[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).
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\2\ We note that in this proposed rule, when we speak of
``updates to'' or ``updating'' the RACCs established in 1993, we are
referring to amendments to RACCs for products that are currently
listed in the tables in Sec. 101.12(b), and for which the NHANES
2003-2008 consumption data showed a significant change in
consumption (as discussed in the proposed amendments section, we
have determined that an increase or decrease in consumption by at
least 25 percent from the amount listed in the tables in Sec.
101.12(b) would be considered a significant change).
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3. Comparison of Calories in Foods of Different Portion Sizes
As noted in the ``Calories Count'' report, the Federal Trade
Commission had suggested that we consider ``allowing food marketers to
make truthful, non-misleading label claims comparing foods of different
portion sizes (Ref. 1).'' Our regulations discuss requirements to use
certain characterizing terms to make comparative nutrient content
claims (called ``relative claims'') that compare the level of nutrients
in two foods, including calorie comparisons, and require that all such
comparisons be based on a uniform amount of food, i.e., per RACC for
individual foods or per 100 g for meals and main dishes (see 21 CFR
Part 101, Subpart D, and Sec. 101.13(j)). Section 101.13(j) also
requires that such comparisons made in ``relative claims'' reflect
actual nutrient differences in the same quantity of similar foods
(e.g., ``Reduced calorie chocolate ice cream, 25 percent fewer calories
than the leading brand of chocolate ice cream. The leading brand
contains 150 calories per \1/2\ cup serving. Our ice cream contains 100
calories per \1/2\ cup serving'') or dissimilar foods within a product
category that can be substituted for one another (e.g., ``Reduced
sodium pretzels, 33 percent less sodium than the leading brand of
potato chips. Our pretzels contain 105 mg of sodium per serving. The
leading brand of potato chips contains 320 mg of sodium per serving).
The nutrient content claim regulations do not specifically discuss
claims that compare the amount of calories based on different sized
portions of the same food product. However, FDA's regulations do allow
certain statements in the label or labeling of a food product about the
amount or percentage of a nutrient in the food (see Sec. 101.13(i)).
As noted in the ``Calories Count'' report, ``using the food label to
promote consumption of smaller portions may have merit, particularly if
consumers understand that: (1) The calorie reduction is solely a
function of the reduction in portion size and, (2) the smaller portion
size is actually less than what they usually consume.'' Thus, the ANPRM
invited comment regarding the appropriateness of label claims based on
the amount of calories in a specified portion of a product (i.e., the
amount of food specified by the claim, e.g., one 15 g cookie) versus
claims based on the RACC and specified in the labeled serving size of a
product (i.e., the amount specified on the Nutrition Facts label (e.g.,
two 15 g cookies)) (70 FR 17010 at 17013).
4. Overview of Comments on the Advance Notice of Proposed Rulemaking
The ANPRM resulted in approximately 850 comments from health
advocacy groups, industry, trade associations, consumer groups,
individual consumers, government, health professionals, and academia.
Not all of the comments received addressed the questions posed in the
ANPRM, and many comments were outside the scope of the rulemaking. We
discuss the comments within the scope of the ANPRM later in this
proposed rule.
[[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.
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\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).
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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.
http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
8. Henderson, C., Memorandum to file, ``Historical documents
requesting a new Reference Amount Customarily Consumed or to modify
an existing Reference Amount Customarily Consumed'' February 11,
2014.
9. Knupfer, D., Letter from W & F Products Inc. to FDA, March 31,
1993.
10. Mercurio, K. C., Letter from Nestle USA Inc. to FDA, May 11,
1993.
11. Park, Y., Memorandum to the file, List of products for each
product category, October 8, 1992.
12. Litner, R. J., Letter from Nutrinfo Corporation to F. E.
Scarbrough, FDA, August 24, 1994.
13. Marcouiller, S. A., Letter from Kraft Foods to F. E. Scarbrough,
FDA, June 28, 1996.
14. Flegal, K. M., M. D. Carroll, C. L. Ogden, L. R. Curtin.
``Prevalence and Trends in
[[Page 12021]]
Obesity Among US Adults, 1999-2008,'' The Journal of the American
Medical Association, 303:235-41, 2010.
15. Flegal, K. M., M. D. Carroll, R. J. Kuczmarski, C. L. Johnson.
``Overweight and Obesity in the United States: Prevalence and
Trends, 1960-1994,'' International Journal of Obesity and Related
Metabolic Disorders, 22:39-47, 1998.
16. Center for Disease Control and Prevention, ``Obesity and
Overweight for Professionals: Health Consequences, 2011.'' http://www.cdc.gov/obesity/causes/health.html.
17. Malnick, S. D., H. Knobler. ``The Medical Complications of
Obesity,'' QJM: Monthly Journal of the Association of Physicians,
99:565-79, 2006.
18. Center for Disease Control and Prevention, Chronic Diseases and
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[[Page 12022]]
to Federal Food Labeling Requirements for Meats and Poultry
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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