[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Rules and Regulations]
[Pages 65493-65506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27431]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2012-N-1210]
Food Labeling; Revision of the Nutrition and Supplement Facts
Labels; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
regulations pertaining to the Nutrition Facts and Supplement Facts
labels. The amendments correct errors that were made in labeling
examples, restore incorrect deletions, correct the edition of a
reference cited in the rule, and correct cross-references to other
regulations. This action is ministerial or editorial in nature.
DATES: This rule is effective December 21, 2018.
FOR FURTHER INFORMATION CONTACT: Mark Kantor, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2082.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 27, 2016 (81 FR 33742 and 81 FR
34000), we published two final rules entitled ``Food Labeling: Revision
of the Nutrition and Supplement Facts Labels'' (the Nutrition Facts
Label Final Rule) 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'' (the Serving Size Final Rule). The Nutrition Facts Label
Final Rule revises the Nutrition Facts label by:
Removing the declaration of ``Calories from fat''
because current science supports a view that the type of fat is more
relevant than overall total fat intake in increased risk of chronic
diseases;
[[Page 65494]]
requiring the declaration of the gram amount of ``added
sugars'' in a serving of a product, establishing a Daily Reference
Value (DRV), and requiring the percent Daily Value (DV) declaration
for added sugars;
changing ``Sugars'' to ``Total Sugars'' and requiring
that ``Includes `X' g Added Sugars'' be indented and declared
directly below ``Total Sugars'' on the label;
updating the list of vitamins and minerals of public
health significance. For example, the Nutrition Facts Label Final
Rule requires the declaration of vitamin D and potassium and
permits, rather than requires, the declaration of vitamins A and C;
updating certain reference values used in the
declaration of percent DVs of nutrients on the Nutrition Facts and
Supplement Facts labels;
revising the format of the Nutrition Facts label to
increase the prominence of the term ``Calories;''
removing the requirement for the footnote table listing
the reference values for certain nutrients for 2,000 and 2,500
calorie diets;
requiring the maintenance of records to support the
declarations of certain nutrients under specified circumstances. For
example, because there are no analytical methods that can
distinguish between dietary fiber (soluble and insoluble fiber) and
nondigestible carbohydrates that do not meet the definition of
dietary fiber; added and naturally occurring sugars or the various
forms of vitamin E; or folate and folic acid, the Nutrition Facts
Label Final Rule requires manufacturers to make and keep certain
written records to verify the declarations of dietary fiber, added
sugars, vitamin E, and folate and folic acid in the labeling of the
food associated with such records. The Nutrition Facts Label Final
Rule requires these records to be kept for at least 2 years after
introduction or delivery for introduction of the food into
interstate commerce. A similar requirement exists with respect to
added sugars in foods subject to nonenzymatic browning and
fermentation because there are no analytical methods that can
determine the amount of added sugar in specific foods containing
added sugars alone or in combination with naturally occurring
sugars, where the added sugars are subject to nonenzymatic browning
and fermentation. However, for manufacturers of such foods who are
unable to reasonably approximate the amount of added sugars in a
serving of food to which the records requirements apply, the
Nutrition Facts Label Final Rule allows manufacturers to submit a
petition to request an alternative means of compliance; and
establishing a compliance date of 2 years after the
Nutrition Facts Label Final Rule's effective date, except that
manufacturers with less than $10 million in annual food sales have a
compliance date of 3 years after the Nutrition Facts Label Final
Rule's effective date. (In the Federal Register of May 4, 2018 (83
FR 19619), however, we extended the compliance date for
manufacturers with $10 million or more in annual food sales from
July 26, 2018, to January 1, 2020, and the compliance date for
manufacturers with less than $10 million in annual food sales from
July 26, 2019, to January 1, 2021.)
The Serving Size Final Rule requires all containers, including
containers of products with ``large'' reference amounts customarily
consumed (RACCs) (i.e., products with RACCs of at least 100 grams
(g) or 100 milliliters (mL)), containing less than 200 percent of
the RACC to be labeled as a single-serving container. Except for
when certain exceptions apply, the Serving Size Final Rule further
requires 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).
The Serving Size Final Rule also updates, modifies, and establishes
RACCs for certain foods and product categories.
II. Description of the Technical Amendments
Since we published the two final rules in the Federal Register, we
have noted or have been made aware of errors that appeared in the final
rules. Most errors are non-substantive; for example, Sec. 101.9(e)(5)
and (6) (21 CFR 101.9(e)(5) and (6)) show sample Nutrition Facts
labels. The sample labels, however, differed from the other sample
labels in the Nutrition Facts Label Final Rule in that the line
underneath ``Saturated Fat'' did not extend completely to the left edge
of the label. Through this technical amendment, we are revising the
sample labels so that the line extends completely to the left edge of
the label.
Other errors reflected inconsistencies between the Nutrition Facts
Label Final Rule's requirements and sample labels. For example, one
sample label omitted information regarding the number of servings per
container and serving size; both information elements are required.
Through this technical amendment, we are revising the sample label to
include the missing information.
