Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65493 

Appendix G to Part 91—Operations in 

Reduced Vertical Separation Minimum 

(RVSM) Airspace 

Section 1. Definitions 

Reduced Vertical Separation Minimum 

(RVSM) Airspace. Within RVSM airspace, air 

traffic control (ATC) separates aircraft by a 

minimum of 1,000 feet vertically between FL 

290 and FL 410 inclusive. Air-traffic control 

notifies operators of RVSM airspace by 

providing route planning information. 

* * * * * 

Section 2. Aircraft Approval 

(a) Except as specified in Section 9 of this 

appendix, an operator may be authorized to 

conduct RVSM operations if the 

Administrator finds that its aircraft comply 

with this section. 

* * * * * 

Section 3. Operator Authorization 

(a) Except as specified in Section 9 of this 

appendix, authority for an operator to 

conduct flight in airspace where RVSM is 

applied is issued in operations specifications, 

a Letter of Authorization, or management 

specifications issued under subpart K of this 

part, as appropriate. To issue an RVSM 

authorization under this section, the 

Administrator must find that the operator’s 

aircraft have been approved in accordance 

with Section 2 of this appendix and the 

operator complies with this section. 

(b) Except as specified in Section 9 of this 

appendix, an applicant seeking authorization 

to operate within RVSM airspace must apply 

in a form and manner prescribed by the 

Administrator. The application must include 

the following: 

* * * * * 

(c) In a manner prescribed by the 

Administrator, an operator seeking 

authorization under this section must 

provide evidence that: 

* * * * * 

(2) Each pilot has knowledge of RVSM 

requirements, policies, and procedures 

sufficient for the conduct of operations in 

RVSM airspace. 

Section 4. RVSM Operations 

* * * * * 

(b) * * * 

(1) The operator is authorized by the 

Administrator to perform such operations in 

accordance with Section 3 or Section 9 of 

this appendix, as applicable. 

(2) The aircraft— 

(i) Has been approved and complies with 

Section 2 this appendix; or 

(ii) Complies with Section 9 of this 

appendix. 

(3) Each pilot has knowledge of RVSM 

requirements, policies, and procedures 

sufficient for the conduct of operations in 

RVSM airspace. 

Section 5. Deviation Authority Approval 

The Administrator may authorize an 

aircraft operator to deviate from the 

requirements of §§ 91.180 or 91.706 for a 

specific flight in RVSM airspace if— 

* * * * * 

(b) At the time of filing the flight plan for 

that flight, ATC determines that the aircraft 

may be provided appropriate separation and 

that the flight will not interfere with, or 

impose a burden on, RVSM operations. 

* * * * * 

Section 7. Removal or Amendment of 

Authority 

The Administrator may prohibit or restrict 

an operator from conducting operations in 

RVSM airspace, if the Administrator 

determines that the operator is not 

complying, or is unable to comply, with this 

appendix or subpart H of this part. Examples 

of reasons for amendment, revocation, or 

restriction include, but are not limited to, an 

operator’s: 

* * * * * 

Section 8. Airspace Designation 

RVSM may be applied in all ICAO Flight 

Information Regions (FIRs). 

Section 9. Aircraft Equipped With Automatic 

Dependent Surveillance—Broadcast Out 

An operator is authorized to conduct flight 

in airspace in which RVSM is applied 

provided: 

(a) The aircraft is equipped with the 

following: 

(1) Two operational independent altitude 

measurement systems. 

(2) At least one automatic altitude control 

system that controls the aircraft altitude— 

(i) Within a tolerance band of ±65 feet 

about an acquired altitude when the aircraft 

is operated in straight and level flight under 

nonturbulent, nongust conditions; or 

(ii) Within a tolerance band of ±130 feet 

under nonturbulent, nongust conditions for 

aircraft for which application for type 

certification occurred on or before April 9, 

1997, that are equipped with an automatic 

altitude control system with flight 

management/performance system inputs. 

