[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Rules and Regulations]
[Pages 34000-34047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11865]
[[Page 34000]]
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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, 240-402-1450, [email protected].
With regard to the information collection: Domini Bean, Office of
Information Management, Food and Drug Administration, 8455 Colesville
Rd., Rm. 14537G, Silver Spring, MD 20903, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Legal Authority
C. Summary of the Major Provisions of the Final Rule
D. Technical Amendments
E. Effective and Compliance Dates
F. Costs and Benefits
II. Background
A. Serving Size Proposed Rule
B. Legal Authority
III. Comments and FDA's Responses
A. General Comments
B. Single-Serving Containers
C. Dual-Column Labeling
D. Reference Amounts Customarily Consumed
E. Impact of Changes in RACCs on the Eligibility To Make
Nutrient Content Claims and Health Claims
F. Establishing a New Serving Size for Breath Mints
G. Technical Amendments
IV. Effective and Compliance Dates
V. Analysis of Environmental Impact
VI. Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References
I. Executive Summary
A. Purpose of the Final Rule
Following the passage of the Nutrition Labeling and Education Act
(NLEA) of 1990 (Pub. L. 101-535), which added section 403(q) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)),
we issued various regulations related to serving size requirements (see
21 CFR 101.9 and 101.12). Since we established those regulations, there
have been developments that have compelled us to reevaluate our
regulations on serving sizes and determine whether and what, if any,
revisions are needed to ensure that the Nutrition Facts label meets its
intended goal of providing consumers information to assist them in
maintaining healthy dietary practices. Specifically, such developments
include the availability of newer consumption data, research showing
that amounts of food consumed by the American public have changed, and
the availability of recent consumer research on the use and
understanding of the Nutrition Facts label.
In consideration of these new developments, this rule amends our
regulations in Sec. Sec. 101.9 and 101.12. Resulting from our
evaluation of the new consumption data, this rule amends the RACCs that
are used to determine serving sizes consistent with section
403(q)(1)(A)(i) of the FD&C Act, which states that a serving size is an
amount of food customarily consumed. Additionally, in consideration of
recent consumption data, research on consumption, and research on
consumer understanding of the Nutrition Facts label, this rule amends
some of the required procedures used to determine serving sizes, amends
the definition of a single-serving container, and requires that certain
containers of foods bear an additional column of nutrition information
to help consumers understand the nutritional significance of consuming
an entire container of certain foods containing multiple servings.
Overall, the changes finalized in this rule are designed to ensure that
serving sizes are based on current consumption data and to provide
consumers with information on the Nutrition Facts label related to the
serving size that will assist them in maintaining healthy dietary
practices.
B. Summary of the Legal Authority
The NLEA amended the FD&C Act to provide FDA with the authority to
require nutrition labeling on most packaged foods we regulate.
Specifically, section 403(q)(1)(A)(i) of the FD&C Act requires, with
certain exceptions, that food that is intended for human consumption
and offered for sale bear nutrition information that provides a serving
size that reflects the amount of food customarily consumed and is
expressed in a common household measure that is appropriate to the
food, and is our primary legal authority to issue the regulations in
this final rule. Section 2(b)(1)(B) of the NLEA further requires the
Secretary of Health and Human Services to issue regulations ``which
establish standards . . . to define serving size.'' Additionally, we
are relying on section 2(b)(1)(A) of the NLEA, which states that
requirements in regulations issued under the authority of the NLEA,
including serving size requirements, shall be ``conveyed to the public
in a manner which enables the public to readily observe and comprehend
such information and to understand its relative significance in the
context of a total daily diet.'' Finally, we are relying on the
authorities in sections 701(a), 403(a)(1), and 201(n) of the FD&C Act
(21 U.S.C. 371(a), 343(a)(1), and 321(n)) for amendments in this final
rule. Under section 701(a) of the FD&C Act, we have authority to issue
regulations for the efficient enforcement of the FD&C Act. Under
section 403(a) of the FD&C Act, a food is deemed misbranded if its
labeling is false or misleading in any particular. Additionally, under
section 201(n) of the FD&C Act, in determining whether or not a food is
misbranded because its labeling is misleading, we must take into
account not only representations made or suggested, but also the extent
to which the labeling fails to reveal facts that are material in light
of such representations or material with respect to consequences that
may result from the use of the food. All of the authorities listed in
this paragraph
[[Page 34001]]
give us the authority to issue this final rule related to serving size
labeling.
C. Summary of the Major Provisions of the Final Rule
1. Single-Serving Containers and Dual-Column Labeling
Over the last 20 years, evidence has accumulated demonstrating that
container and unit sizes can influence the amount of food consumed. For
containers and units of certain sizes, consumers are likely to eat the
entire container or unit in one sitting. For other container and unit
sizes, consumers may consume the container or unit in one sitting or
may consume the container or unit over multiple sittings or share the
container or unit contents with other consumers. To address containers
that may be consumed in a single-eating occasion, we are requiring that
all containers, including containers of products with ``large'' RACCs
(i.e., products with RACCs of at least 100 grams (g) or 100 milliliters
(mL)), containing less than 200 percent of the RACC be labeled as a
single-serving container. To address containers and units that may be
consumed in one or more sittings, or shared, we are requiring that
containers and units that contain at least 200 percent and up to and
including 300 percent of the RACC be labeled with a column of nutrition
information within the Nutrition Facts label that lists the
quantitative amounts and percent DVs for the entire container, in
addition to the required column listing the quantitative amounts and
percent DVs for a serving that is less than the entire container (i.e.,
the serving size derived from the RACC).
2. Changing the RACCs
We established RACCs in 1993 based, in part, on data from
Nationwide Food Consumption Surveys (1977-1978 and 1987-1988) conducted
by the U.S. Department of Agriculture (USDA). Over the last decade,
there has been general recognition that consumption patterns have
changed. To determine changes in serving sizes and whether the RACCs
should be updated, we analyzed recent food consumption data from the
2003-2008 National Health and Nutrition Examination Surveys (NHANES)
(hereinafter referred to as the NHANES 2003-2008 surveys or NHANES
2003-2008 consumption data, as applicable). Generally, this rule amends
RACCs if the NHANES median consumption data have increased or decreased
by at least 25 percent compared to the 1993 RACCs. However, consistent
with our regulations in Sec. 101.12(a), we have considered other
factors, such as designating the same RACCs for products with similar
consumption data and similar dietary usage or product characteristics.
In addition, since the final rule on serving sizes published in
1993, we have received requests from manufacturers to modify,
establish, and identify appropriate product categories within the
tables in Sec. 101.12(b) and change the serving size for various food
products. Using the data currently available to us, we are also
addressing these requests in this final rule.
D. Technical Amendments
We have been alerted to a number of technical amendments that
should be made to the serving size regulations in Sec. Sec. 101.9 and
101.12. This final rule includes a number of technical amendments to
help clarify the serving size requirements in these regulations.
E. Effective and Compliance Dates
We are establishing a compliance date of 2 years after the final
rule's effective date for manufacturers with $10 million or more in
annual food sales, and 3 years after the final rule's effective date
for manufacturers with less than $10 million in annual food sales. (For
more details, see Section IV, Effective and Compliance Dates.)
F. Costs and Benefits
We have developed one final regulatory impact analysis (FRIA) for
this final rule as well as the final rule entitled ``Food Labeling:
Revision of the Nutrition and Supplement Facts Labels'' (the Nutrition
Facts final rule). The FRIA discusses key inputs in the estimation of
costs and benefits of the changes finalized by the rules and assesses
the sensitivity of cost and benefit totals to those inputs. The two
nutrition labeling rules--which have a compliance date of 2 years after
the final rule's effective date for manufacturers with $10 million or
more in annual food sales, and 3 years after the final rule's effective
date for manufacturers with less than $10 million in annual food
sales--have impacts, including the sign on net benefits, that are
characterized by substantial uncertainty. The primary sensitivity
analysis shows benefits having the potential to range between $0.2 and
$2 or $5 billion, and costs ranging between $0.2, $0.5 and $0.8 billion
(annualized over the next 20 years, in 2014 dollars, at seven percent
interest).\1\
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\1\ There is substantial uncertainty regarding the impacts of
the two nutrition labeling rules. For a full discussion of the
uncertainty, please see the Welfare Estimates--Primary Sensitivity
Analysis section of the Regulatory Impact Analysis.
Table 1--Summary of the Primary Sensitivity Analysis of the Costs and Benefits of the Final Rules
[in billions of 2014$]
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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).
[[Page 34002]]
II. Background
A. Serving Size Proposed Rule
In the Federal Register of March 3, 2014 (79 FR 11989), we
published a proposed rule (the serving size proposed rule or the
proposed rule) to amend our serving size regulations, in part, in
response to recommendations of the Report of the Working Group on
Obesity, ``Calories Count,'' March 12, 2004 (Ref. 1), and our
recognition that portion sizes have changed since we first published
serving size regulations in 1993 (1993 serving size final rule, 58 FR
2229, January 6, 1993). We also published technical amendments to the
1993 serving size final rule on August 18, 1993 (58 FR 44039). The
proposed rule also discussed six citizen petitions. The intended effect
of the proposed rule, when finalized, was to provide consumers with
more accurate and up-to-date information on serving sizes. In brief,
the proposed rule would:
Amend the definition of a single-serving container to
remove the exception for products with large RACCs. Preexisting Sec.
101.9(b)(6), which this rule will replace upon the effective date,
required that a product that is packaged and sold individually that
contains less than 200 percent of the applicable RACC be considered to
be a single-serving container, and that the entire content of the
product be labeled as one serving, unless the product contains more
than 150 but less than 200 percent of the RACC and has an RACC of 100 g
or 100 mL or larger. Under the preexisting regulation, manufacturers of
products that contain more than 150 but less than 200 percent of the
RACC and have an RACC of 100 g or 100 mL or larger (large-RACC
products) are permitted to label the product as containing 1 or 2
servings, at the manufacturer's discretion (Sec. 101.9(b)(6)). The
proposed rule would remove the exception for large-RACC products being
labeled as one or two servings so that all products packaged and sold
individually and that contain less than 200 percent of the RACC would
be required to be labeled as a single-serving container.
Require an additional column within the Nutrition Facts
label to list the quantitative amounts and percent DVs for the entire
container, to the right of the preexisting column listing the
quantitative amounts and percent DVs for a serving that is less than
the entire container (i.e., the serving size derived from the RACC),
for products that are packaged and sold individually and contain at
least 200 percent and up to and including 400 percent of the applicable
RACC.
Update the RACCs when there is a significant change
between the median amount consumed from 2003-2008 NHANES consumption
data and the RACCs established in the 1993 serving size final rule.
Modify and establish RACCs for certain product categories
based on manufacturer requests and our initiative.
Amend the serving size for breath mints.
Make technical amendments to various aspects of the
serving size regulations.
We provided an opportunity to comment on the serving size proposed
rule until June 2, 2014. On May 27, 2014, we extended the comment
period until August 1, 2014 (79 FR 30056). We received more than 500
comments in response to the proposed rule. Most submissions came from
individuals. We also received comments from industry and trade
associations, consumer and advocacy groups, academic organizations,
State governments, and foreign government agencies.
B. Legal Authority
Our primary legal authority to issue regulations that establish
requirements for serving size is derived from section 403(q) of the
FD&C Act. Specifically, section 403(q)(1)(A)(i) of the FD&C Act
requires, with certain exceptions, that food that is intended for human
consumption and offered for sale bear nutrition information that
provides a serving size that reflects the amount of food customarily
consumed and is expressed in a common household measure that is
appropriate to the food.
The NLEA added section 403(q)(1)(A)(i) to the FD&C Act and, under
section 2(b)(1)(B) of NLEA, required that we issue regulations that
establish standards to define serving size. We established those
standards in the 1993 serving size final rule, and we have determined
that amendments to those regulations are needed. We have analyzed
consumption data for various food products and have determined that the
data warrant amending many of the RACCs established in 1993.
Additionally, both on our own initiative and in response to various
requests, we have analyzed data for products that are not listed in the
tables in Sec. 101.12(b), and are establishing additional RACCs. Thus,
in accordance with section 403(q)(1)(A)(i) of the FD&C Act, we are
amending the RACCs in Sec. 101.12(b) to reflect the current amounts
customarily consumed for products already listed in Sec. 101.12(b), as
well as products not listed in Sec. 101.12(b). Additionally, under the
same authority we are amending related regulations in Sec. Sec. 101.9
and 101.12 that set forth procedures for determining serving sizes for
use on product labels based on the reference amounts. Included among
these amendments are revisions to the procedures for determining what
products must be labeled as a single serving.
Further, in addition to requiring FDA to issue regulations that
establish standards to define serving size, section 2(b)(1)(A) of the
NLEA states that the regulations shall require such information to be
``conveyed to the public in a manner which enables the public to
readily observe and comprehend such information and to understand its
relative significance in the context of a total daily diet.'' Under
this authority, we are amending Sec. 101.9 to require that certain
products provide an additional column within the Nutrition Facts label
that lists the quantitative amounts of the required nutrients and food
components, and percent DVs for such nutrients and food components, for
the entire container or unit of food as well as the column listing the
quantitative amounts and percent DVs for a serving of food that is less
than the entire container or unit. Section 2(b)(1)(A) of the NLEA
provides authority for this amendment because the additional column of
information will help consumers to understand the nutritional
significance of consuming an entire container or unit of certain foods
containing multiple servings in the context of a total daily diet. As
discussed further in section III.C.1., research has shown that package
and portion size play a role in influencing the amounts that consumers
eat, and that consumers can be confused about the amount of nutrients
they consume in packages containing more than one serving but that
could be consumed in a single eating occasion. The amendment is
intended to help consumers understand the amounts of nutrients in
certain containers and units of food, as well as the DVs for those
nutrients, so that those amounts can be taken into consideration when
evaluating a daily diet.
Other relevant authorities that we are relying on for the
amendments in this rule include sections 701(a), 403(a)(1), and 201(n)
of the FD&C Act. Under section 701(a) of the FD&C Act, we have
authority to issue regulations for the efficient enforcement of the
FD&C Act. We may issue regulations for the efficient enforcement of the
FD&C Act in order to ``effectuate a congressional objective expressed
elsewhere in the Act'' (Association of American Physicians and
Surgeons, Inc. v. FDA,
[[Page 34003]]
226 F. Supp. 2d 204, 213 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v.
FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980))). Under section 403(a) of
the FD&C Act, a food is deemed misbranded if its labeling is false or
misleading in any particular. Additionally, under section 201(n) of the
FD&C Act, in determining whether or not a food is misbranded because
its labeling is misleading, we must take into account not only
representations made or suggested, but also the extent to which the
labeling fails to reveal facts that are material in light of such
representations or material with respect to consequences that may
result from the use of the food. These other authorities, in addition
to the authorities described previously in this document, give us the
authority to issue this final rule related to serving size labeling.
III. Comments and FDA's Responses
This section discusses the issues raised in the comments on the
proposed rule and describes the final rule. For ease of reading, we
preface each comment discussion with a numbered ``Comment'' and each
response by a corresponding numbered ``Response.'' We have numbered
each comment to help distinguish among different topics. The number
assigned is for organizational purposes only and does not signify the
comment's value, importance, or the order in which it was received.
A. General Comments
(Comment 1) Many comments stated that the labeled serving size
represents a recommended amount of food to consume. Other comments
stated that we were changing the RACCs from a recommended amount of
food to eat to the amount of food that people actually eat. Some
comments that thought we were changing the serving size from a
recommended amount of food to eat to an amount of food that is
customarily consumed supported the change. Some of these comments
stated that basing the serving size on the actual amount eaten would
make it easier for consumers to understand how many calories and other
nutrients they are consuming.
In contrast, other comments asserting that we were changing the
serving size from a recommended amount to an amount of food that is
customarily consumed opposed the perceived change because, according to
those comments, such changes would make it more difficult to use the
labeled serving size for diet planning or other dietary practices.
Further comments stated that updating the serving size portion of the
Nutrition Facts label would increase consumer confusion and encourage
excess consumption among those who think that the serving size is based
on a recommended amount.
(Response 1) Some of these comments reflect a misunderstanding of
the definition of serving size. Under section 403(q)(1)(A)(i) of the
FD&C Act, serving size is an amount of food customarily consumed and
which is expressed in a common household measure appropriate to the
food. Thus, the serving size is not a recommended amount of food to eat
and was not described as such in the 1993 serving size final rule.
We acknowledge that some consumers may misconstrue the meaning of
the serving size set forth in the FD&C Act. Since the publication of
the proposed rule, several studies have been conducted that indicate
that some consumers believe serving size specifies a recommended amount
of food to eat (Refs. 2, 3, and 4), and we recognize that that such an
understanding could lead to increased levels of consumption. In order
to help consumers understand issues relating to this final rule, as
discussed further in response to comment 2, we intend to conduct
nutrition education to help clarify the meaning of the serving size and
RACCs.
With regard to the comments that stated that updates to serving
sizes would make it difficult to use the serving size for diet planning
or other dietary practices, we disagree. Providing the nutrition
content of the food based on current consumption amounts informs
consumers of the amount of nutrients they are likely to ingest.
(Comment 2) Several comments recommended that we conduct extensive
consumer education on the changes in this final rule. Some comments
requested that we conduct consumer education in conjunction with the
USDA regarding all proposed changes to the Nutrition Facts label and
the underlying calculations used to determine the quantities presented
on the labels. Several comments asserted that without public education,
consumers may not fully understand how to use the Nutrition Facts label
so that they can maintain healthy dietary practices.
(Response 2) We agree that an extensive consumer education campaign
will serve an important role in continuing to provide information to
assist consumers in maintaining healthy dietary practices. Currently,
we have available a collection of various educational materials (e.g.,
videos and an array of other education materials (in English and other
languages)) on numerous nutrition topics, including materials on the
Nutrition Facts label (e.g., Read the Label, Make Your Calories Count,
Using the Nutrition Facts Label) (Ref. 5). These materials are intended
for educators, teachers, health professionals (e.g., dietitians,
nutritionists), as well as for consumers. Our intent is to update our
existing educational materials and create new educational opportunities
to explain the overall role of using the label to assist consumers in
maintaining healthy dietary practices, with an emphasis on each of the
new changes of the label.
We intend to continue to work in collaboration, and create new
partnership opportunities, with other Federal government agencies
including other parts of the Department of Health and Human Services,
USDA, State health departments, health professional organizations, food
manufacturers, retailers, and non-profit organizations that have an
interest and responsibilities in nutrition education and health
promotion. These partnerships will help us to develop and disseminate
our educational materials, which will ease the transition to the
revised nutrition label and help consumers to use the label to make
informed dietary choices. Through our collaboration with both
government and non-government entities, our continued goal is to
increase consumers' knowledge and effective use of the new food label,
and to ensure that consumers have accurate and adequate resource
materials and information to assist them in maintaining healthy dietary
practices. Furthermore, we intend to continue with a variety of
activities, such as conducting and reporting on existing and planned
food labeling research, developing education initiatives at the
national and local level, holding regularly scheduled meetings to build
labeling education exchanges, and integrating food labeling education
into the existing programs (e.g., USDA school-based nutrition education
programs). We plan to continue to build partnerships capable of
developing and evaluating labeling education targeted to the dietary
needs of diverse populations, such as low-literacy consumers, those
with lower incomes, minorities and various specific subpopulations
(e.g., children, older adults, women of childbearing age), as well as
to the public at large.
(Comment 3) Several comments requested we require that a footnote
be added to the Nutrition Facts label to indicate that the serving size
is based on typically consumed, not recommended, servings. The comments
stated that the purpose of adding this footnote would be to serve as
nutrition education to
[[Page 34004]]
make consumers aware of the true meaning of the labeled serving size.
(Response 3) We recognize the importance of providing consumers
with more in-depth information about the meaning of the serving size
and, as explained in response to comment 2, intend to make this a key
component of our future nutrition education efforts for consumers. At
this time, however, we decline to establish as part of this rulemaking
a requirement to add a footnote to the Nutrition Facts label that would
indicate that the serving size is based on what is typically consumed,
rather than what is recommended. We would like to consider this issue
further before finalizing a provision that would mandate or voluntarily
permit the addition of such a footnote to the Nutrition Facts label. We
also note that, while no such footnote as requested in this comment can
be added to the Nutrition Facts label voluntarily, manufacturers can
voluntarily include a truthful and not misleading statement explaining
the meaning of serving size elsewhere on the product label.
(Comment 4) Some comments requested that we change the term
``serving size'' to prevent consumers from assuming that the serving
sizes are recommended servings. Some terms that the comments suggested
we use instead were ``typical serving,'' ``unit,'' or ``quantity.''
Another suggestion was to remove the two lines that mention ``serving''
and add, next to the words ``Amount per ___,'' the fraction of the
container that the RACC represents (for example, ``Amount per \2/3\ cup
(\1/8\ of container)'').
(Response 4) We decline to revise or remove the terms ``serving''
and ``serving size'' as suggested by the comments. Section 403(q)(1)(A)
of the FD&C Act deems food, unless subject to an exception, to be
misbranded unless its label or labeling bears the ``serving size.''
Therefore, we will continue to require that the terms ``serving'' and
``serving size'' be used on product labels.
(Comment 5) Some comments stated that the ``serving size'' should
be expressed in household measurements or that serving size of similar
food products should be based off of the same amount of food.
(Response 5) We agree. Section 403(q)(1)(A) of the FD&C Act
requires that the serving size be expressed in a common household
measure that is appropriate to the food or, if the use of the food is
not typically expressed in a serving size, the common household unit of
measure that expresses the serving size of the food. In addition, Sec.
101.12(a)(9) states that products that have similar dietary usage,
product characteristics, and customarily consumed amounts should have a
uniform reference amount. Section 101.12(a)(9) is not being changed in
this final rule and was used as part of the decision making when
determining what RACCs to update, modify, and establish in the proposed
rule and this final rule.
(Comment 6) Several comments indicated that we should consider a
uniform serving size for all food products as is done in some other
countries, such as 1 cup or 100 g. The comments stated that having a
uniform serving size would allow consumers to be able to make side-by-
side comparisons of all products in the grocery store.
(Response 6) We do not agree that a uniform serving size should be
used for all foods. Under section 403(q)(1)(A) of the FD&C Act, serving
size is defined as the amount of food customarily consumed. As all
foods are not customarily consumed in the same amount, establishing a
uniform serving size for all foods would not meet this statutory
requirement.
B. Single-Serving Containers
Preexisting Sec. 101.9(b)(6) requires that a product that is
packaged and sold individually and that contains less than 200 percent
of the applicable RACC be labeled as a single serving. This provision,
however, does not apply to products that have ``large'' RACCs (i.e.,
products that have reference amounts of 100 g (or mL) or larger). Under
preexisting Sec. 101.9(b)(6), manufacturers of large-RACC products
could decide whether a package that contains more than 150 percent but
less than 200 percent of the applicable RACC is 1 or 2 servings (Sec.
101.9(b)(6)). We provided the exception for large-RACC products based
on consumption data available at the time the 1993 rule was issued that
showed that ``[i]t was much less likely that a person will consume
approximately twice the reference amount of a food with a reference
amount of 100 g (or mL) or more, than it is that he or she would
consume twice the reference amount of a food with a smaller reference
amount'' (79 FR 11989 at 12000).
In the preamble to the proposed rule (79 FR 11989 at 12001), we
discussed the correlation between the consumption variation and the
RACCs for all products containing less than 200 percent of the
applicable RACC, including products with large RACCs and products that
have RACCs that are less than 100 g (or mL), using combined consumption
data from the NHANES 2003-2008 surveys (Refs. 6, 7, and 8). The
consumption variation is calculated as the standard deviation of the
median consumption amount divided by the median consumption amount and
then multiplied by 100 to express the figure as the percent variation
from the median consumption amount (Ref. 9). The result shows that the
correlation coefficient is 0.13, which means that there is a low
correlation between the RACCs and the consumption variation for all
products containing less than 200 percent of the RACC, regardless of
whether the RACC is large. In other words, it is not less likely that a
person would consume approximately twice the reference amount of a food
with a reference amount of 100 g (or mL) or more than it is that he or
she would consume approximately twice the reference amount of a food
with a smaller reference amount. Therefore, in the preamble to the
proposed rule we proposed to remove the exemption from the requirement
to label a product with a large RACC containing between 150 percent and
200 percent of the applicable RACC as a single-serving container
because the exemption is no longer supported by consumption data (79 FR
11889 at 12001).
Additionally, as noted in the preamble to the proposed rule,
raising the required cutoff for labeling a product with a large RACC as
a single serving may help consumers to more accurately interpret the
nutrient amounts in these products (79 FR 11889 at 12001). Research
shows that package and portion sizes tend to have a considerable impact
on the amount of food consumed (Refs. 10 and 11). Taking into account
this research, we stated in the proposed rule that removing the
exemption from the requirement to label a product with a large RACC as
a single-serving container may help consumers to correctly interpret
the nutrient amounts in the food that they are consuming (79 FR 11989
at 12001). In light of this research and the previously discussed
analysis on consumption variation, we proposed to remove the large-RACC
exemption for single-serving containers.
We also proposed to remove the text in preexisting Sec.
101.9(b)(2)(i)(D), which states that if a unit weighs 200 percent or
more of the RACC, the manufacturer may declare one unit as the serving
size if the entire unit can reasonably be consumed in one eating
occasion, and replace the text with the text in proposed Sec.
101.9(b)(2)(i)(D) (which is discussed in section III.C.).
[[Page 34005]]
1. Definition of a Single-Serving Container
(Comment 7) Some comments supported our proposed changes to the
definition of a single-serving container. The comments said that
labeling foods that are less than 200 percent of the RACC as a single
serving would increase consumer understanding of the nutritional
content of foods. Some comments also stated that the proposed changes
would provide consistency across all food products on the amount that
constitutes a single serving. Other comments provided research in
support of our proposed changes to the definition of a single-serving
container.
(Response 7) The research provided in the comments is the same as
the research discussed in the preamble of the proposed rule (79 FR
11989 at 11998). Lando & Labiner-Wolfe (2007) found that many focus
group study participants believed that products like a large muffin or
a 20 ounce (oz) soda that contain more than one serving, but are often
eaten at a single eating occasion, should be labeled as a single
serving (Ref. 12). Other studies have shown that some consumers may
tend to experience a ``unit bias'' and view intact units/packages of
food as a marker of the appropriate amount of food to consume (Ref.
13).
(Comment 8) One comment asked that we raise the cutoff for a
single-serving container to include containers with up to 300 percent
of the RACC. The comment stated that our proposed amendment for single-
serving containers to include anything less than 200 percent of the
RACC excludes many foods that can reasonably be consumed by one person
in a single eating occasion and that food companies could avoid ``per
package'' labeling by simply increasing the container size to slightly
more than 200 percent of the RACC.
(Response 8) While we understand the concern that keeping the
cutoff for single-serving containers at less than 200 percent may
exclude some food products that can reasonably be consumed by one
person in a single eating occasion, we decline to increase the
definition of a single-serving container to include products containing
up to 300 percent of the RACC. Under section 403(q)(1)(A)(i) of the
FD&C Act, serving size means the amount customarily consumed. The RACCs
we have established are reference amounts of food that are customarily
consumed per eating occasion. As such, we do not consider it
appropriate to label foods containing 200 percent or more of the
applicable RACC as single-serving containers because that would be at
least twice the amount we have determined is customarily consumed.
However, we agree with these comments that such products may reasonably
be consumed by one person in a single eating occasion, and as discussed
in section III.B., full-package nutrition information, or per-unit
nutrition information, as applicable, for products containing at least
200 percent and up to and including 300 percent of the RACC will be
required for certain products through dual-column labeling.
(Comment 9) One comment requested clarification on the meaning of
the phrase ``products that are packaged and sold individually.'' The
comment noted that it understood the phrase ``products that are
packaged and sold individually'' to mean products that consist of a
single unit and to exclude products that are divided into discrete
units. The comment stated that if the phrase ``products that are
packaged and sold individually'' does include products that are divided
in discrete units, every product would be a product that is ``packaged
and sold individually.'' Accordingly, the comment questioned whether
the proposed single-serving and dual-column labeling requirements would
apply only to products that consist of a single unit, or whether the
requirements would also apply to non-discrete bulk products and
products divided into discrete units. The comment also requested
clarification on whether a product that is ``packaged and sold
individually'' must be considered a single-serving container if it
contains less than 200 percent of the RACC, and whether it must provide
dual-column labeling if it contains 200 percent to 400 percent of the
RACC.
(Response 9) In proposed Sec. 101.9(b)(6) we use the phrase
``products that are packaged and sold individually'' and weighing less
than 200 percent of the RACC to describe products for which single-
serving container labeling requirements would apply. The phrase
``products that are packaged and sold individually'' was also used in
the serving size proposed rule to describe products for which the
proposed dual-column labeling requirements would apply, provided that
they contained at least 200 and up to and including 400 percent of the
RACC. In both of these cases we are using the phrase ``products that
are packaged and sold individually'' to describe any package bearing a
Nutrition Facts label.
A product that is packaged and sold individually, i.e., a container
that bears a Nutrition Facts panel, is considered a single-serving
container if it contains less than 200 percent of the RACC. A product
that is packaged and sold individually would be required to provide
dual-column labeling if it contains at least 200 percent and up to and
including 300 percent of the RACC, unless an exception from the
requirement applies. The change from 400 percent of the RACC as the
upper limit for the dual-column labeling requirements to 300 percent of
the RACC as the upper limit for the dual-column labeling requirements
is discussed in section III.B. While Sec. 101.9(b)(2)(i) provides
requirements for the serving size declaration for multiserving products
in discrete units, products that satisfy the requirements of Sec.
101.9(b)(6) (i.e., products that are packaged and sold individually and
that contain less than 200 percent of the applicable reference amount)
are excepted from Sec. 101.9(b)(2) (see 58 FR 2229 at 2234). There was
no proposal to change this provision in the proposed rule, and it has
not been amended in this final rule. Therefore, products in discrete
units that are packaged and sold individually and that contain less
than 200 percent of the applicable reference amount are required to be
labeled as a single serving under Sec. 101.9(b)(6). Products that
contain discrete units and in which each discrete unit weighs at least
200 percent and up to and including 300 percent of the reference amount
are required under Sec. 101.9(b)(2)(i)(D) to bear two columns listing
the quantitative amounts and percent DVs: One providing nutrition
information for a serving that is less than the unit (i.e., the serving
size derived from the reference amount) and one providing nutrition
information for the entire unit. Further, products in discrete units
that are packaged and sold individually and contain at least 200
percent and up to and including 300 percent of the reference amount are
required to comply with the dual-column labeling requirements in Sec.
101.9(b)(12)(i). Similarly, products not in discrete units that are
packaged and sold individually and contain at least 200 percent and up
to and including 300 percent of the reference amount are required to
satisfy the dual-column labeling requirements in Sec. 101.9(b)(12)(i).
(Comment 10) Several comments pertained to multiple individually
wrapped units in a single container, for which the combined weight of
the units in the larger package is less than 200 percent of the RACC.
The comments stated that products containing individual units in a
container where the entire container weighs less than
[[Page 34006]]
200 percent of the RACC are unlikely to be consumed in a single eating
occasion. One comment requested an exemption from the single-serving
container requirement in a scenario in which a package weighing less
than 200 percent of the RACC contains two discrete stuffed sandwiches,
and requested that each sandwich, rather than the entire package, be
considered one serving. The comment stated that under the proposed
amendments to the definition of a single-serving container, the entire
package containing the two stuffed sandwiches would need to be labeled
as one serving. The comment stated that labeling each discrete stuffed
sandwich as a single serving would be consistent with how consumers use
and eat these types of products and asserted that consumers typically
eat one individually wrapped unit in a single eating occasion, rather
than opening a second unit. Another comment requested that we provide
an exemption generally from the definition of single-serving container
where a package contains multiple individually wrapped units, and each
individual unit is labeled as a serving.
(Response 10) We disagree with comments suggesting that products
containing discrete units in a container that weighs less than 200
percent of the RACC should be exempt from the single-serving container
requirements, regardless of whether the individual units in the
container are wrapped. Products containing discrete units in a
container weighing less than 200 percent of the RACC were required to
be labeled as a single-serving container under the 1993 requirements,
unless the product qualified for the large-RACC exception discussed in
section III.B. We did not propose to change this requirement in the
proposed rule and are not changing it in the final rule. Other
provisions of our regulations permit additional flexibility with
respect to how products in discrete units are labeled. As explained in
response to comment 12 and as reflected in Sec. 101.9(b)(6), for
products that are packaged and sold individually (i.e., products
bearing a Nutrition Facts panel) that contain more than 150 percent and
less than 200 percent of the applicable reference amount, manufacturers
may voluntarily add a second column of nutrition information to the
left of the column that provides nutrition information per container
that will provide nutrition information per common household measure
that most closely approximates the reference amount. This would allow
manufacturers of products that are packaged and sold individually and
that contain two discrete units weighing more than 75 percent and less
than 100 percent of the reference amount to voluntarily provide a
second column that provides nutrition information per unit.
Additionally, for packages that weigh less than 200 percent of the RACC
each and that are contained within a larger outer container,
manufacturers have the option of labeling each individual package with
a Nutrition Facts panel that states that the individual package or
container is one serving, and then labeling the outer container to
state the number of servings as the number of individual packages
within the outer container (Sec. 101.9(b)(8)(iv)). Finally, in order
to provide additional flexibility to manufacturers that want to list
nutrition information per unit of food, this final rule amends Sec.
101.9(b)(10)(ii), which allows manufacturers to provide an additional
column of nutrition information ``[p]er one unit if the serving size of
a product in discrete units in a multiserving container is more than 1
unit.'' This final rule removes language in Sec. 101.9(b)(10)(ii)
limiting the provision to use only with multiserving containers. These
amendments will allow single-serving products to voluntarily provide an
additional column of nutrition information per unit of a product that
is in discrete units.
