of the serving size on the label, additional
educational efforts may be needed to reinforce to consumers that a
larger serving size on the container is not a ``recommended'' serving
size. The ANPRM invited comment on how recent consumption data should
factor into the determination of which, if any, RACCs should be updated
\2\ and what criteria should be used as the basis for change (70 FR
17010 at 17012). We also invited comment on how we could make serving
size information on the Nutrition Facts label easier for consumers to
use when deciding what foods and how much of these foods to eat (70 FR
17010 at 17012).
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    \2\ We note that in this proposed rule, when we speak of
``updates to'' or ``updating'' the RACCs established in 1993, we are
referring to amendments to RACCs for products that are currently
listed in the tables in Sec.  101.12(b), and for which the NHANES
2003-2008 consumption data showed a significant change in
consumption (as discussed in the proposed amendments section, we
have determined that an increase or decrease in consumption by at
least 25 percent from the amount listed in the tables in Sec.
101.12(b) would be considered a significant change).
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3. Comparison of Calories in Foods of Different Portion Sizes
    As noted in the ``Calories Count'' report, the Federal Trade
Commission had suggested that we consider ``allowing food marketers to
make truthful, non-misleading label claims comparing foods of different
portion sizes (Ref. 1).'' Our regulations discuss requirements to use
certain characterizing terms to make comparative nutrient content
claims (called ``relative claims'') that compare the level of nutrients
in two foods, including calorie comparisons, and 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 (see 21 CFR
Part 101, Subpart D, and Sec.  101.13(j)). Section 101.13(j) also
requires that such comparisons made in ``relative claims'' reflect
actual nutrient differences in the same quantity of similar foods
(e.g., ``Reduced calorie chocolate ice cream, 25 percent 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'') or dissimilar foods within a product
category that can be substituted for one another (e.g., ``Reduced
sodium pretzels, 33 percent less sodium than the leading brand of
potato chips. Our pretzels contain 105 mg of sodium per serving. The
leading brand of potato chips contains 320 mg of sodium per serving).
The nutrient content claim regulations do not specifically discuss
claims that compare the amount of calories based on different sized
portions of the same food product. However, FDA's regulations do allow
certain statements in the label or labeling of a food product about the
amount or percentage of a nutrient in the food (see Sec.  101.13(i)).
As noted in the ``Calories Count'' 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, the ANPRM
invited comment 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) versus
claims based on the RACC and specified in the labeled serving size of a
product (i.e., the amount specified on the Nutrition Facts label (e.g.,
two 15 g cookies)) (70 FR 17010 at 17013).
4. Overview of Comments on the Advance Notice of Proposed Rulemaking
    The ANPRM resulted in approximately 850 comments from health
advocacy groups, industry, trade associations, consumer groups,
individual consumers, government, health professionals, and academia.
Not all of the comments received addressed the questions posed in the
ANPRM, and many comments were outside the scope of the rulemaking. We
discuss the comments within the scope of the ANPRM later in this
proposed rule.

D. Requests for Changes to Serving Size Requirements

    This section describes the six citizen petitions, as well as other
documentation related to requests for changes to serving size
requirements and requests for dual column labeling that will be
addressed, in part, in this proposed rule.
1. Requests To Modify and Establish Certain RACCs and Add Products to
Product Categories
    We have received several requests (Ref. 8), and six citizen
petitions that are discussed in this document, to modify \3\ the
current RACCs for specific products that are already listed in the
tables in Sec.  101.12(b). We have also received several requests to
establish \4\ ``new'' RACCs for food products that are not listed in
the tables in Sec.  101.12(b) by adding ``new'' product categories to a
general category or ``new'' products to a product category (Refs. 8, 9,
and 10). We discuss these requests in sections II.D.3.b., II.D.6 and
II.E.
---------------------------------------------------------------------------

    \3\ We note that in this rule, when we speak of ``modify'' or
``modifying'' RACCs, we are referring to changes to existing RACCs
in the tables in Sec.  101.12(b) for which the NHANES 2003-2008
consumption data did not show an increase or decrease in consumption
by at least 25 percent.
    \4\ We note that in this rule, when we speak of ``establish'' or
``establishing'' RACCs, we are referring to the addition of products
(and assigning RACCs for such products) that are not already listed
in the tables in Sec.  101.12(b).
---------------------------------------------------------------------------

2. Adding Products to the List of Products for Each Product Category
    In the 1991 serving size proposed rule, we provided as a reference
(Ref. 20 of the 1991 serving size proposed rule) an extensive list that
manufacturers could use, which included examples of products for a
given product category (Ref. 11). The List of Products for Each Product
Category was updated in the 1993 serving size final rule and we stated
that we would revise the list as necessary (58 FR 2229 at 2241) and
that those who were not sure about which product category their
specific products belong to should refer to the list or consult us (58
FR 2229 at 2291). Copies of the list are available from the Office of
Nutrition, Labeling and Dietary Supplements, Food and Drug
Administration 5100 Paint Branch Parkway, College Park, MD 20740.
Separately from this rulemaking, we are planning to update the list and
make it available as draft guidance after the publication of this
proposed rule. If finalized, the guidance document would be made
available on our Web site.
3. Citizen Petitions
a. Petition for Food and Beverages Sold in Single-Serving Containers
    On October 29, 2004, the Center for Science in the Public Interest
(CSPI) submitted a citizen petition (Docket No. FDA-2004-P-0210,
formerly Docket No. 2004P-0483) (the CSPI petition) (http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0210). The CSPI
petition claimed that trends of increasing sizes of snack foods and
beverages make the current Nutrition Facts label on some products
misleading for the average consumer. The CSPI petition discussed three
groups of products: Soft drinks, snack food products, and baked goods.
The CSPI petition claimed that larger package sizes for snack food
products and soft drinks have led to increased consumption of these
items, which contributes to the obesity epidemic. The CSPI petition
requested that we improve the nutrition labeling in three areas for
foods and beverages. Specifically, the CSPI petition requested that we:
(1) Amend the definition of a single-serving container by increasing
the cutoff for single-serving containers to include 300 percent of the
applicable RACC for soft drinks/beverages and muffins/pastries; (2)
consider whether the cutoff level for the single-serving labeling of
other food categories should be raised; (3) require dual columns on the
Nutrition Facts label on a per serving and per package basis for snack
packages that contain at least 200 percent and up to and including 400
percent of the applicable RACC, if the snack package can be consumed by
one person, but is often consumed by multiple people; (4) require snack
packages that contain at least 200 percent and up to and including 400
percent of the applicable RACC to be labeled as a single serving if the
package is usually consumed by one person; and (5) require disclosure
on the principal display panel (PDP) of food labels for products that
contain at least 200 percent and up to and including 400 percent of the
applicable RACC of the number of servings in the package. We discuss
issues raised in the first four requests from the CSPI petition in
sections II.C.2.b and II.C.3.b. The fifth request for requiring
disclosure on the PDP of food labels on the number of servings in the
package for certain size packages is outside the scope of this
rulemaking.
b. Petition for a New RACC for Fruitcake
    We received a citizen petition (the fruitcake petition) on
September 15, 2008, from certain fruitcake manufacturing companies
(Docket No. FDA-2008-P-0511) (http://www.regulations.gov/#!docketDetail;D=FDA-2008-P-0511), requesting that we exercise
administrative discretion to establish 43 g (~1\1/2\ oz) as the RACC
for fruitcake rather than the current RACC of 125 g. The fruitcake
petition provided labels, order forms, and other documents establishing
that the fruitcake industry has been using 1\1/2\ oz as a serving size.
The fruitcake petition did not provide any consumption data to
establish a RACC. We will be discussing issues raised in this citizen
petition in section II.D.3.b.
c. Petition for a New RACC for Yogurt
    On June 2, 2011, the National Yogurt Association (NYA) submitted a
citizen petition (Docket No. FDA-2011-P-0440) (the NYA petition)
(http://www.regulations.gov/#!docketDetail;D=FDA-2011-P-0440),
requesting that we change the existing RACC for yogurt from 225 g
(roughly 8 oz) to 170 g (6 oz). Nutrient content claims and health
claims for yogurt are based on the 8-oz RACC (Sec.  101.12(g)).
According to the petition, over half of the yogurt containers on the
market today are sold in 6-oz containers. However, manufacturers cannot
make nutrient content claims and health claims for yogurt based on a 6-
oz amount, because the 8-oz RACC must be used to determine if the
criteria for the claims has been met (see Sec.  101.12(g)). The NYA
petition used current consumption data to justify their request for a
smaller RACC. We discuss the issues in the NYA petition in section
II.D.3.b.
d. Petition for a New RACC for Mint Wafers and Similar Candy Products
    On February 17, 1996, we filed a petition submitted by the
Nutrition Research Group for Andes Candies, Inc., (the Andes petition)
(Docket No. FDA-1996-P-0309, formerly Docket No. 96P-0023) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-1996-p-
0309;fp=true;ns=true. The petition requests that we amend the RACC for
Andes mint wafers and products that are similar to Andes mint wafers.
Specifically, the Andes petition requested that we: (1) Change the RACC
for Andes mint wafers and similar products from 40 g (the current RACC
for ``All other candies'') to 15 g; and (2) amend the ``Sugars and
Sweets'' product category for ``Hard candies, others'' to read ``Hard
candies, mint wafers and others''.
    The Andes petition provided data from a 1995 consumer study
conducted by Andes to support a RACC of 15 g for

