[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Rules and Regulations]
[Pages 34000-34047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11865]



[[Page 34000]]

-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is issuing a 
final rule to define a single-serving container; require dual-column 
labeling for certain containers; update, modify, and establish several 
reference amounts customarily consumed (RACCs); amend the label serving 
size for breath mints; and make technical amendments to various aspects 
of the serving size regulations. We are taking this action to provide 
consumers with more accurate and up-to-date information on serving 
sizes.

DATES: Effective date: The final rule becomes effective on July 26, 
2016.
    Compliance date: The compliance date of this final rule is July 26, 
2018, for manufacturers with $10 million or more in annual food sales, 
and July 26, 2019, for manufacturers with less than $10 million in 
annual food sales. See Section IV, Effective and Compliance Dates, for 
more detail.

FOR FURTHER INFORMATION CONTACT: With regard to the final rule: Cherisa 
Henderson, Center for Food Safety and Applied Nutrition (HFS-830), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1450, [email protected].
    With regard to the information collection: Domini Bean, Office of 
Information Management, Food and Drug Administration, 8455 Colesville 
Rd., Rm. 14537G, Silver Spring, MD 20903, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Legal Authority
    C. Summary of the Major Provisions of the Final Rule
    D. Technical Amendments
    E. Effective and Compliance Dates
    F. Costs and Benefits
II. Background
    A. Serving Size Proposed Rule
    B. Legal Authority
III. Comments and FDA's Responses
    A. General Comments
    B. Single-Serving Containers
    C. Dual-Column Labeling
    D. Reference Amounts Customarily Consumed
    E. Impact of Changes in RACCs on the Eligibility To Make 
Nutrient Content Claims and Health Claims
    F. Establishing a New Serving Size for Breath Mints
    G. Technical Amendments
IV. Effective and Compliance Dates
V. Analysis of Environmental Impact
VI. Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References

I. Executive Summary

A. Purpose of the Final 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 reevaluate 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 providing consumers information to assist them in 
maintaining 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 amends our 
regulations in Sec. Sec.  101.9 and 101.12. Resulting from our 
evaluation of the new consumption data, this rule amends the 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 amends 
some of the required procedures used to determine serving sizes, amends 
the definition of a single-serving container, and requires 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 changes finalized in this rule are designed to ensure that 
serving sizes are based on current consumption data and to provide 
consumers with information on the Nutrition Facts label related to the 
serving size that will assist them in maintaining healthy dietary 
practices.

B. 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 we regulate. 
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 final rule. Section 2(b)(1)(B) of the NLEA further requires the 
Secretary of Health and Human Services to issue regulations ``which 
establish standards . . . to define serving size.'' Additionally, we 
are relying on section 2(b)(1)(A) of the 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 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 final 
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 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 the authorities listed in 
this paragraph

[[Page 34001]]

give us the authority to issue this final rule related to serving size 
labeling.

C. Summary of the Major Provisions of the Final Rule

1. Single-Serving Containers and Dual-Column Labeling
    Over the last 20 years, evidence has accumulated demonstrating that 
container and unit sizes can influence the amount of food consumed. For 
containers and units of certain sizes, consumers are likely to eat the 
entire container or unit in one sitting. For other container and unit 
sizes, consumers may consume the container or unit in one sitting or 
may consume the container or unit over multiple sittings or share the 
container or unit contents with other consumers. To address containers 
that may be consumed in a single-eating occasion, we are requiring 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 and units that may be 
consumed in one or more sittings, or shared, we are requiring that 
containers and units that contain at least 200 percent and up to and 
including 300 percent of the RACC be labeled with a column of nutrition 
information within the Nutrition Facts label that lists the 
quantitative amounts and percent DVs for the entire container, in 
addition to the 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).
2. Changing the RACCs
    We 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, we analyzed recent food consumption data from the 
2003-2008 National Health and Nutrition Examination Surveys (NHANES) 
(hereinafter referred to as the NHANES 2003-2008 surveys or NHANES 
2003-2008 consumption data, as applicable). Generally, this rule amends 
RACCs 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 have considered other 
factors, such as designating the same RACCs for products with similar 
consumption data and similar dietary usage or product characteristics.
    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 final rule.

D. 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 final rule includes a number of technical amendments to 
help clarify the serving size requirements in these regulations.

E. Effective and Compliance Dates

    We are establishing a compliance date of 2 years after the final 
rule's effective date for manufacturers with $10 million or more in 
annual food sales, and 3 years after the final rule's effective date 
for manufacturers with less than $10 million in annual food sales. (For 
more details, see Section IV, Effective and Compliance Dates.)

F. Costs and Benefits

    We have developed one final regulatory impact analysis (FRIA) for 
this final rule as well as the final rule entitled ``Food Labeling: 
Revision of the Nutrition and Supplement Facts Labels'' (the Nutrition 
Facts final rule). The FRIA discusses key inputs in the estimation of 
costs and benefits of the changes finalized by the rules and assesses 
the sensitivity of cost and benefit totals to those inputs. The two 
nutrition labeling rules--which have a compliance date of 2 years after 
the final rule's effective date for manufacturers with $10 million or 
more in annual food sales, and 3 years after the final rule's effective 
date for manufacturers with less than $10 million in annual food 
sales--have impacts, including the sign on net benefits, that are 
characterized by substantial uncertainty. The primary sensitivity 
analysis shows benefits having the potential to range between $0.2 and 
$2 or $5 billion, and costs ranging between $0.2, $0.5 and $0.8 billion 
(annualized over the next 20 years, in 2014 dollars, at seven percent 
interest).\1\
---------------------------------------------------------------------------

    \1\ There is substantial uncertainty regarding the impacts of 
the two nutrition labeling rules. For a full discussion of the 
uncertainty, please see the Welfare Estimates--Primary Sensitivity 
Analysis section of the Regulatory Impact Analysis.

        Table 1--Summary of the Primary Sensitivity Analysis of the Costs and Benefits of the Final Rules
                                             [in billions of 2014$]
----------------------------------------------------------------------------------------------------------------
                                      Benefits     Benefits     Benefits      Costs        Costs        Costs
                                       (low)        (mean)       (high)       (low)        (mean)       (high)
----------------------------------------------------------------------------------------------------------------
Present Value:
    3%............................         $2.8        $33.1        $77.7         $2.3         $4.8         $8.6
    7%............................          1.9         22.3         52.5          2.2          4.5          8.3
Annualized Amount:
    3%............................          0.2          2.2          5.2          0.2          0.3          0.6
    7%............................          0.2          2.1          5.0          0.2          0.4          0.8
----------------------------------------------------------------------------------------------------------------
Notes: Costs estimates reflect an assumption that the rules have the same compliance date. Compliance period is
  36 months for small businesses and 24 months for large businesses. For purposes of this analysis, we consider
  a small business to be a business with annual food sales of less than $10 million, and a large business to be
  a business with annual food sales of $10 million or more. Costs include relabeling, recordkeeping, fiber
  study, additional labeling, future UPC growth labeling, and reformulation costs. Annualized Amount = Amount/
  Annualizing Factor. Three percent annualizing factor = 14.88. Seven percent annualizing factor = 10.59. The
  annualizing factors are calculated by summing the inverse of 1 plus the discount rate to the power of the year
  (t = 1 through t = 20).


[[Page 34002]]

II. Background

A. Serving Size Proposed Rule

    In the Federal Register of March 3, 2014 (79 FR 11989), we 
published a proposed rule (the serving size proposed rule or the 
proposed rule) to amend our serving size regulations, in part, in 
response to recommendations of the Report of the Working Group on 
Obesity, ``Calories Count,'' March 12, 2004 (Ref. 1), and our 
recognition that portion sizes have changed since we first published 
serving size regulations in 1993 (1993 serving size final rule, 58 FR 
2229, January 6, 1993). We also published technical amendments to the 
1993 serving size final rule on August 18, 1993 (58 FR 44039). The 
proposed rule also discussed six citizen petitions. The intended effect 
of the proposed rule, when finalized, was to provide consumers with 
more accurate and up-to-date information on serving sizes. In brief, 
the proposed rule would:
     Amend the definition of a single-serving container to 
remove the exception for products with large RACCs. Preexisting Sec.  
101.9(b)(6), which this rule will replace upon the effective date, 
required that a product that is packaged and sold individually 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, unless the product contains more 
than 150 but less than 200 percent of the RACC and has an RACC of 100 g 
or 100 mL or larger. Under the preexisting regulation, manufacturers of 
products that contain more than 150 but less than 200 percent of the 
RACC and have an RACC of 100 g or 100 mL or larger (large-RACC 
products) are permitted to label the product as containing 1 or 2 
servings, at the manufacturer's discretion (Sec.  101.9(b)(6)). The 
proposed rule would remove the exception for large-RACC products being 
labeled as one or two servings so that all products packaged and sold 
individually and that contain less than 200 percent of the RACC would 
be required to be labeled as a single-serving container.
     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.
     Update the RACCs when there is a significant change 
between the median amount consumed from 2003-2008 NHANES consumption 
data and the RACCs established in the 1993 serving size final rule.
     Modify and establish RACCs for certain product categories 
based on manufacturer requests and our initiative.
     Amend the serving size for breath mints.
     Make technical amendments to various aspects of the 
serving size regulations.
    We provided an opportunity to comment on the serving size proposed 
rule until June 2, 2014. On May 27, 2014, we extended the comment 
period until August 1, 2014 (79 FR 30056). We received more than 500 
comments in response to the proposed rule. Most submissions came from 
individuals. We also received comments from industry and trade 
associations, consumer and advocacy groups, academic organizations, 
State governments, and foreign government agencies.

B. Legal Authority

    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 we have determined 
that amendments to those regulations are needed. We have analyzed 
consumption data for various food products and have determined that the 
data warrant amending many of the RACCs established in 1993. 
Additionally, both on our own initiative and in response to various 
requests, we have analyzed data for products that are not listed in the 
tables in Sec.  101.12(b), and are establishing additional RACCs. Thus, 
in accordance with section 403(q)(1)(A)(i) of the FD&C Act, we are 
amending the RACCs in Sec.  101.12(b) to reflect the current amounts 
customarily consumed for products already listed in Sec.  101.12(b), as 
well as products not listed in Sec.  101.12(b). Additionally, under the 
same authority we are amending related regulations in Sec. Sec.  101.9 
and 101.12 that set forth procedures for determining serving sizes for 
use on product labels based on the reference amounts. Included among 
these 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 the 
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 amending 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 column listing the 
quantitative amounts and percent DVs for a serving of food that is less 
than the entire container or unit. Section 2(b)(1)(A) of the NLEA 
provides authority for this 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 
discussed further in section III.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 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 
amendments in this rule include sections 701(a), 403(a)(1), and 201(n) 
of the FD&C Act. 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,

[[Page 34003]]

226 F. Supp. 2d 204, 213 (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 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 final rule related to serving size labeling.

III. Comments and FDA's Responses

    This section discusses the issues raised in the comments on the 
proposed rule and describes the final rule. For ease of reading, we 
preface each comment discussion with a numbered ``Comment'' and each 
response by a corresponding numbered ``Response.'' We have numbered 
each comment to help distinguish among different topics. The number 
assigned is for organizational purposes only and does not signify the 
comment's value, importance, or the order in which it was received.

A. General Comments

    (Comment 1) Many comments stated that the labeled serving size 
represents a recommended amount of food to consume. Other comments 
stated that we were changing the RACCs from a recommended amount of 
food to eat to the amount of food that people actually eat. Some 
comments that thought we were changing the serving size from a 
recommended amount of food to eat to an amount of food that is 
customarily consumed supported the change. Some of these comments 
stated that basing the serving size on the actual amount eaten would 
make it easier for consumers to understand how many calories and other 
nutrients they are consuming.
    In contrast, other comments asserting that we were changing the 
serving size from a recommended amount to an amount of food that is 
customarily consumed opposed the perceived change because, according to 
those comments, such changes would make it more difficult to use the 
labeled serving size for diet planning or other dietary practices. 
Further comments stated that updating the serving size portion of the 
Nutrition Facts label would increase consumer confusion and encourage 
excess consumption among those who think that the serving size is based 
on a recommended amount.
    (Response 1) Some of these comments reflect a misunderstanding of 
the definition of serving size. Under section 403(q)(1)(A)(i) of the 
FD&C Act, serving size is an amount of food customarily consumed and 
which is expressed in a common household measure appropriate to the 
food. Thus, the serving size is not a recommended amount of food to eat 
and was not described as such in the 1993 serving size final rule.
    We acknowledge that some consumers may misconstrue the meaning of 
the serving size set forth in the FD&C Act. Since the publication of 
the proposed rule, several studies have been conducted that indicate 
that some consumers believe serving size specifies a recommended amount 
of food to eat (Refs. 2, 3, and 4), and we recognize that that such an 
understanding could lead to increased levels of consumption. In order 
to help consumers understand issues relating to this final rule, as 
discussed further in response to comment 2, we intend to conduct 
nutrition education to help clarify the meaning of the serving size and 
RACCs.
    With regard to the comments that stated that updates to serving 
sizes would make it difficult to use the serving size for diet planning 
or other dietary practices, we disagree. Providing the nutrition 
content of the food based on current consumption amounts informs 
consumers of the amount of nutrients they are likely to ingest.
    (Comment 2) Several comments recommended that we conduct extensive 
consumer education on the changes in this final rule. Some comments 
requested that we conduct consumer education in conjunction with the 
USDA regarding all proposed changes to the Nutrition Facts label and 
the underlying calculations used to determine the quantities presented 
on the labels. Several comments asserted that without public education, 
consumers may not fully understand how to use the Nutrition Facts label 
so that they can maintain healthy dietary practices.
    (Response 2) We agree that an extensive consumer education campaign 
will serve an important role in continuing to provide information to 
assist consumers in maintaining healthy dietary practices. Currently, 
we have available a collection of various educational materials (e.g., 
videos and an array of other education materials (in English and other 
languages)) on numerous nutrition topics, including materials on the 
Nutrition Facts label (e.g., Read the Label, Make Your Calories Count, 
Using the Nutrition Facts Label) (Ref. 5). These materials are intended 
for educators, teachers, health professionals (e.g., dietitians, 
nutritionists), as well as for consumers. Our intent is to update our 
existing educational materials and create new educational opportunities 
to explain the overall role of using the label to assist consumers in 
maintaining healthy dietary practices, with an emphasis on each of the 
new changes of the label.
    We intend to continue to work in collaboration, and create new 
partnership opportunities, with other Federal government agencies 
including other parts of the Department of Health and Human Services, 
USDA, State health departments, health professional organizations, food 
manufacturers, retailers, and non-profit organizations that have an 
interest and responsibilities in nutrition education and health 
promotion. These partnerships will help us to develop and disseminate 
our educational materials, which will ease the transition to the 
revised nutrition label and help consumers to use the label to make 
informed dietary choices. Through our collaboration with both 
government and non-government entities, our continued goal is to 
increase consumers' knowledge and effective use of the new food label, 
and to ensure that consumers have accurate and adequate resource 
materials and information to assist them in maintaining healthy dietary 
practices. Furthermore, we intend to continue with a variety of 
activities, such as conducting and reporting on existing and planned 
food labeling research, developing education initiatives at the 
national and local level, holding regularly scheduled meetings to build 
labeling education exchanges, and integrating food labeling education 
into the existing programs (e.g., USDA school-based nutrition education 
programs). We plan to continue to build partnerships capable of 
developing and evaluating labeling education targeted to the dietary 
needs of diverse populations, such as low-literacy consumers, those 
with lower incomes, minorities and various specific subpopulations 
(e.g., children, older adults, women of childbearing age), as well as 
to the public at large.
    (Comment 3) Several comments requested we require that a footnote 
be added to the Nutrition Facts label to indicate that the serving size 
is based on typically consumed, not recommended, servings. The comments 
stated that the purpose of adding this footnote would be to serve as 
nutrition education to

[[Page 34004]]

make consumers aware of the true meaning of the labeled serving size.
    (Response 3) We recognize the importance of providing consumers 
with more in-depth information about the meaning of the serving size 
and, as explained in response to comment 2, intend to make this a key 
component of our future nutrition education efforts for consumers. At 
this time, however, we decline to establish as part of this rulemaking 
a requirement to add a footnote to the Nutrition Facts label that would 
indicate that the serving size is based on what is typically consumed, 
rather than what is recommended. We would like to consider this issue 
further before finalizing a provision that would mandate or voluntarily 
permit the addition of such a footnote to the Nutrition Facts label. We 
also note that, while no such footnote as requested in this comment can 
be added to the Nutrition Facts label voluntarily, manufacturers can 
voluntarily include a truthful and not misleading statement explaining 
the meaning of serving size elsewhere on the product label.
    (Comment 4) Some comments requested that we change the term 
``serving size'' to prevent consumers from assuming that the serving 
sizes are recommended servings. Some terms that the comments suggested 
we use instead were ``typical serving,'' ``unit,'' or ``quantity.'' 
Another suggestion was to remove the two lines that mention ``serving'' 
and add, next to the words ``Amount per ___,'' the fraction of the 
container that the RACC represents (for example, ``Amount per \2/3\ cup 
(\1/8\ of container)'').
    (Response 4) We decline to revise or remove the terms ``serving'' 
and ``serving size'' as suggested by the comments. Section 403(q)(1)(A) 
of the FD&C Act deems food, unless subject to an exception, to be 
misbranded unless its label or labeling bears the ``serving size.'' 
Therefore, we will continue to require that the terms ``serving'' and 
``serving size'' be used on product labels.
    (Comment 5) Some comments stated that the ``serving size'' should 
be expressed in household measurements or that serving size of similar 
food products should be based off of the same amount of food.
    (Response 5) We agree. Section 403(q)(1)(A) of the FD&C Act 
requires that the serving size be expressed in a common household 
measure that is appropriate to the food or, if the use of the food is 
not typically expressed in a serving size, the common household unit of 
measure that expresses the serving size of the food. In addition, Sec.  
101.12(a)(9) states that products that have similar dietary usage, 
product characteristics, and customarily consumed amounts should have a 
uniform reference amount. Section 101.12(a)(9) is not being changed in 
this final rule and was used as part of the decision making when 
determining what RACCs to update, modify, and establish in the proposed 
rule and this final rule.
    (Comment 6) Several comments indicated that we should consider a 
uniform serving size for all food products as is done in some other 
countries, such as 1 cup or 100 g. The comments stated that having a 
uniform serving size would allow consumers to be able to make side-by-
side comparisons of all products in the grocery store.
    (Response 6) We do not agree that a uniform serving size should be 
used for all foods. Under section 403(q)(1)(A) of the FD&C Act, serving 
size is defined as the amount of food customarily consumed. As all 
foods are not customarily consumed in the same amount, establishing a 
uniform serving size for all foods would not meet this statutory 
requirement.

B. Single-Serving Containers

    Preexisting Sec.  101.9(b)(6) requires that a product that is 
packaged and sold individually and that contains less than 200 percent 
of the applicable RACC be labeled as a single serving. 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). Under 
preexisting Sec.  101.9(b)(6), manufacturers of large-RACC products 
could decide whether a package that contains more than 150 percent but 
less than 200 percent of the applicable RACC is 1 or 2 servings (Sec.  
101.9(b)(6)). We provided the exception for large-RACC products based 
on consumption data available at the time the 1993 rule was issued that 
showed that ``[i]t was much less likely that a person will 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 twice the reference amount of a food with a smaller reference 
amount'' (79 FR 11989 at 12000).
    In the preamble to the proposed rule (79 FR 11989 at 12001), we 
discussed the correlation between the consumption variation and the 
RACCs for all products containing less than 200 percent of the 
applicable RACC, including products with large RACCs and products that 
have RACCs that are less than 100 g (or mL), using combined consumption 
data from the NHANES 2003-2008 surveys (Refs. 6, 7, and 8). 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 to express the figure as the percent variation 
from the median consumption amount (Ref. 9). The result shows that the 
correlation coefficient is 0.13, which means that there is a low 
correlation between the RACCs and the consumption variation for all 
products containing less than 200 percent of the RACC, regardless of 
whether the RACC is large. 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, in the preamble to the 
proposed rule we proposed to remove the exemption from the requirement 
to label a product with a large RACC containing between 150 percent and 
200 percent of the applicable RACC as a single-serving container 
because the exemption is no longer supported by consumption data (79 FR 
11889 at 12001).
    Additionally, as noted in the preamble to the proposed rule, 
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 (79 FR 11889 at 12001). Research 
shows that package and portion sizes tend to have a considerable impact 
on the amount of food consumed (Refs. 10 and 11). Taking into account 
this research, we stated in the proposed rule that 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 food that they are consuming (79 FR 11989 
at 12001). In light of this research and the previously discussed 
analysis on consumption variation, we proposed to remove the large-RACC 
exemption for single-serving containers.
    We also proposed to remove the text in preexisting 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 III.C.).

[[Page 34005]]

1. Definition of a Single-Serving Container
    (Comment 7) Some comments supported our proposed changes to the 
definition of a single-serving container. The comments said that 
labeling foods that are less than 200 percent of the RACC as a single 
serving would increase consumer understanding of the nutritional 
content of foods. Some comments also stated that the proposed changes 
would provide consistency across all food products on the amount that 
constitutes a single serving. Other comments provided research in 
support of our proposed changes to the definition of a single-serving 
container.
    (Response 7) The research provided in the comments is the same as 
the research discussed in the preamble of the proposed rule (79 FR 
11989 at 11998). Lando & Labiner-Wolfe (2007) found that many focus 
group study participants believed that products like a large muffin or 
a 20 ounce (oz) soda that contain more than one serving, but are often 
eaten at a single eating occasion, should be labeled as a single 
serving (Ref. 12). Other studies have 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. 
13).
    (Comment 8) One comment asked that we raise the cutoff for a 
single-serving container to include containers with up to 300 percent 
of the RACC. The comment stated that our proposed amendment for single-
serving containers to include anything less than 200 percent of the 
RACC excludes many foods that can reasonably be consumed by one person 
in a single eating occasion and that food companies could avoid ``per 
package'' labeling by simply increasing the container size to slightly 
more than 200 percent of the RACC.
    (Response 8) While we understand the concern that keeping the 
cutoff for single-serving containers at less than 200 percent may 
exclude some food products that can reasonably be consumed by one 
person in a single eating occasion, we decline to increase the 
definition of a single-serving container to include products containing 
up to 300 percent of the RACC. Under section 403(q)(1)(A)(i) of the 
FD&C Act, serving size means the 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 because that would be at 
least twice the amount we have determined is customarily consumed. 
However, we agree with these comments that such products may reasonably 
be consumed by one person in a single eating occasion, and as discussed 
in section III.B., full-package nutrition information, or per-unit 
nutrition information, as applicable, for products containing at least 
200 percent and up to and including 300 percent of the RACC will be 
required for certain products through dual-column labeling.
    (Comment 9) One comment requested clarification on the meaning of 
the phrase ``products that are packaged and sold individually.'' The 
comment noted that it understood the phrase ``products that are 
packaged and sold individually'' to mean products that consist of a 
single unit and to exclude products that are divided into discrete 
units. The comment stated that if the phrase ``products that are 
packaged and sold individually'' does include products that are divided 
in discrete units, every product would be a product that is ``packaged 
and sold individually.'' Accordingly, the comment questioned whether 
the proposed single-serving and dual-column labeling requirements would 
apply only to products that consist of a single unit, or whether the 
requirements would also apply to non-discrete bulk products and 
products divided into discrete units. The comment also requested 
clarification on whether a product that is ``packaged and sold 
individually'' must be considered a single-serving container if it 
contains less than 200 percent of the RACC, and whether it must provide 
dual-column labeling if it contains 200 percent to 400 percent of the 
RACC.
    (Response 9) In proposed Sec.  101.9(b)(6) we use the phrase 
``products that are packaged and sold individually'' and weighing less 
than 200 percent of the RACC to describe products for which single-
serving container labeling requirements would apply. The phrase 
``products that are packaged and sold individually'' was also used in 
the serving size proposed rule to describe products for which the 
proposed dual-column labeling requirements would apply, provided that 
they contained at least 200 and up to and including 400 percent of the 
RACC. In both of these cases we are using the phrase ``products that 
are packaged and sold individually'' to describe any package bearing a 
Nutrition Facts label.
    A product that is packaged and sold individually, i.e., a container 
that bears a Nutrition Facts panel, is considered a single-serving 
container if it contains less than 200 percent of the RACC. A product 
that is packaged and sold individually would be required to provide 
dual-column labeling if it contains at least 200 percent and up to and 
including 300 percent of the RACC, unless an exception from the 
requirement applies. The change from 400 percent of the RACC as the 
upper limit for the dual-column labeling requirements to 300 percent of 
the RACC as the upper limit for the dual-column labeling requirements 
is discussed in section III.B. While Sec.  101.9(b)(2)(i) provides 
requirements for the serving size declaration for multiserving products 
in discrete units, products that satisfy the requirements of Sec.  
101.9(b)(6) (i.e., products that are packaged and sold individually and 
that contain less than 200 percent of the applicable reference amount) 
are excepted from Sec.  101.9(b)(2) (see 58 FR 2229 at 2234). There was 
no proposal to change this provision in the proposed rule, and it has 
not been amended in this final rule. Therefore, products in discrete 
units that are packaged and sold individually and that contain less 
than 200 percent of the applicable reference amount are required to be 
labeled as a single serving under Sec.  101.9(b)(6). Products that 
contain discrete units and in which each discrete unit weighs at least 
200 percent and up to and including 300 percent of the reference amount 
are required under Sec.  101.9(b)(2)(i)(D) to bear two columns listing 
the quantitative amounts and percent DVs: One providing nutrition 
information for a serving that is less than the unit (i.e., the serving 
size derived from the reference amount) and one providing nutrition 
information for the entire unit. Further, products in discrete units 
that are packaged and sold individually and contain at least 200 
percent and up to and including 300 percent of the reference amount are 
required to comply with the dual-column labeling requirements in Sec.  
101.9(b)(12)(i). Similarly, products not in discrete units that are 
packaged and sold individually and contain at least 200 percent and up 
to and including 300 percent of the reference amount are required to 
satisfy the dual-column labeling requirements in Sec.  101.9(b)(12)(i).
    (Comment 10) Several comments pertained to multiple individually 
wrapped units in a single container, for which the combined weight of 
the units in the larger package is less than 200 percent of the RACC. 
The comments stated that products containing individual units in a 
container where the entire container weighs less than

[[Page 34006]]

200 percent of the RACC are unlikely to be consumed in a single eating 
occasion. One comment requested an exemption from the single-serving 
container requirement in a scenario in which a package weighing less 
than 200 percent of the RACC contains two discrete stuffed sandwiches, 
and requested that each sandwich, rather than the entire package, be 
considered one serving. The comment stated that under the proposed 
amendments to the definition of a single-serving container, the entire 
package containing the two stuffed sandwiches would need to be labeled 
as one serving. The comment stated that labeling each discrete stuffed 
sandwich as a single serving would be consistent with how consumers use 
and eat these types of products and asserted that consumers typically 
eat one individually wrapped unit in a single eating occasion, rather 
than opening a second unit. Another comment requested that we provide 
an exemption generally from the definition of single-serving container 
where a package contains multiple individually wrapped units, and each 
individual unit is labeled as a serving.
    (Response 10) We disagree with comments suggesting that products 
containing discrete units in a container that weighs less than 200 
percent of the RACC should be exempt from the single-serving container 
requirements, regardless of whether the individual units in the 
container are wrapped. Products containing discrete units in a 
container weighing less than 200 percent of the RACC were required to 
be labeled as a single-serving container under the 1993 requirements, 
unless the product qualified for the large-RACC exception discussed in 
section III.B. We did not propose to change this requirement in the 
proposed rule and are not changing it in the final rule. Other 
provisions of our regulations permit additional flexibility with 
respect to how products in discrete units are labeled. As explained in 
response to comment 12 and as reflected in Sec.  101.9(b)(6), for 
products that are packaged and sold individually (i.e., products 
bearing a Nutrition Facts panel) that contain more than 150 percent and 
less than 200 percent of the applicable reference amount, manufacturers 
may voluntarily add a second column of nutrition information to the 
left of the column that provides nutrition information per container 
that will provide nutrition information per common household measure 
that most closely approximates the reference amount. This would allow 
manufacturers of products that are packaged and sold individually and 
that contain two discrete units weighing more than 75 percent and less 
than 100 percent of the reference amount to voluntarily provide a 
second column that provides nutrition information per unit. 
Additionally, for packages that weigh less than 200 percent of the RACC 
each and that are contained within a larger outer container, 
manufacturers have the option of labeling each individual package with 
a Nutrition Facts panel that states that the individual package or 
container is one serving, and then labeling the outer container to 
state the number of servings as the number of individual packages 
within the outer container (Sec.  101.9(b)(8)(iv)). Finally, in order 
to provide additional flexibility to manufacturers that want to list 
nutrition information per unit of food, this final rule amends Sec.  
101.9(b)(10)(ii), which allows manufacturers to provide an additional 
column of nutrition information ``[p]er one unit if the serving size of 
a product in discrete units in a multiserving container is more than 1 
unit.'' This final rule removes language in Sec.  101.9(b)(10)(ii) 
limiting the provision to use only with multiserving containers. These 
amendments will allow single-serving products to voluntarily provide an 
additional column of nutrition information per unit of a product that 
is in discrete units.
2. Single-Serving Container Option for Large-RACC Products
    (Comment 11) Several comments said that our analysis of the 
correlation between the consumption variation and the RACCs for all 
products containing less than 200 percent of the applicable RACC is 
flawed. The comments stated that we defined the average variability in 
the analysis as the standard deviation as a percent of the mean and 
that this represents the standard deviation of individual intakes from 
one person to the next. The comments stated that the standard 
deviations of the medians in all tables in our analysis are actually 
the standard errors of the medians and not the standard deviations of 
individual intakes as previously described (Ref. 9). The comments 
stated that because we did not actually conduct the appropriate 
analysis, no conclusion should be drawn from these reported summaries.
    (Response 11) After carefully reexamining the data described in the 
Memorandum-to-file dated February 11, 2014 (Ref. 9), we agree that the 
standard deviations of the median are, in fact, the standard errors of 
the medians. Therefore, we have revised the correlation between the 
consumption variation and the RACCs for all products.
    We disagree, however, that no conclusion should be drawn because of 
the error. The revised correlation coefficient, after adjusting the 
standard errors to standard deviations by multiplying with square roots 
of the sample size, is reduced to 0.13 from 0.18. This means that there 
is an even lower 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.'' In other words, the 
correct calculation reinforces the conclusion that 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.
    (Comment 12) One comment expressed concern about the impact that 
removing the exception for large-RACC products in Sec.  101.9(b)(6) 
would have on products with varying densities. According to the 
comment, some varieties of the same type of product have serving sizes 
that are less than 200 percent of the RACC, while other varieties of 
the same type of product have serving sizes that are 200 percent of the 
RACC or greater. The comment noted as an example canned soups of 
different varieties that are often packaged in the same size and type 
of container, for which the different varieties may have different 
densities (e.g., a cream-based soup may be heavier than a broth-based 
soup). According to the comment, under the proposed rule soups 
containing less than 200 percent of the RACC, or less than 490 g, would 
be required to be labeled as a single serving, while soups containing 
200 to 400 percent of the RACC, or 490 to 980 g, would be labeled with 
dual-column labeling.
    Another comment noted that inconsistencies in nutrition label 
formats could result from the use of single- and dual-column labeling 
for similar products which could lead to consumer confusion and make it 
difficult for consumers to compare identical products that may contain 
200 percent or more of the RACC and use a dual-column label with 
single-serving container products that use a single-column label (e.g., 
19 oz, 24 oz, and 40 oz products of identical formulation). The comment 
said that these products are often merchandised side-by-side in 
supermarkets and asserted that the