2. Single-Serving Container Option for Large-RACC Products
(Comment 11) Several comments said that our analysis of the
correlation between the consumption variation and the RACCs for all
products containing less than 200 percent of the applicable RACC is
flawed. The comments stated that we defined the average variability in
the analysis as the standard deviation as a percent of the mean and
that this represents the standard deviation of individual intakes from
one person to the next. The comments stated that the standard
deviations of the medians in all tables in our analysis are actually
the standard errors of the medians and not the standard deviations of
individual intakes as previously described (Ref. 9). The comments
stated that because we did not actually conduct the appropriate
analysis, no conclusion should be drawn from these reported summaries.
(Response 11) After carefully reexamining the data described in the
Memorandum-to-file dated February 11, 2014 (Ref. 9), we agree that the
standard deviations of the median are, in fact, the standard errors of
the medians. Therefore, we have revised the correlation between the
consumption variation and the RACCs for all products.
We disagree, however, that no conclusion should be drawn because of
the error. The revised correlation coefficient, after adjusting the
standard errors to standard deviations by multiplying with square roots
of the sample size, is reduced to 0.13 from 0.18. This means that there
is an even lower correlation between the RACCs (whether the reference
amount is more than or less than 100 g or mL) and the consumption
variation for all products containing less than 200 percent of the
RACC, regardless of whether the RACC is ``large.'' In other words, the
correct calculation reinforces the conclusion that it is not less
likely that a person would consume approximately twice the reference
amount of a food with a reference amount of 100 g (or mL) or more than
it is that he or she would consume approximately twice the reference
amount of a food with a smaller reference amount.
(Comment 12) One comment expressed concern about the impact that
removing the exception for large-RACC products in Sec. 101.9(b)(6)
would have on products with varying densities. According to the
comment, some varieties of the same type of product have serving sizes
that are less than 200 percent of the RACC, while other varieties of
the same type of product have serving sizes that are 200 percent of the
RACC or greater. The comment noted as an example canned soups of
different varieties that are often packaged in the same size and type
of container, for which the different varieties may have different
densities (e.g., a cream-based soup may be heavier than a broth-based
soup). According to the comment, under the proposed rule soups
containing less than 200 percent of the RACC, or less than 490 g, would
be required to be labeled as a single serving, while soups containing
200 to 400 percent of the RACC, or 490 to 980 g, would be labeled with
dual-column labeling.
Another comment noted that inconsistencies in nutrition label
formats could result from the use of single- and dual-column labeling
for similar products which could lead to consumer confusion and make it
difficult for consumers to compare identical products that may contain
200 percent or more of the RACC and use a dual-column label with
single-serving container products that use a single-column label (e.g.,
19 oz, 24 oz, and 40 oz products of identical formulation). The comment
said that these products are often merchandised side-by-side in
supermarkets and asserted that the
[[Page 34007]]
presence of two different serving sizes and two different formats
(dual-column labeling for the 19 and 24 oz product versus single-column
labeling for 13 and 15 oz products) would confuse the consumer.
We also received a comment requesting that we allow voluntary dual-
column labeling for products that contain more than 150 and less than
200 percent of the RACC to present nutrition information per serving
and per common household measure closest to the RACC. The comment noted
that under the proposed rule, such products would be single-serving
containers and would be required to declare nutrition information on a
``per container'' basis (proposed Sec. 101.9(b)(6)). The comment
asserted that it would be appropriate to provide nutrition information
on a ``per container'' basis for these products but noted that some
consumers may not eat the entire container in one sitting. The comment
suggested that some consumers would find it helpful to have nutrition
information on the label for an amount of food that approximates or is
closest to the RACC.
One comment noted that it is a common practice for retailers to
create a private label product with a ``slightly lower'' net content.
In these instances, consumers would compare a brand name product to a
private label product with a slightly lower net content and think the
private label brand has a better nutritional profile than the brand
name. The comment stated that this is because consumers would fail to
understand that the nutritional difference is a result of the
difference in net contents between the two products, not the actual
nutritional value.
(Response 12) We recognize that certain differences will appear on
product labels between the amounts of nutrients per serving listed on
products that contain close to, but less than, 200 percent of the RACC,
and products that contain 200 percent of the RACC or more. Allowing
products that contain less than 200 percent of the RACC to voluntarily
display an additional column with nutrition information per common
household measure that most closely approximates the reference amount
will allow consumers to easily compare the nutrition information of
products containing more than 150 percent but less than 200 percent of
the RACC with products that contain 200 percent of the RACC or more.
Therefore, we are amending Sec. 101.9(b)(6) to add a provision that
allows manufacturers of products that contain more than 150 percent and
less than 200 percent of the applicable reference amount to voluntarily
add a second column of nutrition information to the left of the column
that provides nutrition information per container (i.e., per serving)
that will provide nutrition information per common household measure
that most closely approximates the reference amount. This provision
will allow consumers to compare more easily the nutrition information
amongst similar products that are packaged in containers that are near
200 percent of the RACC by allowing manufacturers to use a similar
dual-column label format. This voluntary labeling provision is not
limited to large-RACC products, but is permitted for all products that
are packaged and sold individually in containers that are more than 150
percent and less than 200 percent of the RACC.
With regard to the concern that products of nearly identical size
could appear to have significantly different amounts of nutrients per
serving due to the fact that some products could be required to be
labeled as a single serving while similar products could be labeled as
having two servings, we note that the dual-column labeling requirements
(see section III.C.) will help ensure that consumers have the
opportunity to compare the nutritional information for the package as a
whole for products containing at least 200 percent and up to and
including 300 percent of the RACC with the serving size for those
products containing just under 200 percent of the RACC.
To address the comment that stated that a lower net content in some
product manufacturing would cause consumers to think that a certain
product has a better nutritional profile than another, we note that the
nutrition information that is provided on these products would still be
accurate. If the net content is lower, the amount of product a person
is likely to consume is also lower, which is reflected in the nutrition
information on the label.
(Comment 13) We received numerous comments that supported the
removal of the exemption for large-RACC products from the definition of
a single-serving container. These comments stated that products
containing less than 200 percent of the RACC are likely to be consumed
in a single eating occasion and should be labeled as a single serving.
Several comments opposed the removal of language from Sec.
101.9(b)(6), which gives manufactures the flexibility to label large-
RACC products that contain more than 150 percent but less than 200
percent of the RACC as 1 or 2 servings, or to label packages that
contain 200 percent or more of the applicable RACC as a single serving
if the contents of the entire package can reasonably be consumed at a
single eating occasion. The comments stated that eliminating this
option takes away a manufacturer's flexibility and asserted that
manufacturers are in the best position to determine if a product should
be labeled as one or two servings. Other comments stated that labeling
products with less than 200 percent of the RACC as one serving may not
be appropriate for all foods. For example, several comments stated that
some side dishes, such as frozen potato products, frozen vegetables,
and macaroni and cheese kits, are consumed in smaller quantities than
entr[eacute]e items, and a consumer could not reasonably consume an
amount close to 200 percent of the RACC.
A few comments objected to requiring products that were previously
labeled as two servings to be labeled as one serving and asserted there
was no change in consumption data. Other comments did not like the
``one size fits all'' approach and suggested that we look at actual
usage of each product category before requiring that a product be
labeled as a single serving. One comment noted that labeling products
that are regulated by FDA and the USDA, such as chili, soup, stews, and
several mixed dishes that often come in 15 oz cans (425 g), as a single
serving would be a shift from the industry standard of labeling cans of
this size as containing ``about 2 servings.''
(Response 13) We disagree with the comments opposing the removal of
the option of large-RACC products (i.e., those products with an RACC of
100 g or 100 mL or larger) that contain more than 150 percent but less
than 200 percent of the RACC to be labeled as one or two servings. We
also disagree with the assertion that there has been no change in
consumption data since 1993. We stated in the 1993 serving size final
rule that we agreed with the comments that the 200 percent cutoff level
may be too high for some products with large RACCs. Further, we stated
that the reference amounts of these products are very large compared to
many other products, and examination of food consumption data showed
that the average variability (defined as the standard deviation as a
percent of the mean) in the amount customarily consumed for foods
having a reference amount of 100 g (or mL) or larger is about two-
thirds of the variability for foods having a reference amount less than
100 g (58 FR 2229 at 2233). In other words, in 1993, we concluded that
it was much less likely that a person would consume approximately twice
the reference amount of a food with a
[[Page 34008]]
reference amount of 100 g (or mL) or more, than it was that he or she
would consume approximately twice the reference amount of a food with a
smaller reference amount. Therefore, in the 1993 serving size final
rule, we concluded that, for those products that have large RACCs, 150
percent may be a reasonable cutoff for a single-serving container (58
FR 2229 at 2233).
However, as discussed previously in this document, in developing
the proposed rule, we examined the correlation between the consumption
variation and the RACCs for all products containing less than 200
percent of the applicable RACC, including the products with large RACCs
and products that have RACCs that are less than 100 g (or mL), using
combined consumption data from the NHANES 2003-2008 surveys (Ref. 9).
The result shows that the correlation coefficient is 0.13, which means
that there is a low correlation between the RACCs (whether the
reference amount is more than or less than 100 g or mL) and the
consumption variation for all products containing less than 200 percent
of the RACC, regardless of whether the RACC is ``large.'' In other
words, it is not less likely that a person would consume approximately
twice the reference amount of a food with a large RACC than it is that
he or she would consume approximately twice the reference amount of a
food with a smaller reference amount. Therefore, we determined that the
exemption from the requirement to label a product with a large RACC
that contains more than 150 percent but less than 200 percent of the
applicable RACC as a single-serving container is no longer warranted.
We are also working with USDA to harmonize our regulations.
In response to the comments that stated that we are reducing the
flexibility of our regulations, although we work to increase the
flexibility of our regulations when appropriate, the purpose of this
option was not to allow manufacturers the ability to make a choice, but
to allow for foods to be labeled in a way that reflects how much a
person is consuming a certain product. Our decision to remove this
option is based on the data indicating that consumers are consuming the
same amount of large-RACC products in proportion to the RACC as they
are of smaller-RACC products in proportion to the RACC.
To address the comments that stated that not all foods that are
less than 200 percent of the RACC should be considered a single
serving, we reiterate that research demonstrates that package and
portion sizes tend to have a considerable impact on the amount of food
consumed (Refs. 10 and 11). We also note that we did not propose to
change the upper limit for the definition of a single serving container
in the serving size proposed rule. Additionally, as explained in
comment 12, we are amending Sec. 101.9(b)(6) to allow manufacturers of
products that contain more than 150 percent and less than 200 percent
of the applicable reference amount to voluntarily add a second column
of nutrition information to the left of the column that provides
nutrition information per container, which will provide nutrition
information per common household measure that most closely approximates
the reference amount.
(Comment 14) Some comments stated that requiring products that were
previously labeled as two servings to be labeled as one serving would
encourage consumers to eat more. One comment asserted that the
information on the label of a single-serving container could discourage
consumption of a particular food product due to the quantity of a
specific nutrient in the container or other information about the
product, while on the whole that product could provide valuable
nutrients in the diet. The comment gave an example of a frozen
entr[eacute]e that may be high in saturated fat, yet be a good source
of protein, dietary fiber, and potassium. The comment stated that, if
consumers were to focus only on the saturated fat content of the
product, they may choose not to eat the frozen entr[eacute]e, even
though it is a good source of other essential nutrients.
(Response 14) As noted previously, research demonstrates that
package and portion sizes tend to have a considerable impact on the
amount of food consumed (Refs. 10 and 11). We acknowledge that certain
consumers may pay attention to specific, individual nutrients, but one
of the main goals of nutrition labeling is to provide consumers with
accurate nutrition information to assist them in maintaining healthy
dietary practices. If a product is high or low in a specific nutrient
for which an individual consumer is looking to either increase or
decrease intake, this information is useful to consumers who are
interested in the specific nutrient. Consumer education on
understanding the Nutrition Facts label and the diet can be used to
help explain the benefits and risks associated with the intake of
nutrients. Additionally, for products that satisfy the requirements to
make a nutrient content claim such as a ``good source'' claim (see 21
CFR 101.54), the product may include such a claim to draw attention to
the positive attributes of the product.
C. Dual-Column Labeling
Preexisting Sec. 101.9 provides various provisions for types of
voluntary dual-column labeling (e.g., paragraphs (b)(10), (e), and
(h)(4)) and one provision for mandatory dual-column labeling under
certain circumstances (paragraph (b)(11)). In comment 10 we discuss a
revision in this final rule to the voluntary dual-column labeling
provision in Sec. 101.9(b)(10)(ii), which broadens the scope of the
provision to allow dual-column labeling per unit for single-serving
products. Also, in comment 12 we discuss a new voluntary provision for
dual-column labeling for products that are packaged in containers that
include more than 150 percent but less than 200 percent of the RACC, in
Sec. 101.9(b)(6).
In the preamble of the proposed rule (79 FR 11989 at 11998 to
11999), we cited research that shows that dual-column labeling with the
nutrition information given per serving and per package may help
certain consumers recognize nutrient amounts per package in certain
types of packaged foods (Refs. 14 and 15). In the preamble of the
proposed rule (79 FR 11989 at 11999), we also discussed consumer
research that we conducted to help increase our understanding of
whether modifications to the label format may help consumers use the
label. Our study compared participants' ability to perform various
tasks, such as evaluating product healthfulness and calculating the
number of calories and other nutrients per serving and per container,
when using the current label versus modified versions of the current
label. The main findings from this study are that the availability of
single-serving-per-container labels and dual-column labels resulted in
more participants correctly identifying the number of calories per
container and the amount of other nutrients per container and per
serving compared to single-column labels that listed two servings per
container.
The proposed rule would require, under certain circumstances, the
use of dual-column labeling to provide nutrition information per
serving and per container (proposed Sec. 101.9(b)(12)(i)), or per
serving and per unit of food (proposed Sec. 101.9(b)(2)(i)(D)). As
noted in the preamble of the proposed rule, such dual-column labeling
will provide nutrition information for those who consume the entire
container in one eating occasion as well as those who consume the
container over multiple
[[Page 34009]]
eating occasions or share the container with others (79 FR 11989 at
12003).
In the preamble of the proposed rule we stated that to determine an
upper limit for the range of package sizes for which dual-column
labeling would be required, we looked at food consumption data from
NHANES 2003-2008 surveys (Ref. 16) (79 FR 11989 at 12003). The intake
distribution per eating occasion for each product showed that for
almost all products, regardless of the amount of the RACC, the ratio of
the intake at the 90th percentile level to the RACC was 400 percent or
less. Therefore, we determined that dual-column labeling for packages
containing at least 200 percent of and up to and including 400 percent
of the RACC would capture the most frequent consumption habits for
almost all product categories. Conversely, the data show that products
that contain more than 400 percent of the current RACC are less likely
to be consumed in one eating occasion compared to products that contain
400 percent or less of the current RACC. Therefore, we proposed dual-
column labeling to be required for all packages that contain at least
200 percent of and up to and including 400 percent of the applicable
RACC (proposed Sec. 101.9(b)(12)(i)).
In the preamble of the proposed rule (79 FR 11989 at 12004) we
requested comment on exemptions from dual-column labeling for products
that require further preparation, such as macaroni and cheese kits,
pancake mixes, pasta products, and for products that are commonly
consumed in combination with other foods (e.g., cereal and milk), and
that contain at least 200 percent and up to and including 400 percent
of the applicable RACC. Under our regulations, nutrition information
for these types of products may be presented for two or more forms of
the same food (e.g., both as ``purchased'' and ``prepared'') (Sec.
101.9(e)). Some of these products voluntarily contain two columns of
nutrition information on the ``as purchased'' and ``as prepared'' forms
of the food. Therefore, we tentatively concluded in the proposed rule
that these types of products that require further preparation and
voluntarily include two columns of nutrition information on the ``as
purchased'' and ``as prepared'' forms of the food, and for products
that are commonly consumed in combination with other foods (e.g.,
cereal and skim milk) (Sec. 101.9(h)(4)) should be exempt from the
dual-column labeling requirements.
In Sec. 101.9(b)(12)(ii) we proposed to require that if a health
or nutrient content claim is made on the label of a product that uses
dual-column labeling, as would be required under proposed Sec.
101.9(b)(12)(i) and (b)(2)(i)(D), the claim would be required to be
followed by a statement that sets forth the basis on which the claim is
made if the product qualifies for the claim based on the amount of the
nutrient per RACC and not the amount in the entire container or unit of
food (e.g., for nutrient content claims, ``good source of calcium'' ``a
serving of __oz. of this product contains 150 mg of calcium'' or, for
health claims, ``A serving of __ounces of this product conforms to such
a diet'').
As noted previously in the introduction to section III.B., we also
proposed to remove the text in preexisting Sec. 101.9(b)(2)(i)(D),
which states that if a unit weighs 200 percent or more of the RACC, the
manufacturer may declare one unit as the serving size if the entire
unit can reasonably be consumed in one eating occasion. Proposed Sec.
101.9(b)(2)(i)(D) states that if a unit weighs at least 200 percent and
up to and including 400 percent of the applicable reference amount, the
manufacturer must provide an additional column within the Nutrition
Facts label that lists the quantitative amounts and percent DVs for the
individual unit, as well as the preexisting columns listing the
quantitative amounts and percent DVs for a serving that is less than
the unit (i.e., the serving size derived from the RACC).
1. General Comments on Dual-Column Labeling
(Comment 15) We received several comments in support of the dual-
column labeling requirements as proposed. The comments stated that
because consumers may eat a full package of food regardless of its
serving size, those consumers must be able to easily understand the
nutrition content of the full package of food as consumed. A few
comments stated that consumers who might otherwise simply assume that
the Nutrition Facts label applies to the entire package would see, at a
glance, that the nutrition information for the entire package is
considerably greater than the serving size. These comments stated that
seeing two sets of nutrition information per serving and per container
could prompt people to think about the portion size they are consuming.
Some comments mentioned specific food product categories that they
thought would be ideal for dual-column labeling because they are
sometimes consumed by a single person in one eating occasion and
sometimes eaten over multiple meals or by multiple people. The products
mentioned in the comments included pints of ice cream, frozen pizzas,
main entr[eacute]es, side dishes, frozen vegetables, bags of chips,
large candy bars, snack foods, cookies, and 20 oz sodas.
(Response 15) We agree that dual-column labeling will help
consumers more easily understand the contents of a particular package
both on a per-serving and per-container basis. As discussed in the
introduction to section III.C., research suggests that dual-column
labeling helps consumers understand the amount of nutrients in an
entire container of food. The foods that were listed in the comments as
being appropriate for dual-column labeling are similar to the foods
that were mentioned in the April 4, 2005, Advance Notice of Proposed
Rulemaking (ANPRM) entitled ``Food Labeling: Serving Sizes of Products
that Can Reasonably Be Consumed At One Eating Occasion; Updating of
Reference Amounts Customarily Consumed; Approaches for Recommending
Smaller Portion Sizes'' as foods that consumers thought were single
servings, but were really multiple servings (70 FR 17010 at 17013). To
the extent these comments suggest that the requirements relating to
dual-column labeling should apply only to certain types of products, we
disagree. This issue is addressed in our response to comment 19.
(Comment 16) We received several comments that opposed the
additional wording that we proposed to require in Sec.
101.9(b)(12)(ii) if a health or nutrient content claim is made on a
product containing a dual-column label. The comments asserted that the
proposed statements are too lengthy and unnecessary, would clutter the
label and take focus away from information in the claim, and would
create inconsistency across package sizes. The comments asserted that
there is no consumer research to establish that nutrient content claims
on dual-column labels present the potential for consumer confusion
(i.e., without the ``basis'' language), that consumers would believe
that the claims are based on an entire container in the event dual-
column labeling were used, or that the proposed language would assist
consumers in understanding the basis for the claim. The comments
further questioned whether we had an adequate legal basis for requiring
the proposed explanatory statement and noted that there is a current
regulation that allows for indicating the basis of a claim if the claim
is not based on the RACC. A few comments indicated that if some type of
[[Page 34010]]
statement becomes necessary, then it should be very simple and short,
such as the addition of ``per serving'' or ``per X oz. serving.'' We
received one comment in support of the statement as proposed. We
received one comment that requested we limit the qualifying statement
to nutrient content claims about the absence of a nutrient (e.g., low
fat), as when these type of claims are made on products that include a
dual-column label, the product would only meet the criteria for the
claim on the basis of the RACC and per labeled serving, but not the
entire container.
(Response 16) We do not agree that a statement explaining the basis
of a nutrient content claim or health claim, as described in proposed
Sec. 101.9(b)(12)(ii), is always unnecessary. Because the use of dual-
column labeling per serving and per container will become more
prevalent on food labels, consumers will more often encounter nutrition
claims on foods with dual-column labeling. When consumers encounter a
nutrient content claim or health claim (e.g., low fat) and are also
presented with two sets of nutrition information (i.e., per serving
information and per container information), and the criteria for the
claim would only be met based on the set of nutrition information that
does not apply to the entire container or unit, as applicable,
explanation is needed to avoid consumer deception and clarify which set
of nutrition information the claim applies to. When the claim relates
to the nutritional information presented in one column, but not the
other, the possibility for consumer deception is self-evident. Due to
the expected use of nutrient content claims and health claims on
products using dual-column labeling, we want to ensure that consumers
understand the basis on which the claim is made. We are authorized to
prohibit claims that are false or misleading under sections 403(a) and
201(n) of the FD&C Act. See also Cent. Hudson Gas & Elec. Corp. v.
Public Serv. Comm'n, 447 U.S. 557, 593 (1980) (explaining that ``false
and misleading commercial speech is not entitled to any First Amendment
protection''). Current provisions for claims require a manufacturer to
communicate if a product meets the criteria for a nutrient content
claim or health claim only on the basis of the reference amount (e.g.,
a product with a serving size of 2 cookies weighing 35g, but that only
meets the criteria for a nutrient content claim based on the 30 g RACC
for cookies) (Sec. 101.12(g)), but there are currently no provisions
which require a claim to explain which set of nutrition information it
is based on in the context of dual-column labeling. When a nutrient
content claim or health claim is made on a package that does not use
dual-column nutrition labeling, consumers are provided with only one
set of nutrition information (based on the serving size) in the
Nutrition Facts label to associate with the claim. In the case of dual-
column labeling, however, consumers are presented with two sets of
nutrition information and would not be able to determine which set of
data to associate with the claim. Therefore, in order to help consumers
understand the context of the claim, there is a need for a provision
requiring a statement that sets forth the basis on which the claim is
made under certain circumstances when dual-column labeling is presented
on the product label.
We agree, however, that the proposed statements could be lengthy.
The comments provided examples of concise language that could accompany
nutrient content claims and still meet the objective of indicating the
basis of the claim. We agree that, when possible, shorter clarifying
statements on the food label are preferable and that more concise
language than that in proposed Sec. 101.9(b)(12)(ii) is available for
nutrient content claims. Therefore, for nutrient content claims, Sec.
101.9(b)(12)(ii) requires manufacturers to state that the claim refers
to the amount of a nutrient per serving or per reference amount but
allows the use of simpler language to explain the basis on which
nutrient content claims are made per serving (e.g., ``good source of
calcium per serving'' or ``per X [insert unit]__serving'') or per
reference amount (e.g., ``good source of calcium per [insert reference
amount (e.g., per 8 ounces)]''), as required based on Sec. 101.12(g).
For health claims, no examples of more concise language were provided
in comments to the proposed rule, and upon further evaluation of the
explanatory statement provided in the proposed rule (i.e., ``A serving
of __ounces of this product conforms to such a diet''), we believe that
the statement is as concise as possible to convey the intended message.
Health claims, as opposed to nutrient content claims, already
frequently require informational statements related to the substance of
the claim, the disease condition, and/or the target populations.
Therefore, we conclude that the statement related to the basis of the
claim, as proposed, is an appropriate statement to include with health
claims, is consistent with other types of accompanying statements to
health claims, and is as concise as needed for the intended message.
With regard to the assertion that the additional wording that we
proposed to require in Sec. 101.9(b)(12)(ii) if a health or nutrient
content claim is made on a dual-column label would create inconsistency
across package sizes, we note that distinctions already may arise among
products of different sizes with regard to which package sizes are
eligible to bear a nutrient content or health claim. Claims are
typically based on the RACC, but in some cases they are based on both
an RACC and a per label serving size. Existing requirements may already
result in differences in the eligibility of a food packaged in
different forms (e.g., bulk package versus individual serving packages)
to bear a specific claim. Likewise, differences exist with regard to
the ability of products to make nutrient content or health claims
because of the variety of possible size options (e.g., one very large
cookie versus an individual serving container of small cookies).
With regard to the comment that suggested the requirement to
include the qualifying statement should be limited to nutrient content
claims about the absence of a nutrient, we disagree with establishing a
limitation based on the specific claim at issue (e.g., low fat) but
agree with the comment to the extent that it suggests that the
qualifying statement should not be required on product labels when the
product would meet the criteria to make the claim at issue based on
both columns of nutritional information. We agree, for example, that if
a product for which dual-column labeling would be required under Sec.
101.9(b)(12)(i) were to contain sufficient vitamin C per serving to
make a ``high'' claim regarding vitamin C content, and the container as
a whole were to meet the criteria for a ``high'' in vitamin C claim,
consumers are not likely to be misled by the presence of such a claim
in the absence of a qualifying statement. The language in proposed
Sec. 101.9(b)(12)(ii) already provides an exception from the
requirement for products when the nutrient that is the subject of the
claim meets the criteria based on the entire container or unit amount.
We have modified that language in the final rule to explain that a
clarifying statement is not required for products when the nutrient
that is the subject of the claim meets the criteria for the claim based
on the reference amount for the product and the entire container or the
unit amount.
(Comment 17) One comment questioned our legal authority to require
dual-column labeling. The comment
[[Page 34011]]
stated that section 403(q)(1)(A)(i) of the FD&C Act requires nutrition
information to be provided on the basis of an amount customarily
consumed and which is expressed in a common household measure that is
appropriate to the food. The comment stated that the quantity of
nutrients in a package or unit that contains at least 200 percent and
up to and including 400 percent of the RACC is not an amount
customarily consumed and that none of the exemptions stated in the NLEA
give us the authority to require nutrition information to be declared
on the basis of an amount other than the serving size.
(Response 17) We disagree with the suggestion that we lack the
legal authority to require dual-column labeling. The mandatory dual-
column label will continue to provide nutrition information based on
the labeled serving size, which is the amount that is customarily
consumed. As explained previously in section II.B., the primary legal
authority for requirements pertaining to the labeled serving size is
derived from section 403(q)(1)(A) of the FD&C Act, with additional
authority coming from section 2(b)(1)(B) of the NLEA. Additionally, the
legal authority for the second column in a dual-column label is derived
from section 2(b)(1)(A) of NLEA, which states that requirements in
regulations issued under the authority of the NLEA shall ``be conveyed
to the public in a manner which enables the public to readily observe
and comprehend such information and to understand its relative
significance in the context of a total daily diet'' (79 FR 11989 at
11991). As explained previously in section III.C. and in the preamble
to the proposed rule (79 FR 11989 at 11999), consumer research shows
that the availability of dual-column labels results in more
participants correctly identifying the number of calories per container
and the amount of other nutrients per container compared to single-
column labels that listed two servings per container. Additional
authority for the dual-column labeling requirements includes section
701(a) of the FD&C Act, which provides us with authority to issue
regulations for the efficient enforcement of the FD&C Act.
(Comment 18) One comment asserted that we failed to consider
certain First Amendment concerns associated with the proposed dual-
column labeling requirements. The comment asserted that the purpose of
dual-column labeling is to shape consumer behavior rather than to
provide purely factual information, and that we justified our proposal
to require dual-column labeling based on a study that concluded that
dual-column labeling reduces snack food consumption when compared to
single-column labeling for people who are not currently dieting. The
comment stated that by explaining that we would continue to conduct
consumer research throughout the rulemaking process to help enhance our
understanding of whether and how much any modifications to the label
format may help consumers use the label, we impliedly conceded the
insufficiency of our reliance on this study in the proposed rule.
The comment further questioned our asserted reliance on statutory
authority granted in section 2(b)(1)(A) of the NLEA in light of our
mandate to implement regulations in accordance with the First
Amendment. The comment asserted that because dual-column labeling ``is
unnecessarily duplicative,'' the dual-column labeling requirement would
be subject to analysis under the standard set forth in Central Hudson
Gas & Elec. Corp. v. Public Serv. Comm'n, 447 U.S. 557 (1980), rather
than Zauderer v. Office of Disciplinary Counsel of Supreme Court, 471
U.S. 626 (1985). The comment asserted that the Supreme Court's decision
in Zauderer and its progeny supports the proposition that the
government may require a clarifying disclosure ``to dissipate the
possibility of consumer confusion or deception'' after finding that the
possibility of deception is ``self-evident,'' id. at 652, and that
mandatory disclosures are not permitted unless the state demonstrates
an actual likelihood that consumers will be misled absent the
disclosure.
The comment asserted that we admitted that the dual-column labeling
requirement attempts to influence consumer behavior by discouraging
consumers from consuming food that is packaged between 200 percent and
400 percent of the RACC. The comment stated that we failed to establish
that dual-column labeling would serve a substantial government interest
in discouraging consumption of food that is packaged between 200
percent and 400 percent of the RACC. The comment further asserted that
we failed to establish in the proposed rule that dual-column labeling
would have a discernable effect on consumer behavior and, therefore,
that the proposed rule cannot satisfy the third prong of Central Hudson
in that it did not present evidence that dual-column labeling would
directly advance the interest in promoting consumer health and
preventing overconsumption of certain foods. The comment stated that we
rely in part on study results suggesting that dual-column labeling
reduces snack food consumption but asserted that we failed to consider
the effect of dual-column labeling on consumption of other categories
of food besides snacks. According to the comment, we inexplicably
concluded, based on studies of ``junk foods'', that consumption of all
foods packaged as RACCs between 200 percent and 400 percent should be
discouraged.
The comment asserted that the dual-column labeling requirement as
proposed is ``vastly overbroad'' and fails to satisfy Central Hudson's
reasonable fit test, in part because we acknowledged in the proposed
rule that modifying the Nutrition Facts label would require some
reeducation on how to read the Nutrition Facts label. The comment
asserted that we failed to adequately consider comments that suggested
that the dual-column format may be confusing and that we erroneously
suggested that the burden is on opponents of the regulation to provide
evidence that dual-column labeling may be confusing.
(Response 18) We recognize the importance of the First Amendment
protections raised in this comment, and we disagree with the assertion
that we neglected to consider such protections in proposing the dual-
column labeling requirements. In Zauderer, the Supreme Court explained
that ``[b]ecause the extension of First Amendment protection to
commercial speech is justified principally by the value to consumers of
the information such speech provides, [a speaker's] constitutionally
protected interest in not providing any particular factual information
in his advertising is minimal.'' 471 U.S. at 651 (emphasis in original)
(internal citations omitted). Requirements ``to make purely factual
disclosures related to . . . business affairs, whether to prevent
deception or simply to promote informational transparency, have a
`purpose . . . consistent with the reasons for according constitutional
protection to commercial speech' . . . [and] facilitate rather than
impede the `free flow of commercial information.' '' Beeman v. Anthem
Prescription Mgmt., 58 Cal. 4th 329, 356 (Cal. 2013) (quoting 44
Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 501 (1996) and Va.
Pharmacy Bd. v. Va. Consumer Council, 425 U.S. 748, 765 (1976),
respectively). As a result, government requirements to disclose factual
commercial information are subject to a more lenient constitutional
standard than that set forth under the Central Hudson framework.
Zauderer, 471 U.S. at 651. Under Zauderer, the government can
[[Page 34012]]
require disclosure of factual information in the realm of commercial
speech as long as the disclosure provides accurate, factual
information; is not unjustified or unduly burdensome; and is
``reasonably relate[d]'' to an adequate interest. Id.
Contrary to the comment's assertion, the validity of the dual-
column labeling requirements under the First Amendment is properly
evaluated under Zauderer, 471 U.S. 626, rather than Central Hudson, 447
U.S. 557. Courts generally apply Zauderer's rational relationship test,
as opposed to intermediate scrutiny under Central Hudson, ``in
compelled commercial disclosure cases'' because ``mandated disclosure
of accurate, factual, commercial information does not offend the core
First Amendment values of promoting efficient exchange of information
or protecting individual liberty interests.'' Nat'l Elec. Mfrs. Ass'n
v. Sorrell, 272 F.3d 104, 114-15 (2d Cir. 2001) (explaining that the
disclosure of accurate, factual commercial information ``furthers,
rather than hinders, the First Amendment goal of the discovery of
truth''). Case law interpreting Zauderer clarifies that the government
need not establish that compelled disclosure will prevent consumer
deception for the Zauderer standard to apply. In American Meat
Institute v. USDA, the court held that ``[t]he language with which
Zauderer justified its approach. . .sweeps far more broadly than the
interest in remedying deception.'' 760 F.3d 18, 22 (D.C. Cir. 2014) (en
banc). In reaching the conclusion that the applicability of Zauderer
extends beyond regulations in which the government is attempting to
mandate a disclosure to remedy deception, the court focused on the
``material differences between disclosure requirements and outright
prohibitions on speech,'' id. (quoting Zauderer, 471 U.S. at 650), the
fact that ``the First Amendment interests implicated by disclosure
requirements are substantially weaker than those at stake when speech
is actually suppressed,'' id. (quoting Zauderer, 471 U.S. at 652 n.14),
and the fact that ``[b]ecause the extension of First Amendment
protection to commercial speech is justified principally by the value
to consumers of the information such speech provides, [a]
constitutionally protected interest in not providing any particular
factual information in his advertising is minimal,'' id. (citing
Zauderer, 471 U.S. at 651). The court found that, ``[a]ll told,
Zauderer's characterization of the speaker's interest in opposing
forced disclosure of such information as `minimal' seems inherently
applicable beyond the problem of deception.'' Id. Several other
circuits concur. See Pharm. Care Mgmt. Ass'n v. Rowe, 429 F.3d 294,
297-98, 310, 316 (1st Cir. 2005); N.Y. State Rest. Ass'n v. N.Y. City
Bd. of Health, 556 F.3d 114, 133 (2d Cir. 2009); Nat'l Elec. Mfrs.