Andes mint wafers. The Andes petition also stated that the USDA
national food consumption data available at the time (1995) also
supported a RACC of 15 g for Andes mint wafers. These data included the
1987-1988 NFCS and 1989-1991 Continuing Survey of Food Intake by
Individuals (CSFII).
e. Petition for a New RACC for Certain Candies Weighing 20 g or Less
per Piece
    On May 30, 1996, the Chocolate Manufacturers Association (CMA) and
the National Confectioners Association (NCA), trade associations
representing chocolate and confectionary companies, jointly submitted a
citizen petition (the CMA/NCA petition) to FDA (Docket No. FDA-1996-P-
0246, formerly Docket No. 96P-0179) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-1996-P-0246;fp=true;ns=true. The CMA/
NCA petition requested that we amend the ``Sugars and Sweets'' general
category by establishing a new 25 g RACC for candies (other than hard
candies or baking candies) weighing 20 g or less per piece.
    The CMA/NCA petition pointed out that the current 40 g RACC for
``All other candies'' encompasses a large variety of candy products,
ranging from very small pieces weighing only a few grams each, to king-
size candy bars and novelty items that can weigh more than a pound.
CMA/NCA submitted data from two consumer studies to support their
request for a new 25 g RACC. The CMA/NCA petition concluded that a
smaller RACC for chocolate and non-chocolate candies (other than hard
candies or baking candies) weighing 20 g or less was warranted, and
would result in labels that provide more useful nutrition information
to consumers.
    We discussed the Andes petition and the CMA/NCA petition in a
proposed rule entitled ``Food Labeling; Serving Sizes; Reference
Amounts for Candies'' on January 8, 1998 (63 FR 1078) (Docket Nos. FDA-
1996-P-0309 and FDA-1996-P-0246 (formerly Docket Nos. 96P-0023 and 96P-
0179)). Later, we announced the withdrawal of that proposed rule in the
Federal Register on November 26, 2004 (69 FR 68831). Because we are
updating, modifying, or establishing RACCs for all product categories
in this proposed rule, we discuss the issues raised in the Andes
petition and the CMA/NCA petition in this proposed rule. These issues
are discussed in sections II.D.3.b and II.D.6., respectively.
f. Petition for a New Product Category and New RACC for Small Breath
Mints Weighing 0.5 g or Less
    We received a petition (the breath mints petition) dated April 20,
1994 (Docket No. FDA-1994-P-0314, formerly Docket No. 94P-0168) (http://www.regulations.gov/#!documentDetail;D=FDA-1994-P-0314-0001) from
Ferrero USA, Inc. requesting that we amend the product category for
``Sugars and Sweets: Hard candies, breath mints'' to create a separate
product category for small breath mints (weighing 0.5 g or less) having
the same breath-freshening capacity as larger mints. The breath mints
petition explained that small breath mints weigh about 0.4 g each, and
therefore the current RACC of 2.0 g is unrealistic for this product
category because it means the serving size would be 5 mints. The breath
mints petition emphasized that because consumers typically eat one
breath mint at a time, the serving size for small breath mints should
be ``1 mint'' and that the RACC for this product category should be 0.5
g.
    The breath mints petition contained study data collected from two
telephone interviews with a randomly selected, nationally
representative sample of consumers who acknowledged using breath mints
during the past three months. The results of these studies, which
included data on both small and large breath mint products, indicated
that one breath mint was the amount customarily consumed per eating
occasion by the majority of breath mint users. We also received two
letters from breath mints manufacturers suggesting that breath mint
products should have a ``one mint'' serving size (Refs. 12 and 13).
    We discussed the breath mints petition in a proposed rule entitled
``Food Labeling; Serving Sizes: Reference Amount and Serving Size
Declaration for Hard Candies, Breath Mints'' on December 30, 1997 (62
FR 67775) (the 1997 breath mints proposed rule) (Docket No. FDA-1994-P-
0314, formerly Docket No. 94P-0168). This proposed rule also discussed
changing the rounding rules for calories to allow the nutrition label
on any product with less than 5 calories per serving to optionally
declare the exact amount of calories in lieu of zero calories.
    Because we are addressing issues related to the label serving size
for breath mints, in conjunction with other serving size issues, in
this proposed rule, we are withdrawing the 1997 breath mints proposed
rule elsewhere in this issue of the Federal Register.

E. Technical Issues

    Since the 1993 serving size final rule and the 1993 technical
amendments were published, we have been alerted to several additional
technical amendments that should be made. These technical amendments
include: (1) Clarifying the rounding rules for products that have more
than five servings when the number of servings fall exactly between two
values; (2) clarifying options when the number of servings per
container varies; (3) making minor corrections to the general and
product category names; (4) making minor changes in the footnotes to
the tables in Sec.  101.12(b); (5) making minor changes to Table 2 in
Sec.  101.12(b); (6) making minor corrections and clarifications to the
rules for reference amounts for products that require further
preparation (e.g., mixes); and (7) clarifying the rules for reference
amounts for products that consist of two or more separate foods that
are packaged together and are intended to be eaten together (e.g.,
pancake and syrup). These amendments are discussed in section II.F.

II. The Proposed Rule

A. Legal Authority/Statutory Directive

    Our primary legal authority to issue regulations that establish
requirements for serving size is derived from section 403(q) of the
FD&C Act. Specifically, section 403(q)(1)(A)(i) of the FD&C Act
requires, with certain exceptions, that food that is intended for human
consumption and offered for sale bear nutrition information that
provides a serving size that reflects the amount of food customarily
consumed and is expressed in a common household measure that is
appropriate to the food.
    The NLEA added section 403(q)(1)(A)(i) to the FD&C Act, and, under
section 2(b)(1)(B) of NLEA, required that we issue regulations that
establish standards to define serving size. We established those
standards in the 1993 serving size final rule, and at this time we have
determined that amendments to those regulations are needed. We have
analyzed consumption data for various food products, and have
determined that many of the RACCs established in 1993 have changed
enough to warrant amending the current RACCs. Additionally, both on our
own initiative and in response to various requests, we have analyzed
data for products that are not currently listed in the tables in Sec.
101.12(b), and are proposing to establish additional RACCs. Thus, in
accordance with section 403(q)(1)(A)(i) of the FD&C Act, we are
proposing to amend the RACCs

in Sec.  101.12(b) to reflect the current amounts customarily consumed
for products that are already listed in Sec.  101.12(b), as well as
those not currently listed in Sec.  101.12(b). Additionally, under the
same authority we are proposing to amend related regulations in
Sec. Sec.  101.9 and 101.12 that set forth procedures for determining
serving sizes for use on product labels from the reference amounts.
Included among these proposed amendments are revisions to the
procedures for determining what products must be labeled as a single
serving.
    Further, in addition to requiring FDA to issue regulations that
establish standards to define serving size, section 2(b)(1)(A) of NLEA
states that the regulations shall require such information to be
``conveyed to the public in a manner which enables the public to
readily observe and comprehend such information and to understand its
relative significance in the context of a total daily diet.'' Under
this authority, we are proposing to amend Sec.  101.9 to require that
certain products provide an additional column within the Nutrition
Facts label that lists the quantitative amounts of the required
nutrients and food components, and percent DVs for such nutrients and
food components, for the entire container or unit of food as well as
the preexisting columns listing the quantitative amounts and percent
DVs for a serving of food that is less than the entire container.
Section 2(b)(1)(A) of the NLEA provides authority for this proposed
amendment because the additional column of information will help
consumers to understand the nutritional significance of consuming an
entire container or unit of certain foods containing multiple servings
in the context of a total daily diet. As is discussed further in
section II.C.1., research has shown that package and portion size play
a role in influencing the amounts that consumers eat, and that
consumers can be confused about the amount of nutrients they consume in
packages containing more than one serving but that could be consumed in
a single eating occasion. The proposed amendment is intended to help
consumers understand the amounts of nutrients in certain containers and
units of food, as well as the DVs for those nutrients, so that those
amounts can be taken into consideration when evaluating a daily diet.
    Other relevant authorities that we are relying on for the proposed
amendments in this rule include sections 701(a), 403(a)(1), and 201(n)
of the FD&C Act (21 U.S.C. 371(a), 343(a)(1), and 321(n)). Under
section 701(a) of the FD&C Act, we have authority to issue regulations
for the efficient enforcement of the FD&C Act. We may issue regulations
for the efficient enforcement of the FD&C Act in order to ``effectuate
a congressional objective expressed elsewhere in the Act'' (Association
of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Sup. 1179,
1183 (D. Del. 1980). Under section 403(a) of the FD&C Act, a food is
deemed misbranded if its labeling is deemed false or misleading in any
particular. Additionally, under section 201(n) of the FD&C Act, in
determining whether or not a food is misbranded because its labeling is
misleading, we must take into account not only representations made or
suggested, but also the extent to which the labeling fails to reveal
facts that are material in light of such representations or material
with respect to consequences that may result from the use of the food.
These other authorities, in addition to the authorities described
previously in this document, give us the authority to issue this
proposed rule related to serving size labeling.