[[Page 34007]]

presence of two different serving sizes and two different formats 
(dual-column labeling for the 19 and 24 oz product versus single-column 
labeling for 13 and 15 oz products) would confuse the consumer.
    We also received a comment requesting that we allow voluntary dual-
column labeling for products that contain more than 150 and less than 
200 percent of the RACC to present nutrition information per serving 
and per common household measure closest to the RACC. The comment noted 
that under the proposed rule, such products would be single-serving 
containers and would be required to declare nutrition information on a 
``per container'' basis (proposed Sec.  101.9(b)(6)). The comment 
asserted that it would be appropriate to provide nutrition information 
on a ``per container'' basis for these products but noted that some 
consumers may not eat the entire container in one sitting. The comment 
suggested that some consumers would find it helpful to have nutrition 
information on the label for an amount of food that approximates or is 
closest to the RACC.
    One comment noted that it is a common practice for retailers to 
create a private label product with a ``slightly lower'' net content. 
In these instances, consumers would compare a brand name product to a 
private label product with a slightly lower net content and think the 
private label brand has a better nutritional profile than the brand 
name. The comment stated that this is because consumers would fail to 
understand that the nutritional difference is a result of the 
difference in net contents between the two products, not the actual 
nutritional value.
    (Response 12) We recognize that certain differences will appear on 
product labels between the amounts of nutrients per serving listed on 
products that contain close to, but less than, 200 percent of the RACC, 
and products that contain 200 percent of the RACC or more. Allowing 
products that contain less than 200 percent of the RACC to voluntarily 
display an additional column with nutrition information per common 
household measure that most closely approximates the reference amount 
will allow consumers to easily compare the nutrition information of 
products containing more than 150 percent but less than 200 percent of 
the RACC with products that contain 200 percent of the RACC or more. 
Therefore, we are amending Sec.  101.9(b)(6) to add a provision that 
allows manufacturers of products that contain more than 150 percent and 
less than 200 percent of the applicable reference amount to voluntarily 
add a second column of nutrition information to the left of the column 
that provides nutrition information per container (i.e., per serving) 
that will provide nutrition information per common household measure 
that most closely approximates the reference amount. This provision 
will allow consumers to compare more easily the nutrition information 
amongst similar products that are packaged in containers that are near 
200 percent of the RACC by allowing manufacturers to use a similar 
dual-column label format. This voluntary labeling provision is not 
limited to large-RACC products, but is permitted for all products that 
are packaged and sold individually in containers that are more than 150 
percent and less than 200 percent of the RACC.
    With regard to the concern that products of nearly identical size 
could appear to have significantly different amounts of nutrients per 
serving due to the fact that some products could be required to be 
labeled as a single serving while similar products could be labeled as 
having two servings, we note that the dual-column labeling requirements 
(see section III.C.) will help ensure that consumers have the 
opportunity to compare the nutritional information for the package as a 
whole for products containing at least 200 percent and up to and 
including 300 percent of the RACC with the serving size for those 
products containing just under 200 percent of the RACC.
    To address the comment that stated that a lower net content in some 
product manufacturing would cause consumers to think that a certain 
product has a better nutritional profile than another, we note that the 
nutrition information that is provided on these products would still be 
accurate. If the net content is lower, the amount of product a person 
is likely to consume is also lower, which is reflected in the nutrition 
information on the label.
    (Comment 13) We received numerous comments that supported the 
removal of the exemption for large-RACC products from the definition of 
a single-serving container. These comments stated that products 
containing less than 200 percent of the RACC are likely to be consumed 
in a single eating occasion and should be labeled as a single serving.
    Several comments opposed the removal of language from Sec.  
101.9(b)(6), which gives manufactures the flexibility to label large-
RACC products that contain more than 150 percent but less than 200 
percent of the RACC as 1 or 2 servings, or to label packages that 
contain 200 percent or more of the applicable RACC as a single serving 
if the contents of the entire package can reasonably be consumed at a 
single eating occasion. The comments stated that eliminating this 
option takes away a manufacturer's flexibility and asserted that 
manufacturers are in the best position to determine if a product should 
be labeled as one or two servings. Other comments stated that labeling 
products with less than 200 percent of the RACC as one serving may not 
be appropriate for all foods. For example, several comments stated that 
some side dishes, such as frozen potato products, frozen vegetables, 
and macaroni and cheese kits, are consumed in smaller quantities than 
entr[eacute]e items, and a consumer could not reasonably consume an 
amount close to 200 percent of the RACC.
    A few comments objected to requiring products that were previously 
labeled as two servings to be labeled as one serving and asserted there 
was no change in consumption data. Other comments did not like the 
``one size fits all'' approach and suggested that we look at actual 
usage of each product category before requiring that a product be 
labeled as a single serving. One comment noted that labeling products 
that are regulated by FDA and the USDA, such as chili, soup, stews, and 
several mixed dishes that often come in 15 oz cans (425 g), as a single 
serving would be a shift from the industry standard of labeling cans of 
this size as containing ``about 2 servings.''
    (Response 13) We disagree with the comments opposing the removal of 
the option of large-RACC products (i.e., those products with an RACC of 
100 g or 100 mL or larger) that contain more than 150 percent but less 
than 200 percent of the RACC to be labeled as one or two servings. We 
also disagree with the assertion that there has been no change in 
consumption data since 1993. 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, in 1993, we concluded that 
it was much less likely that a person would consume approximately twice 
the reference amount of a food with a

[[Page 34008]]

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 large RACCs, 150 
percent may be a reasonable cutoff for a single-serving container (58 
FR 2229 at 2233).
    However, as discussed previously in this document, in developing 
the 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 
and products that have RACCs that are less than 100 g (or mL), using 
combined consumption data from the NHANES 2003-2008 surveys (Ref. 9). 
The result shows that the correlation coefficient is 0.13, 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.'' In other 
words, it is not less likely that a person would consume approximately 
twice the reference amount of a food with a large RACC than it is that 
he or she would consume approximately twice the reference amount of a 
food with a smaller reference amount. Therefore, we determined that the 
exemption from the requirement to label a product with a large RACC 
that contains more than 150 percent but less than 200 percent of the 
applicable RACC as a single-serving container is no longer warranted. 
We are also working with USDA to harmonize our regulations.
    In response to the comments that stated that we are reducing the 
flexibility of our regulations, although we work to increase the 
flexibility of our regulations when appropriate, the purpose of this 
option was not to allow manufacturers the ability to make a choice, but 
to allow for foods to be labeled in a way that reflects how much a 
person is consuming a certain product. Our decision to remove this 
option is based on the data indicating that consumers are consuming the 
same amount of large-RACC products in proportion to the RACC as they 
are of smaller-RACC products in proportion to the RACC.
    To address the comments that stated that not all foods that are 
less than 200 percent of the RACC should be considered a single 
serving, we reiterate that research demonstrates that package and 
portion sizes tend to have a considerable impact on the amount of food 
consumed (Refs. 10 and 11). We also note that we did not propose to 
change the upper limit for the definition of a single serving container 
in the serving size proposed rule. Additionally, as explained in 
comment 12, we are amending Sec.  101.9(b)(6) to allow manufacturers of 
products that contain more than 150 percent and less than 200 percent 
of the applicable reference amount to voluntarily add a second column 
of nutrition information to the left of the column that provides 
nutrition information per container, which will provide nutrition 
information per common household measure that most closely approximates 
the reference amount.
    (Comment 14) Some comments stated that requiring products that were 
previously labeled as two servings to be labeled as one serving would 
encourage consumers to eat more. One comment asserted that the 
information on the label of a single-serving container could discourage 
consumption of a particular food product due to the quantity of a 
specific nutrient in the container or other information about the 
product, while on the whole that product could provide valuable 
nutrients in the diet. The comment gave an example of a frozen 
entr[eacute]e that may be high in saturated fat, yet be a good source 
of protein, dietary fiber, and potassium. The comment stated that, if 
consumers were to focus only on the saturated fat content of the 
product, they may choose not to eat the frozen entr[eacute]e, even 
though it is a good source of other essential nutrients.
    (Response 14) As noted previously, research demonstrates that 
package and portion sizes tend to have a considerable impact on the 
amount of food consumed (Refs. 10 and 11). We acknowledge that certain 
consumers may pay attention to specific, individual nutrients, but one 
of the main goals of nutrition labeling is to provide consumers with 
accurate nutrition information to assist them in maintaining healthy 
dietary practices. If a product is high or low in a specific nutrient 
for which an individual consumer is looking to either increase or 
decrease intake, this information is useful to consumers who are 
interested in the specific nutrient. Consumer education on 
understanding the Nutrition Facts label and the diet can be used to 
help explain the benefits and risks associated with the intake of 
nutrients. Additionally, for products that satisfy the requirements to 
make a nutrient content claim such as a ``good source'' claim (see 21 
CFR 101.54), the product may include such a claim to draw attention to 
the positive attributes of the product.

C. Dual-Column Labeling

    Preexisting Sec.  101.9 provides various provisions for types of 
voluntary dual-column labeling (e.g., paragraphs (b)(10), (e), and 
(h)(4)) and one provision for mandatory dual-column labeling under 
certain circumstances (paragraph (b)(11)). In comment 10 we discuss a 
revision in this final rule to the voluntary dual-column labeling 
provision in Sec.  101.9(b)(10)(ii), which broadens the scope of the 
provision to allow dual-column labeling per unit for single-serving 
products. Also, in comment 12 we discuss a new voluntary provision for 
dual-column labeling for products that are packaged in containers that 
include more than 150 percent but less than 200 percent of the RACC, in 
Sec.  101.9(b)(6).
    In the preamble of the proposed rule (79 FR 11989 at 11998 to 
11999), we cited research that shows 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 (Refs. 14 and 15). In the preamble of the 
proposed rule (79 FR 11989 at 11999), we also discussed consumer 
research that we conducted to help increase our understanding of 
whether modifications to the label format may help consumers use the 
label. Our 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. The main findings from this study are that the availability of 
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 single-column labels that listed two servings per 
container.
    The proposed rule would require, under certain circumstances, the 
use of dual-column labeling to provide nutrition information per 
serving and per container (proposed Sec.  101.9(b)(12)(i)), or per 
serving and per unit of food (proposed Sec.  101.9(b)(2)(i)(D)). As 
noted in the preamble of the proposed rule, such dual-column labeling 
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

[[Page 34009]]

eating occasions or share the container with others (79 FR 11989 at 
12003).
    In the preamble of the proposed rule we stated that to determine an 
upper limit for the range of package sizes for which dual-column 
labeling would be required, we looked at food consumption data from 
NHANES 2003-2008 surveys (Ref. 16) (79 FR 11989 at 12003). The 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. Therefore, we determined that dual-column labeling for packages 
containing at least 200 percent of and up to and including 400 percent 
of the RACC would capture the most frequent consumption habits for 
almost all product categories. Conversely, the data show that products 
that contain more than 400 percent of the current RACC are less likely 
to be consumed in one eating occasion compared to products that contain 
400 percent or less of the current RACC. Therefore, we proposed dual-
column labeling to be required for all packages that contain at least 
200 percent of and up to and including 400 percent of the applicable 
RACC (proposed Sec.  101.9(b)(12)(i)).
    In the preamble of the proposed rule (79 FR 11989 at 12004) we 
requested comment on exemptions from dual-column labeling for products 
that require further preparation, such as macaroni and cheese kits, 
pancake mixes, pasta products, and for products that are commonly 
consumed in combination with other foods (e.g., cereal and milk), and 
that contain at least 200 percent and up to and including 400 percent 
of the applicable RACC. 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)). Some of these products voluntarily contain two columns of 
nutrition information on the ``as purchased'' and ``as prepared'' forms 
of the food. Therefore, we tentatively concluded in the proposed rule 
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, and for products 
that are commonly consumed in combination with other foods (e.g., 
cereal and skim milk) (Sec.  101.9(h)(4)) should be exempt from the 
dual-column labeling requirements.
    In Sec.  101.9(b)(12)(ii) we proposed to require that if a health 
or nutrient content claim is made on the label of a product that uses 
dual-column labeling, as would be required under proposed Sec.  
101.9(b)(12)(i) and (b)(2)(i)(D), the claim would be required to be 
followed by a statement that sets forth the basis on which the claim is 
made if the product qualifies for the claim based on the amount of the 
nutrient per RACC and not the amount in the entire container or unit of 
food (e.g., for nutrient content claims, ``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'').
    As noted previously in the introduction to section III.B., we also 
proposed to remove the text in preexisting 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. Proposed Sec.  
101.9(b)(2)(i)(D) states that 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 DVs for the 
individual unit, as well as the preexisting columns listing the 
quantitative amounts and percent DVs for a serving that is less than 
the unit (i.e., the serving size derived from the RACC).
1. General Comments on Dual-Column Labeling
    (Comment 15) We received several comments in support of the dual-
column labeling requirements as proposed. The comments stated that 
because consumers may eat a full package of food regardless of its 
serving size, those consumers must be able to easily understand the 
nutrition content of the full package of food as consumed. A few 
comments stated that consumers who might otherwise simply assume that 
the Nutrition Facts label applies to the entire package would see, at a 
glance, that the nutrition information for the entire package is 
considerably greater than the serving size. These comments stated that 
seeing two sets of nutrition information per serving and per container 
could prompt people to think about the portion size they are consuming.
    Some comments mentioned specific food product categories that they 
thought would be ideal for dual-column labeling because they are 
sometimes consumed by a single person in one eating occasion and 
sometimes eaten over multiple meals or by multiple people. The products 
mentioned in the comments included pints of ice cream, frozen pizzas, 
main entr[eacute]es, side dishes, frozen vegetables, bags of chips, 
large candy bars, snack foods, cookies, and 20 oz sodas.
    (Response 15) We agree that dual-column labeling will help 
consumers more easily understand the contents of a particular package 
both on a per-serving and per-container basis. As discussed in the 
introduction to section III.C., research suggests that dual-column 
labeling helps consumers understand the amount of nutrients in an 
entire container of food. The foods that were listed in the comments as 
being appropriate for dual-column labeling are similar to the foods 
that were mentioned in the April 4, 2005, Advance Notice of Proposed 
Rulemaking (ANPRM) 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'' as foods that consumers thought were single 
servings, but were really multiple servings (70 FR 17010 at 17013). To 
the extent these comments suggest that the requirements relating to 
dual-column labeling should apply only to certain types of products, we 
disagree. This issue is addressed in our response to comment 19.
    (Comment 16) We received several comments that opposed the 
additional wording that we proposed to require in Sec.  
101.9(b)(12)(ii) if a health or nutrient content claim is made on a 
product containing a dual-column label. The comments asserted that the 
proposed statements are too lengthy and unnecessary, would clutter the 
label and take focus away from information in the claim, and would 
create inconsistency across package sizes. The comments asserted that 
there is no consumer research to establish that nutrient content claims 
on dual-column labels present the potential for consumer confusion 
(i.e., without the ``basis'' language), that consumers would believe 
that the claims are based on an entire container in the event dual-
column labeling were used, or that the proposed language would assist 
consumers in understanding the basis for the claim. The comments 
further questioned whether we had an adequate legal basis for requiring 
the proposed explanatory statement and noted that there is a current 
regulation that allows for indicating the basis of a claim if the claim 
is not based on the RACC. A few comments indicated that if some type of

[[Page 34010]]

statement becomes necessary, then it should be very simple and short, 
such as the addition of ``per serving'' or ``per X oz. serving.'' We 
received one comment in support of the statement as proposed. We 
received one comment that requested we limit the qualifying statement 
to nutrient content claims about the absence of a nutrient (e.g., low 
fat), as when these type of claims are made on products that include a 
dual-column label, the product would only meet the criteria for the 
claim on the basis of the RACC and per labeled serving, but not the 
entire container.
    (Response 16) We do not agree that a statement explaining the basis 
of a nutrient content claim or health claim, as described in proposed 
Sec.  101.9(b)(12)(ii), is always unnecessary. Because the use of dual-
column labeling per serving and per container will become more 
prevalent on food labels, consumers will more often encounter nutrition 
claims on foods with dual-column labeling. When consumers encounter a 
nutrient content claim or health claim (e.g., low fat) and are also 
presented with two sets of nutrition information (i.e., per serving 
information and per container information), and the criteria for the 
claim would only be met based on the set of nutrition information that 
does not apply to the entire container or unit, as applicable, 
explanation is needed to avoid consumer deception and clarify which set 
of nutrition information the claim applies to. When the claim relates 
to the nutritional information presented in one column, but not the 
other, the possibility for consumer deception is self-evident. Due to 
the expected use of nutrient content claims and health claims on 
products using dual-column labeling, we want to ensure that consumers 
understand the basis on which the claim is made. We are authorized to 
prohibit claims that are false or misleading under sections 403(a) and 
201(n) of the FD&C Act. See also Cent. Hudson Gas & Elec. Corp. v. 
Public Serv. Comm'n, 447 U.S. 557, 593 (1980) (explaining that ``false 
and misleading commercial speech is not entitled to any First Amendment 
protection''). Current provisions for claims require a manufacturer to 
communicate if a product meets the criteria for a nutrient content 
claim or health claim only on the basis of the reference amount (e.g., 
a product with a serving size of 2 cookies weighing 35g, but that only 
meets the criteria for a nutrient content claim based on the 30 g RACC 
for cookies) (Sec.  101.12(g)), but there are currently no provisions 
which require a claim to explain which set of nutrition information it 
is based on in the context of dual-column labeling. When a nutrient 
content claim or health claim is made on a package that does not use 
dual-column nutrition labeling, consumers are provided with only one 
set of nutrition information (based on the serving size) in the 
Nutrition Facts label to associate with the claim. In the case of dual-
column labeling, however, consumers are presented with two sets of 
nutrition information and would not be able to determine which set of 
data to associate with the claim. Therefore, in order to help consumers 
understand the context of the claim, there is a need for a provision 
requiring a statement that sets forth the basis on which the claim is 
made under certain circumstances when dual-column labeling is presented 
on the product label.
    We agree, however, that the proposed statements could be lengthy. 
The comments provided examples of concise language that could accompany 
nutrient content claims and still meet the objective of indicating the 
basis of the claim. We agree that, when possible, shorter clarifying 
statements on the food label are preferable and that more concise 
language than that in proposed Sec.  101.9(b)(12)(ii) is available for 
nutrient content claims. Therefore, for nutrient content claims, Sec.  
101.9(b)(12)(ii) requires manufacturers to state that the claim refers 
to the amount of a nutrient per serving or per reference amount but 
allows the use of simpler language to explain the basis on which 
nutrient content claims are made per serving (e.g., ``good source of 
calcium per serving'' or ``per X [insert unit]__serving'') or per 
reference amount (e.g., ``good source of calcium per [insert reference 
amount (e.g., per 8 ounces)]''), as required based on Sec.  101.12(g). 
For health claims, no examples of more concise language were provided 
in comments to the proposed rule, and upon further evaluation of the 
explanatory statement provided in the proposed rule (i.e., ``A serving 
of __ounces of this product conforms to such a diet''), we believe that 
the statement is as concise as possible to convey the intended message. 
Health claims, as opposed to nutrient content claims, already 
frequently require informational statements related to the substance of 
the claim, the disease condition, and/or the target populations. 
Therefore, we conclude that the statement related to the basis of the 
claim, as proposed, is an appropriate statement to include with health 
claims, is consistent with other types of accompanying statements to 
health claims, and is as concise as needed for the intended message.
    With regard to the assertion that the additional wording that we 
proposed to require in Sec.  101.9(b)(12)(ii) if a health or nutrient 
content claim is made on a dual-column label would create inconsistency 
across package sizes, we note that distinctions already may arise among 
products of different sizes with regard to which package sizes are 
eligible to bear a nutrient content or health claim. Claims are 
typically based on the RACC, but in some cases they are based on both 
an RACC and a per label serving size. Existing requirements may already 
result in differences in the eligibility of a food packaged in 
different forms (e.g., bulk package versus individual serving packages) 
to bear a specific claim. Likewise, differences exist with regard to 
the ability of products to make nutrient content or health claims 
because of the variety of possible size options (e.g., one very large 
cookie versus an individual serving container of small cookies).
    With regard to the comment that suggested the requirement to 
include the qualifying statement should be limited to nutrient content 
claims about the absence of a nutrient, we disagree with establishing a 
limitation based on the specific claim at issue (e.g., low fat) but 
agree with the comment to the extent that it suggests that the 
qualifying statement should not be required on product labels when the 
product would meet the criteria to make the claim at issue based on 
both columns of nutritional information. We agree, for example, that if 
a product for which dual-column labeling would be required under Sec.  
101.9(b)(12)(i) were to contain sufficient vitamin C per serving to 
make a ``high'' claim regarding vitamin C content, and the container as 
a whole were to meet the criteria for a ``high'' in vitamin C claim, 
consumers are not likely to be misled by the presence of such a claim 
in the absence of a qualifying statement. The language in proposed 
Sec.  101.9(b)(12)(ii) already provides an exception from the 
requirement for products when the nutrient that is the subject of the 
claim meets the criteria based on the entire container or unit amount. 
We have modified that language in the final rule to explain that a 
clarifying statement is not required for products when the nutrient 
that is the subject of the claim meets the criteria for the claim based 
on the reference amount for the product and the entire container or the 
unit amount.
    (Comment 17) One comment questioned our legal authority to require 
dual-column labeling. The comment

[[Page 34011]]

stated that section 403(q)(1)(A)(i) of the FD&C Act requires nutrition 
information to be provided on the basis of an amount customarily 
consumed and which is expressed in a common household measure that is 
appropriate to the food. The comment stated that the quantity of 
nutrients in a package or unit that contains at least 200 percent and 
up to and including 400 percent of the RACC is not an amount 
customarily consumed and that none of the exemptions stated in the NLEA 
give us the authority to require nutrition information to be declared 
on the basis of an amount other than the serving size.
    (Response 17) We disagree with the suggestion that we lack the 
legal authority to require dual-column labeling. The mandatory dual-
column label will continue to provide nutrition information based on 
the labeled serving size, which is the amount that is customarily 
consumed. As explained previously in section II.B., the primary legal 
authority for requirements pertaining to the labeled serving size is 
derived from section 403(q)(1)(A) of the FD&C Act, with additional 
authority coming from section 2(b)(1)(B) of the NLEA. Additionally, the 
legal authority for the second column in a dual-column label is derived 
from section 2(b)(1)(A) of NLEA, which states that requirements in 
regulations issued under the authority of the NLEA 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'' (79 FR 11989 at 
11991). As explained previously in section III.C. and in the preamble 
to the proposed rule (79 FR 11989 at 11999), consumer research shows 
that the availability of dual-column labels results in more 
participants correctly identifying the number of calories per container 
and the amount of other nutrients per container compared to single-
column labels that listed two servings per container. Additional 
authority for the dual-column labeling requirements includes section 
701(a) of the FD&C Act, which provides us with authority to issue 
regulations for the efficient enforcement of the FD&C Act.
    (Comment 18) One comment asserted that we failed to consider 
certain First Amendment concerns associated with the proposed dual-
column labeling requirements. The comment asserted that the purpose of 
dual-column labeling is to shape consumer behavior rather than to 
provide purely factual information, and that we justified our proposal 
to require dual-column labeling based on a study that concluded that 
dual-column labeling reduces snack food consumption when compared to 
single-column labeling for people who are not currently dieting. The 
comment stated that by explaining that we would continue to conduct 
consumer research throughout the rulemaking process to help enhance our 
understanding of whether and how much any modifications to the label 
format may help consumers use the label, we impliedly conceded the 
insufficiency of our reliance on this study in the proposed rule.
    The comment further questioned our asserted reliance on statutory 
authority granted in section 2(b)(1)(A) of the NLEA in light of our 
mandate to implement regulations in accordance with the First 
Amendment. The comment asserted that because dual-column labeling ``is 
unnecessarily duplicative,'' the dual-column labeling requirement would 
be subject to analysis under the standard set forth in Central Hudson 
Gas & Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557 (1980), rather 
than Zauderer v. Office of Disciplinary Counsel of Supreme Court, 471 
U.S. 626 (1985). The comment asserted that the Supreme Court's decision 
in Zauderer and its progeny supports the proposition that the 
government may require a clarifying disclosure ``to dissipate the 
possibility of consumer confusion or deception'' after finding that the 
possibility of deception is ``self-evident,'' id. at 652, and that 
mandatory disclosures are not permitted unless the state demonstrates 
an actual likelihood that consumers will be misled absent the 
disclosure.
    The comment asserted that we admitted that the dual-column labeling 
requirement attempts to influence consumer behavior by discouraging 
consumers from consuming food that is packaged between 200 percent and 
400 percent of the RACC. The comment stated that we failed to establish 
that dual-column labeling would serve a substantial government interest 
in discouraging consumption of food that is packaged between 200 
percent and 400 percent of the RACC. The comment further asserted that 
we failed to establish in the proposed rule that dual-column labeling 
would have a discernable effect on consumer behavior and, therefore, 
that the proposed rule cannot satisfy the third prong of Central Hudson 
in that it did not present evidence that dual-column labeling would 
directly advance the interest in promoting consumer health and 
preventing overconsumption of certain foods. The comment stated that we 
rely in part on study results suggesting that dual-column labeling 
reduces snack food consumption but asserted that we failed to consider 
the effect of dual-column labeling on consumption of other categories 
of food besides snacks. According to the comment, we inexplicably 
concluded, based on studies of ``junk foods'', that consumption of all 
foods packaged as RACCs between 200 percent and 400 percent should be 
discouraged.
    The comment asserted that the dual-column labeling requirement as 
proposed is ``vastly overbroad'' and fails to satisfy Central Hudson's 
reasonable fit test, in part because we acknowledged in the proposed 
rule that modifying the Nutrition Facts label would require some 
reeducation on how to read the Nutrition Facts label. The comment 
asserted that we failed to adequately consider comments that suggested 
that the dual-column format may be confusing and that we erroneously 
suggested that the burden is on opponents of the regulation to provide 
evidence that dual-column labeling may be confusing.
    (Response 18) We recognize the importance of the First Amendment 
protections raised in this comment, and we disagree with the assertion 
that we neglected to consider such protections in proposing the dual-
column labeling requirements. In Zauderer, the Supreme Court explained 
that ``[b]ecause the extension of First Amendment protection to 
commercial speech is justified principally by the value to consumers of 
the information such speech provides, [a speaker's] constitutionally 
protected interest in not providing any particular factual information 
in his advertising is minimal.'' 471 U.S. at 651 (emphasis in original) 
(internal citations omitted). Requirements ``to make purely factual 
disclosures related to . . . business affairs, whether to prevent 
deception or simply to promote informational transparency, have a 
`purpose . . . consistent with the reasons for according constitutional 
protection to commercial speech' . . . [and] facilitate rather than 
impede the `free flow of commercial information.' '' Beeman v. Anthem 
Prescription Mgmt., 58 Cal. 4th 329, 356 (Cal. 2013) (quoting 44 
Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 501 (1996) and Va. 
Pharmacy Bd. v. Va. Consumer Council, 425 U.S. 748, 765 (1976), 
respectively). As a result, government requirements to disclose factual 
commercial information are subject to a more lenient constitutional 
standard than that set forth under the Central Hudson framework. 
Zauderer, 471 U.S. at 651. Under Zauderer, the government can