Ass'n v. Sorrell, 272 F.3d 104, 115 (2d Cir. 2001) (affirming use of
the ``reasonable-relationship'' Zauderer standard when ``the compelled
disclosure at issue . . . was not intended to prevent `consumer
confusion or deception'''); Discount Tobacco City & Lottery, Inc. v.
United States, 674 F.3d 509, 556 (6th Cir. 2012) (holding that
``Zauderer's framework can apply even if the required disclosure's
purpose is something other than or in addition to preventing consumer
deception''); CTIA--The Wireless Ass'n[supreg] v. City of Berkeley, No.
C-15-2529, 2015 U.S. Dist. LEXIS 126071, at *46 (N.D. Cal. 2015)
(holding that Zauderer is not ``limited to preventing consumer
deception'' and explaining that ``it would make little sense to
conclude that the government has greater power to regulate commercial
speech in order to prevent deception than to protect public health and
safety'').
The dual-column labeling requirements readily satisfy the Zauderer
test. First, the proposed dual-column labeling provisions, which are
being finalized in this rule, require accurate disclosures of factual
commercial information. The required disclosure will help facilitate
the free flow of commercial information and does not ``prescribe what
shall be orthodox in politics, nationalism, religion, or other matters
of opinion.'' Zauderer, 471 U.S. at 651 (quoting W. Va. State Bd. of
Educ. v. Barnette, 319 U.S. 624, 642 (1943)). The comment did not
dispute the accuracy of the information at issue.
Second, the dual-column labeling requirements would not be unduly
burdensome. Factual nutrition information is currently required to be
provided on packaged foods. While dual-column labeling will require
more space on certain packages for factual nutrition information, the
majority of the label space on products subject to the dual-column
labeling requirements will still be available for product messaging by
the manufacturer. We also note that, as discussed in our economic
analysis (Ref. 17), the cost to manufacturers is relatively low under
the compliance timelines in the final rule which will allow most
manufacturers to add dual-column labeling during regularly scheduled
label changes for their products. Additionally, this final rule reduces
from the proposed rule the amount of products for which dual-column
labeling will be required, as we are lowering the upper limit for which
dual-column labeling is required from those containers weighing up to
400 percent of the RACC to those containers weighing up to 300 percent
of the RACC. Furthermore, certain packages for which dual-column
labeling would require a greater proportion of the label space are
exempt from these requirements. For example, under Sec.
101.9(b)(12)(i)(A), the dual-column labeling requirements in Sec.
101.9(b)(12) do not apply to products that meet the requirements to
present the Nutrition Facts label using the tabular format under
current Sec. 101.9(j)(13)(ii)(A)(1) or the linear format under current
Sec. 101.9(j)(13)(ii)(A)(2).
Third, the requirement to provide dual-column labeling is
reasonably related to the Government's interests in promoting the
public health and providing consumers access to factual information
that will help them understand the nutrient content on certain packages
that contain more than one serving of food. The factual information
could be used to assist consumers in maintaining healthy dietary
practices. Recent NHANES data shows that products containing up to and
including 300 percent of the RACC could reasonably be consumed in a
single eating occasion. Additionally, our research demonstrates that
some consumers may have difficulties determining nutrition information
per container when a label declares that the package contains more than
one serving and is reasonably consumed in a single eating occasion. Our
recent format experimental study, however, showed that, in the case of
a proposed label with percent DVs listed on the left of the label,
dual-column labeling improved the percentage of participants that were
able to identify correctly the amount of nutrients in the entire
container. In addition, our recent eye-tracking study showed
participants both the current and proposed format of the Nutrition
Facts labels, with one label showing one serving and the other two
servings. Only about half of the participants noticed the number of
servings on the label, and less than one third of the participants were
able to identify which product contained fewer calories per container
(Refs. 18 and 19). These results suggest that some consumers may not
correctly recognize the accurate nutrient contents of packages
containing more than one serving, including packages that may be
consumed in a single eating occasion,
[[Page 34013]]
and therefore may not be able to use the label information to assist
them in maintaining healthy dietary practices.
The dual-column labeling requirement is reasonably related to the
Government's interest in enhancing consumer understanding of nutrient
packaging and promoting the public health because it presents nutrition
information in a manner that is easy to understand, giving consumers
helpful tools to assist them in maintaining healthy dietary practices.
As noted previously, our research shows that some consumers have
difficulty determining the nutrient amounts in packages that contain
more than one serving of food and that do not display the nutrient
content of the entire package on the product label. Dual-column
labeling helps to ensure that consumers have access to nutrient
information for containers of certain sizes that could reasonably be
consumed in a single eating occasion and therefore could assist
consumers in maintaining healthy dietary practices.
The comment incorrectly asserts that the purpose of the proposed
dual-column labeling requirements is to shape consumer behavior by
discouraging consumption of food in containers that weigh between 200
percent and 400 percent of the reference amount. As explained in the
proposed rule (see 79 FR 11989 at 12003), and as reiterated in this
final rule, the purpose of dual-column labeling is not to discourage
the consumption of certain foods but rather to increase consumer
understanding of the quantity of nutrients in packages and containers
of certain sizes that may be reasonably consumed in a single eating
occasion. The reference provided in the proposed rule to a study that
showed a reduction in snack food consumption amounts was included for
the purpose of demonstrating that dual-column labeling could raise
contextual awareness of the quantity of nutrients in a given container.
While the reduction in the consumption amounts for certain products
could potentially be associated with dual-column labeling, such changes
in consumption are not the purpose of the requirement. Our findings,
both as reported in the proposed rule and as explained previously in
this final rule, demonstrate that the presence of dual-column labeling
could help consumers understand the quantity of nutrients they are
actually consuming if they consume the entire package in one eating
occasion. Consumption data further shows that it is reasonably likely
that some consumers will consume, in a single eating occasion, the
entire container of products containing at least 200 percent and up to
and including 300 percent of the RACC. We therefore disagree with the
assertion that the dual-column labeling requirement ``is unnecessarily
duplicative'' or that our reliance on the statutory authority granted
in section 2(b)(1)(A) of NLEA conflicts with our obligation to
promulgate regulations consistent with the protections granted by the
First Amendment. Additionally, as discussed in the preamble to the
proposed rule (79 FR 11989 at 11998), there is evidence that consumers
do not correctly calculate nutrient amounts in food products by
multiplying the nutrient amount by the number of servings per
container, and research shows that dual-column labeling can help
consumers more accurately determine the number of calories and
nutrients in a food product compared to single-column labeling (Ref.
15). In short, dual-column labeling provides consumers with information
that can assist them in maintaining healthy dietary practices.
While we disagree that the Central Hudson standard would be
applicable to the requirement to provide a second column of nutrition
information, the requirement to provide dual-column labeling would
nonetheless be Constitutional under the standard set forth in Central
Hudson, 447 U.S. 557. If the Central Hudson standard were applicable to
the evaluation of the dual-column labeling requirement, we would be
required to identify a ``government interest [that] is substantial,''
establish that ``the regulation directly advances the government
interest asserted,'' and show that the regulation ``is not more
extensive than is necessary to serve that interest.'' Id. at 566. Under
the Central Hudson test, we have the discretion to ``judge what manner
of regulation may best be employed'' to serve the substantial
government interest. See City of Cincinnati v. Discovery Network, Inc.,
507 U.S. 410, 416 n.12 (1993) (citing Bd. of Trs. v. Fox, 492 U.S. 469,
480 (1989)).
There can be no question that the government has a substantial
interest in promoting the health of its citizens. E.g., Rubin v. Coors
Brewing Co., 514 U.S. 476, 485 (1995). Our asserted interests are in
promoting the public health and ensuring consumer access to information
that could assist in maintaining healthy dietary practices. These
interests are substantial because the consumption of excess and limited
amounts of certain nutrients is linked to risk of chronic disease.
Dual-column labeling directly advances our asserted interests in
promoting the public health and ensuring that consumers have access to
information that could assist in maintaining healthy dietary practices.
Our research shows that providing a second column of nutrition
information on containers of certain sizes provides consumers
information that allows them to understand the nutrient content of
packaged foods. We disagree that our decision is based on ``mere
speculation or conjecture.'' See Rubin, 514 U.S. at 487. Our conclusion
that dual-column labeling helps consumers understand the nutrient
content of packaged foods when a label declares the package contains
more than one serving and is reasonably consumed in a single eating
occasion is supported by the consumer research cited throughout this
document (Refs. 13 and 17).
Finally, the requirement to provide a second column of nutrition
information is no more extensive than necessary to serve its purpose.
See Central Hudson, 447 U.S. at 566. The standard is not a ``least
restrictive means'' test, and instead requires a reasonable fit between
the ends and the narrowly tailored means chosen to accomplish those
ends. Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 556 (2001). The
dual-column labeling requirement requires only factual disclosures of
information about the nutrient content of products, and the required
disclosure is limited to the information that we have determined is
necessary to assist consumers in maintaining healthy dietary practices.
The required disclosure is confined to one area of the food label and
will enable consumers to understand the information in the Nutrition
Facts label. Overall, this additional factual disclosure is limited in
scope, and there are not ``numerous and obvious less-burdensome
alternatives'' to this requirement. See Discovery Network, 507 U.S. at
418 n. 13. In our research we looked at labels that provided a second
column only for calories. Our research showed that this type of label
was not as effective as providing a full second column of information
about all nutrients listed on the Nutrition Facts label because
different consumers are mindful of distinct nutrients and because the
nutritional benefits of a product does not depend on a limited number
of nutrients only. For example, some consumers need to ensure adequate
consumption of specific vitamins or minerals, while others are
concerned about protein intake. Full, dual-column nutritional
information is more helpful to consumers and does not suggest that
consumers should place greater emphasis only on selected nutrients. We
therefore disagree with
[[Page 34014]]
the implication that this requirement is more burdensome than necessary
because it requires the full set of nutritional information in the
second column. Requiring that a second column of nutrition information
appear on the label is a limited requirement that would serve the
purpose of ensuring that consumers have access to information about the
nutrient contents of packages and containers of certain sizes that
could assist consumers in maintaining healthy dietary practices.
We disagree with the comment's assertion that the dual-column
labeling requirement is ``vastly overbroad,'' which the comment asserts
is demonstrated by our intent to conduct consumer education once the
rule is finalized. Such education efforts are beneficial any time such
a significant change in our regulations is made, and the addition of a
second column of nutrition information is not the sole basis for our
plan to continue to educate consumers. Additionally, as noted
previously, certain packages for which dual-column labeling would
require a greater proportion of the label space are exempt from these
requirements (see Sec. 101.9(b)(12)(i)(A)).
Because the dual-column labeling requirement supports a government
interest that is substantial, directly advances that government
interest, and is no more extensive than is necessary to serve that
interest, the requirement would pass Constitutional scrutiny under
Central Hudson. However, as noted previously in this section, case law
makes clear that Zauderer applies to cases in which the government
mandates the disclosure of factual and accurate disclosures of
commercial information, Zauderer, 471 U.S. at 651, as is the case here.
With regard to other specific issues raised in this comment, we
disagree with the assertion that by explaining that we would continue
to conduct consumer research throughout the rulemaking process we
impliedly conceded the insufficiency of our consumer research cited in
the proposed rule. The consumption data and research cited in the
proposed rule provides sound justification for dual-column labeling.
Additionally, since the publication of the proposed rule, we have
conducted an additional study that corroborates the results discussed
in the proposed rule, i.e., that consumers were more likely to
accurately determine the amount of nutrients shown on a label when
dual-column labeling was used (Ref. 19). We continued to conduct
research throughout the rulemaking process because the Lando and Lo
study used the current format and we wanted to explore whether findings
derived from that study would replicate on a different label format as
outlined in our proposed rule. The subsequent study did, in fact,
replicate the original finding that more consumers were able to
accurately identify the amount of total nutrients shown on a product
label when using the dual-column label, as compared to a single-column
label with multiple servings per container (Ref. 15).
We further disagree with the assertions that we justified our
proposal for dual-column labeling based on one study or that our
conclusions for dual-column labeling are based solely on a study of
snack foods. In addition to the studies discussed in the previous
paragraph, we received a citizen petition and many comments to the
ANPRM from consumers that said that labeling products that were
considered to be single servings as having two or more servings is
``confusing'' and ``misleading.'' We also note that the labels tested
in the Lando and Lo study (Ref. 15), which were also cited in the
proposed rule, included sample Nutrition Facts labels for frozen meals,
which are not considered ``snack foods.'' Dual-column labeling would
require certain containers to display easy-to-understand nutrition
information for the primary ways in which people consume these
products. The studies that were cited in the proposed rule were used as
part of the support for the need for dual-column labeling, not as our
sole justification for dual-column labeling.
Finally, we disagree that dual-column labeling may be confusing to
consumers, that we failed to consider comments that suggested dual-
column labeling may be confusing, and that we have suggested that those
who are looking to challenge the dual-column labeling requirements have
the burden to provide evidence that dual-column labeling may be
confusing. As discussed previously in this document, our research has
shown that single-serving-per-container labels and dual-column labels
resulted in more participants correctly identifying the number of
calories per container and the quantity of other nutrients per
container and per serving compared to two-serving, single-column labels
(such as the current label) (Ref. 19).
2. Dual-Column Labeling Requirements
(Comment 19) We received several comments from manufacturers
objecting to 400 percent of the RACC as the upper limit for mandatory
dual-column labeling.
Several comments suggested that we consider the type of product at
issue in establishing an upper limit. Some of the comments stated that
an upper limit of 400 percent of the RACC was not appropriate for all
product categories. Other comments stated that dual-column labeling
should only be required for certain types of products. A few comments
objected to what they called a one-size-fits-all approach to applying
the dual-column labeling requirements. One comment stated that we
should take into account how people use and consume specific types of
food in establishing an upper limit, such as whether the food is a
snack, an ingredient, or a center-of-plate food in a main meal, and
whether a person is likely to eat more than two servings of food at one
time. Another comment suggested that we reanalyze the data to provide
category-specific RACC upper thresholds for dual-column labeling.
A few comments stated that we should only require dual-column
labeling for product categories of food for which we have data
indicating that a consumer can reasonably consume the entire package of
a product between 200 percent and up to and including 400 percent of
the RACC in one eating occasion. Other comments argued that an upper
limit of 400 percent of the RACC would require dual-column labeling on
foods that are not likely to be consumed in one eating occasion.
Several other comments requested that we require a lower upper
limit for dual-column labeling generally. Some comments stated that
dual-column labeling should only be required for packages up to 250
percent of the RACC, while other comments requested that dual-column
labeling be required for packages up to 300 percent of the RACC.
We received comments that stated that by setting 400 percent as the
upper limit for dual-column labeling, we would create the unintended
consequence of establishing a dual-column labeling requirement for some
products for which a 90th percentile of intake is much lower than 400
percent of the RACC, meaning that such products would be required to
have dual-column labeling on package sizes for which consumption data
shows that people do not reasonably consume the entire amount in one
eating occasion. One example given in comments was for 100 percent
fruit juices such as orange juice. Comments stated that the amount of
fruit juice equal to 400 percent of the RACC would be 32 fl ozs, which
is inconsistent with data showing that the amount of 100 percent fruit
juice consumed at the 90th percentile is 219 percent of the RACC. One
comment
[[Page 34015]]
noted that, based on NHANES 2003-2006 data, the 75th percentile of 100
percent orange juice consumption by adults is 8.8 fl ozs per day (Ref.
20) and for children age 2 to 18 years is 12.5 fl ozs per day (Ref.
21). Comments argued that requiring a dual-column label on a 32-oz
container of orange juice does not represent the amount consumed by the
majority of individuals.
Other examples given in comments of products for which a 90th
percentile of intake is lower than 400 percent of the RACC were fluid
milk and cottage cheese. Comments noted that the intake at the 90th
percentile is 205 percent of the RACC for cottage cheese (226 g or 1
cup) and 181 percent of the RACC for milk (444 g or 14.5 fl oz). Some
comments stated that a quart of fluid milk and a 16-oz container of
cottage cheese are both at 400 percent of the RACC and would be
required to have a dual-column label. Comments stated that labeling
these two product packaging sizes with dual-column labels is
inconsistent with how they are consumed.
Yet another example given in a comment of a product for which the
90th percentile of intake is lower than 400 percent of the RACC was
frozen waffles. The comment described a 12.3 oz 8-pack of waffles where
two waffles equal a serving based on the 85 g RACC. The comment stated
that an 8-pack of waffles would be required to have a dual-column label
listing nutrition information per two-waffle serving and per container.
The comment stated that the 90th percentile intake for waffles is 168
percent of the RACC (about 3 waffles) and that it is difficult to
imagine a consumer eating 8 waffles on one eating occasion.
Other comments asserted the following additional types of foods
have consumption amounts at the 90th percentile that are less than 400
percent of the RACC and therefore are not appropriate for dual-column
labeling: Beverage product categories, frozen potato products, side
dishes, natural cheese in 3.5 oz packages, sausage, nuts, frozen
vegetables, frozen oatmeal, frozen pizza, frozen entr[eacute]es, canned
beans, canned vegetables, canned fruits, 100 percent fruit juices,
veggie ``burger'' patties, and cereal bars.
A few comments stated that they reviewed our data used to support
the decision to use an upper limit of up to and including 400 percent
of the RACC and found that in 84 percent of the food categories
reviewed, average consumption was 299 percent or less of the RACC, and
in 68 percent of categories, average consumption was 250 percent or
less of the RACC. These comments stated that only a small number of
product categories had consumption greater than 300 percent of the
RACC, and those categories, which included wine coolers, fluid cream,
lemon and lime juice, horseradish, and mustard, are not commonly
consumed categories that should drive labeling changes.
Several comments argued that the 90th percentile was too high of an
upper limit to be considered as a reasonably consumed amount and that
the basis for our picking this value was unclear. One comment further
requested that we provide information about the statistical
distribution of these ratios to justify our cutoff of 400 percent.
Other comments asserted that our decision to establish 400 percent of
the RACC as the cutoff for dual-column labeling is arbitrary,
incongruous with most common eating patterns, and could result in
consumer confusion and needless changes for food manufacturers. Another
comment suggested that we use the proposed RACCs, instead of RACCs from
1993, as the basis to compare to 90th percentile of intake.
(Response 19) In the preamble of the proposed rule (79 FR 11989 at
12003), we stated that our review of the intake distribution per eating
occasion for each product showed that for almost all products,
regardless of the amount of the RACC, the ratio of the intake at the
90th percentile level to the RACC was 400 percent or less. Use of the
90th percentile of intake distribution allows us to capture the
substantial majority of consumption amounts per eating occasion (i.e.,
90 percent) for the U.S. population, but this level is not so high as
to impose dual-column labeling requirements on most package sizes for
which consumption data shows that people do not reasonably consume the
entire amount in one sitting.
As noted previously, the purpose of dual-column labeling is to
provide nutrition information for multiple ways in which people are
likely to consume a product. Consumption data show that while some
people eat certain products in a single eating occasion, others eat the
product over time or share it. Dual-column labeling provides nutrition
information for all of these scenarios. To the extent that comments
suggested that dual-column labeling requirements generally would
require needless changes to food labeling for manufacturers to comply
with the dual-column labeling requirement and that the requirements may
result in consumer confusion, we disagree. Dual-column labeling
requirements are not intended to be limited to the single most common
consumption pattern for a particular product. When determining the
criteria for dual-column labeling, we therefore looked at data that
shows how the product is consumed in 90 percent of eating occasions, to
ensure that the requirements would encompass the distinct ways such
products could reasonably be consumed. In the proposed rule we
determined that dual-column labeling for products with 400 percent or
less of the RACC would capture the most frequent consumption habits for
almost all product categories.
We disagree with comments stating that the upper limit for dual-
column labeling should be 250 percent. Eighteen percent of products
have 90th percentile of consumption between 250 percent and 300 percent
of the RACC based on the 1993 RACCs and the proposed RACCs, meaning
that establishing an upper limit of 250 percent would eliminate from
dual-column labeling requirements a significant proportion of products
which data show are reasonably likely to be consumed in a single eating
occasion.
In light of information provided in comments, we examined which
food products have consumption levels at the 90th percentile between
300 percent and 400 percent of the 1993 RACCs and the proposed RACCs.
Our analysis was consistent with those of comments that suggested that
a substantial majority of food products (i.e., more than 90 percent)
have consumption levels that are 300 percent or less of the RACC at the
90th percentile (Ref.16). We agree with comments to the extent they
state that in the substantial majority of the food categories the
average consumption was 300 percent or less of the RACC at the 90th
percentile and that only a small number of product categories had
consumption greater than 300 percent of the RACC at the 90th
percentile. We also agree with comments that stated that setting an
upper limit for dual-column labeling at 400 percent of the RACC could
have the unintended consequence of requiring dual-column labels on
packages for which data shows people do not reasonably consume in a
single eating occasion, such as a quart of milk, a 32 fl oz bottle of
juice, or a 12.3 oz 8-pack of waffles where two waffles equal a serving
based on the 85 g RACC.
In consideration of the information provided in comments and
further evaluation of relevant consumption data compared with the
proposed RACCs, we are lowering the upper limit of dual-column labeling
from 400 percent to 300 percent of the RACC. Providing an upper limit
at 300 percent of the RACC would ensure that dual-column labeling
captures 90 percent of the consumption
[[Page 34016]]
habits for about 91 percent of food products and limit the possibility
that dual-column labeling will be required for package sizes that are
not likely to be consumed in a single eating occasion. As a result of
our decision to lower the upper limit for dual-column labeling from 400
percent to 300 percent, certain products about which comments expressed
specific concerns--such as a quart of milk, a 32 fl oz container of
juice, a 16- oz container of cottage cheese, and a package of waffles
containing 4 servings--would not be required to have a dual-column
label.
In response to those comments that suggested that we consider the
type of product at issue in establishing an upper limit, we decline to
apply different upper thresholds for dual-column labeling or to require
dual-column labeling only for specific product categories. The use of a
uniform upper criterion for all product categories will ensure that
consumers are able to compare nutrition information across various
product types that are packaged in the sizes that we have determined
are reasonably likely to be consumed at one eating occasion or shared
with others. For the same reason, we disagree with those comments that
suggested that dual-column labeling is not appropriate for certain
types of foods and decline to limit the dual-column labeling
requirement to certain types of foods.
In response to the comment that recommended that we use the
proposed RACCs, instead of RACCs from 1993, as the basis to compare to
the 90th percentile of intake, this final rule relies upon both 2003-
2008 consumption data and the 1993 RACCs as a basis to determine the
90th percentile of intake when determining an upper threshold for dual-
column labeling. While the proposed rule used the 1993 RACCs as the
basis to compare to the 90th percentile of intake, we agree that
comparison to the proposed RACCs provides useful information. We have
now reviewed the 90th percentile of intake for the proposed RACCs that
we are finalizing with this rule. A review of this information shows
that almost all of the proposed product categories have a 90th
percentile of consumption that is less than 300 percent of the RACC.
This information is included as a reference to this rule (Ref. 22).
(Comment 20) We received a few comments that stated that dual-
column labeling should be voluntary instead of mandatory. Other
comments suggested that all packages containing 200 percent or more of
the RACC that can be reasonably consumed in a single eating occasion
should be labeled as a single serving instead of using dual-column
labeling.
(Response 20) We disagree with comments that state that dual-column
labeling under Sec. 101.9(b)(12) should be voluntary. As discussed
previously in section III.C., we consider the benefits of dual-column
labeling to the consumer--in particular, ensuring greater consumer
understanding of the package's contents--to be significant enough to
require dual-column labeling for products in containers that meet the
criteria for dual-column labeling. As discussed in response to comment
8, to address the comment that suggested that we require mandatory
listing as a single serving for packages over 200 percent of the RACC
that can be reasonably consumed in a single eating occasion in place of
dual-column labeling, the purpose of dual-column labeling is to provide
label information for products that may be consumed in a single eating
occasion, but can also be shared or eaten in multiple eating occasions.
If these products are labeled as single-serving containers, then they
would not provide nutrition information for all three of these
scenarios. Additionally, as explained in detail previously in section
II.B., under section 403(q)(1)(A)(i) of the FD&C Act, ``serving size''
means the amount customarily consumed. The RACCs we have established
are reference amounts of food that are customarily consumed per eating
occasion. As such, we do not consider it appropriate to label foods
containing 200 percent or more of the applicable RACC as single-serving
containers because that would be twice the amount or more than we have
determined is customarily consumed.
(Comment 21) Some comments asserted that a multiserving container
would only require dual-column labeling if the individual units
contained at least 200 percent and up to and including 400 percent of
the RACC, and argued that the relevant factor in establishing whether
dual-column labeling is required is not the size of the entire
multiserving container, but the size of each individually packaged
unit. Therefore, the comments concluded that the proposed dual-column
labeling in Sec. 101.9(b)(2)(i)(D) and (b)(12)(i) would be required if
a unit in the multiserving container weighs at least 200 percent and up
to and including 400 percent of the applicable reference amount. A few
comments noted that for a multiserving container, the consumer must in
some cases unwrap each unit, and thus would know how many units he or
she has eaten. According to these comments, the number of those
individual units should represent the number of servings in the
multiserving container.
Several comments requested that we clarify that the proposed
changes in Sec. 101.9(b)(2)(i)(D) and (12)(i) are not intended to
require dual-column labeling on a multiserving retail container
comprised of individual discrete units, when the multiserving retail
container as a whole contains at least 200 percent and up to and
including 400 percent of the RACC. Examples provided in comments of
these types of packaging configurations were a four-pack of
individually packaged 6 oz yogurt containers, individually wrapped
cupcakes, muffins, and breakfast pastries. In the examples given, the
multiserving retail container contained at least 200 percent and up to
and including 400 percent of the RACC, but each of the individual
discrete units contained less than 200 percent of the RACC.
One comment noted we typically do not use the phrase ``packaged and
sold individually'' to describe multipack products and, citing to Sec.
101.9(b)(2)(i), stated that we instead refer to the multipack
containers as ``packages containing several individual single-serving
containers'' and that we refer to units as ``individually packaged
products within a multiserving package.'' The comment asked us to
clarify that the proposed criteria for mandatory dual-column labeling
applies only to those individual units that have between 200 and 400
percent of the RACC and not to the multipack container when the weight
of the multipack is between 200 and 400 percent of the RACC. The
comment stated that in the proposed rule we specifically identify a
``grab-size bags of chips'' as an example of a product that would be
subject to dual-column labeling if it contains 200 percent to 400
percent of the applicable RACC, even though the comment considered
chips to appear to be a non-discrete bulk product.
(Response 21) Dual-column labeling with nutrition information
listed per serving and per unit is required for each product in
discrete units in multiserving containers when the unit weighs at least
200 percent and up to and including 300 percent of the applicable RACC.
Section 101.9(b)(2)(i) provides, in part, the requirements for serving
sizes for products in discrete units (e.g., muffins, sliced products,
such as sliced bread, or individually packaged products within a
multiserving package). Under proposed Sec. 101.9(b)(2)(i)(D), if the
individual unit within a multiserving container weighs at least 200
percent and up to and including 400 percent of
[[Page 34017]]
the applicable RACC, the manufacturer would need to provide an
additional column that lists the quantitative amounts and percent DVs
for the individual unit, as well as a column listing the quantitative
amounts and percent DVs for a serving that is less than the unit (i.e.,
the serving size derived from the RACC). The first column would be
based on the serving size for the product, and the second column would
be based on the individual unit. We are amending Sec.
101.9(b)(2)(i)(D) in this final rule to apply to individual units
within a multiserving container that weigh at least 200 percent and up
to and including 300 percent of the applicable RACC. The reason for the
change from 400 percent of the RACC as the upper limit to 300 percent
of the RACC as the upper limit is discussed in section III.B. We have
also modified the language for clarity.
Under the proposed rule, dual-column labeling would be required on
a multiserving retail container comprised of individual discrete units,
when the multiserving retail container as a whole contains at least 200
percent and up to and including 400 percent of the RACC. As explained
in response to comment 9, a product that is packaged and sold
individually (i.e., a container that bears a Nutrition Facts panel)
that is comprised of individual discrete units and that as a whole
contains at least 200 percent and up to and including 300 percent of
the RACC would be subject to the dual-column labeling requirements
under Sec. 101.9(b)(12)(i) in this final rule, unless an exemption
applies. If, for example, the product at issue is a box containing two
individually bottled, 16 oz sodas, and if the box, and not the bottles,
were to display the Nutrition Facts label, the multipack container
would be required to bear dual-column labeling because the multipack
would be packaged and sold individually and would contain at least 200
percent and up to and including 300 percent of the RACC. In contrast,
if the product at issue is encased in a clear plastic wrapper and
includes two individually bottled, 16 oz sodas for which each bottle is
labeled with a Nutrition Facts panel that is visible at the point of
sale, the outside wrapper would not be required to bear dual-column
labeling even though the combined weight of all bottles would be at
least 200 percent and up to and including 300 percent of the RACC. We
note that Sec. 101.9(b)(12)(i) pertains to products that are packaged
and sold individually and contain at least 200 and up to and including
300 percent of the RACC, regardless of whether the product is in
discrete units.
With respect to the comment's request for clarification about
whether a ``grab bag'' of chips would be subject to the dual-column
labeling requirements, we note that if such a bag of chips were to bear
a Nutrition Facts panel and contain at least 200 percent and up to and
including 300 percent of the RACC, it would be subject to the dual-
column labeling requirements unless an exemption applied. Whether a
product contains discrete units or non-discrete bulk food, dual-column
labeling is required if the criteria for such labeling is met, and if
no exemptions apply. Section 101.9(b)(2)(i)(D) explains when a second
column of nutrition information that describes the nutrient content per
unit is required, and Sec. 101.9(b)(12)(i) explains when a second
column of nutrition information that describes the nutrient content per
container is required.
(Comment 22) One comment noted that our rounding rule requirements
may present inherent problems because the requirements may cause
quantitative amounts and percent DVs to look inconsistent when
displayed in a dual-column format per serving and per container. The
comment suggested that this result may not satisfy the requirements of
section 2(b)(1)(A) of the NLEA if dual-column labeling does not convey
information in a manner that ``enables the public to readily observe
and comprehend such information and to understand its relative
significance in the context of a total daily diet.'' To demonstrate the
potential inconsistency, the comment provided an example of a Nutrition
Facts label of two different flavors of candy bars which presented
nutrition information per two pieces and per one piece. The comment
noted that the calories from fat for two pieces is 111.0 g (actual) but
is rounded to 110 g using our rounding rules, while the calories from
fat for 1 piece is 55.5 g (actual), but rounded to 60 g using our
rounding rules. The comment noted that this discrepancy may cause
consumer confusion since if the serving size were halved they would
expect the declaration of ``Calories from fat'' to be 55 g. The example
provided in the comment also demonstrated inconsistencies in the values
provided for total fat, sodium, and protein due to our rounding rules.
The comment suggested that we permit the use of a footnote such as
``Columns may not add due to rounding'' when such inconsistences exist.
(Response 22) We acknowledge that the use of dual-column labeling
per serving and per container could, under certain conditions, cause
apparent discrepancies in the nutrition values between the two columns.
The discrepancies would result from mathematical rounding procedures
and our requirements for the increments in which nutrition values are
declared in the Nutrition Facts label under Sec. 101.9(c). We
recognize that consumers viewing nutrition information per serving and
per container may expect the nutrition values per container to result
from multiplying the number of nutrients per serving by the number of
servings per container, and that the numbers that may result under
existing regulations may not reflect this expectation in all cases.
However, under the preexisting nutrition labeling regulations,
consumers may have already seen such rounding issues in the labeling of
products in discrete units in a multiserving container that are more
than 1 unit (Sec. 101.9(b)(10)(ii)).
While we acknowledge that in some instances apparent discrepancies
may occur, we are not proposing to change our requirements for the
increments in which nutrition values are declared in the Nutrition
Facts label (Sec. 101.9(c)). Changes to this regulation, such as a
requirement that the per-container information be provided by
multiplying the nutrients per serving by the number of servings, would
likely result in the need to round the information twice. This could
result in a requirement to provide nutrition information per container
in a way that does not accurately reflect the amount of nutrients in
the product. We consider this result to be more problematic than any
apparent discrepancies that may result from existing rounding
requirements. However, we will monitor this situation as more products
are introduced into the marketplace with dual-column labeling per
serving and per container.
We disagree with the comment suggesting the need for a footnote
such as ``Columns may not add due to rounding.'' The presence of a
footnote will require additional space, and we do not believe at this
time that any apparent rounding discrepancies are significant enough as
to warrant a requirement to include such a footnote or to permit the
use of such a footnote voluntarily. We do, however, plan to include
information about potential rounding discrepancies as part of our
planned nutrition education efforts to clarify why the per-serving and
per-container nutrition values appearing on dual-column labels may not
appear consistent. We also note that, while no such footnote as
requested in this comment can be added to the Nutrition
[[Page 34018]]
Facts label, manufacturers can voluntarily include a truthful and not
misleading statement explaining how rounding effects dual-column
labeling elsewhere on the product label.
3. Exemptions From Dual-Column Labeling
(Comment 23) One comment asserted that we acted arbitrarily in
proposing to exempt the following types of products from the dual-
column labeling requirement because we determined that labeling of such
products with nutrition information based on the entire container would
not be consistent with how these products are typically consumed: Bulk
products that are used primarily as ingredients (e.g., flour,
sweeteners, shortenings, oils), bulk products traditionally used for
multipurposes (e.g., eggs, butter, margarine), and multipurpose baking
mixes.
(Response 24) After further consideration of this exemption, and as
explained in response to comment 19, the use of a uniform upper
criterion for all product categories will ensure that consumers are
able to compare nutrition information across various product types that
are packaged in the sizes that we have determined are reasonably likely
to be consumed at one eating occasion or shared with others. We have no
consumption data showing that it is reasonably likely that bulk
products are consumed differently from non-bulk products. Therefore, we
are not finalizing the exemption for bulk products that are used
primarily as ingredients, bulk products traditionally used for
multipurposes, and multipurpose baking mixes as proposed in Sec.
101.9(b)(12)(i)(B).