B. Need for This Regulation

    Since we adopted the Nutrition Facts and Supplements Facts labels,
there have been developments that have compelled us to re-evaluate our
regulations on serving sizes and determine whether and what, if any,
revisions are needed to ensure that the Nutrition Facts label meets its
intended goal of helping consumers maintain healthy dietary practices.
Specifically, such developments include the availability of newer
consumption data; research showing that the amount of food consumed by
the American public has changed; and the availability of recent
findings of consumer research on the use and understanding of the
Nutrition Facts label. In light of these factors, we propose to amend
the serving size regulations to provide consumers with information,
including the serving size, in order to help them maintain healthy
dietary practices. These factors are discussed in sections II.C.1 and
II.D.1.
    The proposed amendments are important because poor dietary
practices have public health impacts (Refs. 14, 15, 16, 17, 18, and
19). Since 1993, there has been a shift in the population prevalence of
being overweight or obese among the U.S. population. The U.S. Centers
for Disease Control and Prevention (CDC) identifies as overweight an
adult whose body-mass index, or BMI (defined as weight in kilograms
divided by the height in meters squared), is between 25 and 29.9. CDC
defines an obese adult as a person 20 years of age or older whose BMI
is 30 or above (Ref. 16). CDC data indicate that 68 percent of the
adult U.S. population is overweight or obese, including 34 percent who
are considered obese (Ref. 14). The prevalence of obesity in the United
States has increased dramatically in the past 30 years. In the 1976-
1980 NHANES II data, 15 percent of participants were obese, while in
the 2007-2008 NHANES data, 34 percent of people were obese (Refs. 14
and 15). The primary risk factors for overweight and obesity in the
general population are overconsumption of calories (i.e., eating more
calories than are needed to maintain body weight) and physical
inactivity (i.e., getting an amount of exercise below the amount
required to burn excess calories consumed over the amount needed to
maintain body weight) (Ref. 7). For adults, being overweight or obese
increases the risk for a number of chronic diseases, including coronary
heart disease, type 2 diabetes, stroke, hypertension, arthritis, and
certain types of cancer (Ref. 16). A BMI over 35 is associated with
excess mortality, primarily from cardiovascular disease, diabetes, and
certain types of cancer (Refs. 14, 17, and 19). Heart disease, cancer,
and, stroke account for more than 50 percent of all deaths in the
United States each year (Ref. 18). In 2005, 133 million Americans
(almost one out of every two adults) had at least one chronic illness
(Ref. 18).
    In addition, portion sizes of foods served at home and in
restaurants have increased. The package or portion sizes of foods
purchased at supermarkets, stores, fast food restaurants, and chain
restaurants were two to eight times larger than serving size standards
set by Federal Agencies, including the USDA's Food Guide Pyramid and
FDA's serving size standards, based on RACCs (Ref. 4). This change has
been especially true for portion sizes of salty snacks, soft drinks,
fruit drinks, and some fast foods (Ref. 6).
    Studies have shown that increases in package size and portion size
are related to higher calorie intake among individual consumers and
overconsumption in American culture (Refs. 20, 21, 22, 23, and 24). In
a study conducted by Rolls et al., participants were given afternoon
snacks in prepackaged containers with varying portion sizes. They were
given dinner later in the day to determine the effects of varying snack
sizes on the subsequent meal. Study results showed that snack intake
increased significantly as the package size increased. In most cases,
participants did not significantly reduce

intake at dinner to compensate for the increased calorie intake from
the snack, and overall combined calorie intake from the dinner and
snack increased when subjects were given larger snack packages (Ref.
21). The primary risk factors for overweight and obesity in the general
population are overconsumption of calories and physical inactivity
(Ref. 7). Therefore, it is significant that increased package and
portion size may contribute to increase consumption of total calories.
    In consideration of all of the previously-mentioned factors,
amendments to the serving size requirements are necessary to help
consumers maintain healthy dietary practices. These amendments are
described in sections II.C.2.b, II.C.3.b, II.D.2.c, II.D.3.b, and II.F.
We invite comments on all aspects of this proposed rule, including the
amendments described in these sections.

C. Single-Serving Containers and Dual-Column Labeling

    FDA regulations require that a product that is packaged and sold
individually and that contains less than 200 percent of the applicable
RACC be considered to be a single-serving container, and that the
entire content of the product be labeled as one serving, except that,
for products that have RACCs of 100 g or 100 mL or larger,
manufacturers may decide whether a package that contains more than 150
percent, but less than 200 percent of the RACC, will be labeled as 1 or
2 servings (Sec.  101.9(b)(6)). In the 1991 serving size proposed rule,
we proposed to set the upper limit of a single-serving container at
``less than 200 percent,'' in part, because products that contain 200
percent of the reference amount are, by definition, two servings. Thus,
they are not single servings (56 FR 60394 at 60398). A reference amount
is an amount customarily consumed (section 403(q)(1)(A)(i) of the FD&C
Act). The RACCs we established are based primarily on nationally
representative food consumption data and represent the amount of a food
that a U.S. individual customarily consumes per eating occasion. Thus,
if a product contains 200 percent or more of the applicable RACC, this
amount would be twice as much as the customarily consumed amount per
eating occasion.
    Section 101.9 provides various provisions for types of voluntary
dual-column labeling (e.g., Sec.  101.9(b)(10)(i)) and one provision
for mandatory dual-column labeling under certain circumstances (Sec.
101.9(b)(11)).
    As explained in detail in this document, we are amending Sec.
101.9(b) to change the criteria for when a food product must be labeled
as a single serving, and to require the use of dual-column labeling
that provides nutrition information per serving and per container, or
per serving and per unit of food under certain circumstances.
1. Research Related to Single-Serving Containers and Dual-Column
Labeling
a. Research on the Impact of Package and Portion Sizes on Consumption
    Research has shown that package and portion sizes have a
considerable impact on the amount of food consumed, and that the size
of the unit of food or package can set a consumption norm for consumers
(Refs. 25 and 26). In one study, moviegoers were given either medium or
large containers of popcorn that were either fresh or stale (Ref. 25).
Study results showed that moviegoers who were given fresh popcorn in
larger containers ate 45.3 percent more popcorn than those given medium
containers of fresh popcorn. Moviegoers who were given stale popcorn in
large containers still ate 33.6 percent more popcorn than those given
medium containers even though they reported that they disliked the
popcorn (Ref. 25). In another study, subjects were given four different
sizes of a deli sandwich, which were 4-inches, 6-inches, 8-inches and
12-inches. The results show that increasing the portion size of a food
in a discrete unit, such as a sandwich had a significant effect on
calorie intake (Ref. 26). These and other studies have demonstrated
that the size of the package or unit may implicitly suggest what might
be construed to be a ``normal,'' or ``appropriate,'' amount of food to
consume (Refs. 20, 25, and 26). Using young adults enrolled at one
university, another study found that participants experienced portion
distortion (perceiving large portion sizes as appropriate amounts to
eat at a single-eating occasion) and needed guidance in monitoring how
much they ate (Ref. 27). Studies have also shown that some consumers
may tend to experience a ``unit bias,'' and view intact units/packages
of food as a marker of the appropriate amount of food to consume (Ref.
28).
b. Research on Consumer Use and Understanding of the Serving Size
Labeling
    Research also suggests that many consumers do not correctly
calculate nutrient amounts in food products by multiplying the nutrient
amount by the number of servings per container. A review article of
studies on nutrition labels in the United States, Canada, and Northern
Europe has found that although consumers could understand some
information, they reported finding nutrition labeling confusing,
especially the use of numerical information (Ref. 28). One study looked
at participants of different socioeconomic backgrounds (Ref. 29). It
found that only 32 percent of study participants could correctly
calculate the amounts of carbohydrates in a 20 oz bottle of soda that
had 2.5 servings in the bottle. Only 60 percent of participants could
correctly calculate the amount of carbohydrates consumed if they ate
half a bagel, when the serving size was a whole bagel (Ref. 29). Common
errors found in the study were that participants: (1) Did not attempt
to apply the serving size or servings per container information, or
used it inappropriately; (2) were confused by complex information on
the label; and (3) had calculation and other errors. Similar results
were reported in the ``Calories Count'' report. Although some focus
group participants knew how to correctly multiply by the number of
servings to calculate nutrition information per package, others were
confused or made mathematical mistakes (Ref. 2).
    Other research conducted suggests that individuals might not make
the distinction between serving size labeling and total package
nutrition information, which could result in consumers considering the
entire package as one serving despite the declaration of multiple
(e.g., 2) servings per container on the Nutrition Facts label. For
example, in one study, participants were interviewed to determine
whether they could calculate the total calories in sample snack food
packages that contained two to three servings (Ref. 30). Ninety percent
of the subjects correctly identified the number of calories per
individual serving, but only 37 percent were able to recognize the
number of calories per package (Ref. 30). Some subjects tended to think
of the multiple-serving package as one serving, and they underestimated
and under-reported caloric intake from snack food sources (Ref. 30).
c. Research on Dual-Column Labeling
    Other research has shown that dual-column labeling with the
nutrition information given per serving and per package may help
certain consumers recognize nutrient amounts per package in certain
types of packaged foods (Ref. 31). In one study, participants were
given a snack food product and either a single-column nutrition label
or dual-column nutrition label (i.e., labeling

