[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Rules and Regulations]
[Pages 34000-34047]
[FR Doc No: 2016-11865]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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,<PHONE_NUMBER><EMAIL_ADDRESS>    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_ADDRESS>
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

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\
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    \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$]
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                                      Benefits     Benefits     Benefits      Costs        Costs        Costs
                                       (low)        (mean)       (high)       (low)        (mean)       (high)
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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
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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).

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,

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

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.).

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

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

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

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

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

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

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

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,

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

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

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

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