(3) An altitude alert system that signals an 

alert when the altitude displayed to the 

flightcrew deviates from the selected altitude 

by more than— 

(i) ±300 feet for aircraft for which 

application for type certification was made 

on or before April 9, 1997; or 

(ii) ±200 feet for aircraft for which 

application for type certification is made 

after April 9, 1997. 

(4) A TCAS II that meets TSO C–119b 

(Version 7.0), or a later version, if equipped 

with TCAS II, unless otherwise authorized by 

the Administrator. 

(5) Unless authorized by ATC or the 

foreign country where the aircraft is 

operated, an ADS–B Out system that meets 

the equipment performance requirements of 

§ 91.227 of this part. The aircraft must have 

its height-keeping performance monitored in 

a form and manner acceptable to the 

Administrator. 

(b) The altimetry system error (ASE) of the 

aircraft does not exceed 200 feet when 

operating in RVSM airspace. 

Issued under authority provided by 49 

U.S.C. 106(f), 40103(b), 40113(a), and 

44701(a) in Washington, DC, on December 

10, 2018. 

Daniel K. Elwell, 

Acting Administrator. 

[FR Doc. 2018–27401 Filed 12–20–18; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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; 


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• 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 singleserving 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, 

§ 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 crossreferences; 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 crossreference to another provision. The 

technical amendment corrects the crossreferences. 

We describe the amendments in more 

detail below. 

A. Section 101.9(b) and a CrossReference 

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 § 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, 

§ 101.9(b)(2)(i)(G) was redesignated as 

§ 101.9(b)(2)(i)(F). 

However, the Serving Size Final Rule 

neglected to revise a reference to 

previous § 101.9(b)(2)(i)(G) that appears 

in § 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 § 101.9(b)(5)(vi) to refer 

to § 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, § 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 § 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 § 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 § 101.9(c)(2)(i) 

through (iv). 


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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 

§ 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 

§ 101.81(c)(2)(ii)(B)(1), and so we have 

revised § 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, § 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 

§ 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 

§ 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 § 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 

§ 101.9(c)(8)(ii) so that the declaration of 

quantitative weights for these vitamins 

and minerals are not required for labels 

described in § 101.9(j)(13). 

Additionally, § 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 § 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 b-carotene, 12 micrograms 

b-carotene, or 24 micrograms acarotene, or 24 micrograms bcryptoxanthin. 

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 bcarotene, 12 mcg of dietary b-carotene, 

or 24 mcg of other dietary provitamin A 

carotenoids (a-carotene or bcryptoxanthin) (81 FR 33742 at 33913) 

(emphasis added). However, we 

neglected to insert the word ‘‘dietary’’ 

before b-carotene, a-carotene, and bcryptoxanthin in footnote 2. 

The technical amendment inserts 

‘‘dietary’’ before b-carotene, a-carotene, 

and b-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 § 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 

§ 101.9(d)(1)(iii) omitted the paragraph 

designations for ‘‘Amount per serving’’ 

and ‘‘% Daily Value,’’ which are 

§ 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 § 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 § 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 § 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 


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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 § 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 § 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 § 101.9(j)(13)(i), we did not 

intend to affect the preexisting 

paragraphs at § 101.9(j)(13)(i)(A), which 

pertains to the use of an address or 

telephone number where consumers can 

obtain required information, and 

§ 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 

§ 101.9(j)(13)(i) and also correcting an 

error in § 101.9(j)(13)(i)(B) by replacing 

the reference to ‘‘§ 101.2(c)(5)’’ with 

‘‘§ 101.2(c)(2).’’ The correction is 

necessary because § 101.2(c)(5) does not 

exist, and the correct reference is to 

§ 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 § 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 

§ 101.36(b)(2)(ii)(B) because 

§ 101.9(c)(8)(iv), among other things, 

does set forth the RDI, nomenclature, 

and unit of measure for potassium. 