(Comment 24) We received comments relating to proposed exemptions
from dual-column labeling requirements for products that require
further preparation, such as macaroni and cheese kits, pancake mixes,
pasta products, and common combinations of food (e.g., cereal and milk)
that contain at least 200 percent and up to and including 400 percent
of the applicable RACC. Comments we received regarding this exemption
were generally supportive of the exemption. A few comments, however,
stated that instead of allowing products to be exempt from dual-column
labeling, we should instead require dual-column labeling per serving
and per container for the as-prepared form of the product and eliminate
the as-purchased information altogether.
We received a few comments requesting that we allow an exemption
for any product that provides voluntary dual-column labeling as allowed
under the preexisting regulations in Sec. 101.9(b)(10)(i) to (iii).
Another comment requested that we provide exemptions from dual-column
labeling under Sec. 101.9(e) not only for products that provide an
additional column of information for two or more forms of the same food
``as purchased'' and ``as prepared'' and for common combinations of
food, but also when nutrition information is provided for two or more
groups for which Reference Daily Intakes (RDI's) are established (e.g.,
both infants and children less than 4 years of age) or when nutrition
information is provided in different units (e.g., slices of bread or
per 100 g).
(Response 24) We agree, in part, with comments that support
allowing an exemption to the dual-column labeling requirements if the
voluntary provisions provided for in Sec. 101.9(b)(10) are used. The
exemptions under Sec. 101.9(b)(10) are for products that provide
another column of figures that may be used to declare the nutrient and
food component information per 100 g or 100 mL, or per 1 oz or 1 fl oz
of the food as packaged or purchased (Sec. 101.9(b)(10)(i)); per one
unit if the serving size of a product in discrete units in a
multiserving container is more than 1 unit (Sec. 101.9(b)(10)(ii));
and per cup popped for popcorn in a multiserving container (Sec.
101.9(b)(10)(iii)). We agree that providing voluntary dual-column
labeling per unit if the serving size of a product in discrete units in
a multiserving container is more than 1 unit would provide useful
information to those that consume one unit, and therefore are
permitting the use of such a second column of information in lieu of a
second column that provides per-container information. We also agree
that providing voluntary nutrition information per cup of popped
popcorn per serving in a multiserving container (Sec.
101.9(b)(10)(iii)) in an as-consumed form will be more beneficial to
consumers than having nutrition information for the ``as purchased''
form on both a per-serving and per-container basis. As explained
further in comment 25, while we recognize that popcorn is not consumed
in the as-purchased form, the as-purchased nutrition information is
still needed. Therefore, we are permitting the label of such products
to contain a second column of information for the popped form, in lieu
of a second column that provides per-container information.
As noted in the serving size proposed rule, we tentatively
concluded that it would be helpful to consumers to have access to
nutrition information based on the prepared form of the product in
addition to the ``as purchased'' form of the product (79 FR 11989 at
12004). We are reaffirming that conclusion in this final rule. The ``as
prepared'' information on labels indicates the nutritional information
per serving if a package is prepared according to package directions,
which may require the use of additional ingredients. We disagree,
however, with those comments that stated we should require dual-column
labeling to be done only based on the as-prepared form, per serving and
per package. If a consumer does not use the stated directions or uses
substitute ingredients, then the information in the as-prepared portion
of the label would not be accurate. Therefore it is important that each
product include nutrition information for the product as packaged and
not just the product as it is prepared. We also noted in the proposed
rule that if products that voluntarily included one column of nutrition
information for the prepared form of the food per serving and met the
requirements for dual-column labeling, they would have to include at
least three columns of nutrition information unless the products were
subject to an exemption (79 FR 11989 at 12004). We are reaffirming our
conclusion from the proposed rule that nutrition information based on
the entire container of the unprepared food may be less meaningful to
consumers than information based on a serving of the prepared form of
the food and are therefore finalizing an exemption from the dual-column
labeling requirements in Sec. 101.9(b)(12)(i)(C) for those products
that voluntarily include a second column of nutrition labeling for the
as-prepared form of the food per serving.
We do not agree with comments that requested an exemption for
products that provide an additional column that declares the nutrition
information per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as
packaged or purchased. In the introduction to section III.C., we
discussed our basis for concluding that per-container information helps
certain consumers recognize nutrient amounts per package and that the
consumption data shows that consumers are reasonably likely to consume
a full package containing at least 200 percent and up to an including
300 percent of the RACC. In contrast, consumers may not be able to
readily measure 100 g or 100 mL amounts, so the information may not be
useful to them. Because we have determined that nutrition information
per serving and per container is more likely to be useful to consumers,
and therefore is more
[[Page 34019]]
important than voluntary nutrition information given in metric or
common household measurements (oz) for the food in the as-purchased
form per serving, we decline to establish an exemption when a second
column of nutrition information is provided per 100 g or 100 mL, or per
1 oz or 1 fl oz of the food as packaged or purchased. While nutrition
information per 100 g or 100 mL cannot be listed in lieu of the
information required under Sec. 101.9(b)(2)(i)(D) and (b)(12)(i),
Sec. 101.9(b)(10)(i) allows the manufacturer to provide this
information in an additional column (e.g., a third column) on a
voluntary basis.
We agree with the comment that requested that we expand the
exemptions from dual-column labeling to include products that voluntary
provide a second column of nutrition information for two or more groups
for which RDIs are established (e.g., both infants and children less
than 4 years of age). Providing voluntary nutrition information for two
or more groups for which RDIs are established provides useful
information for the different populations that may consume the food
product. Providing nutrition information for two subpopulations, such
as infants 7 to 12 months old and children aged 1 through 3, will
provide beneficial information to purchasers of these products. Such
nutrition information will provide meaningful information about foods
that are typically consumed in distinct amounts by distinct
subpopulations. This exemption has been added to Sec.
101.9(b)(12)(i)(C) in this final rule.
We note that in this final rule we are also providing an exemption
from dual-column labeling for varied-weight products covered under
Sec. 101.9(b)(8)(iii), for which dual-column labeling would be less
practical given the variation in product sizes.
(Comment 25) We received several comments questioning why popped
popcorn needed a dual-column label listing nutrition information with
one column for ``as purchased'' unpopped popcorn and another column for
``as prepared popped'' popcorn. The comments noted that no one consumed
raw popcorn and that the ``as purchased'' popcorn information is
unnecessary. One comment requested that the RACC for popcorn be changed
from 30 g unpopped (raw) to 30 g as consumed because variations in
hybrids, popping volume and other ingredients can significantly alter
the amount of kernels in a single serving based on the household
measure (typically tablespoons) for the finished product. The comment
requested that we change the current declaration for uncooked popcorn
to reflect how the product is actually consumed by the consumer versus
``as packaged.'' The comment noted that providing the nutrition
information about unpopped popcorn could be confusing and misleading to
the consumer and that no other snack has its raw form as the basis for
its nutritional information.
(Response 25) We decline to amend the way in which nutrition
information is required to be presented for popcorn, which is that
popcorn must provide nutrition information on the ``as packaged'' or
``purchased'' form of the food (i.e., unpopped form), as described in
Sec. 101.9(b)(9). We disagree with the assertion that providing
nutrition information about popcorn in the ``as packaged'' form is
unnecessary and that the ``as packaged'' nutrition information should
not be required to appear on the product label if the ``as prepared''
information is provided. The ``as prepared'' information on labels
indicates whether a package is prepared according to package
directions, which may require the use of additional ingredients. If a
consumer does not use the stated directions or uses substitute
ingredients, then the information in the as-prepared portion of the
label would not be accurate. Therefore it is important that each
product include nutrition information for the product as packaged and
not just the product as it is prepared. We note, however, that although
it is not permitted for popcorn to provide a single-column label
containing only as-purchased information, our regulations provide that
popcorn products can provide a second column of nutrition information
``per cup popped'' for popcorn in a multiserving container (Sec.
101.9(b)(10)(iii)); many popcorn products already voluntarily have a
second column of nutrition information per serving for the ``as
popped'' form. We are not changing this voluntary provision. In
addition, we have provided an exemption from the dual-column labeling
provisions in Sec. 101.9(b)(12)(i) for products that require further
preparation, which would apply to popcorn products that contain at
least 200 percent and up to and including 300 percent of the RACC and
voluntarily provide an additional column of nutrition information on
the ``as popped'' form.
With regard to the comment that stated that listing popcorn on the
as-purchased basis would be confusing to consumers, the comment did not
explain the basis on which the as-purchased information would be
confusing or misleading, and we do not agree that such information
would be confusing or misleading. With regard to the assertion that no
other snack has its raw form as the basis for its nutritional
information, we disagree. All products are required to provide
nutritional information for the as-packaged form, so any products that
are packaged in their raw form are required to provide nutritional
information for the raw form.
We also decline the request to change the RACC of popcorn to 30 g
popped per serving ``as consumed.'' In the preamble of the 1993 serving
size final rule (58 FR 2229 at 2265 to 2266), we discussed comments
that requested that popcorn be able to use a volume-based rather than a
weight-based reference amount. We declined to follow the recommendation
from those comments because we determined that there is no well-
established standard procedure for determining the weight equivalents
of the household measures. This is still true today. However, for the
benefit of those consumers who consume popcorn on a volume basis, we
permit the use of a voluntary dual-column label with the second column
of nutrition information being based on a per cup popped basis.
Therefore we decline to change the popcorn RACC to an as-consumed
amount.
(Comment 26) A few comments requested clarity on whether raw fruits
and vegetables would be exempt from dual-column labeling when nutrition
labeling is voluntarily provided or when claims are made for such
products. An example used in the comment was a medium avocado that has
a proposed RACC of 50 g, or about \1/3\ of the avocado. According to
the comment, the entire avocado would be about 150 g and would require
dual-column labeling if nutrition labeling is voluntarily provided or
if claims are made for such product in labeling or advertising. Another
comment requested that we exempt all fruits and vegetables without
added sugar, salt, or fat from dual-column labeling.
(Response 26) Under Sec. 101.9(j)(10), raw fruits, vegetables, and
fish are exempt from mandatory nutrition labeling, contingent on the
food bearing no nutrition claims or other nutrition information in any
context on the label or in labeling or advertising. The labeling of
such products is generally done on a voluntary basis, with guidelines
for such labeling set forth under Sec. 101.45. Under Sec.
101.45(a)(3)(i), such products are not required to provide information
about the number of servings per container. Because the number of
servings per container would vary from container to container, we do
not expect those selling raw fruit,
[[Page 34020]]
vegetables, and fish to be able to provide information about the number
of servings for an individual container and therefore do not expect
them to be able to provide a second column of information with
nutrition information per container. Additionally, when voluntary
nutrition information for raw fruits, vegetables, and seafood is
provided under Sec. 101.45(a)(1), it should be displayed at the point
of purchase by an appropriate means such as by a label affixed to the
food or through labeling including shelf labels, signs, posters,
brochures, notebooks, or leaflets that are readily available and in
close proximity to the foods. The nutrition labeling information that
is voluntarily provided may also be supplemented by a video, live
demonstration, or other media. Because no information about the number
of servings per container is generally required in voluntary labeling,
and because the nutrition labeling for such products is often provided
in a non-standardized manner, we agree that such products should be
exempt from dual-column labeling. Therefore, we will amend Sec.
101.9(b)(12)(i)(B) to provide that raw fruits, vegetables, and seafood
will be exempted from the dual-column labeling requirements, regardless
of whether voluntary nutrition information is provided for the product,
either in labeling or in advertising, or whether nutrition claims are
made for the product.
We decline to exempt canned or frozen fruits and vegetables without
added sugar, salt, or fat from the dual-column labeling requirements.
Unlike raw fruits and vegetables, the presentation of nutrition
information, including the number of servings per container, has been
established in Sec. 101.9 for canned or frozen fruits and vegetables,
regardless of whether they contain added sugar, salt, or fat. It is
therefore less difficult for canned or frozen fruits and vegetables to
provide dual-column labeling when the applicable dual-column labeling
requirements would apply.
(Comment 27) One comment requested that bottled water products be
exempt from the requirements of dual-column labeling. Other comments
questioned the benefits to consumers of requiring dual-column labeling
for bottled water products when most of the values in the two columns
would be zero. The comments further noted that many bottled water
products are already exempt from the nutrition labeling requirements
under Sec. 101.9(j)(4) because they contain insignificant amounts of
all nutrients required to be declared in the nutrition facts label, and
requested that we amend Sec. 101.9(j)(4) to clarify that such products
would be exempt. The comments noted that under the proposed rule, the
RACC for bottled water products would increase from 240 mL (8 oz) to
360 mL (12 oz) and that this increase in the RACC would mean that the
sodium content per RACC in some bottled water products would exceed the
current 5 mg per serving threshold, below which the amount of sodium
would be considered insignificant. Therefore, the comment requested
that we revise the definition of an insignificant amount in Sec.
101.9(j)(4) to be an ``amount that allows a declaration of zero in
nutrition labeling, except that for sodium, it shall be an amount that
exceeds a declaration of zero percent of the daily value, and except
that for total carbohydrate, dietary fiber, and protein, it shall be an
amount that allows a declaration of less than 1 gram.''
(Response 27) We decline to establish an exemption to the dual-
column requirements in this final rule for bottled water products. We
also decline to amend Sec. 101.9(j)(4) at this time as suggested by
the comment. We intend to consider the applicability of an exemption
from nutrition labeling requirements in a future rulemaking with
respect to certain products. Until such time as we have had the
opportunity to consider such matters further, we intend to consider the
exercise of enforcement discretion with respect to mandatory nutrition
labeling on bottled water products and other products that would have
been exempt under Sec. 101.9(j)(4) prior to the effective date of this
rule and the Nutrition Facts final rule.
(Comment 28) One comment stated that providing nutrition
information on a ``per container'' basis for a consumer who intends to
eat some now and some later, or for a consumer who will share the
container with others, is not useful information. The comment asserted
that consumers have all the nutrition information they need to make
food choices in the ``per serving'' declaration.
(Response 28) To the extent that this comment asserts dual-column
labeling does not provide additional, useful information to consumers,
we disagree. The intent of dual-column labeling is to provide nutrition
information for products that may be consumed by one consumer in a
single eating occasion, over several eating occasions, or shared among
multiple consumers. A dual-column nutrition label provides easy-to-
interpret nutrition information for a consumer who may eat the contents
of a package in one sitting. Dual-column labeling serves as a
contextual cue that there is more than one serving in a package and
helps consumers to easily figure out how much is in the entire
container.
(Comment 29) We received a comment requesting that we exempt foods
specifically represented or marketed to infants or children 1 to 3
years of age. The comments stated that presenting the nutrition
information for the entire container could inappropriately communicate
that a young child could reasonably consume the entire contents of a
container. The comment used juice as an example with an RACC of 4 fl oz
and noted that a 16 fl oz juice container marketed for children 1 to 3
years would need to include a column for the entire container under the
proposed rule. The comment stated that such labeling could indicate to
consumers that juice is recommended to be consumed in greater
quantities and would conflict with portion guidance provided to parents
regarding limiting juice consumption to no more than 4 fl oz per day.
(Response 29) We decline to exempt foods specifically represented
or marketed to infants or children 1 to 3 years of age from mandatory
dual-column labeling. The purpose of dual-column labeling is to provide
nutrition information for those who consume the entire container in one
eating occasion, as well as those who consume the container over
multiple eating occasions or share the container with others, and to
help consumers more easily understand the contents of a particular
package both on a per-serving and per-container basis. In terms of
consumers misconstruing the serving size as a recommended amount of
food, we noted previously in section III.A. that we will engage in
consumer education to help clarify the meaning of the serving size. We
note that since we have lowered the upper level of dual-column labeling
to 300 percent of the RACC, the example stated in the comment would not
occur.
4. Research and Consumer Understanding of Dual-Column Labeling
(Comment 30) We received comments that questioned the research
cited in the proposed rule in support of dual-column labeling (Ref.
14). Some comments stated that consumer research should include an
evaluation of whether consumers would use the dual-column information
to modify dietary choices when provided. Comments stated that the
limited amount of research on dual-column labeling was not enough to
require mandatory dual-column labeling for all products.
Various comments questioned the format of the dual-column labels
used in the studies. Some comments pointed out that both studies cited
in the
[[Page 34021]]
proposed rule evaluated the current label format with dual columns,
rather than the proposed new label format with dual columns. The
comments stated that with the proposed label formats, dual-column
labeling is not needed because the values consumers need to determine
the total calories in the container would already be available to the
consumer.
Some comments questioned the results of the study conducted by
Antonuk and Block that was cited in the proposed rule. These comments
stated that the results of the study are not generalizable because the
study was conducted with undergraduate students in a classroom setting.
Some comments stated that the study only used labels for snack food
products and that the results should not be used to evaluate the
effects of dual-column labels on other product categories. Other
comments questioned the different results for dieters versus
nondieters.
(Response 30) We disagree with the comments that suggest that in
order to support the requirement for dual-column labeling, research
must demonstrate that dual-column information modifies dietary choices.
As noted previously, the purpose of dual-column labeling is to provide
nutrition information for multiple ways that people are likely to
consume a product that contains at least 200 percent and up to and
including 300 percent of the RACC. Consumption data shows that while
some people eat such products in a single eating occasion, others eat
the product over time or share it. Dual-column labeling provides
nutrition information for all of these scenarios.
The comment incorrectly asserts that the studies on which we relied
in the proposed rule used only labels for snack food products. The
labels tested in the Lando and Lo study (Ref. 15), which were also
cited in the proposed rule, included sample Nutrition Facts labels for
frozen meals, which are not considered ``snack foods.'' Additionally,
since the publication of the proposed rule, we have conducted further
research on dual-column labeling. The new study has tested dual-column
labels using the proposed label formats, recruited participants from a
Web-based panel of English speaking adults, and examined multiple food
products (Ref. 19). The results from the research showed that dual-
column labeling significantly improved respondents' ability to identify
the amount of nutrients in the entire container of a two-serving
package compared to both a single-column label and a dual-calorie
label. Based on this research, as well as the research cited in the
proposed rule, we conclude that consumers can more easily and more
accurately comprehend the nutrient contents of an entire package when
dual-column labeling is available, and we disagree with those comments
that stated that dual-column labeling is not needed.
With respect to comments that questioned whether the results of the
study conducted by Antonuk and Block that was cited in the proposed
rule are generalizable, we acknowledge the study's limitations as noted
in the comments. In spite of the fact that the results are not
generalizable, we note that the study suggests that, at least under
circumstances that are the same as or similar to those in the study, it
is possible that some consumers may behave like the study participants.
The finding of this study is consistent with other research that we are
aware of; therefore, we are convinced by the totality of the research
that dual-column labeling can help consumers better understand the
nutrition contents of containers of certain sizes and assist them in
maintaining healthy dietary practices.
(Comment 31) Several comments stated that providing nutrition
information for the entire package will cause consumer confusion and
increase consumption. Some comments argued that consumers would
interpret the nutrition information for the entire package to be a
recommended amount to eat and consume more of the product than they
would have likely consumed without the dual-column label.
(Response 31) These comments did not provide data or other
information in support of their assertions. Based on a review of
available information, we have seen no indication that dual-column
labeling may be confusing to consumers or that dual-column labeling
would imply that consumers should eat more of an item.
(Comment 32) We received a comment that included results of a study
conducted by the commenter on the proposed Nutrition Facts label
formats. The study was designed to investigate the extent to which
consumers are able to quickly notice and understand label information,
as they would during grocery shopping. The study compared consumer
reactions to FDA's current and proposed versions of four different
Nutrition Facts label formats, each portraying a different food
product, so that a total of eight different labels were examined. The
current and proposed label formats, and the foods depicted, were
standard format for single-serve yogurt; tabular format for frozen
vegetables; dual-column label for breakfast cereal (per serving and
with \1/2\ cup skim milk); and a dual-column label for a multiserving
snack mix package (per serving and per container). Each participant
viewed and reacted to one label.
According to the comment, the study found that, in general, the
proposed formats performed no better than the current formats in
conveying nutrition information to respondents, but the results varied
according to the information on the labels being considered. With
respect to the dual-column labels, the comment stated that no
differences were found in the ``quick readability'' or in participants'
comprehension of the serving size or calories information between the
current and proposed formats of both the snack mix and cereal products.
The authors also asserted that participant understanding of nutrition
information was better with the proposed dual-column cereal label but
not with the proposed dual-column snack mix product. Further, the
authors stated that respondents found the information for vitamins and
minerals to be less confusing on the snack mix label that displayed
both the percent DV and the absolute amounts per serving and per
container (i.e., the proposed dual-column format) than on the label
showing this information only per serving (i.e., the current single-
column format). However, according to the study authors, when asked an
open-ended question about items that were easy to understand or
confusing on the label, a larger percentage of respondents indicated
that it was more difficult to understand the percent DV information on
the proposed snack mix label than on the current version of this label.
The comment stated that the result also suggest that respondents were
less likely to initially notice the serving size information on the
proposed labels for both the snack mix and cereal products compared to
the current formats for these products. The authors postulated that
these results were due to the complexity of the proposed dual-column
label formats, and they recommended that FDA should not implement the
proposed changes in format for the Nutrition Facts label because their
study indicated that participants perceived few differences between the
current and proposed label formats.
(Response 32) We have significant questions about the methodology
and design of this study. Although we acknowledge that this study did
not demonstrate a clear advantage to the proposed versus the current
format under all experimental conditions, the
[[Page 34022]]
results are difficult to interpret because a number of details were not
provided. Among other things, the authors did not adequately describe
the study's methodology, such as by explaining the demographic
characteristics of the participants, the statistical methods that were
used, how the participants were selected, how the study was
administered, and why 90 percent confidence levels were chosen to
indicate significant differences rather than the conventional 95
percent confidence interval. Further, the proposed snack mix label that
was used in the study appeared to be inconsistent with the proposed
requirements in how the ``per serving'' and ``per container'' values
were listed for various nutrients. Although the label indicated ``3\1/
2\ servings per container,'' the amounts of some nutrients (e.g.,
calories, carbohydrates, sodium, protein) that were listed on the label
suggested that there were 4 servings per container, and the amount of
dietary fiber shown on the label indicated there were only 2\1/2\
servings per container. Because of these substantial questions about
the sufficiency in the study design and the study's methodology, we are
not persuaded by this comment.
As noted previously, recent NHANES data shows that consumers are
reasonably likely to consume products containing at least 200 percent
and up to and including 300 percent of the RACC in a single eating
occasion. Our research demonstrates that some consumers may have
difficulties determining nutrition information per container when a
label declares the package contains more than one serving and is
reasonably consumed in a single eating occasion. We are therefore
finalizing dual-column labeling requirements in this rule to help
consumers better understand the nutrition contents of packaged foods
containing at least 200 percent and up to and including 300 percent of
the RACC.
5. Dual-Column Labeling Format
(Comment 33) We received several comments regarding the format of
dual-column labels relating to whether per-container nutrition
information should appear for all nutrients for which information is
available on a per-serving basis, whether per-container nutrition
information should be limited to calorie content, or whether per-
container information should be limited to calories, saturated fat and
sodium.
The comments were divided on whether we should require dual-column
labeling with per-serving and per-container (or unit, as applicable)
information for all nutrients or whether we should require only calorie
information per serving and per container with the rest of the
nutrition information listed in a single column. Only one comment
requested that we consider using the option to provide nutrition
information per serving and per container (or unit, as applicable) for
calories, saturated fat and sodium only. Although comments were divided
on which of the other two formats to use (i.e., per-container
information for all nutrients versus per-container information for
calories only), many comments stated that the decision on which dual-
column label format to use should be based on consumer research on what
information would be most useful to consumers in deciding the amount of
a food or beverage to consume.
Comments that requested that we use dual-column labeling for all of
the nutrition information per serving and per container stated this
option would allow consumers to base decisions on the product's overall
nutrient profile. A few comments stated that access to the full
nutritional information for a serving as well as the entire container
is necessary for consumers who are looking for specific nutrition
information. The comments stated that individuals have varying
nutritional requirements and need to see dual-column nutrition
information for all nutrients in order to maintain healthy dietary
practices.
Comments that requested that we require dual-column labeling for
calories only stated this approach would provide consumers with
information they need to accurately identify the number of calories in
a product, but would also save space and avoid cluttering the Nutrition
Facts label. Comments argued that the issues we were looking to address
with dual-column labeling would be alleviated through the proposed
formatting changes and, specifically, the larger type size and
prominence for calories and servings per container, as proposed in
``Food Labeling: Revision of the Nutrition and Supplement Facts Label''
(79 FR 11880, March 3, 2014). These comments asserted that our proposal
to increase the prominence of calories and servings per container would
give consumers the piece of information most relevant to a package that
might be eaten by a single consumer during a single eating occasion,
i.e., the calorie content of the entire container.
One comment stated that full dual-column labeling information is
not needed because a consumer that chooses to eat two, three, or four
servings of the product can easily calculate the quantity of calories
and nutrients consumed through simple math. Another comment noted that
in the study we conducted (Ref. 15), a label format with dual listings
for calories only had the next highest level of accuracy (total
correct) on the broad index of the nutrient content questions posed to
study participants compared to the accuracy of the one serving, single-
column format and two serving, dual-column formats (Ref. 15). Other
comments said dual-column labeling for food packages that contain 200
percent and up to and including 400 percent of the RACC could actually
decrease the utility of the Nutrition Facts label by cluttering the
label and making it difficult for consumers to read. Another comment
questioned whether requiring that information per container be
available for consumers so they don't have to do the math by
multiplying the per serving values by the number of servings is
justified in spite of the additional space this information will
occupy. The comment stated that a dual-calorie label, which highlights
the calories per serving and per container, is a better and more
targeted use of limited label space than a dual-column label for all
nutrients.
(Response 33) We agree with the comments that noted that dual-
column labeling with information per package and per serving for all
nutrients is most useful for consumers who are looking for specific
nutrition information. The research cited in the proposed rule has
shown that consumers better understand nutrition information when using
a dual-column label that shows two columns of nutrition information,
per serving and per container, as compared with a label that shows dual
information for calories only. Further, because different consumers are
interested in different nutrients when evaluating products, providing
dual-column labeling for all nutrients would be helpful to more
consumers. We are not aware of any studies that have evaluated a
Nutrition Facts label with only dual-column information for calories,
saturated fat, and sodium per serving and per container.
In response to those comments that requested that we base our
decision on which label format to use on consumer research, it is in
light of the research findings discussed in section III.C. and in
comment 29, as well as the usefulness of full nutrition information for
different types of consumers, that we are choosing the option for dual-
column labeling per serving and per container (or unit, as applicable)
for all nutrition information on the label.
[[Page 34023]]
In response to comments that stated that consumers do not need the
additional information or that consumers can easily do the math to
determine nutrition information per container, the research does not
support this assertion. Studies have found that consumers are able to
most accurately determine the quantity of nutrients in specific foods
when using labels that list full nutrition information for the entire
package (Ref. 19). In addition, as discussed in the preamble to the
proposed rule (79 FR 11989 at 11998), research suggests that many
consumers do not correctly calculate nutrient amounts in food products
by multiplying the nutrient amount by the number of servings per
container (Refs. 23 and 24). One research study of 200 primary care
patients found that many patients, especially those with lower literacy
and numeracy skills, had trouble using food labels for performing
certain tasks, especially those that involved calculations with serving
size information (Ref. 24). Similar results were reported in the
``Calories Count'' report (Ref. 1).
We disagree that consumers do not need the additional information
or that consumers can easily do the math to determine nutrition
information per container. Our study with 160 consumers showed
participants a pair of single-column Nutrition Facts labels, with one
label showing a serving size of one and another label a serving size of
two and asked them to identify which product contained fewer calories
per container (Refs. 18 and 19). The proportion of participants who
noticed the calorie declaration or the number of servings declaration
did not vary between a single-column current format and a single-column
proposed format (Refs. 18 and 19). Neither did the proportions of
participants differ with regard to how many could identify which
product contained fewer calories per container. The study also showed
that while the majority of participants noticed the calorie disclosure,
less than one third of the participants were able to identify whether
the label with a serving size of one or the label with a serving size
of two contained fewer calories per container. These results suggest
that some consumers may not notice and use all the information
available on a single-column, multiserving label that could reasonably
be consumed in a single eating occasion and that some consumers may not
accurately use (e.g., as a result of mathematical errors) and correctly
recognize a product's nutrient contents if a product contains more than
one serving.
We do not agree with the comment that asserted that the proposed
changes for increasing the prominence of calories and the serving size
information will alleviate issues that we are seeking to address with
dual-column labeling. In our study, the proportion of participants who
saw the proposed format changes (i.e., increased prominence of calories
and the serving size information) and did not notice the number of
servings was not different from the proportion of participants who saw
the preexisting format and did not notice the number of servings, even
though calories and the number of servings were made more prominent on
the proposed format (Ref. 18). We are also concerned about ensuring
that consumers have access to per-container nutrition information for
products that contain at least 200 percent and up to and including 300
percent of the RACC so consumers who eat the entire container in one
eating occasion, over multiple eating occasions, or shared with others
can accurately identify the information for the entire container.
To address the comment that stated that listing dual-column
nutrition information for calories only is a better and more targeted
use of limited label space than a dual-column label for all nutrients,
we disagree. Findings from a study we conducted after the publication
of the proposed rule found that participants were able to better
identify total nutrients per container when using the full dual-column
label, as compared with the dual-column label for calories only (Ref.
19). Providing dual-column labeling for the entire container gives
consumers access to nutrient information for each specific nutrient on
the Nutrition Facts label.
(Comment 34) One comment stated that, as grocery shelf space has
become increasingly expensive, packages have become narrower and
taller, ultimately increasing vertical space to greater than 3 inches
in height and making the back panel longer and thinner. The comment
stated that, for these types of small or tall and narrow packages with
seams down the back, it will be difficult, if not impossible, for
manufacturers to fit a dual-column nutrition facts label, which is
nearly twice as wide as the current single-column facts panel. The
comment requested that we propose additional dual-column options for
industry review that account for the constraints associated with
different product formats and smaller package sizes.
(Response 34) We recognize the concerns expressed in this comment.
Under proposed Sec. 101.9(b)(12)(i)(A), which this rule finalizes
without changes, the dual-column labeling requirements in proposed
Sec. 101.9(b)(12) would not apply to products that meet the
requirements to present the Nutrition Facts label using the tabular
format under current Sec. 101.9(j)(13)(ii)(A)(1) or the linear format
under current Sec. 101.9(j)(13)(ii)(A)(2). If a product has limited
space and uses a tabular or linear format as described in the
regulations, it would not be required to use dual-column labeling. We
also recognize that the shape of the container will play a role in the
amount of space available to display the Nutrition Facts label and note
that information related to placement of information on the information
panel is described in Sec. 101.2. An example of a dual-column label
using the tabular display format in Sec. 101.9(d)(11)(iii) is being
published elsewhere in this issue of the Federal Register in the
Nutrition Facts final rule.
D. Reference Amounts Customarily Consumed
We proposed to update, modify, or establish RACCs. Updating RACCs
refers to amendments to the RACCs for products that are listed in the
tables in Sec. 101.12(b) and for which the NHANES 2003-2008
consumption data showed an increase or decrease in consumption of at
least 25 percent. Modifying RACCs refers to changes to current RACCs in
the tables in Sec. 101.12(b) for which the NHANES 2003-2008
consumption data did not show an increase or decrease in consumption of
at least 25 percent for the preexisting product categories.
Establishing RACCs refers to the addition of products and the
assignment of RACCs for such products that are not listed in
preexisting tables in Sec. 101.12(b).
In the proposed rule, we analyzed current food consumption data and
determined that, for some product categories listed in the tables in
Sec. 101.12(b), the RACCs have changed. Additionally, we recognized
that, since 1993, information regarding the RACCs for certain products
not currently listed in the tables in Sec. 101.12(b) has become
necessary. These factors, combined with findings from the ``Calories
Count'' report, information regarding the rise in obesity, increase in
package sizes, and requests to establish and modify the RACCs, led us
to propose amendments to the RACCs.
When determining when to update, modify, and establish RACCs, we
analyzed consumption by combining data from the survey years of the
NHANES, 2003-2004, 2005-2006, and
[[Page 34024]]
2007-2008 (NHANES 2003-2008 surveys), which provide an indication of
the current amount of food being consumed by individuals at one eating
occasion (Refs. 6, 7, and 8). Food consumption data from the NHANES
surveys are released in 2-year cycles.
When determining whether to update an RACC, we first considered two
factors. If both of these factors were not met, we did not consider
updating the 1993 RACC. The first factor was to determine whether there
was an adequate sample size from the NHANES 2003-2008 consumption data
for each product in the 140 product categories. The data collection for
NHANES, which is completed by Centers for Disease Control and
Prevention (CDC), is used to assess intake by the U.S. population.
Because CDC's purpose in collecting NHANES data differed from our
purpose in updating RACCs, sample sizes that CDC collected were not
always adequate for considering updates to the RACCs. Thus, we
retrospectively determined the adequate, minimum required sample size
based on the calculated design effect for each product within the
product categories with a 90 percent confidence level and 20 percent
margin of error. For some products, sample sizes are not large enough
to obtain a reliable estimate of consumption. We have determined that
for these products there is no compelling evidence (due to an
insufficient number of samples) to consider updating the RACCs
established in 1993.