[[Page 34012]]

require disclosure of factual information in the realm of commercial 
speech as long as the disclosure provides accurate, factual 
information; is not unjustified or unduly burdensome; and is 
``reasonably relate[d]'' to an adequate interest. Id.
    Contrary to the comment's assertion, the validity of the dual-
column labeling requirements under the First Amendment is properly 
evaluated under Zauderer, 471 U.S. 626, rather than Central Hudson, 447 
U.S. 557. Courts generally apply Zauderer's rational relationship test, 
as opposed to intermediate scrutiny under Central Hudson, ``in 
compelled commercial disclosure cases'' because ``mandated disclosure 
of accurate, factual, commercial information does not offend the core 
First Amendment values of promoting efficient exchange of information 
or protecting individual liberty interests.'' Nat'l Elec. Mfrs. Ass'n 
v. Sorrell, 272 F.3d 104, 114-15 (2d Cir. 2001) (explaining that the 
disclosure of accurate, factual commercial information ``furthers, 
rather than hinders, the First Amendment goal of the discovery of 
truth''). Case law interpreting Zauderer clarifies that the government 
need not establish that compelled disclosure will prevent consumer 
deception for the Zauderer standard to apply. In American Meat 
Institute v. USDA, the court held that ``[t]he language with which 
Zauderer justified its approach. . .sweeps far more broadly than the 
interest in remedying deception.'' 760 F.3d 18, 22 (D.C. Cir. 2014) (en 
banc). In reaching the conclusion that the applicability of Zauderer 
extends beyond regulations in which the government is attempting to 
mandate a disclosure to remedy deception, the court focused on the 
``material differences between disclosure requirements and outright 
prohibitions on speech,'' id. (quoting Zauderer, 471 U.S. at 650), the 
fact that ``the First Amendment interests implicated by disclosure 
requirements are substantially weaker than those at stake when speech 
is actually suppressed,'' id. (quoting Zauderer, 471 U.S. at 652 n.14), 
and the fact that ``[b]ecause the extension of First Amendment 
protection to commercial speech is justified principally by the value 
to consumers of the information such speech provides, [a] 
constitutionally protected interest in not providing any particular 
factual information in his advertising is minimal,'' id. (citing 
Zauderer, 471 U.S. at 651). The court found that, ``[a]ll told, 
Zauderer's characterization of the speaker's interest in opposing 
forced disclosure of such information as `minimal' seems inherently 
applicable beyond the problem of deception.'' Id. Several other 
circuits concur. See Pharm. Care Mgmt. Ass'n v. Rowe, 429 F.3d 294, 
297-98, 310, 316 (1st Cir. 2005); N.Y. State Rest. Ass'n v. N.Y. City 
Bd. of Health, 556 F.3d 114, 133 (2d Cir. 2009); Nat'l Elec. Mfrs. 
Ass'n v. Sorrell, 272 F.3d 104, 115 (2d Cir. 2001) (affirming use of 
the ``reasonable-relationship'' Zauderer standard when ``the compelled 
disclosure at issue . . . was not intended to prevent `consumer 
confusion or deception'''); Discount Tobacco City & Lottery, Inc. v. 
United States, 674 F.3d 509, 556 (6th Cir. 2012) (holding that 
``Zauderer's framework can apply even if the required disclosure's 
purpose is something other than or in addition to preventing consumer 
deception''); CTIA--The Wireless Ass'n[supreg] v. City of Berkeley, No. 
C-15-2529, 2015 U.S. Dist. LEXIS 126071, at *46 (N.D. Cal. 2015) 
(holding that Zauderer is not ``limited to preventing consumer 
deception'' and explaining that ``it would make little sense to 
conclude that the government has greater power to regulate commercial 
speech in order to prevent deception than to protect public health and 
safety'').
    The dual-column labeling requirements readily satisfy the Zauderer 
test. First, the proposed dual-column labeling provisions, which are 
being finalized in this rule, require accurate disclosures of factual 
commercial information. The required disclosure will help facilitate 
the free flow of commercial information and does not ``prescribe what 
shall be orthodox in politics, nationalism, religion, or other matters 
of opinion.'' Zauderer, 471 U.S. at 651 (quoting W. Va. State Bd. of 
Educ. v. Barnette, 319 U.S. 624, 642 (1943)). The comment did not 
dispute the accuracy of the information at issue.
    Second, the dual-column labeling requirements would not be unduly 
burdensome. Factual nutrition information is currently required to be 
provided on packaged foods. While dual-column labeling will require 
more space on certain packages for factual nutrition information, the 
majority of the label space on products subject to the dual-column 
labeling requirements will still be available for product messaging by 
the manufacturer. We also note that, as discussed in our economic 
analysis (Ref. 17), the cost to manufacturers is relatively low under 
the compliance timelines in the final rule which will allow most 
manufacturers to add dual-column labeling during regularly scheduled 
label changes for their products. Additionally, this final rule reduces 
from the proposed rule the amount of products for which dual-column 
labeling will be required, as we are lowering the upper limit for which 
dual-column labeling is required from those containers weighing up to 
400 percent of the RACC to those containers weighing up to 300 percent 
of the RACC. Furthermore, certain packages for which dual-column 
labeling would require a greater proportion of the label space are 
exempt from these requirements. For example, under Sec.  
101.9(b)(12)(i)(A), the dual-column labeling requirements in Sec.  
101.9(b)(12) do not apply to 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).
    Third, the requirement to provide dual-column labeling is 
reasonably related to the Government's interests in promoting the 
public health and providing consumers access to factual information 
that will help them understand the nutrient content on certain packages 
that contain more than one serving of food. The factual information 
could be used to assist consumers in maintaining healthy dietary 
practices. Recent NHANES data shows that products containing up to and 
including 300 percent of the RACC could reasonably be consumed in a 
single eating occasion. Additionally, our research demonstrates that 
some consumers may have difficulties determining nutrition information 
per container when a label declares that the package contains more than 
one serving and is reasonably consumed in a single eating occasion. Our 
recent format experimental study, however, showed that, in the case of 
a proposed label with percent DVs listed on the left of the label, 
dual-column labeling improved the percentage of participants that were 
able to identify correctly the amount of nutrients in the entire 
container. In addition, our recent eye-tracking study showed 
participants both the current and proposed format of the Nutrition 
Facts labels, with one label showing one serving and the other two 
servings. Only about half of the participants noticed the number of 
servings on the label, and less than one third of the participants were 
able to identify which product contained fewer calories per container 
(Refs. 18 and 19). These results suggest that some consumers may not 
correctly recognize the accurate nutrient contents of packages 
containing more than one serving, including packages that may be 
consumed in a single eating occasion,

[[Page 34013]]

and therefore may not be able to use the label information to assist 
them in maintaining healthy dietary practices.
    The dual-column labeling requirement is reasonably related to the 
Government's interest in enhancing consumer understanding of nutrient 
packaging and promoting the public health because it presents nutrition 
information in a manner that is easy to understand, giving consumers 
helpful tools to assist them in maintaining healthy dietary practices. 
As noted previously, our research shows that some consumers have 
difficulty determining the nutrient amounts in packages that contain 
more than one serving of food and that do not display the nutrient 
content of the entire package on the product label. Dual-column 
labeling helps to ensure that consumers have access to nutrient 
information for containers of certain sizes that could reasonably be 
consumed in a single eating occasion and therefore could assist 
consumers in maintaining healthy dietary practices.
    The comment incorrectly asserts that the purpose of the proposed 
dual-column labeling requirements is to shape consumer behavior by 
discouraging consumption of food in containers that weigh between 200 
percent and 400 percent of the reference amount. As explained in the 
proposed rule (see 79 FR 11989 at 12003), and as reiterated in this 
final rule, the purpose of dual-column labeling is not to discourage 
the consumption of certain foods but rather to increase consumer 
understanding of the quantity of nutrients in packages and containers 
of certain sizes that may be reasonably consumed in a single eating 
occasion. The reference provided in the proposed rule to a study that 
showed a reduction in snack food consumption amounts was included for 
the purpose of demonstrating that dual-column labeling could raise 
contextual awareness of the quantity of nutrients in a given container. 
While the reduction in the consumption amounts for certain products 
could potentially be associated with dual-column labeling, such changes 
in consumption are not the purpose of the requirement. Our findings, 
both as reported in the proposed rule and as explained previously in 
this final rule, demonstrate that the presence of dual-column labeling 
could help consumers understand the quantity of nutrients they are 
actually consuming if they consume the entire package in one eating 
occasion. Consumption data further shows that it is reasonably likely 
that some consumers will consume, in a single eating occasion, the 
entire container of products containing at least 200 percent and up to 
and including 300 percent of the RACC. We therefore disagree with the 
assertion that the dual-column labeling requirement ``is unnecessarily 
duplicative'' or that our reliance on the statutory authority granted 
in section 2(b)(1)(A) of NLEA conflicts with our obligation to 
promulgate regulations consistent with the protections granted by the 
First Amendment. Additionally, as discussed in the preamble to the 
proposed rule (79 FR 11989 at 11998), there is evidence that consumers 
do not correctly calculate nutrient amounts in food products by 
multiplying the nutrient amount by the number of servings per 
container, and research shows that dual-column labeling can help 
consumers more accurately determine the number of calories and 
nutrients in a food product compared to single-column labeling (Ref. 
15). In short, dual-column labeling provides consumers with information 
that can assist them in maintaining healthy dietary practices.
    While we disagree that the Central Hudson standard would be 
applicable to the requirement to provide a second column of nutrition 
information, the requirement to provide dual-column labeling would 
nonetheless be Constitutional under the standard set forth in Central 
Hudson, 447 U.S. 557. If the Central Hudson standard were applicable to 
the evaluation of the dual-column labeling requirement, we would be 
required to identify a ``government interest [that] is substantial,'' 
establish that ``the regulation directly advances the government 
interest asserted,'' and show that the regulation ``is not more 
extensive than is necessary to serve that interest.'' Id. at 566. Under 
the Central Hudson test, we have the discretion to ``judge what manner 
of regulation may best be employed'' to serve the substantial 
government interest. See City of Cincinnati v. Discovery Network, Inc., 
507 U.S. 410, 416 n.12 (1993) (citing Bd. of Trs. v. Fox, 492 U.S. 469, 
480 (1989)).
    There can be no question that the government has a substantial 
interest in promoting the health of its citizens. E.g., Rubin v. Coors 
Brewing Co., 514 U.S. 476, 485 (1995). Our asserted interests are in 
promoting the public health and ensuring consumer access to information 
that could assist in maintaining healthy dietary practices. These 
interests are substantial because the consumption of excess and limited 
amounts of certain nutrients is linked to risk of chronic disease.
    Dual-column labeling directly advances our asserted interests in 
promoting the public health and ensuring that consumers have access to 
information that could assist in maintaining healthy dietary practices. 
Our research shows that providing a second column of nutrition 
information on containers of certain sizes provides consumers 
information that allows them to understand the nutrient content of 
packaged foods. We disagree that our decision is based on ``mere 
speculation or conjecture.'' See Rubin, 514 U.S. at 487. Our conclusion 
that dual-column labeling helps consumers understand the nutrient 
content of packaged foods when a label declares the package contains 
more than one serving and is reasonably consumed in a single eating 
occasion is supported by the consumer research cited throughout this 
document (Refs. 13 and 17).
    Finally, the requirement to provide a second column of nutrition 
information is no more extensive than necessary to serve its purpose. 
See Central Hudson, 447 U.S. at 566. The standard is not a ``least 
restrictive means'' test, and instead requires a reasonable fit between 
the ends and the narrowly tailored means chosen to accomplish those 
ends. Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 556 (2001). The 
dual-column labeling requirement requires only factual disclosures of 
information about the nutrient content of products, and the required 
disclosure is limited to the information that we have determined is 
necessary to assist consumers in maintaining healthy dietary practices. 
The required disclosure is confined to one area of the food label and 
will enable consumers to understand the information in the Nutrition 
Facts label. Overall, this additional factual disclosure is limited in 
scope, and there are not ``numerous and obvious less-burdensome 
alternatives'' to this requirement. See Discovery Network, 507 U.S. at 
418 n. 13. In our research we looked at labels that provided a second 
column only for calories. Our research showed that this type of label 
was not as effective as providing a full second column of information 
about all nutrients listed on the Nutrition Facts label because 
different consumers are mindful of distinct nutrients and because the 
nutritional benefits of a product does not depend on a limited number 
of nutrients only. For example, some consumers need to ensure adequate 
consumption of specific vitamins or minerals, while others are 
concerned about protein intake. Full, dual-column nutritional 
information is more helpful to consumers and does not suggest that 
consumers should place greater emphasis only on selected nutrients. We 
therefore disagree with

[[Page 34014]]

the implication that this requirement is more burdensome than necessary 
because it requires the full set of nutritional information in the 
second column. Requiring that a second column of nutrition information 
appear on the label is a limited requirement that would serve the 
purpose of ensuring that consumers have access to information about the 
nutrient contents of packages and containers of certain sizes that 
could assist consumers in maintaining healthy dietary practices.
    We disagree with the comment's assertion that the dual-column 
labeling requirement is ``vastly overbroad,'' which the comment asserts 
is demonstrated by our intent to conduct consumer education once the 
rule is finalized. Such education efforts are beneficial any time such 
a significant change in our regulations is made, and the addition of a 
second column of nutrition information is not the sole basis for our 
plan to continue to educate consumers. Additionally, as noted 
previously, certain packages for which dual-column labeling would 
require a greater proportion of the label space are exempt from these 
requirements (see Sec.  101.9(b)(12)(i)(A)).
    Because the dual-column labeling requirement supports a government 
interest that is substantial, directly advances that government 
interest, and is no more extensive than is necessary to serve that 
interest, the requirement would pass Constitutional scrutiny under 
Central Hudson. However, as noted previously in this section, case law 
makes clear that Zauderer applies to cases in which the government 
mandates the disclosure of factual and accurate disclosures of 
commercial information, Zauderer, 471 U.S. at 651, as is the case here.
    With regard to other specific issues raised in this comment, we 
disagree with the assertion that by explaining that we would continue 
to conduct consumer research throughout the rulemaking process we 
impliedly conceded the insufficiency of our consumer research cited in 
the proposed rule. The consumption data and research cited in the 
proposed rule provides sound justification for dual-column labeling. 
Additionally, since the publication of the proposed rule, we have 
conducted an additional study that corroborates the results discussed 
in the proposed rule, i.e., that consumers were more likely to 
accurately determine the amount of nutrients shown on a label when 
dual-column labeling was used (Ref. 19). We continued to conduct 
research throughout the rulemaking process because the Lando and Lo 
study used the current format and we wanted to explore whether findings 
derived from that study would replicate on a different label format as 
outlined in our proposed rule. The subsequent study did, in fact, 
replicate the original finding that more consumers were able to 
accurately identify the amount of total nutrients shown on a product 
label when using the dual-column label, as compared to a single-column 
label with multiple servings per container (Ref. 15).
    We further disagree with the assertions that we justified our 
proposal for dual-column labeling based on one study or that our 
conclusions for dual-column labeling are based solely on a study of 
snack foods. In addition to the studies discussed in the previous 
paragraph, we received a citizen petition and many comments to the 
ANPRM from consumers that said that labeling products that were 
considered to be single servings as having two or more servings is 
``confusing'' and ``misleading.'' We also note that the labels tested 
in the Lando and Lo study (Ref. 15), which were also cited in the 
proposed rule, included sample Nutrition Facts labels for frozen meals, 
which are not considered ``snack foods.'' Dual-column labeling would 
require certain containers to display easy-to-understand nutrition 
information for the primary ways in which people consume these 
products. The studies that were cited in the proposed rule were used as 
part of the support for the need for dual-column labeling, not as our 
sole justification for dual-column labeling.
    Finally, we disagree that dual-column labeling may be confusing to 
consumers, that we failed to consider comments that suggested dual-
column labeling may be confusing, and that we have suggested that those 
who are looking to challenge the dual-column labeling requirements have 
the burden to provide evidence that dual-column labeling may be 
confusing. As discussed previously in this document, our research has 
shown that single-serving-per-container labels and dual-column labels 
resulted in more participants correctly identifying the number of 
calories per container and the quantity of other nutrients per 
container and per serving compared to two-serving, single-column labels 
(such as the current label) (Ref. 19).
2. Dual-Column Labeling Requirements
    (Comment 19) We received several comments from manufacturers 
objecting to 400 percent of the RACC as the upper limit for mandatory 
dual-column labeling.
    Several comments suggested that we consider the type of product at 
issue in establishing an upper limit. Some of the comments stated that 
an upper limit of 400 percent of the RACC was not appropriate for all 
product categories. Other comments stated that dual-column labeling 
should only be required for certain types of products. A few comments 
objected to what they called a one-size-fits-all approach to applying 
the dual-column labeling requirements. One comment stated that we 
should take into account how people use and consume specific types of 
food in establishing an upper limit, such as whether the food is a 
snack, an ingredient, or a center-of-plate food in a main meal, and 
whether a person is likely to eat more than two servings of food at one 
time. Another comment suggested that we reanalyze the data to provide 
category-specific RACC upper thresholds for dual-column labeling.
    A few comments stated that we should only require dual-column 
labeling for product categories of food for which we have data 
indicating that a consumer can reasonably consume the entire package of 
a product between 200 percent and up to and including 400 percent of 
the RACC in one eating occasion. Other comments argued that an upper 
limit of 400 percent of the RACC would require dual-column labeling on 
foods that are not likely to be consumed in one eating occasion.
    Several other comments requested that we require a lower upper 
limit for dual-column labeling generally. Some comments stated that 
dual-column labeling should only be required for packages up to 250 
percent of the RACC, while other comments requested that dual-column 
labeling be required for packages up to 300 percent of the RACC.
    We received comments that stated that by setting 400 percent as the 
upper limit for dual-column labeling, we would create the unintended 
consequence of establishing a dual-column labeling requirement for some 
products for which a 90th percentile of intake is much lower than 400 
percent of the RACC, meaning that such products would be required to 
have dual-column labeling on package sizes for which consumption data 
shows that people do not reasonably consume the entire amount in one 
eating occasion. One example given in comments was for 100 percent 
fruit juices such as orange juice. Comments stated that the amount of 
fruit juice equal to 400 percent of the RACC would be 32 fl ozs, which 
is inconsistent with data showing that the amount of 100 percent fruit 
juice consumed at the 90th percentile is 219 percent of the RACC. One 
comment

[[Page 34015]]

noted that, based on NHANES 2003-2006 data, the 75th percentile of 100 
percent orange juice consumption by adults is 8.8 fl ozs per day (Ref. 
20) and for children age 2 to 18 years is 12.5 fl ozs per day (Ref. 
21). Comments argued that requiring a dual-column label on a 32-oz 
container of orange juice does not represent the amount consumed by the 
majority of individuals.
    Other examples given in comments of products for which a 90th 
percentile of intake is lower than 400 percent of the RACC were fluid 
milk and cottage cheese. Comments noted that the intake at the 90th 
percentile is 205 percent of the RACC for cottage cheese (226 g or 1 
cup) and 181 percent of the RACC for milk (444 g or 14.5 fl oz). Some 
comments stated that a quart of fluid milk and a 16-oz container of 
cottage cheese are both at 400 percent of the RACC and would be 
required to have a dual-column label. Comments stated that labeling 
these two product packaging sizes with dual-column labels is 
inconsistent with how they are consumed.
    Yet another example given in a comment of a product for which the 
90th percentile of intake is lower than 400 percent of the RACC was 
frozen waffles. The comment described a 12.3 oz 8-pack of waffles where 
two waffles equal a serving based on the 85 g RACC. The comment stated 
that an 8-pack of waffles would be required to have a dual-column label 
listing nutrition information per two-waffle serving and per container. 
The comment stated that the 90th percentile intake for waffles is 168 
percent of the RACC (about 3 waffles) and that it is difficult to 
imagine a consumer eating 8 waffles on one eating occasion.
    Other comments asserted the following additional types of foods 
have consumption amounts at the 90th percentile that are less than 400 
percent of the RACC and therefore are not appropriate for dual-column 
labeling: Beverage product categories, frozen potato products, side 
dishes, natural cheese in 3.5 oz packages, sausage, nuts, frozen 
vegetables, frozen oatmeal, frozen pizza, frozen entr[eacute]es, canned 
beans, canned vegetables, canned fruits, 100 percent fruit juices, 
veggie ``burger'' patties, and cereal bars.
    A few comments stated that they reviewed our data used to support 
the decision to use an upper limit of up to and including 400 percent 
of the RACC and found that in 84 percent of the food categories 
reviewed, average consumption was 299 percent or less of the RACC, and 
in 68 percent of categories, average consumption was 250 percent or 
less of the RACC. These comments stated that only a small number of 
product categories had consumption greater than 300 percent of the 
RACC, and those categories, which included wine coolers, fluid cream, 
lemon and lime juice, horseradish, and mustard, are not commonly 
consumed categories that should drive labeling changes.
    Several comments argued that the 90th percentile was too high of an 
upper limit to be considered as a reasonably consumed amount and that 
the basis for our picking this value was unclear. One comment further 
requested that we provide information about the statistical 
distribution of these ratios to justify our cutoff of 400 percent. 
Other comments asserted that our decision to establish 400 percent of 
the RACC as the cutoff for dual-column labeling is arbitrary, 
incongruous with most common eating patterns, and could result in 
consumer confusion and needless changes for food manufacturers. Another 
comment suggested that we use the proposed RACCs, instead of RACCs from 
1993, as the basis to compare to 90th percentile of intake.
    (Response 19) In the preamble of the proposed rule (79 FR 11989 at 
12003), we stated that our review of the 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. Use of the 
90th percentile of intake distribution allows us to capture the 
substantial majority of consumption amounts per eating occasion (i.e., 
90 percent) for the U.S. population, but this level is not so high as 
to impose dual-column labeling requirements on most package sizes for 
which consumption data shows that people do not reasonably consume the 
entire amount in one sitting.
    As noted previously, the purpose of dual-column labeling is to 
provide nutrition information for multiple ways in which people are 
likely to consume a product. Consumption data show that while some 
people eat certain products in a single eating occasion, others eat the 
product over time or share it. Dual-column labeling provides nutrition 
information for all of these scenarios. To the extent that comments 
suggested that dual-column labeling requirements generally would 
require needless changes to food labeling for manufacturers to comply 
with the dual-column labeling requirement and that the requirements may 
result in consumer confusion, we disagree. Dual-column labeling 
requirements are not intended to be limited to the single most common 
consumption pattern for a particular product. When determining the 
criteria for dual-column labeling, we therefore looked at data that 
shows how the product is consumed in 90 percent of eating occasions, to 
ensure that the requirements would encompass the distinct ways such 
products could reasonably be consumed. In the proposed rule we 
determined that dual-column labeling for products with 400 percent or 
less of the RACC would capture the most frequent consumption habits for 
almost all product categories.
    We disagree with comments stating that the upper limit for dual-
column labeling should be 250 percent. Eighteen percent of products 
have 90th percentile of consumption between 250 percent and 300 percent 
of the RACC based on the 1993 RACCs and the proposed RACCs, meaning 
that establishing an upper limit of 250 percent would eliminate from 
dual-column labeling requirements a significant proportion of products 
which data show are reasonably likely to be consumed in a single eating 
occasion.
    In light of information provided in comments, we examined which 
food products have consumption levels at the 90th percentile between 
300 percent and 400 percent of the 1993 RACCs and the proposed RACCs. 
Our analysis was consistent with those of comments that suggested that 
a substantial majority of food products (i.e., more than 90 percent) 
have consumption levels that are 300 percent or less of the RACC at the 
90th percentile (Ref.16). We agree with comments to the extent they 
state that in the substantial majority of the food categories the 
average consumption was 300 percent or less of the RACC at the 90th 
percentile and that only a small number of product categories had 
consumption greater than 300 percent of the RACC at the 90th 
percentile. We also agree with comments that stated that setting an 
upper limit for dual-column labeling at 400 percent of the RACC could 
have the unintended consequence of requiring dual-column labels on 
packages for which data shows people do not reasonably consume in a 
single eating occasion, such as a quart of milk, a 32 fl oz bottle of 
juice, or a 12.3 oz 8-pack of waffles where two waffles equal a serving 
based on the 85 g RACC.
    In consideration of the information provided in comments and 
further evaluation of relevant consumption data compared with the 
proposed RACCs, we are lowering the upper limit of dual-column labeling 
from 400 percent to 300 percent of the RACC. Providing an upper limit 
at 300 percent of the RACC would ensure that dual-column labeling 
captures 90 percent of the consumption

[[Page 34016]]

habits for about 91 percent of food products and limit the possibility 
that dual-column labeling will be required for package sizes that are 
not likely to be consumed in a single eating occasion. As a result of 
our decision to lower the upper limit for dual-column labeling from 400 
percent to 300 percent, certain products about which comments expressed 
specific concerns--such as a quart of milk, a 32 fl oz container of 
juice, a 16- oz container of cottage cheese, and a package of waffles 
containing 4 servings--would not be required to have a dual-column 
label.
    In response to those comments that suggested that we consider the 
type of product at issue in establishing an upper limit, we decline to 
apply different upper thresholds for dual-column labeling or to require 
dual-column labeling only for specific product categories. The use of a 
uniform upper criterion for all product categories will ensure that 
consumers are able to compare nutrition information across various 
product types that are packaged in the sizes that we have determined 
are reasonably likely to be consumed at one eating occasion or shared 
with others. For the same reason, we disagree with those comments that 
suggested that dual-column labeling is not appropriate for certain 
types of foods and decline to limit the dual-column labeling 
requirement to certain types of foods.
    In response to the comment that recommended that we use the 
proposed RACCs, instead of RACCs from 1993, as the basis to compare to 
the 90th percentile of intake, this final rule relies upon both 2003-
2008 consumption data and the 1993 RACCs as a basis to determine the 
90th percentile of intake when determining an upper threshold for dual-
column labeling. While the proposed rule used the 1993 RACCs as the 
basis to compare to the 90th percentile of intake, we agree that 
comparison to the proposed RACCs provides useful information. We have 
now reviewed the 90th percentile of intake for the proposed RACCs that 
we are finalizing with this rule. A review of this information shows 
that almost all of the proposed product categories have a 90th 
percentile of consumption that is less than 300 percent of the RACC. 
This information is included as a reference to this rule (Ref. 22).
    (Comment 20) We received a few comments that stated that dual-
column labeling should be voluntary instead of mandatory. Other 
comments suggested that all packages containing 200 percent or more of 
the RACC that can be reasonably consumed in a single eating occasion 
should be labeled as a single serving instead of using dual-column 
labeling.
    (Response 20) We disagree with comments that state that dual-column 
labeling under Sec.  101.9(b)(12) should be voluntary. As discussed 
previously in section III.C., we consider the benefits of dual-column 
labeling to the consumer--in particular, ensuring greater consumer 
understanding of the package's contents--to be significant enough to 
require dual-column labeling for products in containers that meet the 
criteria for dual-column labeling. As discussed in response to comment 
8, to address the comment that suggested that we require mandatory 
listing as a single serving for packages over 200 percent of the RACC 
that can be reasonably consumed in a single eating occasion in place of 
dual-column labeling, the purpose of dual-column labeling is to provide 
label information for products that may be consumed in a single eating 
occasion, but can also be shared or eaten in multiple eating occasions. 
If these products are labeled as single-serving containers, then they 
would not provide nutrition information for all three of these 
scenarios. Additionally, as explained in detail previously in section 
II.B., under section 403(q)(1)(A)(i) of the FD&C Act, ``serving size'' 
means the 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 because that would be twice the amount or more than we have 
determined is customarily consumed.
    (Comment 21) Some comments asserted that a multiserving container 
would only require dual-column labeling if the individual units 
contained at least 200 percent and up to and including 400 percent of 
the RACC, and argued that the relevant factor in establishing whether 
dual-column labeling is required is not the size of the entire 
multiserving container, but the size of each individually packaged 
unit. Therefore, the comments concluded that the proposed dual-column 
labeling in Sec.  101.9(b)(2)(i)(D) and (b)(12)(i) would be required if 
a unit in the multiserving container weighs at least 200 percent and up 
to and including 400 percent of the applicable reference amount. A few 
comments noted that for a multiserving container, the consumer must in 
some cases unwrap each unit, and thus would know how many units he or 
she has eaten. According to these comments, the number of those 
individual units should represent the number of servings in the 
multiserving container.
    Several comments requested that we clarify that the proposed 
changes in Sec.  101.9(b)(2)(i)(D) and (12)(i) are not intended to 
require dual-column labeling on a multiserving retail container 
comprised of individual discrete units, when the multiserving retail 
container as a whole contains at least 200 percent and up to and 
including 400 percent of the RACC. Examples provided in comments of 
these types of packaging configurations were a four-pack of 
individually packaged 6 oz yogurt containers, individually wrapped 
cupcakes, muffins, and breakfast pastries. In the examples given, the 
multiserving retail container contained at least 200 percent and up to 
and including 400 percent of the RACC, but each of the individual 
discrete units contained less than 200 percent of the RACC.
    One comment noted we typically do not use the phrase ``packaged and 
sold individually'' to describe multipack products and, citing to Sec.  
101.9(b)(2)(i), stated that we instead refer to the multipack 
containers as ``packages containing several individual single-serving 
containers'' and that we refer to units as ``individually packaged 
products within a multiserving package.'' The comment asked us to 
clarify that the proposed criteria for mandatory dual-column labeling 
applies only to those individual units that have between 200 and 400 
percent of the RACC and not to the multipack container when the weight 
of the multipack is between 200 and 400 percent of the RACC. The 
comment stated that in the proposed rule we specifically identify a 
``grab-size bags of chips'' as an example of a product that would be 
subject to dual-column labeling if it contains 200 percent to 400 
percent of the applicable RACC, even though the comment considered 
chips to appear to be a non-discrete bulk product.
    (Response 21) Dual-column labeling with nutrition information 
listed per serving and per unit is required for each product in 
discrete units in multiserving containers when the unit weighs at least 
200 percent and up to and including 300 percent of the applicable RACC. 
Section 101.9(b)(2)(i) provides, in part, the requirements for serving 
sizes for products in discrete units (e.g., muffins, sliced products, 
such as sliced bread, or individually packaged products within a 
multiserving package). Under proposed Sec.  101.9(b)(2)(i)(D), if the 
individual unit within a multiserving container weighs at least 200 
percent and up to and including 400 percent of

[[Page 34017]]

the applicable RACC, the manufacturer would need to provide an 
additional column that lists the quantitative amounts and percent DVs 
for the individual unit, as well as a column listing the quantitative 
amounts and percent DVs for a serving that is less than the unit (i.e., 
the serving size derived from the 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. We are amending Sec.  
101.9(b)(2)(i)(D) in this final rule to apply to individual units 
within a multiserving container that weigh at least 200 percent and up 
to and including 300 percent of the applicable RACC. The reason for the 
change from 400 percent of the RACC as the upper limit to 300 percent 
of the RACC as the upper limit is discussed in section III.B. We have 
also modified the language for clarity.
    Under the proposed rule, dual-column labeling would be required on 
a multiserving retail container comprised of individual discrete units, 
when the multiserving retail container as a whole contains at least 200 
percent and up to and including 400 percent of the RACC. As explained 
in response to comment 9, a product that is packaged and sold 
individually (i.e., a container that bears a Nutrition Facts panel) 
that is comprised of individual discrete units and that as a whole 
contains at least 200 percent and up to and including 300 percent of 
the RACC would be subject to the dual-column labeling requirements 
under Sec.  101.9(b)(12)(i) in this final rule, unless an exemption 
applies. If, for example, the product at issue is a box containing two 
individually bottled, 16 oz sodas, and if the box, and not the bottles, 
were to display the Nutrition Facts label, the multipack container 
would be required to bear dual-column labeling because the multipack 
would be packaged and sold individually and would contain at least 200 
percent and up to and including 300 percent of the RACC. In contrast, 
if the product at issue is encased in a clear plastic wrapper and 
includes two individually bottled, 16 oz sodas for which each bottle is 
labeled with a Nutrition Facts panel that is visible at the point of 
sale, the outside wrapper would not be required to bear dual-column 
labeling even though the combined weight of all bottles would be at 
least 200 percent and up to and including 300 percent of the RACC. We 
note that Sec.  101.9(b)(12)(i) pertains to products that are packaged 
and sold individually and contain at least 200 and up to and including 
300 percent of the RACC, regardless of whether the product is in 
discrete units.
    With respect to the comment's request for clarification about 
whether a ``grab bag'' of chips would be subject to the dual-column 
labeling requirements, we note that if such a bag of chips were to bear 
a Nutrition Facts panel and contain at least 200 percent and up to and 
including 300 percent of the RACC, it would be subject to the dual-
column labeling requirements unless an exemption applied. Whether a 
product contains discrete units or non-discrete bulk food, dual-column 
labeling is required if the criteria for such labeling is met, and if 
no exemptions apply. Section 101.9(b)(2)(i)(D) explains when a second 
column of nutrition information that describes the nutrient content per 
unit is required, and Sec.  101.9(b)(12)(i) explains when a second 
column of nutrition information that describes the nutrient content per 
container is required.
    (Comment 22) One comment noted that our rounding rule requirements 
may present inherent problems because the requirements may cause 
quantitative amounts and percent DVs to look inconsistent when 
displayed in a dual-column format per serving and per container. The 
comment suggested that this result may not satisfy the requirements of 
section 2(b)(1)(A) of the NLEA if dual-column labeling does not convey 
information in a manner that ``enables the public to readily observe 
and comprehend such information and to understand its relative 
significance in the context of a total daily diet.'' To demonstrate the 
potential inconsistency, the comment provided an example of a Nutrition 
Facts label of two different flavors of candy bars which presented 
nutrition information per two pieces and per one piece. The comment 
noted that the calories from fat for two pieces is 111.0 g (actual) but 
is rounded to 110 g using our rounding rules, while the calories from 
fat for 1 piece is 55.5 g (actual), but rounded to 60 g using our 
rounding rules. The comment noted that this discrepancy may cause 
consumer confusion since if the serving size were halved they would 
expect the declaration of ``Calories from fat'' to be 55 g. The example 
provided in the comment also demonstrated inconsistencies in the values 
provided for total fat, sodium, and protein due to our rounding rules. 
The comment suggested that we permit the use of a footnote such as 
``Columns may not add due to rounding'' when such inconsistences exist.
    (Response 22) We acknowledge that the use of dual-column labeling 
per serving and per container could, under certain conditions, cause 
apparent discrepancies in the nutrition values between the two columns. 
The discrepancies would result from mathematical rounding procedures 
and our requirements for the increments in which nutrition values are 
declared in the Nutrition Facts label under Sec.  101.9(c). We 
recognize that consumers viewing nutrition information per serving and 
per container may expect the nutrition values per container to result 
from multiplying the number of nutrients per serving by the number of 
servings per container, and that the numbers that may result under 
existing regulations may not reflect this expectation in all cases. 
However, under the preexisting nutrition labeling regulations, 
consumers may have already seen such rounding issues in the labeling of 
products in discrete units in a multiserving container that are more 
than 1 unit (Sec.  101.9(b)(10)(ii)).
    While we acknowledge that in some instances apparent discrepancies 
may occur, we are not proposing to change our requirements for the 
increments in which nutrition values are declared in the Nutrition 
Facts label (Sec.  101.9(c)). Changes to this regulation, such as a 
requirement that the per-container information be provided by 
multiplying the nutrients per serving by the number of servings, would 
likely result in the need to round the information twice. This could 
result in a requirement to provide nutrition information per container 
in a way that does not accurately reflect the amount of nutrients in 
the product. We consider this result to be more problematic than any 
apparent discrepancies that may result from existing rounding 
requirements. However, we will monitor this situation as more products 
are introduced into the marketplace with dual-column labeling per 
serving and per container.
    We disagree with the comment suggesting the need for a footnote 
such as ``Columns may not add due to rounding.'' The presence of a 
footnote will require additional space, and we do not believe at this 
time that any apparent rounding discrepancies are significant enough as 
to warrant a requirement to include such a footnote or to permit the 
use of such a footnote voluntarily. We do, however, plan to include 
information about potential rounding discrepancies as part of our 
planned nutrition education efforts to clarify why the per-serving and 
per-container nutrition values appearing on dual-column labels may not 
appear consistent. We also note that, while no such footnote as 
requested in this comment can be added to the Nutrition