indicating the nutrition information per serving and per package).
Participants were classified as either dieters or non-dieters based on
self-reported dieting behavior. Study results found that a dual-column
label reduces snack food consumption when compared to a single-column
labeling for people who are not currently dieting. When the dual-column
label was used, non-dieters in the study ate smaller portions that were
closer to those portions consumed by dieters. The authors of this study
speculated that a dual column label works as a contextual cue that
raises awareness of the amount of food consumed in a package among
certain consumers (Ref. 31).
    We will be conducting consumer research throughout this rulemaking.
The overall goal of the consumer research is to help enhance our
understanding of whether and how much modifications to the label format
may help consumers use the label. The research conducted thus far has
examined the effects of modifications to the Nutrition Facts label on
foods that could reasonably be consumed at a single-eating occasion,
but were sometimes listed as having more than one serving per
container, such as a grab bag of chips or a frozen meal. Participants
were randomly assigned to one of ten label formats that could be
classified into three groups: Listing two servings per container with a
single column (``two-serving single-column labels''), listing two
servings per container with a dual-column that listed the nutrients in
both ``per serving'' and ``per container'' columns (``dual-column
labels''), and declaring the entire package as one serving and listing
all of the nutrients as a single serving (``single serving per
container labels''). The study compared participants' ability to
perform various tasks, such as evaluating product healthfulness and
calculating the number of calories and other nutrients per serving and
per container, when using the current label versus modified versions of
the current label, and compared participants' overall attitudes toward
these labels. The main findings are that single serving per container
labels and dual-column labels resulted in more participants correctly
identifying the number of calories per container and the amount of
other nutrients per container and per serving compared to two-serving
single-column labels (such as the current label). Overall, participants
reported more positive attitudes toward single-serving and dual-column
labels in comparison to two- serving single-column formats (Ref. 32).
2. Single-Serving Containers
a. Comments on the ANPRM Regarding Single-Serving Containers
Amending the Definition for Single-Serving Containers
    The ANPRM invited comment on whether we should begin rulemaking to
require packages that can reasonably be consumed at one-eating occasion
to provide the nutrition information for the entire package (70 FR
17010 at 17013).
    Most comments indicated that we need to address the labeling of
packages that appear to be single-serving packages, but are actually
labeled as containing multiple servings, which they considered to be
``fraudulent'' and ``deceitful.'' Many comments stated that
manufacturers should not be allowed to list multiple servings for items
that an average person would consume at one-eating occasion. Examples
of such items consumed at one-eating occasion that commenters thought
to be misleading included 16 and 20 oz bottles of carbonated beverages,
canned soup, snack size packages of potato chips, corn chips and
pretzels, individual packs and cans of fruit juice, microwave popcorn,
canned chili and ravioli, packages of shelled nuts, iced tea, frozen
entrees and meals, energy drinks, 5-inch pizzas, dairy beverages, pre-
packaged lunches, vending machine items, pre-packed breakfast cereals,
cookies, and crackers. Many comments also objected to the use of
fractional portions when declaring the numbers of servings for these
products (i.e., 2.5 servings) and noted that we should require
nutrition labeling for the entire package for products that could
reasonably be consumed at one-eating occasion. One comment understood
the listed serving sizes to be recommendations, rather than amounts
customarily consumed, and stated that serving sizes such as a single
sandwich divided into 2 servings, a single muffin divided into 3
servings, or a single bag of chips sold as a side to sandwiches divided
into 2 servings were very confusing and unrealistic.
    We agree, in part, with comments that opposed individually packaged
foods that appeared to be single-serving containers, but which declared
two or more servings on their package labels. We agree that these types
of packaged foods can be confusing to consumers; however, we do not
agree that all of these products should be labeled as a single serving.
As discussed in detail below, these types of products should provide
nutrition information for the whole package, as the only column of
nutrition information for some products, or with dual-column labeling
for other products, which would provide nutrition information per
serving and per container or per unit, as applicable. As discussed in
section II.C.1.a., scientific evidence has shown that some consumers
may tend to experience a ``unit bias,'' and view certain sizes of
intact units/packages of food as a marker of the appropriate amount of
food to consume, and thus consumers should be provided with nutrition
information for the amount of calories and nutrients that they might
reasonably consume in an individual package or unit (Refs. 25, 26, 30,
and 33).
    Several comments noted that requiring larger products that could be
eaten in a single serving to include nutrition information for the
entire package could be problematic or confusing to consumers in that
the labels may encourage overconsumption.
    We disagree with comments suggesting that providing nutrition
information for the entire package would be problematic or confusing to
consumers on the grounds that the labels may encourage consumers to eat
more. In an FDA-commissioned study (Ref. 32), participants who viewed
nutrition information for a food labeled as a single serving container
tended to rate the products as less healthful on average than
participants who viewed nutrition information for the same food
declared as a two-serving product. As noted in a recent literature
review (Ref. 34), people often expect that they can eat more of foods
that they perceive as healthful. Research has shown that when smaller
serving sizes were used to present nutrition information, participants
were led to believe that they would experience less guilt after
consuming the entire package and reported that they would be more
likely to purchase these products than when nutrition information for
the same products was declared using a larger serving size (Ref. 34).
In light of the findings from FDA's research, which suggest that
providing nutrition information for an entire package of a food that
would be consumed in a single eating occasion could result in more
discerning product judgments, and the conclusions by Chandon and
Wansink (Ref. 34), the data to date suggest that providing nutrition
information for the entire package would provide consumers with more
accurate information about the nutritional significance of foods that
are likely to be consumed in a single eating occasion. Therefore, FDA
disagrees that providing nutrition information for the entire package
would be problematic or

confusing to consumers or encourage overconsumption.
    Finally, one comment indicated that the current nutrition labeling
format and the criteria to define a single-serving container should be
maintained because this would allow manufacturers flexibility to
respond to their markets.
    We disagree with the comment that states that the current criteria
used to define a single-serving container should be maintained because
it adds more ``flexibility to respond to their markets.'' The comment
did not explain what it meant by ``flexibility to respond to their
markets'' or why changes to the criteria used to define a single-
serving container would not provide such flexibility. As is discussed
in detail in the following section, the current criteria for the
labeling of certain products as single-serving containers in Sec.
101.9(b)(6) are not consistent with the current consumption data.
Criteria for Determining When a Product Is a Single-Serving Container
    The ANPRM invited comment on the criteria we should use to
determine which multi-serving products would require nutrition
information for the entire package (70 FR 17010 at 17013). We also
asked whether the criteria should be based on the total amount in the
container, the types of food, or something else, and whether the
current criteria to define single-serving containers should be changed
(70 FR 17010 at 17013).
    Most comments stated that single-serving labeling should be used
even if a serving size is 200 percent or more of the applicable RACC
when evidence indicates the product rarely is eaten by more than one
person or at more than one time. Several other comments pointed out
that factors such as whether a product is ready to eat, how the product
is packaged (e.g., packaged in a re-sealable container), and how the
food is presented by the media are relevant to determining whether a
package is truly a single serving. Another comment stated that single-
wrapped items, such as muffins or pastries, where the item is not
divided should not be labeled as multiple servings. Several comments
stated that foods containing one to three servings or less, regardless
of the food, should list the nutrient information for the entire
package (alone or with another column listing the nutrient information
per serving). Another comment stated that sodas, chips, and candy bars
should be labeled as single-serving containers if a package contained
three servings under the current labeling requirements, and in
instances when the package contains more than three servings, the
product should be labeled as family sized.
    One comment indicated that products containing and including 3.5
servings under the current labeling requirements should be labeled as a
single-serving container. Another comment recommended that products
containing two to four servings per container be labeled as a single-
serving container for products that potentially could be consumed at a
single-eating occasion. A comment also stated that if the food
contained fewer than five servings, it should also have nutrition
information provided per package. Lastly, a comment noted that allowing
anything less than 200 percent of the RACC to constitute one serving
was too high of a cutoff, which could cause confusion about the amount
of a serving size and potentially encouraging overeating. The comment
suggested that the cutoff for a single-serving container should be
lowered to between 75 to 150 percent of the applicable RACC.
    We do not agree that single-wrapped items such as muffins and
pastries, which are not divided for consumption, should always be
labeled as single-serving containers. As explained previously in this
document, products that contain 200 percent or more of the RACC by
definition contain more than one serving, because they contain at least
two times the amount that is customarily consumed.
    We also disagree with the comments that suggested the criteria for
determining a single-serving container should be 200 percent or more of
the RACC if the product is rarely eaten by more than one person,
comments that suggested that the criteria should be 300 percent or less
of the RACC, and with comments that suggested that the criteria should
be 350 percent or less of the RACC. Products that contain 200, 300, or
350 percent of the RACC, by definition, contain 2, 3, or 3.5 servings,
respectively, and thus are not single-serving containers. We also
disagree that, in order to avoid encouraging overeating, the cutoff for
a single-serving container should be lowered to between 75 to 150
percent of the RACC. Prior research has demonstrated that using smaller
serving sizes to declare nutrition information may lead consumers to
form more positive impressions of the nutritional attributes of foods
than are warranted (Refs. 32 and 35). Therefore, we believe that
lowering the cutoff for a single-serving container could increase the
likelihood that the product would be perceived more positively, which
in turn may encourage overeating. Further, as noted previously in
section II.C.1.b., research shows that giving consumers nutrition
information for the entire package will help them to more easily
comprehend the nutrient amounts in the food.
b. Proposed Amendments for Single-Serving Containers
    We are proposing to revise, in part, the definition of a single-
serving container so that a product that is packaged and sold
individually and contains less than 200 percent of the applicable RACC
must be considered a single-serving container, and the entire content
of the product must be labeled as one serving (proposed Sec.
101.9(b)(6)) regardless of the size of the RACC of the product.
Currently the definition of a single-serving container is a product
that is packaged and sold individually and that contains less than 200
percent of the RACC. This provision, however, does not apply to
products that have ``large'' RACCs (i.e., products that have reference
amounts of 100 g (or mL) or larger). Manufacturers of these products
may decide whether a package that contains more than 150 but less than
200 percent of the applicable RACC can be labeled as having one or two
servings. See Sec.  101.9(b)(6). We provided this qualification for
products with large RACCs based in part on comments to the 1991 serving
size proposed rule.
    We stated in the 1993 serving size final rule that we agreed with
the comments that the 200 percent cutoff level may be too high for some
products with large RACCs. Further, we stated that the reference
amounts of these products are very large compared to many other
products, and examination of food consumption data showed that the
average variability (defined as the standard deviation as a percent of
the mean) in the amount customarily consumed for foods having a
reference amount of 100 g (or mL) or larger is about two-thirds of the
variability for foods having a reference amount less than 100 g (58 FR
2229 at 2233). In other words, at that time, we concluded that it was
much less likely that a person would consume approximately twice the
reference amount of a food with a reference amount of 100 g (or mL) or
more, than it was that he or she would consume approximately twice the
reference amount of a food with a smaller reference amount. Therefore,
in the 1993 serving size final rule, we concluded that, for those
products that have reference amounts of 100 g (or mL) or larger, 150
percent is a more reasonable cutoff for a single-serving container. As
a result of this, we revised Sec.  101.9(b)(6) to allow manufacturers
to choose whether to declare 1 or 2 servings in packages that contain
more