Thus, because § 101.9(c)(8)(iv) sets forth 

an RDI and units of measure for 

potassium, the exclusion for potassium 

in § 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, § 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 § 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 § 101.36(b)(2)). 

The sample label in paragraph (e)(12) 

contained two errors. The sample label 

incorrectly placed choline after 

potassium when, under 

§ 101.36(b)(2)(i)(B), choline should 

appear after pantothenic acid. 

Additionally, the sample label 

incorrectly gave a value for potassium. 

Under § 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 § 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. 


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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 

■ 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. 

■ 2. In § 101.9: 

■ a. Revise paragraph (b)(5)(vi); 

■ b. Add paragraphs (c)(2)(i) through 

(iv); 

■ 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 

■ d. Add paragraphs (j)(13)(i)(A) and 

(B). 

The revisions and additions read as 

follows: 

§ 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 ‘‘Polyunsaturated’’ (VOLUNTARY): A 

statement of the number of grams of 

polyunsaturated fat in a serving defined 

as cis,cis-methylene-interrupted 


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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 § 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 § 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 

§ 101.81(c)(2)(ii)(A)), psyllium husk (as 

described in § 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 § 101.30 or for Brix 

standardization under § 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 §§ 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: 


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RDI 

Nutrient Unit of measure 

Adults and 

children ≥ 4 

years 

Infants 1

through 12 

months 

Children 1 

through 3 

years 

Pregnant 

women and 

lactating 

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 RAE3 (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 NE5 (mg) ............................................ 16 4 6 18 

Vitamin B6 ...................... Milligrams (mg) .................................................... 1.7 0.3 0.5 2.0 

Folate 6 ........................... Micrograms DFE7 (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. 

2The 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 b-carotene, 12 micrograms dietary bcarotene, or 24 micrograms dietary a-carotene, or dietary 24 micrograms dietary b-cryptoxanthin. 4 1 mg a-tocopherol (label claim) = 1 mg a-tocopherol = 1 mg RRR- a-tocopherol = 2 mg all rac-a-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. 

8Based 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: 


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(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. 


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Dual Column Display, Per Serving and Per Container 

Nutrition Facts 

2 servings per container 

Serving size 1 cup (255gJ 

Peraervlng Per container 

Calories 220 440 

% DV* 'li>DV" 

Total Fat 5g 8% 10g 13% 

Saturated Fat 2g 10% 4g 20% 

Trans Fat Og Og 

Cholesterol 15mg 5% 30mg 10% 

Sodium 240mg 10% 460mg 21% 

Total Carb. 35g 13% 70g 25% 

Dietary Fiber 6g 21% 12g 43% 

Total Sugars 7g 14g 

Incl. Added SUgars 4g 8% Bg 18% 

Protein 9g 18g 

Vitamin D 5mcg 25% 10mcg 50% 

Calcium 200mg 15% 400mg 30% 

Iron 1mg 6% 2mg 10% 

Potassium 470mg 10% 940mg 20% 

• The % Dally Value (DV) tells you how much a nutrient In a serving of 

food contributes to a dally diet 2,000 calories a day Is used tor general 

nutrition advice. 
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(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. 

* * * * * 

(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 § 101.2(c)(2). 

* * * * * 

■ 3. In § 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: 

§ 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 


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left side of the nutritional label in the 

order and manner of indentation 

specified in § 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 § 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 

§ 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): 

* * * * * (iv) Dietary supplement containing 

dietary ingredients with and without 

RDIs and DRVs: 


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* * * * * 

(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: 

* * * * * ■ 4. Revise appendix B to part 101 to 

read as follows: 

Appendix B to Part 101—Graphic 

Enhancements Used by the FDA 


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Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65505 


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Examples ofGrapble Enbaneenwtts used by the FDA 

1. The Nutrition Facts label is boxed and contains all black or one oolortype printed on a white 

or neutral background. 