[[Page 34018]]

Facts label, manufacturers can voluntarily include a truthful and not 
misleading statement explaining how rounding effects dual-column 
labeling elsewhere on the product label.
3. Exemptions From Dual-Column Labeling
    (Comment 23) One comment asserted that we acted arbitrarily in 
proposing to exempt the following types of products from the dual-
column labeling requirement because we determined that labeling of such 
products with nutrition information based on the entire container would 
not be consistent with how these products are typically consumed: Bulk 
products that are used primarily as ingredients (e.g., flour, 
sweeteners, shortenings, oils), bulk products traditionally used for 
multipurposes (e.g., eggs, butter, margarine), and multipurpose baking 
mixes.
    (Response 24) After further consideration of this exemption, and as 
explained in response to comment 19, the use of a uniform upper 
criterion for all product categories will ensure that consumers are 
able to compare nutrition information across various product types that 
are packaged in the sizes that we have determined are reasonably likely 
to be consumed at one eating occasion or shared with others. We have no 
consumption data showing that it is reasonably likely that bulk 
products are consumed differently from non-bulk products. Therefore, we 
are not finalizing the exemption for bulk products that are used 
primarily as ingredients, bulk products traditionally used for 
multipurposes, and multipurpose baking mixes as proposed in Sec.  
101.9(b)(12)(i)(B).
    (Comment 24) We received comments relating to proposed exemptions 
from dual-column labeling requirements for products that require 
further preparation, such as macaroni and cheese kits, pancake mixes, 
pasta products, and common combinations of food (e.g., cereal and milk) 
that contain at least 200 percent and up to and including 400 percent 
of the applicable RACC. Comments we received regarding this exemption 
were generally supportive of the exemption. A few comments, however, 
stated that instead of allowing products to be exempt from dual-column 
labeling, we should instead require dual-column labeling per serving 
and per container for the as-prepared form of the product and eliminate 
the as-purchased information altogether.
    We received a few comments requesting that we allow an exemption 
for any product that provides voluntary dual-column labeling as allowed 
under the preexisting regulations in Sec.  101.9(b)(10)(i) to (iii). 
Another comment requested that we provide exemptions from dual-column 
labeling under Sec.  101.9(e) not only for products that provide an 
additional column of information for two or more forms of the same food 
``as purchased'' and ``as prepared'' and for common combinations of 
food, but also when nutrition information is provided for two or more 
groups for which Reference Daily Intakes (RDI's) are established (e.g., 
both infants and children less than 4 years of age) or when nutrition 
information is provided in different units (e.g., slices of bread or 
per 100 g).
    (Response 24) We agree, in part, with comments that support 
allowing an exemption to the dual-column labeling requirements if the 
voluntary provisions provided for in Sec.  101.9(b)(10) are used. The 
exemptions under Sec.  101.9(b)(10) are for products that provide 
another column of figures that may be used to declare the nutrient and 
food component information per 100 g or 100 mL, or per 1 oz or 1 fl oz 
of the food as packaged or purchased (Sec.  101.9(b)(10)(i)); per one 
unit if the serving size of a product in discrete units in a 
multiserving container is more than 1 unit (Sec.  101.9(b)(10)(ii)); 
and per cup popped for popcorn in a multiserving container (Sec.  
101.9(b)(10)(iii)). We agree that providing voluntary dual-column 
labeling per unit if the serving size of a product in discrete units in 
a multiserving container is more than 1 unit would provide useful 
information to those that consume one unit, and therefore are 
permitting the use of such a second column of information in lieu of a 
second column that provides per-container information. We also agree 
that providing voluntary nutrition information per cup of popped 
popcorn per serving in a multiserving container (Sec.  
101.9(b)(10)(iii)) in an as-consumed form will be more beneficial to 
consumers than having nutrition information for the ``as purchased'' 
form on both a per-serving and per-container basis. As explained 
further in comment 25, while we recognize that popcorn is not consumed 
in the as-purchased form, the as-purchased nutrition information is 
still needed. Therefore, we are permitting the label of such products 
to contain a second column of information for the popped form, in lieu 
of a second column that provides per-container information.
    As noted in the serving size proposed rule, we tentatively 
concluded that it would be helpful to consumers to have access to 
nutrition information based on the prepared form of the product in 
addition to the ``as purchased'' form of the product (79 FR 11989 at 
12004). We are reaffirming that conclusion in this final rule. The ``as 
prepared'' information on labels indicates the nutritional information 
per serving if a package is prepared according to package directions, 
which may require the use of additional ingredients. We disagree, 
however, with those comments that stated we should require dual-column 
labeling to be done only based on the as-prepared form, per serving and 
per package. If a consumer does not use the stated directions or uses 
substitute ingredients, then the information in the as-prepared portion 
of the label would not be accurate. Therefore it is important that each 
product include nutrition information for the product as packaged and 
not just the product as it is prepared. We also noted in the proposed 
rule that if products that voluntarily included one column of nutrition 
information for the prepared form of the food per serving and met the 
requirements for dual-column labeling, they would have to include at 
least three columns of nutrition information unless the products were 
subject to an exemption (79 FR 11989 at 12004). We are reaffirming our 
conclusion from the proposed rule that nutrition information based on 
the entire container of the unprepared food may be less meaningful to 
consumers than information based on a serving of the prepared form of 
the food and are therefore finalizing an exemption from the dual-column 
labeling requirements in Sec.  101.9(b)(12)(i)(C) for those products 
that voluntarily include a second column of nutrition labeling for the 
as-prepared form of the food per serving.
    We do not agree with comments that requested an exemption for 
products that provide an additional column that declares the nutrition 
information per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as 
packaged or purchased. In the introduction to section III.C., we 
discussed our basis for concluding that per-container information helps 
certain consumers recognize nutrient amounts per package and that the 
consumption data shows that consumers are reasonably likely to consume 
a full package containing at least 200 percent and up to an including 
300 percent of the RACC. In contrast, consumers may not be able to 
readily measure 100 g or 100 mL amounts, so the information may not be 
useful to them. Because we have determined that nutrition information 
per serving and per container is more likely to be useful to consumers, 
and therefore is more

[[Page 34019]]

important than voluntary nutrition information given in metric or 
common household measurements (oz) for the food in the as-purchased 
form per serving, we decline to establish an exemption when a second 
column of nutrition information is provided per 100 g or 100 mL, or per 
1 oz or 1 fl oz of the food as packaged or purchased. While nutrition 
information per 100 g or 100 mL cannot be listed in lieu of the 
information required under Sec.  101.9(b)(2)(i)(D) and (b)(12)(i), 
Sec.  101.9(b)(10)(i) allows the manufacturer to provide this 
information in an additional column (e.g., a third column) on a 
voluntary basis.
    We agree with the comment that requested that we expand the 
exemptions from dual-column labeling to include products that voluntary 
provide a second column of nutrition information for two or more groups 
for which RDIs are established (e.g., both infants and children less 
than 4 years of age). Providing voluntary nutrition information for two 
or more groups for which RDIs are established provides useful 
information for the different populations that may consume the food 
product. Providing nutrition information for two subpopulations, such 
as infants 7 to 12 months old and children aged 1 through 3, will 
provide beneficial information to purchasers of these products. Such 
nutrition information will provide meaningful information about foods 
that are typically consumed in distinct amounts by distinct 
subpopulations. This exemption has been added to Sec.  
101.9(b)(12)(i)(C) in this final rule.
    We note that in this final rule we are also providing an exemption 
from dual-column labeling for varied-weight products covered under 
Sec.  101.9(b)(8)(iii), for which dual-column labeling would be less 
practical given the variation in product sizes.
    (Comment 25) We received several comments questioning why popped 
popcorn needed a dual-column label listing nutrition information with 
one column for ``as purchased'' unpopped popcorn and another column for 
``as prepared popped'' popcorn. The comments noted that no one consumed 
raw popcorn and that the ``as purchased'' popcorn information is 
unnecessary. One comment requested that the RACC for popcorn be changed 
from 30 g unpopped (raw) to 30 g as consumed because variations in 
hybrids, popping volume and other ingredients can significantly alter 
the amount of kernels in a single serving based on the household 
measure (typically tablespoons) for the finished product. The comment 
requested that we change the current declaration for uncooked popcorn 
to reflect how the product is actually consumed by the consumer versus 
``as packaged.'' The comment noted that providing the nutrition 
information about unpopped popcorn could be confusing and misleading to 
the consumer and that no other snack has its raw form as the basis for 
its nutritional information.
    (Response 25) We decline to amend the way in which nutrition 
information is required to be presented for popcorn, which is that 
popcorn must provide nutrition information on the ``as packaged'' or 
``purchased'' form of the food (i.e., unpopped form), as described in 
Sec.  101.9(b)(9). We disagree with the assertion that providing 
nutrition information about popcorn in the ``as packaged'' form is 
unnecessary and that the ``as packaged'' nutrition information should 
not be required to appear on the product label if the ``as prepared'' 
information is provided. The ``as prepared'' information on labels 
indicates whether a package is prepared according to package 
directions, which may require the use of additional ingredients. If a 
consumer does not use the stated directions or uses substitute 
ingredients, then the information in the as-prepared portion of the 
label would not be accurate. Therefore it is important that each 
product include nutrition information for the product as packaged and 
not just the product as it is prepared. We note, however, that although 
it is not permitted for popcorn to provide a single-column label 
containing only as-purchased information, our regulations provide that 
popcorn products can provide a second column of nutrition information 
``per cup popped'' for popcorn in a multiserving container (Sec.  
101.9(b)(10)(iii)); many popcorn products already voluntarily have a 
second column of nutrition information per serving for the ``as 
popped'' form. We are not changing this voluntary provision. In 
addition, we have provided an exemption from the dual-column labeling 
provisions in Sec.  101.9(b)(12)(i) for products that require further 
preparation, which would apply to popcorn products that contain at 
least 200 percent and up to and including 300 percent of the RACC and 
voluntarily provide an additional column of nutrition information on 
the ``as popped'' form.
    With regard to the comment that stated that listing popcorn on the 
as-purchased basis would be confusing to consumers, the comment did not 
explain the basis on which the as-purchased information would be 
confusing or misleading, and we do not agree that such information 
would be confusing or misleading. With regard to the assertion that no 
other snack has its raw form as the basis for its nutritional 
information, we disagree. All products are required to provide 
nutritional information for the as-packaged form, so any products that 
are packaged in their raw form are required to provide nutritional 
information for the raw form.
    We also decline the request to change the RACC of popcorn to 30 g 
popped per serving ``as consumed.'' In the preamble of the 1993 serving 
size final rule (58 FR 2229 at 2265 to 2266), we discussed comments 
that requested that popcorn be able to use a volume-based rather than a 
weight-based reference amount. We declined to follow the recommendation 
from those comments because we determined that there is no well-
established standard procedure for determining the weight equivalents 
of the household measures. This is still true today. However, for the 
benefit of those consumers who consume popcorn on a volume basis, we 
permit the use of a voluntary dual-column label with the second column 
of nutrition information being based on a per cup popped basis. 
Therefore we decline to change the popcorn RACC to an as-consumed 
amount.
    (Comment 26) A few comments requested clarity on whether raw fruits 
and vegetables would be exempt from dual-column labeling when nutrition 
labeling is voluntarily provided or when claims are made for such 
products. An example used in the comment was a medium avocado that has 
a proposed RACC of 50 g, or about \1/3\ of the avocado. According to 
the comment, the entire avocado would be about 150 g and would require 
dual-column labeling if nutrition labeling is voluntarily provided or 
if claims are made for such product in labeling or advertising. Another 
comment requested that we exempt all fruits and vegetables without 
added sugar, salt, or fat from dual-column labeling.
    (Response 26) Under Sec.  101.9(j)(10), raw fruits, vegetables, and 
fish are exempt from mandatory nutrition labeling, contingent on the 
food bearing no nutrition claims or other nutrition information in any 
context on the label or in labeling or advertising. The labeling of 
such products is generally done on a voluntary basis, with guidelines 
for such labeling set forth under Sec.  101.45. Under Sec.  
101.45(a)(3)(i), such products are not required to provide information 
about the number of servings per container. Because the number of 
servings per container would vary from container to container, we do 
not expect those selling raw fruit,

[[Page 34020]]

vegetables, and fish to be able to provide information about the number 
of servings for an individual container and therefore do not expect 
them to be able to provide a second column of information with 
nutrition information per container. Additionally, when voluntary 
nutrition information for raw fruits, vegetables, and seafood is 
provided under Sec.  101.45(a)(1), it should be displayed at the point 
of purchase by an appropriate means such as by a label affixed to the 
food or through labeling including shelf labels, signs, posters, 
brochures, notebooks, or leaflets that are readily available and in 
close proximity to the foods. The nutrition labeling information that 
is voluntarily provided may also be supplemented by a video, live 
demonstration, or other media. Because no information about the number 
of servings per container is generally required in voluntary labeling, 
and because the nutrition labeling for such products is often provided 
in a non-standardized manner, we agree that such products should be 
exempt from dual-column labeling. Therefore, we will amend Sec.  
101.9(b)(12)(i)(B) to provide that raw fruits, vegetables, and seafood 
will be exempted from the dual-column labeling requirements, regardless 
of whether voluntary nutrition information is provided for the product, 
either in labeling or in advertising, or whether nutrition claims are 
made for the product.
    We decline to exempt canned or frozen fruits and vegetables without 
added sugar, salt, or fat from the dual-column labeling requirements. 
Unlike raw fruits and vegetables, the presentation of nutrition 
information, including the number of servings per container, has been 
established in Sec.  101.9 for canned or frozen fruits and vegetables, 
regardless of whether they contain added sugar, salt, or fat. It is 
therefore less difficult for canned or frozen fruits and vegetables to 
provide dual-column labeling when the applicable dual-column labeling 
requirements would apply.
    (Comment 27) One comment requested that bottled water products be 
exempt from the requirements of dual-column labeling. Other comments 
questioned the benefits to consumers of requiring dual-column labeling 
for bottled water products when most of the values in the two columns 
would be zero. The comments further noted that many bottled water 
products are already exempt from the nutrition labeling requirements 
under Sec.  101.9(j)(4) because they contain insignificant amounts of 
all nutrients required to be declared in the nutrition facts label, and 
requested that we amend Sec.  101.9(j)(4) to clarify that such products 
would be exempt. The comments noted that under the proposed rule, the 
RACC for bottled water products would increase from 240 mL (8 oz) to 
360 mL (12 oz) and that this increase in the RACC would mean that the 
sodium content per RACC in some bottled water products would exceed the 
current 5 mg per serving threshold, below which the amount of sodium 
would be considered insignificant. Therefore, the comment requested 
that we revise the definition of an insignificant amount in Sec.  
101.9(j)(4) to be an ``amount that allows a declaration of zero in 
nutrition labeling, except that for sodium, it shall be an amount that 
exceeds a declaration of zero percent of the daily value, and except 
that for total carbohydrate, dietary fiber, and protein, it shall be an 
amount that allows a declaration of less than 1 gram.''
    (Response 27) We decline to establish an exemption to the dual-
column requirements in this final rule for bottled water products. We 
also decline to amend Sec.  101.9(j)(4) at this time as suggested by 
the comment. We intend to consider the applicability of an exemption 
from nutrition labeling requirements in a future rulemaking with 
respect to certain products. Until such time as we have had the 
opportunity to consider such matters further, we intend to consider the 
exercise of enforcement discretion with respect to mandatory nutrition 
labeling on bottled water products and other products that would have 
been exempt under Sec.  101.9(j)(4) prior to the effective date of this 
rule and the Nutrition Facts final rule.
    (Comment 28) One comment stated that providing nutrition 
information on a ``per container'' basis for a consumer who intends to 
eat some now and some later, or for a consumer who will share the 
container with others, is not useful information. The comment asserted 
that consumers have all the nutrition information they need to make 
food choices in the ``per serving'' declaration.
    (Response 28) To the extent that this comment asserts dual-column 
labeling does not provide additional, useful information to consumers, 
we disagree. The intent of dual-column labeling is to provide nutrition 
information for products that may be consumed by one consumer in a 
single eating occasion, over several eating occasions, or shared among 
multiple consumers. A dual-column nutrition label provides easy-to-
interpret nutrition information for a consumer who may eat the contents 
of a package in one sitting. Dual-column labeling serves as a 
contextual cue that there is more than one serving in a package and 
helps consumers to easily figure out how much is in the entire 
container.
    (Comment 29) We received a comment requesting that we exempt foods 
specifically represented or marketed to infants or children 1 to 3 
years of age. The comments stated that presenting the nutrition 
information for the entire container could inappropriately communicate 
that a young child could reasonably consume the entire contents of a 
container. The comment used juice as an example with an RACC of 4 fl oz 
and noted that a 16 fl oz juice container marketed for children 1 to 3 
years would need to include a column for the entire container under the 
proposed rule. The comment stated that such labeling could indicate to 
consumers that juice is recommended to be consumed in greater 
quantities and would conflict with portion guidance provided to parents 
regarding limiting juice consumption to no more than 4 fl oz per day.
    (Response 29) We decline to exempt foods specifically represented 
or marketed to infants or children 1 to 3 years of age from mandatory 
dual-column labeling. The purpose of dual-column labeling is to 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, and to 
help consumers more easily understand the contents of a particular 
package both on a per-serving and per-container basis. In terms of 
consumers misconstruing the serving size as a recommended amount of 
food, we noted previously in section III.A. that we will engage in 
consumer education to help clarify the meaning of the serving size. We 
note that since we have lowered the upper level of dual-column labeling 
to 300 percent of the RACC, the example stated in the comment would not 
occur.
4. Research and Consumer Understanding of Dual-Column Labeling
    (Comment 30) We received comments that questioned the research 
cited in the proposed rule in support of dual-column labeling (Ref. 
14). Some comments stated that consumer research should include an 
evaluation of whether consumers would use the dual-column information 
to modify dietary choices when provided. Comments stated that the 
limited amount of research on dual-column labeling was not enough to 
require mandatory dual-column labeling for all products.
    Various comments questioned the format of the dual-column labels 
used in the studies. Some comments pointed out that both studies cited 
in the

[[Page 34021]]

proposed rule evaluated the current label format with dual columns, 
rather than the proposed new label format with dual columns. The 
comments stated that with the proposed label formats, dual-column 
labeling is not needed because the values consumers need to determine 
the total calories in the container would already be available to the 
consumer.
    Some comments questioned the results of the study conducted by 
Antonuk and Block that was cited in the proposed rule. These comments 
stated that the results of the study are not generalizable because the 
study was conducted with undergraduate students in a classroom setting. 
Some comments stated that the study only used labels for snack food 
products and that the results should not be used to evaluate the 
effects of dual-column labels on other product categories. Other 
comments questioned the different results for dieters versus 
nondieters.
    (Response 30) We disagree with the comments that suggest that in 
order to support the requirement for dual-column labeling, research 
must demonstrate that dual-column information modifies dietary choices. 
As noted previously, the purpose of dual-column labeling is to provide 
nutrition information for multiple ways that people are likely to 
consume a product that contains at least 200 percent and up to and 
including 300 percent of the RACC. Consumption data shows that while 
some people eat such products in a single eating occasion, others eat 
the product over time or share it. Dual-column labeling provides 
nutrition information for all of these scenarios.
    The comment incorrectly asserts that the studies on which we relied 
in the proposed rule used only labels for snack food products. The 
labels tested in the Lando and Lo study (Ref. 15), which were also 
cited in the proposed rule, included sample Nutrition Facts labels for 
frozen meals, which are not considered ``snack foods.'' Additionally, 
since the publication of the proposed rule, we have conducted further 
research on dual-column labeling. The new study has tested dual-column 
labels using the proposed label formats, recruited participants from a 
Web-based panel of English speaking adults, and examined multiple food 
products (Ref. 19). The results from the research showed that dual-
column labeling significantly improved respondents' ability to identify 
the amount of nutrients in the entire container of a two-serving 
package compared to both a single-column label and a dual-calorie 
label. Based on this research, as well as the research cited in the 
proposed rule, we conclude that consumers can more easily and more 
accurately comprehend the nutrient contents of an entire package when 
dual-column labeling is available, and we disagree with those comments 
that stated that dual-column labeling is not needed.
    With respect to comments that questioned whether the results of the 
study conducted by Antonuk and Block that was cited in the proposed 
rule are generalizable, we acknowledge the study's limitations as noted 
in the comments. In spite of the fact that the results are not 
generalizable, we note that the study suggests that, at least under 
circumstances that are the same as or similar to those in the study, it 
is possible that some consumers may behave like the study participants. 
The finding of this study is consistent with other research that we are 
aware of; therefore, we are convinced by the totality of the research 
that dual-column labeling can help consumers better understand the 
nutrition contents of containers of certain sizes and assist them in 
maintaining healthy dietary practices.
    (Comment 31) Several comments stated that providing nutrition 
information for the entire package will cause consumer confusion and 
increase consumption. Some comments argued that consumers would 
interpret the nutrition information for the entire package to be a 
recommended amount to eat and consume more of the product than they 
would have likely consumed without the dual-column label.
    (Response 31) These comments did not provide data or other 
information in support of their assertions. Based on a review of 
available information, we have seen no indication that dual-column 
labeling may be confusing to consumers or that dual-column labeling 
would imply that consumers should eat more of an item.
    (Comment 32) We received a comment that included results of a study 
conducted by the commenter on the proposed Nutrition Facts label 
formats. The study was designed to investigate the extent to which 
consumers are able to quickly notice and understand label information, 
as they would during grocery shopping. The study compared consumer 
reactions to FDA's current and proposed versions of four different 
Nutrition Facts label formats, each portraying a different food 
product, so that a total of eight different labels were examined. The 
current and proposed label formats, and the foods depicted, were 
standard format for single-serve yogurt; tabular format for frozen 
vegetables; dual-column label for breakfast cereal (per serving and 
with \1/2\ cup skim milk); and a dual-column label for a multiserving 
snack mix package (per serving and per container). Each participant 
viewed and reacted to one label.
    According to the comment, the study found that, in general, the 
proposed formats performed no better than the current formats in 
conveying nutrition information to respondents, but the results varied 
according to the information on the labels being considered. With 
respect to the dual-column labels, the comment stated that no 
differences were found in the ``quick readability'' or in participants' 
comprehension of the serving size or calories information between the 
current and proposed formats of both the snack mix and cereal products. 
The authors also asserted that participant understanding of nutrition 
information was better with the proposed dual-column cereal label but 
not with the proposed dual-column snack mix product. Further, the 
authors stated that respondents found the information for vitamins and 
minerals to be less confusing on the snack mix label that displayed 
both the percent DV and the absolute amounts per serving and per 
container (i.e., the proposed dual-column format) than on the label 
showing this information only per serving (i.e., the current single-
column format). However, according to the study authors, when asked an 
open-ended question about items that were easy to understand or 
confusing on the label, a larger percentage of respondents indicated 
that it was more difficult to understand the percent DV information on 
the proposed snack mix label than on the current version of this label. 
The comment stated that the result also suggest that respondents were 
less likely to initially notice the serving size information on the 
proposed labels for both the snack mix and cereal products compared to 
the current formats for these products. The authors postulated that 
these results were due to the complexity of the proposed dual-column 
label formats, and they recommended that FDA should not implement the 
proposed changes in format for the Nutrition Facts label because their 
study indicated that participants perceived few differences between the 
current and proposed label formats.
    (Response 32) We have significant questions about the methodology 
and design of this study. Although we acknowledge that this study did 
not demonstrate a clear advantage to the proposed versus the current 
format under all experimental conditions, the

[[Page 34022]]

results are difficult to interpret because a number of details were not 
provided. Among other things, the authors did not adequately describe 
the study's methodology, such as by explaining the demographic 
characteristics of the participants, the statistical methods that were 
used, how the participants were selected, how the study was 
administered, and why 90 percent confidence levels were chosen to 
indicate significant differences rather than the conventional 95 
percent confidence interval. Further, the proposed snack mix label that 
was used in the study appeared to be inconsistent with the proposed 
requirements in how the ``per serving'' and ``per container'' values 
were listed for various nutrients. Although the label indicated ``3\1/
2\ servings per container,'' the amounts of some nutrients (e.g., 
calories, carbohydrates, sodium, protein) that were listed on the label 
suggested that there were 4 servings per container, and the amount of 
dietary fiber shown on the label indicated there were only 2\1/2\ 
servings per container. Because of these substantial questions about 
the sufficiency in the study design and the study's methodology, we are 
not persuaded by this comment.
    As noted previously, recent NHANES data shows that consumers are 
reasonably likely to consume products containing at least 200 percent 
and up to and including 300 percent of the RACC in a single eating 
occasion. Our research demonstrates that some consumers may have 
difficulties determining nutrition information per container when a 
label declares the package contains more than one serving and is 
reasonably consumed in a single eating occasion. We are therefore 
finalizing dual-column labeling requirements in this rule to help 
consumers better understand the nutrition contents of packaged foods 
containing at least 200 percent and up to and including 300 percent of 
the RACC.
5. Dual-Column Labeling Format
    (Comment 33) We received several comments regarding the format of 
dual-column labels relating to whether per-container nutrition 
information should appear for all nutrients for which information is 
available on a per-serving basis, whether per-container nutrition 
information should be limited to calorie content, or whether per-
container information should be limited to calories, saturated fat and 
sodium.
    The comments were divided on whether we should require dual-column 
labeling with per-serving and per-container (or unit, as applicable) 
information for all nutrients or whether we should require only calorie 
information per serving and per container with the rest of the 
nutrition information listed in a single column. Only one comment 
requested that we consider using the option to provide nutrition 
information per serving and per container (or unit, as applicable) for 
calories, saturated fat and sodium only. Although comments were divided 
on which of the other two formats to use (i.e., per-container 
information for all nutrients versus per-container information for 
calories only), many comments stated that the decision on which dual-
column label format to use should be based on consumer research on what 
information would be most useful to consumers in deciding the amount of 
a food or beverage to consume.
    Comments that requested that we use dual-column labeling for all of 
the nutrition information per serving and per container stated this 
option would allow consumers to base decisions on the product's overall 
nutrient profile. A few comments stated that access to the full 
nutritional information for a serving as well as the entire container 
is necessary for consumers who are looking for specific nutrition 
information. The comments stated that individuals have varying 
nutritional requirements and need to see dual-column nutrition 
information for all nutrients in order to maintain healthy dietary 
practices.
    Comments that requested that we require dual-column labeling for 
calories only stated this approach would provide consumers with 
information they need to accurately identify the number of calories in 
a product, but would also save space and avoid cluttering the Nutrition 
Facts label. Comments argued that the issues we were looking to address 
with dual-column labeling would be alleviated through the proposed 
formatting changes and, specifically, the larger type size and 
prominence for calories and servings per container, as proposed in 
``Food Labeling: Revision of the Nutrition and Supplement Facts Label'' 
(79 FR 11880, March 3, 2014). These comments asserted that our proposal 
to increase the prominence of calories and servings per container would 
give consumers the piece of information most relevant to a package that 
might be eaten by a single consumer during a single eating occasion, 
i.e., the calorie content of the entire container.
    One comment stated that full dual-column labeling information is 
not needed because a consumer that chooses to eat two, three, or four 
servings of the product can easily calculate the quantity of calories 
and nutrients consumed through simple math. Another comment noted that 
in the study we conducted (Ref. 15), a label format with dual listings 
for calories only had the next highest level of accuracy (total 
correct) on the broad index of the nutrient content questions posed to 
study participants compared to the accuracy of the one serving, single-
column format and two serving, dual-column formats (Ref. 15). Other 
comments said dual-column labeling for food packages that contain 200 
percent and up to and including 400 percent of the RACC could actually 
decrease the utility of the Nutrition Facts label by cluttering the 
label and making it difficult for consumers to read. Another comment 
questioned whether requiring that information per container be 
available for consumers so they don't have to do the math by 
multiplying the per serving values by the number of servings is 
justified in spite of the additional space this information will 
occupy. The comment stated that a dual-calorie label, which highlights 
the calories per serving and per container, is a better and more 
targeted use of limited label space than a dual-column label for all 
nutrients.
    (Response 33) We agree with the comments that noted that dual-
column labeling with information per package and per serving for all 
nutrients is most useful for consumers who are looking for specific 
nutrition information. The research cited in the proposed rule has 
shown that consumers better understand nutrition information when using 
a dual-column label that shows two columns of nutrition information, 
per serving and per container, as compared with a label that shows dual 
information for calories only. Further, because different consumers are 
interested in different nutrients when evaluating products, providing 
dual-column labeling for all nutrients would be helpful to more 
consumers. We are not aware of any studies that have evaluated a 
Nutrition Facts label with only dual-column information for calories, 
saturated fat, and sodium per serving and per container.
    In response to those comments that requested that we base our 
decision on which label format to use on consumer research, it is in 
light of the research findings discussed in section III.C. and in 
comment 29, as well as the usefulness of full nutrition information for 
different types of consumers, that we are choosing the option for dual-
column labeling per serving and per container (or unit, as applicable) 
for all nutrition information on the label.