Three errors resulted in the removal of preexisting provisions even
though the Nutrition Facts Label Final Rule did not intend to remove
those provisions. To the contrary, the preamble to the Nutrition Facts
Label Final Rule discussed the provisions as still existing.
Consequently, the technical amendment restores those provisions.
Other errors pertained to cross-references; in some instances, the
Nutrition Facts Label Final Rule and the Serving Size Final Rule
mistakenly referred to a different provision. In another instance, the
Nutrition Facts Label Final Rule omitted a cross-reference to another
provision. The technical amendment corrects the cross-references.
We describe the amendments in more detail below.
A. Section 101.9(b) and a Cross-Reference
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). The Serving Size Final Rule revised
Sec. 101.9(b)(2)(i) by removing paragraph (b)(2)(i)(E) (which had
pertained to the serving size declaration of individual units in
certain multiserving packages where the product has a reference amount
of 100 grams (or milliliters) or larger) and redesignated paragraphs
(b)(2)(i)(F) through (I) accordingly (see 81 FR 34000 at 34040). For
example, Sec. 101.9(b)(2)(i)(G) was redesignated as Sec.
101.9(b)(2)(i)(F).
However, the Serving Size Final Rule neglected to revise a
reference to previous Sec. 101.9(b)(2)(i)(G) that appears in Sec.
101.9(b)(5)(vi) (which pertains to ounces as a common household
measure, with an appropriate visual unit of measure, for products that
naturally vary in size). Consequently, we are revising Sec.
101.9(b)(5)(vi) to refer to Sec. 101.9(b)(2)(i)(F).
B. Section 101.9(c)(2) and Statements Regarding Saturated Fat, Trans
Fat, Polyunsaturated Fat, and Monounsaturated Fat
Section 101.9(c)(2) discusses how a statement of the number of
grams of total fat in a serving must be expressed. Before we issued the
Nutrition Facts Label Final Rule, Sec. 101.9(c)(2) contained four
subordinate paragraphs that discussed how the number of grams of
saturated fat, trans fat, polyunsaturated fat, and monounsaturated fat
must be expressed; these subordinate paragraphs were numbered as Sec.
101.9(c)(2)(i) through (iv). The Nutrition Facts Label Final Rule did
not amend or revise these subordinate paragraphs; to the contrary, in
the preamble to the Nutrition Facts Label Final Rule, we either
referred to them to describe an existing requirement or expressly
stated that we did not intend to change them (see 81 FR 33742 at 33785,
33860).
Nevertheless, after we published the Nutrition Facts Label Final
Rule, we learned that Sec. 101.9(c)(2)(i) through (iv) had been
removed from the Code of Federal Regulations. Because we did not intend
such a result, the technical amendment restores Sec. 101.9(c)(2)(i)
through (iv).
[[Page 65495]]
C. Section 101.9(c)(6)(i), Fiber, and a Cross-Reference
Section 101.9(c)(6)(i) discusses, among other things, specific
isolated or synthetic non-digestible carbohydrates that we have
determined to have physiological effects that are beneficial to human
health and that must be included in the calculation of the amount of
dietary fiber. One such carbohydrate is psyllium husk, and the
Nutrition Facts Label Final Rule contained a cross-reference to Sec.
101.81(c)(2)(ii)(A)(6) (21 CFR 101.81(c)(2)(ii)(A)(6)).
The cross-reference was in error. The correct cross-reference is
Sec. 101.81(c)(2)(ii)(B)(1), and so we have revised Sec.
101.9(c)(6)(i) accordingly.
D. Section 101.9(c)(6)(iii), Added Sugars, and Simplified Format
Section 101.9(c)(6)(iii) discusses how the ``added sugars''
statement must appear. The provision states, among other things, that
if a statement of the added sugars content is not required and, as a
result, is not declared on the Nutrition Facts label, then the
statement ``Not a significant source of added sugars'' must be placed
at the bottom of the table of nutrient values.
However, Sec. 101.9(f) discusses when the declaration of nutrition
information may be presented in a simplified format. In general, a
simplified format may be used when a food product contains
insignificant amounts of eight or more of specific nutrients; these
nutrients include ``added sugars.'' Therefore, the technical amendment
revises Sec. 101.9(c)(6)(iii) by adding ``Except as provided for in
paragraph (f) of this section,'' at the start of the sentence
describing where the statement, ``Not a significant source of added
sugars,'' must be placed.
E. Section 101.9(c)(8)(ii) and Quantitative Weight and Sec.
101.9(c)(8)(iv) and Retinol Activity Equivalents (RAE) and the Order of
Nutrients on the Nutrition Facts Label
Section 101.9(c)(8) establishes requirements related to the
disclosure of vitamins and minerals on the Nutrition Facts label. The
rule, at Sec. 101.9(c)(8)(ii), discusses the declaration of vitamins
and minerals as a quantitative amount by weight and percent of the
Reference Daily Intake (RDI). In the preamble to the proposed rule to
revise the Nutrition Facts and Supplement Facts labels, we described
the proposed rule as requiring the declaration of the absolute amounts
for all mandatory and voluntary vitamins and minerals, in addition to
the requirement for percent DV declaration; we also said that an
exception to the proposed requirement would be Nutrition Facts labels
for foods in small packages that have a total surface area available to
bear labeling of 40 or less square inches (79 FR 11880 at 11952, March
3, 2014). The preamble to the Nutrition Facts Label Final Rule noted
the same exception for smaller packages (81 FR 33742 at 33946).