The second factor was to determine if, for those products with a
sufficient sample size, the median intake estimate from the NHANES
2003-2008 consumption data for the product significantly differed from
the 1993 RACC for that product. We chose the value of 25 percent to
represent a meaningful change based on our analysis of the data and
after evaluating other values for percentage differences (e.g., 5
percent, 10 percent) when applied to the data. To be conservative, we
determined if the 25 percent change in intake was significantly
different from the 1993 RACC by comparing the upper or lower 95 percent
confidence interval for the new median estimates to the either 0.75 or
1.25 times the1993 RACC, respectively. If the new NHANES 2003-2008
consumption median estimate was higher than the 1993 RACC and the 95
percent lower confidence bound of the median estimate was greater than
1.25 times the 1993 RACC, we considered the new median to be
significantly greater. If the new NHANES 2003-2008 consumption median
estimate was lower than the 1993 RACC and if the 95 percent upper
confidence bound of the median estimate was less than 0.75 times the
1993 RACC, we considered the new median to be significantly less (Ref.
12). When the consumption amount calculated from NHANES 2003-2008
surveys increased or decreased by at least 25 percent from the RACCs
established in 1993 (i.e., less than 75 percent of the 1993 RACC or
more than 125 percent of the 1993 RACC), we concluded that the current
consumption amount needed to be updated; otherwise, we did not propose
to update the 1993 RACC. In addition to determining whether the
consumption amount had increased or decreased at least 25 percent from
the 1993 RACC, we considered the skewness of the data. If the intake
distribution was skewed and we could not rely on the median intake
estimate from the NHANES 2003-2008 consumption data to propose a change
in the RACC, we examined the data from the Food and Nutrient Database
for Dietary Studies (FNDDS) 4.1 (Ref. 25). The data from FNDDS provides
the ``reasonable consumption amount,'' which we used to assist in our
decision about whether to propose a change to the RACC. The reasonable
consumption amount is a default consumption amount of food that
researchers have defined and is used by NHANES when survey participants
cannot recall the amount of food that was consumed at one eating
occasion (Ref. 25). If the reasonable consumption amount for the
product was consistent with the median intake estimate, we considered
whether to propose a change to the 1993 RACC on a case-by-case basis.
If the median intake estimate from the NHANES 2003-2008 consumption
data was not consistent with the reasonable consumption amount for the
product, and if a conversion to a common household measure is
applicable for the product, we then looked to see if there was a
significant difference between the median intake estimates from the
NHANES 2003-2008 consumption data for the product, converted to an
applicable common household measure, and the 1993 RACC for the product.
We received multiple comments asking for clarification or
discussing our proposed amendments to specific RACCs or product
categories. In the preamble of the proposed rule (79 11989 at 12005),
we invited comment on whether we should propose changes to other
product categories, including products identified as products of
concern in comments to the ANPRM. Several comments recommended that we
change RACCs for some of these additional product categories. We
discuss these comments in section III.D.2. Comments relating to
changing RACCs for specific product categories appear in alphabetical
order, by product category.
1. Methodology Used To Determine When To Change RACCs
(Comment 35) Many comments supported the proposed changes to the
RACCs and the methods used to update the RACCs. Many comments were in
favor of the 25 percent criterion to determine if a change was
statistically significant. One comment stated that the methodology used
is consistent with the statutory mandate to base serving sizes on the
amount customarily consumed and provides for a consistent approach
across all food categories. Another comment stated that the comment
analyzed newer NHANES consumption data (NHANES 2009-2010) for certain
product categories and found that the results for the product
categories analyzed were the same as our results when looking at NHANES
2003-2008 survey data.
Other comments questioned the methodology used to determine when to
change the RACCs. Comments questioned why 25 percent was used as the
criterion to determine when a change in RACCs was statistically
significant. Some comments stated that the 25 percent cutoff is
arbitrary and that proposing to update only RACCs with changes of 25
percent or greater neglects some categories that deserve reevaluation
due to their impact on public health. Other comments questioned why we
only looked at NHANES 2003-2008 data. The comments questioned why we
did not consider newer consumption data in our analysis of when to make
changes to the RACCs.
(Response 35) We chose the value of 25 percent to represent a
meaningful change based on our analysis of the data and after
evaluating other values for percentage differences (e.g., 5 percent, 10
percent), when applied to the data. To be conservative, we determined
if the 25 percent change of intake was significantly different from the
1993 RACC by comparing the upper or lower 95 percent confidence
interval for the new median estimates to the either 0.75 or 1.25 times
of the 1993 RACC, respectively. The 95 percent level of confidence is a
general benchmark that is widely accepted in statistics and provides a
conservative estimate to determine whether the recent nationwide
consumption data capture the actual change of the amount being
[[Page 34025]]
consumed from the 1993 RACC while taking into account for the
variability of the measurement when collecting dietary intake data for
the U.S. population. We have not modified our methodology in this final
rule.
With regard to why we did not look at newer NHANES consumption
data, the nationwide food consumption data are released every 2 years
and with 2-year lag time (e.g., the NHANES 2007-2008 consumption data
were released in 2010). The current RACCs, which were established in
1993, are based on data from Nationwide Food Consumption Surveys (1977-
1978 and 1987-1988) conducted by USDA. The 2007-2008 NHANES data were
the most recent consumption data available at the time that we
conducted our analysis. We will continue to monitor consumption trends
and update RACCs in the future as needed. Any consideration of newer
consumption data would be addressed in a future rulemaking.
2. Changing RACCs for Specific Product Categories
(Comment 36) After-dinner confectionaries--We received one comment
on the proposed RACC for after-dinner confectionaries. The comment
supported the 10 g RACC for this product category, but requested that
we provide clarification regarding the description of the product
category. Specifically, the comment requested that any product marketed
as an ``after-dinner confectionery'' or ``after-dinner mint'' and that
is available in units of 10 g or less be included in the ``after-dinner
confectionaries'' product category. The comment pointed out that all of
these products have similar dietary usage. Examples given of products
that should be included in the after-dinner confectionaries product
category were: (1) Small chocolate squares that are similar in size to
after-dinner mints and intended to be used like mint wafers and (2)
``butter mints'' that are often displayed on restaurant counters for
customers to take with them as they leave following a meal. The comment
also recommended that we adopt the spelling of confectionaries as
``confectioneries.''
(Response 36) We agree with this comment and agree that, generally,
chocolate squares, butter mints, and similar products would be included
in the ``after-dinner confectionaries'' product category since these
products have similar dietary usage as after-dinner confectionaries. We
also agree that confectioneries is the more widely used spelling and
are amending table 2 in Sec. 101.12(b) to reflect this spelling.
(Comment 37) Alfredo sauce--One comment opposed placing Alfredo
sauce in the ``Minor main entr[eacute]e sauces (e.g., pizza sauce,
pesto sauce, Alfredo sauce), other sauces used as toppings (e.g.,
gravy, white sauce, cheese sauce), cocktail sauce'' product category.
The comment stated that the amount of sauce typically consumed for
other sauces in this product category is much less than the typical
amount of Alfredo sauce used to coat a serving of pasta. The comment
said that several large Italian restaurant chains were contacted and
those chains stated that they typically use as much Alfredo sauce as
tomato sauce. The comment requested that we keep Alfredo sauce in the
``Major main entr[eacute]e sauces, e.g., spaghetti sauce'' product
category with an RACC of 125 g.
(Response 37) Consumption data for Alfredo sauce is consistent with
other products in the minor main entr[eacute]e sauces product category.
While some may use Alfredo sauce in the same manner as tomato sauce,
others use Alfredo sauce in the same manner as pesto sauce, which is
also in the minor main entr[eacute]e sauces product category. Because
this product can be used in either way, we must rely on consumption
data, which shows that people are typically consuming less Alfredo
sauce than spaghetti sauce. Therefore, we are finalizing our decision
to place Alfredo sauce in the ``Minor main entr[eacute]e sauces (e.g.,
pizza sauce, pesto sauce, Alfredo sauce), other sauces used as toppings
(e.g., gravy, white sauce, cheese sauce), cocktail sauce'' product
category.
(Comment 38) All other candies--We received one comment that
supported our proposal to amend the RACC of the ``All other candies''
product category to 30 g. We received no comments that opposed this
amendment. The supporting comment noted that the 30 g RACC was
consistent with industry analyses of national food consumption data and
other data sources, which suggested that Americans typically consume
candy in moderation. The comment also indicated that the confectionery
industry has been supporting messages that endorse eating candy in
moderation, and has been promoting this concept by marketing
individually wrapped candy units in moderate portion sizes. Further,
the comment expressed concerns that lowering the RACC to 30 g for the
``All other candies'' product category may affect the ability of
manufacturers to make nutrient content claims for certain products. The
comment requested that we consider updating the requirement that foods
with smaller RACCs meet the nutrient criteria per 50 g for the purpose
of making nutrient content claims and that we allow public comments on
the implications to nutrient content claim requirements that are
affected by the proposed rule.
(Response 38) We agree with the comment to the extent that it
supports establishing a 30 g RACC for ``All other candies'' and are
finalizing the change in RACC to 30 g. We decline, however, to reopen
the comment period on the proposed rule or to amend the 50 g criteria
for products that have RACCs of 30 g or less. We accepted comment on
all issues pertaining to the impact that the RACCs have on nutrient
content claims. We believe the comment period on the proposed rule
provided a sufficient opportunity to comment on this and other related
issues. As discussed in section III. E., once this final rule and the
Nutrition Facts final rule are published, we plan to assess the impacts
of these rules on claim eligibility. We intend to consider issues such
as whether any changes in eligibility for claims continues to help
consumers construct healthful diets and whether the criteria for
claims, including the 50 g criteria for products that have RACCs of 30
g or less, remain appropriate. However, as we noted in the proposed
rule, changes in the eligibility to bear claims may be appropriate for
some foods in light of changes in the amounts of food being customarily
consumed (79 FR 11989 at 12016).
(Comment 39) Appetizers, hors d'oeuvres, mini mixed dishes, e.g.,
mini bagel pizzas, breaded mozzarella sticks, egg rolls, dumplings,
potstickers, wontons, mini quesadillas, mini quiches, mini sandwiches,
mini pizza rolls, potato skins--Some comments supported the new
Appetizers product category. The comments stated it is appropriate to
establish a separate category for these smaller-sized versions of the
current product category ``Not measurable with cup, e.g., burritos, egg
rolls, enchiladas, pizza, pizza rolls, quiche, all types of
sandwiches'' in the ``Mixed Dishes'' general category because
appetizers will be consumed in smaller amounts than the current mixed
dishes product category based on their intended use. Some comments
stated that this new product category would align with USDA labeling
requirements for similar products.
One comment requested that, based on the similarities between the
products that qualify for the ``Mixed Dishes'' general category and the
new product category for Appetizers, we consider allowing products in
the new product category for Appetizers to be eligible for
[[Page 34026]]
a ``lean'' claim and requested that we clarify that products in the
Appetizer category are eligible for a ``lean'' claim provided they meet
the appropriate criteria. The regulations for ``lean'' claims currently
permit, in part, products that fall within the product category of
``Mixed dishes not measurable with cup'' to bear the claim, provided
they contain less than 8 g total fat, 3.5 g or less saturated fat, and
less than 80 mg cholesterol per RACC (Sec. 101.62(e)(2)).
(Response 39) We agree that establishing a separate product
category for appetizer products is necessary. Consumption data shows
that appetizers are consumed in smaller amounts than products in the
mixed dish product category. The median consumption for mini pizza
rolls is 83 g and for meatless egg rolls is 57 g. Appetizers are foods
served before a meal, while products in the mixed dish product category
are foods primarily used as entr[eacute]es or main dishes (Ref. 26). We
also note that the products in this new product category (e.g., mini
pizza rolls) are similar to those found in a category in USDA's Guide
to Federal Food Labeling Requirements for Meat and Poultry Products
(USDA's Guide) (Ref. 27), which will allow consumers to compare
nutrition information across food labels for these types of products.
In terms of the ``lean'' claim, we note that while products in the
Appetizers product category that were previously in the ``Mixed dishes
not measurable with cup'' product category no longer fall under the
requirements of Sec. 101.62(e)(2), such products would be permitted to
use a ``lean'' claim on their label if the products satisfy the
requirements of Sec. 101.62(e)(1).
(Comment 40) Fruits used primarily as ingredients, avocado--Some
comments supported updating the RACC for avocado from 30 g to 50 g. The
comments stated that updating the ``Fruits used primarily as
ingredients, avocado'' product category will give Americans more
reasons to choose avocados and increase their fruit and vegetable
intake. The comment stated that the change in the avocado RACC will
help Americans meet their nutrient needs, including some nutrients
identified in the 2010 Dietary Guidelines for Americans as being of
public health concern (e.g., fiber and potassium). The comments said
that updating the RACC for fresh avocados to 50 g (i.e., a \1/3\ medium
avocado serving size) would contribute certain nutrients to the diet.
(Response 40) While this final rule affirms our decision to update
the RACC for avocado, our decision to update the RACC was based on
consumption data, rather than a desire to promote specific products or
product categories.
(Comment 41) Bagel Thins, Mini Bagels--One comment requested that
we include bagel thins and mini bagels in the bread product category,
with an RACC of 50 g, instead of the new ``Bagels, toaster pastries,
muffins (excluding English muffins)'' product category with an RACC of
110 g. The comment stated that bagel thins are a smaller, more calorie-
conscious alternative to full-sized bagels and that each bagel thin,
which is comprised of two slices, weighs 46 g. The comment further
stated that bagel thins are marketed as a perforated unit, like an
English muffin, and are typically suggested for use in making
sandwiches, so that a consumer can enjoy the taste and texture of a
bagel without the full thickness and accompanying calories of a regular
bagel. The comment stated that with the new ``Bagels, toaster pastries,
muffins (excluding English muffins)'' product category, the serving
size for this product would be two separate bagel thins.
The comment also expressed concern with the RACC for mini bagels,
which are sold in 40 g servings. The comment stated that under the
current RACC for bagels, each serving size is one mini bagel, but the
proposed RACC would increase the serving size to three mini bagels. The
comment argued that this change could in turn encourage consumers to
eat more mini bagels than is recommended under the current RACC and
requested that we establish a separate category for these products that
takes into account this discrepancy in serving size and different
intended use. The comment questioned whether NHANES data used to
determine the RACC for bagels included products such as mini bagels and
mini muffins as a separate item from their full-size counterparts. The
comment requested that if there is separate data for mini bagels and
mini muffins, we establish a separate RACC for these mini products and
recommended that we consider adopting a similar approach for other
innovative foods to avoid the unintended consequence of suggesting a
serving size larger than what consumers are likely to consume in a
single eating occasion.
(Response 41) We note that bagel thins have a similar dietary usage
to sandwich bread--namely, to make sandwiches--rather than that of
traditional bagels (i.e., as a breakfast item that is often eaten with
cream cheese or other toppings) (Ref. 26). In addition, a review of
recipes that used bagel thins as an ingredient reveals that most
recipes using bagel thins are recipes for sandwiches that used bagel
thins in a comparable manner to bread (Ref. 28). Section 101.12(a)(7)
states that ``[t]he reference amount is based on the major intended use
of the food. . . .'' The reference amount reflects the major dietary
usage of the food because the major usage determines the customarily
consumed amount (Ref. 29). Therefore, we would include bagel thins in
the ``Breads (excluding sweet quick type), rolls'' product category.
The product category name will remain unchanged, but we intend to
indicate that this type of product will be in the ``Breads (excluding
sweet quick type), rolls'' product category with an RACC of 50 g in
future guidance concerning serving sizes.
With regard to mini bagels, we disagree with the comment and are
finalizing the placement of mini bagels in the ``Bagels, toaster
pastries, muffins (excluding English muffins)'' product category with
an RACC of 110 g. RACCs are not recommended amounts; rather, RACCs are
based on the amount customarily consumed. The comment argues that
increasing the RACC for mini bagels will encourage a consumer to eat
more, but the rationale for increasing the RACC is that consumption
data shows that consumers are already eating more bagel products. In
order to allow consumers to make easy product comparisons we group
products with similar dietary usage together. The primary usage of mini
bagels, like regular-sized bagels, is as a breakfast item. NHANES does
not provide information about mini bagels and mini muffins that is
separate from their larger-sized counterparts, and we have identified
no other data indicating that consumption levels differ between mini
bagels and regular-sized bagels. Further, mini bagels have similar
product characteristics to their larger-sized counterparts (e.g., both
are doughnut-shaped yeast rolls with a dense, chewy texture and shiny
crust) (Ref. 25). Therefore, we decline to establish a separate RACC
for mini bagels.
(Comment 42) Coffee Beans, Tea Leaves, and Certain Plain
Unsweetened Coffee and Tea Products--Some comments noted that products
such as plain unsweetened coffee and tea are exempt from the nutrition
labeling requirements under Sec. 101.9(j)(4) because they contain
insignificant amounts of all nutrients required to be declared in the
Nutrition Facts label. These comments noted that the increased RACC for
these products combined with the proposed mandatory declaration of
potassium in ``Food Labeling: Revision of the
[[Page 34027]]
Nutrition and Supplement Facts Labels'' may cause unsweetened coffee
and tea to have low but detectable levels of potassium, which would
cause them to lose their current exemption from nutrition labeling. The
comments stated that nutrition labeling on these products could pose
challenges for Nutrition Facts labels on small packages. Therefore,
these comments requested that we reexamine Sec. 101.9(j)(4) and make
any necessary adjustments.
(Response 42) We recognize the discrepancy between the explicit
exemption from nutrition labeling for certain coffee and tea products
under Sec. 101.9(j)(4), and the changes to the RACCs and nutrient
declaration requirements that generally subject such products to
nutrition labeling requirements. Although we asked for comment in the
proposed rule about all issues pertaining to the proposed RACCs, we did
not ask for comments specifically about the continued applicability of
the exemption from nutrition labeling provisions under Sec.
101.9(j)(4) in light of the proposed changes to the RACCs and the
proposed changes to the nutrient declaration requirements under the
proposed rule entitled ``Food Labeling: Revision of the Nutrition and
Supplement Facts labels.'' We intend to consider the future
applicability of the exemption with respect to coffee beans (whole or
ground), tea leaves, plain unsweetened coffee and tea, condiment-type
dehydrated vegetables, flavor extracts, and food colors in a separate
rulemaking. Until such time as we have had the opportunity for any
future rulemaking, we intend to consider the exercise of enforcement
discretion with respect to the mandatory nutrition labeling on any
products that would have been exempt under Sec. 101.9(j)(4) prior to
the effective date of this final rule.
We also understand that providing Nutrition Facts labels on
packages with limited space may be challenging for manufacturers. We
have special labeling provisions for packages with limited space in
existing regulations (see Sec. 101.9(j)(13)(i)).
(Comment 43) Canned Fish--One comment discussed the ``Fish,
shellfish, or game meat, canned'' product category. The comment opposed
the increase in the RACC of fish, shellfish, or game meat, canned from
55 g to 85 g. The comment stated that the most common use for canned
seafood was as an ingredient in sandwiches, and that the RACC for the
canned fish product category should remain at 55 g. The comment stated
that canned fish is comparable with the product category ``Substitute
for luncheon meat, meat spreads, Canadian bacon, sausages and
frankfurters'' and four product categories for meat and poultry
products regulated by USDA (i.e., luncheon meat, luncheon products,
canned meats, and canned poultry) (Ref. 27). The comment stated that
the common usage for canned fish in recipes reflects a 55 g RACC since
canned seafood is typically used as an ingredient to prepare
sandwiches, salads and casseroles. The comment also questioned the
validity of the ``reasonable consumption amount'' of 85 g. The comment
stated that the ``reasonable consumption amount'' is a default value
that may be used to indicate the quantity consumed during the dietary
recall survey tool when the participant cannot recall the amount
consumed and that a typical 5 oz can of tuna will provide the consumer
with two, 2 oz (56 g) servings; thus, using 85 g as the default
``reasonable consumption amount'' will inflate the consumption amounts
by over 50 percent. The comment stated that the other serving size
descriptions for canned tuna and other canned seafoods (e.g., canned
salmon) used for the USDA FNDDS need to be updated to reflect current
can sizes. For the product ``Tuna canned, non-specified as to oil or
water pack,'' two of the size options are a 13 oz can with a drained
tuna amount of 321 g and a 6.5 oz can with a drained tuna amount of 160
g. The comment expressed concern that the use of larger-than-available
can sizes and default serving size values will artificially inflate the
amount of canned seafood that is recorded during diet recall surveys.
The comment further stated that the current RACC allows canned
seafood, in particular canned tuna, to be offered in different-sized
cans that reflect one or more servings per can. For example, a 3 oz can
is a single serving, a 5 oz can has two servings, a 7 oz can has two
and a half servings, and a 12 oz can has four and a half servings. The
comment stated that with the proposed change to an 85 g RACC and the
proposal to require products with less than 200 percent of the RACC to
be labeled as a single serving, the 3 oz, 5 oz, and 7 oz can sizes will
all be labeled as a single serving but each with different serving
sizes.
The comment also stated that there is an inconsistency in the
codified table of the proposed rule. The comment stated that the
``Fish, shellfish, or game meat, canned'' product category in the
right-hand column lists examples of label statements and that two of
the examples correspond to a 55 g RACC rather than the proposed 85 g
RACC. The comment noted that the table states, ``2 oz. (56 g/__cup) for
products that are difficult to measure the g weight of cup measure
(e.g., tuna); 2 oz. (56 g/__pieces) for products that naturally vary in
size (e.g., sardines).'' The comment asserted that the examples
provided in the table should reflect the finalized RACC.
(Response 43) In response to the comment that expressed concern
that increasing the RACC will make the product category ``Fish,
shellfish, or game meat, canned'' not easily comparable with the
product category ``Substitute for luncheon meat, meat spreads, Canadian
bacon, sausages and frankfurters,'' although products in both of these
product categories can be used to make sandwiches, the consumption data
for the product categories is different enough to warrant different
RACCs.
To address the comment that questioned the validity of using the
reasonable consumption amount, this comment misunderstands the basis
for the proposed RACC. The change in RACC for this product category was
based primarily on median consumption data and not the reasonable
consumption amount. While we agree that the reasonable consumption
amount is a default value that may be used to indicate the quantity
consumed during the dietary recall survey tool when a participant
cannot recall the amount consumed, this information is not considered
relevant to our proposed RACC for ``Fish, shellfish, or game meat,
canned.'' The decision to increase the RACC for canned fish products is
primarily based on the median consumption NHANES 2003-2008 data of 84
g. Since the reasonable consumption amount did not provide the main
basis for which we determined the RACC, we disagree that using 85 g as
the default ``reasonable consumption amount'' will inflate the
consumption amounts by over 50 percent. The 2003-2008 median
consumption is 84 g for fish, shellfish or game meat, canned, which is
also similar to the reasonable consumption amount from the currently
available FNDDS of 85 g.
To address the comment asserting that the serving size descriptions
for canned tuna and other canned seafood used for the USDA FNDDS need
to be updated to reflect current can sizes, we note that such data is
developed by USDA, and not FDA. To the extent that the comment is
asking that we rely on more recent data, the data we used to establish
the RACC for canned fish is consistent with our use of data in NHANES
as discussed in comment 34.
[[Page 34028]]
The fact that the recent data has shown an increase in consumption
outweighs the argument that the current 55 g RACC is the amount that is
currently used in recipes for sandwiches, salads, and casseroles and
that more can sizes will be labeled as a single serving with an
increase in the RACC. The data suggest that consumers are consuming
larger amounts of canned fish compared to the 1993 RACC of 55 g and
that labeling some larger can sizes as a single serving will accurately
reflect how consumers are eating the product. In addition, while we
recognize the impact that package size has on consumption levels,
package sizes are not taken into consideration when determining RACCs,
as we cannot predict what package sizes will be in the marketplace.
Rather, consumption amount is the primary factor in determining RACCs.
We have addressed the error in the label statement of the new 85 g
RACC in the codified section of this rule. The label statement will be
changed to ``3 oz. (85 g/__cup)'' and ``3 oz. (85 g/__pieces).''
(Comment 44) Cereal--We received several comments concerning the
RACC for breakfast cereal. Some comments supported the decision to
maintain the existing RACC for cereal, yet other comments questioned
the decision to keep the RACC for medium weight cereals the same
despite a significant increase in consumption when compared to the 1993
RACC. The comments stated that ready-to-eat cereals are a common
breakfast food, particularly for children and adolescents, who
typically consume more than the RACC. The comments stated that many
cereals are high in added sugars, which are particularly concerning for
children. Some comments stated that the Children's Food and Beverage
Advertising Initiative (CFBAI) has established voluntary criteria for
the nutritional quality of cereals marketed to children (Ref. 30). The
current CFBAI standard limits the advertising of cereals to ones that
contain no more than 10 g of total sugar per serving (Ref. 30). The
comments noted that if we increased the RACC for medium-dense cereals,
fewer sugary cereals would meet CFBAI's advertising criterion, fewer
would be marketed to children, and companies would reduce the sugar
content of popular cereals to enable them to be marketed to children.
Other comments questioned why the serving size on the labels of
cereals varies so much. For example, a box of one type of cereal may
have a serving size of 1 cup, while a box of another cereal may have a
serving size of \1/2\ cup. Package serving sizes on cereal labels
appear to have greater variation than other product categories.
(Response 44) The 2003-2008 median intake estimates for breakfast
cereals, weighing between 20 g and 43 g per cup (mediumweight cereals)
is 39 g, which is significantly different from the 1993 RACC of 30 g.
However, we did not propose to update the RACC for this product
category in order to keep the household measure most closely associated
with the reference amount consistent with the product category
``Breakfast cereals, ready-to-eat weighing less than 20 g per cup,
e.g., plain puffed cereal grains'' (lightweight cereals) and the
product category ``Breakfast cereals, ready-to-eat weighing 43 g or
more per cup; biscuit types'' (heavy weight cereals), for which
existing RACCs are 15 g and 55 g, respectively (Ref. 31). Although the
serving sizes for low, medium, and heavyweight cereals may appear to be
varied, they are all based on comparable volumetric amounts. The
differences in the density (e.g., grams per cup) of cereals make for
the variation in their serving sizes. A consumer would have to eat more
of a lightweight cereal to equal the weight of a cup of a heavyweight
cereal. For example, the weight of 1 cup of a lightweight cereal, such
as a puffed rice cereal, could be equivalent to the weight of a \1/2\
cup of a heavyweight cereal such as an oat bran cereal. The current
cereal RACCs correspond to 1 cup of cereal for the various cereal
densities. The decision to maintain the current RACC for mediumweight
cereals was to be able to maintain the same volumetric serving size of
cereal for all three product categories. This way, although it may not
appear as such on labels, a consumer is actually comparing similar
amounts in terms of volume regardless of the type of cereal.
In light of the comments, and consistent with our evaluation of
consumption data, we have decided to update the mediumweight cereal
RACC to 40 g (Ref. 32). This amount corresponds to a 1.1 cup
equivalent. Mediumweight cereal has the largest sample size of the
three cereal product categories. We have determined that ensuring
consistency in the RACC for all three breakfast cereal product
categories to reflect the current consumption of mediumweight cereal,
which has the largest sample size of the three product categories, is
more in line with the changes that we made in other product categories.
No change to the RACC is needed for low-density breakfast cereals
weighing less than 20 g per cup, as the existing reference amount of 15
g continues to correspond to 1.1 cups. To ensure consistency with
lightweight and mediumweight cereals, we are updating the RACC for the
heavyweight breakfast cereals weighing 43 g or more per cup from 55 g
(corresponding to 1 cup) to 60 g (corresponding to 1.1. cups). By
making these amendments, the RACCs for all cereals will now correspond
to 1.1 cups.
(Comment 45) Cupcake Filling--One comment requested that we
establish an RACC for cupcake filling. The comment explained that
cupcake filling is frosting, pudding, fruit preserves or other items
that are used to fill a cupcake. The comment asserted that cupcake
filling is different from cake frosting because it is a product that is
made for the purpose of being used inside the cupcake and not on top of
a cupcake or cake. According to the commenter, cupcake fillings use
less frosting or other filling ingredient than is used to ice a cake,
and products from various product categories can be used as cupcake
fillings including pie fillings, non-dairy whipped topping, and
frosting.
(Response 45) We recognize a need for an RACC for this specific
food product as well as for other types of cake or pastry fillings.
Cake, pastry, and cupcake fillings include fillings for products such
as donuts, cakes, and cupcakes. However, because the proposed rule was
silent about an RACC for cupcake filling, and because we intend to
provide the opportunity for public comment on this specific issue, we
intend to establish an RACC for this product category in future
rulemaking and intend to add a suggested RACC of 1 tbsp for this
product category distinct from the ``Cake frostings or icings'' product
category in a future guidance document.
(Comment 46) Drink Mixes--Some comments discussed the two new drink
mix product categories: ``Milk, milk substitute, and fruit based drink
mixes (without alcohol) e.g., drink mixers, fruit flavored powdered
drink mixes, sweetened cocoa powder)'' and ``Drink mixes (without
alcohol): all other types (e.g., flavored syrups and powdered drink
mixes).'' The comments were generally in favor of the proposed changes
to the drink mix product categories, but requested a revision to the
fruit-based drink mixes. The comments requested that the subcategory of
``fruit-based drink mixes,'' which includes fruit-flavored powdered
drink mixes, be removed from the ``Milk, milk substitutes, and fruit
based drink mixers (without alcohol), e.g., drink mixers, fruit
[[Page 34029]]
flavored powdered drink mixes, sweetened cocoa powder)'' product
category with an RACC of ``Amount to make 240 mL drink (without ice)''
and added to the ``Drink mixes (without alcohol): all other types
(e.g., flavored syrups and powdered drink mixes)'' product category
with an RACC of ``Amount to make 360 mL drink (without ice)'' based on
its primary use as a mix added to water. The comments stated that the
categorization of drink mixes causes inconsistencies. For example,
powdered tea mixes are currently in the amount to make 360 mL product
category, and non-flavored tea mixes would have an RACC of 360 mL;
however, fruit-flavored tea mixes (e.g., raspberry-flavored tea) would
have an RACC of 240 mL. The comments stated that this categorization of
drink mixes could foster confusion for consumers and lead to
unnecessary and unwarranted changes for industry.
One comment asked for clarity on the categorization of liquid
concentrate beverage mixes and requested that a subcategory for
``liquid beverage concentrates'' be added to the product category
``Drink mixes (without alcohol): all other types (e.g., flavored syrups
and product drink mixes),'' with an RACC of 360 mL (12 fl oz), since
this product subcategory is primarily added to water when consumed.
(Response 46) The proposed ``Milk, milk substitutes, and fruit
based drink mixers (without alcohol), e.g., drink mixers, fruit
flavored powdered drink mixes, sweetened cocoa powder)'' product
category is intended to contain drink mixes containing 100 percent
fruit-based ingredients, such as fruit juice concentrate, which have
similar dietary usages as 100 percent fruit juices or fruit drinks.
This product category was not intended to include products that are
fruit flavored. Therefore, a fruit-based drink mix with an RACC of 8 fl
oz is necessary. However, we understand the issue addressed in the
comment and see that it is necessary to create an additional RACC for
fruit-flavored drink mixes that have an RACC of 360 mL (12 fl oz).
Therefore, we are revising the product category names to reflect the
changes. We are clarifying that the 240 mL (8 fl oz) RACC product
category is intended for fruit drink mixes that substitute 100 percent
juice blends such as frozen fruit juice concentrates and that the 360
mL (12 fl oz) RACC product category is intended for powdered fruit-
flavored drink mixes that are comparable to iced tea mixes and other
beverages that have an RACC of 360 mL (12 fl oz). Fruit juice
concentrates should have an RACC of 240 mL (8 fl oz), consistent with
100 percent fruit juices and fruit drinks. The name for the ``Milk,
milk substitutes, and fruit based drink mixers (without alcohol), e.g.,
drink mixers, fruit flavored powdered drink mixes, sweetened cocoa
powder)'' product category is amended in Sec. 101.12(b) to ``Milk,
milk substitute, and fruit juice concentrates (without alcohol) (e.g.,
drink mixers, frozen fruit juice concentrate, sweetened cocoa
powder).'' The category name for ``Drink mixes (without alcohol): all
other types (e.g., flavored syrups and powdered drink mixes'' will
remain the same.
With respect to the comment concerning liquid beverage
concentrates, the comment does not describe what a liquid beverage
concentrate is. We are unsure if the products referred to are different
than the fruit juice concentrates discussed previously. However, if the
product is fruit flavored, rather than a fruit juice concentrate, then
it should be included in the ``Drink mixes (without alcohol): all other
types (e.g., flavored syrups and powdered drink mixes)'' product
category with an RACC of 360 mL (12 fl oz).
(Comment 47) Fruit juice--Several comments supported keeping the
RACC for fruit juice at 240 mL (8 fl oz). One comment stated that a 240
mL (8 fl oz) RACC is consistent with guidelines established by the
American Academy of Pediatrics and the Robert Wood Johnson Foundation
(which both recommend 8 oz of juice for adults and older children), in
addition to the 2010 Dietary Guidelines for Americans. The comment
requested that all juice beverages have the same 240 mL (8 fl oz) RACC
regardless of whether it is manufactured with still water or carbonated
water.
(Response 47) Based on our review of the data as described in the
proposed rule (79 FR 11989 at 12010), we agree that the RACC for fruit
juice should remain at 240 mL (8 fl oz). Products that contain less
than 100 percent and more than 0 percent fruit or vegetable juice and
that meet the requirements under Sec. 102.33(a) to be labeled as a
juice ``beverage,'' ``drink,'' or ``cocktail'' have an RACC of 240 mL
(8 fl oz) regardless of whether they are manufactured with still water
or carbonated water. We note, however, that drink mixers do not fall
within the product category ``Juices, nectars, fruit drinks''; rather,
products such as strawberry daiquiri mix and Bloody Mary mix are part
of the product category ``Drink mixes (without alcohol): all types
(e.g., flavored syrups and powdered drink mixes).''
(Comment 48) Hazelnut spread--We received a comment requesting that
we either: (1) Expand the existing product category for ``Honey, jams,
jellies, fruit butter, molasses'' to include nut cocoa based spreads,
such as hazelnut spread or (2) establish a new RACC of 1 tbsp for nut
cocoa based spreads. The comment stated that hazelnut spread is
currently in the product category ``other dessert toppings'' because it
was considered to be comparable with chocolate syrup at the time of the
1991 proposed rule. The comment indicated that hazelnut spread is
currently primarily used on bread or as a spread for snacks, crackers,
and fruits. The comment also stated that the mean, median, and mode
consumption amounts for hazelnut spread in NHANES are all equal to 1
tbsp.
(Response 48) We recognize a need for an RACC for hazelnut spread
outside of the dessert product category. We agree that the primary
usage of hazelnut spread is as a spread for bread instead of as a
dessert topping. However, because the proposed rule was silent about an
RACC for hazelnut spread, and because we intend to provide the
opportunity for public comment on this specific issue, we intend to
consider whether to move hazelnut spread to a different appropriate
product category in a future rulemaking.