B. Typeteee and me 

1. The "Nutrition Facts"label uses 6 point or larger Helvetica Black and/or Helvetica Regular 

type. In order to fit some formats, the typography may be kemed as much as 4 (tighter kerning 

reduces legibility). 

2. Key nutrients and their% DailyValuesare set in 8 point Helvetica Black. The"%" symbol 

also may be set in Helvetica Black. 

3 ... Nutrition Facts" is set in either Franklin Gothic Heavy or Helvetica Black to fit the width of 

the lab'et flush left 1llld tlU$hright 

4. "Servings per container" is set in 10 point Helvetica Regular and "Serving size" is set in 10 

point Helvetica Black and with 1 point ot leading. ''Amount per serving'' is set in 6 point 

Helvetica Black. 

5. "Calories"' is set in 16 .point Helvetiea Black and the numerical value of calories is set in 22. 

point Helvetica Black. 

6. Absolute measures of nutrient content (for exampt~. ''l g'') .and .nutrient subgroups are set in a 

point Helvetica Regular with.4 points of leading, 

7. Vitamins and minerals are set in 8 point Helvetica Regular, with 4 points of leading, separated 

by 8 point bullets. 

8. The type for the footnote is set in 6 point Helvetica Regular with 1 point ofleading. 

C. Rules 

1. A 7 point rule separates large groupings as shown in the example. A 3 point rule separates 

calorie information from the nutrient infonnation. 

2. A hairline rule or !4 point rule separates individual nutrients, as shown in the example. 

Descendeta do not touch rule. The top half of the label (nutrient infonnati.on) has 2 points of 

leading between the type and the rules and the bottom half of the label (footnote) has 1 point of 

leading between the type and the rules. The rule above the .. Added Sugars~• declaration is 

shortened as shown in the example. 

D. Box 

1. All labels are enclOsed by* point box rule within 3 points of text m.easure. 
65506 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Part 543 

RIN 3141–AA60 

Minimum Internal Control Standards 

AGENCY: National Indian Gaming 

Commission, Interior. 

ACTION: Final rule. 

SUMMARY: The National Indian Gaming 

Commission (NIGC) amends its 

minimum internal control standards for 

Class II gaming under the Indian 

Gaming Regulatory Act to correct an 

erroneous deletion of the key control 

standards and to make other minor edits 

and additions for clarity. 

DATES: Effective Date: January 22, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Lawson at (202) 632–7003 or by 

fax (202) 632–7066 (these numbers are 

not toll free). 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Indian Gaming Regulatory Act 

(IGRA or Act), Public Law 100–497, 25 

U.S.C. 2701 et seq., was signed into law 

on October 17, 1988. The Act 

established the National Indian Gaming 

Commission (‘‘NIGC’’ or ‘‘Commission’’) 

and set out a comprehensive framework 

for the regulation of gaming on Indian 

lands. On January 5, 1999, the NIGC 

published a final rule in the Federal 

Register called Minimum Internal 

Control Standards. 64 FR 590. The rule 

added a new part to the Commission’s 

regulations establishing Minimum 

Internal Control Standards (MICS) to 

reduce the risk of loss because of 

customer or employee access to cash 

and cash equivalents within a casino. 

The rule contains standards and 

procedures that govern cash handling, 

documentation, game integrity, 

auditing, surveillance, and variances, as 

well as other areas. 

The Commission recognized from 

their inception that the MICS would 

require periodic review and updates to 

keep pace with technology and has 

substantively amended them numerous 

times, most recently in late 2013 (78 FR 

63873). 

II. Development of the Rule 

On September 21, 2012, the 

Commission concluded nearly two years 

of consultation and drafting with the 

publication of comprehensive 

amendments, additions, and updates to 

Part 543, the minimum internal control 

standards (MICS) for Class II gaming 

operations (77 FR 58708). The 

regulations require tribes to establish 

controls and implement procedures at 

least as stringent as those described in 


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