However, the codified text inadvertently omitted the language
creating the exception. Consequently, we are restoring the exception to
Sec. 101.9(c)(8)(ii) so that the declaration of quantitative weights
for these vitamins and minerals are not required for labels described
in Sec. 101.9(j)(13).
Additionally, Sec. 101.9(c)(8)(ii) contains a sentence mentioning
the statement of the amount per serving of the vitamins and minerals
``as described in this paragraph.'' To clarify the reference of ``this
paragraph,'' the technical amendment revises ``this paragraph'' to read
as ``this paragraph (c)(8)(ii)''.
Our regulations, at Sec. 101.9(c)(8)(iv), describe, among other
things, the units of measure for certain vitamins and minerals. The
rule lists the nutrients, their units of measure, and their RDIs in a
table; for vitamin A, the unit of measure is in micrograms RAE.
Footnote 2 to the table explains that RAE means retinol activity
equivalents and that 1 microgram RAE equals 1 microgram retinol, 2
microgram supplemental [beta]-carotene, 12 micrograms [beta]-carotene,
or 24 micrograms [alpha]-carotene, or 24 micrograms [beta]-
cryptoxanthin.
In the preamble to the Nutrition Facts Label Final Rule, in
response to a comment regarding the unit of measure for vitamin A, we
explained that the conversions for microgram RAE were 1 retinol
activity equivalent (mcg RAE) = 1 mcg retinol, 2 mcg supplemental
[beta]-carotene, 12 mcg of dietary [beta]-carotene, or 24 mcg of other
dietary provitamin A carotenoids ([alpha]-carotene or [beta]-
cryptoxanthin) (81 FR 33742 at 33913) (emphasis added). However, we
neglected to insert the word ``dietary'' before [beta]-carotene,
[alpha]-carotene, and [beta]-cryptoxanthin in footnote 2.
The technical amendment inserts ``dietary'' before [beta]-carotene,
[alpha]-carotene, and [beta]-cryptoxanthin in the footnote and also
renumbers the footnote as footnote 3. The renumbering of the footnote
is necessary because the technical amendment also revises the order of
the nutrients in the table at 21 CFR 101.8(c)(8)(iv); the nutrients
were supposed to be placed in order so that nutrients that must be
disclosed on the label appear first. However, the Nutrition Facts Label
Final Rule inadvertently neglected to reorder the nutrients in the
table to reflect the status of vitamin D, calcium, iron, and potassium
as nutrients that must be disclosed. As a result of reordering the
nutrients in the table, footnote 2 is now footnote 3.
F. Section 101.9(d)(1)(iii) and Type Size
Section 101.9(d)(1)(iii) establishes the type sizes for information
on the Nutrition Facts label. Among other things, the regulation
requires information required under Sec. 101.9(d)(9) (regarding the
footnote to the Nutrition Facts label) to be in a type size no smaller
than 6 point.
In the preamble to the Nutrition Facts Label Final Rule, we
discussed how other information pertaining to ``Amount per serving''
and ``% Daily Value'' also would be required to be in a type size no
smaller than 6 point (see 81 FR 33742 at 33944 (discussing the type
size for ``Amount per serving'') and 81 FR 33742 at 33952 (discussing
the type size for ``% Daily Value'')). However, the codified text at
Sec. 101.9(d)(1)(iii) omitted the paragraph designations for ``Amount
per serving'' and ``% Daily Value,'' which are Sec. 101.9(d)(4) and
(6), respectively. Consequently, the technical amendment adds
paragraphs (d)(4) and (6) to the information that must be in a type
size no smaller than 6 point.
G. Section 101.9(e)(5) and (6) and Corrections to Sample Labels
Section 101.9(e)(5) and (6) show sample Nutrition Facts labels. The
sample labels illustrate how dual column labels might appear. Some
sample labels, however, differed from the other sample labels in the
Nutrition Facts Label Final Rule in that the line underneath
``Saturated Fat'' did not extend completely to the left edge of the
label.
The technical amendment revises the sample labels so that the line
extends completely to the left edge of the label.
In Sec. 101.9(e)(5), the revised sample label also changes the
value for potassium from 45 mg to 40 mg because the declaration of
potassium is to be expressed to the nearest 10 mg. increment.
Additionally, in Sec. 101.9(e)(6)(i), we have revised the title
for one sample label from ``Dual Column Display'' to ``Dual Column
Display, Per Serving and Per Container.'' This revised title should
help distinguish this sample label from the other sample label in Sec.
