[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Proposed Rules]
[Pages 11990-12029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04385]



[[Page 11989]]

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  

[[Page 11990]]


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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, 240-402-5429, [email protected].
    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 protected].

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

[[Page 11991]]

    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

[[Page 11992]]

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

[[Page 11993]]

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.

[[Page 11994]]

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).
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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.

[[Page 11995]]

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

[[Page 11996]]

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

[[Page 11997]]

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

[[Page 11998]]

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

[[Page 11999]]

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

[[Page 12000]]

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

[[Page 12001]]

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

[[Page 12002]]

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

[[Page 12003]]

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

[[Page 12004]]

(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

[[Page 12005]]

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

[[Page 12006]]

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.

[[Page 12007]]

Consumer Interpretation of ``Serving Size'' and Consumer Perception of 
Increased Serving Sizes
    The ANPRM invited comment on whether consumers would think that an 
increase in serving size on food labels means that more of the food 
should be eaten and what additional education efforts should be 
provided to consumers to avoid such a conclusion. We also sought 
comment on whether we should reconsider the definition of ``serving'' 
and ``serving size'' or how we interpret ``customarily consumed.''
    Many comments urged us to harmonize label serving sizes and RACCs 
with recommended dietary guidance and the Food Guide Pyramid. The 
comments indicated that an increase in serving sizes might suggest to 
consumers that they should eat larger portions. One comment indicated 
that if the serving size was increased to accommodate current 
consumption levels, consumers might choose to consume 125 percent of a 
new serving size which would result in increased consumption and is 
opposite of the intended effect. Some comments indicated that further 
science-based research is needed to obtain consumers' perceptions and 
reaction to serving sizes.
    In response to the question concerning reconsidering the definition 
of serving size, two comments indicated that the terms ``serving'' and 
``serving size'' may be confusing to consumers, because they are the 
same terms used in dietary guidance, such as the USDA Food Guide and 
the Dietary Guidelines for Americans. Other comments indicated that we 
should take into account dietary guidance recommendations when defining 
``serving'' and ``serving size,'' or how we interpret ``customarily 
consumed.'' One comment suggested that ``FDA consider testing terms 
such as `suggested serving size,' `reasonable serving size,' or 
`sensible serving size' to evaluate consumer usefulness.''
    With regard to the comments that RACCs and serving sizes should be 
based on what people should eat rather than what they usually eat, we 
acknowledge that there may be benefits to have serving sizes on product 
labels that are consistent with the serving sizes in the dietary 
guidance documents published by Federal Government Agencies. However, 
the FD&C Act specifically defines serving size as an ``amount 
customarily consumed,'' rather than a recommended amount people should 
eat. In addition, dietary guidance documents published by Federal 
Government Agencies usually list approximate amounts of food for the 
purpose of providing ``general'' guidance as to what quantity of each 
food group a person should consume to maintain good health. Therefore, 
the amount that represents a serving is often not well defined. For 
example, dietary guidance documents define a serving of bread as 1 
slice of bread. However, the weight of a slice of bread varies and 
would not be able to be converted into a reference amount without a 
specific gram weight. Another example is that the 2010 Dietary 
Guidelines for Americans recommended total cups to consume per day of 
fruits and vegetables, but does not list specific amounts of particular 
types of fruits and vegetables to be consumed per eating occasion (Ref. 
7). In addition, not all foods are represented in the dietary 
guidelines while all foods would need to be represented in the serving 
size RACCs.
    With respect to the comments that indicated that consumers might 
think that an increase in serving sizes on the food label suggest that 
they should eat larger portions, we agree that some consumers may 
misconstrue the meaning of the serving size. We recognize that research 
has shown that over half of consumers generally misunderstood the 
meaning of serving size on the food label to be a recommended amount 
(Ref. 40). Given this confusion among consumers, we will consider 
education efforts to help increase consumer understanding of the term 
serving size. However, we also note that some consumer comments on the 
ANPRM overwhelmingly indicated that current serving sizes in use are 
confusing and can be misleading. For example, some indicated that the 
RACCs and serving sizes currently in use (e.g., 2 servings on a 16 fl 
oz can of soft drink, or an 8 oz pot pie) are confusing because they do 
not reflect the amount of food that is currently customarily consumed. 
Providing the nutrition composition of the food based on current 
consumption amounts informs consumers of the amount of nutrients they 
are likely to ingest from a particular food.
    In response to the comment suggesting that we consider testing 
terms such as ``suggested serving size,'' ``reasonable serving size,'' 
or ``sensible serving size'' to evaluate consumer usefulness, as 
previously explained, under section 403(q)(1)(A)(i) of the FD&C Act, 
serving size is based on the amount of food people customarily consume 
and is not a suggested or recommended amount of food to eat. The terms 
suggested by the comment are not an accurate indication of the value 
that the serving size represents.
b. Methods Used to Update the Existing RACCs
Food Consumption Database
    To update existing RACCs that reflect the amounts of food products 
customarily consumed, we analyzed food consumption data from the NHANES 
2003-2008 surveys to assess the amount of food reported consumed per 
eating occasion. The NHANES collects nutrition and health related 
measures among the civilian non-institutionalized U.S. population. The 
NHANES oversamples African Americans, Mexican Americans, low-income 
whites, adolescents 12 to 19 years of age, and persons 60 years of age 
and older. The dietary interview component of NHANES, called ``What We 
Eat in America'' (WWEIA), is conducted as a partnership between USDA 
and the U.S. Department of Health and Human Services (DHHS) (Ref. 41). 
Under this partnership, DHHS' National Center for Health Statistics is 
responsible for the sample design and data collection and USDA's Food 
Surveys Research Group (FSRG) is responsible for the data collection 
methodology and maintaining the food and nutrient database (i.e., the 
Food and Nutrient Database for Dietary Studies (FNDDS)) (Ref. 42), 
which is used for the survey. The WWEIA provides gram amounts of each 
food reported consumed in the past 24-hours (24-hour recall) from each 
survey participant. More details of the survey design procedure can be 
found in the NHANES Data (Refs. 41 and 43).
    We analyzed the recent consumption by combining data from the 
survey years of the NHANES, 2003-2004, 2005-2006, and 2007-2008 (NHANES 
2003-2008 surveys) using Statistical Analysis Systems (SAS) and Survey 
Data Analysis (SUDAAN) procedures (Refs. 44 and 45) which provide a 
current indication of the amount of food being consumed by individuals 
(Ref. 46). Food consumption data from the NHANES-WWEIA surveys are 
released in 2-year cycles. Since the survey of 2003-2004, there are 
two, 24-hour recalls of food intake data (day 1 and day 2) available 
for each survey participant and recall of intake data are collected 
using the USDA AMPM (Ref. 47). The AMPM is designed to provide an 
efficient and accurate way of collecting dietary intake data for a 
large-scale national survey (such as NHANES) based on a 5-step probing 
technique for extensive compilation of standardized food-specific 
questions and possible response

[[Page 12008]]

options (Ref. 47). USDA's validation study showed that AMPM provides an 
acceptable accuracy of collecting reported intake data by comparing the 
estimated calorie intake with total energy expenditure, and estimated 
protein intake with urinary nitrogen excretion as measured by the 
doubly-labeled water method (Refs. 48 and 49). In our analyses, we used 
data to determine the median and mean estimates of consumption (in 
grams or in household measurements) for the food products in the 140 
product categories for the three population groups: Infants up to 12 
months of age, children 1 through 3 years of age, and the general 
population of persons 4 years of age or older (Ref. 46). For the bakery 
products that were in ``as-consumed'' form (e.g., toasted bread), we 
multiplied by a factor of 1.1 or 1.2 to convert the consumption amount 
to an ``as-purchased'' form (e.g. untoasted bread) and those foods were 
then included in the analysis. The factor is the ratio of the moisture 
content between the foods in an ``as-purchased'' to ``as-consumed'' 
form due to loss of water during the toasting process. The factor was 
necessary in order to determine the consumption amount of bakery 
products in the form that is listed in table 2 in Sec.  101.12(b).
Steps and Factors Used in Determining the Need to Update the 1993 RACCs 
(Ref. 50)
Step I--Evaluate Whether To Consider Updating the 1993 RACCs
    Under Step I, FDA considered two factors. Under this step, if both 
of these factors were not met, FDA did not consider updating the 1993 
RACC.
    (1) The first factor was to determine whether there was an adequate 
sample size from the NHANES 2003-2008 consumption data for each product 
in the 140 product categories. The adequate sample size was determined 
based on the design effect of the data source for the analyses (Ref. 
50). The design effect \5\ is calculated using the ratio of the 
variance of the estimate that is based on a sample weighted design to 
the variance of the estimate based on a simple random sample by 
products within a product category (Ref. 50). This is necessary because 
NHANES uses a complex, stratified, probability survey design for data 
collection, which is a cost-saving data collection method often used 
for population surveys, rather than a simple random sampling method.
---------------------------------------------------------------------------

    \5\ The design effect of the survey is a sample size adjustment 
compared to the survey if it would have been completed using a 
simple random sampling method. For example, if the design effect of 
a survey is 3, this means that the sample variance is 3 times larger 
than it would be if the data collection for the survey was based on 
a simple random sampling method. In other words, only one-third as 
many sample cases would be needed to measure the given statistic if 
a simple random sampling method were used instead of the cluster 
survey sampling method with a design effect of 3.0.
---------------------------------------------------------------------------

    The data collection for NHANES, which is completed by CDC, is used 
to assess intake by the U.S. population; a purpose that differed from 
our purpose of updating RACCs. Therefore, sample sizes that CDC 
collected were not always adequate for considering updates to the 
RACCs. Thus, we retrospectively determined the adequate, minimum 
required sample size based on the calculated design effect for each 
product within the product categories with a 90 percent confidence 
level and 20 percent margin of error. For some products, sample sizes 
are not large enough to obtain a reliable estimate of consumption. 
Therefore, we have determined that for these products there is no 
compelling evidence (due to an insufficient number of samples) to 
consider updating the RACCs established in 1993 for those products.
    (2) The second factor was to determine if, for those products with 
a sufficient sample size, the median intake estimate from the NHANES 
2003-2008 consumption data for the product significantly differed from 
the 1993 RACC for that product. Thus, we compared the median intake 
estimate from the NHANES 2003-2008 consumption data with the 1993 RACCs 
to determine if there was a at least a 25 percent difference (i.e. a 
significant difference) from the current RACCs. We used the median 
estimate of the intake distribution because it represents the central 
tendency of the amount customarily consumed per eating occasion. Also, 
the median is less influenced by outliers than the mean. In addition, 
we used a statistically conservative approach when considering the 
difference between the median intake estimate and the 1993 RACC for a 
product, to provide a 90 percent confidence level, with a 20 percent 
margin of error, to determine whether significant differences occur 
when the 95 percent confidence intervals of the consumption amount from 
the NHANES 2003-2008 surveys is outside of the 25 percent range ( 25 percent) of the RACCs established in 1993 (Ref. 50). In other 
words, when the consumption amount calculated from NHANES 2003-2008 
surveys increased or decreased by at least 25 percent from the RACCs 
established in 1993 (i.e., less than 0.75 of the RACC or more than 1.25 
of the RACC), we concluded that the current consumption amount is 
significantly different than the RACCs established in 1993. We chose 
the 25 percent approach based on our analysis of the data and after 
evaluating other values for percentage differences (e.g. 5%, 10%), when 
applied to the data, to reach a reasonable conservative estimate based 
on statistical principles. We further evaluated a product in Step II 
below if we found at least a 25 percent difference in consumption from 
the product in Step I. For a product for which there was not at least a 
25 percent difference in consumption, we did not consider updating the 
1993 RACC.
Step II--Determine Whether the 1993 RACCs Need To Be Updated
    When a product had an adequate sample size to provide a reliable 
median intake estimate and this amount was significantly different than 
the 1993 RACC for the product, we then considered the factors below in 
a step-wise process to determine whether to update the 1993 RACCs:
(1) The Skewness of the Intake Distribution
    We compared the median intake estimate from the NHANES 2003-2008 
consumption data for the product consumed with the mean intake estimate 
from the NHANES 2003-2008 consumption data to determine whether the 
distribution of intake was skewed (Ref 48). A skewed intake 
distribution suggested that an empirical number of the reported 
consumption amounts were inconsistent and therefore, the variability 
between the mean and median estimates was considered to be large. The 
median intake estimate could not by itself provide sufficient evidence 
for the amount customarily consumed of that product by the United 
States target population if the intake distribution was skewed.
(2) The Reasonable Consumption Amount
    If the intake distribution was skewed and we could not rely on the 
median intake estimate from the NHANES 2003-2008 consumption data as 
the sole basis to propose a change in the RACC, we examined the data 
from the FNDDS 4.1 (Ref. 42). The data from FNDDS provides the 
``reasonable consumption amount,'' which we used to assist in our 
decision about whether to propose a change to the RACC. The reasonable 
consumption amount is a default consumption amount of food that 
researchers have defined and is used by NHANES when survey participants 
cannot recall the amount of food that was consumed at one eating 
occasion (Ref. 42). If the reasonable consumption

[[Page 12009]]

amount for the product was consistent with the median intake estimate, 
we considered whether to propose a change to the 1993 RACC on a case-
by-case basis. If the median intake estimate from the NHANES 2003-2008 
consumption data was not consistent with the reasonable consumption 
amount for the product, we then looked at if there was a significant 
difference between the median intake estimates from the NHANES 2003-
2008 consumption data for the product, converted to a common household 
measure as applicable, and the 1993 RACC for the product.
(3) The Difference Between the Median Intake Estimates, Converted to 
Common Household Measures as Applicable, With the 1993 RACC for the 
Products
    If we determined, based on our analysis, that the distribution of 
the intake of a product was not skewed, or skewed and not consistent 
with the reasonable consumption amount, we next compared the median 
intake estimate from the NHANES 2003-2008 consumption data for the 
product, converted to a common household measure as applicable, with 
the 1993 RACC for the product.
    If the median intake estimate from the NHANES 2003-2008 consumption 
data for the product, converted to a common household measure as 
applicable, was not significantly different from the 1993 RACC for the 
product, we did not propose to update the 1993 RACC. This sometimes 
occurred when we converted the median intake estimate from the NHANES 
2003-2008 consumption data to determine the common household 
measurement. If the converted median intake estimate from the NHANES 
2003-2008 consumption data was significantly different from the 1993 
RACC for the product, we used other considerations to determine whether 
the 1993 RACC should be changed.
(4) Other Considerations When the Median Intake Estimate From the 
NHANES 2003-2008 Consumption Data Is Significantly Different From the 
1993 RACC for the Product
    If there was no other comparable product with a median intake 
estimate from the NHANES 2003-2008 consumption data, we considered 
whether the estimated median intake from the NHANES 2003-2008 
consumption data for the product was consistent with the reasonable 
consumption amount. If the median intake estimate from the NHANES 2003-
2008 consumption data was consistent with the reasonable consumption 
amount, we proposed to update the 1993 RACC based on the median intake 
estimate from the NHANES 2003-2008 consumption data; otherwise, we 
considered each food product case-by-case to determine whether to 
change the 1993 RACC.
    If there were comparable products with median intake estimates from 
the NHANES 2003-2008 consumption data, we considered these other 
comparable products to determine on a case-by-case basis whether to 
change the RACC for the product so that comparable products have the 
same RACC. In general, if multiple products were represented in a 
product category, we attempted to maintain a consistent RACC so that 
products with similar dietary usage (e.g., hot breakfast cereals, 
hominy, and grits are often used as breakfast items), similar product 
characteristics, and similar amounts customarily consumed could be 
easily compared. Similarly, we considered it beneficial to generally 
use the same RACCs for products that are in different product 
categories, when the products have similar amounts customarily 
consumed, similar dietary usage, and similar product characteristics 
(e.g., the ``All varieties, chips, pretzels, popcorns, extruded snacks, 
fruit-based snacks (e.g., fruit chips,) grain-based snack mixes'' 
product category and the ``Crackers that are usually used as snacks'' 
product category). Again, this is intended to help consumers to more 
easily compare nutrition information on the Nutrition Facts label 
across product categories. If the median intake estimate from the 
NHANES 2003-2008 consumption data for products in a product category 
varied, we gave greater consideration to the product that had the 
largest sample size (i.e., was consumed most frequently) in that 
product category when proposing a change to the 1993 RACC because there 
were more eating occasions reported by consumers for that product.
    While we have taken a conservative approach in the methodology used 
to determine which RACCs should be updated, we recognize that there may 
be other methods that could be used. We invite comment on our analysis 
and rationale, and request data and factual information on alternative 
methodologies that we should use for determining which RACCs to update.
c. Proposed Amendments To Update the Existing RACCs
    Using the methods described above, we propose to change the current 
RACCs used to determine the serving size for those products where 
consumption has changed significantly when compared to the RACCs 
established in 1993. These changes, if finalized, will be reflected in 
Table 1 ``Reference Amounts Customarily Consumed Per Eating Occasion: 
Foods for Infants and Children 1 through 3 years of age'' and Table 2 
``Reference Amounts Customarily Consumed Per Eating Occasion: General 
Food Supply'' of Sec.  101.12(b).
    Detailed information about how the principles, factors and steps 
were applied to change or not change the RACCs for specific food 
products is provided in a memorandum (Ref. 50). We analyzed consumption 
data for all 129 product categories in Table 2 in Sec.  101.12(b) for 
persons 4 years of age or older and for the 11 product categories in 
Table 1 (Sec.  101.12(b)), for infants and children 1 through 3 years 
of age (Ref. 50). The proposed amendments that follow in this section 
are for food products where consumption has increased or decreased by 
at least 25 percent when compared to the RACCs established in 1993. 
Proposed amendments for food products where consumption has not 
increased or decreased by at least 25 percent when compared to the 
RACCs established in 1993 are provided in section II.D.3.b.
Changes to Table 1: Reference Amounts Customarily Consumed Per Eating 
Occasion: Food for Infants and Children 1 Through 3 Years of Age in 
Sec.  101.12(b)
    In the product category ``Dinners, desserts, fruits, vegetables or 
soups, ready-to-serve, strained type'' we are proposing to change the 
RACC to 110 g from 60 g. The median consumption for desserts, ready-to-
serve, strained type was 103 g and dinners, ready-to-serve, strained 
type was 104 g. The median consumption for fruits and vegetables, 
ready-to-serve, strained type was about 70 g. Products in this product 
category have similar dietary usage and product characteristics to the 
products in the ``Dinners, desserts, fruits, vegetables or soups, 
ready-to-serve, junior type'' product category. We are proposing to 
change the RACC to 110 g, which would allow for consumers to make easy 
comparisons of nutrition information.
Changes to Table 2: Reference Amounts Customarily Consumed per Eating 
Occasion: General Food Supply in Sec.  101.12(b)
    In the general category of ``Bakery products,'' we propose to 
remove ``bagels,'' ``toaster pastries,'' and ``muffins'' from their 
current product categories, and to create a new product category for 
``Bagels, toaster pastries, muffins (excluding English muffins),'' with 
a proposed RACC of 110 g compared to the current RACC of 55 g that was 
used for all of those food