than 150 percent but less than 200 percent of the reference amount if
the food in the package has a reference amount of 100 g (or mL) or
larger.
    For this proposed rule, we examined the correlation between the
consumption variation and the RACCs for all products containing less
than 200 percent of the applicable RACC, including the products with
large RACCs (i.e., those products with RACCs of at least 100 g or 100
mL) and products that have RACCs that are less than 100 g (or mL),
using combined consumption data from the NHANES 2003-2008 surveys (Ref.
36). The consumption variation is calculated as the standard deviation
of the median consumption amount divided by the median consumption
amount and then multiplied by 100 and is expressed as the percent of
the median consumption amount (Ref. 36). The result shows that the
correlation coefficient is 0.18, which means that there is a low
correlation between the RACCs (whether the reference amount is more
than or less than 100 g or mL) and the consumption variation for all
products containing less than 200 percent of the RACC, regardless of
whether the RACC is ``large'' or not. In other words, it is not less
likely that a person would consume approximately twice the reference
amount of a food with a reference amount of 100 g (or mL) or more, than
it is that he or she would consume approximately twice the reference
amount of a food with a smaller reference amount. Therefore, the
exemption from the requirement to label a product with a large RACC,
and containing between 150 percent and 200 percent of the applicable
RACC, as a single-serving container is no longer warranted.
Additionally, raising the required cutoff for labeling a product with a
large RACC as a single serving may help consumers to more accurately
interpret the nutrient amounts in these products. As discussed in
section II.C.1., research shows that consumers have trouble accurately
calculating the nutrient amounts in the entire package of a food that
is labeled as containing multiple servings, and research also shows
that package size tends to have a considerable impact on the amount of
food consumed. Therefore, removing the exemption from the requirement
to label a product with a large RACC as a single-serving container may
help consumers to correctly interpret the nutrient amounts in the
amount of food that they are consuming.
    We are not proposing to change the current cutoff of less than 200
percent of the applicable RACC as the criterion for labeling a product
as a single-serving container. Additionally, we are not proposing to
increase the cutoff of less than 200 percent of the applicable RACC
because, by definition, a product that contains 200 percent or more of
the RACC means that it contains at least twice as much as the RACC and
it is not a ``single'' serving container. Under section 403(q)(1)(A)(i)
of the FD&C Act, a serving size is an amount customarily consumed. The
RACCs we have established are reference amounts of food that are
customarily consumed per eating occasion. As such, we do not consider
it appropriate to label foods containing 200 percent or more of the
applicable RACC as single-serving containers. Therefore, proposed Sec.
101.9(b)(6) would remove the provision that products packaged and sold
individually and containing 200 percent or more of the applicable RACC
may be labeled as a single serving if the entire contents of the
container can reasonably be consumed at a single- eating occasion.
    For consistency with the proposed changes to the definition of a
single-serving container, we propose to remove Sec.  101.9(b)(2)(i)(E),
which provides that if a discrete unit of food contains more than 150
percent but less than 200 percent of the RACC, the manufacturer may
decide whether to declare the individual unit as 1 or 2 servings, for
units that have large RACCs of 100 g (or 100 ml) or larger and are
individual units within a multi-serving container. Also consistent with
the changes in proposed Sec.  101.9(b)(6), we are proposing to remove
the text in current Sec.  101.9(b)(2)(i)(D), which states that if a
unit weighs 200 percent or more of the RACC the manufacturer may
declare one unit as the serving size if the entire unit can reasonably
be consumed in one-eating occasion, and replace the text with the text
in proposed Sec.  101.9(b)(2)(i)(D) (which is discussed in section
II.C.3.b). Finally, we also propose to redesignate Sec.
101.9(b)(2)(i)(F) as Sec.  101.9(b)(2)(i)(E), redesignate Sec.
101.9(b)(2)(i)(G) as Sec.  101.9(b)(2)(i)(F), redesignate Sec.
101.9(b)(2)(i)(H) as Sec.  101.9(b)(2)(i)(G), and redesignate Sec.
101.9(b)(2)(i)(I) as Sec.  101.9(b)(2)(i)(H), because the proposed rule
would remove current Sec.  101.9(b)(2)(i)(E).
3. Dual-Column Labeling--Mandatory Listing of a Second Column of
Nutrient Values on the Nutrition Facts Label Based on the Entire
Container or Unit
a. Comments on the ANPRM Regarding Dual-Column Labeling
Dual-Column Labeling Requirements
    The ANPRM invited comment on whether to require certain products to
include an additional column within the Nutrition Facts label to list
the quantitative amounts and percent DVs for the entire package, as
well as the required columns listing the quantitative amounts and
percent DVs for a serving that is less than the entire package (i.e.,
the serving size derived from the RACC) (70 FR 17010-17013).
    Some comments supported the use of dual-column labeling. One
comment suggested dual-column labeling for products that may be
consumed in their entirety at a single occasion, but often are shared
or eaten over time. Several comments requested that we not require
dual-column labeling on the packaging of all food products. These
comments stated that any discussion of disclosing information per
package should address only packages that potentially could be consumed
by one person at a single-eating occasion or possibly shared between
one or more persons. Other comments suggested that we provide dual-
column labeling on all packages with multiple servings such as a family
sized package of frozen lasagna.
    We agree with comments supporting a requirement for the use of an
additional column of nutrition labeling (i.e., dual-column labeling)
under certain conditions. As discussed in section II.C.1.c., research
suggests that dual-column labeling helps consumers understand what the
nutrient amounts are in an entire container of food. We also agree that
dual-column labeling should be used for products that may be eaten by
one individual in one-eating occasion or over several-eating occasions,
but may also be eaten by multiple individuals. Information on the
nutrient amounts in an entire container of food would not be as
relevant to consumers if the food could not reasonably be consumed by
one individual in a single-eating occasion. For this reason, we agree
that it is unreasonable to require dual-column labeling on the
containers of all food products. As discussed in this section, data
show that products that contain more than 400 percent of the RACC are
less likely to be consumed in one-eating occasion when compared to
products that contain 400 percent or less of the RACC (Ref. 37). For
this reason, we do not believe it is appropriate to require a second
column of nutrient values on containers that contain more than 400
percent of the applicable RACC. Additionally, the proposed rule would
not require dual-column labeling for bulk products that are used
primarily as ingredients (e.g., flour, sweeteners, shortenings, oils);
bulk products traditionally used for multi-purposes (e.g., eggs,
butter, margarine); and