101.9(e)(6)(i). As for the other sample label titled ``Dual Columns,
Per Serving and Per Unit''), the sample label inadvertently omitted
information regarding the
[[Page 65496]]
servings per container and serving size. The technical amendment
revises the sample label for ``Dual Columns, Per Serving and Per Unit''
to include information on servings per container and serving size.
In Sec. 101.9(e)(6)(ii), the sample label appeared blurred or
difficult to read when printed in the Federal Register.
The technical amendment substitutes a better quality image for the
sample label. There are no changes to the contents of the sample label
itself.
H. Section 101.9(j)(13) and Addresses or Phone Numbers for Obtaining
Required Nutrition Information and the Exception for Certain Individual
Serving Size Packages
Section 101.9(j)(13)(i) discusses requirements for foods in small
packages. The Nutrition Facts Label Final Rule revised Sec.
101.9(j)(13)(i) so that the Nutrition Facts label on small packages
would not be required to bear a footnote explaining what the ``% Daily
Value'' means and manufacturers could voluntarily include an
abbreviated footnote of ``% DV = % Daily Value'' in a type size no
smaller than 6 point.
In revising Sec. 101.9(j)(13)(i), we did not intend to affect the
preexisting paragraphs at Sec. 101.9(j)(13)(i)(A), which pertains to
the use of an address or telephone number where consumers can obtain
required information, and Sec. 101.9(j)(13)(i)(B), which pertains to
an exception for certain individual serving size packages of food.
After we issued the Nutrition Facts Label Final Rule, we were informed
that both paragraphs (j)(13)(i)(A) and (B) had, nevertheless, been
deleted. Because we did not intend such a result, we are restoring
paragraphs (j)(13)(i)(A) and (B) to Sec. 101.9(j)(13)(i) and also
correcting an error in Sec. 101.9(j)(13)(i)(B) by replacing the
reference to ``Sec. 101.2(c)(5)'' with ``Sec. 101.2(c)(2).'' The
correction is necessary because Sec. 101.2(c)(5) does not exist, and
the correct reference is to Sec. 101.2(c)(2).
I. Section 101.36 and Corrections to the Spelling of Phosphorus, the
Listing of Potassium, the Size of Calories, and a Cross-Reference
Section 101.36(b)(2)(i)(B) (21 CFR 101.36(b)(2)(i)(B)) names
dietary ingredients that are to be declared on the Supplement Facts
label. The Nutrition Facts Label Final Rule incorrectly spelled
phosphorus as ``phosphorous,'' so the technical amendment uses the
correct spelling. Additionally, we have replaced ``Vitamin A'' with
``vitamin A'' for purposes of punctuation.
Section 101.36(b)(2)(ii)(B) discusses how the amounts of vitamins
and minerals must be declared on the Supplement Facts label. In brief,
the regulation states that the amounts of vitamins and minerals,
excluding sodium and potassium, must be the amount of vitamin or
mineral included in one serving of the product, using the units of
measurement and levels of significance given in Sec. 101.9(c)(8)(iv).
The exclusion regarding potassium was based originally on the fact that
there was no RDI value for potassium. The technical amendment deletes
``and potassium'' from the exclusion in Sec. 101.36(b)(2)(ii)(B)
because Sec. 101.9(c)(8)(iv), among other things, does set forth the
RDI, nomenclature, and unit of measure for potassium. Thus, because
Sec. 101.9(c)(8)(iv) sets forth an RDI and units of measure for
potassium, the exclusion for potassium in Sec. 101.36(b)(2)(ii)(B) is
no longer appropriate.
Section 101.36(e) discusses type sizes for certain information on
the Supplement Facts label. The rule specifies a minimum type size for
footnotes (among other things) and gives an example of a footnote
statement. However, the example, ``Percent Daily Values are based on a
2,000 calorie diet,'' was missing a quotation mark. The technical
amendment restores the missing quotation mark for the phrase ``Percent
Daily Values are based on a 2,000 calorie diet.''
Additionally, Sec. 101.36(e) contains a sentence specifying the
font size for ``Calories'' and the heading ``Calories'' and the actual
number of calories per serving. This sentence, however, should have
been removed from the codified text because, as we stated in our
response to comment 483 in the Nutrition Facts Label Final Rule, many
dietary supplement products may contribute a negligible amount of
calories (81 FR 33742 at 33939). We stated that the Nutrition Facts
Label Final Rule does not require information about calories to be
displayed in a larger type size or highlighted on any Supplement Facts
labels (id.). Therefore, we are removing the sentence regarding the
font size and highlighting for ``Calories'' and the actual number of
calories from Sec. 101.36(e).
J. Section 101.36 and Sample Labels
Section 101.36(e)(11) shows two samples of Supplement Facts labels.
The sample label in paragraph (e)(11)(ii) has an ingredient list that
has ``Sucrose'' as the first ingredient.
The correct term, however, is ``sugar'' instead of ``sucrose,'' so
the technical amendment replaces ``Sucrose'' with ``Sugar'' in the
sample label.