[[Page 12010]]

products. This change is being proposed because the amounts customarily 
consumed in recent consumption data for these products are much higher 
than the amounts customarily consumed for the other products in their 
current product categories (i.e., the product categories established in 
1993). Additionally, bagels, toaster pastries, and muffins (excluding 
English muffins) have similar product characteristics and dietary usage 
(e.g., they are products that can be used as breakfast products). The 
median consumption amounts for bagels, toaster pastries, and muffins 
are 104 g, 97 g, and 105 g, respectively. The median consumption 
amounts for those products are close to the reasonable consumption 
amount of one medium muffin, and the weight in grams of one regular-
sized bagel.
    In the general category of ``Beverages,'' we propose new RACCs of 
360 mL and 360 mL for ``Carbonated and noncarbonated beverages, wine 
coolers, water'' and ``Coffee or tea flavored and sweetened,'' 
respectively, compared to the current RACCs of 240 mL and 240 mL 
prepared because current median intakes are 360 mL (or 12 fluid ounces) 
for these products. We also propose to change the label statements for 
these product categories within the general category of ``Beverages'' 
to 12 fl oz (360 mL) from 8 fl oz (240 mL). The consumption data for 
milk, fruit juices and vegetable juices remained unchanged from the 
current RACC of 240 mL. In the 1991 proposed serving size rule, we 
stated that a uniform RACC for all beverages would help consumers make 
nutritional comparisons across beverage categories (56 FR 60394 at 
60407). While this is true, we still must base the RACCs on the amounts 
customarily consumed, and current data show that consumption amounts of 
carbonated and non-carbonated beverages, wine coolers, water, and 
coffee or tea flavored and sweetened are much greater than consumption 
amounts for milk, fruit juices, and vegetable juices. In addition to 
the consumption amounts being dissimilar, the product characteristics 
are somewhat different between milk, fruit juice, and vegetable juice 
compared to carbonated and non-carbonated beverages, wine coolers, 
water, and coffee or tea flavored and sweetened, because they are 
inherently nutrient dense (unlike carbonated and non-carbonated 
beverages, wine coolers, water, and coffee or tea flavored and 
sweetened). For these reasons we are not proposing to change the 
current RACC of 240 mL for milk, fruit juices, nectars, fruit drinks, 
and vegetable juices.
    In the general category of ``Fish, Shellfish, Game Meats, and Meat 
or Poultry Substitutes,'' we propose a new RACC of 85 g for the ``Fish, 
shellfish or game meat, canned'' product category, compared to the 
current RACC of 55 g because the median intake estimate from the NHANES 
2003-2008 consumption data is approximately 85 g.
    In the general category of ``Fruits and Fruit Juices,'' we propose 
a new RACC of 50 g for the product category of ``Fruits used primarily 
as ingredients, avocado'', compared to the current RACC of 30 g because 
the median intake estimate from the NHANES 2003-2008 consumption data 
for avocado is 50 g, and avocado is often used as an ingredient (e.g., 
in salads and sandwiches), similar to the product category ``Fruits 
used primarily as ingredients, others (cranberries, lemon, line)'' for 
which we are also proposing a new RACC of 50 g. Proposing a new RACC of 
50 g for the ``Fruits used primarily as ingredients, avocado'' product 
category would help consumers easily compare nutrition information 
between all fruits used primarily as ingredients.
    In the general category of ``Fruits and Fruit Juices,'' we propose 
a new RACC of 50 g for the product category of ``Fruits used primarily 
as ingredients, others (cranberries, lemon, lime)'' compared to the 
current RACC of 55 g. Because of the large variation between mean and 
median intake estimates from the NHANES 2003-2008 consumption data, we 
looked at the reasonable consumption amount for the products in the 
product category. The reasonable consumption amount for this product 
category is 50 g. Products in this product category are comparable to 
the product category ``Fruits used primarily as ingredients, avocado,'' 
which we are proposing a new RACC of 50 g. Proposing a new RACC of 50 g 
for the ``Fruits used primarily as ingredients, others (cranberries, 
lemon, lime)'' product category would help consumers easily compare 
nutrition information between all fruits used primarily as ingredients.
    In the general category of ``Sugars and Sweets,'' we propose a new 
RACC of 30 g for the ``All other candies'' product category compared to 
the current RACC of 40 g. The median consumption amount for this 
product category was 22 g and the mean was 33 g. Because intake 
distribution is not considered skewed and there is no comparable 
product with a reliable median intake estimate from the NHANES 2003-
2008 consumption data, we looked at data from the FNDDS (Ref. 42) on 
the reasonable consumption amounts of candies other than baking 
candies; hard candies, breath mints; hard candies, roll-type, mini-size 
in dispenser packages and hard candies. The reasonable consumption 
amount ranges from 14 to 59 g with the majority of the reasonable 
consumption amounts being 28 g. Therefore, given the variance in the 
median and mean we rounded the reasonable consumption amount of 28 g up 
to 30 g, which can be easily converted to a convenient household 
measure of one ounce for the proposed RACC for ``All other candies.'' 
We are also proposing to change the label statement to ---- pieces (--
-- g); 1 oz (30 g/visual unit of measure) for bulk products.
    In the general category of ``Sugars and Sweets,'' we propose a new 
RACC of 8 g for the ``Sugar'' product category compared to the current 
RACC of 4 g. The median intake estimate from the NHANES 2003-2008 
consumption data for sugar is 8 g.
    In the general category of ``Sugars and Sweets,'' we propose a new 
RACC of 30 mL for all syrups in the ``Syrups'' product category, 
compared to the RACC of 30 mL for syrups used primarily as an 
ingredient (e.g., light or dark corn syrup) and 60 mL for all others 
because the median intake estimate from the NHANES 2003-2008 
consumption data for all syrups is 2 tablespoons (tbsp), which is close 
to 30 mL. We also propose to change the label statement for all Syrups 
to 2 tbsp (30 mL) from 2 tbsp (30 mL) for syrups used primarily as an 
ingredient; \1/4\ cup (60 mL) for all others.
3. Modifying and Establishing RACCs
    This section discusses changes we are proposing that modify or 
establish RACCs. Since the final rule on serving sizes published in 
1993, we have received requests from manufacturers to modify RACCs for 
products currently listed in the tables in Sec.  101.12(b), establish 
RACCs for products not currently listed in the tables in Sec.  
101.12(b) and identify appropriate product categories for various food 
products (i.e., establish a RACC for that food product). These requests 
have come through various forms, including four citizen petitions 
referenced in section I.D.3., requests by manufacturers, and public 
comments to the ANPRM. In this section, we also propose to modify some 
product categories, on our own initiative, so that comparable products 
are grouped together. Thus, this proposed rule would establish certain 
RACCs for

[[Page 12011]]

products not currently listed in the tables in Sec.  101.12(b) (in some 
cases by placing a product in a new product category with a new RACC, 
and in other cases by placing a product in an existing product 
category), and would modify RACCs for some existing products.
a. Methods Used To Modify Existing RACCs and Establish New RACCs
    The products in this category are either new products for which no 
RACC is currently established, or products for which RACCs are 
currently established, but for which there has not been a significant 
increase or decrease in consumption (i.e., an increase or decrease in 
consumption representing a 25 percent difference) when compared to the 
RACCs established in 1993 (Ref. 50). Some products discussed below are 
ingredients of foods or other food products that are not available in 
the NHANES database. When determining where to place food products and 
what their RACCs should be, we looked first to the NHANES database, 
using similar methods to those used to update the 1993 RACCs, as 
described previously in this document. We analyzed recent consumption 
from the NHANES 2003-2008 surveys, when available, using SAS and SUDAAN 
procedures (Refs. 44 and 45). The factors considered when looking at 
NHANES 2003-2008 consumption data included: (1) The sample size and the 
median intake estimate from the NHANES 2003-2008 consumption data, and 
the mean intake estimate from the NHANES 2003-2008 consumption data 
(unlike the methods used to update the RACCs, the mean estimate was 
used as a guide when the median estimate was not available), (2) the 
difference between the NHANES 2003-2008 consumption data, converted to 
a common household measure as applicable, and the 1993 RACC for the 
product, (3) the reasonable consumption amount, (4) information 
received in manufacturers' requests, public comments, and (5) the 
NHANES 2003-2008 consumption data for comparable products and the 
largest sample size from the NHANES 2003-2008 consumption data within a 
product category. Detailed information about how these factors were 
applied to individual products is provided in a memorandum to the file 
(Ref 48).
    If the food product was not available in the NHANES database, we 
looked to the main dietary usage of the product to determine if the 
product could fit into an existing product category. For accuracy and 
consistency in determining dietary usage, we used a culinary reference 
book entitled ``Food Lover's Companion,'' which has been used by 
nutrition professionals as a food dictionary reference (Ref. 51), and 
internet resources with extensive recipe collections such as, http://www.allrecipes.com, http://www.food.com, and http://www.recipe.com 
(Refs. 52, 53 and 54). Market data (e.g., Neilson sales data) were used 
to examine the top selling products. Additionally, the Gladson and 
Mintel databases, which provide labeling information for products that 
are currently available in the market, were used to look at industry 
practice (Refs. 55 and 56). For foods that are used as ingredients, the 
RACCs are generally determined based on the amount of the ingredient 
that is needed to prepare the finished product per eating occasion 
(e.g., cocoa powder, unsweetened is used as an ingredient for chocolate 
cakes). For all products in this section, we considered additional data 
sources, such as data from the gram weight information for various 
portion sizes based on the National Nutrient Database for Standard 
Reference, release 24 (Ref. 57), recipe information from FNDDS, a 
guidance document entitled ``Guidance for Industry: A Food Labeling 
Guide'' (Ref. 58), and other federal guidance documents (Ref. 59).
b. Proposed Amendments To Modify Existing RACCs and Establish New RACCs
    In this section we propose to modify RACCs, establish RACCs, and 
place products in appropriate product categories in Table 2 in Sec.  
101.12(b).
    In the general category of ``Bakery products,'' we propose to:
    1. Add ``scones, crumpets, and English muffins'' to the current 
product category ``Biscuits, croissants, bagels, tortillas, soft bread 
sticks, soft pretzels, corn bread, hush puppies'' with a RACC of 55 g. 
The new name for this product category would be ``Biscuits, croissants, 
tortillas, soft bread sticks, soft pretzels, corn bread, hush puppies, 
scones, crumpets, and English muffins'' (as discussed in section 
II.D.2.c., we also are proposing to move bagels to a new product 
category). Currently there is no RACC for scones and crumpets. The 
median intake estimate from the NHANES 2003-2008 consumption data for 
scones and crumpets is 37 g. The reasonable consumption amount of one 
scone with or without fruit is 42 g, and one crumpet weighs 45 g. The 
median intake estimate from the NHANES 2003-2008 consumption data for 
biscuits and croissants is 51 g and 57 g, respectively. Biscuits and 
croissants have a larger sample size compared to scones and crumpets. 
Biscuits, croissants, scones, crumpets and English muffins are 
comparable to other products in this category and can be used as 
breakfast bakery products. Therefore, based on these factors, we 
propose to add scones, crumpets, and English muffins to the current 
product category ``Biscuits, croissants, bagels, tortillas, soft bread 
sticks, soft pretzels, corn bread, hush puppies'' with a RACC of 55 g; 
and
    2. Add to proposed footnote 5 that the serving size for fruitcake 
is 1\1/2\ oz. Fruitcake belongs in the ``Cakes, heavy weight'' product 
category, which has a RACC of 125 g, because it is generally 18 g per 
cubic inch, which meets the 10 g or more per cubic inch weight minimum 
for this category (see current footnote 6 in table 2 of Sec.  
101.12(b)). The NHANES 2003-2008 surveys have limited consumption data 
for fruitcake because there are only 24 eating occasions for fruitcake 
from NHANES 2003-2008 surveys. The fruitcake petition requested a new 
RACC for fruitcake and noted that fruitcake is a specialty item 
consumed primarily over the holidays and that the industry has 
traditionally, before mandatory nutrition labeling was implemented, 
used 1\1/2\ oz as the serving size. We propose to add to proposed 
footnote 5 that the serving size for fruitcake is 1\1/2\ oz because: 
(1) It is a specialty item consumed primarily over the holidays; and 
(2) industry has traditionally used 1\1/2\ oz as a serving size; and
    3. Establish a new product category ``Eggroll, dumpling, wonton, or 
potsticker wrappers'' with a RACC of 20 g. The proposed label statement 
is ``---- sheet (g)'' or ``---- wrapper (g).'' Wrappers for eggrolls, 
dumplings, wontons, or potstickers are generally used as ingredients to 
make eggrolls, dumplings, wontons, and potstickers. Eggrolls, 
dumplings, wontons, and potstickers are used primarily as appetizers. 
Generally about 1 eggroll, 5 wontons, and 3 potstickers will make 1 
serving of an appetizer with a RACC of 85 g (as discussed in this 
section of the document, we are proposing a new product category for 
appetizers with a RACC of 85 g). The amount of wrappers that are needed 
to make 1 serving of an appetizer with a RACC of 85 g is about 20 g; 
and
    4. Add ``crepes'' to the product category ``French toast, pancakes, 
variety mixes,'' with a RACC of 110 g prepared for French toast, 
crepes, and pancakes and 40 g dry mix for variety mixes. The new name 
for this product category would be ``French toast, crepes, pancakes, 
variety mixes.'' The median consumption for crepes is 101 g, and crepes 
are comparable products to pancakes and French toast (e.g.,