(Comment 49) Several comments questioned the regrouping of the
``Ice cream, ice milk, frozen yogurt, sherbet: all types, bulk and
novelties (e.g., bars, sandwiches, cones)'' product category and the
``Frozen flavored and sweetened ice and pops, frozen fruit juices: all
types, bulk and novelties (e.g., bars, cups)'' product category to the
following product categories: ``Ice cream, ice milk, frozen yogurt,
sherbet, frozen flavored and sweetened ice, frozen fruit juices: all
types bulk'' and ``Ice cream, ice milk, frozen yogurt, sherbet, frozen
flavored and sweetened ice and pops, frozen fruit juices: all types
novelties (e.g., bars, sandwiches, cones, cups).'' The comments stated
that the decision to increase the RACC for ice cream was arbitrary and
that it is only by proposing to separate the ice cream product category
into separate RACCs for bulk ice cream and novelties that we were able
to determine that consumption of one of those categories (i.e., ``bulk
ice cream'') had increased by more than 25 percent compared to the 1993
RACC.
The comments stated that the separation of the ice cream category
into two sub-categories raises an issue of consistency between the two
product categories. The comments stated that the exact type of ice
cream sold in a \1/2\ cup individual novelty serving can be packaged in
a larger bulk container such as a pint or \1/2\ gallon. The comments
[[Page 34030]]
stated that although the products will have identical formulations, the
differing RACCs between the bulk and novelties package sizes would
result in different criteria for the nutrient content claims such as
``low fat,'' ``fat free,'' or ``non-fat.'' This would mean the same ice
cream could meet the criteria for ``low fat'' when packaged in a small,
novelty-sized cup, but not when it is packaged in a larger container.
Similarly, a frozen yogurt or ice cream product may be considered a
``good source'' of calcium when dispensed from a bulk container, but
not a good source of calcium when provided in a single-serve cup. One
comment asserted that using two different RACCs depending upon the
package size (e.g., bulk or single-serve cup) would create consumer
confusion through the distinction in nutrient content claims each
product would be permitted to make.
One comment requested that we remove the term ice milk from the
product category name ``Ice cream, ice milk, frozen yogurt, sherbet,
frozen flavored and sweetened ice, frozen fruit juices: all types
bulk.'' The comment noted that the standard for ice milk was abolished
in 1994 when we acted on a citizen petition from the International Ice
Cream Association and issued a final rule entitled ``Frozen Desserts:
Removal of Standards of Identity for Ice Milk and Goat's Milk Ice Milk;
Amendment of Standards of Identity for Ice Cream and Frozen Custard and
Goat's Milk Ice Cream'' (59 FR 47072, September 14, 1994).
One comment stated that soft-serve products are distinct from
traditional (hard pack) ice cream and frozen desserts. The comment
asserted, for example, that a typical soft-serve ice cream has less
fat, more milk solids, a lower sugar content, and a lower percent
overrun (referring to the amount of air that is whipped into the
product), and is generally eaten at a warmer serving temperature
compared to a typical hard ice cream. The comment stated that a typical
hard ice cream has a density of 1.0 weight ozs per 1.8 fl oz (128 g per
cup), while a survey of the soft-serve ice cream industry revealed an
average product density of 1.0 weight ozs per 1.25 fl oz (181 g per
cup). The comment requested a new product category for soft-serve ice
cream named ``Soft serve ice cream, soft serve frozen custard, soft
serve gelato: all types bulk'' with an RACC of \1/2\ cup. The comment
noted that there is precedent for delineation of products by
differences in density--for example, ``Cakes'' are separated into
categories of heavyweight, mediumweight, and lightweight; and
``Breakfast cereals'' are separated into categories by density (puffed,
medium density, and biscuit type). The comment stated that because of
their differences in density, such a separation seems appropriate for
frozen dairy desserts as well.
(Response 49) With respect to the comments regarding the
reorganization of the two product categories--``Ice cream, ice milk,
frozen yogurt, sherbet, frozen flavored and sweetened ice, frozen fruit
juices: all types bulk'' and ``Ice cream, ice milk, frozen yogurt,
sherbet, frozen flavored and sweetened ice and pops, frozen fruit
juices: all types novelties (e.g., bars, sandwiches, cones, cups)''--we
have reconsidered our position on whether distinct product categories
are necessary. Upon further consideration, we agree that bulk frozen
dairy products are similar to novelty frozen dairy products, and that
bulk frozen fruit flavored products are similar to novelty frozen fruit
flavored products, both in terms of dietary usage and in terms of
product characteristics. We recognize that the same type of ice cream
sold in a \1/2\ cup individual novelty serving can be packaged in a
larger bulk container such as a pint or \1/2\ gallon and that these
products may have identical formulations. In order to allow for
comparable frozen dessert products to be grouped together we are
modifying the preexisting RACCs to create one combined product category
with the product category name ``Ice cream, frozen yogurt, sherbet,
frozen flavored and sweetened ice, frozen fruit juices: all types bulk
and novelties (e.g., bars, sandwiches, cones, cups).'' This change
should also eliminate concerns expressed by comments that using two
different RACCs depending upon the package from which the product is
dispensed (e.g., bulk or single-serve cup) might be confusing to
consumers.
In order to determine the median consumption amount for the product
category ``Ice cream, frozen yogurt, sherbet, frozen flavored and
sweetened ice, frozen fruit juices: all types bulk and novelties (e.g.,
bars, sandwiches, cones, cups),'' we analyzed the NHANES 2003-2008
intake data for all products in this product category and found that
the median consumption of these products is 0.7 cup. Under Sec.
101.9(b)(5)(i), when the use of cups is the appropriate household unit
in which to express serving size, the quantity in cups shall be
expressed in \1/4\- or \1/3\-cup increments. Under this provision, 0.7
cups rounds to \2/3\ of a cup. Therefore, we are creating an RACC for
the new product category ``Ice cream, frozen yogurt, sherbet, frozen
flavored and sweetened ice, frozen fruit juices: all types bulk and
novelties (e.g., bars, sandwiches, cones, cups)'' of \2/3\ of a cup.
The regrouping of these product categories allows for like products to
have the same RACCs based on similar dietary usage, product
characteristics, and customary consumption amounts.
With respect to the comment that requested that we remove the term
``ice milk'' from the product category ``Ice cream, ice milk, frozen
yogurt, sherbet, frozen flavored and sweetened ice, frozen fruit
juices: all types bulk,'' we agree. Ice milk has not been included in
the new frozen desserts product category.
With respect to the comment requesting a separate product category
for soft serve ice cream, we decline to make this change. Bulk soft-
serve ice cream has similar dietary usage and is consumed in the same
manner as non-soft-serve ice cream (Ref. 26). Providing the same RACC
for these two types of products allows consumers to easily compare
nutrition information between the two products.
(Comment 50) Ice cream--Several comments addressed the change in
the RACC for ice cream from \1/2\ cup to 1 cup. Some comments favored
the proposed changes to the RACC for ice cream, while others were
opposed to it. The comments in favor of the 1 cup RACC for ice cream
stated that the new RACC was more reasonable and consistent with the
amount that a person typically consumes.
Other comments stated that a \1/2\ cup measure for ice cream is a
more practical and realistic reference amount. One comment stated that
a \1/2\ cup of ice cream is not misleading. The comment noted that the
common household ice cream scoop dispenses 8 servings of ice cream per
quart, or exactly a \1/2\ cup of ice cream. The comment further noted
that the \1/2\ cup measure is a simple common reference point that
consumers clearly understand and that, with ongoing concerns about
obesity in America, it is important to have simple tools to help
consumers manage their weight. A few comments suggested that if we
increased the RACC to 1 cup, consumers might interpret the RACC as an
indication that two scoops of ice cream is an appropriate portion.
(Response 50) With respect to the comments stating that the RACC
for bulk ice cream should remain at \1/2\ cup because this is the
typical amount in a household scoop, the comment did not provide data
to confirm that a \1/2\ cup ice cream scoop is the most common
household size. There are ice cream scoops that are commercially
available to consumers in sizes ranging from 0.5 oz (1 tablespoon
(tbsp)) to 5 oz (1 cup)
[[Page 34031]]
(Ref. 33). Although it may be common for ice cream scoops to scoop ice
cream in the amount of \1/2\ cup, ice cream scoop sizes vary. We also
note that the comment provided no support for the assertion that
consumers eat one scoop of ice cream. It is less subjective and
consistent with FDA's legal authority to base the RACC on the amount
customarily consumed. As explained in comment 49, we are finalizing an
RACC for the product category ``Ice cream, frozen yogurt, sherbet,
frozen flavored and sweetened ice, frozen fruit juice: all types bulk
and novelties (e.g. bars, sandwiches, cones, cups)'' of \2/3\ of a cup.
With respect to the comment that stated that increasing the RACC
for ice cream would be confusing to consumers and encourage them to eat
more, we note that some consumer comments on the ANPRM and the proposed
rule suggested strongly that the existing RACC is misleading and
requested that the RACC for ice cream be based on a more realistic
amount. To help ensure that consumers understand the meaning of changes
to the serving size portion of the Nutrition Facts label, we intend to
conduct nutrition education to help clarify the meaning of the serving
size and RACCs after this rule becomes effective.
(Comment 51) Some comments questioned the density measurements we
used when converting from the amount of ice cream consumed, as reported
in NHANES data, to the common household measure based on cups in order
to determine the RACC for bulk ice cream. One comment stated that a
memo to the file for the proposed rule (Ref. 31) states the household
units were calculated using the following conversion factors: 1 oz of
ice cream or frozen yogurt = 1.5 fl oz; 1 cup = 8 fl oz (citing Sec.
101.9(b)(5)(viii)). The comment agreed with this conversion factor
based on the air typically incorporated into ice cream, but did not
believe we applied the conversion factor correctly. The comment stated
that the median weight for ``Ice cream, bulk, and regular'' from 2003-
2008 NHANES is 116 g, but that, in the proposed rule (79 FR 11989 at
12012), we stated that the ``[c]urrent consumption data for bulk ice
cream has increased to 0.875 cup, which is closer to 1 cup as compared
to the current RACC of \1/2\ cup.'' The comment stated that, if the
footnote conversion factor were applied to the median serving size of
ice cream expressed by weight, it would result in a lower value of
6.108 fl ozs or 0.767 cup, which would round in household measures to
\3/4\ of a cup (116 g/28.35 g per oz = 4.09 oz x 1.5 = 6.138 fl oz) and
that this corresponds to a density value of 151 g per cup for ice cream
and frozen yogurt (i.e., (1 oz/1.5 fl oz)(8 fl oz/1 cup)(28.35 g/oz) =
151g/cup)). The comment noted that a \3/4\ cup household measure for
bulk ice cream reflects current consumption data and product
composition and said that the comment relied upon used the most current
density measurement for ice cream of 148 g per cup, based on NHANES
data from 2003-2010, which will result in an RACC of \3/4\ cup for bulk
ice cream. The comment stated that when the 148 g per cup density
measurement for ice cream is applied to the 2003-2008 NHANES median
amount consumption per eating occasion (116 g), the household measure
is calculated at 0.783 cup (6.26 fl oz or \3/4\ cup). The comment
stated that consumers now favor more dense ice creams, and that the ice
cream industry has changed processing and formulations to meet consumer
expectations. The comment stated that if the 163.5 g density was
applied to the 120 g serving size (2003-2010 NHANES) the household
measure would also round to \3/4\ cup (120 g median serving NHANES
2003-2010/163.5 g per cup = 0.736 cup (5.89 fl oz or \3/4\ cup).
(Response 51) With respect to the comments questioning the density
measurements used to calculate the RACCs, the comment used a different
procedure to calculate the density measurements than we did in the
proposed rule. When we calculate density, the median ice cream
consumption in cups is based on the median consumption distribution of
all varieties of ice cream using the consumption amount for each
individual product (e.g., strawberry ice cream, chocolate ice cream).
The consumption amount is then converted from gram weight to volume in
cups for each individual product. The method described in the comment,
in contrast, looked at the density of the product category as a whole--
instead of the consumption amount for each individual product--and
converted the median of gram weight amount to the median consumption in
cups to determine the median of consumption amount in a household
measurement. Therefore, 0.875 cup was the median consumption amount for
the bulk ice cream product category discussed in the proposed rule
based on consumption distribution when each participant's ice cream
consumption has already been converted from gram weight to volume in
cups, and there is no further conversion for that median gram weight
estimate. We did not consider a \3/4\ cup RACC for bulk ice cream to be
appropriate because the consumption data shows that 0.875 cup (half way
between 0.75 cup and 1 cup, therefore, rounding up to 1 cup) is the
amount customarily consumed, not 0.736 cup as stated in the comment. As
discussed previously in response to comment 34, our calculations relied
on 2003-2008 NHANES data rather than 2003-2010 data. As explained in
comment 49, we have combined the proposed categories ``Ice cream, ice
milk, frozen yogurt, sherbet, frozen flavored and sweetened ice, frozen
fruit juices: all types bulk'' and ``Ice cream, ice milk, frozen
yogurt, sherbet, frozen flavored and sweetened ice and pops, frozen
fruit juices: all types novelties (e.g., bars, sandwiches, cones,
cups)'' into one product category, ``Ice cream, frozen, yogurt,
sherbet, frozen flavored and sweetened ice, frozen fruit juice: all
types bulk and novelties (e.g., bars, sandwiches, cones, cups).'' The
RACC for the new product category is \2/3\ of a cup. The methodology
used in determining this reference amount is consistent with the
methodology we used in the proposed rule (Ref. 32).
(Comment 52) Foods for Infants and Children 1 through 3 Years of
Age--We received one comment that supported changing the RACC for the
``Dinners, dessert, fruits, vegetables or soups, ready-to-serve,
strained type'' product category from 60 g to 110 g. The comment noted
that the proposed RACC was similar to the consumption amount calculated
by the comment after evaluating available data. The comment also
requested changes to the product categories for infant and toddler
(children 1 through 3 years of age) foods. The comment stated that the
number of foods available and specifically marketed to infants and
children 1 through 3 years of age has grown significantly since the
1993 RACCs were created, including yogurt, pasta, snacks, breakfast
cereal, entr[eacute]es, and main dish items. The comment stated that
many foods now available for infants and young children 1 through 3
years of age do not have specific RACCs, and that more guidance on
RACCs for foods for infants and children 1 through 3 years of age
should be codified to ensure consistency in serving sizes, labeling and
claims for foods marketed for infants and young children. The comment
included a table of recommendations for new product categories for
foods for infants and children 1 through 3 years of age, along with
proposed corresponding RACCs.
(Response 52) We agree more products for infants and children 1
through 3 years of age are currently on the market than were available
in 1993.
[[Page 34032]]
At the time of publication of the serving size proposed rule, there was
limited data for these new types of infants and toddler foods in
NHANES. We intend to review the data submitted in the comment and
address these additional foods in a separate rulemaking.
(Comment 53) Milk and soy beverages--One comment supported our
proposal to modify the product category ``Milk, milk-based drinks,
e.g., instant breakfast, meal replacement, cocoa'' to ``Milk, milk-
substitute beverages, milk-based drinks, e.g., instant breakfast, meal
replacement, cocoa, soy beverage.'' The comment stated that it agreed
with the change in name and is gratified to see our acknowledgement and
proper use of the term ``soy beverage.''
(Response 53) The final rule uses the new product category name of
``Milk, milk-substitute beverages, milk-based drinks, e.g., instant
breakfast, meal replacement, cocoa, soy beverage.'' We note, however,
that our adoption of this product category name does not constitute an
official ``acknowledgement'' that the term ``soy beverage'' is the sole
appropriate descriptor for all beverages containing soy.
(Comment 54) Mixed dishes measurable with cup--We received a
comment asking us to change the label statement for mixed dishes
measurable with cup in Sec. 101.12(b), table 2 from 1 cup (__ g) to
``__ cup (__ g).'' The comment stated that the current label statement
of 1 cup (__ g) is not applicable for fully cooked frozen fried rice
that only requires heating to be ready-to-serve. The comment stated
that it was requesting a change to the label statement because not all
``almost-ready-to-serve products'' maintain the same density after
heating. The comment stated that in order to obtain 1 cup of ready-to-
serve cooked rice, it is necessary to measure 1\1/3\ cups of the frozen
rice and that the correct serving size should be 1\1/3\ cups. The
comment requested that the label statement for mixed dishes measurable
with a cup be left blank and written as ``__ cup (__ g).''
(Response 54) We disagree with changing the label statement for
this product category based on the information provided in the comment.
Section 101.12(b), table 2, footnote 2 says that the reference amounts
are for the ready-to-serve or almost ready-to-serve form of the product
(e.g., heat and serve, brown and serve), and if not listed separately,
the reference amount for the unprepared form (e.g., dry mixes,
concentrates, dough, batter, fresh and frozen pasta) is the amount
required to make the reference amount of the prepared form. This means
that although the RACC for mixed-dish products is 1 cup, this amount is
for the prepared product. The serving size, however, must represent the
product as packaged. Because the weight of the cooked rice depends on
the amount of water used in the preparation, the amount required to
make one reference amount in cooked form can vary widely. Additionally,
as we explained in the 1993 serving size final rule, establishing a
reference amount on a cooked basis could allow manipulation of the
reference amount for dry rice (58 FR 2229 at 2253). The serving size,
therefore, is the amount of the frozen rice, expressed in a household
measure, which will make 1 cup when prepared according to package
directions.
We also disagree with the assertion in this comment that fully
cooked frozen fried rice is an almost ready-to-serve product. Frozen
rice is not an almost ready-to-serve product; rather, it is an
unprepared product because it is frozen and requires cooking before
being consumed. This means that the product should be labeled with the
reference amount of 1 cup of rice, using the amount of frozen rice
required to make 1 cup of prepared rice to determine the nutrition
values on the label.
(Comment 55) One comment supported maintaining the product category
``Not measurable with cup e.g., burritos, egg rolls, enchiladas, pizza,
pizza rolls, quiche, all types of sandwiches,'' under the general
category ``Mixed Dish'' at the current RACC of 140 g, add 55 g for
products with gravy or sauce topping. The comment stated that it
analyzed consumption data from NHANES 2003-2010 and found that the
median estimated intake for pizza (all crust types) is 169 g, or 21
percent of the current RACC, which is below the amount to be considered
significant and does not indicate that the RACC needs to be updated.
The comment stated that this supports our assessment that maintaining
the current RACC is still an appropriate representation of amounts
customarily consumed for this product category.
(Response 55) We agree that no change to the RACC for the ``Not
measurable with cup, e.g., burritos, egg rolls, enchiladas, pizza,
pizza rolls, quiche, all types of sandwiches'' product category is
necessary. We note, however, that our analysis is based on 2003-2008
NHANES consumption data, rather than 2003-2010 consumption data as this
comment purported to use.
(Comment 56) Muffins--One comment opposed increasing the RACC for
muffins from 55 g to 110 g. The comment questioned whether we included
muffins sold in restaurants in the data analysis used to update the
muffin RACC. The comment stated that the sizes of packaged muffins sold
in the retail store were closer to or less than the current 55 g RACC
for muffins. In contrast, the sizes for muffins sold in cafes and
restaurants are substantially larger and closer to the proposed RACC of
110 g. The comment stated that 110 g does not reflect the amount of
packaged retail muffins customarily consumed in one eating occasion,
particularly given that muffins are consumed in discrete units.
The comment also asked for clarification on whether products such
as mini-muffins packaged in a multipack of pouches that typically
contain about 5 mini muffins per pouch, with a weight of about 47 g per
pouch, will be required to declare the serving size on the outer carton
of the multipacks of pouches as 2 packs (94 g) instead of 1 pack (47
g). With the increase in the RACC for muffins to 110 g, 2 packs of mini
muffins would be the amount that most closely approximates the RACC.
The comment suggested that one pouch would be a more appropriate
serving size.
(Response 56) The 2003-2008 NHANES consumption data captures all
possible sources of the food (e.g., restaurant, vending machine,
grocery store). Our analysis considered all sources of food because the
data available does not allow us to distinguish consumption at home
from consumption in retail stores, restaurants or other eating
establishments. We note, however, that only one-third of the food
represented in NHANES data is consumed away from home, meaning that the
majority of consumption reported is food eaten in the home. Food eaten
at home is more likely to be packaged food. The 2003-2008 NHANES data
shows an increased consumption for muffins, so we are updating the RACC
accordingly. We also note that muffins that are sold in restaurants may
be distributed through retail stores.
With regard to the request for clarification on how to label a
multipack of pouches of mini muffins, this would depend on a number of
factors, including whether the pouches bear Nutrition Fact panels. As
discussed in the response to comment 10, manufacturers of packages that
weigh less than 200 percent of the RACC each that are contained within
a larger container have the option of labeling each individual package
with a Nutrition Facts panel, and then labeling the outer container to
state the number of servings as the number of individual packages
within the outer container in
[[Page 34033]]
accordance with Sec. 101.9(b)(8)(iv). As is discussed in the response
to comment 9, a product that is packaged and sold individually, i.e., a
container that bears a Nutrition Facts panel, is considered a single-
serving container if it contains less than 200 percent of the RACC, and
would be required to provide dual-column labeling if it contains at
least 200 percent to 300 percent of the RACC, unless an exception from
the requirement applies.
(Comment 57) Pasta with sauce--Several comments requested that we
increase the RACC for pasta with sauce. The comments stated that
consumption for pasta with sauce increased by 50 percent to 1.5 cups.
One comment noted that we did not propose to increase the RACC for
pasta with sauce because the two products with the largest samples
sizes in the product category--``Rice, flavored'' (consumed by 3,477
respondents) and ``Mixtures with sauce'' (consumed by 2,919
respondents)--did not increase to more than 1 cup and that pasta with
sauce was the third most popular food group (consumed by 2,871
respondents). The comment disagreed with our rationale to keep the
entire ``measureable by a cup'' category at 1 cup because it stated
that the foods in that product category vary so widely (e.g., pot pies,
lasagna and ravioli, casseroles, chili and stew, mixtures with sauce,
and mixtures without sauce). The comment requested that we increase the
RACC for pasta with sauce to 1.5 cups based on the 2003-2008 NHANES
consumption data. The comment stated that lumping pasta with sauce in
with other foods in the ``Measurable with cup, e.g., casseroles, hash,
macaroni and cheese, pot pies, spaghetti with sauce, stews, etc.''
product category under the ``Mixed Dishes'' general category violates
the FD&C Act, which requires RACCs to be based on amounts ``customarily
consumed.''
(Response 57) While consumption of pasta with sauce did increase
since we established the 1993 RACCs, as the comment noted, consumption
for other products in the product category with larger sample sizes did
not increase. All of the products in this product category are mixed
dishes that are generally used as entr[eacute]es. Products in this
category are mixtures and usually contain starch (e.g., rice, pasta),
dried beans and/or animal source ingredients (e.g., cheese, fish,
shellfish). They come with or without vegetables (Ref. 34). Thus, all
of these products are comparable in that they have similar dietary
usage and product characteristics (e.g., they are mixed dishes that are
measurable with a cup). Frozen entr[eacute]es are included in the mixed
dishes product category. One manufacturer may have a product line with
a variety of frozen meals that includes frozen spaghetti with tomato
sauce, frozen lasagna, frozen rice mixture, and frozen macaroni and
cheese. We note that it would not be helpful to a consumer who is
choosing among the different varieties of the same product line if one
box shows a serving size that is based on the RACC of 1 cup, while
another box which has similar packaging, and is part of the same
product line, shows an RACC of 1.5 cups. It is important that the RACCs
of comparable products be similar to help consumers to more easily
compare nutrition information on the Nutrition Facts label across
similar products.
With respect to the comment asserting that including pasta with
sauce in the product category ``Measurable with cup, e.g., casseroles,
hash, macaroni and cheese, pot pies, spaghetti with sauce, stews,
etc.'' under the ``Mixed Dishes'' general category violates the FD&C
Act, we disagree. Products in this category are mixtures that usually
contain starch (e.g., rice, pasta), dried beans and/or animal source
ingredients (e.g., cheese, fish, and shellfish) (Ref. 34). These
products have similar dietary usage and are usually consumed in the
same way as an entr[eacute]e or main dish. Other comparable products in
this product category include casserole, lasagna, and macaroni and
cheese. The RACC for pasta is based on the amount that is customarily
consumed for products in this product category. We disagree with the
assertion that grouping foods in such a manner violates the FD&C Act.
We followed the methodology used for all products categories when
determining the RACC for the ``Measurable with cup, e.g., casseroles,
hash, macaroni and cheese, pot pies, spaghetti with sauce, stews,
etc.'' product category under the ``Mixed Dishes'' general category.
Products with a larger sample size in the product category did not show
a significant amount of change; therefore, we did not update the RACC
for pasta with sauce.
(Comment 58) We received a comment requesting us to clarify if
plant-based beverages with added ingredients are included in the
proposed product category for ``Milk, milk-substitute beverages, milk-
based drinks, e.g., instant breakfast, meal replacement, cocoa, soy
beverage.'' The comment stated that the proposed rule does not discuss
the appropriate RACC for plant-based beverages with added ingredients,
such as protein, fiber, or fruit, including those that may be
positioned as a plant-based ``smoothie.'' The comment argued that
plant-based beverages with added ingredients should be included within
the RACC for milk and milk-substitute beverages because plant-based
beverages with added ingredients are more nutrient dense than a
carbonated or non-carbonated beverage like a soda or water, and
typically contain higher levels of protein, vitamins, and minerals.
(Response 58) We did not intend plant-based beverages with added
ingredients to be included in the proposed product category for ``Milk,
milk-substitute beverages, milk-based drinks, e.g., instant breakfast,
meal replacement, cocoa, soy beverage,'' and we disagree that plant-
based beverages with added ingredients should be included in this
product category. Whether or not plant-based beverages with added
ingredients are more nutrient dense than a carbonated or non-carbonated
beverage like a soda or water depends on the contents of a specific
product; however, we do agree that plant-based beverages do not belong
in the same product category as carbonated and non-carbonated
beverages. A plant-based beverage such as a smoothie is a beverage that
is made by blending fruit with yogurt, milk, or ice cream until it is
thick and smooth (Ref. 26). Plant-based beverages with added
ingredients are otherwise more similar to other items in the product
category ``Shakes and shake substitute, e.g., dairy shake mixes, fruit
frost mixes'' than to products in the category ``Milk, milk-substitute
beverages, milk-based drinks, e.g., instant breakfast, meal
replacement, cocoa, soy beverage.'' The comment's description of a
plant-based mix includes products with fruit or cocoa as added
ingredients. Fruit and cocoa are commonly added ingredients in
milkshakes (Ref. 26). Regardless of the distinction between product
categories, we note that the RACC for the milk and milk substitute
product category is the same as the RACC for the milkshake product
category.
(Comment 59) Powdered candies and liquid candies--We received one
comment in support of our proposals to add ``powdered candies'' and
``liquid candies'' to the product category currently designated as
``Hard candies, others'' and to establish an RACC of 15 mL for liquid
candies and 15 g for powdered candies and all other hard candies. The
comment noted that the proposed RACCs are consistent with ``suggested
RACCs'' provided in FDA guidance and are consistent with current
industry practices. The comment also supported our proposal to rename
this product category ``Hard candies, others; powdered candies, liquid
candies'' to indicate that
[[Page 34034]]
powdered and liquid candies would now be included in this product
category.
(Response 59) We agree with this comment. Powdered candies may be
dispensed from straws, and liquid candy can be dispensed from small
bottles or waxy containers. This final rule establishes an RACC of 15 g
for powdered candies and an RACC of 15 mL for liquid candies and
includes both in the product category ``Hard candies, others; powdered
candies, liquid candies.'' Additionally, the label statement for this
category in table 2 of Sec. 101.12(b) will include label statements
for powdered candies (``____straw(s) (____g) for powdered candies'')
and liquid candies (`` ____wax bottle(s) (____mL) for liquid
candies'').
(Comment 60) Powdered coffee creamer--Some comments requested that
we increase the RACC for powdered coffee creamer from the current RACC
of 2 g, which is equal to 1 teaspoon (tsp). The comments stated that
the NHANES data show that the median consumption of powdered coffee
creamer has doubled to 4 g, or 2 tsps. One comment stated that
consumers use much more than 2 g or 4 g and suggested that we use 6 g,
or 1 tbsp, as the RACC. The comment stated that we should increase the
RACC for powdered creamers to 1 tbsp so that it can be the same serving
size as is used for liquid creamers.
(Response) The current 1993 RACC for ``Cream or cream substitutes,
powder'' is 2 g (or 1 tsp). Although the median 2003-2008 NHANES
consumption is 4 g, the data available in 2003-2008 NHANES were
insufficient to provide adequate information on which to base a change
from the 1993 RACC (Ref. 31). The data available did not meet the
criteria to update the RACC from the 1993 RACC of 2 g because there was
not an adequate sample size to provide a reliable median intake
estimate. Therefore, we did not propose to change the RACC for powdered
creamers.
With respect to the comment that suggested we use the same RACC for
both liquid and powdered creamers, we disagree. Powdered creamer and
liquid creamer have different product characteristics (e.g., powder vs.
liquid), and the household measurement for the two types of products is
different. A weight measurement is used for powdered creamer, and a
volume measurement is used for liquid creamer. Additionally, the
consumption amounts for powdered and liquid creamers are not similar.
The current RACC for ``Cream or cream substitute, liquid'' did not show
a significant increase from the current RACC of 15 mL (or 1 tbsp);
therefore, we did not propose to change it.
(Comment 61) Soup--Several comments addressed the ``All varieties''
product category under the ``Soups'' general category. Most comments
requested that we update the RACC for canned soup. The comments stated
that the current RACC for soups is too small and that many consumers
can eat an entire can of soup in one sitting. Some comments referred to
a single serving container of soup that is typically 15 oz and lists
the serving size as 2 servings.
(Response 61) While we understand the concern that some canned
soups that appear to be single-serving containers are being labeled as
having more than one serving, consumption data for this product
category has not significantly increased. However, we note that under
the new requirements for single-serving containers finalized in this
rulemaking, products that are packaged and sold individually and that
contain less than 200 percent of the RACC will be labeled as single-
serving containers. Additionally, under the new dual-column labeling
requirements finalized in this rulemaking, products containing at least
200 percent but less than 300 percent of the RACC will be required to
provide nutrition information for the full container. Pursuant to this
rule, canned soups that are currently labeled as containing ``about 2
servings'' will be required to provide nutrition information for the
entire container, either using a single-serving container label or
using a voluntary or mandatory dual-column label format.
(Comment 62) Sugar--One comment opposed updating the RACC for
sugar. The comment stated that a change in consumption data is not
enough to justify a change in the RACC. The comment noted that
consumption data used in the 1991 proposed rule also showed that sugar
should have an RACC of 8 g, but we nonetheless chose to finalize the
RACC at 4 g in 1993. The comment stated that consumption data for sugar
is limited and that we should, therefore, take into account other
sources of information when determining the RACC. The comment stated
that consumers typically add sugar to foods 1 tsp at a time and that
the proposed 8 g RACC (2 tsp serving size) is cumbersome for most
consumers who do not measure out sugar 2 tsp at a time. The comment
also stated that if we update the RACC for sugar, consumers will
believe that 2 tsp is the recommended serving size.
(Response 62) The decision to update the RACC for sugar is based on
consumption data. The methodology used in the decisionmaking process
for updating the RACC for sugar is the same methodology used to
determine when to update the RACC for all product categories. While the
current RACC for sugar has been used for more than two decades, RACCs
are based primarily on the amount that is customarily consumed.
Consumption data shows that the amount of sugar that is customarily
consumed is 8 g, which is 2 tsp. We further disagree that the amount of
consumption data available for sugar was ``limited,'' as the sample
size of data available met the criteria set forth in our methodology
memo (Ref. 31). Therefore, we are finalizing the RACC for sugar as
proposed.
We acknowledge that determining nutrition values on the label when
measuring an odd number of teaspoons of sugar (such as 3 tsp, which
equals 1\1/2\ servings) might be cumbersome for some consumers. Given
the data showing a significant increase in consumption, however, we
determined it was important for the RACC to reflect current consumption
amounts.
The comment is correct in noting that we received no comments in
favor of our changes to the RACC for sugar. We do not consider this
relevant to our decision, however, as the consumption data is clear
with respect to this product category.
To address the statement that updating the RACC for sugar would
cause consumers to view the larger serving size as a recommended amount
to eat, as discussed in comment 2, we intend to conduct nutrition
education to help clarify that the meaning of ``serving size'' is not a
recommended amount, but rather is based on an amount customarily
consumed.
(Comment 63) Raisins--One comment requested that we add a separate
product category for raisins with an RACC of 28/30 g (1 oz). The
comment stated that the existing RACC does not represent the quantity
of raisins contained in individual packages typically purchased by
consumers and, therefore, is not representative of the actual amount
customarily consumed per eating occasion. The comment stated that mini
raisins boxes are packaged in \1/2\ oz (14.2 g) boxes and sold in bags
of various quantities, primarily 12 or 14 minis per bag. The comment
also stated that the larger individual snack size products are
currently packaged in boxes that are 1 oz (28.3 g) and are sold in
packages of six. The comment asserted that the two different individual
unit sizes of 14.2 g and 28.3 g are both widely consumed and represent
the predominant proportion of industry retail raisin sales
[[Page 34035]]
to consumers for out-of-hand snacking. The comment requested a separate
RACC for raisins that is in line with the amount of raisins that is in
an individual package of raisins. The comment stated that multiple-
serving raisin packages are a different category from other dried
fruits and are consumed in different ways by different consumers.
(Response 63) We decline to establish a new product category for
raisins. Raisins are currently under the product category ``Dried''
under the ``Fruits and Fruit Juices'' general category with an RACC of
40 g. We group together like products with similar dietary usage so
consumers can easily compare nutrient information between similar
products. Raisins are comparable to other dried fruits such as
cranberries and are used in similar ways (e.g., as an ingredient in
cookies); other dried fruits, such as cranberries are also consumed as
snacks (Ref. 26). It would not be helpful for a consumer if there was a
different RACC for raisins than there was for similar products on the
market.
RACCs are determined primarily using consumption data, and other
factors we consider in grouping products include similarities in
dietary usage and product characteristics. Package size, which is not
consistent and can change over time, is not a factor we considered in
determining RACCs (see Sec. 101.12(a)).