The sample label in paragraph (e)(11)(iv) has an entry of 0 grams
of trans fat.
The technical amendment removes the trans fat line from the sample
label because certain dietary ingredients or subcomponents, including
trans fat, that are not present or are present in amounts that can be
declared as zero, must not be declared on the Supplement Facts label
(see Sec. 101.36(b)(2)).
The sample label in paragraph (e)(12) contained two errors. The
sample label incorrectly placed choline after potassium when, under
Sec. 101.36(b)(2)(i)(B), choline should appear after pantothenic acid.
Additionally, the sample label incorrectly gave a value for potassium.
Under Sec. 101.36(b)(2), vitamins and minerals cannot be declared on
the Supplement Facts label that are not present, or that are present in
amounts that can be declared as zero in Sec. 101.9(c) (such as amounts
corresponding to less than 2 percent of the RDI for the nutrient). In
the sample label that appeared in the Nutrition Facts Label Final Rule,
the level for potassium was less than 2 percent of the RDI.
Consequently, the technical amendment revises the sample label to
provide a level of potassium that would cause potassium to be listed on
the Supplement Facts label.
K. Appendix B and Examples of Graphic Enhancements Used by FDA
The regulations at part 101 (21 CFR part 101) contain several
appendices. One appendix, identified as Appendix B and entitled
``Examples of Graphic Enhancements used by the FDA,'' illustrates
various features of the Nutrition Facts label and identifies type
sizes, fonts, and other specifications that we use in our illustrations
of the Nutrition Facts label.
When we issued the Nutrition Facts Label Final Rule, we did not
update Appendix B to correspond to the Nutrition Facts Label Final
Rule's new and revised requirements. The technical amendment,
therefore, updates Appendix B so that the illustration corresponds to
the Nutrition Facts Label Final Rule. The updated image also changes
the value for potassium from 235 mg to 240 mg; the change to 240 mg is
consistent with the rounding increments used for potassium when a
serving contains greater than 140 mg of potassium. In such cases, the
declared value is rounded to the nearest 10 mg increment.
[[Page 65497]]
III. The Administrative Procedure Act
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
Under 5 U.S.C. 553(b)(3)(B) of the APA, an Agency may, for good cause,
find (and incorporate the finding and a brief statement of reasons in
the rules issued) that notice and public comment procedure on a rule is
impracticable, unnecessary, or contrary to the public interest. We have
determined that notice and public comment are unnecessary because these
amendments only make technical or non-substantive changes, such as
correcting sample labels, correcting cross-references, and restoring
provisions that were never intended to be removed. For these reasons,
we have determined that publishing a notice of proposed rulemaking and
providing opportunity for public comment is unnecessary.
In addition, FDA finds good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as provided by an
Agency for good cause found and published with the rule (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendments do not impose any new regulatory requirements on
affected parties. As a result, affected parties do not need time to
prepare before the rule takes effect. Therefore, we find good cause for
this correction to become effective on the date of publication of this
action.
IV. Paperwork Reduction Act of 1995
This final rule refers to previously approved collections of
information found in FDA regulations. These collections of information
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). The
collections of information in part 101 have been approved under OMB
control number 0910-0381.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) 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. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.
VII. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.
List of Subjects in 21 CFR Part 101
Food labeling, Incorporation by reference, Nutrition, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 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)(5)(vi);
0
b. Add paragraphs (c)(2)(i) through (iv);
0
c. Revise paragraphs (c)(6)(i) introductory text, (c)(6)(iii),
(c)(8)(ii) introductory text, (c)(8)(iv), (d)(1)(iii), (e)(5), and
(e)(6)(i) and (ii); and
0
d. Add paragraphs (j)(13)(i)(A) and (B).
The revisions and additions read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(b) * * *
(5) * * *
(vi) Ounces with an appropriate visual unit of measure, as
described in paragraph (b)(5)(iii) of this section, may be used for
products that naturally vary in size as provided for in paragraph
(b)(2)(i)(F) of this section.
* * * * *
(c) * * *
(2) * * *
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number
of grams of saturated fat in a serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat in a serving if no claims are
made about fat, fatty acid, or cholesterol content, and if ``calories
from saturated fat'' is not declared. Except as provided for in
paragraph (f) of this section, if a statement of the saturated fat
content is not required and, as a result, not declared, the statement
``Not a significant source of saturated fat'' shall be placed at the
bottom of the table of nutrient values. Saturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5 gram
(\1/2\) gram increment below 5 grams and to the nearest gram increment
above 5 grams. If the serving contains less than 0.5 gram, the content
shall be expressed as zero.
(ii) ``Trans fat'' or ``Trans'': A statement of the number of grams
of trans fat in a serving, defined as the sum of all unsaturated fatty
acids that contain one or more isolated (i.e., nonconjugated) double
bonds in a trans configuration, except that label declaration of trans
fat content information is not required for products that contain less
than 0.5 gram of total fat in a serving if no claims are made about
fat, fatty acid or cholesterol content. The word ``trans'' may be
italicized to indicate its Latin origin. Trans fat content shall be
indented and expressed as grams per serving to the nearest 0.5 (\1/2\)-
gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content, when
declared, shall be expressed as zero. Except as provided for in
paragraph (f) of this section, if a statement of the trans fat content
is not required and, as a result, not declared, the statement ``Not a
significant source of trans fat'' shall be placed at the bottom of the
table of nutrient values.