[[Page 12012]]

breakfast bakery products) and are similar to pancakes without the 
leavening ingredients that are used in pancakes; and
    5. Add ``pie shell'' and ``pastry sheets'' to the product category 
``Pie crust'' and modify the RACC to be ``the allowable declaration 
closest to an 8 square inch surface area.'' The new product category 
name would be ``Pie crust, pie shell, pastry sheets (e.g., phyllo, puff 
pastry sheets).'' We recognize a need to establish additional reference 
amounts for crusts to provide a basis for determining serving sizes for 
crusts and shells with diameters other than 8 or 9 inches. We also 
propose to change the label statement for this product category to ``--
-- fractional slice(s) (---- g) for large discrete units; ---- shells 
(---- g); ---- fractional ---- sheet(s) (---- g) for distinct pieces 
(e.g., Pastry sheet).'' An example of a label statement for pastry 
sheets would be \1/6\ of 1 sheet (---- g). This modified product 
category would include, for example, miniature crusts, phyllo pastry 
sheets, puff pastry, and pie crusts with a diameter of 10 inches. 
Changing the RACC would make the crust and shell category consistent 
with the way that pies are treated in this product category, such that 
the fraction of the total pie will be equal to the same fraction of the 
crust or shell plus filling. In the case of small individual units, the 
serving size would be the same number of units whether filled or 
unfilled. Pie shells and pastry sheets have similar dietary usage to 
pie crusts as an ingredient of dessert products.
    In the ``Dairy Products and Substitutes,'' general category, we are 
proposing to:
    1. Change the name of the product category ``Milk, milk-based 
drinks, e.g., instant breakfast, meal replacement, cocoa'' to ``Milk, 
milk-substitute beverages, milk-based drinks, e.g., instant breakfast, 
meal replacement, cocoa, soy beverage'' with a RACC of 240 mL. We are 
adding milk-substitute beverages to this product category because milk 
and milk-substitute beverages are comparable products and consumers can 
make nutrition information comparisons among these products. 
Nutritionally equivalent (see Sec.  101.3(e)(2)) soy beverages are an 
example of milk-substitute beverages and can be used as a substitute 
for milk (Ref. 51).
    2. Change the RACC of the product category ``Yogurt'' to 170 g, 
which is approximately 6 oz. The current RACC for yogurt is 225 g or 
approximately 8 oz. The NHANES 2003-2008 consumption data show the 
median consumption for yogurt is about 6 oz, but did not meet the 25 
percent change level we are using in this proposed rule as a factor to 
consider whether to update the RACCs. However, comments on the ANPRM 
from the yogurt industry and the NYA citizen petition have requested 
that we change the RACC for yogurt to reflect what is the most commonly 
consumed in the market place. In addition, 2009-2010 AC Nielson sales 
data has 6 oz containers of yogurt ranked highest among annual sales 
data for yogurt. We have decided to change the RACC for yogurt based on 
current consumption data, information in the NYA citizen petition, 
information from industry comments on yogurt consumption, and market 
trends.
    In the general category of ``Desserts'' we propose to:
    1. Change the name of the product category ``Ice cream, ice milk, 
frozen yogurt, sherbet: All types, bulk and novelties (e.g., bars, 
sandwiches, cones)'' to ``Ice cream, ice milk, frozen yogurt, sherbet, 
frozen flavored and sweetened ice, frozen fruit juices: All types 
bulk'' and change the RACC for this product category to 1 cup, as 
compared to the current RACC of \1/2\ cup. We also propose to change 
the label statement for this product category to ``1 cup (---- g).'' 
This new product category would not include ice cream novelties because 
ice cream novelties are not comparable to the other products in this 
product category. Ice cream novelties are often prepackaged and come in 
multiple individual units per package. We received comments on the 
ANPRM stating that the RACC for ice cream is ``unrealistic and 
misleading.'' The comments stated that a \1/2\ cup of ice cream is 
smaller than a household ice cream scoop and should be increased to an 
amount people normally consume. Current consumption data for bulk ice 
cream has increased to 0.875 cup, which is closer to 1 cup as compared 
to the current RACC of \1/2\ cup. Bulk ice cream, ice milk, frozen 
yogurt, sherbet, frozen flavored and sweetened ice, frozen fruit juices 
are all comparable products and are usually all sold in the same area 
of the grocery store. We propose to change the RACC to 1 cup although, 
based on the calculations from the current consumption data, the 
products in the original product category (which included ice cream 
novelties) generally did not change by at least 25 percent; and
    2. Change the name of the product category ``Frozen flavored and 
sweetened ice and pops, frozen fruit juices: All types, bulk and 
novelties (e.g., bars, cups)'' to ``Ice cream, ice milk, frozen yogurt, 
sherbet, frozen flavored and sweetened ice and pops, frozen fruit 
juices: All types novelties (e.g., bars, sandwiches, cones, cups)'' and 
change the RACC for this product category to ``\1/2\ cup--includes the 
volume for coatings and wafers,'' as compared to the current RACC of 85 
g. We changed the RACC from a weight measurement (grams) to a volume 
measurement (cups) because of the difference in density between various 
ice creams, frozen flavored and sweetened ice and pops, frozen yogurts, 
and sherbets. For example, 1 cup of ice cream generally weighs about 
133 g, while 1 cup of frozen yogurt generally weighs 200 g, and 1 cup 
of ice pop generally weighs 254 g. However, the median consumption for 
all of these products is \1/2\ cup regardless of weight. The new 
product category will include ice cream, ice milk, frozen yogurt, and 
sherbet novelties. Current consumption for ice cream sandwiches, bars 
and cones is 68 g (about \1/2\ cup) and for frozen yogurt cones is 78 g 
(about \1/2\ cup), which is similar to the consumption data for frozen 
flavored novelties. Ice cream, ice milk, frozen yogurt, and sherbet 
novelties are more comparable with frozen flavored novelties than they 
are with bulk ice creams, ice milks, frozen yogurts, and sherbets; and 
are usually sold in the same area of the grocery store as the other 
products listed in this product category; and
    3. Change the RACC for the product category ``Custard, gelatin, or 
pudding'' to ``\1/2\ cup prepared; Amount to make \1/2\ cup prepared 
when dry.'' The current RACC for this category is ``\1/2\ cup.'' 
Custard powder, gelatin, and pudding powder are often used to make 
custard, gelatin, and pudding desserts. There is currently a RACC for 
the prepared version of these products, but not the dry form used in 
preparation mixtures.
    In the general category of ``Dessert Toppings and Fillings'' we 
propose to:
    1. Change the weight-based RACC for the product category of ``Cake 
frostings or icings'' with a RACC of 35 g to a volume-based RACC of 2 
tbsp. The RACC of 35 g does not take into account whipped frosting and 
icings that may not weigh 35 g. Changing to a volume based reference 
amount would allow for consistency in the category and allow comparison 
of nutrition information for these products based on the same RACC.
    In the general category of ``Egg and Egg Substitutes'' (proposed to 
be renamed as the general category of ``Egg and Egg Substitutes'' as 
discussed as follows), we propose to:
    1. Change the name of the product category ``Egg Substitutes'' 
(which has a RACC of ``An amount to make 1 large

[[Page 12013]]

(50 g) egg'') to ``Egg whites, sugared eggs, sugared egg yolks, and egg 
substitutes (fresh, frozen, dried).'' The median consumption for egg 
white, sugared egg, and sugared egg yolk is 64 g. Egg white, sugared 
egg, and sugared egg yolk are comparable products and can be used as a 
substitution of a whole egg.
    In the general category of ``Fish, Shellfish, Game Meats, and Meat 
or Poultry Substitutes,'' we propose to:
    Add ``seafood'' to the product category ``Substitute for luncheon 
meat, meat spreads, Canadian bacon, sausages and frankfurters,'' which 
has a RACC of 55 g. The median consumption for seafood substitutes is 
60 g. The new name for the product category would be ``Substitute for 
luncheon meat, meat spreads, Canadian bacon, sausages, frankfurters, 
and seafood.'' Seafood substitutes are comparable products to other 
products in this product category.
    In the current general category of ``Miscellaneous Category'' 
(proposed to be renamed as the general category of ``Miscellaneous'' as 
discussed in section II.F.3.), we propose to:
    1. Establish a new product category for ``Cocoa powder, carob 
powder, unsweetened'' with a RACC of 1 tbsp. The proposed label 
statement is 1 tbsp (---- g). Unsweetened cocoa powder or baking cocoa 
is a dry, unsweetened, chocolate-flavored powder that is often used as 
an ingredient in various recipes, including cakes, brownies, and 
cookies. Because it is an ingredient, there is no direct consumption 
data from the NHANES 2003-2008 surveys. Carob powder is used as a 
substitution for unsweetened cocoa powder in baking; thus, it has 
similar dietary usage to unsweetened cocoa powder (Ref. 51). Examining 
a variety of chocolate cake recipes (Ref. 52), the weight of baking 
cocoa powder ranges from 3 g to 5 g to make a reference amount of 55 g 
for chocolate cake without icing or filling; and
    2. Change the name of the product category ``Drink mixers (without 
alcohol)'' to ``Milk, milk substitute, and fruit based drink mixes 
(without alcohol): (e.g., drink mixers, fruit flavored powdered drink 
mixes, sweetened cocoa powder)'' with a RACC of ``Amount to make 240 mL 
drink (without ice).'' The NHANES 2003-2008 consumption data show that 
the median intake estimate for milk-substitute beverages is 184 g 
(about 6 fl oz). Based on the Gladson database, the majority of 
products are using 8 fl oz or 1 cup as the serving size on the label. 
This proposed RACC is the same as the RACC for comparable products 
(i.e., milk, milk-based drinks, fruit juices, and fruit drinks). This 
new product category includes products that were not included in the 
1993 serving size final rule. The 1993 serving size final rule includes 
prepared versions of the products in this category, but not the dry 
forms used to make the prepared beverages. We propose to establish a 
label statement for this product category of ``---- fl oz (---- ml), --
-- tsp (---- g), ---- tbsp (---- g)''; and
    3. Establish a new product category ``Drink mixes (without 
alcohol): all other types (e.g., flavored syrups and powdered drink 
mixes'' with a RACC of ``Amount to make 360 mL drink (without ice).'' 
This new product category includes products that were not included in 
the 1993 serving size final rule. The 1993 serving size final rule 
includes prepared versions of these products in the ``Beverages'' 
general category, but not the dry forms used to make the prepared 
beverages. The current RACC for the ``Beverages'' general category is 
240 mL. We are proposing to change the RACC for ``Beverages'' to 360 
mL. The products in this proposed product category are comparable to 
the products in the ``Beverages'' general category. We also propose to 
establish a label statement for this product category of ``---- fl oz 
(---- mL), ---- tsp (---- g), ---- tbsp (---- g)''; and
    4. Establish a new product category ``Seasoning oils and seasoning 
sauces (e.g., coconut concentrate, sesame oil, almond oil, chili oil, 
coconut oil, walnut oil)'' with a RACC of 1 tbsp. This product category 
includes flavorings, seasonings and spices that are in a liquid form 
and are primarily used as ingredients in a product, rather than as 
sauces or dips with finished foods. Coconut concentrate is an extract 
of the cooked mixture of water and coconut meat, which is often used as 
an ingredient of a sauce or dressing (such as curry sauce) (Ref. 51). 
The reasonable consumption amount for the flavoring oils (sesame oil, 
almond oil, coconut oil, and walnut oil) is 13.6 g (about 1 tbsp) based 
on the FNDDS (Ref. 42). We also propose to establish a label statement 
for this product category of 1 tbsp (---- g); and
    5. Establish a new product category ``Seasoning pastes (e.g., 
garlic paste, ginger paste, curry paste, chili paste, miso paste, fresh 
or frozen)'' with a RACC of 1 teaspoon (tsp). This product category 
includes seasonings and spices that are in a paste form and are 
primarily used as ingredients (such as miso in making miso soup), 
rather than as sauces or dips for finished foods. The current median 
intake estimate is 4 g. The reasonable consumption amount for miso 
paste, which is an example product in this product category, is 3 g 
(about 1 tsp). We also propose to establish a label statement for this 
product category of 1 tsp (---- g).
    In the general category of ``Mixed Dishes,'' we propose to:
    1. Change the name of the product category ``Not measurable with 
cup, e.g., burritos, egg rolls, enchiladas, pizza, pizza rolls, quiche, 
all types of sandwiches'' to ``Not measurable with cup, e.g., burritos, 
enchiladas, pizza, pizza rolls, quiche, sandwiches.'' We are proposing 
to include smaller sized versions of some of these products in a new 
appetizer product category. Smaller versions of these products are 
primarily used as appetizers, while products in the mixed dish category 
are primarily used as entrees or main dishes. We have updated the 
category name to reflect the change; and
    2. Establish a new product category for ``Appetizers, hors 
d'oeuvres, mini mixed dishes, e.g., mini bagel pizzas, breaded 
mozzarella sticks, egg rolls, dumplings, potstickers, wontons, mini 
quesadillas, mini quiches, mini sandwiches, mini pizza rolls, potato 
skins,'' with a RACC of 85 g, add 35 g for products with gravy or sauce 
topping. The new ``Appetizers, hors d'oeuvres, mini mixed dishes'' 
product category would contain products that are not included in table 
2 of Sec.  101.12(b). The products in this new product category (e.g., 
mini pizza rolls) are similar to those found in a category in USDA's 
Guide to Federal Food Labeling Requirements for Meat and Poultry 
Products (USDA's Guide) (Ref. 59), which provides a RACC of 85 g for 
``Appetizers hors d'oeuvres, mini eggrolls, mini pizza rolls, bagel 
pizza with meat or poultry.'' The USDA products are mostly the same as 
the products being proposed in our new ``Appetizers, hors d'oeuvres, 
mini mixed dishes'' product category, except that the USDA products 
always contain meat. The median consumption for mini pizza rolls is 83 
g and for egg rolls is between 57 and 59 g. Additionally, all of the 
products in this proposed ``Appetizers, hors d'oeuvres, mini mixed 
dishes'' product category are comparable in their usage. Therefore, we 
propose a RACC of ``85 g add 35 g for products with gravy or sauce 
topping'' for this product category, which is consistent with USDA's 
RACC for ``Appetizers hors d'oeuvres, mini eggrolls, mini pizza rolls, 
bagel pizza with meat or poultry,'' which will allow consumers to 
compare nutrition information across food labels for these types of 
products. The addition of 35 g sauce is calculated proportionally by 
the