(Comment 64) Spray type fats and oils--Several comments requested
that we amend the RACC for the product category ``spray types'' in the
general category ``Fats and Oils.'' The comments noted that the current
RACC for this product category is 0.25 g. The comments stated that
cooking sprays have tiny serving sizes which allow them to make certain
claims such as ``zero calorie'' or ``fat free,'' even though they are
essentially pure oil. One comment recognized that no intake data were
available from NHANES at the time of the proposed rule, but referred to
a survey of 15 people that found that consumers spray a pan for 1.6
seconds on average, with the range being 1 to 3 seconds, compared to
the one second spray that is found on the label of a common brand of
cooking spray oil (Ref). The comments requested that we increase the
RACC for spray cooking oils to a 2-second spray so consumers have a
better understanding of the calories and fat they are consuming.
(Response 64) We decline to make a change to the RACC for spray
oils. There are no data available in NHANES that can be used to update
the RACC for cooking spray oils. We also have not identified any other
information on consumption of cooking spray oils that we can use as a
basis for determining a different RACC. Although one comment referred
to a study that it conducted, the comment provided no information about
the methodology used and included a small sample size of only 15
people; therefore, this information provides an insufficient basis on
which to update the RACC. Additionally, we note that serving size is
based on the amount an individual consumes. Spray oils are often used
to prepare food for multiple individuals, so even if the typical spray
is longer than one second, the amount consumed by each individual may
be significantly less.
(Comment 65) Yogurt--Several comments supported the proposed
changes to the RACC for yogurt. Some comments asked us to clarify that
the proposed 170 g (6 oz) RACC for yogurt applies to all forms of
``yogurt'' (e.g., cup, drinkable, squeezable) that comply with our
standard of identity for yogurt. The comments specifically wanted
clarification that drinkable yogurts would be subject to the proposed
170 g (6 fl oz) yogurt RACC versus the 240 mL (8 fl oz) RACC for the
``Milk, milk substitutes, and fruit based drink mixers (without
alcohol) (e.g., drink mixers, fruit flavored powdered drink mixes,
sweetened cocoa powder)'' product category. One comment stated that a
product labeled as ``drinkable yogurt'' is ``yogurt'' and must, like
cup yogurt, meet one of our standards of identity for yogurt. The
comment stated that drinkable yogurts are produced, marketed, and used
by consumers as food (not as beverages) and are fundamentally different
in both form and use from fluid milk, milk-substitute beverages, and
other milk-based drinks.
(Response 65) We agree that drinkable yogurt is more similar to
other forms of yogurt than to milk beverages. Drinkable yogurt is a
product that is consistent with the standard of identity for yogurt
under 21 CFR 131.200 but that is more fluid than other forms of yogurt.
Therefore, we are clarifying that the new yogurt RACC applies to all
forms of yogurt including drinkable yogurt.
E. Impact of Changes in RACCs on the Eligibility To Make Nutrient
Content Claims and Health Claims
We stated in the proposed rule that we were aware that individual
foods that currently meet the requirements for certain claims based on
existing RACCs may potentially become ineligible to continue to bear
such claims if their RACCs change. Also, we recognized that other
regulatory requirements for nutrient content claims and health claims
are considered on a per-RACC basis, and changes to the RACCs could
affect the ability of foods to meet these requirements. We noted that
changes in the eligibility to bear claims may be appropriate in light
of the changes in the amounts of food being customarily consumed but
that it would be difficult to fully understand any potential impacts of
changes to the RACCs on the eligibility to bear claims until the rules
for both serving sizes and updating the Nutrition Facts label are
finalized. We invited comment on any concerns related to changes to
current claims used on specific foods that will be affected if the
serving size rule is finalized as proposed (79 FR 11989 at 12015 to
12016).
(Comment 66) We received a number of comments in response to our
discussion on claim eligibility in the proposed rule agreeing with us
that foods could potentially become ineligible to bear a claim based on
changes to the RACCs. A number of these comments suggested that we
consider potential impacts on claim eligibility and evaluate if
resulting changes in eligibility assists consumers in constructing
healthful diets. Some comments stated that any changes that will be
needed to regulations for nutrient content claims (NCCs) and health
claims should be coordinated with the changes to the Nutrition Facts
label and serving sizes. A few comments cited examples of specific
issues that could affect the foods that the commenters produce. One
such example indicated that foods with the terms ``Healthy'' or
``Lean'' in their brand name may become ineligible to bear such claims
and could be considered misbranded if the products would continue to
bear such claims. Another example discussed the changes to the RACCs
that make the RACCs different between bulk and novelty ice cream
products and noted that such changes could make identical food
products, but of different sizes, unable to bear the same claims. One
example discussed changes to the RACC of confections and noted that
because of the smaller proposed RACC, some confections would become
subject to the NCC criteria for foods with small RACCs and become
ineligible to bear some claims.
(Response 66) As we discussed in the proposed rule, we anticipate
that there may be changes needed with regard to claims based on the new
and updated regulations for Nutrition Facts and serving sizes. We agree
with the comments that suggested that we evaluate claim regulations and
any change to eligibility for claims. Changes to nutrition labeling is
a step-wise
[[Page 34036]]
process, and all changes to Nutrition Facts and serving sizes need to
become final before we can determine any and all necessary changes to
claim regulations. Because it is prudent for us to be fully aware of
all final and official changes to the RACCs (and to the information in
Nutrition Facts) before determining the scope of all of the changes
needed to claim regulations, we are not publishing rules updating claim
regulations simultaneously with the publication of the rules for
serving sizes and Nutrition Facts. With the publication of this final
rule (and the publication of the Nutrition Facts final rule, we can
assess the impacts of all of the updates on claim eligibility.
We intend to consider in a future rulemaking issues such as whether
any changes in eligibility for claims would assist consumers in
constructing healthy diets and whether the criteria for claims remain
appropriate. However, as we noted in the proposed rule, changes in the
eligibility to bear claims may be appropriate for some foods (79 FR
11989 at 12016). Reformulation of some foods in line with current
dietary recommendations may be expected in order to continue to bear
claims. Manufacturers will have some time to make necessary changes
before the compliance dates for the final rules on serving size and
Nutrition Facts. This time will allow manufacturers to update food
labels to come into compliance with the new regulations for serving
size and Nutrition Facts, and it also allows time to discontinue use of
individual voluntary claims that the labeling of certain products may
no longer be eligible to make. The time will also allow us to evaluate
the existing claim regulations and publish, in a separate rulemaking,
any amendments to those claim regulations.
(Comment 67) One comment regarding the changes in the definition of
a single-serving container and a product's ability to qualify for
``free'' claims stated that beverages that are routinely sold in
single-serving containers for which the labeled serving is less than
the RACC may no longer be able to make a calorie ``free'' or other
``free'' claims, even though the caloric or other nutrient content may
be trivial in those particular single-serving packages. The comment
said this outcome may occur because ``free'' claims are based on the
nutrient content for both the labeled serving and the RACC. The comment
gave the example of certain energy drink products that are commonly
sold in 8 oz, single-serving containers. The comment asserted that the
caloric content of these below-RACC, single-serving beverages is
insignificant, which supports a calorie-free claim. However, 12 ozs of
the product would contain just enough calories to preclude a calorie-
free claim. Consequently, even though the single-serving product would
not contain any more calories than before the RACCs would be updated,
the small, single-serving beverage would be precluded from bearing a
calorie-free claim because of the combined effect of the proposed RACC
and the requirement that calorie-free claims must be based on both per-
labeled-serving and per-RACC nutrient content.
(Response 67) When we established ``free'' claims, we decided to
make the basis of the claim on a per-RACC and per-labeled-serving basis
(56 FR 60421 and 58 FR 2302). When we developed our general principles
on nutrient content claims, we concluded that it would be misleading to
allow certain claims to be based only on the RACC, particularly with
single-serving containers, since the consumer would be expected to
consume the entire labeled serving size. Likewise, we concluded that it
would be misleading to allow claims based only on the labeled serving
size. This decision was made to prevent potentially misleading claims
and to provide a level field for industry. Since that time, consumption
patterns have changed so that the RACC for some beverages has increased
from 8 oz to 12 oz. Because the consumption amount has increased for
certain beverages, such products for which the RACC has increased may
appropriately no longer be able to make ``free'' claims. As noted
previously, we intend to consider in a future rulemaking issues such as
whether any changes in eligibility for claims would assist consumers in
constructing healthy diets and whether the criteria for claims remain
appropriate.
F. Establishing a New Serving Size for Breath Mints
In the serving size proposed rule, we proposed to establish a new
serving size of ``1 unit'' for breath mints while maintaining the
current reference amount of 2 g for the product category ``Hard
candies, breath mints.'' We proposed this action in response to a
petition that suggested the appropriate serving size for small breath
mints should be ``one mint'' instead of the number of pieces that is
closest to the 2 g RACC. The petitioner had also requested that a
separate product category, having an RACC of 0.5 g, should be
established for small breath mints weighing 0.5 g or less.
We received one comment that supported a ``1-unit'' serving size
for breath mints and no comments that addressed changing the RACC for
breath mints. As mentioned in the serving size proposed rule (79 FR
11989 at 12016), we have determined through our analysis of two large
commercial databases that 2 g remains an appropriate RACC for the
product category ``Hard candies, breath mints.'' Further, because only
a limited number of small breath mint products are commercially
available, establishing a separate product category for small breath
mints weighing 0.5 g or less, as the petitioner requested, is not
warranted. Therefore, we will keep 2 g as the single reference amount
for the ``Hard candies, breath mints'' product category, which includes
breath mints of all sizes. However, we will now require that the label
statement for the serving size of all breath mints be 1 unit, rather
than declaring the serving size in terms of the number of mints closest
to the 2 g RACC. We have indicated this in table 2 of Sec. 101.12(b)
by changing footnote 8 (formerly footnote 9) to state, in part, ``Label
serving size of ice cream cones, eggs, and breath mints of all sizes
will be 1 unit.''
G. Technical Amendments
1. Rounding Rules for Products That Have More Than Five Servings and
the Number of Servings Falls Exactly Between Two Values
In the serving size proposed rule (79 FR 11989) we proposed to add
the following to Sec. 101.9(b)(8)(i): ``For containers that contain
greater than 5 servings, if the number of servings determined from the
procedures provided in this section falls exactly halfway between two
allowable declarations, the manufacturer must round the number of
servings up to the nearest incremental size.'' We made this proposal to
provide information to manufacturers who have products that contain
five or more servings to round the number of servings up when the
number of servings falls exactly between two values.
We received no comments on this topic but are not finalizing the
amendment as proposed. Standard rounding rules require numbers that
fall exactly half way between two declarations to be rounded up to the
nearest incremental size. This rule applies to all provisions where
rounding is required and is not unique to rounding required for
containers that contain greater than 5 servings. Because this proposed
addition to Sec. 101.9(b)(8)(i) is unnecessary, we are not finalizing
the proposed amendment.
[[Page 34037]]
2. Options for When the Number of Servings per Container Varies
In the serving size proposed rule (79 FR 11989) we proposed to
amend Sec. 101.9(b)(8)(iii) by: (1) Defining ``random-weight
products'' and (2) eliminating the wording that specifies that the
nutrition information is based on the reference amount expressed in
ounces. The proposed rule would define random-weight products as
``foods such as cheeses that are sold as random weights that vary in
size, such that the net contents for different containers would vary.''
We received no comments on this topic, and will finalize the
amendment as proposed. We are also amending the final sentence of this
paragraph to read ``in parentheses'' rather than ``in parenthesis.''
3. Minor Corrections to General and Product Category Names
In the serving size proposed rule (79 FR 11989) we proposed to make
minor changes to the names of certain general categories and product
categories to clarify the products contained in the category, and to
correct minor errors in these categories.
We received no comments on this topic, and will make these
corrections in table 2 in Sec. 101.12(b).
4. Minor Changes to Footnotes
In the serving size proposed rule (79 FR 11989) we proposed to
remove footnote 4 from table 1 in Sec. 101.12(b) to provide clearer
guidance on the types of products that can be included in the product
categories listed in the tables. We further proposed to renumber
footnote 5 as footnote 4 and revise it by removing the first sentence
and replacing it with the following: ``The label statements are meant
to provide examples of serving size statements that may be used on the
label, but the specific wording may be changed as appropriate for
individual products.'' In table 2 we proposed to remove footnote 4 and
renumber the remaining footnotes. We further proposed to revise
renumbered footnote 4 by removing the first sentence and replacing it
with the following: ``The label statements are meant to provide
examples of serving size statements that may be used on the label, but
the specific wording may be changed as appropriate for individual
products.'' We also proposed to revise renumbered footnote 5 to include
the sentence, ``The serving size for fruitcake is 1\1/2\ ounces''; to
add renumbered footnote 10 as a superscript to the word ``pimento'' in
the ``Vegetables, primarily used for garnish or flavor, e.g., pimento,
parsley, fresh or dried)'' product category; and to revise renumbered
footnote 12 to state, ``For raw fruit, vegetables, and fish,
manufacturers should follow the label statement for the serving size
specified in Appendices C and D to part 101 (21 CFR 101) Code of
Federal Regulations.''
We received no comments to these minor technical amendments and
will make the changes in tables 1 and 2 in Sec. 101.12(b).
In addition to the changes to various footnotes proposed in the
proposed rule, we are making several additional technical amendments to
table 2 by adding language to footnote 1 explaining that the values
have been updated with data from various NHANES surveys, adding
renumbered footnote 10 to the product category ``Fruits for garnish or
flavor, e.g., maraschino cherries,'' removing the ``(b)'' from the Code
of Federal Regulations citation ``101.9(b)(j)(11)'' in renumbered
footnote 11, and revising renumbered footnote 12 to state, ``For raw
fruit, vegetables, and fish, manufacturers should follow the label
statement for the serving size specified in Appendices C and D to part
101 (21 CFR 101) Code of Federal Regulations.''
5. Minor Changes to Table 1 in Sec. 101.12(b)
In the serving size proposed rule (79 FR 11989) we proposed to
change the title of table 1 from ``Reference Amounts Customarily
Consumed Per Eating Occasion: Infant and Toddler Foods'' to ``Reference
Amounts Customarily Consumed Per Eating Occasion: Foods for Infants and
Young Children 1 through 3 years of age.'' We also proposed to make
other conforming changes in the product category names, by changing the
product category name ``Dinners, stews or soups for toddlers, ready-to-
serve'' to ``Dinners, stews or soups for young children, ready-to-
serve,'' the product category name ``Fruits for toddlers, ready-to-
serve'' to ``Fruits for young children, ready-to-serve,'' and the
product category name ``Vegetables for toddlers, ready-to-serve'' to
``Vegetables for young children, ready-to-serve.''
We received no comments to these minor technical amendments and
will make the changes in table 1 in Sec. 101.12(b).
6. Minor Changes to Table 2 in Sec. 101.12(b)
In the serving size proposed rule (79 FR 11989) we proposed to make
some editorial changes to the product category names.
We received no comments to these minor technical amendments and
will make the changes in table 2 in Sec. 101.12(b).
7. Reference Amounts for Products That Require Further Preparation
In the serving size proposed rule (79 FR 11989), we proposed to
amend Sec. 101.12(c) to change the definition of the reference amount
for products that require further preparation in which the entire
contents of the package are used to prepare one large discrete unit
usually divided for consumption.
We received no comments on this topic, and will finalize this
amendment as proposed.
8. Reference Amount for Combined Products Consisting of Two or More
Separate Foods That Are Packaged Together and Are Intended To Be Eaten
Together and That Have No Reference Amount for the Combined Product
Section 101.12(f) establishes the approach for determining the
reference amount for combined products consisting of two or more
separate foods, packaged together and intended to be eaten together,
that have no established reference amount in the tables for the
combined product. In the serving size proposed rule (79 FR 11989) we
proposed to amend Sec. 101.9(f)(1) and (2) to change the definition of
the RACC for these products consisting of two or more separate foods,
packaged together and intended to be eaten together, so that it will
not affect the serving size declaration on the label.
We received no comments on this topic, and will finalize the
amendment as proposed.
9. Reference Amounts for Varieties or Assortments of Foods in Gift
Packages That Have No Appropriate Reference Amount
Section 101.9(h)(3)(ii) establishes the procedure for determining
the serving size for varieties or assortments of foods in gift packages
when there is no appropriate reference amount. The current language in
Sec. 101.9(h)(3)(ii) states that 8 fl ozs may be used as the standard
serving size for beverage varieties or assortments in gift packages.
Because we are amending the RACCs for some beverages, we proposed
conforming amendments to this section to state that 12 fl oz should be
used as the standard serving size for beverages, except that the
standard serving size for milk, fruit juices, nectars, and fruit drinks
will be based on 8 fl ozs.
We received no comments on this topic, and will finalize the
amendment
[[Page 34038]]
as proposed, with minor edits for clarity.
IV. Effective and Compliance Dates
In the preamble of the proposed rule (79 FR 11989 at 12019), we
proposed that any final rule resulting from this rulemaking, as well as
any final rule resulting from the proposed rule entitled ``Food
Labeling: Revision of the Nutrition and Supplement Facts Labels'' (the
Nutrition Facts proposed rule), would become effective 60 days after
the date of the final rule's publication in the Federal Register. We
also proposed that any final rule that resulted would have a compliance
date that would be 2 years after the effective date (79 FR 11989 at
12019). We explained that industry might need some time to analyze
products for which there may be new mandatory nutrient declarations,
make any required changes to the Nutrition Facts label (which may be
coordinated with other planned label changes), review and update
records of product labels, and print new labels.
After considering comments submitted to the docket for the
Nutrition Facts proposed rule regarding the effective and compliance
dates, we have maintained the compliance date of 2 years after the
effective date, except that for manufacturers with less than $10
million in annual food sales, we are providing a compliance date of 3
years after the effective date. Comments to the Nutrition Facts
proposed rule emphasized the rule's potential impact on small
businesses. We agree that the impacts to smaller businesses may be more
substantial than those on larger businesses; thus, for manufacturers
with less than $10 million in annual food sales, the compliance date
will be July 26, 2019. Using Nielsen data, we estimate that
manufacturers with less than $10 million in annual food sales
constitute approximately 95 percent of all food manufacturers and
market 48 percent of food UPCs.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(i) and (k) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
are publishing two final rules on nutrition labeling in the Federal
Register. We have developed a comprehensive Regulatory Impact Analysis
(RIA) that assesses the impacts of the two final nutrition labeling
rules taken together. We believe that the final rules on nutrition
labeling, taken as a whole, are an economically significant regulatory
action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Additional costs per entity from the final rules are small,
but not negligible, and as a result we find that the final rules on
nutrition labeling, taken as a whole, will have a significant economic
impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. We have determined that the final rules on
nutrition labeling, taken as a whole, would result in an expenditure in
any year that meets or exceeds this amount.
The full analysis of economic impacts for the final rules on
nutrition labeling is available in the docket for this final rule (Ref.
35) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.
VII. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given in this section with an
estimate of the annual third-party disclosure burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
Title: Third-Party Disclosure Requirements for Serving Sizes of
Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-
Column Labeling; Updating, Modifying and Establishing Certain RACCs;
Serving Size for Breath Mints; and Technical Amendments
Description of Respondents: The respondents to this information
collection are manufacturers of retail food products marketed in the
United States.
Description: In major part, this final rule revises Sec. Sec.
101.9 and 101.12 to: (1) Amend the definition of a single serving, (2)
require a second column of nutrition information per package for
products that contain at least 200 and up to and including 300 percent
of the applicable RACCs, as well as per unit for discrete units in
multiserving packages in which each unit contains at least 200 percent
and up to and including 300 percent of the applicable RACCs, (3)
update, modify, and establish RACCs for certain food products, (4) make
several technical amendments to the regulations for serving sizes, and
(5) change the label serving size for breath mints to ``1 unit.'' These
revisions, in many instances, will require changes to the nutrition
information that is presented on the Nutrition Facts label of retail
food products. Preexisting Sec. Sec. 101.9 and 101.12 are approved by
OMB in accordance with the PRA under OMB control number 0910-0381. This
final rule will modify the information collection associated with
preexisting Sec. Sec. 101.9 and 101.12 by adding to the burden
associated with the collection by requiring the following manufacturers
to make changes to their product labels: Those whose retail food
products are labeled with a serving size that is inconsistent with the
provisions of the final rule, and those whose retail food products
would be required to use dual-column labeling.\2\ The nutrient
information disclosed on labels of retail food products is necessary to
inform purchasers of the nutritional value of the food.
---------------------------------------------------------------------------
\2\ Included in this burden are the labeling costs that result
from changes in the eligibility to bear nutrient content claims or
health claims (e.g., the cost of removing a claim from labeling or
adding a required disclaimer).
---------------------------------------------------------------------------
We estimate the burden of this collection of information as
follows:
[[Page 34039]]
Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital
Number of Number of Total annual Average burden costs (in
21 CFR Section respondents disclosures per disclosures per disclosure Total hours billions of
respondent 2014$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.9 and 101.12....................................... 13,452 25 336,300 2 672,600 $1.00
Total Initial Hours and Capital Costs.............. 672,600 $1.00
New Products........................................... 500 1 500 2 1,000 $0.01
Total Recurring Hours and Capital Costs............ 1,000 $0.01
Total Burden Hours and Capital Costs............... 673,600 $1.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
Under Sec. Sec. 101.9 and 101.12, some manufacturers of retail
food products would need to make a labeling change to modify the
serving sizes and other nutrition information based on changes to what
products may be or are required to be labeled as a single serving or
based on updated, modified, or established RACCs. Additionally, some
manufacturers would need to change their product labels to add a second
column of nutrition information per package or per discrete unit as
part of the Nutrition Facts label. The third-party disclosure burden
consists of the setup time required to design a revised label and
incorporate it into the manufacturing process. The third-party
disclosure burden for this final rule is estimated in table 1.
Based upon our knowledge of food labeling, we estimate that the
affected manufacturers would require 2 hours per product to modify the
label's Nutrition Facts panel. We estimate that it would take an
affected manufacturer 1 hour to review a label to assess how to bring
it into compliance with the requirements of this final rule. Each label
redesign would require an estimated 1 additional hour per UPC, for a
total of 2 hours per UPC.
We estimate that about 13,452 manufacturers would initially be
affected by this final rule and that about 336,300 products would
initially be required to be relabeled, for an average of 25 (336,300/
13,452) products per respondent. The total initial third-party
disclosure burden of 672,600 hours is reported in table 1. The final
column of table 1 gives the estimated initial capital cost of the
relabeling associated with this final rule. Based on the RIA, we
estimate the initial capital cost to be approximately $1 billion
(2014$).
This final rule generates recurring burdens related to the
requirement that some manufacturers undertake an extensive label change
due to the effect of the changed definition of a single-serving
container on the permissibility of certain health and nutrient content
claims and also to the requirement that some manufacturers undertake a
major redesign of their labels to include a Nutrition Facts Panel that
had not previously been required.\3\ We estimate that about 500 new
products would be affected by these requirements each year, and that
the required third party disclosure burden would be 2 hours per
product, for an annual recurring third party disclosure burden of 1,000
hours. Based on the RIA, we estimate the annual recurring capital cost
to be approximately $0.01 billion (2014$).
---------------------------------------------------------------------------
\3\ This final rule does not otherwise generate any recurring
burdens because establishments must already print packaging for food
products as part of normal business practices and must disclose
required nutrition and serving size information under NLEA.
---------------------------------------------------------------------------
Adding the recurring burden from new products to the initial burden
for existing products results in a total of 673,600 third party
disclosure burden hours and $1.01 billion (2014$) in capital costs as
reported in table 1.
The information collection provisions in this final rule and the
Nutrition Facts Label final rule have been submitted to OMB for review
as required by section 3507(d) of the PRA of 1995.
Before the effective date of this final rule, we will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule.
An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
VIII. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive Order
requires agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.''
Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides that ``.
. . no State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as to
any food in interstate commerce. . . (4) any requirement for nutrition
labeling of food that is not identical to the requirement of section
403(q) [of the FD&C Act]. . . .''
The express preemption provision of section 403A(a) of the FD&C Act
does not preempt any State or local requirement respecting a statement
in the labeling of food that provides for a warning concerning the
safety of the food or component of the food (section 6(c)(2) of the
NLEA).
This final rule will create requirements that fall within the scope
of section 403A(a) of the FD&C Act.
IX. References
The following references are on display in FDA's Division of
Dockets Management (see ADDRESSES) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
1. Report of the Working Group on Obesity, ``Calories Count,''
March 12, 2004.
2. Dallas, S. K., P. J. Liu, P. A. Ubel, ``Potential Problems
with Increasing Serving Sizes on the Nutrition Facts
Label,'''Appetite, 95:577-84, 2015.
3. Zhang, Y., M. A. Kantor, W. Juan, ``Usage and Understanding
of Serving Size Information on Food Labels in the United States,''
American Journal of Health Promotion, 30:181-7, 2016.
4. Chung-Tung, Lin., Memorandum to file: ``2014 Health and Diet
Survey,'' May 6, 2016.
[[Page 34040]]
5. FDA, Resources for You, August 10, 2015: http://www.fda.gov/Food/ResourcesForYou/default.htm.
6. CDC, National Center for Health Statistics (NCHS), ``National
Health and Nutrition Examination Survey Data 2007-2008''. http://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx.
7. CDC, NCHS, ``National Health and Nutrition Examination Survey
Data 2005-2006.''
8. CDC, NCHS, ``National Health and Nutrition Examination Survey
Data 2003-2004.'' http://www.cdc.gov/nchs/nhanes/nhanes2003-2004/nhanes03_04.htm.
9. Juan, W., Memorandum to File: ``Technical Support for
Documentation on Examining the Association Between the Consumption
Variability and the Reference Amounts Customarily Consumed (RACCs)
per Eating Occasion for All Products in Each Product Category,''
February 11, 2014.
10. Wansink, B., J. Kim. ``Bad Popcorn in Big Buckets: Portion
Size Can Influence Intake as Much as Taste,'' Journal of Nutrition
Education and Behavior, 37:242-5, 2005.
11. Rolls, B. J., L. S. Roe, J. Meengs, D. Wall, ``Increasing
the Portion Size of A Sandwich Increases Energy Intake,'' Journal of
the American Dietetic Association, 104:367-72, 2004.
12. Lando, A. M., J. Labiner-Wolfe, ``Helping Consumers Make
More Healthful Food Choices: Consumer Views on Modifying Food Labels
and Providing Point-of-Purchase Nutrition Information at Quick-
Service Restaurants,'' Journal of Nutrition Education and Behavior,
39:157-63, 2007.
13. Geier, A., P. Rozin, G. Doros, ``Unit Bias. A New Heuristic
That Helps Explain the Effect of Portion Size on Food Intake,''
Psychological Science, 17:521-5, 2006.
14. Antonuk, B., L. Block, ``The Effect of Single Serving Versus
Entire Package Nutritional Information on Consumption Norms and
Actual Consumption of a Snack Food,'' Journal of Nutrition Education
and Behavior, 38:365-70, 2006.
15. Lando, A. M., S. C. Lo, ``Single-Larger-Portion-Size and
Dual-Column Nutrition Labeling May Help Consumers Make More
Healthful Food Choices,'' Journal of the Academy of Nutrition and
Dietetics, 113:241-50, 2013.
16. Juan, W., Memorandum to File: ``Comparison Between the Foods
Consumed in the United States from NHANES 2003-2008 at the 90th
Percentile and Reference Amounts Customarily Consumed (RACCs) Per
Eating Occasion by General Category and Product Category,'' February
11, 2014.
17. FDA, ``Preliminary Regulatory Impact Analysis (PRIA) for the
Food Labeling: Revision of the Nutrition and Supplement Facts Labels
Proposed Rule (Docket No. FDA-2012-N-1210) and Food Labeling:
Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating
Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments Proposed Rule
(Docket No. FDA-2004-N-0258),'' 2014.
18. Chung-Tung, Lin., Memorandum to File: ``Eye-Tracking
Experimental Study on Consumer Responses to Modifications to the
Nutrition Facts Label Outlined in the Food and Drug Administration's
Proposed Rulemaking,'' June 30, 2015.
19. Lando, A., Liu, S., Lo, S., and Yu, K., Memorandum to File:
``Experimental Study of Proposed Changes to the Nutrition Facts
Label Formats'' June 30, 2015.
20. O'Neil, C. E., T. A. Nicklas, G. C. Rampersaud, and V. L.
Fulgoni III, ``100% Orange juice Consumption is Associated with
Better Diet Quality, Improved Nutrient Adequacy, Decreased Risk for
obesity, and Improved Biomarkers of Health in Adults: National
Health and Nutrition Examination Survey, 2003-2006,'' Nutrition
Journal, 11:107-16, 2012.
21. O'Neil, C. E., T. A. Nicklas, G. C. Rampersaud, and V. L.
Fulgoni III, ``One Hundred Percent Orange Juice Consumption is
Associated with Better Diet Quality, Improved Nutrient Adequacy, and
no Increased Risk for Overweight/Obesity in Children,'' Nutrition
Research, 31:673-82, 2011.
22. Juan, W., Memorandum to File: ``Evaluation of Consumption
Amounts of Food Consumed in the United States for Which 2003-2008
Consumption at the 90th Percentile Exceeds 300% of the 1993
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion;
Comparison of 2003-2008 Food Consumption Amounts to the Proposed
RACCs'' April 7, 2016.
23. Cowburn, G. and L. Stockley, ``Consumer Understanding and
Use of Nutrition Labelling: A Systematic Review,'' Public Health
Nutrition, 8:21-8, 2005.
24. Rothman, R., R. Housam, H. Weiss, D. Davis, R. Gregory, T.
Gebretsadik, et al., ``Patient Understanding of Food Labels: The
Role of Literacy and Numeracy,'' American Journal of Preventive
Medicine, 31:391-8, 2006.
25. Agricultural Research Service, Food Surveys Research Group,
``U.S. Department of Agriculture, Food and Nutrient Database for
Dietary Studies, 4.1'' Beltsville, MD, 2010.
26. Herbst, S.T. and R. Herbst, ``The New Food Lover's
Companion,'' Fourth Edition. Barron's Educational Series, Inc, 2007.
27. USDA, Food Safety and Inspection Service, ``A Guide to
Federal Food Labeling Requirements for Meats and Poultry Products,''
2007. http://www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.
28. Allrecipes. Allrecipes, December 6, 2012. http://www.allrecipes.com.
29. Park, Y., Memorandum to File: ``Documentation for
Determining Reference Amounts Customarily Consumed per Eating
Occasion,'' October 30, 1991.
30. ``Council of Better Business Bureaus. Children's Food and
Beverage Advertising Initiative. 2014 Cereals Snapshot. March
2014.'' Available online: http://www.bbb.org/globalassets/shared/media/cfbai/cereal-fact-sheet-march-2014.pdf.
31. Juan, W., Memorandum to File: ``Methodology used to
Determine Whether to Propose to Update, Modify, or Establish the
Reference Amounts Customarily Consumed (RACCs) per Eating
Occasion,'' February 11, 2014.
32. Juan, W., Memorandum to File: ``Rationale Used to Amend
Reference Amounts Customarily Consumed (RACCs) per Eating Occasion
for Specific Product Categories,'' April 7, 2016.
33. Henderson, C., Memorandum to File, ``Sample of Ice Cream
Scoops Available to Consumers from National Retailers'' May 16,
2016.
34. Park, Y., Memorandum to the file, List of products for each
product category, October 8, 1992.
35. FDA, ``Regulatory Impact Analysis for Final Rules on Food
Labeling: Revision of the Nutrition and Supplement Facts Labels
(Docket No. FDA-2012-N-1210 and Food Labeling: Serving Sizes of
Foods That Can Reasonably Be Consumed At One Easting Occsion; Dual-
Column Labeling; Updating, Modifying and Establishing Certain RACCs;
Serving Size for Breath Mints; and Technical Amendments (Docket No.
FDA-2004-N-0258 (formerly Docket No. 2004N-0456),'' 2016.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and record keeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
1. The authority citation for part 101 continues to read as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. In Sec. 101.9:
0
a. Revise paragraph (b)(2)(i)(D);
0
b. Remove paragraph (b)(2)(i)(E) and redesignate paragraphs
(b)(2)(i)(F) through (I) as paragraphs (b)(2)(i)(E) through (H)
respectively;
0
c. Revise paragraphs (b)(6), (b)(8)(iii), and (b)(10)(ii);
0
d. Add paragraph (b)(12); and
0
e. Revise paragraph (h)(3)(ii).
The revisions and addition read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(D) If a unit weighs at least 200 percent and up to and including
300 percent of the applicable reference amount, the serving size shall
be the amount that approximates the reference amount. In addition to
providing a column within the Nutrition Facts label that lists the
quantitative amounts and percent Daily Values per serving size, the
manufacturer shall provide a column within the Nutrition Facts label
that lists the quantitative amounts and
[[Page 34041]]
percent Daily Values per individual unit. The first column would be
based on the serving size for the product and the second column would
be based on the individual unit. The exemptions in paragraphs
(b)(12)(i)(A), (B), and (C) of this section apply to this provision.
* * * * *
(6) A product that is packaged and sold individually that contains
less than 200 percent of the applicable reference amount must be
considered to be a single-serving container, and the entire content of
the product must be labeled as one serving. In addition to providing a
column within the Nutrition Facts label that lists the quantitative
amounts and percent Daily Values per serving, for a product that is
packaged and sold individually that contains more than 150 percent and
less than 200 percent of the applicable reference amount, the Nutrition
Facts label may voluntarily provide, to the left of the column that
provides nutrition information per container (i.e., per serving), an
additional column that lists the quantitative amounts and percent Daily
Values per common household measure that most closely approximates the
reference amount.
* * * * *
(8) * * *
(iii) For random weight products, manufacturers may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the reference amount expressed in the
appropriate household measure based on the hierarchy described in
paragraph (b)(5) of this section. Random weight products are foods such
as cheeses that are sold as random weights that vary in size, such that
the net contents for different containers would vary. The manufacturer
may provide the typical number of servings in parentheses following the
``varied'' statement.