[[Page 34023]]

    In response to comments that stated that consumers do not need the 
additional information or that consumers can easily do the math to 
determine nutrition information per container, the research does not 
support this assertion. Studies have found that consumers are able to 
most accurately determine the quantity of nutrients in specific foods 
when using labels that list full nutrition information for the entire 
package (Ref. 19). In addition, as discussed in the preamble to the 
proposed rule (79 FR 11989 at 11998), research 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 (Refs. 23 and 24). One research study of 200 primary care 
patients found that many patients, especially those with lower literacy 
and numeracy skills, had trouble using food labels for performing 
certain tasks, especially those that involved calculations with serving 
size information (Ref. 24). Similar results were reported in the 
``Calories Count'' report (Ref. 1).
    We disagree that consumers do not need the additional information 
or that consumers can easily do the math to determine nutrition 
information per container. Our study with 160 consumers showed 
participants a pair of single-column Nutrition Facts labels, with one 
label showing a serving size of one and another label a serving size of 
two and asked them to identify which product contained fewer calories 
per container (Refs. 18 and 19). The proportion of participants who 
noticed the calorie declaration or the number of servings declaration 
did not vary between a single-column current format and a single-column 
proposed format (Refs. 18 and 19). Neither did the proportions of 
participants differ with regard to how many could identify which 
product contained fewer calories per container. The study also showed 
that while the majority of participants noticed the calorie disclosure, 
less than one third of the participants were able to identify whether 
the label with a serving size of one or the label with a serving size 
of two contained fewer calories per container. These results suggest 
that some consumers may not notice and use all the information 
available on a single-column, multiserving label that could reasonably 
be consumed in a single eating occasion and that some consumers may not 
accurately use (e.g., as a result of mathematical errors) and correctly 
recognize a product's nutrient contents if a product contains more than 
one serving.
    We do not agree with the comment that asserted that the proposed 
changes for increasing the prominence of calories and the serving size 
information will alleviate issues that we are seeking to address with 
dual-column labeling. In our study, the proportion of participants who 
saw the proposed format changes (i.e., increased prominence of calories 
and the serving size information) and did not notice the number of 
servings was not different from the proportion of participants who saw 
the preexisting format and did not notice the number of servings, even 
though calories and the number of servings were made more prominent on 
the proposed format (Ref. 18). We are also concerned about ensuring 
that consumers have access to per-container nutrition information for 
products that contain at least 200 percent and up to and including 300 
percent of the RACC so consumers who eat the entire container in one 
eating occasion, over multiple eating occasions, or shared with others 
can accurately identify the information for the entire container.
    To address the comment that stated that listing dual-column 
nutrition information for calories only is a better and more targeted 
use of limited label space than a dual-column label for all nutrients, 
we disagree. Findings from a study we conducted after the publication 
of the proposed rule found that participants were able to better 
identify total nutrients per container when using the full dual-column 
label, as compared with the dual-column label for calories only (Ref. 
19). Providing dual-column labeling for the entire container gives 
consumers access to nutrient information for each specific nutrient on 
the Nutrition Facts label.
    (Comment 34) One comment stated that, as grocery shelf space has 
become increasingly expensive, packages have become narrower and 
taller, ultimately increasing vertical space to greater than 3 inches 
in height and making the back panel longer and thinner. The comment 
stated that, for these types of small or tall and narrow packages with 
seams down the back, it will be difficult, if not impossible, for 
manufacturers to fit a dual-column nutrition facts label, which is 
nearly twice as wide as the current single-column facts panel. The 
comment requested that we propose additional dual-column options for 
industry review that account for the constraints associated with 
different product formats and smaller package sizes.
    (Response 34) We recognize the concerns expressed in this comment. 
Under proposed Sec.  101.9(b)(12)(i)(A), which this rule finalizes 
without changes, the dual-column labeling requirements in proposed 
Sec.  101.9(b)(12) would not apply to 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). If a product has limited 
space and uses a tabular or linear format as described in the 
regulations, it would not be required to use dual-column labeling. We 
also recognize that the shape of the container will play a role in the 
amount of space available to display the Nutrition Facts label and note 
that information related to placement of information on the information 
panel is described in Sec.  101.2. An example of a dual-column label 
using the tabular display format in Sec.  101.9(d)(11)(iii) is being 
published elsewhere in this issue of the Federal Register in the 
Nutrition Facts final rule.

D. Reference Amounts Customarily Consumed

    We proposed to update, modify, or establish RACCs. Updating RACCs 
refers to amendments to the RACCs for products that are 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 of at 
least 25 percent. Modifying RACCs refers to changes to current 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 of 
at least 25 percent for the preexisting product categories. 
Establishing RACCs refers to the addition of products and the 
assignment of RACCs for such products that are not listed in 
preexisting tables in Sec.  101.12(b).
    In the proposed rule, we analyzed current food consumption data and 
determined that, for some product categories listed in the tables in 
Sec.  101.12(b), the RACCs have changed. Additionally, we recognized 
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, led us 
to propose amendments to the RACCs.
    When determining when to update, modify, and establish RACCs, we 
analyzed consumption by combining data from the survey years of the 
NHANES, 2003-2004, 2005-2006, and

[[Page 34024]]

2007-2008 (NHANES 2003-2008 surveys), which provide an indication of 
the current amount of food being consumed by individuals at one eating 
occasion (Refs. 6, 7, and 8). Food consumption data from the NHANES 
surveys are released in 2-year cycles.
    When determining whether to update an RACC, we first considered two 
factors. If both of these factors were not met, we did not consider 
updating the 1993 RACC. 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 data collection for 
NHANES, which is completed by Centers for Disease Control and 
Prevention (CDC), is used to assess intake by the U.S. population. 
Because CDC's purpose in collecting NHANES data differed from our 
purpose in updating RACCs, 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. 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.
    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. We chose the value of 25 percent to 
represent a meaningful change based on our analysis of the data and 
after evaluating other values for percentage differences (e.g., 5 
percent, 10 percent) when applied to the data. To be conservative, we 
determined if the 25 percent change in intake was significantly 
different from the 1993 RACC by comparing the upper or lower 95 percent 
confidence interval for the new median estimates to the either 0.75 or 
1.25 times the1993 RACC, respectively. If the new NHANES 2003-2008 
consumption median estimate was higher than the 1993 RACC and the 95 
percent lower confidence bound of the median estimate was greater than 
1.25 times the 1993 RACC, we considered the new median to be 
significantly greater. If the new NHANES 2003-2008 consumption median 
estimate was lower than the 1993 RACC and if the 95 percent upper 
confidence bound of the median estimate was less than 0.75 times the 
1993 RACC, we considered the new median to be significantly less (Ref. 
12). 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 75 percent of the 1993 RACC or 
more than 125 percent of the 1993 RACC), we concluded that the current 
consumption amount needed to be updated; otherwise, we did not propose 
to update the 1993 RACC. In addition to determining whether the 
consumption amount had increased or decreased at least 25 percent from 
the 1993 RACC, we considered the skewness of the data. If the intake 
distribution was skewed and we could not rely on the median intake 
estimate from the NHANES 2003-2008 consumption data to propose a change 
in the RACC, we examined the data from the Food and Nutrient Database 
for Dietary Studies (FNDDS) 4.1 (Ref. 25). 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. 25). If the reasonable consumption 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, and if a conversion to a common household measure is 
applicable for the product, we then looked to see if there was a 
significant difference between the median intake estimates from the 
NHANES 2003-2008 consumption data for the product, converted to an 
applicable common household measure, and the 1993 RACC for the product.
    We received multiple comments asking for clarification or 
discussing our proposed amendments to specific RACCs or product 
categories. In the preamble of the proposed rule (79 11989 at 12005), 
we invited comment on whether we should propose changes to other 
product categories, including products identified as products of 
concern in comments to the ANPRM. Several comments recommended that we 
change RACCs for some of these additional product categories. We 
discuss these comments in section III.D.2. Comments relating to 
changing RACCs for specific product categories appear in alphabetical 
order, by product category.
1. Methodology Used To Determine When To Change RACCs
    (Comment 35) Many comments supported the proposed changes to the 
RACCs and the methods used to update the RACCs. Many comments were in 
favor of the 25 percent criterion to determine if a change was 
statistically significant. One comment stated that the methodology used 
is consistent with the statutory mandate to base serving sizes on the 
amount customarily consumed and provides for a consistent approach 
across all food categories. Another comment stated that the comment 
analyzed newer NHANES consumption data (NHANES 2009-2010) for certain 
product categories and found that the results for the product 
categories analyzed were the same as our results when looking at NHANES 
2003-2008 survey data.
    Other comments questioned the methodology used to determine when to 
change the RACCs. Comments questioned why 25 percent was used as the 
criterion to determine when a change in RACCs was statistically 
significant. Some comments stated that the 25 percent cutoff is 
arbitrary and that proposing to update only RACCs with changes of 25 
percent or greater neglects some categories that deserve reevaluation 
due to their impact on public health. Other comments questioned why we 
only looked at NHANES 2003-2008 data. The comments questioned why we 
did not consider newer consumption data in our analysis of when to make 
changes to the RACCs.
    (Response 35) We chose the value of 25 percent to represent a 
meaningful change based on our analysis of the data and after 
evaluating other values for percentage differences (e.g., 5 percent, 10 
percent), when applied to the data. To be conservative, we determined 
if the 25 percent change of intake was significantly different from the 
1993 RACC by comparing the upper or lower 95 percent confidence 
interval for the new median estimates to the either 0.75 or 1.25 times 
of the 1993 RACC, respectively. The 95 percent level of confidence is a 
general benchmark that is widely accepted in statistics and provides a 
conservative estimate to determine whether the recent nationwide 
consumption data capture the actual change of the amount being

[[Page 34025]]

consumed from the 1993 RACC while taking into account for the 
variability of the measurement when collecting dietary intake data for 
the U.S. population. We have not modified our methodology in this final 
rule.
    With regard to why we did not look at newer NHANES consumption 
data, the nationwide food consumption data are released every 2 years 
and with 2-year lag time (e.g., the NHANES 2007-2008 consumption data 
were released in 2010). The current RACCs, which were established in 
1993, are based on data from Nationwide Food Consumption Surveys (1977-
1978 and 1987-1988) conducted by USDA. The 2007-2008 NHANES data were 
the most recent consumption data available at the time that we 
conducted our analysis. We will continue to monitor consumption trends 
and update RACCs in the future as needed. Any consideration of newer 
consumption data would be addressed in a future rulemaking.
2. Changing RACCs for Specific Product Categories
    (Comment 36) After-dinner confectionaries--We received one comment 
on the proposed RACC for after-dinner confectionaries. The comment 
supported the 10 g RACC for this product category, but requested that 
we provide clarification regarding the description of the product 
category. Specifically, the comment requested that any product marketed 
as an ``after-dinner confectionery'' or ``after-dinner mint'' and that 
is available in units of 10 g or less be included in the ``after-dinner 
confectionaries'' product category. The comment pointed out that all of 
these products have similar dietary usage. Examples given of products 
that should be included in the after-dinner confectionaries product 
category were: (1) Small chocolate squares that are similar in size to 
after-dinner mints and intended to be used like mint wafers and (2) 
``butter mints'' that are often displayed on restaurant counters for 
customers to take with them as they leave following a meal. The comment 
also recommended that we adopt the spelling of confectionaries as 
``confectioneries.''
    (Response 36) We agree with this comment and agree that, generally, 
chocolate squares, butter mints, and similar products would be included 
in the ``after-dinner confectionaries'' product category since these 
products have similar dietary usage as after-dinner confectionaries. We 
also agree that confectioneries is the more widely used spelling and 
are amending table 2 in Sec.  101.12(b) to reflect this spelling.
    (Comment 37) Alfredo sauce--One comment opposed placing Alfredo 
sauce in the ``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'' product category. 
The comment stated that the amount of sauce typically consumed for 
other sauces in this product category is much less than the typical 
amount of Alfredo sauce used to coat a serving of pasta. The comment 
said that several large Italian restaurant chains were contacted and 
those chains stated that they typically use as much Alfredo sauce as 
tomato sauce. The comment requested that we keep Alfredo sauce in the 
``Major main entr[eacute]e sauces, e.g., spaghetti sauce'' product 
category with an RACC of 125 g.
    (Response 37) Consumption data for Alfredo sauce is consistent with 
other products in the minor main entr[eacute]e sauces product category. 
While some may use Alfredo sauce in the same manner as tomato sauce, 
others use Alfredo sauce in the same manner as pesto sauce, which is 
also in the minor main entr[eacute]e sauces product category. Because 
this product can be used in either way, we must rely on consumption 
data, which shows that people are typically consuming less Alfredo 
sauce than spaghetti sauce. Therefore, we are finalizing our decision 
to place Alfredo sauce in the ``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'' product 
category.
    (Comment 38) All other candies--We received one comment that 
supported our proposal to amend the RACC of the ``All other candies'' 
product category to 30 g. We received no comments that opposed this 
amendment. The supporting comment noted that the 30 g RACC was 
consistent with industry analyses of national food consumption data and 
other data sources, which suggested that Americans typically consume 
candy in moderation. The comment also indicated that the confectionery 
industry has been supporting messages that endorse eating candy in 
moderation, and has been promoting this concept by marketing 
individually wrapped candy units in moderate portion sizes. Further, 
the comment expressed concerns that lowering the RACC to 30 g for the 
``All other candies'' product category may affect the ability of 
manufacturers to make nutrient content claims for certain products. The 
comment requested that we consider updating the requirement that foods 
with smaller RACCs meet the nutrient criteria per 50 g for the purpose 
of making nutrient content claims and that we allow public comments on 
the implications to nutrient content claim requirements that are 
affected by the proposed rule.
    (Response 38) We agree with the comment to the extent that it 
supports establishing a 30 g RACC for ``All other candies'' and are 
finalizing the change in RACC to 30 g. We decline, however, to reopen 
the comment period on the proposed rule or to amend the 50 g criteria 
for products that have RACCs of 30 g or less. We accepted comment on 
all issues pertaining to the impact that the RACCs have on nutrient 
content claims. We believe the comment period on the proposed rule 
provided a sufficient opportunity to comment on this and other related 
issues. As discussed in section III. E., once this final rule and the 
Nutrition Facts final rule are published, we plan to assess the impacts 
of these rules on claim eligibility. We intend to consider issues such 
as whether any changes in eligibility for claims continues to help 
consumers construct healthful diets and whether the criteria for 
claims, including the 50 g criteria for products that have RACCs of 30 
g or less, remain appropriate. However, as we noted in the proposed 
rule, changes in the eligibility to bear claims may be appropriate for 
some foods in light of changes in the amounts of food being customarily 
consumed (79 FR 11989 at 12016).
    (Comment 39) 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--Some comments supported the new 
Appetizers product category. The comments stated it is appropriate to 
establish a separate category for these smaller-sized versions of the 
current product category ``Not measurable with cup, e.g., burritos, egg 
rolls, enchiladas, pizza, pizza rolls, quiche, all types of 
sandwiches'' in the ``Mixed Dishes'' general category because 
appetizers will be consumed in smaller amounts than the current mixed 
dishes product category based on their intended use. Some comments 
stated that this new product category would align with USDA labeling 
requirements for similar products.
    One comment requested that, based on the similarities between the 
products that qualify for the ``Mixed Dishes'' general category and the 
new product category for Appetizers, we consider allowing products in 
the new product category for Appetizers to be eligible for

[[Page 34026]]

a ``lean'' claim and requested that we clarify that products in the 
Appetizer category are eligible for a ``lean'' claim provided they meet 
the appropriate criteria. The regulations for ``lean'' claims currently 
permit, in part, products that fall within the product category of 
``Mixed dishes not measurable with cup'' to bear the claim, provided 
they contain less than 8 g total fat, 3.5 g or less saturated fat, and 
less than 80 mg cholesterol per RACC (Sec.  101.62(e)(2)).
    (Response 39) We agree that establishing a separate product 
category for appetizer products is necessary. Consumption data shows 
that appetizers are consumed in smaller amounts than products in the 
mixed dish product category. The median consumption for mini pizza 
rolls is 83 g and for meatless egg rolls is 57 g. Appetizers are foods 
served before a meal, while products in the mixed dish product category 
are foods primarily used as entr[eacute]es or main dishes (Ref. 26). We 
also note that 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. 27), which will allow consumers to compare 
nutrition information across food labels for these types of products. 
In terms of the ``lean'' claim, we note that while products in the 
Appetizers product category that were previously in the ``Mixed dishes 
not measurable with cup'' product category no longer fall under the 
requirements of Sec.  101.62(e)(2), such products would be permitted to 
use a ``lean'' claim on their label if the products satisfy the 
requirements of Sec.  101.62(e)(1).
    (Comment 40) Fruits used primarily as ingredients, avocado--Some 
comments supported updating the RACC for avocado from 30 g to 50 g. The 
comments stated that updating the ``Fruits used primarily as 
ingredients, avocado'' product category will give Americans more 
reasons to choose avocados and increase their fruit and vegetable 
intake. The comment stated that the change in the avocado RACC will 
help Americans meet their nutrient needs, including some nutrients 
identified in the 2010 Dietary Guidelines for Americans as being of 
public health concern (e.g., fiber and potassium). The comments said 
that updating the RACC for fresh avocados to 50 g (i.e., a \1/3\ medium 
avocado serving size) would contribute certain nutrients to the diet.
    (Response 40) While this final rule affirms our decision to update 
the RACC for avocado, our decision to update the RACC was based on 
consumption data, rather than a desire to promote specific products or 
product categories.
    (Comment 41) Bagel Thins, Mini Bagels--One comment requested that 
we include bagel thins and mini bagels in the bread product category, 
with an RACC of 50 g, instead of the new ``Bagels, toaster pastries, 
muffins (excluding English muffins)'' product category with an RACC of 
110 g. The comment stated that bagel thins are a smaller, more calorie-
conscious alternative to full-sized bagels and that each bagel thin, 
which is comprised of two slices, weighs 46 g. The comment further 
stated that bagel thins are marketed as a perforated unit, like an 
English muffin, and are typically suggested for use in making 
sandwiches, so that a consumer can enjoy the taste and texture of a 
bagel without the full thickness and accompanying calories of a regular 
bagel. The comment stated that with the new ``Bagels, toaster pastries, 
muffins (excluding English muffins)'' product category, the serving 
size for this product would be two separate bagel thins.
    The comment also expressed concern with the RACC for mini bagels, 
which are sold in 40 g servings. The comment stated that under the 
current RACC for bagels, each serving size is one mini bagel, but the 
proposed RACC would increase the serving size to three mini bagels. The 
comment argued that this change could in turn encourage consumers to 
eat more mini bagels than is recommended under the current RACC and 
requested that we establish a separate category for these products that 
takes into account this discrepancy in serving size and different 
intended use. The comment questioned whether NHANES data used to 
determine the RACC for bagels included products such as mini bagels and 
mini muffins as a separate item from their full-size counterparts. The 
comment requested that if there is separate data for mini bagels and 
mini muffins, we establish a separate RACC for these mini products and 
recommended that we consider adopting a similar approach for other 
innovative foods to avoid the unintended consequence of suggesting a 
serving size larger than what consumers are likely to consume in a 
single eating occasion.
    (Response 41) We note that bagel thins have a similar dietary usage 
to sandwich bread--namely, to make sandwiches--rather than that of 
traditional bagels (i.e., as a breakfast item that is often eaten with 
cream cheese or other toppings) (Ref. 26). In addition, a review of 
recipes that used bagel thins as an ingredient reveals that most 
recipes using bagel thins are recipes for sandwiches that used bagel 
thins in a comparable manner to bread (Ref. 28). Section 101.12(a)(7) 
states that ``[t]he reference amount is based on the major intended use 
of the food. . . .'' The reference amount reflects the major dietary 
usage of the food because the major usage determines the customarily 
consumed amount (Ref. 29). Therefore, we would include bagel thins in 
the ``Breads (excluding sweet quick type), rolls'' product category. 
The product category name will remain unchanged, but we intend to 
indicate that this type of product will be in the ``Breads (excluding 
sweet quick type), rolls'' product category with an RACC of 50 g in 
future guidance concerning serving sizes.
    With regard to mini bagels, we disagree with the comment and are 
finalizing the placement of mini bagels in the ``Bagels, toaster 
pastries, muffins (excluding English muffins)'' product category with 
an RACC of 110 g. RACCs are not recommended amounts; rather, RACCs are 
based on the amount customarily consumed. The comment argues that 
increasing the RACC for mini bagels will encourage a consumer to eat 
more, but the rationale for increasing the RACC is that consumption 
data shows that consumers are already eating more bagel products. In 
order to allow consumers to make easy product comparisons we group 
products with similar dietary usage together. The primary usage of mini 
bagels, like regular-sized bagels, is as a breakfast item. NHANES does 
not provide information about mini bagels and mini muffins that is 
separate from their larger-sized counterparts, and we have identified 
no other data indicating that consumption levels differ between mini 
bagels and regular-sized bagels. Further, mini bagels have similar 
product characteristics to their larger-sized counterparts (e.g., both 
are doughnut-shaped yeast rolls with a dense, chewy texture and shiny 
crust) (Ref. 25). Therefore, we decline to establish a separate RACC 
for mini bagels.
    (Comment 42) Coffee Beans, Tea Leaves, and Certain Plain 
Unsweetened Coffee and Tea Products--Some comments noted that products 
such as plain unsweetened coffee and tea are exempt from the nutrition 
labeling requirements under Sec.  101.9(j)(4) because they contain 
insignificant amounts of all nutrients required to be declared in the 
Nutrition Facts label. These comments noted that the increased RACC for 
these products combined with the proposed mandatory declaration of 
potassium in ``Food Labeling: Revision of the

[[Page 34027]]

Nutrition and Supplement Facts Labels'' may cause unsweetened coffee 
and tea to have low but detectable levels of potassium, which would 
cause them to lose their current exemption from nutrition labeling. The 
comments stated that nutrition labeling on these products could pose 
challenges for Nutrition Facts labels on small packages. Therefore, 
these comments requested that we reexamine Sec.  101.9(j)(4) and make 
any necessary adjustments.
    (Response 42) We recognize the discrepancy between the explicit 
exemption from nutrition labeling for certain coffee and tea products 
under Sec.  101.9(j)(4), and the changes to the RACCs and nutrient 
declaration requirements that generally subject such products to 
nutrition labeling requirements. Although we asked for comment in the 
proposed rule about all issues pertaining to the proposed RACCs, we did 
not ask for comments specifically about the continued applicability of 
the exemption from nutrition labeling provisions under Sec.  
101.9(j)(4) in light of the proposed changes to the RACCs and the 
proposed changes to the nutrient declaration requirements under the 
proposed rule entitled ``Food Labeling: Revision of the Nutrition and 
Supplement Facts labels.'' We intend to consider the future 
applicability of the exemption with respect to coffee beans (whole or 
ground), tea leaves, plain unsweetened coffee and tea, condiment-type 
dehydrated vegetables, flavor extracts, and food colors in a separate 
rulemaking. Until such time as we have had the opportunity for any 
future rulemaking, we intend to consider the exercise of enforcement 
discretion with respect to the mandatory nutrition labeling on any 
products that would have been exempt under Sec.  101.9(j)(4) prior to 
the effective date of this final rule.
    We also understand that providing Nutrition Facts labels on 
packages with limited space may be challenging for manufacturers. We 
have special labeling provisions for packages with limited space in 
existing regulations (see Sec.  101.9(j)(13)(i)).
    (Comment 43) Canned Fish--One comment discussed the ``Fish, 
shellfish, or game meat, canned'' product category. The comment opposed 
the increase in the RACC of fish, shellfish, or game meat, canned from 
55 g to 85 g. The comment stated that the most common use for canned 
seafood was as an ingredient in sandwiches, and that the RACC for the 
canned fish product category should remain at 55 g. The comment stated 
that canned fish is comparable with the product category ``Substitute 
for luncheon meat, meat spreads, Canadian bacon, sausages and 
frankfurters'' and four product categories for meat and poultry 
products regulated by USDA (i.e., luncheon meat, luncheon products, 
canned meats, and canned poultry) (Ref. 27). The comment stated that 
the common usage for canned fish in recipes reflects a 55 g RACC since 
canned seafood is typically used as an ingredient to prepare 
sandwiches, salads and casseroles. The comment also questioned the 
validity of the ``reasonable consumption amount'' of 85 g. The comment 
stated that the ``reasonable consumption amount'' is a default value 
that may be used to indicate the quantity consumed during the dietary 
recall survey tool when the participant cannot recall the amount 
consumed and that a typical 5 oz can of tuna will provide the consumer 
with two, 2 oz (56 g) servings; thus, using 85 g as the default 
``reasonable consumption amount'' will inflate the consumption amounts 
by over 50 percent. The comment stated that the other serving size 
descriptions for canned tuna and other canned seafoods (e.g., canned 
salmon) used for the USDA FNDDS need to be updated to reflect current 
can sizes. For the product ``Tuna canned, non-specified as to oil or 
water pack,'' two of the size options are a 13 oz can with a drained 
tuna amount of 321 g and a 6.5 oz can with a drained tuna amount of 160 
g. The comment expressed concern that the use of larger-than-available 
can sizes and default serving size values will artificially inflate the 
amount of canned seafood that is recorded during diet recall surveys.
    The comment further stated that the current RACC allows canned 
seafood, in particular canned tuna, to be offered in different-sized 
cans that reflect one or more servings per can. For example, a 3 oz can 
is a single serving, a 5 oz can has two servings, a 7 oz can has two 
and a half servings, and a 12 oz can has four and a half servings. The 
comment stated that with the proposed change to an 85 g RACC and the 
proposal to require products with less than 200 percent of the RACC to 
be labeled as a single serving, the 3 oz, 5 oz, and 7 oz can sizes will 
all be labeled as a single serving but each with different serving 
sizes.
    The comment also stated that there is an inconsistency in the 
codified table of the proposed rule. The comment stated that the 
``Fish, shellfish, or game meat, canned'' product category in the 
right-hand column lists examples of label statements and that two of 
the examples correspond to a 55 g RACC rather than the proposed 85 g 
RACC. The comment noted that the table states, ``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).'' The comment asserted that the examples 
provided in the table should reflect the finalized RACC.
    (Response 43) In response to the comment that expressed concern 
that increasing the RACC will make the product category ``Fish, 
shellfish, or game meat, canned'' not easily comparable with the 
product category ``Substitute for luncheon meat, meat spreads, Canadian 
bacon, sausages and frankfurters,'' although products in both of these 
product categories can be used to make sandwiches, the consumption data 
for the product categories is different enough to warrant different 
RACCs.
    To address the comment that questioned the validity of using the 
reasonable consumption amount, this comment misunderstands the basis 
for the proposed RACC. The change in RACC for this product category was 
based primarily on median consumption data and not the reasonable 
consumption amount. While we agree that the reasonable consumption 
amount is a default value that may be used to indicate the quantity 
consumed during the dietary recall survey tool when a participant 
cannot recall the amount consumed, this information is not considered 
relevant to our proposed RACC for ``Fish, shellfish, or game meat, 
canned.'' The decision to increase the RACC for canned fish products is 
primarily based on the median consumption NHANES 2003-2008 data of 84 
g. Since the reasonable consumption amount did not provide the main 
basis for which we determined the RACC, we disagree that using 85 g as 
the default ``reasonable consumption amount'' will inflate the 
consumption amounts by over 50 percent. The 2003-2008 median 
consumption is 84 g for fish, shellfish or game meat, canned, which is 
also similar to the reasonable consumption amount from the currently 
available FNDDS of 85 g.
    To address the comment asserting that the serving size descriptions 
for canned tuna and other canned seafood used for the USDA FNDDS need 
to be updated to reflect current can sizes, we note that such data is 
developed by USDA, and not FDA. To the extent that the comment is 
asking that we rely on more recent data, the data we used to establish 
the RACC for canned fish is consistent with our use of data in NHANES 
as discussed in comment 34.