[[Page 12014]]

weight of the RACC for the product category ``Mixed Dishes not 
measurable with cup'' where the addition of 55 g of sauce is used for 
the 140 g of RACC. We propose that an individual unit in this new 
product category should not weigh more than 85 g, or it would not be 
considered an appetizer, hors d'oeuvre, or mini mixed dish. For 
example, if an individual eggroll were to weigh more than 85 g, it 
would be appropriate to use the RACC from the general category ``Mixed 
Dishes'' and the product Category ``Not measurable with cup.'' We also 
propose to establish a label statement for this product category of --
-- pieces(s) (---- g).
    In the general category of ``Sauces, Dips, Gravies and 
Condiments,'' we propose to:
    1. Add ``Alfredo sauce'' to the product category ``Minor main 
entr[eacute]e sauces (e.g., pizza sauce, pesto sauce)'' with a RACC of 
\1/4\ cup. The new product category name would be ``Minor main 
entr[eacute]e sauces (e.g., pizza sauce, pesto sauce, Alfredo sauce), 
other sauces used as toppings (e.g., gravy, white sauce, cheese sauce), 
cocktail sauce.'' Alfredo sauce is mixed with and coats a pasta product 
(Ref. 51). This dietary usage is similar to that of pesto sauce in the 
``Minor main entr[eacute]e sauces'' product category.
    In the general category of ``Soups,'' we propose to:
    1. Establish a product category ``Dry soup mixes, bouillon.'' The 
RACC for this category would be the ``Amount to make 245 g.'' Bouillon 
and dry soup mixes are often used to make soups and broths (Ref. 51). 
There is currently a RACC for the prepared version of these products, 
but not the dry form used in preparation mixtures. The RACC for soups 
is 245 g. We also propose to establish a label statement for this 
product category of ---- cup (---- g); ---- cup (---- mL).
    In the general category of ``Sugars and Sweets,'' we propose to:
    1. Establish a new product category ``After-dinner 
confectionaries'' with a RACC of 10 g. We reviewed consumption data 
from the NHANES 2003-2008 surveys to determine whether a change in the 
RACC for Andes mint wafers and other after-dinner confectionaries, as 
requested in the Andes petition, was warranted. These types of candies 
are currently included in the ``All other candies'' product category. 
Because there are no intake data available from the NHANES 2003-2008 
surveys to determine intake estimates for after-dinner confectionaries, 
we relied on industry product information available through the Gladson 
and Mintel databases (Refs. 55 and 56). These databases are 
comprehensive and include label information for products currently on 
the market. The databases indicated that products marketed as ``after-
dinner confectionaries'' or comparable candy products ranged in weight 
from approximately 2 to 12 g per piece. According to the serving size 
information on after-dinner confectionary product labels in the Gladson 
and Mintel databases, the weight of an individual piece varies 
considerably among the different products in this category. To avoid 
having the serving size of the larger size products expressed as a 
faction of a piece, we propose that all products marketed as after-
dinner confectionaries (or after-dinner mints) should have the same 
RACC of 10 g, which is slightly smaller than the 15 g RACC requested in 
the Andes petition. We also propose to establish a label statement for 
this product category of ---- piece(s) (---- g);
    2. Add ``powdered candies'' and ``liquid candies'' to the product 
category ``Hard candies, others'' with a RACC of 15 mL for liquid 
candies and 15 g for all others. We propose to rename the product 
category to ``Hard candies, others; powdered candies, liquid candies'' 
to indicate that powdered and liquid candies would be added to this 
product category. After publication of the 1993 serving size final 
rule, two manufacturers asked that powdered candies, which are 
frequently sold in straws or small packets, be included in the ``Hard 
candies, others'' product category with a RACC of 15 g (Refs. 9 and 
10). One manufacturer also asked to classify liquid candy (which is 
very sweet and frequently sold in wax containers containing syrup or 
flavored liquid) in the ``Hard candies, others'' product category with 
a RACC of 15 mL. The manufacturers stated that 15 g (or 15 mL) was a 
more reasonable RACC than 40 g in the ``All other candies category.'' 
We suggested that manufacturers use a RACC of 15 g for flavored and 
colored powdered candies and 15 mL for syrup-filled wax liquid candies 
(Refs. 60 and 61). In ``Guidance for Industry: A Food Labeling Guide'' 
(Question L62), we listed 15 g as the suggested RACC for powdered, 
flavored candy and 15 mL as the suggested RACC for colored, flavored 
syrup-filled wax candy (Ref. 58). There are no median intake estimates 
for either powdered or liquid candies and the mean intake estimate for 
liquid candies is 13 g in the NHANES 2003-2008 surveys. Based on 
product label information from the Mintel database, 15 g has been used 
for various powdered candy products, and 20 mL has been used for wax 
candies. Because powdered and liquid candies are used comparably, we 
propose to establish RACCs of 15 g for powdered candies and 15 mL for 
liquid candies and to add them to the ``Hard candies, others'' product 
category. These are the same RACCs we suggested in 1993 that 
manufacturers should use, and which are listed in our ``Guidance for 
Industry: A Food Labeling Guide'' (Question L62) (Ref. 58). We also 
propose to establish a label statement ---- piece(s) (---- g) for large 
pieces; ---- tbsp(s) (g) for ``mini-size'' candies measurable by tbsp; 
---- straw(s) (---- g) for powdered candies; ---- wax bottle(s) (---- 
mL) for liquid candies; and 1/2 oz (14 g/visual unit of measure) for 
bulk products; and
    3. Add ``fruit paste and fruit chutney'' to the product category 
``Honey, jams, jellies, fruit butter, molasses'' with a RACC of 1 tbsp. 
The new product category name would be ``Honey, jams, jellies, fruit 
butter, molasses, fruit paste, fruit chutney.'' The current median 
consumption for fruit chutney and fruit paste is similar to the 1 tbsp 
RACC used for the product category ``Honey, jams, jellies, fruit 
butter, molasses.'' Fruit chutneys and fruit pastes have similar 
dietary usage to jams, jellies, and fruit pastes, as all can be used to 
spread on breads (Ref. 51).
    In the general category of ``Vegetables,'' we propose to:
    1. Change the name of the product category ``Chili pepper, green 
onion'' to ``Fresh or canned chili peppers, jalapeno peppers, other hot 
peppers, green onion.'' Jalapeno pepper and other hot peppers are 
comparable products to chili peppers;
    2. Establish a new product category for ``Dried vegetables, dried 
tomatoes, sun-dried tomatoes, dried mushrooms, dried seaweed'' with a 
RACC of 5 g, add 5 g for products packaged in oil. We also propose to 
establish a label statement for this product category of ``---- 
piece(s); \1/3\ cup (---- g).'' The median intake estimate from the 
NHANES 2003-2008 consumption data for dried vegetables is about 2 g and 
6 g for dried tomatoes. One cup of dried seaweed weighs 15 g. Dried 
vegetables, dried tomatoes, sun-dried tomatoes, dried mushrooms, and 
dried seaweed are comparable products. Sun-dried tomatoes are dried 
tomatoes and are often packed in oil (Ref. 51). One tsp of oil weighs 
about 5 g;
    3. Establish a new product category ``Dried seaweed sheets'' with a 
RACC of 3 g. We also propose to establish a label statement for this 
product category of ---- piece(s) (---- g); cup(s) (---- g). Industry 
uses 2.5 g to 3 g per sheet, with

[[Page 12015]]

one sheet per serving, on the product labels and the current suggested 
RACC for dried seaweed sheets is 3 g in our guidance ``Guidance for 
Industry: A Food Labeling Guide'' (Ref. 58); and
    4. Establish a new product category ``Sprouts, all types: fresh or 
canned'' with a RACC of 10 g. The median intake estimate from the 
NHANES 2003-2008 consumption data for all sprouts, is 14 g. However, 
because there is a large variation in the density (i.e., the gram 
weight per cup) for various types of sprouts, we propose to establish a 
RACC of \1/4\ cup for this new product category. We also propose a 
label statement for this product category of ``\1/4\ cup (---- g).''
    We also considered modifying the RACCs for burritos, pizza and 
sandwiches. We note that burritos, pizza, and sandwiches appear to be 
commonly consumed products, as demonstrated by their relatively large 
sample sizes in the NHANES 2003-2008 surveys. The intake distributions 
for burritos, pizza, and sandwiches are not considered skewed, and 
although the median intake estimates from the NHANES 2003-2008 
consumption data for burritos, pizza, and sandwiches products are 184 
g, 172 g, and 170 g, respectively, they are not significantly different 
from the 1993 RACC of 140 g (Refs. 46 and 50). Therefore, we are not 
proposing to change to the 1993 RACC. However, the median intake 
estimates from the NHANES 2003-2008 surveys are higher for these 
products compared to the median intake estimates from the NHANES 2003-
2008 surveys for other comparable products (e.g., Turnovers, 142 g; 
other mixed dishes, 149 g) in the same product category ``Mixed dishes 
not measureable with cup.'' Therefore, we invite comment on whether the 
current RACC for these products should be increased, and if so, by what 
amount.
4. Products of Concern Listed in Consumer Comments--Agency Request for 
Information
    The majority of consumer comments on the ANPRM stated that the food 
labels on the following foods are misleading and recommended that the 
serving size be increased: 20 fluid oz bottles of carbonated beverages, 
canned soup, snack size packages of potato chips and pretzels (e.g., 
salty snacks), fruit juice, microwave popcorn, canned chili, shelled 
nuts, iced tea, TV dinners, energy drinks, canned ravioli, 5-inch 
pizzas, dairy beverages, pre-packaged lunches, vending machine items, 
breakfast cereals, macaroni and cheese, cookies, crackers, ice cream, 
coffee creamer and muffins. Most of these foods did not have a change 
in consumption of at least 25 percent, which is a factor we consider in 
this rule to update the RACC. Although the proposed rule would not 
change the RACC for most of these products, we feel that the comments' 
concerns have been addressed with the proposed definition of single-
serving containers and the proposed requirements for dual-column 
labeling. The proposed requirements would allow for products that 
contain less than 200 percent of the RACC to be labeled as a single-
serving container and for products that contain 200 percent and up to 
and including 400 percent of the RACC to be labeled with dual-column 
labeling that would provide nutrition information per serving and per 
container in the Nutrition Facts label. The majority of the products of 
concern listed above would meet either of the proposed requirements for 
single-serving containers or dual-column labeling.
    We invite comment on whether we should change the RACC for foods in 
these categories due to consumer concern of misleading label 
information. If so, which foods should we change? What factor(s) should 
we use to determine when these foods should be changed? Are there any 
data available to support a change in the RACCs of these foods? 
Additionally, to the extent that some comments may be concerned about 
misleading package sizes when compared to labeled serving sizes, as 
opposed to being concerned with the appropriate serving size for 
specific food products within a product category, we invite comment on 
whether the proposed requirements for single serving and dual-column 
labeling alleviate the comments' concerns.
5. Impact of Changes in RACCs on the Eligibility of Nutrient Content 
Claims and Health Claims
    We recognize that changes to the serving size regulations, 
especially updating the RACCs, could affect the eligibility of 
individual foods to bear nutrient content claims or health claims. The 
amount of a nutrient that is the subject of a nutrient content claim or 
health claim is typically calculated on a per RACC basis. For example, 
for individual foods (i.e., foods that are not meal products or main 
dish products) that have RACCs greater than 30 g or greater than 2 
tbsp, to be eligible to bear a ``low fat'' nutrient content claim, the 
food must meet the criterion of 3 g of total fat or less per RACC 
(Sec.  101.62(b)(2)(i)(A)). Using the health claim on intake of sodium 
and reduced risk of hypertension as an example, the levels of sodium in 
an individual food eligible to bear the claim must meet the criterion 
of ``low sodium'' claim under Sec.  101.61(b)(4), which contains 
specific requirements respecting maximum amounts of sodium per RACC for 
various foods eligible to bear the claim (see Sec.  101.74(c)(2)(ii)).
    We are aware that individual foods that currently meet the 
requirements for certain claims based on existing RACCs may potentially 
become ineligible to continue to bear such claims if their RACCs 
change. For example, an individual food with a total fat value of 3 g 
of total fat per \1/2\ cup serving may have been eligible for a ``low 
fat'' claim with the existing RACC, but if the RACC increases to 1 cup, 
the food would have a total fat value of 6 g total fat per RACC and 
would no longer be able to be considered ``low fat.'' Additionally, we 
are aware that individual foods that are currently ineligible to bear 
certain claims may potentially become eligible to bear such claims if 
their RACCs change. For example, foods that are currently ineligible 
for a ``good source of calcium'' claim (Sec.  101.54(c)) at the current 
RACCs may be able to meet the specific criterion in the regulations if 
their RACCs increased in size, causing the food to have an accompanying 
increase in the calcium levels per RACC. Another example is that 
individual foods that are currently ineligible for a ``low sodium 
claim'' may be able to meet the specific criterion in the regulations 
if their RACCs are decreased in size, causing the food to have an 
accompanying decrease in the sodium levels per RACC.
    Other regulatory requirements for nutrient content claims and 
health claims are considered on a per RACC basis, and changes to the 
RACCs could affect the ability of foods to meet these requirements as 
well. For example, the levels of total fat, saturated fat, cholesterol, 
and sodium that trigger the need for a disclosure statement for 
individual foods bearing a nutrient content claim are on a per RACC and 
per labeled serving basis (Sec.  101.13(h)). The disclosure levels for 
most foods are 13.0 g of total fat, 4.0 g of saturated fat, 60 mg of 
cholesterol, and 480 mg of sodium per RACC. Foods that currently bear 
nutrient content claims and do not exceed the disclosure values per 
RACC would not need to include any disclosure statement; however, if 
the RACC for that food were to increase, and values for total fat, 
saturated fat, cholesterol, or sodium per RACC were also to increase, 
the food may then potentially be required to bear a disclosure 
statement. Further, the same levels of total fat, saturated fat, 
cholesterol, and sodium per RACC that trigger the need for a disclosure

[[Page 12016]]

statement on certain products bearing nutrient content claims, also 
disqualify certain foods from making any health claims (Sec.  
101.14(a)(4)). Therefore, an increase in a RACC with an accompanying 
increase in nutrient value per RACC could potentially disqualify that 
food from bearing a health claim. To bear a health claim, foods must 
also generally contain a minimum of 10 percent or more of the DV for 
one of the following nutrients: Vitamin A, vitamin C, iron, calcium, 
protein, or dietary fiber per RACC (Sec.  101.14(e)(6)). Changes to the 
RACCs could affect whether a food is able to meet this requirement. An 
increase in a RACC could cause a food to be able to meet the minimum 
nutrient content requirement, while a decrease in a RACC could cause a 
food to have decreased nutrient values per RACC and potentially lose 
its' ability to bear a health claim based on minimum nutrient content 
requirements.
    Although changes to the existing RACCs have the potential to impact 
individual foods' eligibility to bear nutrition claims, changes in the 
eligibility to bear claims may be appropriate in light of the changes 
in the amounts of food being customarily consumed. It is difficult to 
fully understand any potential impacts of changes to the RACCs on the 
eligibility to bear claims until such time that rulemaking for both 
serving sizes and updating the Nutrition Facts label are finalized. We 
are inviting comment on any concerns related to changes to current 
claims used on specific foods that will be affected if RACCs are 
finalized as proposed.
6. Request To Establish a New 25 g RACC for Candies Weighing 20 g or 
Less
    As discussed in section I.D.3.e., two trade associations 
representing chocolate and confectionary companies jointly submitted a 
citizen petition (the CMA/NCA petition) to FDA. The petitioners 
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.
    Because the national food consumption data (i.e., from the NHANES 
2003-2008 surveys) upon which we primarily rely to establish RACCs 
generally does not capture data for different sizes of candy products, 
we cannot establish a new candy product category with a RACC of 25 g 
for candies weighing 20 g or less per piece, as requested in the CMA/
NCA petition. NHANES is designed to provide total intake amounts per 
eating occasion for different types of products. If the total 
consumption amount of a chocolate candy bar was 100 g, we would not be 
able to discern whether this amount was derived from 1 large-size candy 
bar weighing 100 g, or from 10 mini-sized bars weighing 10 g each. 
Therefore, we do not have data to support basing the RACC on the weight 
of individual pieces of candy, as requested in the petition.

E. Establishing a New Serving Size for Breath Mints

    As discussed in section I.D.3.F., we received a petition from a 
breath mints manufacturer requesting that we create a separate product 
category with a 0.5 g RACC for small breath mints (weighing 0.5 g or 
less). The petitioner also specified that the serving size for small 
breath mints should be ``one mint.'' In response to this petition, we 
published the 1997 breath mints proposed rule (62 FR 67775), which 
would require that the label serving size of products included in the 
product category ``Hard candies, breath mints'' be one unit. However, 
we determined that it would not be appropriate to establish a separate 
0.5 g RACC for small breath mints because there was insufficient 
evidence for revising the current RACC of 2 g for breath mints. 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.
    Consumption of breath mints cannot be determined using NHANES 2003-
2008 consumption data, which provide the most recent national food 
consumption data available to us. This is because a specific category 
for breath mints does not exist in the FNDDS to process and analyze 
dietary intake data for the NHANES 2003-2008 surveys. Rather, breath 
mints are included as part of the large ``hard candy'' group (food code 
91745020), which contains approximately 50 items. However, the 
reasonable consumption amount for breath mints in the FNDDS database is 
2 g for one-piece breath mints. Further, based on the Mintel and 
Gladson databases (large commercial databases containing full product 
details on currently available product packages), we determined that 
the median estimate of the gram weight distribution of breath mints 
from these databases is 3 g and 2 g, respectively (Ref. 62). Therefore, 
we have determined that 2 g remains an appropriate RACC for the product 
category ``Hard candies, breath mints.''
    Although the 2 g RACC for ``Hard candies, breath mints'' remains 
reasonable, we share concerns about the apparent inappropriateness of 
the resulting serving sizes on the labels of small and very small 
breath mints when the 2 g RACC is used to determine the serving size 
(e.g., 5 small breath mints or 15 very small breath mints per serving). 
The data submitted to us through the citizen petition suggests that 
these products were designed to be consumed singly or in small numbers 
and that consumers do, in fact, customarily consume such amounts 
(Docket No. FDA-1994-P-0314, formerly Docket No 94P-0168). Requiring 
the serving size on the label of all breath mints to be declared as one 
mint (or one unit) would more accurately reflect the amount customarily 
consumed across a wide variety of breath mint sizes that are 
commercially available.
    Therefore, using a label statement of one unit for the serving size 
of all breath mints is more appropriate than declaring the serving size 
in terms of the number of mints closest to the 2 g RACC, because the 
RACC of 2 g for all breath mint products does not specifically 
represent the amount customarily consumed per eating occasion for small 
breath mints and very small breath mints. This action would allow for 
efficient enforcement of the FD&C Act by maintaining one subcategory in 
table 2 of Sec.  101.12(b) for all breath mints, while requiring the 
label statement for the serving size to accurately reflect the amount 
customarily consumed. Thus, we are proposing to amend footnote 9 (which 
we are proposing to redesignate as footnote 8 in this rule) of table 2 
in Sec.  101.12(b) to state that ``Label serving size for ice cream 
cones, eggs, and breath mints of all sizes will be 1 unit . . .'' while 
keeping 2 g as the reference amount for the product category ``Hard 
candies, breath mints.''