multipurpose baking mixes, because labeling these products with
nutrition information based on the entire container would not be
consistent with how these products are typically consumed.
    We also do not agree with the comment that stated that dual-column
labeling should be required for all multi-serving products, such as a
family-sized package of lasagna. Products that contain more than 400
percent of the RACC are less likely to be consumed in one-eating
occasion compared to products that contain 400 percent or less of the
RACC (Ref. 37).
    Some comments opposed mandatory dual-column labeling. A few
comments opposed dual-column labeling noting that it would require
changes that could cost a significant amount of money for companies and
would use up valuable package space that is often used for other types
of nutrition education messages. These comments noted that dual-column
labels would be difficult for products with small label space. Some
comments suggested that dual-column labeling be voluntary and not
mandatory.
    We agree that it may be difficult to fit an extra column of
nutrition information on the labels of some products. However, many
food packages, such as grab-size bags of chips, cookies, crackers, and
frozen entrees that would be affected by the proposed dual-column
labeling requirements provide enough space to accommodate a second
column of nutrition information based on the entire container. We
address the concern about providing dual-column labels for small
products with a limited amount of space on the Nutrition Facts label in
section II.C.3.b.
    We also agree that a dual-column labeling requirement would have
some costs for industry. The costs of the proposed dual-column labeling
requirement are addressed in section IV.
Dual-Column Labeling and Consumer Understanding
    The ANPRM invited comment on how listing the nutrient amount per
serving size and per package side-by-side in separate columns would
affect consumers' ability to understand the Nutrition Facts label (70
FR 17010-17013).
    A few comments that objected to the use of dual-column labeling
stated that the second column of values would be confusing to consumers
or provide too much information, and would thus contribute to label
clutter. Several comments noted that dual-column labeling may confuse
the consumer in that it could imply to consumers that larger serving
sizes were a recommended amount to consume and would have the opposite
effect from what was intended and result in overconsumption. These
comments also stated that consumers may not need, want, or understand
why this information is on the label and how this quantity differs from
a typical serving size. One comment noted that a problem with dual-
column labeling was that consumers were unlikely to be interested in
information provided in the second set of nutrition values and that the
nutrition label format would become more complicated, potentially
making the Nutrition Facts labels less friendly and manageable. None of
these comments, however, provided data or information to support the
possible consumer reactions identified.
    We are not convinced that dual-column labeling may be confusing to
consumers and that dual-column labeling would imply that consumers
should eat more of an item. In fact, as discussed in section II.C.1.c.,
research findings from a study suggest that dual-column labeling would
lead consumers who are not dieting to reduce rather than increase the
amount of food they consume as suggested by comments (Ref. 31). We also
conducted a study (Ref. 32) to help enhance our understanding of
whether and what types of modifications to the label format may help
consumers use the label. The main finding was that single serving per
container labels and dual-column labels resulted in more participants
correctly identifying the number of calories per container and the
number of other nutrients per container and per serving compared to
two-serving single-column labels (such as the current label) (Ref. 32).
    One comment suggested that an appropriate and informative approach
may be to have products that can be consumed in one-eating occasion
provide both ``Servings Per Package'' and ``Calories Per Package'' near
the top of the Nutrition Facts label. Finally, multiple comments noted
that modifying the Nutrition Facts label would require consumer re-
education on how to read an amended Nutrition Facts label.
    We tested a format similar to the one suggested in the comment, in
which ``Servings Per Package'' and ``Calories Per Serving'' were in
close proximity, in our consumer study (Ref. 32). The test format
included a listing of ``Calories in 1 cup serving'' followed by the
declaration of servings per container (i.e., ``2 Servings per
container'') near the top of the Nutrition Facts label (Label 4).
Results from this study showed that dual-column labels were read with
somewhat better accuracy when compared against labels that were similar
to the one suggested in the comment. Based on these results, we do not
agree with the comment.
    We agree with the comment that modifying the Nutrition Facts label
would require some re-education on how to read the Nutrition Facts
label. We consider it important to provide consumers with education and
outreach on nutrition labeling. We will consider appropriate education
methods after the publication of this proposed rule.
Criteria for Determining Dual-Column Labeling
    The ANPRM did not address the criteria to be used to determine what
types of products should require dual-column labeling. However, some
comments provided criteria for the use of dual-column labeling on
Nutrition Facts labels based on the quantity of food in the container.
One comment suggested that dual-column labeling on the Nutrition Facts
label could be required for products that contained 200 to 300 percent
of the RACC, unless the Nutrition Facts label for the product provided
a single column for the entire packaged amount. The comment further
suggested that for products with RACCs of 100 g or 100 mL or greater,
and that contain more than 150 percent but less than 200 percent of the
RACC, dual-column labeling could be optional, similar to the existing
requirement for the Nutrition Facts label declaration for single-
serving containers. Finally, the comment suggested that dual-column
labeling should not be required for products that: (1) Contain up to
150 percent of the RACC or (2) contained 5 calories or less per RACC
and were not fortified. Another comment suggested that products with 2,
3, or 4 servings per container that are likely to be consumed at a
single-eating occasion be required to add an additional column with a
disclosure for calories per container at the top of Nutrition Facts
label, just below the servings per container. Other comments requested
that information based on the entire package be listed for products
with up to five servings and that this information be provided in a
second column of the label.
    In consideration of an upper limit for dual-column labeling, we
looked at food consumption data from the NHANES 2003-2008 surveys.
Dual-column labeling can, in part, provide information for products
that may be consumed by one person in a single-eating occasion, but are
oftentimes consumed by more than one person or

in more than one-eating occasion. To determine an upper limit for these
products, we looked at NHANES 2003-2008 consumption data (Ref. 37).
Intake distribution per eating occasion for each product showed that
for almost all products, regardless of the amount of the RACC, the
ratio of the intake at the 90th percentile level to the RACC was 400
percent or less. Thus, the data suggest that 90 percent of the reported
consumption amount is 400 percent of the RACC or less for almost all
product categories, meaning that dual-column labeling for products with
400 percent or less of the RACC would capture the most frequent
consumption habits for all product categories. Conversely, the data
show that products that contain more than 400 percent of the RACC are
less likely to be consumed in one-eating occasion compared to products
that contain 400 percent or less of the RACC. An upper limit of 400
percent of the RACC for dual-column labeling would be consistent with
the upper limit suggested in the CSPI citizen petition, which requested
that we consider dual-column labeling for snack packages containing
between 200 percent and up to and including 400 percent of the RACC.
    Given the consumption data, we do not agree with the comments that
suggested thresholds for requiring dual-column labeling for products
that contain 200 to 300 percent of the RACC or the comments that
suggested that dual-column labeling be provided for up to five
servings. As noted in the preceding paragraph, the data suggest that 90
percent of the reported consumption amount is 400 percent or less of
the RACC for almost all product categories. Therefore, based on the
consumption data, 300 percent of the RACC appears to be too low of a
cutoff level for dual-column labeling and 500 percent is too high.
    We disagree with the comment that suggested that for products with
RACCs of 100 g or 100 mL or greater, and that contain more than 150
percent but less than 200 percent of the RACC, dual-column labeling
could be optional, similar to the existing requirement for the
Nutrition Facts label declaration for single-serving containers. As
noted previously in section II.C.2.b, current consumption data indicate
that there is no difference in intake of large RACC products containing
100 g or 100 mL or greater and smaller RACC products. Therefore, there
is no need to make a distinction for large RACC products. Additionally,
we are proposing to require that all products that contain less than
200 percent of the RACC be labeled as a single serving. Therefore, a
proposal for dual-column labeling for these packages is unnecessary,
because the products would already contain nutrition information based
on the amounts in the entire container under the proposed revisions to
the single-serving requirements.
    We agree with the comment that suggested that dual-column labeling
should not be required for products that contain up to 150 percent of
the RACC. As noted previously in section II.C.2.b, we are proposing
that all products packaged in containers with less than 200 percent of
the RACC must be labeled as a single serving and have a Nutrition Facts
label per container only. However, we disagree with the second part of
the comment that suggested that dual-column labeling should not be
required for products that contained 5 calories or less per RACC and
were not fortified. If we were to adopt this provision, then this would
allow for products, such as diet soft drinks, to be exempt from dual-
column labeling. We believe that, for consistency purposes, dual-column
labeling should apply to these products as well. This will allow
consumers to view the same type of label and make an easy comparison
when looking at different soft drinks.
b. Proposed Amendments for Dual-Column Labeling
    We have carefully considered all available data, information, and
comments for and against a second column of nutrient values based on
the entire container and have concluded that mandatory labeling of a
second column of nutrient values based on the entire container for
containers that contain 200 percent and up to and including 400 percent
of the applicable RACC is warranted. This will provide nutrition
information for those who consume the entire container in one-eating
occasion as well as those who consume the container over multiple-
eating occasions or share the container with others. We base our
conclusion, in part, on results of a consumer study we conducted that
suggested that dual-column labels resulted in more participants
correctly identifying the number of calories per container and the
number of other nutrients per container and per serving compared to
two-serving single-column labels (such as the current label) (Ref. 32).
In addition, we are basing our conclusion, in part, on another study
that suggested that dual-column labeling would lead consumers who are
not dieting to reduce rather than increase the amount of food they
consume (Ref. 31). This additional awareness is important in light of
studies that indicate that package sizes influence the amount consumers
consume (Refs. 21 and 25). We are proposing the cutoff of 400 percent
for dual-column labeling based on our analysis of the intake
distribution per eating occasion for all products. Based on this
analysis, we concluded that for each product the ratio of the intake at
the 90th percentile level to the RACC was 400 percent or less. As such,
dual-column labeling for products 400 percent or less of the RACC would
capture the most frequent consumption habits for all product
categories. We propose a threshold of 200 percent of the applicable
RACC to trigger the requirement for dual-column labeling, because under
the proposed requirements discussed in section II.C.2.b., all products
containing less than 200 percent of the RACC would be labeled as a
single-serving container (proposed Sec.  101.9(b)(6)). Therefore,
products containing less than 200 percent of the RACC will already
contain nutrient information based on the contents of the entire
container.
    Consequently, we are proposing to add a new Sec.  101.9(b)(12)
which would require an additional column within the Nutrition Facts
label to list the quantitative amounts and percent DVs for the entire
container, to the right of the preexisting column listing the
quantitative amounts and percent DVs for a serving that is less than
the entire container (i.e., the serving size derived from the RACC),
for products that are packaged and sold individually and contain at
least 200 percent and up to and including 400 percent of the applicable
RACC. For example, under the proposed amendment, a manufacturer would
have to use dual-column labeling on a bag of chips that contained 3 oz
(90 g) (about 300 percent of the RACC). A major advantage of the
proposed approach of dual-column labeling is that it will not require
math to determine nutrition information for consumers who consume the
entire container in a single-eating occasion and will continue to
provide nutrient information per RACC for consumers who do not consume
the entire container in a single-eating occasion, and for consumers who
share the product. Thus, easily understandable information will be
provided for all types of consumers of these products. For an example
of a dual-column label as described in this section, see the proposed
codified of the ``Food Labeling; Revision of the Nutrition and
Supplement Facts Labels'' proposed rule published elsewhere in this
issue of the Federal Register.
    In addition to proposing dual-column labeling per serving and per
container