* * * * *
(10) * * *
(ii) Per one unit if the serving size of a product in discrete
units is more than 1 unit.
* * * * *
(12)(i) Products that are packaged and sold individually and that
contain at least 200 percent and up to and including 300 percent of the
applicable reference amount must provide an additional column within
the Nutrition Facts label that lists the quantitative amounts and
percent Daily Values for the entire package, as well as a column
listing the quantitative amounts and percent Daily Values for a serving
that is less than the entire package (i.e., the serving size derived
from the reference amount). The first column would be based on the
serving size for the product and the second column would be based on
the entire contents of the package.
(A) This provision does not apply to products that meet the
requirements to use the tabular format in paragraph (j)(13)(ii)(A)(1)
of this section or to products that meet the requirements to use the
linear format in paragraph (j)(13)(ii)(A)(2) of this section.
(B) This provision does not apply to raw fruits, vegetables, and
seafood for which voluntary nutrition labeling is provided in the
product labeling or advertising or when claims are made about the
product.
(C) This provision does not apply to products that require further
preparation and provide an additional column of nutrition information
under paragraph (e) of this section, to products that are commonly
consumed in combination with another food and provide an additional
column of nutrition information under paragraph (e) of this section, to
products that provide an additional column of nutrition information for
two or more groups for which RDIs are established (e.g., both infants
and children less than 4 years of age), to popcorn products that
provide an additional column of nutrition information per 1 cup popped
popcorn, or to varied-weight products covered under paragraph
(b)(8)(iii) of this section.
(ii) When a nutrient content claim or health claim is made on the
label of a product that uses a dual column as required in paragraph
(b)(2)(i)(D) or (b)(12)(i) of this section, the claim must be followed
by a statement that sets forth the basis on which the claim is made,
except that the statement is not required for products when the
nutrient that is the subject of the claim meets the criteria for the
claim based on the reference amount for the product and the entire
container or the unit amount. When a nutrient content claim is made,
the statement must express that the claim refers to the amount of the
nutrient per serving (e.g., ``good source of calcium per serving'' or
``per X [insert unit]_serving'') or per reference amount (e.g., ``good
source of calcium per [insert reference amount (e.g., per 8 ounces)]),
as required based on Sec. 101.12(g). When a health claim is made, the
statement shall be ``A serving of _ounces of this product conforms to
such a diet.''
* * * * *
(h) * * *
(3) * * *
(ii) In the absence of a reference amount customarily consumed in
Sec. 101.12(b) that is appropriate for the variety or assortment of
foods in a gift package, the following may be used as the standard
serving size for purposes of nutrition labeling of foods subject to
this paragraph: 1 ounce for solid foods; 2 fluid ounces for nonbeverage
liquids (e.g., syrups); 8 ounces for beverages that consist of milk and
fruit juices, nectars and fruit drinks; and 12 fluid ounces for other
beverages. However, the reference amounts customarily consumed in Sec.
101.12(b) shall be used for purposes of evaluating whether individual
foods in a gift package qualify for nutrient content claims or health
claims.
* * * * *
0
3. In Sec. 101.12:
0
a. In paragraph (b), revise tables 1 and 2;
0
b. Revise paragraphs (c) and (f)(1);
0
c. Remove paragraph (f)(2) and redesignate paragraph (f)(3) as
paragraph (f)(2); and
0
d. Revise newly redesignated paragraph (f)(2).
The revisions read as follows:
Sec. 101.12 Reference amounts customarily consumed per eating
occasion.
* * * * *
(b) * * *
Table 1--Reference Amounts Customarily Consumed per Eating Occasion:
Foods for Infants and Young Children 1 Through 3 Years of Age \1\ \2\
\3\
------------------------------------------------------------------------
Label statement
Product category Reference amount \4\
------------------------------------------------------------------------
Cereals, dry instant............ 15 g.............. _ cup (_ g)
Cereals, prepared, ready-to- 110 g............. _ cup(s) (_ g)
serve.
Other cereal and grain products, 7 g for infants _ cup(s) (_ g) for
dry ready-to-eat, e.g., ready- and 20 g for ready-to-eat
to-eat cereals, cookies, young children (1 cereals; piece(s)
teething biscuits, and toasts. through 3 years (_ g) for others
of age) for ready-
to-eat cereals; 7
g for all others.
Dinners, deserts, fruits, 15 g.............. _ tbsp(s) (_ g); _
vegetables or soups, dry mix. cup(s) (_ g)
[[Page 34042]]
Dinners, desserts, fruits, 110 g............. _ cup(s) (_ g);
vegetables or soups, ready-to- cup(s) (_ mL)
serve, junior type.
Dinners, desserts, fruits, 110 g............. _ cup(s) (_ g);
vegetables or soups, ready-to- cup(s) (_ mL)
serve, strained type.
Dinners, stews or soups for 170 g............. _ cup(s) (_ g);
young children, ready-to-serve. cup(s) (_ mL)
Fruits for young children, ready- 125 g............. _ cup(s) (_ g)
to-serve.
Vegetables for young children, 70 g.............. _ cup(s) (_ g)
ready-to-serve.
Eggs/egg yolks, ready-to serve.. 55 g.............. _ cup(s) (_ g)
Juices all varieties............ 120 mL............ 4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture. We further considered data from the
National Health and Nutrition Examination Survey, 2003-2004, 2005-
2006, and 2007-2008 conducted by the Centers for Disease Control and
Prevention, in the U.S. Department of Health and Human Services.
\2\ Unless otherwise noted in the reference amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (e.g., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
mixes, concentrates, dough, batter, fresh and frozen pasta) is the
amount required to make the reference amount of the prepared form.
Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
statements that may be used on the label, but the specific wording may
be changed as appropriate for individual products. The term ``piece''
is used as a generic description of a discrete unit. Manufacturers
should use the description of a unit that is most appropriate for the
specific product (e.g., sandwich for sandwiches, cookie for cookies,
and bar for frozen novelties).
Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
General Food Supply \1\ \2\ \3\
------------------------------------------------------------------------
Label statement
Product category Reference amount \4\
------------------------------------------------------------------------
Bakery Products:
Bagels, toaster pastries, 110 g............. _ piece(s) (_ g)
muffins (excluding English
muffins).
Biscuits, croissants, 55 g.............. _ piece(s) (_ g)
tortillas, soft bread
sticks, soft pretzels, corn
bread, hush puppies,
scones, crumpets, English
muffins.
Breads (excluding sweet 50 g.............. _ piece(s) (_ g)
quick type), rolls. for sliced bread
and distinct
pieces (e.g.,
rolls); 2 oz (56
g/_ inch slice)
for unsliced
bread
Bread sticks--see crackers..
Toaster pastries--see
bagels, toaster pastries,
muffins (excluding English
muffins).
Brownies.................... 40 g.............. _ piece(s) (_ g)
for distinct
pieces;
fractional slice
(_ g) for bulk
Cakes, heavyweight (cheese 125 g............. _ piece(s) (_ g)
cake; pineapple upside-down for distinct
cake; fruit, nut, and pieces (e.g.,
vegetable cakes with more sliced or
than or equal to 35 percent individually
of the finished weight as packaged
fruit, nuts, or vegetables products); _
or any of these fractional slice
combinations) \ 5\. (_ g) for large
discrete units
Cakes, mediumweight 80 g.............. _ piece(s) (_ g)
(chemically leavened cake for distinct
with or without icing or pieces (e.g.,
filling except those cupcake); _
classified as light weight fractional slice
cake; fruit, nut, and (_ g) for large
vegetable cake with less discrete units
than 35 percent of the
finished weight as fruit,
nuts, or vegetables or any
of these combinations;
light weight cake with
icing; Boston cream pie;
cupcake; eclair; cream
puff) \6\.
Cakes, lightweight (angel 55 g.............. _ piece(s) (_ g)
food, chiffon, or sponge for distinct
cake without icing or pieces (e.g.,
filling) \7\. sliced or
individually
packaged
products); _
fractional slice
(_ g) for large
discrete units
Coffee cakes, crumb cakes, 55 g.............. _ piece(s) (_ g)
doughnuts, Danish, sweet for sliced bread
rolls, sweet quick type and distinct
breads. pieces (e.g.,
doughnut); 2 oz
(56 g/visual unit
of measure) for
bulk products
(e.g., unsliced
bread)
Cookies..................... 30 g.............. _ piece(s) (_ g)
Crackers that are usually 15 g.............. _ piece(s) (_ g)
not used as snack, melba
toast, hard bread sticks,
ice cream cones \8\.
Crackers that are usually 30 g.............. _ piece(s) (_ g)
used as snacks.
Croutons.................... 7 g............... _ tbsp(s) (_ g); _
cup(s) (_ g); _
piece(s) (_ g)
for large pieces
Eggroll, dumpling, wonton, 20 g.............. _ sheet (_ g);
or potsticker wrappers. wrapper (_ g)
French toast, crepes, 110 g prepaed for _ piece(s) (_ g);
pancakes, variety mixes. French toast, _ cup(s) (_ g)
crepes, and for dry mix
pancakes; 40 g
dry mix for
variety mixes.
[[Page 34043]]
Grain-based bars with or 40 g.............. _ piece(s) (_ g)
without filling or coating,
e.g., breakfast bars,
granola bars, rice cereal
bars.
Ice cream cones--see
crackers.
Pies, cobblers, fruit 125 g............. _ piece(s) (_ g)
crisps, turnovers, other for distinct
pastries. pieces; _
fractional slice
(_ g) for large
discrete units
Pie crust, pie shells, the allowable _ fractional
pastry sheets, (e.g., declaration slice(s) (_ g)
phyllo, puff pastry sheets). closest to an 8 for large
square inch discrete units; _
surface area. shells (_ g); _
fractional _
sheet(s) (_ g)
for distinct
pieces (e.g.,
Pastry sheet).
Pizza crust................. 55 g.............. _ fractional slice
(_ g)
Taco shells, hard........... 30 g.............. _ shell(s) (_ g)
Waffles..................... 85 g.............. _ piece(s) (_ g)
Beverages:
Carbonated and noncarbonated 360 mL............ 12 fl oz (360 mL)
beverages, wine coolers,
water.
Coffee or tea, flavored and 360 mL prepared... 12 fl oz (360 mL)
sweetened.
Cereals and Other Grain
Products:
Breakfast cereals (hot 1 cup prepared; 40 _ cup(s) (_ g)
cereal type), hominy grits. g plain dry
cereal; 55 g
flavored,
sweetened cereal.
Breakfast cereals, ready-to- 15 g.............. _ cup(s) (_ g)
eat, weighing less than 20
g per cup, e.g., plain
puffed cereal grains.
Breakfast cereals, ready-to- 40 g.............. _ cup(s) (_ g)
eat, weighing 20 g or more
but less than 43 g per cup;
high fiber cereals
containing 28 g or more of
fiber per 100 g.
Breakfast cereals, ready-to- 60 g.............. _ piece(s) (_ g)
eat, weighing 43 g or more for large
per cup; biscuit types. distinct pieces
(e.g., biscuit
type); _ cup(s)
(_ g) for all
others
Bran or wheat germ.......... 15 g.............. _ tbsp(s) (_ g); _
cup(s) (_ g)
Flours or cornmeal.......... 30 g.............. _ tbsp(s) (_ g); _
cup(s) (_ g)
Grains, e.g., rice, barley, 140 g prepared; 45 _ cup(s) (_ g)
plain. g dry.
Pastas, plain............... 140 g prepared; 55 _ cup(s) (_ g); _
g dry. piece(s) (_ g)
for large pieces
(e.g., large
shells or lasagna
noodles) or 2 oz
(56 g/visual unit
of measure) for
dry bulk products
(e.g., spaghetti)
Pastas, dry, ready-to-eat, 25 g.............. _ cup(s) (_ g)
e.g., fried canned chow
mein noodles.
Starches, e.g., cornstarch, 10 g.............. _ tbsp (_ g)
potato starch, tapioca, etc.
Stuffing.................... 100 g............. _ cup(s) (_ g)
Dairy Products and Substitutes:
Cheese, cottage............. 110 g............. _ cup (_ g)
Cheese used primarily as 55 g.............. _ cup (_ g)
ingredients, e.g., dry
cottage cheese, ricotta
cheese.
Cheese, grated hard, e.g., 5 g............... _ tbsp (_ g)
Parmesan, Romano.
Cheese, all others except 30 g.............. _ piece(s) (_ g)
those listed as separate for distinct
categories--includes cream pieces; _ tbsp(s)
cheese and cheese spread. (_ g) for cream
cheese and cheese
spread; 1 oz (28
g/visual unit of
measure) for bulk
Cheese sauce--see sauce
category.
Cream or cream substitutes, 15 mL............. 1 tbsp (15 mL)
fluid.
Cream or cream substitutes, 2 g............... _ tsp (_ g)
powder.
Cream, half & half.......... 30 mL............. 2 tbsp (30 mL)
Eggnog...................... 120 mL............ \1/2\ cup (120
mL); 4 fl oz (120
mL)
Milk, condensed, undiluted.. 30 mL............. 2 tbsp (30 mL)
Milk, evaporated, undiluted. 30 mL............. 2 tbsp (30 mL)
Milk, milk-substitute 240 mL............ 1 cup (240 mL); 8
beverages, milk-based fl oz (240 mL)
drinks, e.g., instant
breakfast, meal
replacement, cocoa, soy
beverage.
Shakes or shake substitutes, 240 mL............ 1 cup (240 mL); 8
e.g., dairy shake mixes, fl oz (240 mL)
fruit frost mixes.
Sour cream.................. 30 g.............. _ tbsp (_ g)
Yogurt...................... 170 g............. _ cup (_ g)
Desserts:
Ice cream, frozen yogurt, \2/3\ cup-- \2/3\ cup (_ g), _
sherbet, frozen flavored includes the piece(s) (_ g)
and sweetened ice and pops, volume for for individually
frozen fruit juices: all coatings and wrapped or
types bulk and novelties wafers. packaged products
(e.g., bars, sandwiches,
cones, cups).
Sundae...................... 1 cup............. 1 cup (_ g)
Custards, gelatin, or \1/2\ cup _ piece(s) (_ g)
pudding. prepared; amount for distinct unit
to make \1/2\ cup (e.g.,
prepared when dry. individually
packaged
products); \1/2\
cup (_ g) for
bulk
Dessert Toppings and Fillings:
Cake frostings or icings.... 2 tbsp............ _ tbsp(s) (_ g)
Other dessert toppings, 2 tbsp............ 2 tbsp (_ g); 2
e.g., fruits, syrups, tbsp (30 mL)
spreads, marshmallow cream,
nuts, dairy and non-dairy
whipped toppings.
[[Page 34044]]
Pie fillings................ 85 g.............. _ cup(s) (_ g)
Egg and Egg Substitutes:
Egg mixtures, e.g., egg foo 110 g............. _ piece(s) (_ g)
young, scrambled eggs, for discrete
omelets. pieces; _ cup(s)
(_ g)
Eggs (all sizes) \8\........ 50 g.............. 1 large, medium,
etc. (_ g)
Egg whites, sugared eggs, An amount to make _ cup(s) (_ g); _
sugared egg yolks, and egg 1 large (50 g) cup(s) (_ mL)
substitutes (fresh, frozen, egg.
dried).
Fats and Oils:
Butter, margarine, oil, 1 tbsp............ 1 tbsp (_ g); 1
shortening. tbsp (15 mL)
Butter replacement, powder.. 2 g............... _ tsp(s) (_ g)
Dressings for salads........ 30 g.............. _ tbsp (_ g); _
tbsp (_ mL)
Mayonnaise, sandwich 15 g.............. _ tbsp (_ g)
spreads, mayonnaise-type
dressings.
Spray types................. 0.25 g............ About _ seconds
spray (_ g)
Fish, Shellfish, Game Meats,\9\
and Meat or Poultry
Substitutes:
Bacon substitutes, canned 15 g.............. _ piece(s) (_ g)
anchovies,\10\ anchovy for discrete
pastes, caviar. pieces; _ tbsp(s)
(_ g) for others
Dried, e.g., jerky.......... 30 g.............. _ piece(s) (_ g)
Entrees with sauce, e.g., 140 g cooked...... _ cup(s) (_ g); 5
fish with cream sauce, oz (140 g/visual
shrimp with lobster sauce. unit of measure)
if not measurable
by cup
Entrees without sauce, e.g., 85 g cooked; 110 g _ piece(s) (_ g)
plain or fried fish and uncooked \11\. for discrete
shellfish, fish and pieces; _ cup(s)
shellfish cake. (_ g); _ oz (_ g/
visual unit of
measure) if not
measurable by cup
\12\
Fish, shellfish, or game 85 g.............. _ piece(s) (_ g)
meat \9\, canned \10\. for discrete
pieces; _ cup(s)
(_ g); 3 oz (85 g/
_ cup) for
products that are
difficult to
measure the g
weight of cup
measure (e.g.,
tuna); 3 oz (85 g/
_ pieces) for
products that
naturally vary in
size (e.g.,
sardines)
Substitute for luncheon 55 g.............. _ piece(s) (_ g)
meat, meat spreads, for distinct
Canadian bacon, sausages, pieces (e.g.,
frankfurters, and seafood. slices, links); _
cup(s) (_ g); 2
oz (56 g/visual
unit of measure)
for nondiscrete
bulk product
Smoked or pickled fish,\10\ 55 g.............. _ piece(s) (_ g)
shellfish, or game meat for distinct
\9\; fish or shellfish pieces (e.g.,
spread. slices, links) or
_ cup(s) (_ g); 2
oz (56 g/visual
unit of measure)
for nondiscrete
bulk product
Substitutes for bacon bits--
see Miscellaneous.
Fruits and Fruit Juices:
Candied or pickled \10\..... 30 g.............. _ piece(s) (_ g)
Dehydrated fruits--see snack
category.
Dried....................... 40 g.............. _ piece(s) (_ g)
for large pieces
(e.g., dates,
figs, prunes); _
cup(s) (_ g) for
small pieces
(e.g., raisins)
Fruits for garnish or 4 g............... 1 cherry (_ g); _
flavor, e.g., maraschino piece(s) (_ g)
cherries \10\.
Fruit relishes, e.g., 70 g.............. _ cup(s) (_ g)
cranberry sauce, cranberry
relish.
Fruits used primarily as 50 g.............. See footnote \12\
ingredients, avocado.
Fruits used primarily as 50 g.............. _ piece(s) (_ g)
ingredients, others for large fruits;
(cranberries, lemon, lime). _ cup(s) (_ g)
for small fruits
measurable by
cup\12\
Watermelon.................. 280 g............. See footnote \12\
All other fruits (except 140 g............. _ piece(s) (_ g)
those listed as separate for large pieces
categories), fresh, canned (e.g.,
or frozen. strawberries,
prunes, apricots,
etc.); _ cup(s)
(_ g) for small
pieces (e.g.,
blueberries,
raspberries,
etc.) \12\
Juices, nectars, fruit 240 mL............ 8 fl oz (240 mL)
drinks.
Juices used as ingredients, 5 mL.............. 1 tsp (5 mL)
e.g., lemon juice, lime
juice.
Legumes:
Tofu,\10\ tempeh............ 85 g.............. _ piece(s) (_ g)
for discrete
pieces; 3 oz (84
g/visual unit of
measure) for bulk
products
Beans, plain or in sauce.... 130 g for beans in _ cup (_ g)
sauce or canned
in liquid and
refried beans
prepared; 90 g
for others
prepared; 35 g
dry.
Miscellaneous:
Baking powder, baking soda, 0.6 g............. _ tsp (_ g)
pectin.
Baking decorations, e.g., 1 tsp or 4 g if _ piece(s) (_ g)
colored sugars and not measurable by for discrete
sprinkles for cookies, cake teaspoon. pieces; 1 tsp (_
decorations. g)
Batter mixes, bread crumbs.. 30 g.............. _ tbsp(s) (_ g); _
cup(s) (_ g)
Chewing gum \8\............. 3 g............... _ piece(s) (_ g)
Cocoa powder, carob powder, 1 tbsp............ 1 tbsp (_ g)
unsweetened.
Cooking wine................ 30 mL............. 2 tbsp (30 mL)
[[Page 34045]]
Dietary supplements......... The maximum amount _ tablet(s), _
recommended, as capsules(s), _
appropriate, on packet(s), _
the label for tsp(s) (_ g),
consumption per etc.
eating occasion
or, in the
absence of
recommendations,
1 unit, e.g.,
tablet, capsule,
packet,
teaspoonful, etc.
Meat, poultry, and fish Amount to make one _ tsp(s) (_ g); _
coating mixes, dry; reference amount tbsp(s) (_ g)
seasoning mixes, dry, e.g., of final dish.
chili seasoning mixes,
pasta salad seasoning mixes.
Milk, milk substitute, and Amount to make 240 _ fl oz (_ mL); _
fruit juice concentrates mL drink (without tsp (_ g); tbsp
(without alcohol) (e.g., ice). (_ g)
drink mixers, frozen fruit
juice concentrate,
sweetened cocoa powder).
Drink mixes (without Amount to make 360 _ fl oz (_ mL); _
alcohol): All other types mL drink (without tsp (_ g); _ tbsp
(e.g., flavored syrups and ice). (_ g)
powdered drink mixes).
Salad and potato toppers, 7 g............... _ tbsp(s) (_ g)
e.g., salad crunchies,
salad crispins, substitutes
for bacon bits.
Salt, salt substitutes, \1/4\ tsp......... \1/4\ tsp (_ g); _
seasoning salts (e.g., piece(s) (_ g)
garlic salt). for discrete
pieces (e.g.,
individually
packaged
products)
Seasoning oils and seasoning 1 tbsp............ 1 tbsp (_ g)
sauces (e.g., coconut
concentrate, sesame oil,
almond oil, chili oil,
coconut oil, walnut oil).
Seasoning pastes (e.g., 1 tsp............. 1 tsp (_ g)
garlic paste, ginger paste,
curry paste, chili paste,
miso paste), fresh or
frozen.
Spices, herbs (other than \1/4\ tsp or 0.5 g \1/4\ tsp (_ g); _
dietary supplements). if not measurable piece(s) (_ g) if
by teaspoon. not measurable by
teaspoons (e.g.,
bay leaf)
Mixed Dishes:
Appetizers, hors d'oeuvres, 85 g, add 35 g for _ piece(s) (_ g)
mini mixed dishes, e.g., products with
mini bagel pizzas, breaded gravy or sauce
mozzarella sticks, egg topping.
rolls, dumplings,
potstickers, wontons, mini
quesadillas, mini quiches,
mini sandwiches, mini pizza
rolls, potato skins.
Measurable with cup, e.g., 1 cup............. 1 cup (_ g)
casseroles, hash, macaroni
and cheese, pot pies,
spaghetti with sauce,
stews, etc.
Not measurable with cup, 140 g, add 55 g _ piece(s) (_ g)
e.g., burritos, enchiladas, for products with for discrete
pizza, pizza rolls, quiche, gravy or sauce pieces; _
all types of sandwiches. topping, e.g., fractional slice
enchilada with (_ g) for large
cheese sauce, discrete units
crepe with white
sauce \13\.
Nuts and Seeds:
Nuts, seeds and mixtures, 30 g.............. _ piece(s) (_ g)
all types: Sliced, chopped, for large pieces
slivered, and whole. (e.g., unshelled
nuts); _ tbsp(s)
(_ g); _ cup(s)
(_ g) for small
pieces (e.g.,
peanuts,
sunflower seeds)
Nut and seed butters, 2 tbsp............ 2 tbsp (_ g)
pastes, or creams.
Coconut, nut and seed flours 15 g.............. _ tbsp(s) (_ g); _
cup (_ g)
Potatoes and Sweet Potatoes/
Yams:
French fries, hash browns, 70 g prepared; 85 _ piece(s) (_ g)
skins, or pancakes. g for frozen for large
unprepared French distinct pieces
fries. (e.g., patties,
skins); 2.5 oz
(70 g/_ pieces)
for prepared
fries; 3 oz (84 g/
_ pieces) for
unprepared fries
Mashed, candied, stuffed or 140 g............. _ piece(s) (_ g)
with sauce. for discrete
pieces (e.g.,
stuffed potato);
_ cup(s) (_ g)
Plain, fresh, canned, or 110 g for fresh or _ piece(s) (_ g)
frozen. frozen; 125 g for for discrete
vacuum packed; pieces; _ cup(s)
160 g for canned (_ g) for sliced
in liquid. or chopped
products
Salads:
Gelatin salad............... 120 g............. _ cup (_ g)
Pasta or potato salad....... 140 g............. _ cup(s) (_ g)
All other salads, e.g., egg, 100 g............. _ cup(s) (_ g)
fish, shellfish, bean,
fruit, or vegetable salads.
Sauces, Dips, Gravies, and
Condiments:
Barbecue sauce, hollandaise 2 tbsp............ 2 tbsp (_ g); 2
sauce, tartar sauce, tomato tbsp (30 mL)
chili sauce, other sauces
for dipping (e.g., mustard
sauce, sweet and sour
sauce), all dips (e.g.,
bean dips, dairy-based
dips, salsa).
Major main entree sauces, 125 g............. _ cup (_ g); _ cup
e.g., spaghetti sauce. (_ mL)
Minor main entree sauces \1/4\ cup......... \1/4\ cup (_ g);
(e.g., pizza sauce, pesto \1/4\ cup (60 mL)
sauce, Alfredo sauce),
other sauces used as
toppings (e.g., gravy,
white sauce, cheese sauce),
cocktail sauce.
[[Page 34046]]
Major condiments, e.g., 1 tbsp............ 1 tbsp (_ g); 1
catsup, steak sauce, soy tbsp (15 mL)
sauce, vinegar, teriyaki
sauce, marinades.
Minor condiments, e.g., 1 tsp............. 1 tsp (_ g); 1 tsp
horseradish, hot sauces, (5 mL)
mustards, Worcestershire
sauce.
Snacks:
All varieties, chips, 30 g.............. _ cup (_ g) for
pretzels, popcorn, extruded small pieces
snacks, fruit and vegetable- (e.g., popcorn);
based snacks (e.g., fruit _ piece(s) (_ g)
chips), grain-based snack for large pieces
mixes. (e.g., large
pretzels; pressed
dried fruit
sheet); 1 oz (28g/
visual unit of
measure) for bulk
products (e.g.,
potato chips)
Soups:
All varieties............... 245 g............. _ cup (_ g); _ cup
(_ mL)
Dry soup mixes, bouillon.... Amount to make 245 _ cup (_ g); _ cup
g. (_ mL)
Sugars and Sweets:
Baking candies (e.g., chips) 15 g.............. _ piece(s) (_ g)
for large pieces;
_ tbsp(s) (_ g)
for small pieces;
\1/2\ oz (14 g/
visual unit of
measure) for bulk
products
After-dinner confectioneries 10 g.............. _ piece(s) (_ g)
Hard candies, breath mints 2 g............... _ piece(s) (_ g)
\8\.
Hard candies, roll-type, 5 g............... _ piece(s) (_ g)
mini-size in dispenser
packages.
Hard candies, others; 15 mL for liquid _ piece(s) (_ g)
powdered candies, liquid candies; 15 g for for large pieces;
candies. all others. _ tbsp(s) (_ g)
for ``mini-size''
candies
measurable by
tablespoon; _
straw(s) (_ g)
for powdered
candies; _ wax
bottle(s) (_ mL)
for liquid
candies; \1/2\ oz
(14 g/visual unit
of measure) for
bulk products
All other candies........... 30 g.............. _ piece(s) (_ g);
1 oz (30 g/visual
unit of measure)
for bulk products
Confectioner's sugar........ 30 g.............. _ cup (_ g)
Honey, jams, jellies, fruit 1 tbsp............ 1 tbsp (_ g); 1
butter, molasses, fruit tbsp (15 mL)
pastes, fruit chutneys.
Marshmallows................ 30 g.............. _ cup(s) (_ g) for
small pieces; _
piece(s) (_ g)
for large pieces
Sugar....................... 8 g............... _ tsp (_ g); _
piece(s) (_ g)
for discrete
pieces (e.g.,
sugar cubes,
individually
packaged
products)
Sugar substitutes........... An amount _ tsp(s) (_ g) for
equivalent to one solids; _ drop(s)
reference amount (_ g) for liquid;
for sugar in _ piece(s) (_ g)
sweetness. (e.g.,
individually
packaged
products)
Syrups...................... 30 mL for all 2 tbsp (30 mL)
syrups.
Vegetables:
Dried vegetables, dried 5 g, add 5 g for _ piece(s); \1/3\
tomatoes, sun-dried products packaged cup (_ g)
tomatoes, dried mushrooms, in oil.
dried seaweed.
Dried seaweed sheets........ 3 g............... _ piece(s) (_ g);
_ cup(s) (_ g)
Vegetables primarily used 4 g............... _ piece(s) (_ g);
for garnish or flavor _ tbsp(s) (_ g)
(e.g., pimento,\10\ for chopped
parsley, fresh or dried). products
Fresh or canned chili 30 g.............. _ piece(s) (_ g)
peppers, jalapeno peppers, \12\; _ tbsp(s)
other hot peppers, green (_ g); _ cup(s)
onion. (_ g) for sliced
or chopped
products
All other vegetables without 85 g for fresh or _ piece(s) (_ g)
sauce: Fresh, canned, or frozen; 95 g for for large pieces
frozen. vacuum packed; (e.g., Brussels
130 g for canned sprouts); _
in liquid, cream- cup(s) (_ g) for
style corn, small pieces
canned or stewed (e.g., cut corn,
tomatoes, green peas); 3 oz
pumpkin, or (84 g/visual unit
winter squash. of measure) if
not measurable by
cup
All other vegetables with 110 g............. _ piece(s) (_ g)
sauce: Fresh, canned, or for large pieces
frozen. (e.g., Brussels
sprouts); _
cup(s) (_ g) for
small pieces
(e.g., cut corn,
green peas); 4 oz
(112 g/visual
unit of measure)
if not measurable
by cup
Vegetable juice............. 240 mL............ 8 fl oz (240 mL)
Olives \10\................. 15 g.............. _ piece(s) (_ g);
_ tbsp(s) (_ g)
for sliced
products
Pickles and pickled 30 g.............. 1 oz (28 g/visual
vegetables, all types \10\. unit of measure)
Pickle relishes............. 15 g.............. _ tbsp (_ g)
Sprouts, all types: Fresh or 1/4 cup........... \1/4\ cup (_ g)
canned.
Vegetable pastes, e.g., 30 g.............. _ tbsp (_ g)
tomato paste.
Vegetable sauces or purees, 60 g.............. _ cup (_ g); _ cup
e.g., tomato sauce, tomato (_ mL)
puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
customarily consumed per eating occasion and were primarily derived
from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
Surveys conducted by the U.S. Department of Agriculture and updated
with data from the National Health and Nutrition Examination Survey,
2003-2004, 2005-2006 and 2007-2008 conducted by the Centers for
Diseases Control and Prevention, in the Department of Health and Human
Services.
\2\ Unless otherwise noted in the Reference Amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (e.g., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
mixes, concentrates, dough, batter, fresh and frozen pasta) is the
amount required to make the reference amount of the prepared form.
Prepared means prepared for consumption (e.g., cooked).
[[Page 34047]]
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\ The label statements are meant to provide examples of serving size
statements that may be used on the label, but the specific wording may
be changed as appropriate for individual products. The term ``piece''
is used as a generic description of a discrete unit. Manufacturers
should use the description of a unit that is most appropriate for the
specific product (e.g., sandwich for sandwiches, cookie for cookies,
and bar for ice cream bars). The guidance provided is for the label
statement of products in ready-to-serve or almost ready-to-serve form.
The guidance does not apply to the products which require further
preparation for consumption (e.g., dry mixes, concentrates) unless
specifically stated in the product category, reference amount, or
label statement column that it is for these forms of the product. For
products that require further preparation, manufacturers must
determine the label statement following the rules in Sec. 101.9(b)
using the reference amount determined according to Sec. 101.12(c).
\5\ Includes cakes that weigh 10 g or more per cubic inch. The serving
size for fruitcake is 1 \1/2\ ounces.
\6\ Includes cakes that weigh 4 g or more per cubic inch but less than
10 g per cubic inch.
\7\ Includes cakes that weigh less than 4 g per cubic inch.
\8\ Label serving size for ice cream cones, eggs, and breath mints of
all sizes will be 1 unit. Label serving size of all chewing gums that
weigh more than the reference amount that can reasonably be consumed
at a single-eating occasion will be 1 unit.
\9\ Animal products not covered under the Federal Meat Inspection Act or
the Poultry Products Inspection Act, such as flesh products from deer,
bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\10\ If packed or canned in liquid, the reference amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed (e.g., canned chopped clam in juice).
\11\ The reference amount for the uncooked form does not apply to raw
fish in Sec. 101.45 or to single-ingredient products that consist of
fish or game meat as provided for in Sec. 101.9(j)(11).
\12\ For raw fruit, vegetables, and fish, manufacturers should follow
the label statement for the serving size specified in Appendices C and
D to part 101 (21 CFR part 101) Code of Federal Regulations.
\13\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
(c) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a reference amount for the product in the prepared
form, but not the unprepared form, then the reference amount for the
unprepared product must be the amount of the unprepared product
required to make the reference amount for the prepared product as
established in paragraph (b) of this section.
* * * * *
(f) * * *
(1) The reference amount for the combined product must be the
reference amount, as established in paragraph (b) of this section, for
the ingredient that is represented as the main ingredient (e.g., peanut
butter, pancakes, cake) plus proportioned amounts of all minor
ingredients.
(2) If the reference amounts are in compatible units, the weights
or volumes must be summed (e.g., the reference amount for equal volumes
of peanut butter and jelly for which peanut butter is represented as
the main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter
plus 2 tbsp jelly)). If the reference amounts are in incompatible
units, all amounts must be converted to weights and summed, e.g., the
reference amount for pancakes and syrup would be 110 g (the reference
amount for pancakes) plus the weight of the proportioned amount of
syrup.
* * * * *
Dated: May 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11865 Filed 5-20-16; 8:45 am]
BILLING CODE 4164-01-P