F. Comparison of Calories in Foods of Different Portion Sizes

    As noted in the ``Calories Count'' report (Ref. 1), the Federal 
Trade Commission has suggested that we consider ``allowing food 
marketers to make truthful, non-misleading label claims comparing foods 
of different portion sizes.'' An example of this type of claim would 
be: ``This 4 ounce container of yogurt has 25 percent less calories 
than our 6 ounce container of yogurt.''
    In the ANPRM, we invited comment on whether it would be confusing 
to consumers to have claims made only on the basis of the difference in 
the amount

[[Page 12017]]

of calories in two different labeled serving sizes (i.e., the serving 
size specified in two different Nutrition Facts labels (e.g., an 8 fl 
oz can of soda versus a 12 fl oz can of soda) or two different portions 
(i.e., amounts specified by the claim, e.g., one 15 g cookie versus two 
15 g cookies) of the same food. We also invited comment on other 
questions related to this issue, but we received no comments on these 
other issues.
    Several comments indicated that we should not allow comparison of 
calories to be made among foods of different portion sizes as this 
would increase confusion. Some comments suggested that we increase 
consumer education on serving sizes instead. Other comments noted that 
basing differences in calories on two different label servings or two 
different portions would be confusing to consumers and serve no 
constructive purpose. One comment noted that calorie claims would 
probably be confusing to consumers on bulk-type packages, where 
consumers portion out their own serving. However, this comment noted 
that if claims were made on single-serving containers, where portion 
size is determined by the manufacturer, they could be less confusing 
and more helpful to consumers. The comment stated that calorie 
differences between choosing an 8 fl oz can of soda versus a 12 fl oz 
can of soda could be more apparent to consumers if comparison claims 
were allowed.
    We agree with the comments that stated consumer education on 
serving sizes should be increased. We consider it appropriate to 
provide consumers with education and outreach on serving size issues 
and will consider appropriate education methods after publication of 
this proposed rule. At this time, we do not see the need to propose 
specific regulations for the use of calorie comparison claims, because 
our current regulations do not expressly prohibit such claims. In fact, 
Sec.  101.13(i) allows for the use of quantitative nutrient content 
claims that allow for statements about the amount or percentage of a 
nutrient. We also note that 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. As such, we would look at any calorie comparison 
claims on a case-by-case basis to determine if they were false or 
misleading as used in the particular labeling.

G. Technical Amendments

1. Rounding Rules for Products That Have More Than Five Servings and 
the Number of Servings Falls Exactly Between Two Values
    Section 101.9(b)(8)(i) does not state how to round the number of 
servings for products that contain five or more servings when the 
number of servings falls exactly between two values. To provide clarity 
to manufacturers whose products have a number of servings that falls 
exactly between two values and is greater than five, proposed Sec.  
101.9(b)(8)(i) would add that ``For containers that contain greater 
than 5 servings, if the number of servings determined from the 
procedures provided in this section falls exactly halfway between two 
allowable declarations, the manufacturer must round the number of 
servings up to the nearest incremental size.''
2. Options for When the Number of Servings per Container Varies
    Section 101.9(b)(8)(iii) states that, for random weight products, a 
manufacturer may declare ``varied'' for the number of servings per 
container provided the nutrition information is based on the reference 
amount expressed in ounces. In addition, the manufacturer may provide 
the typical number of servings in parenthesis following the ``varied'' 
statement, e.g., ``varied (about 6 servings).'' We intended that the 
term ``random weight product'' refer to products such as certain 
cheeses that are sold as random weights that vary in size, such that 
the net contents for different packages would vary (56 FR 60394 at 
60412). The serving size for this type of product would be declared on 
the label as the number of ounces closest to the RACC for the product 
category with an accompanying visual unit of measure (Sec.  
101.9(b)(5)(iii) (e.g., ``1 oz (28 g/1-inch cube) for bulk cheese)).''
    We have identified several difficulties with Sec.  101.9(b)(8)(iii) 
because: (1) There is no clear definition for which specific products 
are included in the designation of ``random weight products;'' (2) the 
requirement that nutrition information be based on the RACC expressed 
in ounces is confusing because, although serving sizes may be declared 
in ounces under certain occasions, none of the RACCs are expressed in 
ounces; (3) the ounce declaration is the last option in the hierarchy 
of household measures for expressing the serving size (Sec.  
101.9(b)(5)(i), (b)(5)(ii), and (b)(5)(iii)); and (4) it would not 
necessarily be appropriate for all random weight products to list the 
serving size in ounces. For example, for a random-weight, multi-serving 
package of cooked shrimp or crabs, it would be more appropriate to 
declare the serving size as ``---- shrimp (---- g)'' or ``1 crab (---- 
g),'' and the number of servings would vary depending on the amount of 
shrimp or number of crabs in the package.
    To resolve these difficulties, we propose to amend Sec.  
101.9(b)(8)(iii) to: (1) Define ``random-weight products;'' and (2) 
eliminate the wording that specifies that the nutrition information is 
based on the reference amount expressed in ounces. The proposed rule 
would define random weight products as ``foods such as cheeses that are 
sold as random weights that vary in size, such that the net contents 
for different containers would vary.''
3. Minor Corrections to General and Product Category Names
    We propose to make minor changes to the names of certain general 
categories and product categories to clarify the products contained in 
the category, and to correct minor errors in these categories. The 
proposed rule would:
     Change the name of the general category ``Egg and Egg 
Sustitutes'' to ``Egg and Egg Substitutes'' to correct the error in the 
current spelling;
     Change the general category name ``Miscellaneous 
Category'' to ``Miscellaneous'' to be consistent with the manner in 
which the other general category names are titled;
     In the general category of ``Sauces, Dips, Gravies, and 
Condiments,'' add ``tomato chili sauce'' to the product category name 
``Barbeque sauce, hollandaise sauce, tartar sauce, other sauces for 
dipping (e.g., mustard sauce, sweet and sour sauce), all dips (e.g., 
bean dips, dairy-based dips, salsa).'' Tomato chili sauce was included 
in the initial data analysis for this category, but was accidentally 
omitted from the category name in the codified text of the 1993 serving 
size rule. The modified product category would help clarify that 
although hot chili sauce belongs with hot sauces in the ``Minor 
condiments, e.g., hot sauce . . .'' category, tomato chili belongs in 
the ``Barbecue sauce, . . . tomato chili sauce . . .'' category;
     Also in the general category of ``Sauces, Dips, Gravies, 
and Condiments,'' correct an error in the product category name ``Minor 
condiments, e.g., horseradish, hot sauces, mustards, worcestershire 
sauce.'' The new product category name would be ``Minor condiments, 
e.g., horseradish, hot sauces, mustards, Worcestershire sauce.'' 
``Worcestershire'' should be capitalized

[[Page 12018]]

in the category name and is currently listed in lower case;
     In the general category of ``Snacks,'' correct three 
errors in the product category name ``All varieties, chips, pretzels, 
popcorns, extruded snacks, fruit-based snacks (e.g., fruit chips,) 
grain-based snack mixes.'' First, there is a comma listed in the 
parenthesis as follows ``(fruit chips,)'' that should be listed outside 
of the parenthesis as follows ``(fruit chips),''. Second, the product 
category name ``Fruit-based snacks'' should be changed to ``fruit and/
or vegetable-based snacks'', since these products can be made from 
fruits and/or vegetables. Finally, the word ``popcorns'' should be 
corrected to be written as ``popcorn'';
     In the general category of ``Vegetables,'' clarify the 
products that are encompassed in the product category ``Pickles, all 
types'' by renaming the product category to read as ``Pickles and 
pickled vegetables, all types.'' The current product category of 
``Pickles, all types'' includes all types of pickled vegetables. This 
minor change will clarify this fact and should help manufacturers more 
easily locate the appropriate product category for these types of 
products;
     Also in the general category of ``Vegetables,'' clarify 
that parsley (an example of an herb used for garnish or flavor) can be 
in fresh or dried form in the product category ``Vegetables primarily 
used for garnish or flavor, e.g., pimento, parsley.'' The new product 
category name would be ``Vegetables primarily used for garnish or 
flavor, (e.g., pimento, parsley, fresh or dried);'' and
     Change the product category ``Toaster pastries--see coffee 
cakes'' to ``Toaster pastries--see bagels, toaster pastries, muffins 
(excluding English muffins)'' because we have proposed to move toaster 
pastries to a new product category labeled ``Bagels, toaster pastries, 
muffins (excluding English muffins).''
4. Minor Changes to Footnotes
    We are aware of several areas of minor confusion in the footnotes 
to the RACC tables. Therefore, to reduce misunderstanding, we propose 
the following minor changes to the footnotes:
     As discussed in section I.D.2 in this proposed rule, both 
the 1991 serving size proposed rule and the 1993 serving size final 
rule provided an extensive list of products for each product category 
that manufacturers could use to determine the RACC for their specific 
product. Because we intend to update the list of products for each 
product category and make it available as guidance on our Web site, we 
are proposing to remove footnote 4 from both tables in Sec.  101.12(b). 
We are also proposing to renumber the footnotes in each table to 
reflect the removal of footnote 4.
     Footnote 5 in tables 1 and 2 states that ``[t]he label 
statements are meant to provide guidance to manufacturers on the 
presentation of serving size information on the label, but they are not 
required.'' Several manufacturers have interpreted this language 
incorrectly to mean that the label statements are not required. Because 
label statements do not necessarily have to use the exact wording 
provided, but must contain a presentation of the serving size, the 
proposed rule would correct footnote 5 (proposed footnote 4) to state 
that label statements are meant to provide examples of serving size 
statements that may be used on the label, but that the specific wording 
may be changed as appropriate for individual products.
     Footnote 11 in Table 2 refers to products that are packed 
or canned in liquid where the RACC refers to the drained solids. The 
footnote is included as part of the declaration for ``Fruits for 
garnish or flavor, e.g., maraschino cherries.\11\ '' The footnote was 
inadvertently omitted from the declaration for the current product 
category ``Vegetables primarily used for garnish or flavor, e.g., 
pimento, parsley,'' and the proposed rule would add the footnote 
(proposed Footnote 10) as a superscript to the word ``pimento.''
     Footnote 13 in Table 2 refers the reader to a Federal 
Register document for label statements for serving sizes for raw fruit, 
vegetables, and fish. Because it is more appropriate to direct the 
reader to the appendices of the Code of Federal Regulations, we are 
proposing to amend footnote 13 (proposed footnote 12) to refer the 
reader to the appendices of the Code of Federal Regulations.
5. Minor Changes to Table 1 in 21 CFR 101.12(b)
     Change the title of Table 1 from ``Reference Amounts 
Customarily Consumed Per Eating Occasion: Infant and Toddler Foods'' to 
``Reference Amounts Customarily Consumed Per Eating Occasion: Foods for 
Infants and Children 1 through 3 years of age.''
     Change the product category name ``Dinners, stews or soups 
for toddlers, ready-to-serve'' to ``Dinners, stews or soups for young 
children, ready-to-serve.''
     Change the product category name ``Fruits for toddlers, 
ready-to-serve'' to ``Fruits for young children, ready-to-serve.''
     Change the product category name ``Vegetables for 
toddlers, ready-to-serve'' to ``Vegetables for young children, ready-
to-serve.''
6. Minor Changes to Table 2 in 21 CFR 101.12(b)
     Add ``---- pieces (---- g)'' to the label statement for 
the ``Fruits for garnish or flavor, e.g., maraschino cherries'' to 
provide for other fruits besides cherries that can be used as a garnish 
or for flavor.
     Amend the RACC for the ``French fries, hash browns, skins 
or pancakes'' product category to: ``70 g prepared; 85 g for frozen 
unprepared French fries''. This amendment is necessary to capitalize 
the ``f'' in ``french fries.''
     Amend the product category name ``Bean cake (tofu), 
tempeh'' to ``Tofu, tempeh.''
7. Reference Amounts for Products That Require Further Preparation
    Section 101.12(c)(2) states that: ``For products where the entire 
contents of the package is used to prepare one large discrete unit 
usually divided for consumption, the reference amount for the 
unprepared product shall be the amount of the unprepared product 
required to make the fraction of the large discrete unit closest to the 
reference amount for the prepared product as established in paragraph 
(b) of this section.''
    This provision allows the RACC to vary based on how the product is 
packaged. Although the serving size routinely varies depending upon the 
size of the product and how the product is packaged, the RACC, which is 
the basis for claims, should not vary. Therefore, the proposed rule 
would change the definition of the reference amount for products that 
require further preparation in which the entire contents of the package 
are used to prepare one large discrete unit usually divided for 
consumption. Proposed Sec.  101.12(c) would state that if a product 
requires further preparation, e.g., cooking or the addition of water or 
other ingredients, and if paragraph (b) of this section provides a 
reference amount for the product in the prepared form, but not the 
unprepared form, then the reference amount for the unprepared product 
must be the amount of the unprepared product required to make the 
reference amount for the prepared product as established in paragraph 
(b) of this section. The serving size would remain the same as 
described in Sec.  101.9(b)(2)(ii).

[[Page 12019]]

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
    Section 101.12(f) establishes the approach for determining the 
reference amount for combined products consisting of two or more 
separate foods, packaged together and intended to be eaten together, 
that have no established reference amount in the tables for the 
combined product. For combined products not in discrete units (e.g., 
peanut butter and jelly), the reference amount for the combined product 
is the reference amount for the ingredient that is represented as the 
main food (e.g., peanut butter) plus a proportioned amount of all minor 
ingredients of foods (e.g., jelly) (Sec.  101.12(f)(1)). For combined 
products where the main ingredient is in discrete units (e.g., pancakes 
and syrup, cake packaged together with frosting), the reference amount 
for the combined product is either the number of small discrete units 
(e.g., pancakes) or the fraction of the large discrete unit (e.g., 
cake) that is represented as the main ingredient that is closest to the 
reference amount for that ingredient plus proportioned amounts of all 
minor ingredients (e.g., syrup, frosting) (Sec.  101.12(f)(2)).
    Although the serving size for this type of product varies depending 
on the size of the product or how the product is packaged, the RACC, 
which is the basis for claims, should not vary. Section 101.12(f) 
allows the RACCs to vary based on the size of the discrete units. For 
example, for combined products with the main ingredient in discrete 
units (e.g., pancakes packaged with syrup where pancakes are the main 
ingredient), the current regulation requires that the RACC for the 
combined product be based on the weight of the discrete units (e.g., 
the weight of the pancakes) which varies, rather than on the reference 
amount for pancakes, which does not vary.
    Therefore, the proposed rule would change the definition of the 
RACC for this type of product in proposed Sec.  101.12(f) so that it 
will not affect the serving size declaration on the label. The proposed 
rule would state that the reference amount for the combined products 
must be the reference amount, as established in paragraph (b) of this 
section, for the ingredient that is represented as the main ingredient 
(e.g., peanut butter, pancakes, cakes) plus proportioned amounts of all 
minor ingredients. The serving size would remain the number of discrete 
units (e.g., pancakes) or the fraction of a large discrete unit (e.g., 
cake) plus the proportioned minor ingredients closest to the RACC of 
the combined product.
9. Reference Amounts for Varieties or Assortments of Foods in Gift 
Packages That Have No Appropriate Reference Amount
    Section 101.9(h)(3)(ii) establishes the procedure for determining 
the serving size for varieties or assortments of foods in gift packages 
where there is no appropriate reference amount. The current language in 
Sec.  101.9(h)(3)(ii) states that 8 fluid ounces may be used as the 
standard serving size for beverage varieties or assortments in gift 
packages. We are proposing conforming amendments to this section to 
state that 12 fluid ounces should be used as the standard serving size 
for beverages, except that the standard serving size for milk, fruit 
juices, nectars and fruit drinks will be based on 8 fluid ounces. This 
change is consistent with the changes to the RACCs discussed in section 
II.D.2 of this rule. We are proposing to change the RACCs for the 
``Carbonated and noncarbonated beverages, wine coolers, water'' and 
``Coffee or tea flavored and sweetened'' product categories to 360 mL 
(or 12 fluid ounces). We are not proposing to change the RACC for milk, 
fruit juices, nectars, fruit drinks, and vegetable juices, which 
currently have RACCs of 240 mL or (8 fluid ounces).