(or unit, as applicable) for all nutrition information on the label, we
are considering two additional options that would require nutrition
information per serving and per container for only certain declarations
but not all label declarations for containers of food or units of food,
as applicable, containing at least 200 percent and up to and including
400 percent of the applicable RACC. The first option is for a label
that includes calorie information per serving and per container (or
unit, as applicable) following the serving size information in the
Nutrition Facts label. With this option, the remaining nutrition
information would be listed on a per serving basis only and in a single
column below the calorie information per serving and per container. The
second option is to provide nutrition information per serving and per
container (or unit, as applicable) for calories, saturated fat and
sodium following the serving size information in the Nutrition Facts
label and the remaining nutrition information would be listed on a per
serving basis in a single column below the dual column provided for
calories, saturated fat and sodium declarations. These options may
specifically highlight the calorie content alone, and the calorie
content, saturated fat content, and sodium content, respectively, for
both the serving size and the entire container of food (or unit, as
applicable). These options would focus on a smaller number of nutrients
presented per serving and per container of food (or unit, applicable)
that the U.S. population should limit for those foods with at least 200
percent and up to and including 400 percent of the RACC. We question
whether consumers would be more inclined to use dual column labeling
for a smaller set of nutrients. We invite comment and data on dual
column-labeling as proposed in this rule as well as the options
presented for providing nutrition information per serving and per
container (or unit, as applicable) for only certain declarations.
    For consistency with proposed Sec.  101.9(b)(12), the proposed rule
would change Sec.  101.9(b)(2)(i)(D). Section 101.9(b)(2)(i)(D), which
applies to products in discrete units within a multi-serving container,
provides that if a unit weighs 200 percent or more of the RACC, the
manufacturer may declare the whole unit as the serving size if the
whole unit can reasonably be consumed at a single-eating occasion. As
noted previously, we are proposing to delete the current text in Sec.
101.9(b)(2)(i)(D) and to replace it with text requiring that products
that are discrete units within any size of a multi-serving container,
and contain at least 200 percent and up to and including 400 percent of
the applicable RACC (e.g., a container of six muffins where each muffin
contains 200 percent of the RACC), have an additional column within the
Nutrition Facts label that lists the quantitative amounts and percent
DVs for each discrete unit, as well as the preexisting columns listing
the quantitative amounts and percentage DVs for a serving that is not
based on the discrete unit (i.e., the serving size derived from the
RACC).
    We are also proposing in Sec.  101.9(b)(12)(i)(B) that the
provisions for dual-column labeling would not be required for bulk
products that are used primarily as ingredients (e.g., flour,
sweeteners, shortenings, oils), or bulk products traditionally used for
multi-purposes (e.g., eggs, butter, margarine), and multipurpose baking
mixes because labeling these products with nutrition information based
on the entire container would not be consistent with how these products
are typically consumed. Finally, due to limitations in labeling space,
proposed Sec.  101.9(b)(12)(i)(A) would state that products that meet
the requirements to present the Nutrition Facts label using the tabular
format under current Sec.  101.9(j)(13)(ii)(A)(1) or the linear format
under current Sec.  101.9(j)(13)(ii)(A)(2) are exempt from dual-column
labeling.
    We are aware of several food products that require further
preparation, and contain at least 200 and up to and including 400
percent of the applicable RACC, such as macaroni and cheese kits,
pancake mixes, pasta products, and rice products. Under our
regulations, nutrition information for these types of products may be
presented for two or more forms of the same food (e.g., both as
``purchased'' and ``prepared'') (Sec.  101.9(e)). Most of these
products voluntarily contain two columns of nutrition information on
the ``as purchased'' and ``as prepared'' forms of the food. Therefore,
we tentatively conclude that these types of products that require
further preparation and voluntarily include two columns of nutrition
information on the ``as purchased'' and ``as prepared'' forms of the
food, should be exempt from the dual-column labeling requirement under
proposed Sec.  101.9(b)(12)(i). For products requiring further
preparation for consumption, it is helpful to consumers to include
nutrition information based on the prepared form of the product in
addition to the ``as purchased'' form of the product. If these products
were required to use dual-column labeling with nutrition information
for the serving size based on the RACC and nutrition information for
the entire container, they would have to include at least three columns
if they also voluntarily included one column of nutrition information
representing servings per container for the prepared form of the food.
Manufacturers could opt to not include the voluntary column for the
prepared form of the food if we were to require dual-column labeling
under proposed Sec.  101.9(b)(12)(i) for their product. However,
nutrition information based on the entire container of the unprepared
food may be less meaningful to consumers than information on a serving
of the prepared form of the food, because these types of products are
meant to be consumed after further preparation. Thus, the proposed rule
would exempt food products that require further preparation and also
include voluntary labeling of ``as purchased'' and ``as prepared''
forms of the food under Sec.  101.9(e) from the provisions of dual-
column labeling (proposed Sec.  101.9(b)(12)(i)(C)). Likewise, the
proposed rule would exempt products that are commonly consumed in
combination with other foods (e.g., cereal and skim milk) and that
include another column with information regarding that combination as
specified in Sec.  101.9(e) and (h)(4) (proposed Sec.
101.9(b)(12)(i)(C)). As is the case with foods that require further
preparation, nutrition information based on the entire container of an
uncombined food (for a food that is commonly combined with another
food) may be less meaningful to consumers than information on a serving
of the combined food, because these types of products are commonly
consumed in combination with another food. For consistency, FDA is also
proposing that the exemptions under Sec. Sec.  101.9(b)(12)(i)(A), (B),
and (C) apply to the dual-column labeling requirement under proposed
Sec.  101.9(b)(2)(i)(D) as well.
    We invite comments on our tentative conclusion that products
requiring further preparation and products that are commonly consumed
in combination with other foods, and that voluntarily provide another
column of nutrition information under Sec.  101.9(e), should not be
required to provide dual-column labeling under proposed Sec.
101.9(b)(12)(i) or Sec.  101.9(b)(2)(i)(D). Additionally, we invite
comments regarding whether any other products that voluntarily include
an additional column (or multiple columns) of nutrition information
under our regulations (e.g., products for which

RDI's are established for two or more groups, as discussed under Sec.
101.9(e)) should be exempt from the proposed dual-column labeling
requirements under Sec.  101.9(b)(12)(i) or Sec.  101.9(b)(2)(i)(D).
Use of Nutrient Content Claims and Health Claims on Products With Dual-
Column Labeling per Serving and per Container
    RACCs are used to determine whether individual foods are eligible
to bear nutrient content and health claims (Sec.  101.12(g)). If dual-
column labeling is finalized as proposed, nutrition information will be
presented on a per serving basis and on a per container or per unit
basis, as applicable. To clarify that the level of the nutrient that is
the subject of the claim is based on the RACC and not the amount in the
entire container or unit of food, proposed Sec.  101.9(b)(12)(ii) would
require that the claim be followed by a statement that sets forth the
basis on which the claim is made. The statement must express the amount
of the nutrient in a serving for a nutrient content claim (e.g., ``good
source of calcium'' ``a serving of ---- oz of this product contains 150
mg of calcium'' or for health claims ``A serving of ---- ounces of this
product conforms to such a diet''). However, if the serving size
declared on the product label differs from the RACC, and the amount of
the nutrient contained in the labeled serving does not meet the maximum
or minimum amount criterion in the definition for the descriptor for
that nutrient, the claim must be followed by the criteria for the claim
as required by Sec.  101.12(g). We are also proposing that the
statement that sets forth the basis on which the claim is made would
not be required for products when the nutrient that is the subject of
the claim meets the criteria based on the entire container amount or
unit amount, as applicable.