[[Page 34028]]

    The fact that the recent data has shown an increase in consumption 
outweighs the argument that the current 55 g RACC is the amount that is 
currently used in recipes for sandwiches, salads, and casseroles and 
that more can sizes will be labeled as a single serving with an 
increase in the RACC. The data suggest that consumers are consuming 
larger amounts of canned fish compared to the 1993 RACC of 55 g and 
that labeling some larger can sizes as a single serving will accurately 
reflect how consumers are eating the product. In addition, while we 
recognize the impact that package size has on consumption levels, 
package sizes are not taken into consideration when determining RACCs, 
as we cannot predict what package sizes will be in the marketplace. 
Rather, consumption amount is the primary factor in determining RACCs.
    We have addressed the error in the label statement of the new 85 g 
RACC in the codified section of this rule. The label statement will be 
changed to ``3 oz. (85 g/__cup)'' and ``3 oz. (85 g/__pieces).''
    (Comment 44) Cereal--We received several comments concerning the 
RACC for breakfast cereal. Some comments supported the decision to 
maintain the existing RACC for cereal, yet other comments questioned 
the decision to keep the RACC for medium weight cereals the same 
despite a significant increase in consumption when compared to the 1993 
RACC. The comments stated that ready-to-eat cereals are a common 
breakfast food, particularly for children and adolescents, who 
typically consume more than the RACC. The comments stated that many 
cereals are high in added sugars, which are particularly concerning for 
children. Some comments stated that the Children's Food and Beverage 
Advertising Initiative (CFBAI) has established voluntary criteria for 
the nutritional quality of cereals marketed to children (Ref. 30). The 
current CFBAI standard limits the advertising of cereals to ones that 
contain no more than 10 g of total sugar per serving (Ref. 30). The 
comments noted that if we increased the RACC for medium-dense cereals, 
fewer sugary cereals would meet CFBAI's advertising criterion, fewer 
would be marketed to children, and companies would reduce the sugar 
content of popular cereals to enable them to be marketed to children.
    Other comments questioned why the serving size on the labels of 
cereals varies so much. For example, a box of one type of cereal may 
have a serving size of 1 cup, while a box of another cereal may have a 
serving size of \1/2\ cup. Package serving sizes on cereal labels 
appear to have greater variation than other product categories.
    (Response 44) The 2003-2008 median intake estimates for breakfast 
cereals, weighing between 20 g and 43 g per cup (mediumweight cereals) 
is 39 g, which is significantly different from the 1993 RACC of 30 g. 
However, we did not propose to update the RACC for this product 
category in order to keep the household measure most closely associated 
with the reference amount consistent with the product category 
``Breakfast cereals, ready-to-eat weighing less than 20 g per cup, 
e.g., plain puffed cereal grains'' (lightweight cereals) and the 
product category ``Breakfast cereals, ready-to-eat weighing 43 g or 
more per cup; biscuit types'' (heavy weight cereals), for which 
existing RACCs are 15 g and 55 g, respectively (Ref. 31). Although the 
serving sizes for low, medium, and heavyweight cereals may appear to be 
varied, they are all based on comparable volumetric amounts. The 
differences in the density (e.g., grams per cup) of cereals make for 
the variation in their serving sizes. A consumer would have to eat more 
of a lightweight cereal to equal the weight of a cup of a heavyweight 
cereal. For example, the weight of 1 cup of a lightweight cereal, such 
as a puffed rice cereal, could be equivalent to the weight of a \1/2\ 
cup of a heavyweight cereal such as an oat bran cereal. The current 
cereal RACCs correspond to 1 cup of cereal for the various cereal 
densities. The decision to maintain the current RACC for mediumweight 
cereals was to be able to maintain the same volumetric serving size of 
cereal for all three product categories. This way, although it may not 
appear as such on labels, a consumer is actually comparing similar 
amounts in terms of volume regardless of the type of cereal.
    In light of the comments, and consistent with our evaluation of 
consumption data, we have decided to update the mediumweight cereal 
RACC to 40 g (Ref. 32). This amount corresponds to a 1.1 cup 
equivalent. Mediumweight cereal has the largest sample size of the 
three cereal product categories. We have determined that ensuring 
consistency in the RACC for all three breakfast cereal product 
categories to reflect the current consumption of mediumweight cereal, 
which has the largest sample size of the three product categories, is 
more in line with the changes that we made in other product categories. 
No change to the RACC is needed for low-density breakfast cereals 
weighing less than 20 g per cup, as the existing reference amount of 15 
g continues to correspond to 1.1 cups. To ensure consistency with 
lightweight and mediumweight cereals, we are updating the RACC for the 
heavyweight breakfast cereals weighing 43 g or more per cup from 55 g 
(corresponding to 1 cup) to 60 g (corresponding to 1.1. cups). By 
making these amendments, the RACCs for all cereals will now correspond 
to 1.1 cups.
    (Comment 45) Cupcake Filling--One comment requested that we 
establish an RACC for cupcake filling. The comment explained that 
cupcake filling is frosting, pudding, fruit preserves or other items 
that are used to fill a cupcake. The comment asserted that cupcake 
filling is different from cake frosting because it is a product that is 
made for the purpose of being used inside the cupcake and not on top of 
a cupcake or cake. According to the commenter, cupcake fillings use 
less frosting or other filling ingredient than is used to ice a cake, 
and products from various product categories can be used as cupcake 
fillings including pie fillings, non-dairy whipped topping, and 
frosting.
    (Response 45) We recognize a need for an RACC for this specific 
food product as well as for other types of cake or pastry fillings. 
Cake, pastry, and cupcake fillings include fillings for products such 
as donuts, cakes, and cupcakes. However, because the proposed rule was 
silent about an RACC for cupcake filling, and because we intend to 
provide the opportunity for public comment on this specific issue, we 
intend to establish an RACC for this product category in future 
rulemaking and intend to add a suggested RACC of 1 tbsp for this 
product category distinct from the ``Cake frostings or icings'' product 
category in a future guidance document.
    (Comment 46) Drink Mixes--Some comments discussed the two new drink 
mix product categories: ``Milk, milk substitute, and fruit based drink 
mixes (without alcohol) e.g., drink mixers, fruit flavored powdered 
drink mixes, sweetened cocoa powder)'' and ``Drink mixes (without 
alcohol): all other types (e.g., flavored syrups and powdered drink 
mixes).'' The comments were generally in favor of the proposed changes 
to the drink mix product categories, but requested a revision to the 
fruit-based drink mixes. The comments requested that the subcategory of 
``fruit-based drink mixes,'' which includes fruit-flavored powdered 
drink mixes, be removed from the ``Milk, milk substitutes, and fruit 
based drink mixers (without alcohol), e.g., drink mixers, fruit

[[Page 34029]]

flavored powdered drink mixes, sweetened cocoa powder)'' product 
category with an RACC of ``Amount to make 240 mL drink (without ice)'' 
and added to the ``Drink mixes (without alcohol): all other types 
(e.g., flavored syrups and powdered drink mixes)'' product category 
with an RACC of ``Amount to make 360 mL drink (without ice)'' based on 
its primary use as a mix added to water. The comments stated that the 
categorization of drink mixes causes inconsistencies. For example, 
powdered tea mixes are currently in the amount to make 360 mL product 
category, and non-flavored tea mixes would have an RACC of 360 mL; 
however, fruit-flavored tea mixes (e.g., raspberry-flavored tea) would 
have an RACC of 240 mL. The comments stated that this categorization of 
drink mixes could foster confusion for consumers and lead to 
unnecessary and unwarranted changes for industry.
    One comment asked for clarity on the categorization of liquid 
concentrate beverage mixes and requested that a subcategory for 
``liquid beverage concentrates'' be added to the product category 
``Drink mixes (without alcohol): all other types (e.g., flavored syrups 
and product drink mixes),'' with an RACC of 360 mL (12 fl oz), since 
this product subcategory is primarily added to water when consumed.
    (Response 46) The proposed ``Milk, milk substitutes, and fruit 
based drink mixers (without alcohol), e.g., drink mixers, fruit 
flavored powdered drink mixes, sweetened cocoa powder)'' product 
category is intended to contain drink mixes containing 100 percent 
fruit-based ingredients, such as fruit juice concentrate, which have 
similar dietary usages as 100 percent fruit juices or fruit drinks. 
This product category was not intended to include products that are 
fruit flavored. Therefore, a fruit-based drink mix with an RACC of 8 fl 
oz is necessary. However, we understand the issue addressed in the 
comment and see that it is necessary to create an additional RACC for 
fruit-flavored drink mixes that have an RACC of 360 mL (12 fl oz). 
Therefore, we are revising the product category names to reflect the 
changes. We are clarifying that the 240 mL (8 fl oz) RACC product 
category is intended for fruit drink mixes that substitute 100 percent 
juice blends such as frozen fruit juice concentrates and that the 360 
mL (12 fl oz) RACC product category is intended for powdered fruit-
flavored drink mixes that are comparable to iced tea mixes and other 
beverages that have an RACC of 360 mL (12 fl oz). Fruit juice 
concentrates should have an RACC of 240 mL (8 fl oz), consistent with 
100 percent fruit juices and fruit drinks. The name for the ``Milk, 
milk substitutes, and fruit based drink mixers (without alcohol), e.g., 
drink mixers, fruit flavored powdered drink mixes, sweetened cocoa 
powder)'' product category is amended in Sec.  101.12(b) to ``Milk, 
milk substitute, and fruit juice concentrates (without alcohol) (e.g., 
drink mixers, frozen fruit juice concentrate, sweetened cocoa 
powder).'' The category name for ``Drink mixes (without alcohol): all 
other types (e.g., flavored syrups and powdered drink mixes'' will 
remain the same.
    With respect to the comment concerning liquid beverage 
concentrates, the comment does not describe what a liquid beverage 
concentrate is. We are unsure if the products referred to are different 
than the fruit juice concentrates discussed previously. However, if the 
product is fruit flavored, rather than a fruit juice concentrate, then 
it should be included in the ``Drink mixes (without alcohol): all other 
types (e.g., flavored syrups and powdered drink mixes)'' product 
category with an RACC of 360 mL (12 fl oz).
    (Comment 47) Fruit juice--Several comments supported keeping the 
RACC for fruit juice at 240 mL (8 fl oz). One comment stated that a 240 
mL (8 fl oz) RACC is consistent with guidelines established by the 
American Academy of Pediatrics and the Robert Wood Johnson Foundation 
(which both recommend 8 oz of juice for adults and older children), in 
addition to the 2010 Dietary Guidelines for Americans. The comment 
requested that all juice beverages have the same 240 mL (8 fl oz) RACC 
regardless of whether it is manufactured with still water or carbonated 
water.
    (Response 47) Based on our review of the data as described in the 
proposed rule (79 FR 11989 at 12010), we agree that the RACC for fruit 
juice should remain at 240 mL (8 fl oz). Products that contain less 
than 100 percent and more than 0 percent fruit or vegetable juice and 
that meet the requirements under Sec.  102.33(a) to be labeled as a 
juice ``beverage,'' ``drink,'' or ``cocktail'' have an RACC of 240 mL 
(8 fl oz) regardless of whether they are manufactured with still water 
or carbonated water. We note, however, that drink mixers do not fall 
within the product category ``Juices, nectars, fruit drinks''; rather, 
products such as strawberry daiquiri mix and Bloody Mary mix are part 
of the product category ``Drink mixes (without alcohol): all types 
(e.g., flavored syrups and powdered drink mixes).''
    (Comment 48) Hazelnut spread--We received a comment requesting that 
we either: (1) Expand the existing product category for ``Honey, jams, 
jellies, fruit butter, molasses'' to include nut cocoa based spreads, 
such as hazelnut spread or (2) establish a new RACC of 1 tbsp for nut 
cocoa based spreads. The comment stated that hazelnut spread is 
currently in the product category ``other dessert toppings'' because it 
was considered to be comparable with chocolate syrup at the time of the 
1991 proposed rule. The comment indicated that hazelnut spread is 
currently primarily used on bread or as a spread for snacks, crackers, 
and fruits. The comment also stated that the mean, median, and mode 
consumption amounts for hazelnut spread in NHANES are all equal to 1 
tbsp.
    (Response 48) We recognize a need for an RACC for hazelnut spread 
outside of the dessert product category. We agree that the primary 
usage of hazelnut spread is as a spread for bread instead of as a 
dessert topping. However, because the proposed rule was silent about an 
RACC for hazelnut spread, and because we intend to provide the 
opportunity for public comment on this specific issue, we intend to 
consider whether to move hazelnut spread to a different appropriate 
product category in a future rulemaking.
    (Comment 49) Several comments questioned the regrouping of the 
``Ice cream, ice milk, frozen yogurt, sherbet: all types, bulk and 
novelties (e.g., bars, sandwiches, cones)'' product category and the 
``Frozen flavored and sweetened ice and pops, frozen fruit juices: all 
types, bulk and novelties (e.g., bars, cups)'' product category to the 
following product categories: ``Ice cream, ice milk, frozen yogurt, 
sherbet, frozen flavored and sweetened ice, frozen fruit juices: all 
types bulk'' and ``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).'' The comments stated 
that the decision to increase the RACC for ice cream was arbitrary and 
that it is only by proposing to separate the ice cream product category 
into separate RACCs for bulk ice cream and novelties that we were able 
to determine that consumption of one of those categories (i.e., ``bulk 
ice cream'') had increased by more than 25 percent compared to the 1993 
RACC.
    The comments stated that the separation of the ice cream category 
into two sub-categories raises an issue of consistency between the two 
product categories. The comments stated that the exact type of ice 
cream sold in a \1/2\ cup individual novelty serving can be packaged in 
a larger bulk container such as a pint or \1/2\ gallon. The comments

[[Page 34030]]

stated that although the products will have identical formulations, the 
differing RACCs between the bulk and novelties package sizes would 
result in different criteria for the nutrient content claims such as 
``low fat,'' ``fat free,'' or ``non-fat.'' This would mean the same ice 
cream could meet the criteria for ``low fat'' when packaged in a small, 
novelty-sized cup, but not when it is packaged in a larger container. 
Similarly, a frozen yogurt or ice cream product may be considered a 
``good source'' of calcium when dispensed from a bulk container, but 
not a good source of calcium when provided in a single-serve cup. One 
comment asserted that using two different RACCs depending upon the 
package size (e.g., bulk or single-serve cup) would create consumer 
confusion through the distinction in nutrient content claims each 
product would be permitted to make.
    One comment requested that we remove the term ice milk from the 
product category name ``Ice cream, ice milk, frozen yogurt, sherbet, 
frozen flavored and sweetened ice, frozen fruit juices: all types 
bulk.'' The comment noted that the standard for ice milk was abolished 
in 1994 when we acted on a citizen petition from the International Ice 
Cream Association and issued a final rule entitled ``Frozen Desserts: 
Removal of Standards of Identity for Ice Milk and Goat's Milk Ice Milk; 
Amendment of Standards of Identity for Ice Cream and Frozen Custard and 
Goat's Milk Ice Cream'' (59 FR 47072, September 14, 1994).
    One comment stated that soft-serve products are distinct from 
traditional (hard pack) ice cream and frozen desserts. The comment 
asserted, for example, that a typical soft-serve ice cream has less 
fat, more milk solids, a lower sugar content, and a lower percent 
overrun (referring to the amount of air that is whipped into the 
product), and is generally eaten at a warmer serving temperature 
compared to a typical hard ice cream. The comment stated that a typical 
hard ice cream has a density of 1.0 weight ozs per 1.8 fl oz (128 g per 
cup), while a survey of the soft-serve ice cream industry revealed an 
average product density of 1.0 weight ozs per 1.25 fl oz (181 g per 
cup). The comment requested a new product category for soft-serve ice 
cream named ``Soft serve ice cream, soft serve frozen custard, soft 
serve gelato: all types bulk'' with an RACC of \1/2\ cup. The comment 
noted that there is precedent for delineation of products by 
differences in density--for example, ``Cakes'' are separated into 
categories of heavyweight, mediumweight, and lightweight; and 
``Breakfast cereals'' are separated into categories by density (puffed, 
medium density, and biscuit type). The comment stated that because of 
their differences in density, such a separation seems appropriate for 
frozen dairy desserts as well.
    (Response 49) With respect to the comments regarding the 
reorganization of the two product categories--``Ice cream, ice milk, 
frozen yogurt, sherbet, frozen flavored and sweetened ice, frozen fruit 
juices: all types bulk'' and ``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)''--we 
have reconsidered our position on whether distinct product categories 
are necessary. Upon further consideration, we agree that bulk frozen 
dairy products are similar to novelty frozen dairy products, and that 
bulk frozen fruit flavored products are similar to novelty frozen fruit 
flavored products, both in terms of dietary usage and in terms of 
product characteristics. We recognize that the same type of ice cream 
sold in a \1/2\ cup individual novelty serving can be packaged in a 
larger bulk container such as a pint or \1/2\ gallon and that these 
products may have identical formulations. In order to allow for 
comparable frozen dessert products to be grouped together we are 
modifying the preexisting RACCs to create one combined product category 
with the product category name ``Ice cream, frozen yogurt, sherbet, 
frozen flavored and sweetened ice, frozen fruit juices: all types bulk 
and novelties (e.g., bars, sandwiches, cones, cups).'' This change 
should also eliminate concerns expressed by comments that using two 
different RACCs depending upon the package from which the product is 
dispensed (e.g., bulk or single-serve cup) might be confusing to 
consumers.
    In order to determine the median consumption amount for the product 
category ``Ice cream, frozen yogurt, sherbet, frozen flavored and 
sweetened ice, frozen fruit juices: all types bulk and novelties (e.g., 
bars, sandwiches, cones, cups),'' we analyzed the NHANES 2003-2008 
intake data for all products in this product category and found that 
the median consumption of these products is 0.7 cup. Under Sec.  
101.9(b)(5)(i), when the use of cups is the appropriate household unit 
in which to express serving size, the quantity in cups shall be 
expressed in \1/4\- or \1/3\-cup increments. Under this provision, 0.7 
cups rounds to \2/3\ of a cup. Therefore, we are creating an RACC for 
the new product category ``Ice cream, frozen yogurt, sherbet, frozen 
flavored and sweetened ice, frozen fruit juices: all types bulk and 
novelties (e.g., bars, sandwiches, cones, cups)'' of \2/3\ of a cup. 
The regrouping of these product categories allows for like products to 
have the same RACCs based on similar dietary usage, product 
characteristics, and customary consumption amounts.
    With respect to the comment that requested that we remove the term 
``ice milk'' from the product category ``Ice cream, ice milk, frozen 
yogurt, sherbet, frozen flavored and sweetened ice, frozen fruit 
juices: all types bulk,'' we agree. Ice milk has not been included in 
the new frozen desserts product category.
    With respect to the comment requesting a separate product category 
for soft serve ice cream, we decline to make this change. Bulk soft-
serve ice cream has similar dietary usage and is consumed in the same 
manner as non-soft-serve ice cream (Ref. 26). Providing the same RACC 
for these two types of products allows consumers to easily compare 
nutrition information between the two products.
    (Comment 50) Ice cream--Several comments addressed the change in 
the RACC for ice cream from \1/2\ cup to 1 cup. Some comments favored 
the proposed changes to the RACC for ice cream, while others were 
opposed to it. The comments in favor of the 1 cup RACC for ice cream 
stated that the new RACC was more reasonable and consistent with the 
amount that a person typically consumes.
    Other comments stated that a \1/2\ cup measure for ice cream is a 
more practical and realistic reference amount. One comment stated that 
a \1/2\ cup of ice cream is not misleading. The comment noted that the 
common household ice cream scoop dispenses 8 servings of ice cream per 
quart, or exactly a \1/2\ cup of ice cream. The comment further noted 
that the \1/2\ cup measure is a simple common reference point that 
consumers clearly understand and that, with ongoing concerns about 
obesity in America, it is important to have simple tools to help 
consumers manage their weight. A few comments suggested that if we 
increased the RACC to 1 cup, consumers might interpret the RACC as an 
indication that two scoops of ice cream is an appropriate portion.
    (Response 50) With respect to the comments stating that the RACC 
for bulk ice cream should remain at \1/2\ cup because this is the 
typical amount in a household scoop, the comment did not provide data 
to confirm that a \1/2\ cup ice cream scoop is the most common 
household size. There are ice cream scoops that are commercially 
available to consumers in sizes ranging from 0.5 oz (1 tablespoon 
(tbsp)) to 5 oz (1 cup)

[[Page 34031]]

(Ref. 33). Although it may be common for ice cream scoops to scoop ice 
cream in the amount of \1/2\ cup, ice cream scoop sizes vary. We also 
note that the comment provided no support for the assertion that 
consumers eat one scoop of ice cream. It is less subjective and 
consistent with FDA's legal authority to base the RACC on the amount 
customarily consumed. As explained in comment 49, we are finalizing an 
RACC for the product category ``Ice cream, frozen yogurt, sherbet, 
frozen flavored and sweetened ice, frozen fruit juice: all types bulk 
and novelties (e.g. bars, sandwiches, cones, cups)'' of \2/3\ of a cup.
    With respect to the comment that stated that increasing the RACC 
for ice cream would be confusing to consumers and encourage them to eat 
more, we note that some consumer comments on the ANPRM and the proposed 
rule suggested strongly that the existing RACC is misleading and 
requested that the RACC for ice cream be based on a more realistic 
amount. To help ensure that consumers understand the meaning of changes 
to the serving size portion of the Nutrition Facts label, we intend to 
conduct nutrition education to help clarify the meaning of the serving 
size and RACCs after this rule becomes effective.
    (Comment 51) Some comments questioned the density measurements we 
used when converting from the amount of ice cream consumed, as reported 
in NHANES data, to the common household measure based on cups in order 
to determine the RACC for bulk ice cream. One comment stated that a 
memo to the file for the proposed rule (Ref. 31) states the household 
units were calculated using the following conversion factors: 1 oz of 
ice cream or frozen yogurt = 1.5 fl oz; 1 cup = 8 fl oz (citing Sec.  
101.9(b)(5)(viii)). The comment agreed with this conversion factor 
based on the air typically incorporated into ice cream, but did not 
believe we applied the conversion factor correctly. The comment stated 
that the median weight for ``Ice cream, bulk, and regular'' from 2003-
2008 NHANES is 116 g, but that, in the proposed rule (79 FR 11989 at 
12012), we stated that the ``[c]urrent 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.'' The comment stated that, if the 
footnote conversion factor were applied to the median serving size of 
ice cream expressed by weight, it would result in a lower value of 
6.108 fl ozs or 0.767 cup, which would round in household measures to 
\3/4\ of a cup (116 g/28.35 g per oz = 4.09 oz x 1.5 = 6.138 fl oz) and 
that this corresponds to a density value of 151 g per cup for ice cream 
and frozen yogurt (i.e., (1 oz/1.5 fl oz)(8 fl oz/1 cup)(28.35 g/oz) = 
151g/cup)). The comment noted that a \3/4\ cup household measure for 
bulk ice cream reflects current consumption data and product 
composition and said that the comment relied upon used the most current 
density measurement for ice cream of 148 g per cup, based on NHANES 
data from 2003-2010, which will result in an RACC of \3/4\ cup for bulk 
ice cream. The comment stated that when the 148 g per cup density 
measurement for ice cream is applied to the 2003-2008 NHANES median 
amount consumption per eating occasion (116 g), the household measure 
is calculated at 0.783 cup (6.26 fl oz or \3/4\ cup). The comment 
stated that consumers now favor more dense ice creams, and that the ice 
cream industry has changed processing and formulations to meet consumer 
expectations. The comment stated that if the 163.5 g density was 
applied to the 120 g serving size (2003-2010 NHANES) the household 
measure would also round to \3/4\ cup (120 g median serving NHANES 
2003-2010/163.5 g per cup = 0.736 cup (5.89 fl oz or \3/4\ cup).
    (Response 51) With respect to the comments questioning the density 
measurements used to calculate the RACCs, the comment used a different 
procedure to calculate the density measurements than we did in the 
proposed rule. When we calculate density, the median ice cream 
consumption in cups is based on the median consumption distribution of 
all varieties of ice cream using the consumption amount for each 
individual product (e.g., strawberry ice cream, chocolate ice cream). 
The consumption amount is then converted from gram weight to volume in 
cups for each individual product. The method described in the comment, 
in contrast, looked at the density of the product category as a whole--
instead of the consumption amount for each individual product--and 
converted the median of gram weight amount to the median consumption in 
cups to determine the median of consumption amount in a household 
measurement. Therefore, 0.875 cup was the median consumption amount for 
the bulk ice cream product category discussed in the proposed rule 
based on consumption distribution when each participant's ice cream 
consumption has already been converted from gram weight to volume in 
cups, and there is no further conversion for that median gram weight 
estimate. We did not consider a \3/4\ cup RACC for bulk ice cream to be 
appropriate because the consumption data shows that 0.875 cup (half way 
between 0.75 cup and 1 cup, therefore, rounding up to 1 cup) is the 
amount customarily consumed, not 0.736 cup as stated in the comment. As 
discussed previously in response to comment 34, our calculations relied 
on 2003-2008 NHANES data rather than 2003-2010 data. As explained in 
comment 49, we have combined the proposed categories ``Ice cream, ice 
milk, frozen yogurt, sherbet, frozen flavored and sweetened ice, frozen 
fruit juices: all types bulk'' and ``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)'' into one product category, ``Ice cream, frozen, yogurt, 
sherbet, frozen flavored and sweetened ice, frozen fruit juice: all 
types bulk and novelties (e.g., bars, sandwiches, cones, cups).'' The 
RACC for the new product category is \2/3\ of a cup. The methodology 
used in determining this reference amount is consistent with the 
methodology we used in the proposed rule (Ref. 32).
    (Comment 52) Foods for Infants and Children 1 through 3 Years of 
Age--We received one comment that supported changing the RACC for the 
``Dinners, dessert, fruits, vegetables or soups, ready-to-serve, 
strained type'' product category from 60 g to 110 g. The comment noted 
that the proposed RACC was similar to the consumption amount calculated 
by the comment after evaluating available data. The comment also 
requested changes to the product categories for infant and toddler 
(children 1 through 3 years of age) foods. The comment stated that the 
number of foods available and specifically marketed to infants and 
children 1 through 3 years of age has grown significantly since the 
1993 RACCs were created, including yogurt, pasta, snacks, breakfast 
cereal, entr[eacute]es, and main dish items. The comment stated that 
many foods now available for infants and young children 1 through 3 
years of age do not have specific RACCs, and that more guidance on 
RACCs for foods for infants and children 1 through 3 years of age 
should be codified to ensure consistency in serving sizes, labeling and 
claims for foods marketed for infants and young children. The comment 
included a table of recommendations for new product categories for 
foods for infants and children 1 through 3 years of age, along with 
proposed corresponding RACCs.
    (Response 52) We agree more products for infants and children 1 
through 3 years of age are currently on the market than were available 
in 1993.

[[Page 34032]]

At the time of publication of the serving size proposed rule, there was 
limited data for these new types of infants and toddler foods in 
NHANES. We intend to review the data submitted in the comment and 
address these additional foods in a separate rulemaking.
    (Comment 53) Milk and soy beverages--One comment supported our 
proposal to modify 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.'' The comment stated that it agreed 
with the change in name and is gratified to see our acknowledgement and 
proper use of the term ``soy beverage.''
    (Response 53) The final rule uses the new product category name of 
``Milk, milk-substitute beverages, milk-based drinks, e.g., instant 
breakfast, meal replacement, cocoa, soy beverage.'' We note, however, 
that our adoption of this product category name does not constitute an 
official ``acknowledgement'' that the term ``soy beverage'' is the sole 
appropriate descriptor for all beverages containing soy.
    (Comment 54) Mixed dishes measurable with cup--We received a 
comment asking us to change the label statement for mixed dishes 
measurable with cup in Sec.  101.12(b), table 2 from 1 cup (__ g) to 
``__ cup (__ g).'' The comment stated that the current label statement 
of 1 cup (__ g) is not applicable for fully cooked frozen fried rice 
that only requires heating to be ready-to-serve. The comment stated 
that it was requesting a change to the label statement because not all 
``almost-ready-to-serve products'' maintain the same density after 
heating. The comment stated that in order to obtain 1 cup of ready-to-
serve cooked rice, it is necessary to measure 1\1/3\ cups of the frozen 
rice and that the correct serving size should be 1\1/3\ cups. The 
comment requested that the label statement for mixed dishes measurable 
with a cup be left blank and written as ``__ cup (__ g).''
    (Response 54) We disagree with changing the label statement for 
this product category based on the information provided in the comment. 
Section 101.12(b), table 2, footnote 2 says that the reference amounts 
are for the ready-to-serve or almost ready-to-serve form of the product 
(e.g., heat and serve, brown and serve), and 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. This means 
that although the RACC for mixed-dish products is 1 cup, this amount is 
for the prepared product. The serving size, however, must represent the 
product as packaged. Because the weight of the cooked rice depends on 
the amount of water used in the preparation, the amount required to 
make one reference amount in cooked form can vary widely. Additionally, 
as we explained in the 1993 serving size final rule, establishing a 
reference amount on a cooked basis could allow manipulation of the 
reference amount for dry rice (58 FR 2229 at 2253). The serving size, 
therefore, is the amount of the frozen rice, expressed in a household 
measure, which will make 1 cup when prepared according to package 
directions.
    We also disagree with the assertion in this comment that fully 
cooked frozen fried rice is an almost ready-to-serve product. Frozen 
rice is not an almost ready-to-serve product; rather, it is an 
unprepared product because it is frozen and requires cooking before 
being consumed. This means that the product should be labeled with the 
reference amount of 1 cup of rice, using the amount of frozen rice 
required to make 1 cup of prepared rice to determine the nutrition 
values on the label.
    (Comment 55) One comment supported maintaining the product category 
``Not measurable with cup e.g., burritos, egg rolls, enchiladas, pizza, 
pizza rolls, quiche, all types of sandwiches,'' under the general 
category ``Mixed Dish'' at the current RACC of 140 g, add 55 g for 
products with gravy or sauce topping. The comment stated that it 
analyzed consumption data from NHANES 2003-2010 and found that the 
median estimated intake for pizza (all crust types) is 169 g, or 21 
percent of the current RACC, which is below the amount to be considered 
significant and does not indicate that the RACC needs to be updated. 
The comment stated that this supports our assessment that maintaining 
the current RACC is still an appropriate representation of amounts 
customarily consumed for this product category.
    (Response 55) We agree that no change to the RACC for the ``Not 
measurable with cup, e.g., burritos, egg rolls, enchiladas, pizza, 
pizza rolls, quiche, all types of sandwiches'' product category is 
necessary. We note, however, that our analysis is based on 2003-2008 
NHANES consumption data, rather than 2003-2010 consumption data as this 
comment purported to use.
    (Comment 56) Muffins--One comment opposed increasing the RACC for 
muffins from 55 g to 110 g. The comment questioned whether we included 
muffins sold in restaurants in the data analysis used to update the 
muffin RACC. The comment stated that the sizes of packaged muffins sold 
in the retail store were closer to or less than the current 55 g RACC 
for muffins. In contrast, the sizes for muffins sold in cafes and 
restaurants are substantially larger and closer to the proposed RACC of 
110 g. The comment stated that 110 g does not reflect the amount of 
packaged retail muffins customarily consumed in one eating occasion, 
particularly given that muffins are consumed in discrete units.
    The comment also asked for clarification on whether products such 
as mini-muffins packaged in a multipack of pouches that typically 
contain about 5 mini muffins per pouch, with a weight of about 47 g per 
pouch, will be required to declare the serving size on the outer carton 
of the multipacks of pouches as 2 packs (94 g) instead of 1 pack (47 
g). With the increase in the RACC for muffins to 110 g, 2 packs of mini 
muffins would be the amount that most closely approximates the RACC. 
The comment suggested that one pouch would be a more appropriate 
serving size.
    (Response 56) The 2003-2008 NHANES consumption data captures all 
possible sources of the food (e.g., restaurant, vending machine, 
grocery store). Our analysis considered all sources of food because the 
data available does not allow us to distinguish consumption at home 
from consumption in retail stores, restaurants or other eating 
establishments. We note, however, that only one-third of the food 
represented in NHANES data is consumed away from home, meaning that the 
majority of consumption reported is food eaten in the home. Food eaten 
at home is more likely to be packaged food. The 2003-2008 NHANES data 
shows an increased consumption for muffins, so we are updating the RACC 
accordingly. We also note that muffins that are sold in restaurants may 
be distributed through retail stores.
    With regard to the request for clarification on how to label a 
multipack of pouches of mini muffins, this would depend on a number of 
factors, including whether the pouches bear Nutrition Fact panels. As 
discussed in the response to comment 10, manufacturers of packages that 
weigh less than 200 percent of the RACC each that are contained within 
a larger container have the option of labeling each individual package 
with a Nutrition Facts panel, and then labeling the outer container to 
state the number of servings as the number of individual packages 
within the outer container in