III. Proposed Effective and Compliance Dates

    We intend that any final rule resulting from this rulemaking, as 
well as any final rule resulting from the proposed rule entitled ``Food 
Labeling: Revision of the Nutrition and Supplement Facts Labels'' 
become effective 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. We recognize that it may take industry time to analyze 
products for which there may be new mandatory nutrient declarations, 
make any required changes to the Nutrition Facts label (which may be 
coordinated with other planned label changes), review and update their 
records of product labels and print new labels. A compliance date that 
is 2 years after the effective date is intended to provide industry 
time to revise labeling to come into compliance with the new labeling 
requirements. We invite comment on the proposed compliance date.

IV. Environmental Impact

    We have determined under 21 CFR 25.30(i) and (k) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

V. Analysis of Impacts

    We have examined the impacts of this proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), and the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520).
    Executive Orders 12866 and 13563 direct us to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). We are 
publishing two proposed rules on nutrition labeling in the Federal 
Register. We have developed one comprehensive Preliminary Regulatory 
Impact Analysis (PRIA) (Ref. 63) that presents the benefits and costs 
of the two proposed nutrition labeling rules taken together; the PRIA 
is available at http://www.regulations.gov (Docket No. FDA-2004-N-
0258). The full economic impact analyses of FDA regulations are no 
longer (as of April 2012) published in the Federal Register but are 
submitted to the docket and are available on this site. We believe that 
the cumulative impact of the proposed rules on nutrition labeling, 
taken as a whole, represents a significant regulatory action as defined 
by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Additional costs per entity of the proposed rule are small, 
but not negligible, and as a result we conclude that the proposed rules 
on nutrition labeling, taken as a whole, would have a significant 
economic impact. Section 202(a) of the Unfunded Mandates Reform Act of 
1995 requires that we prepare a written statement, which includes an 
assessment of anticipated costs and benefits, before proposing ``any 
rule that includes any Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more

[[Page 12020]]

(adjusted annually for inflation) in any one year.'' The current 
threshold after adjustment for inflation is $141 million, using the 
most current (2012) Implicit Price Deflator for the Gross Domestic 
Product. We have determined that the proposed rules on nutrition 
labeling, taken as a whole, meet this threshold.
    The analyses that we have performed to examine the impacts of the 
proposed rules under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the PRA (see Section V.) are included 
in the PRIA and are available at http://www.regulations.gov (Docket No. 
FDA-2004-N-0258). We invite comments on the PRIA.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the PRA. A description of these provisions is given in the PRIA 
available at http://www.regulations.gov (Docket No. FDA-2004-N-0258) 
with an estimate of the annual third-party disclosure burden. Included 
in the burden estimate is the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing each collection of information.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to [email protected]. All comments should be 
identified with the title ``Third-Party Disclosure Requirements for 
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.''
    In compliance with the PRA, we have submitted the information 
collection provisions of this proposed rule to OMB for review. These 
requirements will not be effective until we obtain OMB approval. We 
will publish a notice concerning OMB approval of these requirements in 
the Federal Register.

VII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express 
preemption provision. Section 403A(a) of the FD&C Act provides that: 
``. . . no State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect as to 
any food in interstate commerce--(4) any requirement for nutrition 
labeling of food that is not identical to the requirement of section 
403(q) . . . .''
    The express preemption provision of section 403A(a) of the FD&C Act 
does not preempt any State or local requirement respecting a statement 
in the labeling of food that provides for a warning concerning the 
safety of the food or component of the food (section 6(c)(2) of the 
Nutrition Labeling and Education Act of 1990, Public Law 101-535, 104 
Stat. 2353, 2364 (1990)).
    If this proposed rule is made final, the final rule would create 
requirements that fall within the scope of section 403A(a) of the FD&C 
Act.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. References

    We have placed the following references on display in FDA's 
Division of Dockets Management (see ADDRESSES). The references may be 
seen between 9 a.m. and 4 p.m., Monday through Friday. (We have 
verified all the Web site addresses in the References section, but we 
are not responsible for any subsequent changes to the Web sites after 
this document publishes in the Federal Register.)

1. Report of the Working Group on Obesity, ``Calories Count,'' March 
12, 2004.
2. Lando, A. M., J. Labiner-Wolfe. ``Helping Consumers Make More 
Healthful Food Choices: Consumer Views on Modifying Food Labels and 
Providing Point-of-Purchase Nutrition Information at Quick-Service 
Restaurants,'' Journal of Nutrition Education and Behavior, 39:157-
63, 2007.
3. U.S. Department of Health and Human Services, National Institutes 
of Health, National Heart Lung and Blood Institute, ``Portion 
Distortion! Do You Know How Food Portions Have Changed in 20 
Years?'' http://www.nhlbi.nih.gov/health/public/heart/obesity/wecan/portion/index.htm 2004.
4. Young, L. R., M. Nestle. ``Expanding Portion Sizes in the US 
Marketplace: Implications for Nutrition Counseling,'' Journal of the 
American Dietetic Association, 103:231-4, 2003.
5. Smiciklas-Wright, H., D. Mitchell, S. Mickle, J. Goldman, A. 
Cook. ``Foods Commonly Eaten in the United States, 1989-1991 and 
1994-1996: Are Portion Sizes Changing?,'' Journal of the American 
Dietetic Association, 103:41-7, 2003.
6. Nielsen, S., B. Popkin. ``Patterns and trends in food portion 
sizes, 1977-1998,'' The Journal of the American Medical Association, 
289:450-3, 2003.
7. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, 
Washington, DC: U.S. Government Printing Office, December 2010. 
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[[Page 12022]]

to Federal Food Labeling Requirements for Meats and Poultry 
Products,'' 2007. http://www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.
60. Saltsman, J. J., FDA, Letter to Kenneth C. Mercurio, Nestle USA 
Inc., August 11, 1993.
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February 11, 2014.
63. U.S. Food and Drug Administration. ``Preliminary Regulatory 
Impact Analysis (PRIA) for the Food Labeling: Revision of the 
Nutrition and Supplement Facts Labels Proposed Rule (Docket No. FDA-
2012-N-1210) and 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 (Docket No. FDA-2004-N-0258)'', 2014.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.9 is amended as follows:
0
a. Revise paragraph (b)(2)(i)(D);
0
b. Remove paragraph (b)(2)(i)(E) and redesignate paragraphs 
(b)(2)(i)(F) through (b)(2)(i)(I), respectively, as paragraphs 
(b)(2)(i)(E) through (b)(2)(i)(H), respectively;
0
c. Revise paragraphs (b)(6), (b)(8)(i), and (b)(8)(iii);
0
d. Add paragraph (b)(12).
0
e. Revise paragraph (h)(3)(ii)
    The revisions read as follows:


Sec.  101.9  Nutrition labeling of food.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (D) If a unit weighs at least 200 percent and up to and including 
400 percent of the applicable reference amount, the manufacturer must 
provide an additional column within the Nutrition Facts label that 
lists the quantitative amounts and percent Daily Values for the 
individual unit, as well as the preexisting columns listing the 
quantitative amounts and percent Daily Values for a serving that is 
less than the unit (i.e., the serving size derived from the Reference 
Amount Customarily Consumed (RACC)). The first column would be based on 
the serving size for the product and the second column would be based 
on the individual unit. The exemptions in paragraphs (b)(12)(i)(A), 
(b)(12)(i)(B), and (b)(12)(i)(C) of this section apply to this 
provision.
* * * * *
    (6) A product that is packaged and sold individually and contains 
less than 200 percent of the applicable reference amount must be 
considered to be a single-serving container, and the entire content of 
the product must be labeled as one serving.
* * * * *
    (8) * * *
    (i) The number of servings must be rounded to the nearest whole 
number except for the number of servings between 2 and 5 servings and 
random weight products. The number of servings between 2 and 5 servings 
must be rounded to the nearest 0.5 serving. Rounding should be 
indicated by the use of the term about (e.g., about 2 servings, about 
3.5 servings). For containers that contain greater than 5 servings, if 
the number of servings determined from the procedures provided in this 
section falls exactly halfway between two allowable declarations, the 
manufacturer must round the number of servings up to the nearest 
incremental size.
* * * * *
    (iii) For random weight products, manufacturers may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the reference amount expressed in the 
appropriate household measure based on the hierarchy described in 
paragraph (b)(5) of this section. Random weight products are foods such 
as cheeses that are sold as random weights that vary in size, such that 
the net contents for different containers would vary. The manufacturer 
may provide the typical number of servings in parenthesis following the 
``varied'' statement.
* * * * *
    (12)(i) Products that are packaged and sold individually and 
contain at least 200 percent and up to and including 400 percent of the 
applicable reference amount must provide an additional column within 
the Nutrition Facts label that lists the quantitative amounts and 
percent Daily Values for the entire container, as well as the 
preexisting columns listing the quantitative amounts and percent Daily 
Values for a serving that is less than the entire container (i.e., the 
serving size derived from the reference amount). The first column would 
be based on the serving size for the product and the second column 
would be based on the entire contents of the container.
    (A) This provision does not apply to products that meet the 
requirements to use the tabular format in paragraph (j)(13)(ii)(A)(1) 
of this section or to products that meet the requirements to use the 
linear format in paragraph (j)(13)(ii)(A)(2) of this section.
    (B) This provision does not apply to 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.
    (C) This provision does not apply to products that require further 
preparation and provide an additional column of nutrition information 
under paragraph (e) of this section, or products that are commonly 
consumed in combination with another food and provide an additional 
column of nutrition information under paragraph (e) of this section.
    (ii) When a nutrient content claim or health claim is made on the 
label of a product that uses a dual column as required in paragraphs 
(b)(12)(i) and (b)(2)(i)(D) of this section, the claim must 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 
(e.g., ``good source of calcium'' ``a serving of ---- oz of this 
product contains ---- mg of calcium'' or for a health claim ``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) of this chapter. 
This statement is not required for products when the nutrient that is 
the subject of the claim meets the criteria based on the entire 
container amount or the unit amount, as applicable.
* * * * *
    (h) * * *
    (3) * * *

[[Page 12023]]

    (ii) In the absence of a reference amount customarily consumed in 
Sec.  101.12(b) that is appropriate for the variety or assortment of 
foods in a gift package, 1 ounce for solid foods, 2 fluid ounces for 
nonbeverage liquids (e.g., syrups), and 12 fluid ounces for beverages, 
except that milk and fruit juices, nectars and fruit drinks, which will 
be based on 8 fluid ounces, may be used as the standard serving size 
for purposes of nutrition labeling of foods subject to this paragraph. 
However, the reference amounts customarily consumed in Sec.  101.12(b) 
shall be used for purposes of evaluating whether individual foods in a 
gift package qualify for nutrient content claims or health claims.
* * * * *
0
3. Section 101.12 is amended as follows:
0
a. In paragraph (b), revise tables 1 and 2.
0
b. Revise paragraphs (c) and (f)(1), remove paragraph (f)(2), 
redesignate paragraph (f)(3) as paragraph (f)(2), and revise newly 
redesignated paragraph (f)(2).
    The revisions read as follows:


Sec.  101.12  Reference amounts customarily consumed per eating 
occasion.

* * * * *
    (b) * * *

  Table 1--Reference Amounts Customarily Consumed per Eating Occasion:
       Foods for Infants and Children 1 Through 3 Years of Age 2 3
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference Amount           \4\
------------------------------------------------------------------------
Cereals, dry instant............  15 g..............  ---- cup (---- g).
Cereals, prepared, ready-to-      110 g.............  ---- cup(s) (----
 serve.                                                g).
Other cereal and grain products,  7g for infants and  ---- cup(s) (----
 dry ready-to-eat, e.g., ready-    20 g for young      g) for ready-to-
 to-eat cereals, cookies,          children (1         eat cereals; ----
 teething biscuits, and toasts.    through 3 years     piece(s) (---- g)
                                   of age) for ready-  for others.
                                   to-eat cereals; 7
                                   g for all others.
Dinners, deserts, fruits,         15 g..............  ---- tbsp(s) (----
 vegetables or soups, dry mix.                         g); ---- cup(s)
                                                       (---- g).
Dinners, desserts, fruits,        110 g.............  ---- cup(s) (----
 vegetables or soups, ready-to-                        g); cup(s) (----
 serve, junior type.                                   mL).
Dinners, desserts, fruits,        110 g.............  ---- cup(s) (----
 vegetables or soups, ready-to-                        g); cup(s) (mL).
 serve, strained type.
Dinners, stews or soups for       170g..............  ---- cup(s) (----
 young children, ready-to-serve.                       g); cup(s) (----
                                                       mL).
Fruits for young children, ready- 125 g.............  ---- cup(s) (----
 to-serve.                                             g).
Vegetables for young children,    70 g..............  ---- cup(s) (----
 ready-to-serve.                                       g).
Eggs/egg yolks, ready-to serve..  55 g..............  ---- cup(s) (----
                                                       g).
Juices, all varieties...........  120 mL............  4 fl oz (120 mL).
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were derived primarily from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture and updated with data from the National
  Health and Nutrition Examination Survey, 2003-2004, 2005-2006, and
  2007-2008 conducted by the Centers for Disease Control and Prevention,
  in the U.S. Department of Health and Human Services.
\2\ Unless otherwise noted in the Reference Amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes; concentrates; dough; batter; fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. The term ``piece''
  is used as a generic description of a discrete unit. Manufacturers
  should use the description of a unit that is most appropriate for the
  specific product (e.g., sandwich for sandwiches, cookie for cookies,
  and bar for frozen novelties).


  Table 2--Reference Amounts Customarily Consumed per Eating Occasion:
                        General Food Supply 1 2 3
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Bakery Products:
    Bagels, toaster pastries,     110 g.............  ---- piece(s) (----
     muffins (excluding English                         g).
     muffins).
    Biscuits, croissants,         55 g..............  ---- piece(s) (----
     tortillas, soft bread                              g).
     sticks, soft pretzels, corn
     bread, hush puppies,
     scones, crumpets, English
     muffins.
    Breads (excluding sweet       50 g..............  ---- piece(s) (----
     quick type), rolls.                                g) for sliced
                                                       bread and
                                                       distinct pieces
                                                       (e.g., rolls); 2
                                                       oz (56 g/----
                                                       inch slice) for
                                                       unsliced bread.
    Bread sticks--see crackers.                       ..................
    Toaster pastries--see                             ..................
     bagels, toaster pastries,
     muffins (excluding English
     muffins).
    Brownies....................  40 g..............  ---- piece(s) (----
                                                        g) for distinct
                                                       pieces;
                                                       fractional slice
                                                       (---- g) for
                                                       bulk.
    Cakes, heavy weight (cheese   125 g.............  ---- piece(s) (----
     cake; pineapple upside-down                        g) for distinct
     cake; fruit, nut and                              pieces (e.g.,
     vegetable cakes with more                         sliced or
     than or equal to 35 percent                       individually
     of the finished weight as                         packaged
     fruit, nuts, or vegetables                        products); ----
     or any of these                                   fractional slice
     combinations) \ 5\.                               (---- g) for
                                                       large discrete
                                                       units.