D. Reference Amounts Customarily Consumed

    The RACCs in the tables listed in Sec.  101.12(b) are arranged by
categories. The broadest category is the ``general category.'' There
are 21 general categories, which separate the food products into broad
groups, with similar types of products placed together. Examples of
general categories are ``Beverages'' and ``Desserts.'' In each general
category, there are product categories. As noted previously in this
document, currently there are RACCs for 129 product categories for
people 4 years of age or older in Table 2 of Sec.  101.12(b) and 11
product categories for infants and children 1 through 3 years of age in
Table 1 of Sec.  101.12(b), for a total of 140 product categories. A
product category is a group of products with similar dietary usage. The
RACCs are assigned by product categories. In some cases, in the tables
listed in Sec.  101.12(b), examples of the types of products in the
product category are listed.
    The current RACCs for the 140 product categories are derived
primarily from food consumption data from the 1977-1978 (http://www.ars.usda.gov/Services/docs.htm?docid=16184) and 1987-1988 (http://www.ars.usda.gov/Services/docs.htm?docid=16185) NFCS conducted by the
USDA. In light of newer consumption data, newer food products in the
market place, comments received on the ANPRM, several written requests
(Refs. 8, 9, and 10) and four citizen petitions (the fruitcake
petition, the NYA petition, the CMA/NCA petition, and the Andes
petition), we are proposing to update, modify or establish RACCs.
Updating RACCs refers to proposed amendments to RACCs for products that
are currently listed in the tables in Sec.  101.12(b), and for which
the NHANES 2003-2008 consumption data showed an increase or decrease in
consumption by at least 25 percent. Modifying RACCs refers to changes
to existing RACCs in the tables in Sec.  101.12(b) for which the NHANES
2003-2008 consumption data did not show an increase or decrease in
consumption by at least 25 percent. Establishing RACCs refers to the
addition of products (and assigning RACCs for such products) that are
not already listed in the tables in Sec.  101.12(b). In Section II.D.2.
we are proposing to update the RACCs for selected categories for
products that are already in the tables in Sec.  101.12(b). In section
II.D.3., we are proposing to modify or establish new RACCs based, in
part, on requests to establish new RACCs for products that are not in
the tables in Sec.  101.12(b), modify the RACCs for selected products
that are already in the tables in Sec.  101.12(b), or add products to
an existing general category or product category in the tables in Sec.
101.12(b) (Refs. 8, 9, and 10). In section II.D.3., we are also
proposing to modify some product categories on our own initiative. We
invite comment on whether the RACCs and labeled serving size for
certain products identified as products of concern in comments to the
ANPRM should be updated. We also invite comment on whether we should
propose changes to other product categories not amended by this
proposed rule.
1. Research and Data Related to Updating, Modifying, and Establishing
RACCs
    We recognize that many consumers may consume substantially larger
portions than the serving sizes presented on the Nutrition Facts label,
and this could lead consumers to under-estimate the number of calories
and other nutrients consumed. The current RACCs used to determine
serving sizes are based primarily on data obtained through 1977-78 and
1987-88 NFCS conducted by USDA. More recent empirical evidence
suggests, however, that for many types of food the amount of food that
Americans customarily consume has changed significantly since these
data were collected. For instance, a review of nationwide food intake
surveys from 1977-78, 1989, and 1996 concluded that portion sizes for
numerous types of foods grew substantially between 1977 and 1996 (Ref.
6). Another review of data likewise concluded that portion sizes have
increased substantially since the current RACCs were established (Ref.
5). Additionally, a study has noted the supersizing of portion sizes in
America in recent years (Ref. 38).
    Additionally, package sizes for many foods have increased, and the
package size of a food product has been shown to have an impact on the
amount of food that is consumed by a person. Package sizes in grocery
stores, amounts served in restaurants, and dishware sizes at home could
all influence how much people eat and their perceptions about portion
sizes. In one study showing a link between larger portion sizes and
increased calorie intake, participants were given all meals for two
consecutive days each week for three weeks in a laboratory (Ref. 24).
Each week the portion sizes of the meals varied from 100, 150, or 200
percent of the baseline amount. Results showed that a 50 percent
increase in portion size led to a 16 percent increase in calorie intake
and a 100 percent increase in portion size led to a 26 percent increase
in calorie intake (Ref. 24).
    We recognize that increases in portion and/or package sizes may
play a role in overeating because the growth in portion and package
sizes have coincided with the surge of obesity rates in the United
States (Refs. 5, 6, and 39). We also recognize that the serving size
can provide a usable reference point for evaluating the nutritional
content of a food and is a critical tool to those trying to achieve or
maintain a healthy lifestyle and/or body weight. The serving size can
also help consumers select among food products based upon

calories and other nutrients per serving. However, to be an appropriate
reference point, the serving size must be based upon a meaningful
quantity of food, which is what the RACCs provide.
    We have analyzed current data and determined that, for some product
categories listed in the tables in Sec.  101.12(b), the RACCs have
changed. Additionally, we recognize that, since 1993, information
regarding the RACCs for certain products not currently listed in the
tables in Sec.  101.12(b) has become necessary. These factors, combined
with findings from the ``Calories Count'' report, information regarding
the rise in obesity, increase in package sizes, and requests to
establish and modify the RACCs have led us to propose the amendments to
the RACCs below. The proposed amendments would help convey clear and
accurate information on serving sizes and the related nutritional
profile of foods, which is important for consumers to be able to make
choices that support a more healthful diet. Section II.D.2.c. discusses
our proposals for updating existing RACCs and section II.D.3.b
discusses our proposals for modifying and establishing new RACCs.
2. Updating Existing RACCs
    This section discusses public comments, methods used for updating
existing RACCs, and the changes that we are proposing to update
existing RACCs.
a. Comments on the ANPRM Regarding Updating the Existing RACCs
Selection of Food Consumption Data Sources and Criteria for Changing
the RACCs Established in 1993
    The ANPRM invited comment on how recent food consumption data, such
as data from the 1999-2000 and 2001-2002 NHANES, should factor into the
determination of which, if any, RACCs need to be updated and if there
are other food consumption data sources that are available, or that
could be provided for our consideration (70 FR 17010-17012). We also
asked what criteria should be used as the basis for changing the RACCs,
if the RACCs were revised.
    Most comments supported the use of national food consumption data
to establish serving sizes. One comment suggested that we consider the
USDA/Agriculture Research Service Automated Multiple Pass Method
validation study (AMPM) which provides an overall picture of health and
nutrition as a consumption survey tool. Some comments opposed the use
of any data other than food consumption data, arguing that they do not
fulfill the FD&C Act's requirement that the serving sizes reflect
amounts customarily consumed.
    Some comments advised us against using current data to establish
updated RACCs. These comments indicated that basing serving sizes on
current consumption data was unsound from a policy perspective in that
it could suggest to consumers they could or should eat larger amounts,
which contradict current efforts to curb obesity as well as federal
dietary recommendations. Some comments reasoned that food consumption
data have many limitations, and therefore it is not possible to derive
accurate estimates of the customarily consumed amounts from such data.
Several comments indicated that nutrition survey data are not
appropriate and there is no justification to base serving size on food
consumption data because these data have known inaccuracies.
    Regarding the comments on how food consumption data should factor
into updating the RACCs, we note that none of the comments opposing the
use of consumption data to establish RACCs provided any alternative
sources of data to use. Section 403(q)(1)(A)(i) of the FD&C Act states
that a serving size is the amount customarily consumed, making food
consumption data the best source for determining serving sizes. In
addition to the variability among individuals, we are aware of the
limitations of the available food consumption databases. However, these
databases are still the best sources of food consumption data collected
under actual conditions of use available to us. Thus, we conclude that
the use of food consumption data as the primary source for the
customarily consumed amounts of food for nutrition labeling purposes is
appropriate.
    Regarding the comment suggesting that we consider the USDA/
Agriculture Research Service Automated Multiple Pass Method validation
study, this study as well as the food consumption data are used as part
of our methodology to determine which RACCs to update. It is discussed
further in section II.D.2.b.
    With respect to the comment that suggested that basing serving
sizes on current consumption data was unsound and could suggest to
consumers they could or should eat larger amounts, our authority states
that RACCs must be based on the amount customarily consumed. However,
we understand that educational outreach may be needed in the future to
clarify this information to consumers.
    With respect to the criteria that should be used as the basis for
change if the RACCs are revised, one comment indicated that applying
percentages broadly across all product categories would not be fair to
manufacturers of some product categories. For example, a 20 percent
increase in intake of cereal with a 15 g RACC would equal a 3 g
increase versus a 20 percent increase in the serving of a 55 g RACC
cereal that would equal an 11 g increase. The comment suggested that we
consider changes in weight or volume when updating RACCs.
    We agree with the comment that applying percentages broadly across
product categories would not be fair to some product categories. We are
not proposing to update all RACCs using a percentage point, but rather
propose to determine which RACCs should be updated by looking primarily
at whether the amount consumed for each product in a product category
increased or decreased by at least 25 percent compared to the RACCs
established in 1993. Other factors as described below were also
considered. When looking at the products in product categories, we are
proposing that the unit of measurement for each category be taken into
account.
The Impact of Updates to the RACCs on the Use of Nutrient Content
Claims and Health Claims
    Several comments stated that changes in serving sizes could have an
unforeseen consequence of jeopardizing and negating the use of many
nutrient content claims, such as ``low fat'' or ``reduced fat'' claims,
and health claims on the product label. Some comments noted that some
foods that typically would not be considered a ``good source'' of a
particular nutrient might qualify if RACCs were to increase.
    In response to comments regarding the impact of increasing serving
sizes on nutrient content and health claims, we agree that changing the
RACCs may have an impact on the health and nutrient content claims that
can be made on certain products. However, such changes may be
appropriate in light of the changes in the amounts of food being
customarily consumed. For example, a product might qualify to bear a
``low fat'' nutrient content claim currently, but is actually being
customarily consumed in amounts that contain more fat than would
qualify for such a claim. Additionally, products that are not currently
eligible for ``good source'' or ``excellent source'' claims may become
eligible if the RACCs are increased. These products should be able to
bear such claims if the consumption amount has increased enough to
qualify the food for the claim.

Consumer Interpretation of ``Serving Size'' and Consumer Perception of
Increased Serving Sizes
    The ANPRM invited comment on whether consumers would think that an