[[Page 34033]]

accordance with Sec.  101.9(b)(8)(iv). As is discussed in the response 
to comment 9, a product that is packaged and sold individually, i.e., a 
container that bears a Nutrition Facts panel, is considered a single-
serving container if it contains less than 200 percent of the RACC, and 
would be required to provide dual-column labeling if it contains at 
least 200 percent to 300 percent of the RACC, unless an exception from 
the requirement applies.
    (Comment 57) Pasta with sauce--Several comments requested that we 
increase the RACC for pasta with sauce. The comments stated that 
consumption for pasta with sauce increased by 50 percent to 1.5 cups. 
One comment noted that we did not propose to increase the RACC for 
pasta with sauce because the two products with the largest samples 
sizes in the product category--``Rice, flavored'' (consumed by 3,477 
respondents) and ``Mixtures with sauce'' (consumed by 2,919 
respondents)--did not increase to more than 1 cup and that pasta with 
sauce was the third most popular food group (consumed by 2,871 
respondents). The comment disagreed with our rationale to keep the 
entire ``measureable by a cup'' category at 1 cup because it stated 
that the foods in that product category vary so widely (e.g., pot pies, 
lasagna and ravioli, casseroles, chili and stew, mixtures with sauce, 
and mixtures without sauce). The comment requested that we increase the 
RACC for pasta with sauce to 1.5 cups based on the 2003-2008 NHANES 
consumption data. The comment stated that lumping pasta with sauce in 
with other foods in the ``Measurable with cup, e.g., casseroles, hash, 
macaroni and cheese, pot pies, spaghetti with sauce, stews, etc.'' 
product category under the ``Mixed Dishes'' general category violates 
the FD&C Act, which requires RACCs to be based on amounts ``customarily 
consumed.''
    (Response 57) While consumption of pasta with sauce did increase 
since we established the 1993 RACCs, as the comment noted, consumption 
for other products in the product category with larger sample sizes did 
not increase. All of the products in this product category are mixed 
dishes that are generally used as entr[eacute]es. Products in this 
category are mixtures and usually contain starch (e.g., rice, pasta), 
dried beans and/or animal source ingredients (e.g., cheese, fish, 
shellfish). They come with or without vegetables (Ref. 34). Thus, all 
of these products are comparable in that they have similar dietary 
usage and product characteristics (e.g., they are mixed dishes that are 
measurable with a cup). Frozen entr[eacute]es are included in the mixed 
dishes product category. One manufacturer may have a product line with 
a variety of frozen meals that includes frozen spaghetti with tomato 
sauce, frozen lasagna, frozen rice mixture, and frozen macaroni and 
cheese. We note that it would not be helpful to a consumer who is 
choosing among the different varieties of the same product line if one 
box shows a serving size that is based on the RACC of 1 cup, while 
another box which has similar packaging, and is part of the same 
product line, shows an RACC of 1.5 cups. It is important that the RACCs 
of comparable products be similar to help consumers to more easily 
compare nutrition information on the Nutrition Facts label across 
similar products.
    With respect to the comment asserting that including pasta with 
sauce in the product category ``Measurable with cup, e.g., casseroles, 
hash, macaroni and cheese, pot pies, spaghetti with sauce, stews, 
etc.'' under the ``Mixed Dishes'' general category violates the FD&C 
Act, we disagree. Products in this category are mixtures that usually 
contain starch (e.g., rice, pasta), dried beans and/or animal source 
ingredients (e.g., cheese, fish, and shellfish) (Ref. 34). These 
products have similar dietary usage and are usually consumed in the 
same way as an entr[eacute]e or main dish. Other comparable products in 
this product category include casserole, lasagna, and macaroni and 
cheese. The RACC for pasta is based on the amount that is customarily 
consumed for products in this product category. We disagree with the 
assertion that grouping foods in such a manner violates the FD&C Act. 
We followed the methodology used for all products categories when 
determining the RACC for the ``Measurable with cup, e.g., casseroles, 
hash, macaroni and cheese, pot pies, spaghetti with sauce, stews, 
etc.'' product category under the ``Mixed Dishes'' general category. 
Products with a larger sample size in the product category did not show 
a significant amount of change; therefore, we did not update the RACC 
for pasta with sauce.
    (Comment 58) We received a comment requesting us to clarify if 
plant-based beverages with added ingredients are included in the 
proposed product category for ``Milk, milk-substitute beverages, milk-
based drinks, e.g., instant breakfast, meal replacement, cocoa, soy 
beverage.'' The comment stated that the proposed rule does not discuss 
the appropriate RACC for plant-based beverages with added ingredients, 
such as protein, fiber, or fruit, including those that may be 
positioned as a plant-based ``smoothie.'' The comment argued that 
plant-based beverages with added ingredients should be included within 
the RACC for milk and milk-substitute beverages because plant-based 
beverages with added ingredients are more nutrient dense than a 
carbonated or non-carbonated beverage like a soda or water, and 
typically contain higher levels of protein, vitamins, and minerals.
    (Response 58) We did not intend plant-based beverages with added 
ingredients to be included in the proposed product category for ``Milk, 
milk-substitute beverages, milk-based drinks, e.g., instant breakfast, 
meal replacement, cocoa, soy beverage,'' and we disagree that plant-
based beverages with added ingredients should be included in this 
product category. Whether or not plant-based beverages with added 
ingredients are more nutrient dense than a carbonated or non-carbonated 
beverage like a soda or water depends on the contents of a specific 
product; however, we do agree that plant-based beverages do not belong 
in the same product category as carbonated and non-carbonated 
beverages. A plant-based beverage such as a smoothie is a beverage that 
is made by blending fruit with yogurt, milk, or ice cream until it is 
thick and smooth (Ref. 26). Plant-based beverages with added 
ingredients are otherwise more similar to other items in the product 
category ``Shakes and shake substitute, e.g., dairy shake mixes, fruit 
frost mixes'' than to products in the category ``Milk, milk-substitute 
beverages, milk-based drinks, e.g., instant breakfast, meal 
replacement, cocoa, soy beverage.'' The comment's description of a 
plant-based mix includes products with fruit or cocoa as added 
ingredients. Fruit and cocoa are commonly added ingredients in 
milkshakes (Ref. 26). Regardless of the distinction between product 
categories, we note that the RACC for the milk and milk substitute 
product category is the same as the RACC for the milkshake product 
category.
    (Comment 59) Powdered candies and liquid candies--We received one 
comment in support of our proposals to add ``powdered candies'' and 
``liquid candies'' to the product category currently designated as 
``Hard candies, others'' and to establish an RACC of 15 mL for liquid 
candies and 15 g for powdered candies and all other hard candies. The 
comment noted that the proposed RACCs are consistent with ``suggested 
RACCs'' provided in FDA guidance and are consistent with current 
industry practices. The comment also supported our proposal to rename 
this product category ``Hard candies, others; powdered candies, liquid 
candies'' to indicate that

[[Page 34034]]

powdered and liquid candies would now be included in this product 
category.
    (Response 59) We agree with this comment. Powdered candies may be 
dispensed from straws, and liquid candy can be dispensed from small 
bottles or waxy containers. This final rule establishes an RACC of 15 g 
for powdered candies and an RACC of 15 mL for liquid candies and 
includes both in the product category ``Hard candies, others; powdered 
candies, liquid candies.'' Additionally, the label statement for this 
category in table 2 of Sec.  101.12(b) will include label statements 
for powdered candies (``____straw(s) (____g) for powdered candies'') 
and liquid candies (`` ____wax bottle(s) (____mL) for liquid 
candies'').
    (Comment 60) Powdered coffee creamer--Some comments requested that 
we increase the RACC for powdered coffee creamer from the current RACC 
of 2 g, which is equal to 1 teaspoon (tsp). The comments stated that 
the NHANES data show that the median consumption of powdered coffee 
creamer has doubled to 4 g, or 2 tsps. One comment stated that 
consumers use much more than 2 g or 4 g and suggested that we use 6 g, 
or 1 tbsp, as the RACC. The comment stated that we should increase the 
RACC for powdered creamers to 1 tbsp so that it can be the same serving 
size as is used for liquid creamers.
    (Response) The current 1993 RACC for ``Cream or cream substitutes, 
powder'' is 2 g (or 1 tsp). Although the median 2003-2008 NHANES 
consumption is 4 g, the data available in 2003-2008 NHANES were 
insufficient to provide adequate information on which to base a change 
from the 1993 RACC (Ref. 31). The data available did not meet the 
criteria to update the RACC from the 1993 RACC of 2 g because there was 
not an adequate sample size to provide a reliable median intake 
estimate. Therefore, we did not propose to change the RACC for powdered 
creamers.
    With respect to the comment that suggested we use the same RACC for 
both liquid and powdered creamers, we disagree. Powdered creamer and 
liquid creamer have different product characteristics (e.g., powder vs. 
liquid), and the household measurement for the two types of products is 
different. A weight measurement is used for powdered creamer, and a 
volume measurement is used for liquid creamer. Additionally, the 
consumption amounts for powdered and liquid creamers are not similar. 
The current RACC for ``Cream or cream substitute, liquid'' did not show 
a significant increase from the current RACC of 15 mL (or 1 tbsp); 
therefore, we did not propose to change it.
    (Comment 61) Soup--Several comments addressed the ``All varieties'' 
product category under the ``Soups'' general category. Most comments 
requested that we update the RACC for canned soup. The comments stated 
that the current RACC for soups is too small and that many consumers 
can eat an entire can of soup in one sitting. Some comments referred to 
a single serving container of soup that is typically 15 oz and lists 
the serving size as 2 servings.
    (Response 61) While we understand the concern that some canned 
soups that appear to be single-serving containers are being labeled as 
having more than one serving, consumption data for this product 
category has not significantly increased. However, we note that under 
the new requirements for single-serving containers finalized in this 
rulemaking, products that are packaged and sold individually and that 
contain less than 200 percent of the RACC will be labeled as single-
serving containers. Additionally, under the new dual-column labeling 
requirements finalized in this rulemaking, products containing at least 
200 percent but less than 300 percent of the RACC will be required to 
provide nutrition information for the full container. Pursuant to this 
rule, canned soups that are currently labeled as containing ``about 2 
servings'' will be required to provide nutrition information for the 
entire container, either using a single-serving container label or 
using a voluntary or mandatory dual-column label format.
    (Comment 62) Sugar--One comment opposed updating the RACC for 
sugar. The comment stated that a change in consumption data is not 
enough to justify a change in the RACC. The comment noted that 
consumption data used in the 1991 proposed rule also showed that sugar 
should have an RACC of 8 g, but we nonetheless chose to finalize the 
RACC at 4 g in 1993. The comment stated that consumption data for sugar 
is limited and that we should, therefore, take into account other 
sources of information when determining the RACC. The comment stated 
that consumers typically add sugar to foods 1 tsp at a time and that 
the proposed 8 g RACC (2 tsp serving size) is cumbersome for most 
consumers who do not measure out sugar 2 tsp at a time. The comment 
also stated that if we update the RACC for sugar, consumers will 
believe that 2 tsp is the recommended serving size.
    (Response 62) The decision to update the RACC for sugar is based on 
consumption data. The methodology used in the decisionmaking process 
for updating the RACC for sugar is the same methodology used to 
determine when to update the RACC for all product categories. While the 
current RACC for sugar has been used for more than two decades, RACCs 
are based primarily on the amount that is customarily consumed. 
Consumption data shows that the amount of sugar that is customarily 
consumed is 8 g, which is 2 tsp. We further disagree that the amount of 
consumption data available for sugar was ``limited,'' as the sample 
size of data available met the criteria set forth in our methodology 
memo (Ref. 31). Therefore, we are finalizing the RACC for sugar as 
proposed.
    We acknowledge that determining nutrition values on the label when 
measuring an odd number of teaspoons of sugar (such as 3 tsp, which 
equals 1\1/2\ servings) might be cumbersome for some consumers. Given 
the data showing a significant increase in consumption, however, we 
determined it was important for the RACC to reflect current consumption 
amounts.
    The comment is correct in noting that we received no comments in 
favor of our changes to the RACC for sugar. We do not consider this 
relevant to our decision, however, as the consumption data is clear 
with respect to this product category.
    To address the statement that updating the RACC for sugar would 
cause consumers to view the larger serving size as a recommended amount 
to eat, as discussed in comment 2, we intend to conduct nutrition 
education to help clarify that the meaning of ``serving size'' is not a 
recommended amount, but rather is based on an amount customarily 
consumed.
    (Comment 63) Raisins--One comment requested that we add a separate 
product category for raisins with an RACC of 28/30 g (1 oz). The 
comment stated that the existing RACC does not represent the quantity 
of raisins contained in individual packages typically purchased by 
consumers and, therefore, is not representative of the actual amount 
customarily consumed per eating occasion. The comment stated that mini 
raisins boxes are packaged in \1/2\ oz (14.2 g) boxes and sold in bags 
of various quantities, primarily 12 or 14 minis per bag. The comment 
also stated that the larger individual snack size products are 
currently packaged in boxes that are 1 oz (28.3 g) and are sold in 
packages of six. The comment asserted that the two different individual 
unit sizes of 14.2 g and 28.3 g are both widely consumed and represent 
the predominant proportion of industry retail raisin sales

[[Page 34035]]

to consumers for out-of-hand snacking. The comment requested a separate 
RACC for raisins that is in line with the amount of raisins that is in 
an individual package of raisins. The comment stated that multiple-
serving raisin packages are a different category from other dried 
fruits and are consumed in different ways by different consumers.
    (Response 63) We decline to establish a new product category for 
raisins. Raisins are currently under the product category ``Dried'' 
under the ``Fruits and Fruit Juices'' general category with an RACC of 
40 g. We group together like products with similar dietary usage so 
consumers can easily compare nutrient information between similar 
products. Raisins are comparable to other dried fruits such as 
cranberries and are used in similar ways (e.g., as an ingredient in 
cookies); other dried fruits, such as cranberries are also consumed as 
snacks (Ref. 26). It would not be helpful for a consumer if there was a 
different RACC for raisins than there was for similar products on the 
market.
    RACCs are determined primarily using consumption data, and other 
factors we consider in grouping products include similarities in 
dietary usage and product characteristics. Package size, which is not 
consistent and can change over time, is not a factor we considered in 
determining RACCs (see Sec.  101.12(a)).
    (Comment 64) Spray type fats and oils--Several comments requested 
that we amend the RACC for the product category ``spray types'' in the 
general category ``Fats and Oils.'' The comments noted that the current 
RACC for this product category is 0.25 g. The comments stated that 
cooking sprays have tiny serving sizes which allow them to make certain 
claims such as ``zero calorie'' or ``fat free,'' even though they are 
essentially pure oil. One comment recognized that no intake data were 
available from NHANES at the time of the proposed rule, but referred to 
a survey of 15 people that found that consumers spray a pan for 1.6 
seconds on average, with the range being 1 to 3 seconds, compared to 
the one second spray that is found on the label of a common brand of 
cooking spray oil (Ref). The comments requested that we increase the 
RACC for spray cooking oils to a 2-second spray so consumers have a 
better understanding of the calories and fat they are consuming.
    (Response 64) We decline to make a change to the RACC for spray 
oils. There are no data available in NHANES that can be used to update 
the RACC for cooking spray oils. We also have not identified any other 
information on consumption of cooking spray oils that we can use as a 
basis for determining a different RACC. Although one comment referred 
to a study that it conducted, the comment provided no information about 
the methodology used and included a small sample size of only 15 
people; therefore, this information provides an insufficient basis on 
which to update the RACC. Additionally, we note that serving size is 
based on the amount an individual consumes. Spray oils are often used 
to prepare food for multiple individuals, so even if the typical spray 
is longer than one second, the amount consumed by each individual may 
be significantly less.
    (Comment 65) Yogurt--Several comments supported the proposed 
changes to the RACC for yogurt. Some comments asked us to clarify that 
the proposed 170 g (6 oz) RACC for yogurt applies to all forms of 
``yogurt'' (e.g., cup, drinkable, squeezable) that comply with our 
standard of identity for yogurt. The comments specifically wanted 
clarification that drinkable yogurts would be subject to the proposed 
170 g (6 fl oz) yogurt RACC versus the 240 mL (8 fl oz) RACC for the 
``Milk, milk substitutes, and fruit based drink mixers (without 
alcohol) (e.g., drink mixers, fruit flavored powdered drink mixes, 
sweetened cocoa powder)'' product category. One comment stated that a 
product labeled as ``drinkable yogurt'' is ``yogurt'' and must, like 
cup yogurt, meet one of our standards of identity for yogurt. The 
comment stated that drinkable yogurts are produced, marketed, and used 
by consumers as food (not as beverages) and are fundamentally different 
in both form and use from fluid milk, milk-substitute beverages, and 
other milk-based drinks.
    (Response 65) We agree that drinkable yogurt is more similar to 
other forms of yogurt than to milk beverages. Drinkable yogurt is a 
product that is consistent with the standard of identity for yogurt 
under 21 CFR 131.200 but that is more fluid than other forms of yogurt. 
Therefore, we are clarifying that the new yogurt RACC applies to all 
forms of yogurt including drinkable yogurt.

E. Impact of Changes in RACCs on the Eligibility To Make Nutrient 
Content Claims and Health Claims

    We stated in the proposed rule that we were 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. Also, we recognized that 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. We noted that 
changes in the eligibility to bear claims may be appropriate in light 
of the changes in the amounts of food being customarily consumed but 
that it would be difficult to fully understand any potential impacts of 
changes to the RACCs on the eligibility to bear claims until the rules 
for both serving sizes and updating the Nutrition Facts label are 
finalized. We invited comment on any concerns related to changes to 
current claims used on specific foods that will be affected if the 
serving size rule is finalized as proposed (79 FR 11989 at 12015 to 
12016).
    (Comment 66) We received a number of comments in response to our 
discussion on claim eligibility in the proposed rule agreeing with us 
that foods could potentially become ineligible to bear a claim based on 
changes to the RACCs. A number of these comments suggested that we 
consider potential impacts on claim eligibility and evaluate if 
resulting changes in eligibility assists consumers in constructing 
healthful diets. Some comments stated that any changes that will be 
needed to regulations for nutrient content claims (NCCs) and health 
claims should be coordinated with the changes to the Nutrition Facts 
label and serving sizes. A few comments cited examples of specific 
issues that could affect the foods that the commenters produce. One 
such example indicated that foods with the terms ``Healthy'' or 
``Lean'' in their brand name may become ineligible to bear such claims 
and could be considered misbranded if the products would continue to 
bear such claims. Another example discussed the changes to the RACCs 
that make the RACCs different between bulk and novelty ice cream 
products and noted that such changes could make identical food 
products, but of different sizes, unable to bear the same claims. One 
example discussed changes to the RACC of confections and noted that 
because of the smaller proposed RACC, some confections would become 
subject to the NCC criteria for foods with small RACCs and become 
ineligible to bear some claims.
    (Response 66) As we discussed in the proposed rule, we anticipate 
that there may be changes needed with regard to claims based on the new 
and updated regulations for Nutrition Facts and serving sizes. We agree 
with the comments that suggested that we evaluate claim regulations and 
any change to eligibility for claims. Changes to nutrition labeling is 
a step-wise

[[Page 34036]]

process, and all changes to Nutrition Facts and serving sizes need to 
become final before we can determine any and all necessary changes to 
claim regulations. Because it is prudent for us to be fully aware of 
all final and official changes to the RACCs (and to the information in 
Nutrition Facts) before determining the scope of all of the changes 
needed to claim regulations, we are not publishing rules updating claim 
regulations simultaneously with the publication of the rules for 
serving sizes and Nutrition Facts. With the publication of this final 
rule (and the publication of the Nutrition Facts final rule, we can 
assess the impacts of all of the updates on claim eligibility.
    We intend to consider in a future rulemaking issues such as whether 
any changes in eligibility for claims would assist consumers in 
constructing healthy diets and whether the criteria for claims remain 
appropriate. However, as we noted in the proposed rule, changes in the 
eligibility to bear claims may be appropriate for some foods (79 FR 
11989 at 12016). Reformulation of some foods in line with current 
dietary recommendations may be expected in order to continue to bear 
claims. Manufacturers will have some time to make necessary changes 
before the compliance dates for the final rules on serving size and 
Nutrition Facts. This time will allow manufacturers to update food 
labels to come into compliance with the new regulations for serving 
size and Nutrition Facts, and it also allows time to discontinue use of 
individual voluntary claims that the labeling of certain products may 
no longer be eligible to make. The time will also allow us to evaluate 
the existing claim regulations and publish, in a separate rulemaking, 
any amendments to those claim regulations.
    (Comment 67) One comment regarding the changes in the definition of 
a single-serving container and a product's ability to qualify for 
``free'' claims stated that beverages that are routinely sold in 
single-serving containers for which the labeled serving is less than 
the RACC may no longer be able to make a calorie ``free'' or other 
``free'' claims, even though the caloric or other nutrient content may 
be trivial in those particular single-serving packages. The comment 
said this outcome may occur because ``free'' claims are based on the 
nutrient content for both the labeled serving and the RACC. The comment 
gave the example of certain energy drink products that are commonly 
sold in 8 oz, single-serving containers. The comment asserted that the 
caloric content of these below-RACC, single-serving beverages is 
insignificant, which supports a calorie-free claim. However, 12 ozs of 
the product would contain just enough calories to preclude a calorie-
free claim. Consequently, even though the single-serving product would 
not contain any more calories than before the RACCs would be updated, 
the small, single-serving beverage would be precluded from bearing a 
calorie-free claim because of the combined effect of the proposed RACC 
and the requirement that calorie-free claims must be based on both per-
labeled-serving and per-RACC nutrient content.
    (Response 67) When we established ``free'' claims, we decided to 
make the basis of the claim on a per-RACC and per-labeled-serving basis 
(56 FR 60421 and 58 FR 2302). When we developed our general principles 
on nutrient content claims, we concluded that it would be misleading to 
allow certain claims to be based only on the RACC, particularly with 
single-serving containers, since the consumer would be expected to 
consume the entire labeled serving size. Likewise, we concluded that it 
would be misleading to allow claims based only on the labeled serving 
size. This decision was made to prevent potentially misleading claims 
and to provide a level field for industry. Since that time, consumption 
patterns have changed so that the RACC for some beverages has increased 
from 8 oz to 12 oz. Because the consumption amount has increased for 
certain beverages, such products for which the RACC has increased may 
appropriately no longer be able to make ``free'' claims. As noted 
previously, we intend to consider in a future rulemaking issues such as 
whether any changes in eligibility for claims would assist consumers in 
constructing healthy diets and whether the criteria for claims remain 
appropriate.

F. Establishing a New Serving Size for Breath Mints

    In the serving size proposed rule, we proposed to establish a new 
serving size of ``1 unit'' for breath mints while maintaining the 
current reference amount of 2 g for the product category ``Hard 
candies, breath mints.'' We proposed this action in response to a 
petition that suggested the appropriate serving size for small breath 
mints should be ``one mint'' instead of the number of pieces that is 
closest to the 2 g RACC. The petitioner had also requested that a 
separate product category, having an RACC of 0.5 g, should be 
established for small breath mints weighing 0.5 g or less.
    We received one comment that supported a ``1-unit'' serving size 
for breath mints and no comments that addressed changing the RACC for 
breath mints. As mentioned in the serving size proposed rule (79 FR 
11989 at 12016), we have determined through our analysis of two large 
commercial databases that 2 g remains an appropriate RACC for the 
product category ``Hard candies, breath mints.'' Further, because only 
a limited number of small breath mint products are commercially 
available, establishing a separate product category for small breath 
mints weighing 0.5 g or less, as the petitioner requested, is not 
warranted. Therefore, we will keep 2 g as the single reference amount 
for the ``Hard candies, breath mints'' product category, which includes 
breath mints of all sizes. However, we will now require that the label 
statement for the serving size of all breath mints be 1 unit, rather 
than declaring the serving size in terms of the number of mints closest 
to the 2 g RACC. We have indicated this in table 2 of Sec.  101.12(b) 
by changing footnote 8 (formerly footnote 9) to state, in part, ``Label 
serving size of ice cream cones, eggs, and breath mints of all sizes 
will be 1 unit.''

G. Technical Amendments

1. Rounding Rules for Products That Have More Than Five Servings and 
the Number of Servings Falls Exactly Between Two Values
    In the serving size proposed rule (79 FR 11989) we proposed to add 
the following to Sec.  101.9(b)(8)(i): ``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.'' We made this proposal to 
provide information to manufacturers who have products that contain 
five or more servings to round the number of servings up when the 
number of servings falls exactly between two values.
    We received no comments on this topic but are not finalizing the 
amendment as proposed. Standard rounding rules require numbers that 
fall exactly half way between two declarations to be rounded up to the 
nearest incremental size. This rule applies to all provisions where 
rounding is required and is not unique to rounding required for 
containers that contain greater than 5 servings. Because this proposed 
addition to Sec.  101.9(b)(8)(i) is unnecessary, we are not finalizing 
the proposed amendment.

[[Page 34037]]

2. Options for When the Number of Servings per Container Varies
    In the serving size proposed rule (79 FR 11989) we proposed to 
amend Sec.  101.9(b)(8)(iii) by: (1) Defining ``random-weight 
products'' and (2) eliminating 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.''
    We received no comments on this topic, and will finalize the 
amendment as proposed. We are also amending the final sentence of this 
paragraph to read ``in parentheses'' rather than ``in parenthesis.''
3. Minor Corrections to General and Product Category Names
    In the serving size proposed rule (79 FR 11989) we proposed 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.
    We received no comments on this topic, and will make these 
corrections in table 2 in Sec.  101.12(b).
4. Minor Changes to Footnotes
    In the serving size proposed rule (79 FR 11989) we proposed to 
remove footnote 4 from table 1 in Sec.  101.12(b) to provide clearer 
guidance on the types of products that can be included in the product 
categories listed in the tables. We further proposed to renumber 
footnote 5 as footnote 4 and revise it by removing the first sentence 
and replacing it with the following: ``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.'' In table 2 we proposed to remove footnote 4 and 
renumber the remaining footnotes. We further proposed to revise 
renumbered footnote 4 by removing the first sentence and replacing it 
with the following: ``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.'' We also proposed to revise renumbered footnote 5 to include 
the sentence, ``The serving size for fruitcake is 1\1/2\ ounces''; to 
add renumbered footnote 10 as a superscript to the word ``pimento'' in 
the ``Vegetables, primarily used for garnish or flavor, e.g., pimento, 
parsley, fresh or dried)'' product category; and to revise renumbered 
footnote 12 to state, ``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.''
    We received no comments to these minor technical amendments and 
will make the changes in tables 1 and 2 in Sec.  101.12(b).
    In addition to the changes to various footnotes proposed in the 
proposed rule, we are making several additional technical amendments to 
table 2 by adding language to footnote 1 explaining that the values 
have been updated with data from various NHANES surveys, adding 
renumbered footnote 10 to the product category ``Fruits for garnish or 
flavor, e.g., maraschino cherries,'' removing the ``(b)'' from the Code 
of Federal Regulations citation ``101.9(b)(j)(11)'' in renumbered 
footnote 11, and revising renumbered footnote 12 to state, ``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.''
5. Minor Changes to Table 1 in Sec.  101.12(b)
    In the serving size proposed rule (79 FR 11989) we proposed to 
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 
Young Children 1 through 3 years of age.'' We also proposed to make 
other conforming changes in the product category names, by changing the 
product category name ``Dinners, stews or soups for toddlers, ready-to-
serve'' to ``Dinners, stews or soups for young children, ready-to-
serve,'' the product category name ``Fruits for toddlers, ready-to-
serve'' to ``Fruits for young children, ready-to-serve,'' and the 
product category name ``Vegetables for toddlers, ready-to-serve'' to 
``Vegetables for young children, ready-to-serve.''
    We received no comments to these minor technical amendments and 
will make the changes in table 1 in Sec.  101.12(b).
6. Minor Changes to Table 2 in Sec.  101.12(b)
    In the serving size proposed rule (79 FR 11989) we proposed to make 
some editorial changes to the product category names.
    We received no comments to these minor technical amendments and 
will make the changes in table 2 in Sec.  101.12(b).
7. Reference Amounts for Products That Require Further Preparation
    In the serving size proposed rule (79 FR 11989), we proposed to 
amend Sec.  101.12(c) to 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.
    We received no comments on this topic, and will finalize this 
amendment as proposed.
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. In the serving size proposed rule (79 FR 11989) we 
proposed to amend Sec.  101.9(f)(1) and (2) to change the definition of 
the RACC for these products consisting of two or more separate foods, 
packaged together and intended to be eaten together, so that it will 
not affect the serving size declaration on the label.
    We received no comments on this topic, and will finalize the 
amendment as proposed.
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 
when there is no appropriate reference amount. The current language in 
Sec.  101.9(h)(3)(ii) states that 8 fl ozs may be used as the standard 
serving size for beverage varieties or assortments in gift packages. 
Because we are amending the RACCs for some beverages, we proposed 
conforming amendments to this section to state that 12 fl oz 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 fl ozs.
    We received no comments on this topic, and will finalize the 
amendment

[[Page 34038]]

as proposed, with minor edits for clarity.

IV. Effective and Compliance Dates

    In the preamble of the proposed rule (79 FR 11989 at 12019), we 
proposed 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'' (the 
Nutrition Facts proposed rule), would become effective 60 days after 
the date of the final rule's publication in the Federal Register. We 
also proposed that any final rule that resulted would have a compliance 
date that would be 2 years after the effective date (79 FR 11989 at 
12019). We explained that industry might need some 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 
records of product labels, and print new labels.
    After considering comments submitted to the docket for the 
Nutrition Facts proposed rule regarding the effective and compliance 
dates, we have maintained the compliance date of 2 years after the 
effective date, except that for manufacturers with less than $10 
million in annual food sales, we are providing a compliance date of 3 
years after the effective date. Comments to the Nutrition Facts 
proposed rule emphasized the rule's potential impact on small 
businesses. We agree that the impacts to smaller businesses may be more 
substantial than those on larger businesses; thus, for manufacturers 
with less than $10 million in annual food sales, the compliance date 
will be July 26, 2019. Using Nielsen data, we estimate that 
manufacturers with less than $10 million in annual food sales 
constitute approximately 95 percent of all food manufacturers and 
market 48 percent of food UPCs.