[[Page 12024]]

 
    Cakes, medium weight          80 g..............  ---- piece(s) (----
     (chemically leavened cake                          g) for distinct
     with or without icing or                          pieces (e.g.,
     filling except those                              cupcake); ----
     classified as light weight                        fractional slice
     cake; fruit, nut, and                             (---- g) for
     vegetable cake with less                          large discrete
     than 35 percent of the                            units.
     finished weight as fruit,
     nuts, or vegetables or any
     of these combinations;
     light weight cake with
     icing; Boston cream pie;
     cupcake; eclair; cream
     puff) \6\.
    Cakes, light weight (angel    55 g..............  ---- piece(s) (----
     food, chiffon, or sponge                           g) for distinct
     cake without icing or                             pieces (e.g.,
     filling) \7\.                                     sliced or
                                                       individually
                                                       packaged
                                                       products); ----
                                                       fractional slice
                                                       (---- g) for
                                                       large discrete
                                                       units.
    Coffee cakes, crumb cakes,    55 g..............  ---- piece(s) (----
     doughnuts, Danish, sweet                           g) for sliced
     rolls, sweet quick type                           bread and
     breads.                                           distinct pieces
                                                       (e.g., doughnut);
                                                       2 oz (56 g/visual
                                                       unit of measure)
                                                       for bulk products
                                                       (e.g., unsliced
                                                       bread).
    Cookies.....................  30 g..............  ---- piece(s) (----
                                                        g).
    Crackers that are usually     15 g..............  ---- piece(s) (--
     not used as snack; melba                          g).
     toast, hard bread sticks,
     ice cream cones \8\.
    Crackers that are usually     30 g..............  ---- piece(s) (----
     used as snacks.                                    g).
    Croutons....................  7 g...............  ---- tbsp(s) (----
                                                       g); ---- cup(s)
                                                       (---- g); ----
                                                       piece(s) (---- g)
                                                       for large pieces.
    Eggroll, dumpling, wonton,    20 g..............  ---- sheet ( g);
     or potsticker wrappers.                           wrapper ( g).
    French toast, crepes,         110 g prepared for  ---- piece(s) (----
     pancakes, variety mixes.      French toast,        g); ---- cup(s)
                                   crepes, and         (---- g) for dry
                                   pancakes; 40 g      mix.
                                   dry mix for
                                   variety mixes.
    Grain-based bars with or      40 g..............  ---- piece(s) (----
     without filling or coating,                        g).
     e.g., breakfast bars,
     granola bars, rice cereal
     bars.
    Ice cream cones--see                              ..................
     crackers.
    Pies, cobblers, fruit         125 g.............  ---- piece(s) (----
     crisps, turnovers, other                           g) for distinct
     pastries.                                         pieces; ----
                                                       fractional slice
                                                       (---- g) for
                                                       large discrete
                                                       units.
    Pie crust, pie shells,        the allowable       ---- fractional
     pastry sheets, (e.g.,         declaration         slice(s) (---- g)
     phyllo, puff pastry sheets).  closest to an 8     for large
                                   square inch         discrete units; --
                                   surface area.       -- shells (----
                                                       g); ----
                                                       fractional ----
                                                       sheet(s) (---- g)
                                                       for distinct
                                                       pieces (e.g.,
                                                       Pastry sheet).
    Pizza crust.................  55 g..............  ---- fractional
                                                       slice (---- g).
    Taco shells, hard...........  30 g..............  ---- shell(s) (----
                                                        g).
    Waffles.....................  85 g..............  ---- piece(s) (----
                                                        g).
Beverages:
    Carbonated and noncarbonated  360 mL............  12 fl oz (360 mL).
     beverages, wine coolers,
     water.
    Coffee or tea, flavored and   360 mL prepared...  12 fl oz (360 mL).
     sweetened.
Cereals and Other Grain
 Products:
    Breakfast cereals (hot        1 cup prepared; 40  ---- cup(s) (----
     cereal type), hominy grits.   g plain dry         g).
                                   cereal; 55 g
                                   flavored,
                                   sweetened cereal.
    Breakfast cereals, ready-to-  15 g..............  ---- cup(s) (----
     eat, weighing less than 20                        g).
     g per cup, e.g., plain
     puffed cereal grains.
    Breakfast cereals, ready-to-  30 g..............  ---- cup(s) (----
     eat, weighing 20 g or more                        g).
     but less than 43 g per cup;
     high fiber cereals
     containing 28 g or more of
     fiber per 100 g.
    Breakfast cereals, ready-to-  55 g..............  ---- piece(s) (----
     eat, weighing 43 g or more                         g) for large
     per cup; biscuit types.                           distinct pieces
                                                       (e.g., biscuit
                                                       type);---- cup(s)
                                                       (---- g) for all
                                                       others.
    Bran or wheat germ..........  15 g..............  ---- tbsp(s) (----
                                                       g); ---- cup(s)
                                                       (---- g).
    Flours or cornmeal..........  30 g..............  ---- tbsp(s) (----
                                                       g); ---- cup(s)
                                                       (---- g).
    Grains, e.g., rice, barley,   140 g prepared; 45  ---- cup(s) (----
     plain.                        g dry.              g).
    Pastas, plain...............  140 g prepared; 55  ---- cup(s) (----
                                   g dry.              g); ---- piece(s)
                                                       (---- g) for
                                                       large pieces
                                                       (e.g., large
                                                       shells or lasagna
                                                       noodles) or 2 oz
                                                       (56 g/visual unit
                                                       of measure) for
                                                       dry bulk products
                                                       (e.g.,
                                                       spaghetti).
Pastas, dry, ready-to-eat, e.g.,  25 g..............  ---- cup(s) (----
 fried canned chow mein noodles.                       g).
Starches, e.g., cornstarch,       10 g..............  ---- tbsp (----
 potato starch, tapioca, etc.                          g).
Stuffing........................  100 g.............  ---- cup(s) (----
                                                       g).
Dairy Products and Substitutes:
Cheese, cottage.................  110 g.............  ---- cup (---- g).

[[Page 12025]]

 
    Cheese used primarily as      55 g..............  ---- cup (---- g).
     ingredients, e.g., dry
     cottage cheese, ricotta
     cheese.
    Cheese, grated hard, e.g.,    5 g...............  ---- tbsp (----
     Parmesan, Romano.                                 g).
    Cheese, all others except     30 g..............  ---- piece(s) (----
     those listed as separate                           g) for distinct
     categories--includes cream                        pieces;----
     cheese and cheese spread.                         tbsp(s) (---- g)
                                                       for cream cheese
                                                       and cheese
                                                       spread; 1 oz (28
                                                       g/visual unit of
                                                       measure) for
                                                       bulk.
    Cheese sauce--see sauce                           ..................
     category.
    Cream or cream substitutes,   15 mL.............  1 tbsp (15 mL).
     fluid.
    Cream or cream substitutes,   2 g...............  ---- tsp (---- g).
     powder.
    Cream, half & half..........  30 mL.............  2 tbsp (30 mL).
    Eggnog......................  120 mL............  1/2 cup (120 mL);
                                                       4 fl oz (120 mL).
    Milk, condensed, undiluted..  30 mL.............  2 tbsp (30 mL).
    Milk, evaporated, undiluted.  30 mL.............  2 tbsp (30 mL).
    Milk, milk-substitute         240 mL............  1 cup (240 mL); 8
     beverages, milk-based                             fl oz (240 mL).
     drinks, e.g., instant
     breakfast, meal
     replacement, cocoa, soy
     beverage.
    Shakes or shake substitutes,  240 mL............  1 cup (240 mL); 8
     e.g., dairy shake mixes,                          fl oz (240 mL).
     fruit frost mixes.
    Sour Cream..................  30 g..............  ---- tbsp (----
                                                       g).
    Yogurt......................  170 g.............  ---- cup (---- g).
Desserts:
    Ice cream, ice milk, frozen   1 cup.............  1 cup (---- g).
     yogurt, sherbet, frozen
     flavored and sweetened ice,
     frozen fruit juices: all
     types bulk.
    Ice cream, ice milk, frozen   \1/2\ cup--         ---- piece(s) (----
     yogurt, sherbet, frozen       includes the         g) for
     flavored and sweetened ice    volume for          individually
     and pops, frozen fruit        coatings and        wrapped or
     juices: all types novelties   wafers.             packaged
     (e.g., bars, sandwiches,                          products; ----
     cones, cups).                                     cup(s) (---- g)
                                                       for others.
    Sundae......................  1 cup.............  1 cup (---- g).
    Custards, gelatin, or         \1/2\ cup           ---- piece(s) (----
     pudding.                      prepared; Amount     g) for distinct
                                   to make \1/2\ cup   unit (e.g.,
                                   prepared when dry.  individually
                                                       packaged
                                                       products); \1/2\
                                                       cup (---- g) for
                                                       bulk.
Dessert Toppings and Fillings:
    Cake frostings or icings....  2 tbsp............  ---- tbsp(s) (----
                                                       g).
    Other dessert toppings,       2 tbsp............  2 tbsp (---- g); 2
     e.g., fruits, syrups,                             tbsp (30 mL).
     spreads, marshmallow cream,
     nuts, dairy and non-dairy
     whipped toppings.
    Pie fillings................  85 g..............  ---- cup(s) (----
                                                       g).
Egg Whites and Egg Substitutes:
    Egg mixtures, e.g., egg foo   110 g.............  ---- piece(s) (----
     young, scrambled eggs,                             g) for discrete
     omelets.                                          pieces; ----
                                                       cup(s) (---- g).
    Eggs (all sizes)............  50 g..............  1 large, medium,
                                                       etc. (---- g).
    Egg whites, sugared eggs,     An amount to make   ---- cup(s) (----
     sugared egg yolks, and egg    1 large (50 g)      g); ---- cup(s)
     substitutes (fresh, frozen,   egg.                (---- mL).
     dried).
Fats and Oils:
    Butter, margarine, oil,       1 tbsp............  1 tbsp (---- g); 1
     shortening.                                       tbsp (15 mL).
    Butter replacement, powder..  2 g...............  ---- tsp(s) (----
                                                       g).
    Dressings for salads........  30 g..............  ---- tbsp (----
                                                       g); ---- tbsp
                                                       (---- mL).
    Mayonnaise, sandwich          15 g..............  ---- tbsp (----
     spreads, mayonnaise-type                          g).
     dressings.
    Spray types.................  0.25 g............  About ---- seconds
                                                       spray (---- g).
Fish, Shellfish, Game Meats \9\,
 and Meat or Poultry
 Substitutes:
    Bacon substitutes, canned     15 g..............  ---- piece(s) (----
     anchovies \10\, anchovy                            g) for discrete
     pastes, caviar.                                   pieces; ----
                                                       tbsp(s) (---- g)
                                                       for others.
    Dried, e.g., jerky..........  30 g..............  ---- piece(s) (----
                                                        g).
    Entrees with sauce, e.g.      140 g cooked......  ---- cup(s) (----
     fish with cream sauce,                            g); 5 oz (140 g/
     shrimp with lobster sauce.                        visual unit of
                                                       measure) if not
                                                       measurable by
                                                       cup.
    Entrees without sauce, e.g.,  85 g cooked; 110 g  ---- piece(s) (----
     plain or fried fish and       uncooked \11\.       g) for discrete
     shellfish, fish and                               pieces; ----
     shellfish cake.                                   cup(s) (---- g);
                                                       ---- oz (---- g/
                                                       visual unit of
                                                       measure) if not
                                                       measurable by
                                                       cup.\12\
    Fish, shellfish, or game      85 g..............  ---- piece(s) (----
     meat \9\, canned \10\.                             g) for discrete
                                                       pieces; ----
                                                       cup(s) (---- g);
                                                       2 oz (56 g/----
                                                       cup) for products
                                                       that are
                                                       difficult to
                                                       measure the g
                                                       weight of cup
                                                       measure (e.g.,
                                                       tuna); 2 oz (56 g/
                                                       ---- pieces) for
                                                       products that
                                                       naturally vary in
                                                       size (e.g.,
                                                       sardines).

[[Page 12026]]

 
    Substitute for luncheon       55 g..............  ---- piece(s) (----
     meat, meat spreads,                                g) for distinct
     Canadian bacon, sausages,                         pieces (e.g.,
     frankfurters, and seafood.                        slices, links); --
                                                       -- cup(s) (----
                                                       g); 2 oz (56 g/
                                                       visual unit of
                                                       measure) for
                                                       nondiscrete bulk
                                                       product.
    Smoked or pickled fish \10\,  55 g..............  ---- piece(s) (----
     shellfish, or game meat                            g) for distinct
     \9\; fish or shellfish                            pieces (e.g.,
     spread.                                           slices, links) or
                                                       ---- cup(s) (----
                                                       g); 2 oz (56 g/
                                                       visual unit of
                                                       measure) for
                                                       nondiscrete bulk
                                                       product.
    Substitutes for bacon bits--                      ..................
     see Miscellaneous.
Fruits and Fruit Juices:
    Candied or pickled \10\.....  30 g..............  ---- piece(s) (----
                                                        g).
    Dehydrated fruits--see snack                      ..................
     category.
    Dried.......................  40 g..............  ---- piece(s) (----
                                                        g) for large
                                                       pieces (e.g.,
                                                       dates, figs,
                                                       prunes); ----
                                                       cup(s) (---- g)
                                                       for small pieces
                                                       (e.g., raisins).
    Fruits for garnish or         4 g...............  1 cherry (---- g);
     flavor, e.g., maraschino                          ---- piece(s)
     cherries \10\.                                    (---- g).
    Fruit relishes, e.g.,         70 g..............  ---- cup(s) (----
     cranberry sauce, cranberry                        g).
     relish.
    Fruits used primarily as      50 g..............  See footnote.\12\
     ingredients, avocado.
    Fruits used primarily as      50 g..............  ---- piece(s) (----
     ingredients, others                                g) for large
     (cranberries, lemon, lime).                       fruits; ----
                                                       cup(s) (---- g)
                                                       for small fruits
                                                       measurable by
                                                       cup.\12\
    Watermelon..................  280 g.............  See footnote.\12\
    All other fruits (except      140 g.............  ---- piece(s) (----
     those listed as separate                           g) for large
     categories), fresh, canned                        pieces (e.g.,
     or frozen.                                        strawberries,
                                                       prunes, apricots,
                                                       etc.); ----
                                                       cup(s) (---- g)
                                                       for small pieces
                                                       (e.g.,
                                                       blueberries,
                                                       raspberries,
                                                       etc.).\12\
    Juices, nectars, fruit        240 mL............  8 fl oz (240 mL).
     drinks.
    Juices used as ingredients,   5 mL..............  1 tsp (5 mL).
     e.g., lemon juice, lime
     juice.
Legumes:
    Tofu \10\, tempeh...........  85 g..............  ---- piece(s) (----
                                                        g) for discrete
                                                       pieces; 3 oz (84
                                                       g/visual unit of
                                                       measure) for bulk
                                                       products.
    Beans, plain or in sauce....  130 g for beans in  ---- cup (---- g).
                                   sauce or canned
                                   in liquid and
                                   refried beans
                                   prepared; 90 g
                                   for others
                                   prepared; 35 g
                                   dry.
Miscellaneous:
    Baking powder, baking soda,   0.6 g.............  ---- tsp ( ----
     pectin.                                           g).
    Baking decorations, e.g.,     1 tsp or 4 g if     ---- piece(s) (----
     colored sugars and            not measurable by    g) for discrete
     sprinkles for cookies, cake   teaspoon.           pieces; 1 tsp
     decorations.                                      (---- g).
    Batter mixes, bread crumbs..  30 g..............  ---- tbsp(s) (----
                                                       g);---- cup(s) (--
                                                       -- g).
    Chewing gum \8\.............  3 g...............  ---- piece(s) (----
                                                        g).
    Cocoa powder, carob powder,   1 tbsp............  1 tbsp ( ---- g).
     unsweetened.
    Cooking wine................  30 mL.............  2 tbsp (30 mL).
    Dietary Supplements.........  The maximum amount  ---- tablet(s),
                                   recommended, as     ---- capsules(s),
                                   appropriate, on     ---- packet(s), --
                                   the label for       -- tsp(s) (----
                                   consumption per     g), etc.
                                   eating occasion,
                                   or, in the
                                   absence of
                                   recommendations,
                                   1 unit, e.g.,
                                   tablet, capsule,
                                   packet,
                                   teaspoonful, etc..
    Meat, poultry, and fish       Amount to make one  ---- tsp(s) (----
     coating mixes, dry;           reference amount    g); ---- tbsp(s)
     seasoning mixes, dry, e.g.,   of final dish.      (---- g).
     chili seasoning mixes,
     pasta salad seasoning mixes.
    Milk, milk substitutes, and   Amount to make 240  ---- fl oz (----
     fruit based drink mixers      ml drink (without   mL); tsp ( g);
     (without alcohol), e.g.,      ice).               tbsp ( g).
     drink mixers, fruit
     flavored powdered drink
     mixes, sweetened cocoa
     powder).
    Drink mixes (without          Amount to make 360  ---- fl oz ( ----
     alcohol): all other types     mL drink (without   mL); ---- tsp
     (e.g., flavored syrups and    ice).               (---- g); ----
     powdered drink mixes).                            tbsp (---- g).
    Salad and potato toppers,     7 g...............  ---- tbsp(s) (----
     e.g., salad crunchies,                            g).
     salad crispins, substitutes
     for bacon bits.
    Salt, salt substitutes,       \1/4\ tsp.........  \1/4\ tsp ( ----
     seasoning salts (e.g.,                            g); ---- piece(s)
     garlic salt).                                     ( ---- g) for
                                                       discrete pieces
                                                       (e.g.,
                                                       individually
                                                       packaged
                                                       products).
    Seasoning oils and seasoning  1 tbsp............  1 tbsp (---- g).
     sauces (e.g., coconut
     concentrate, sesame oil,
     almond oil, chili oil
     coconut oil, walnut oil).
    Seasoning pastes (e.g.,       1 tsp.............  1 tsp (---- g).
     garlic paste, ginger paste,
     curry paste, chili paste,
     miso paste), fresh or
     frozen.