(iii) ``Polyunsaturated fat'' or ``Poly-unsaturated'' (VOLUNTARY):
A statement of the number of grams of polyunsaturated fat in a serving
defined as cis,cis-methylene-interrupted
[[Page 65498]]
polyunsaturated fatty acids may be declared voluntarily, except that
when monounsaturated fat is declared, or when a claim about fatty acids
or cholesterol is made on the label or in labeling of a food other than
one that meets the criteria in Sec. 101.62(b)(1) for a claim for ``fat
free,'' label declaration of polyunsaturated fat is required.
Polyunsaturated fat content shall be indented and expressed as grams
per serving to the nearest 0.5 (\1/2\) gram increment below 5 grams and
to the nearest gram increment above 5 grams. If the serving contains
less than 0.5 gram, the content shall be expressed as zero.
(iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat in a serving
defined as cis-monounsaturated fatty acids may be declared voluntarily
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
food other than one that meets the criteria in Sec. 101.62(b)(1) for a
claim for ``fat free,'' label declaration of monounsaturated fat is
required. Monounsaturated fat content shall be indented and expressed
as grams per serving to the nearest 0.5 (\1/2\) gram increment below 5
grams and to the nearest gram increment above 5 grams. If the serving
contains less than 0.5 gram, the content shall be expressed as zero.
* * * * *
(6) * * *
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber in a serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5 gram, the content may be
expressed as zero. Dietary fiber is defined as non-digestible soluble
and insoluble carbohydrates (with 3 or more monomeric units), and
lignin that are intrinsic and intact in plants; isolated or synthetic
non-digestible carbohydrates (with 3 or more monomeric units)
determined by FDA to have physiological effects that are beneficial to
human health. Except as provided for in paragraph (f) of this section,
if dietary fiber content is not required, and as a result not declared,
the statement ``Not a significant source of dietary fiber'' shall be
placed at the bottom of the table of nutrient values in the same type
size. The following isolated or synthetic nondigestible carbohydrate(s)
have been determined by FDA to have physiological effects that are
beneficial to human health and, therefore, shall be included in the
calculation of the amount of dietary fiber: [beta]-glucan soluble fiber
(as described in Sec. 101.81(c)(2)(ii)(A)), psyllium husk (as
described in Sec. 101.81(c)(2)(ii)(B)(1)), cellulose, guar gum,
pectin, locust bean gum, and hydroxypropylmethylcellulose. The
manufacturer must make and keep records in accordance with paragraphs
(g)(10) and (11) of this section to verify the declared amount of
dietary fiber in the label and labeling of food when a mixture of
dietary fiber, and added nondigestible carbohydrate(s) that does not
meet the definition of dietary fiber, is present in the food.
* * * * *
(iii) ``Added Sugars'': A statement of the number of grams of added
sugars in a serving, except that label declaration of added sugars
content is not required for products that contain less than 1 gram of
added sugars in a serving if no claims are made about sweeteners,
sugars, added sugars, or sugar alcohol content. Except as provided for
in paragraph (f) of this section, if a statement of the added sugars
content is not required and, as a result, not declared, the statement
``Not a significant source of added sugars'' shall be placed at the
bottom of the table of nutrient values in the same type size. Added
sugars are either added during the processing of foods, or are packaged
as such, and include sugars (free, mono and disaccharides), sugars from
syrups and honey, and sugars from concentrated fruit or vegetable
juices that are in excess of what would be expected from the same
volume of 100 percent fruit or vegetable juice of the same type, except
that fruit or vegetable juice concentrated from 100 percent juices sold
to consumers, fruit or vegetable juice concentrates used towards the
total juice percentage label declaration under Sec. 101.30 or for Brix
standardization under Sec. 102.33(g)(2) of this chapter, fruit juice
concentrates which are used to formulate the fruit component of
jellies, jams, or preserves in accordance with the standard of
identities set forth in Sec. Sec. 150.140 and 150.160 of this chapter,
or the fruit component of fruit spreads shall not be labeled as added
sugars. Added sugars content shall be indented under Total Sugars and
shall be prefaced with the word ``Includes'' followed by the amount (in
grams) ``Added Sugars'' (``Includes `X' g Added Sugars''). It shall be
expressed to the nearest gram, except that if a serving contains less
than 1 gram, the statement ``Contains less than 1 gram'' or ``less than
1 gram'' may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero. When a
mixture of naturally occurring and added sugars is present in the food,
and for specific foods containing added sugars, alone or in combination
with naturally occurring sugars, where the added sugars are subject to
fermentation and/or non-enzymatic browning, the manufacturer must make
and keep records in accordance with paragraphs (g)(10) and (11) of this
section to verify the declared amount of added sugars in the label and
labeling of food.