V. Analysis of 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.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). 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 final rules on nutrition labeling in the Federal 
Register. We have developed a comprehensive Regulatory Impact Analysis 
(RIA) that assesses the impacts of the two final nutrition labeling 
rules taken together. We believe that the final rules on nutrition 
labeling, taken as a whole, are an economically 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 from the final rules are small, 
but not negligible, and as a result we find that the final rules on 
nutrition labeling, taken as a whole, will have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``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 (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $144 
million, using the most current (2014) Implicit Price Deflator for the 
Gross Domestic Product. We have determined that the final rules on 
nutrition labeling, taken as a whole, would result in an expenditure in 
any year that meets or exceeds this amount.
    The full analysis of economic impacts for the final rules on 
nutrition labeling is available in the docket for this final rule (Ref. 
35) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

VII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A 
description of these provisions is given in this section with an 
estimate of the annual third-party disclosure burden. Included in the 
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.
    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 RACCs; 
Serving Size for Breath Mints; and Technical Amendments
    Description of Respondents: The respondents to this information 
collection are manufacturers of retail food products marketed in the 
United States.
    Description: In major part, this final rule revises Sec. Sec.  
101.9 and 101.12 to: (1) Amend the definition of a single serving, (2) 
require a second column of nutrition information per package for 
products that contain at least 200 and up to and including 300 percent 
of the applicable RACCs, as well as per unit for discrete units in 
multiserving packages in which each unit contains at least 200 percent 
and up to and including 300 percent of the applicable RACCs, (3) 
update, modify, and establish RACCs for certain food products, (4) make 
several technical amendments to the regulations for serving sizes, and 
(5) change the label serving size for breath mints to ``1 unit.'' These 
revisions, in many instances, will require changes to the nutrition 
information that is presented on the Nutrition Facts label of retail 
food products. Preexisting Sec. Sec.  101.9 and 101.12 are approved by 
OMB in accordance with the PRA under OMB control number 0910-0381. This 
final rule will modify the information collection associated with 
preexisting Sec. Sec.  101.9 and 101.12 by adding to the burden 
associated with the collection by requiring the following manufacturers 
to make changes to their product labels: Those whose retail food 
products are labeled with a serving size that is inconsistent with the 
provisions of the final rule, and those whose retail food products 
would be required to use dual-column labeling.\2\ The nutrient 
information disclosed on labels of retail food products is necessary to 
inform purchasers of the nutritional value of the food.
---------------------------------------------------------------------------

    \2\ Included in this burden are the labeling costs that result 
from changes in the eligibility to bear nutrient content claims or 
health claims (e.g., the cost of removing a claim from labeling or 
adding a required disclaimer).
---------------------------------------------------------------------------

    We estimate the burden of this collection of information as 
follows:

[[Page 34039]]



                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           Total capital
                                                            Number of       Number of      Total annual   Average burden                     costs (in
                     21 CFR Section                        respondents   disclosures per    disclosures   per disclosure    Total hours     billions of
                                                                            respondent                                                        2014$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.9 and 101.12.......................................          13,452               25         336,300               2         672,600           $1.00
    Total Initial Hours and Capital Costs..............                                                                          672,600           $1.00
New Products...........................................             500                1             500               2           1,000           $0.01
    Total Recurring Hours and Capital Costs............                                                                            1,000           $0.01
    Total Burden Hours and Capital Costs...............                                                                          673,600           $1.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    Under Sec. Sec.  101.9 and 101.12, some manufacturers of retail 
food products would need to make a labeling change to modify the 
serving sizes and other nutrition information based on changes to what 
products may be or are required to be labeled as a single serving or 
based on updated, modified, or established RACCs. Additionally, some 
manufacturers would need to change their product labels to add a second 
column of nutrition information per package or per discrete unit as 
part of the Nutrition Facts label. The third-party disclosure burden 
consists of the setup time required to design a revised label and 
incorporate it into the manufacturing process. The third-party 
disclosure burden for this final rule is estimated in table 1.
    Based upon our knowledge of food labeling, we estimate that the 
affected manufacturers would require 2 hours per product to modify the 
label's Nutrition Facts panel. We estimate that it would take an 
affected manufacturer 1 hour to review a label to assess how to bring 
it into compliance with the requirements of this final rule. Each label 
redesign would require an estimated 1 additional hour per UPC, for a 
total of 2 hours per UPC.
    We estimate that about 13,452 manufacturers would initially be 
affected by this final rule and that about 336,300 products would 
initially be required to be relabeled, for an average of 25 (336,300/
13,452) products per respondent. The total initial third-party 
disclosure burden of 672,600 hours is reported in table 1. The final 
column of table 1 gives the estimated initial capital cost of the 
relabeling associated with this final rule. Based on the RIA, we 
estimate the initial capital cost to be approximately $1 billion 
(2014$).
    This final rule generates recurring burdens related to the 
requirement that some manufacturers undertake an extensive label change 
due to the effect of the changed definition of a single-serving 
container on the permissibility of certain health and nutrient content 
claims and also to the requirement that some manufacturers undertake a 
major redesign of their labels to include a Nutrition Facts Panel that 
had not previously been required.\3\ We estimate that about 500 new 
products would be affected by these requirements each year, and that 
the required third party disclosure burden would be 2 hours per 
product, for an annual recurring third party disclosure burden of 1,000 
hours. Based on the RIA, we estimate the annual recurring capital cost 
to be approximately $0.01 billion (2014$).
---------------------------------------------------------------------------

    \3\ This final rule does not otherwise generate any recurring 
burdens because establishments must already print packaging for food 
products as part of normal business practices and must disclose 
required nutrition and serving size information under NLEA.
---------------------------------------------------------------------------

    Adding the recurring burden from new products to the initial burden 
for existing products results in a total of 673,600 third party 
disclosure burden hours and $1.01 billion (2014$) in capital costs as 
reported in table 1.
    The information collection provisions in this final rule and the 
Nutrition Facts Label final rule have been submitted to OMB for review 
as required by section 3507(d) of the PRA of 1995.
    Before the effective date of this final rule, we will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

VIII. Federalism

    We have analyzed this final 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) [of the FD&C Act]. . . .''
    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 
NLEA).
    This final rule will create requirements that fall within the scope 
of section 403A(a) of the FD&C Act.

IX. References

    The following references are on display in FDA's Division of 
Dockets Management (see ADDRESSES) and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

    1. Report of the Working Group on Obesity, ``Calories Count,'' 
March 12, 2004.
    2. Dallas, S. K., P. J. Liu, P. A. Ubel, ``Potential Problems 
with Increasing Serving Sizes on the Nutrition Facts 
Label,'''Appetite, 95:577-84, 2015.
    3. Zhang, Y., M. A. Kantor, W. Juan, ``Usage and Understanding 
of Serving Size Information on Food Labels in the United States,'' 
American Journal of Health Promotion, 30:181-7, 2016.
    4. Chung-Tung, Lin., Memorandum to file: ``2014 Health and Diet 
Survey,'' May 6, 2016.

[[Page 34040]]

    5. FDA, Resources for You, August 10, 2015: http://www.fda.gov/Food/ResourcesForYou/default.htm.
    6. CDC, National Center for Health Statistics (NCHS), ``National 
Health and Nutrition Examination Survey Data 2007-2008''. http://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx.
    7. CDC, NCHS, ``National Health and Nutrition Examination Survey 
Data 2005-2006.''
    8. CDC, NCHS, ``National Health and Nutrition Examination Survey 
Data 2003-2004.'' http://www.cdc.gov/nchs/nhanes/nhanes2003-2004/nhanes03_04.htm.
    9. Juan, W., Memorandum to File: ``Technical Support for 
Documentation on Examining the Association Between the Consumption 
Variability and the Reference Amounts Customarily Consumed (RACCs) 
per Eating Occasion for All Products in Each Product Category,'' 
February 11, 2014.
    10. Wansink, B., J. Kim. ``Bad Popcorn in Big Buckets: Portion 
Size Can Influence Intake as Much as Taste,'' Journal of Nutrition 
Education and Behavior, 37:242-5, 2005.
    11. Rolls, B. J., L. S. Roe, J. Meengs, D. Wall, ``Increasing 
the Portion Size of A Sandwich Increases Energy Intake,'' Journal of 
the American Dietetic Association, 104:367-72, 2004.
    12. 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.
    13. Geier, A., P. Rozin, G. Doros, ``Unit Bias. A New Heuristic 
That Helps Explain the Effect of Portion Size on Food Intake,'' 
Psychological Science, 17:521-5, 2006.
    14. Antonuk, B., L. Block, ``The Effect of Single Serving Versus 
Entire Package Nutritional Information on Consumption Norms and 
Actual Consumption of a Snack Food,'' Journal of Nutrition Education 
and Behavior, 38:365-70, 2006.
    15. Lando, A. M., S. C. Lo, ``Single-Larger-Portion-Size and 
Dual-Column Nutrition Labeling May Help Consumers Make More 
Healthful Food Choices,'' Journal of the Academy of Nutrition and 
Dietetics, 113:241-50, 2013.
    16. Juan, W., Memorandum to File: ``Comparison Between the Foods 
Consumed in the United States from NHANES 2003-2008 at the 90th 
Percentile and Reference Amounts Customarily Consumed (RACCs) Per 
Eating Occasion by General Category and Product Category,'' February 
11, 2014.
    17. FDA, ``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.
    18. Chung-Tung, Lin., Memorandum to File: ``Eye-Tracking 
Experimental Study on Consumer Responses to Modifications to the 
Nutrition Facts Label Outlined in the Food and Drug Administration's 
Proposed Rulemaking,'' June 30, 2015.
    19. Lando, A., Liu, S., Lo, S., and Yu, K., Memorandum to File: 
``Experimental Study of Proposed Changes to the Nutrition Facts 
Label Formats'' June 30, 2015.
    20. O'Neil, C. E., T. A. Nicklas, G. C. Rampersaud, and V. L. 
Fulgoni III, ``100% Orange juice Consumption is Associated with 
Better Diet Quality, Improved Nutrient Adequacy, Decreased Risk for 
obesity, and Improved Biomarkers of Health in Adults: National 
Health and Nutrition Examination Survey, 2003-2006,'' Nutrition 
Journal, 11:107-16, 2012.
    21. O'Neil, C. E., T. A. Nicklas, G. C. Rampersaud, and V. L. 
Fulgoni III, ``One Hundred Percent Orange Juice Consumption is 
Associated with Better Diet Quality, Improved Nutrient Adequacy, and 
no Increased Risk for Overweight/Obesity in Children,'' Nutrition 
Research, 31:673-82, 2011.
    22. Juan, W., Memorandum to File: ``Evaluation of Consumption 
Amounts of Food Consumed in the United States for Which 2003-2008 
Consumption at the 90th Percentile Exceeds 300% of the 1993 
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion; 
Comparison of 2003-2008 Food Consumption Amounts to the Proposed 
RACCs'' April 7, 2016.
    23. Cowburn, G. and L. Stockley, ``Consumer Understanding and 
Use of Nutrition Labelling: A Systematic Review,'' Public Health 
Nutrition, 8:21-8, 2005.
    24. Rothman, R., R. Housam, H. Weiss, D. Davis, R. Gregory, T. 
Gebretsadik, et al., ``Patient Understanding of Food Labels: The 
Role of Literacy and Numeracy,'' American Journal of Preventive 
Medicine, 31:391-8, 2006.
    25. Agricultural Research Service, Food Surveys Research Group, 
``U.S. Department of Agriculture, Food and Nutrient Database for 
Dietary Studies, 4.1'' Beltsville, MD, 2010.
    26. Herbst, S.T. and R. Herbst, ``The New Food Lover's 
Companion,'' Fourth Edition. Barron's Educational Series, Inc, 2007.
    27. USDA, Food Safety and Inspection Service, ``A Guide to 
Federal Food Labeling Requirements for Meats and Poultry Products,'' 
2007. http://www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.
    28. Allrecipes. Allrecipes, December 6, 2012. http://www.allrecipes.com.
    29. Park, Y., Memorandum to File: ``Documentation for 
Determining Reference Amounts Customarily Consumed per Eating 
Occasion,'' October 30, 1991.
    30. ``Council of Better Business Bureaus. Children's Food and 
Beverage Advertising Initiative. 2014 Cereals Snapshot. March 
2014.'' Available online: http://www.bbb.org/globalassets/shared/media/cfbai/cereal-fact-sheet-march-2014.pdf.
    31. Juan, W., Memorandum to File: ``Methodology used to 
Determine Whether to Propose to Update, Modify, or Establish the 
Reference Amounts Customarily Consumed (RACCs) per Eating 
Occasion,'' February 11, 2014.
    32. Juan, W., Memorandum to File: ``Rationale Used to Amend 
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion 
for Specific Product Categories,'' April 7, 2016.
    33. Henderson, C., Memorandum to File, ``Sample of Ice Cream 
Scoops Available to Consumers from National Retailers'' May 16, 
2016.
    34. Park, Y., Memorandum to the file, List of products for each 
product category, October 8, 1992.
    35. FDA, ``Regulatory Impact Analysis for Final Rules on Food 
Labeling: Revision of the Nutrition and Supplement Facts Labels 
(Docket No. FDA-2012-N-1210 and Food Labeling: Serving Sizes of 
Foods That Can Reasonably Be Consumed At One Easting Occsion; Dual-
Column Labeling; Updating, Modifying and Establishing Certain RACCs; 
Serving Size for Breath Mints; and Technical Amendments (Docket No. 
FDA-2004-N-0258 (formerly Docket No. 2004N-0456),'' 2016.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and record keeping 
requirements.

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

PART 101--FOOD LABELING

0
1. The authority citation for 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. In Sec.  101.9:
0
a. Revise paragraph (b)(2)(i)(D);
0
b. Remove paragraph (b)(2)(i)(E) and redesignate paragraphs 
(b)(2)(i)(F) through (I) as paragraphs (b)(2)(i)(E) through (H) 
respectively;
0
c. Revise paragraphs (b)(6), (b)(8)(iii), and (b)(10)(ii);
0
d. Add paragraph (b)(12); and
0
e. Revise paragraph (h)(3)(ii).
    The revisions and addition 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 
300 percent of the applicable reference amount, the serving size shall 
be the amount that approximates the reference amount. In addition to 
providing a column within the Nutrition Facts label that lists the 
quantitative amounts and percent Daily Values per serving size, the 
manufacturer shall provide a column within the Nutrition Facts label 
that lists the quantitative amounts and

[[Page 34041]]

percent Daily Values per individual unit. 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), and (C) of this section apply to this provision.
* * * * *
    (6) A product that is packaged and sold individually that 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. In addition to providing a 
column within the Nutrition Facts label that lists the quantitative 
amounts and percent Daily Values per serving, for a product that is 
packaged and sold individually that contains more than 150 percent and 
less than 200 percent of the applicable reference amount, the Nutrition 
Facts label may voluntarily provide, to the left of the column that 
provides nutrition information per container (i.e., per serving), an 
additional column that lists the quantitative amounts and percent Daily 
Values per common household measure that most closely approximates the 
reference amount.
* * * * *
    (8) * * *
    (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 parentheses following the 
``varied'' statement.
* * * * *
    (10) * * *
    (ii) Per one unit if the serving size of a product in discrete 
units is more than 1 unit.
* * * * *
    (12)(i) Products that are packaged and sold individually and that 
contain at least 200 percent and up to and including 300 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 package, as well as a column 
listing the quantitative amounts and percent Daily Values for a serving 
that is less than the entire package (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 package.
    (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 raw fruits, vegetables, and 
seafood for which voluntary nutrition labeling is provided in the 
product labeling or advertising or when claims are made about the 
product.
    (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, to products that are commonly 
consumed in combination with another food and provide an additional 
column of nutrition information under paragraph (e) of this section, to 
products that provide an additional column of nutrition information for 
two or more groups for which RDIs are established (e.g., both infants 
and children less than 4 years of age), to popcorn products that 
provide an additional column of nutrition information per 1 cup popped 
popcorn, or to varied-weight products covered under paragraph 
(b)(8)(iii) 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 paragraph 
(b)(2)(i)(D) or (b)(12)(i) of this section, the claim must be followed 
by a statement that sets forth the basis on which the claim is made, 
except that the statement is not required for products when the 
nutrient that is the subject of the claim meets the criteria for the 
claim based on the reference amount for the product and the entire 
container or the unit amount. When a nutrient content claim is made, 
the statement must express that the claim refers to the amount of the 
nutrient per serving (e.g., ``good source of calcium per serving'' or 
``per X [insert unit]_serving'') or per reference amount (e.g., ``good 
source of calcium per [insert reference amount (e.g., per 8 ounces)]), 
as required based on Sec.  101.12(g). When a health claim is made, the 
statement shall be ``A serving of _ounces of this product conforms to 
such a diet.''
* * * * *
    (h) * * *
    (3) * * *
    (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, the following may be used as the standard 
serving size for purposes of nutrition labeling of foods subject to 
this paragraph: 1 ounce for solid foods; 2 fluid ounces for nonbeverage 
liquids (e.g., syrups); 8 ounces for beverages that consist of milk and 
fruit juices, nectars and fruit drinks; and 12 fluid ounces for other 
beverages. 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. In Sec.  101.12:
0
a. In paragraph (b), revise tables 1 and 2;
0
b. Revise paragraphs (c) and (f)(1);
0
c. Remove paragraph (f)(2) and redesignate paragraph (f)(3) as 
paragraph (f)(2); and
0
d. 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 Young Children 1 Through 3 Years of Age \1\ \2\
                                   \3\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Cereals, dry instant............  15 g..............  _ cup (_ g)
Cereals, prepared, ready-to-      110 g.............  _ cup(s) (_ g)
 serve.
Other cereal and grain products,  7 g for infants     _ cup(s) (_ g) for
 dry ready-to-eat, e.g., ready-    and 20 g for        ready-to-eat
 to-eat cereals, cookies,          young children (1   cereals; piece(s)
 teething biscuits, and toasts.    through 3 years     (_ g) for others
                                   of age) for ready-
                                   to-eat cereals; 7
                                   g for all others.
Dinners, deserts, fruits,         15 g..............  _ tbsp(s) (_ g); _
 vegetables or soups, dry mix.                         cup(s) (_ g)

[[Page 34042]]

 
Dinners, desserts, fruits,        110 g.............  _ cup(s) (_ g);
 vegetables or soups, ready-to-                        cup(s) (_ mL)
 serve, junior type.
Dinners, desserts, fruits,        110 g.............  _ cup(s) (_ g);
 vegetables or soups, ready-to-                        cup(s) (_ mL)
 serve, strained type.
Dinners, stews or soups for       170 g.............  _ cup(s) (_ g);
 young children, ready-to-serve.                       cup(s) (_ mL)
Fruits for young children, ready- 125 g.............  _ cup(s) (_ g)
 to-serve.
Vegetables for young children,    70 g..............  _ cup(s) (_ g)
 ready-to-serve.
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 primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture. We further considered 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 (e.g., 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) (_ g)
     muffins (excluding English
     muffins).
    Biscuits, croissants,         55 g..............  _ piece(s) (_ g)
     tortillas, soft bread
     sticks, soft pretzels, corn
     bread, hush puppies,
     scones, crumpets, English
     muffins.
    Breads (excluding sweet       50 g..............  _ piece(s) (_ g)
     quick type), rolls.                               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, heavyweight (cheese    125 g.............  _ piece(s) (_ g)
     cake; pineapple upside-down                       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
    Cakes, mediumweight           80 g..............  _ piece(s) (_ g)
     (chemically leavened cake                         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 large
     vegetable cake with less                          discrete units
     than 35 percent of the
     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, lightweight (angel     55 g..............  _ piece(s) (_ g)
     food, chiffon, or sponge                          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) (_ g)
     doughnuts, Danish, sweet                          for sliced bread
     rolls, sweet quick type                           and distinct
     breads.                                           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) (_ g)
     not used as snack, melba
     toast, hard bread sticks,
     ice cream cones \8\.
    Crackers that are usually     30 g..............  _ piece(s) (_ g)
     used as snacks.
    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 prepaed for   _ piece(s) (_ g);
     pancakes, variety mixes.      French toast,       _ cup(s) (_ g)
                                   crepes, and         for dry mix
                                   pancakes; 40 g
                                   dry mix for
                                   variety mixes.

[[Page 34043]]

 
    Grain-based bars with or      40 g..............  _ piece(s) (_ g)
     without filling or coating,
     e.g., breakfast bars,
     granola bars, rice cereal
     bars.
    Ice cream cones--see
     crackers.
    Pies, cobblers, fruit         125 g.............  _ piece(s) (_ g)
     crisps, turnovers, other                          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) (_ g)
     cereal type), hominy grits.   g plain dry
                                   cereal; 55 g
                                   flavored,
                                   sweetened cereal.
    Breakfast cereals, ready-to-  15 g..............  _ cup(s) (_ g)
     eat, weighing less than 20
     g per cup, e.g., plain
     puffed cereal grains.
    Breakfast cereals, ready-to-  40 g..............  _ cup(s) (_ g)
     eat, weighing 20 g or more
     but less than 43 g per cup;
     high fiber cereals
     containing 28 g or more of
     fiber per 100 g.
    Breakfast cereals, ready-to-  60 g..............  _ piece(s) (_ g)
     eat, weighing 43 g or more                        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) (_ g)
     plain.                        g dry.
    Pastas, plain...............  140 g prepared; 55  _ cup(s) (_ g); _
                                   g dry.              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,    25 g..............  _ cup(s) (_ g)
     e.g., fried canned chow
     mein noodles.
    Starches, e.g., cornstarch,   10 g..............  _ tbsp (_ g)
     potato starch, tapioca, etc.
    Stuffing....................  100 g.............  _ cup(s) (_ g)
Dairy Products and Substitutes:
    Cheese, cottage.............  110 g.............  _ cup (_ g)
    Cheese used primarily as      55 g..............  _ cup (_ g)
     ingredients, e.g., dry
     cottage cheese, ricotta
     cheese.
    Cheese, grated hard, e.g.,    5 g...............  _ tbsp (_ g)
     Parmesan, Romano.
    Cheese, all others except     30 g..............  _ piece(s) (_ g)
     those listed as separate                          for distinct
     categories--includes cream                        pieces; _ tbsp(s)
     cheese and cheese spread.                         (_ 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, frozen yogurt,     \2/3\ cup--         \2/3\ cup (_ g), _
     sherbet, frozen flavored      includes the        piece(s) (_ g)
     and sweetened ice and pops,   volume for          for individually
     frozen fruit juices: all      coatings and        wrapped or
     types bulk and novelties      wafers.             packaged products
     (e.g., bars, sandwiches,
     cones, cups).
    Sundae......................  1 cup.............  1 cup (_ g)
    Custards, gelatin, or         \1/2\ cup           _ piece(s) (_ g)
     pudding.                      prepared; amount    for distinct unit
                                   to make \1/2\ cup   (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.

[[Page 34044]]

 
    Pie fillings................  85 g..............  _ cup(s) (_ g)
Egg and Egg Substitutes:
    Egg mixtures, e.g., egg foo   110 g.............  _ piece(s) (_ g)
     young, scrambled eggs,                            for discrete
     omelets.                                          pieces; _ cup(s)
                                                       (_ g)
    Eggs (all sizes) \8\........  50 g..............  1 large, medium,
                                                       etc. (_ g)
    Egg whites, sugared eggs,     An amount to make   _ cup(s) (_ g); _
     sugared egg yolks, and egg    1 large (50 g)      cup(s) (_ mL)
     substitutes (fresh, frozen,   egg.
     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 (_ g)
     spreads, mayonnaise-type
     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) (_ g)
     anchovies,\10\ anchovy                            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) (_ g); 5
     fish with cream sauce,                            oz (140 g/visual
     shrimp with lobster sauce.                        unit of measure)
                                                       if not measurable
                                                       by cup
    Entrees without sauce, e.g.,  85 g cooked; 110 g  _ piece(s) (_ g)
     plain or fried fish and       uncooked \11\.      for discrete
     shellfish, fish and                               pieces; _ cup(s)
     shellfish cake.                                   (_ g); _ oz (_ g/
                                                       visual unit of
                                                       measure) if not
                                                       measurable by cup
                                                       \12\
    Fish, shellfish, or game      85 g..............  _ piece(s) (_ g)
     meat \9\, canned \10\.                            for discrete
                                                       pieces; _ cup(s)
                                                       (_ g); 3 oz (85 g/
                                                       _ cup) for
                                                       products that are
                                                       difficult to
                                                       measure the g
                                                       weight of cup
                                                       measure (e.g.,
                                                       tuna); 3 oz (85 g/
                                                       _ pieces) for
                                                       products that
                                                       naturally vary in
                                                       size (e.g.,
                                                       sardines)
    Substitute for luncheon       55 g..............  _ piece(s) (_ g)
     meat, meat spreads,                               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) (_ g)
     shellfish, or game meat                           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) (_ g)
     cherries \10\.
    Fruit relishes, e.g.,         70 g..............  _ cup(s) (_ g)
     cranberry sauce, cranberry
     relish.
    Fruits used primarily as      50 g..............  See footnote \12\
     ingredients, avocado.
    Fruits used primarily as      50 g..............  _ piece(s) (_ g)
     ingredients, others                               for large fruits;
     (cranberries, lemon, lime).                       _ cup(s) (_ g)
                                                       for small fruits
                                                       measurable by
                                                       cup\12\
    Watermelon..................  280 g.............  See footnote \12\
    All other fruits (except      140 g.............  _ piece(s) (_ g)
     those listed as separate                          for large pieces
     categories), fresh, canned                        (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 (_ g)
     pectin.
    Baking decorations, e.g.,     1 tsp or 4 g if     _ piece(s) (_ g)
     colored sugars and            not measurable by   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)

[[Page 34045]]

 
    Dietary supplements.........  The maximum amount  _ tablet(s), _
                                   recommended, as     capsules(s), _
                                   appropriate, on     packet(s), _
                                   the label for       tsp(s) (_ g),
                                   consumption per     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) (_ g); _
     coating mixes, dry;           reference amount    tbsp(s) (_ g)
     seasoning mixes, dry, e.g.,   of final dish.
     chili seasoning mixes,
     pasta salad seasoning mixes.
    Milk, milk substitute, and    Amount to make 240  _ fl oz (_ mL); _
     fruit juice concentrates      mL drink (without   tsp (_  g); tbsp
     (without alcohol) (e.g.,      ice).               (_ g)
     drink mixers, frozen fruit
     juice concentrate,
     sweetened cocoa powder).
    Drink mixes (without          Amount to make 360  _ fl oz (_ mL); _
     alcohol): All other types     mL drink (without   tsp (_ g); _ tbsp
     (e.g., flavored syrups and    ice).               (_ g)
     powdered drink mixes).
    Salad and potato toppers,     7 g...............  _ tbsp(s) (_ g)
     e.g., salad crunchies,
     salad crispins, substitutes
     for bacon bits.
    Salt, salt substitutes,       \1/4\ tsp.........  \1/4\ tsp (_ g); _
     seasoning salts (e.g.,                            piece(s) (_ g)
     garlic salt).                                     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.
    Spices, herbs (other than     \1/4\ tsp or 0.5 g  \1/4\ tsp (_ g); _
     dietary supplements).         if not measurable   piece(s) (_ g) if
                                   by teaspoon.        not measurable by
                                                       teaspoons (e.g.,
                                                       bay leaf)
Mixed Dishes:
    Appetizers, hors d'oeuvres,   85 g, add 35 g for  _ piece(s) (_ g)
     mini mixed dishes, e.g.,      products with
     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,      140 g, add 55 g     _ piece(s) (_ g)
     e.g., burritos, enchiladas,   for products with   for discrete
     pizza, pizza rolls, quiche,   gravy or sauce      pieces; _
     all types of sandwiches.      topping, e.g.,      fractional slice
                                   enchilada with      (_ g) for large
                                   cheese sauce,       discrete units
                                   crepe with white
                                   sauce \13\.
Nuts and Seeds:
    Nuts, seeds and mixtures,     30 g..............  _ piece(s) (_ g)
     all types: Sliced, chopped,                       for large pieces
     slivered, and whole.                              (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) (_ g)
     skins, or pancakes.           g for frozen        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) (_ g)
     with sauce.                                       for discrete
                                                       pieces (e.g.,
                                                       stuffed potato);
                                                       _ cup(s) (_ g)
    Plain, fresh, canned, or      110 g for fresh or  _ piece(s) (_ g)
     frozen.                       frozen; 125 g for   for discrete
                                   vacuum packed;      pieces; _ cup(s)
                                   160 g for canned    (_ g) for sliced
                                   in liquid.          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) (_ g)
     fish, shellfish, bean,
     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); _ cup
     e.g., spaghetti sauce.                            (_ mL)
    Minor main entree sauces      \1/4\ cup.........  \1/4\ cup (_ g);
     (e.g., pizza sauce, pesto                         \1/4\ cup (60 mL)
     sauce, Alfredo sauce),
     other sauces used as
     toppings (e.g., gravy,
     white sauce, cheese sauce),
     cocktail sauce.

[[Page 34046]]

 
    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 tsp
     horseradish, hot sauces,                          (5 mL)
     mustards, Worcestershire
     sauce.
Snacks:
    All varieties, chips,         30 g..............  _ cup (_ g) for
     pretzels, popcorn, extruded                       small pieces
     snacks, fruit and vegetable-                      (e.g., popcorn);
     based snacks (e.g., fruit                         _ piece(s) (_ g)
     chips), grain-based snack                         for large pieces
     mixes.                                            (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); _ cup
                                   g.                  (_ 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 confectioneries  10 g..............  _ piece(s) (_ g)
    Hard candies, breath mints    2 g...............  _ piece(s) (_ g)
     \8\.
    Hard candies, roll-type,      5 g...............  _ piece(s) (_ g)
     mini-size in dispenser
     packages.
    Hard candies, others;         15 mL for liquid    _ piece(s) (_ g)
     powdered candies, liquid      candies; 15 g for   for large pieces;
     candies.                      all others.         _ 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) (_ g) for
                                   equivalent to one   solids; _ drop(s)
                                   reference amount    (_ g) for liquid;
                                   for sugar in        _ piece(s) (_ g)
                                   sweetness.          (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); \1/3\
     tomatoes, sun-dried           products packaged   cup (_ g)
     tomatoes, dried mushrooms,    in oil.
     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) (_ g)
     (e.g., pimento,\10\                               for chopped
     parsley, fresh or dried).                         products
    Fresh or canned chili         30 g..............  _ piece(s) (_ g)
     peppers, jalapeno peppers,                        \12\; _ tbsp(s)
     other hot peppers, green                          (_ g); _ cup(s)
     onion.                                            (_ g) for sliced
                                                       or chopped
                                                       products
    All other vegetables without  85 g for fresh or   _ piece(s) (_ g)
     sauce: Fresh, canned, or      frozen; 95 g for    for large pieces
     frozen.                       vacuum packed;      (e.g., Brussels
                                   130 g for canned    sprouts); _
                                   in liquid, cream-   cup(s) (_ g) for
                                   style corn,         small pieces
                                   canned or stewed    (e.g., cut corn,
                                   tomatoes,           green peas); 3 oz
                                   pumpkin, or         (84 g/visual unit
                                   winter squash.      of measure) if
                                                       not measurable by
                                                       cup
    All other vegetables with     110 g.............  _ piece(s) (_ g)
     sauce: Fresh, canned, or                          for large pieces
     frozen.                                           (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 (_ g)
     canned.
    Vegetable pastes, e.g.,       30 g..............  _ tbsp (_ g)
     tomato paste.
    Vegetable sauces or purees,   60 g..............  _ cup (_ g); _ cup
     e.g., tomato sauce, tomato                        (_ mL)
     puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
  customarily consumed per eating occasion and were primarily 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 (e.g., 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).

[[Page 34047]]

 
\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 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.
\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(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 part 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: May 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11865 Filed 5-20-16; 8:45 am]
 BILLING CODE 4164-01-P