[[Page 12027]]

 
    Spices, herbs (other than     \1/4\ tsp or 0.5 g  \1/4\ tsp (----
     dietary supplements).         if not measurable   g); ---- piece(s)
                                   by teaspoon.        (---- g) if not
                                                       measurable by
                                                       teaspoons (e.g.,
                                                       bay leaf).
Mixed Dishes:
    Appetizers, hors d'oeuvres,   85 g, add 35g for   ---- piece(s) (
     mini mixed dishes, e.g.,      products with       ---- ---- g),.
     mini bagel pizzas, breaded    gravy or sauce
     mozzarella sticks, egg        topping.
     rolls, dumplings,
     potstickers, wontons, mini
     quesadillas, mini quiches,
     mini sandwiches, mini pizza
     rolls, potato skins.
    Measurable with cup, e.g.,    1 cup.............  1 cup (---- g).
     casseroles, hash, macaroni
     and cheese, pot pies,
     spaghetti with sauce,
     stews, etc..
    Not measurable with cup,      140g, add 55g for   ---- piece(s) (----
     e.g., burritos, enchiladas,   products with        g) for discrete
     pizza, pizza rolls, quiche,   gravy or sauce      pieces; ----
     sandwiches.                   topping, e.g.,      fractional slice
                                   enchilada with      (---- g) for
                                   cheese sauce,       large discrete
                                   crepe with white    units.
                                   sauce \13\.
Nuts and Seeds:
    Nuts, seeds and mixtures,     30g...............  ---- piece(s) (----
     all types: sliced, chopped,                        g) for large
     slivered, and whole.                              pieces (e.g.,
                                                       unshelled nuts);--
                                                       -- tbsp(s) (----
                                                       g) ;---- cup(s)
                                                       (---- g) for
                                                       small pieces
                                                       (e.g., peanuts,
                                                       sunflower seeds).
    Nut and seed butters,         2 tbsp............  2 tbsp (---- g).
     pastes, or creams.
    Coconut, nut and seed flours  15 g..............  ---- tbsp(s) (----
                                                       g); ---- cup (----
                                                        g).
Potatoes and Sweet Potatoes/
 Yams:
    French fries, hash browns,    70 g prepared; 85   ---- piece(s) (----
     skins, or pancakes.           g for frozen         g) for large
                                   unprepared French   distinct pieces
                                   fries.              (e.g., patties,
                                                       skins); 2.5 oz
                                                       (70 g/----
                                                       pieces) for
                                                       prepared fries; 3
                                                       oz (84 g/----
                                                       pieces) for
                                                       unprepared fries.
    Mashed, candied, stuffed or   140 g.............  ---- piece(s) (----
     with sauce.                                        g) for discrete
                                                       pieces (e.g.,
                                                       stuffed potato);
                                                       ---- cup(s) (----
                                                       g).
    Plain, fresh, canned, or      110 g for fresh or  ---- piece(s) (----
     frozen.                       frozen; 125 g for    g) for discrete
                                   vacuum packed;      pieces;----
                                   160 g for canned    cup(s) (---- g)
                                   in liquid.          for sliced or
                                                       chopped products.
Salads:
    Gelatin Salad...............  120 g.............  ---- cup (---- g).
    Pasta or potato salad.......  140 g.............  ---- cup(s) (----
                                                       g).
    All other salads, e.g., egg,  100 g.............  ---- cup(s) (----
     fish, shellfish, bean,                            g).
     fruit, or vegetable salads.
Sauces, Dips, Gravies, and
 Condiments:
    Barbecue sauce, hollandaise   2 tbsp............  2 tbsp (---- g); 2
     sauce, tartar sauce, tomato                       tbsp (30 mL).
     chili sauce, other sauces
     for dipping (e.g., mustard
     sauce, sweet and sour
     sauce), all dips (e.g.,
     bean dips, dairy-based
     dips, salsa).
    Major main entree sauces,     125 g.............  ---- cup (---- g);
     e.g., spaghetti sauce.                            ---- cup (----
                                                       mL).
    Minor main entree sauces      \1/4\ cup.........  \1/4\ cup (----
     (e.g., pizza sauce, pesto                         g); \1/4\ cup (60
     sauce, Alfredo sauce),                            mL).
     other sauces used as
     toppings (e.g., gravy,
     white sauce, cheese sauce),
     cocktail sauce.
    Major condiments, e.g.,       1 tbsp............  1 tbsp (---- g); 1
     catsup, steak sauce, soy                          tbsp (15 mL).
     sauce, vinegar, teriyaki
     sauce, marinades.
    Minor condiments, e.g.,       1 tsp.............  1 tsp (---- g); 1
     horseradish, hot sauces,                          tsp (5 mL).
     mustards, Worcestershire
     sauce.
Snacks:
    All varieties, chips,         30 g..............  ---- cup (---- g)
     pretzels, popcorn, extruded                       for small pieces
     snacks, fruit and vegetable-                      (e.g., popcorn);
     based snacks (e.g., fruit                         ---- piece(s)
     chips), grain-based snack                         (---- g) for
     mixes.                                            large pieces
                                                       (e.g., large
                                                       pretzels; pressed
                                                       dried fruit
                                                       sheet); 1 oz (28g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products (e.g.,
                                                       potato chips).
Soups:
    All varieties...............  245 g.............  ---- cup (---- g);
                                                       ---- cup (----
                                                       mL).
    Dry soup mixes, bouillon....  Amount to make 245  ---- cup (---- g);
                                   g.                  ---- cup (----
                                                       mL).
Sugars and Sweets:
    Baking candies (e.g., chips)  15 g..............  ---- piece(s) (----
                                                        g) for large
                                                       pieces; ----
                                                       tbsp(s) (---- g)
                                                       for small pieces;
                                                       \1/2\ oz (14 g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products.
    After-dinner confectionaries  10 g..............  piece(s) (---- g).
    Hard candies, breath mints..  2 g...............  ---- piece(s) (----
                                                        g).
    Hard candies, roll-type,      5 g...............  ---- piece(s) (----
     mini-size in dispenser                             g).
     packages.

[[Page 12028]]

 
    Hard candies, others;         15 mL for liquid    ---- piece(s) (----
     powdered candies, liquid      candies; 15 g for    g) for large
     candies.                      all others.         pieces;----
                                                       tbsp(s) (---- g)
                                                       for ``mini-size''
                                                       candies
                                                       measurable by
                                                       tablespoon; ----
                                                       straw(s) ( ----
                                                       g) for powdered
                                                       candies; ---- wax
                                                       bottle(s) (----
                                                       mL) for liquid
                                                       candies; \1/2\ oz
                                                       (14 g/visual unit
                                                       of measure) for
                                                       bulk products.
    All other candies...........  30 g..............  ---- piece(s) (----
                                                        g); 1 oz (30) g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products.
    Confectioner's sugar........  30 g..............  ---- cup (---- g).
    Honey, jams, jellies, fruit   1 tbsp............  1 tbsp (---- g); 1
     butter, molasses, fruit                           tbsp (15 mL).
     pastes, fruit chutneys.
    Marshmallows................  30 g..............  ---- cup(s) (----
                                                       g) for small
                                                       pieces; ----
                                                       piece(s) (---- g)
                                                       for large pieces.
    Sugar.......................  8 g...............  ---- tsp (---- g)
                                                       ; ---- piece(s)
                                                       (---- g) for
                                                       discrete pieces
                                                       (e.g., sugar
                                                       cubes,
                                                       individually
                                                       packaged
                                                       products).
    Sugar substitutes...........  An amount           ---- tsp(s) (----
                                   equivalent to one   g) for solids;
                                   reference amount    ---- drop(s) (----
                                   for sugar in         g) for liquid; --
                                   sweetness.          -- piece(s) (----
                                                       g) (e.g.,
                                                       individually
                                                       packaged
                                                       products).
    Syrups......................  30 mL for all       2 tbsp (30 mL).
                                   syrups.
Vegetables:
    Dried vegetables, dried       5 g, add 5 g for    ---- piece(s); \1/
     tomatoes, sun-dried           products packaged   3\ cup ( ---- ----
     tomatoes, dried mushrooms,    in oil.              g).
     dried seaweed.
    Dried seaweed sheets........  3 g...............  ---- piece(s) (----
                                                        ---- g); ----
                                                       ---- ---- cup(s)
                                                       (---- ---- ----
                                                       g).
    Vegetables primarily used     4 g...............  piece(s) (---- g);
     for garnish or flavor                             ---- tbsp(s) (----
     (e.g., pimento \10\,                               g) for chopped
     parsley, fresh or dried).                         products.
    Fresh or canned chili         30 g..............  ---- piece(s) (----
     peppers, jalapeno peppers,                         g) \12\; ----
     other hot peppers, green                          tbsp(s) (---- g);
     onion.                                            ---- cup(s) (----
                                                       g) for sliced or
                                                       chopped products.
    All other vegetables without  85 g for fresh or   ---- piece(s) (----
     sauce: fresh, canned, or      frozen; 95 g for     g) for large
     frozen.                       vacuum packed;      pieces (e.g.,
                                   130 g for canned    brussel sprouts);
                                   in liquid, cream-   ---- cup(s) (----
                                   style corn,         g) for small
                                   canned or stewed    pieces (e.g., cut
                                   tomatoes,           corn, green
                                   pumpkin, or         peas); 3 oz (84 g/
                                   winter squash.      visual unit of
                                                       measure) if not
                                                       measurable by
                                                       cup.
    All other vegetables with     110 g.............  ---- piece(s) (----
     sauce: fresh, canned, or                           g) for large
     frozen.                                           pieces (e.g.,
                                                       Brussels
                                                       sprouts); ----
                                                       cup(s) (---- g)
                                                       for small pieces
                                                       (e.g., cut corn,
                                                       green peas); 4 oz
                                                       (112 g/visual
                                                       unit of measure)
                                                       if not measurable
                                                       by cup.
    Vegetable juice.............  240 mL............  8 fl oz (240 mL).
    Olives \10\.................  15 g..............  ---- piece(s) (----
                                                        g); ---- tbsp(s)
                                                       (---- g) for
                                                       sliced products.
    Pickles and pickled           30 g..............  1 oz (28 g/visual
     vegetables, all types \10\.                       unit of measure).
    Pickle relishes.............  15 g..............  ---- tbsp (----
                                                       g).
    Sprouts, all types: fresh or  \1/4\ cup.........  \1/4\ cup (----
     canned.                                           ---- ---- g).
    Vegetable pastes, e.g.,       30 g..............  ---- tbsp (----
     tomato paste.                                     g).
    Vegetable sauces or purees,   60 g..............  ---- cup (---- g);
     e.g., tomato sauce, tomato                        ---- cup (----
     puree.                                            mL).
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
  customarily consumed per eating occasion and were derived from the
  1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys
  conducted by the U.S. Department of Agriculture and updated with data
  from the National Health and Nutrition Examination Survey, 2003-2004,
  2005-2006 and 2007-2008 conducted by the Centers for Diseases Control
  and Prevention, in the Department of Health and Human Services.
\2\ Unless otherwise noted in the Reference Amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes; concentrates; dough; batter; fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but that the specific
  wording may be changed as appropriate for individual products. The
  term ``piece'' is used as a generic description of a discrete unit.
  Manufacturers should use the description of a unit that is most
  appropriate for the specific product (e.g., sandwich for sandwiches,
  cookie for cookies, and bar for ice cream bars). The guidance provided
  is for the label statement of products in ready-to-serve or almost
  ready-to-serve form. The guidance does not apply to the products which
  require further preparation for consumption (e.g., dry mixes,
  concentrates) unless specifically stated in the product category,
  reference amount, or label statement column that it is for these forms
  of the product. For products that require further preparation,
  manufacturers must determine the label statement following the rules
  in Sec.   101.9(b) using the reference amount determined according to
  Sec.   101.12(c).
\5\ Includes cakes that weigh 10 g or more per cubic inch. The serving
  size for fruitcake is 1 \1/2\ ounces.
\6\ Includes cakes that weigh 4 g or more per cubic inch but less than
  10 g per cubic inch.
\7\ Includes cakes that weigh less than 4 g per cubic inch.

[[Page 12029]]

 
\8\ Label serving size for ice cream cones, eggs, and breath mints of
  all sizes will be 1 unit. Label serving size of all chewing gums that
  weigh more than the reference amount that can reasonably be consumed
  at a single-eating occasion will be 1 unit.
\9\ Animal products not covered under the Federal Meat Inspection Act or
  the Poultry Products Inspection Act, such as flesh products from deer,
  bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\10\ If packed or canned in liquid, the reference amount is for the
  drained solids, except for products in which both the solids and
  liquids are customarily consumed (e.g., canned chopped clam in juice).
\11\ The reference amount for the uncooked form does not apply to raw
  fish in Sec.   101.45 or to single-ingredient products that consist of
  fish or game meat as provided for in Sec.   101.9(b)(j)(11).
\12\ For raw fruit, vegetables, and fish, manufacturers should follow
  the label statement for the serving size specified in Appendices C and
  D to part 101 (21 CFR 101) Code of Federal Regulations.
\13\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) If a product requires further preparation, e.g., cooking or the 
addition of water or other ingredients, and if paragraph (b) of this 
section provides a reference amount for the product in the prepared 
form, but not the unprepared form, then the reference amount for the 
unprepared product must be the amount of the unprepared product 
required to make the reference amount for the prepared product as 
established in paragraph (b) of this section.
* * * * *
    (f) * * *
    (1) The reference amount for the combined product must be the 
reference amount, as established in paragraph (b) of this section, for 
the ingredient that is represented as the main ingredient (e.g., peanut 
butter, pancakes, cake) plus proportioned amounts of all minor 
ingredients.
    (2) If the reference amounts are in compatible units, the weights 
or volumes must be summed (e.g., the reference amount for equal volumes 
of peanut butter and jelly for which peanut butter is represented as 
the main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter 
plus 2 tbsp jelly). If the reference amounts are in incompatible units, 
all amounts must be converted to weights and summed, e.g., the 
reference amount for pancakes and syrup would be 110 g (the reference 
amount for pancakes) plus the weight of the proportioned amount of 
syrup.
* * * * *

    Dated: February 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04385 Filed 2-27-14; 8:45 am]
BILLING CODE 4160-01-P