* * * * *
(8) * * *
(ii) The declaration of vitamins and minerals as a quantitative
amount by weight and percent of the RDI shall include vitamin D,
calcium, iron, and potassium in that order, for infants through 12
months, children 1 through 3 years of age, pregnant women, lactating
women, and adults and children 4 or more years of age, except
quantitative weights for these vitamins and minerals are not required
for labels described in paragraph (j)(13) of this section. The
declaration of folic acid shall be included as a quantitative amount by
weight when added as a nutrient supplement or a claim is made about the
nutrient. The declaration of vitamins and minerals in a food, as a
quantitative amount by weight and percent of the RDI, may include any
of the other vitamins and minerals listed in paragraph (c)(8)(iv) of
this section. The declaration of vitamins and minerals shall include
any of the other vitamins and minerals listed in paragraph (c)(8)(iv)
of this section as a statement of the amount per serving of the
vitamins and minerals as described in this paragraph (c)(8)(ii),
calculated as a percent of the RDI and expressed as a percent of the
Daily Value, when they are added as a nutrient supplement, or when a
claim is made about them, unless otherwise stated as quantitative
amount by weight and percent of the Daily Value. Other vitamins and
minerals need not be declared if neither the nutrient nor the component
is otherwise referred to on the label or the labeling or advertising
and the vitamins and minerals are:
* * * * *
(iv) The following RDIs, nomenclature, and units of measure are
established for the following vitamins and minerals which are essential
in human nutrition:
[[Page 65499]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
RDI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults and Infants \1\ Children 1 Pregnant women
Nutrient Unit of measure children >= 4 through 12 through 3 and lactating
years months years women
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin D...................................... Micrograms (mcg) \2\................... 20 10 15 15
Calcium........................................ Milligrams (mg)........................ 1,300 260 700 1,300
Iron........................................... Milligrams (mg)........................ 18 11 7 27
Potassium...................................... Milligrams (mg)........................ 4,700 700 3,000 5,100
Vitamin A...................................... Micrograms RAE \3\ (mcg)............... 900 500 300 1,300
Vitamin C...................................... Milligrams (mg)........................ 90 50 15 120
Vitamin E...................................... Milligrams (mg) \4\.................... 15 5 6 19
Vitamin K...................................... Micrograms (mcg)....................... 120 2.5 30 90
Thiamin........................................ Milligrams (mg)........................ 1.2 0.3 0.5 1.4
Riboflavin..................................... Milligrams (mg)........................ 1.3 0.4 0.5 1.6
Niacin......................................... Milligrams NE \5\ (mg)................. 16 4 6 18
Vitamin B6..................................... Milligrams (mg)........................ 1.7 0.3 0.5 2.0
Folate \6\..................................... Micrograms DFE \7\ (mcg)............... 400 80 150 600
Vitamin B12.................................... Micrograms (mcg)....................... 2.4 0.5 0.9 2.8
Biotin......................................... Micrograms (mcg)....................... 30 6 8 35
Pantothenic acid............................... Milligrams (mg)........................ 5 1.8 2 7
Phosphorus..................................... Milligrams (mg)........................ 1,250 275 460 1,250
Iodine......................................... Micrograms (mcg)....................... 150 130 90 290
Magnesium...................................... Milligrams (mg)........................ 420 75 80 400
Zinc........................................... Milligrams (mg)........................ 11 3 3 13
Selenium....................................... Micrograms (mcg)....................... 55 20 20 70
Copper......................................... Milligrams (mg)........................ 0.9 0.2 0.3 1.3
Manganese...................................... Milligrams (mg)........................ 2.3 0.6 1.2 2.6
Chromium....................................... Micrograms (mcg)....................... 35 5.5 11 45
Molybdenum..................................... Micrograms (mcg)....................... 45 3 17 50
Chloride....................................... Milligrams (mg)........................ 2,300 570 1,500 2,300
Choline........................................ Milligrams (mg)........................ 550 150 200 550
Protein........................................ Grams (g).............................. N/A 11 N/A \8\ 71
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
\2\ The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any
declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg.
\3\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental [beta]-carotene, 12 micrograms dietary [beta]-
carotene, or 24 micrograms dietary [alpha]-carotene, or dietary 24 micrograms dietary [beta]-cryptoxanthin.
\4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all rac-[alpha]-tocopherol.
\5\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
\6\ ``Folate'' and ``Folic Acid'' must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The
declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and
percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made
about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
\7\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally occurring folate = 0.6 mcg folic acid.
\8\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women.
* * * * *
(d)(1) * * *
(iii) Information required in paragraphs (d)(7) and (8) of this
section shall be in type size no smaller than 8 point. Information
required in paragraph (d)(5) of this section for the ``Calories''
declaration shall be highlighted in bold or extra bold and shall be in
a type size no smaller than 16 point except the type size for this
information required in the tabular displays as shown in paragraphs
(d)(11), (e)(6)(ii), and (j)(13)(ii)(A)(1) of this section and the
linear display for small packages as shown in paragraph
(j)(13)(ii)(A)(2) of this section shall be in a type size no smaller
than 10 point. The numeric amount for the information required in
paragraph (d)(5) of this section shall also be highlighted in bold or
extra bold type and shall be in a type size no smaller than 22 point,
except the type size for this information required for the tabular
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of
this section, and for the linear display for small packages as shown in
paragraph (j)(13)(ii)(A)(2) of this section no smaller than 14 point.
The information required in paragraphs (d)(4), (6), and (9) of this
section shall be in a type size no smaller than 6 point. When provided,
the information described in paragraph (d)(10) of this section shall be
in a type size no smaller than 6 point.
* * * * *
(e) * * *
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[[Page 65500]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.010
(6) * * *
(i) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed vertically in the following order: Vitamin D, calcium, iron,
and potassium as shown in the following sample labels.
[[Page 65501]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.011
[[Page 65502]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.012
(ii) The following sample label illustrates the provisions of
paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that
use the tabular display.
[GRAPHIC] [TIFF OMITTED] TR21DE18.013
* * * * *
(j) * * *
(13)(i) * * *
(A) The manufacturer, packer, or distributor shall provide on the
label of packages that qualify for and use this exemption an address or
telephone number that a consumer can use to obtain the required
nutrition information (e.g., ``For nutrition information, call 1-800-
123-4567'').
(B) When such products bear nutrition labeling, either voluntarily
or because nutrition claims or other nutrition information is provided,
all required information shall be in type size no smaller than 6 point
or all upper-case type of 1-16 inches minimum height, except that
individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, may comply with Sec. 101.2(c)(2).
* * * * *
0
3. In Sec. 101.36 revise paragraphs (b)(2)(i)(B) introductory text,
(b)(2)(ii)(B), (e) introductory text, (e)(11)(ii) and (iv), and (e)(12)
to read as follows:
Sec. 101.36 Nutrition labeling of dietary supplements.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(B) The names of dietary ingredients that are declared under
paragraph (b)(2)(i) of this section shall be presented in a column
aligned on the
[[Page 65503]]
left side of the nutritional label in the order and manner of
indentation specified in Sec. 101.9(c), except that calcium and iron
shall follow choline, and sodium and potassium shall follow chloride.
This results in the following order for vitamins and minerals: Vitamin
A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin,
niacin, vitamin B6, folate and folic acid, vitamin B12, biotin,
pantothenic acid, choline, calcium, iron, phosphorus, iodine,
magnesium, zinc, selenium, copper, manganese, chromium, molybdenum,
chloride, sodium, potassium, and fluoride. The (b)(2)-dietary
ingredients shall be listed according to the nomenclature specified in
Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
* * * * *
(ii) * * *
(B) The amounts of vitamins and minerals, excluding sodium, shall
be the amount of the vitamin or mineral included in one serving of the
product, using the units of measurement and the levels of significance
given in Sec. 101.9(c)(8)(iv), except that zeros following decimal
points may be dropped, and additional levels of significance may be
used when the number of decimal places indicated is not sufficient to
express lower amounts (e.g., the RDI for zinc is given in whole
milligrams (mg), but the quantitative amount may be declared in tenths
of a mg). The amount of vitamin D may, but is not required to, be
expressed in IUs, in addition to the mandatory declaration in mcg. Any
declaration of the amount of vitamin D in IUs must appear in
parentheses after the declaration of the amount of vitamin D in mcg.
* * * * *
(e) Except as provided for small and intermediate sized packages
under paragraph (h)(3)(i)(2) of this section, information other than
the title, headings, and footnotes shall be in uniform type size no
smaller than 8 point. Type size no smaller than 6 point may be used for
column headings (e.g., ``Amount Per Serving'' and ``% Daily Value'')
and for footnotes (e.g., ``Percent Daily Values are based on a 2,000
calorie diet'').
* * * * *
(11) * * *
(ii) Multiple vitamins for children and adults (excludes Servings
Per Container which is stated in the net quantity of contents
declaration):
[GRAPHIC] [TIFF OMITTED] TR21DE18.014
* * * * *
(iv) Dietary supplement containing dietary ingredients with and
without RDIs and DRVs:
[[Page 65504]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.015
* * * * *
(12) If space is not adequate to list the required information as
shown in the sample labels in paragraph (e)(11) of this section, the
list may be split and continued to the right as long as the headings
are repeated. The list to the right must be set off by a line that
distinguishes it and sets it apart from the dietary ingredients and
percent of Daily Value information given to the left. The following
sample label illustrates this display:
[GRAPHIC] [TIFF OMITTED] TR21DE18.016
* * * * *
0
4. Revise appendix B to part 101 to read as follows:
Appendix B to Part 101--Graphic Enhancements Used by the FDA
[[Page 65505]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.017
[[Page 65506]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.018
Dated: December 13, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-27431 Filed 12-19-18; 8:45 am]
BILLING CODE 4164-01-P