174 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 94–029F]

Nutrition Labeling of Meat and Poultry

Products; Codification

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Final rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is amending

its final nutrition labeling regulations to

provide codified language for provisions

that previously cross-referenced those

requirements contained in the final

nutrition labeling regulations of the

Food and Drug Administration (FDA)

that FSIS adopted. FSIS is taking this

action to provide complete codified

language for the nutrition labeling of

meat and poultry products in the

regulations under 9 CFR parts 317 and

381. Full codification of the final FSIS

nutrition labeling regulations will

facilitate their use by improving their

clarity and accessibility.

EFFECTIVE DATE: January 3, 1995, except

that the amendments to §§ 317.363 and

381.463 are effective on November 10,

1995. The incorporation by reference of

Agriculture Handbook No. 74 (Slightly

revised February 1973), pages 2, 3, 9–11,

and 25, and the ‘‘Report of the Joint

FAO/WHO Expert Consultation on

Protein Quality Evaluation,’’ Rome,

1990, sections 5.4.1, 7.2.1, and 8,

contained in these regulations, is

approved by the Director of the Office

of the Federal Register as of January 3,

1995.

FOR FURTHER INFORMATION CONTACT:

Charles Edwards, Director, Product

Assessment Division, Regulatory

Programs, Food Safety and Inspection

Service, U.S. Department of Agriculture,

Washington, DC 20250, (202) 254–2565.

SUPPLEMENTARY INFORMATION:

Background

FSIS published its final nutrition

labeling regulations in the Federal

Register on January 6, 1993 (58 FR 632).

Corrections and technical amendments

to this final rule were published on

August 18, 1993 (58 FR 43787), and

September 10, 1993 (58 FR 47624),

respectively. The technical

amendments, which were issued as an

interim final rule, were confirmed as

final on March 16, 1994 (59 FR 12157).

FSIS also published a final rule on

placement of nutrition labeling on meat

and poultry products on August 8, 1994

(59 FR 40209), and a final rule with

additional technical amendments to the

nutrition labeling regulations on

September 1, 1994 (59 FR 45189). Most

of the changes FSIS made in the final

rules pertaining to technical

amendments and the placement of

nutrition labeling on meat and poultry

products were designed to parallel

similar changes that FDA made to its

nutrition labeling regulations. FSIS

adopted certain changes made by FDA

in cross-referenced provisions, in

addition to amending certain of its own

provisions to be consistent with those

changes.

The codified portion of FSIS’s final

regulations published on January 6,

1993, cross-referenced provisions of

FDA’s regulations where the

requirements are identical, and, for the

most part, provided codified language

only for those provisions where there

are variations from FDA because of the

different products that FSIS regulates.

FSIS used cross-references in order to

issue its final nutrition labeling

regulations simultaneously with FDA on

January 6, 1993. In the preamble to its

final rule of January 6, 1993, FSIS said

that it had received many comments

which suggested that the Agency

include all of the codified language for

the nutrition labeling of meat and

poultry products in the regulations

under 9 CFR parts 317 and 381. The

commenters stated that it is very

difficult to go back and forth between

FDA and FSIS regulations to look up

different provisions for the nutrition

labeling regulations. FSIS agreed with

these comments and said it planned to

publish the codified language in its

entirety, while noting that future

codification did not postpone the

implementation date of the nutrition

labeling regulations.

The Amendments

This document sets forth in entirety

the codified language for previously

cross-referenced nutrition labeling

provisions. It includes all changes in the

above-mentioned final rules as they

apply to the cross-referenced provisions.

Sections that contain cross-referenced

provisions include those pertaining to

the nutrition label content (serving

sizes; mandatory and voluntary

nutrients; and format requirements for

the standard display, dual column

display, and simplified format);

Reference Amounts Customarily

Consumed per eating occasion; general

principles for nutrient content claims;

nutrient content claims (claims for

‘‘good source,’’ ‘‘high,’’ and ‘‘more’’;

‘‘light’’ or ‘‘lite’’; calorie content;

sodium content; and fat, fatty acids, and

cholesterol content); and label

statements for reducing or maintaining

body weight.

In incorporating the previously crossreferenced provisions contained in 21

CFR, FSIS has made an effort to order

the paragraphs and subdivisions, to the

extent possible, in the same sequence as

the comparable paragraphs and

subdivisions in FDA’s nutrition labeling

regulations in 21 CFR. Accordingly,

some existing paragraphs have been

redesignated. FSIS believes that such

consistency of presentation will be

useful to interested parties who

compare the FSIS and FDA provisions,

and to those manufacturers producing

both FSIS- and FDA-regulated products

who refer to both agencies’ regulations

for nutrition labeling requirements.

FSIS is also making several

amendments to sections of the nutrition

labeling regulations (9 CFR part 317,

subpart B, and part 381, subpart Y) that

do not contain cross-referenced

provisions to correct typographical

errors, make minor editorial changes for

clarity and accuracy, and reorder

information in several paragraphs to

improve clarity and readability. For

example, in part 317, the terminology

for ‘‘meat products’’ is changed, in most

cases, to ‘‘meat or meat food products,’’

which mirrors the statutory language

contained in the Federal Meat

Inspection Act. The term ‘‘product

component’’ is changed to ‘‘food

component’’ when it refers to a

constituent of food whose declaration

on product labeling is mandatory or

voluntary under the regulations, and

ingredients with specific food factors for

calorie calculations. Cross-references

within paragraphs in various sections of

the nutrition labeling provisions are

changed to conform with any

redesignated paragraph that is the

subject of the cross-reference. Units of

measure and weights are, for the most

part, abbreviated after their first

appearance within a section.

FSIS provided provisions at 9 CFR

317.309(e)(2)(i) and 381.409(e)(2)(i) for

use of an aggregate display of nutrition

information on the outer label or

labeling of products that contain two or

more products in the same package.

However, in 9 CFR 317.309(e)(2)(ii) and

381.409(e)(2)(ii) that specify the format

requirements for the aggregate display,

FSIS inadvertently provided that the

identity of each food shall be specified

immediately under the ‘‘Nutrition

Facts’’ title. In fact, the identity of the

food is placed to the right of the

‘‘Nutrition Facts’’ title as illustrated by

a sample label for the aggregate display

at 21 CFR 101.9(d)(13)(ii). FSIS is

correcting this oversight in paragraphs 9
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 175

CFR 317.309(e)(2)(ii) and

381.409(e)(2)(ii), which are redesignated

as 9 CFR 317.309(d)(13)(ii) and

381.409(d)(13)(ii), respectively.

FSIS is revising the language of 9 CFR

317.309(g) and 381.409(g) to clarify the

identity of nutrients that shall be

included in a simplified format and

those that may be included voluntarily.

Sections 317.309(g)(2) and 381.409(g)(2)

(9 CFR 317.309(g)(2) and 381.409(g)(2))

specify that the simplified format shall

include serving size, number of servings

per container, calories, total fat, total

carbohydrate, protein, and sodium. The

provisions do not provide specifically

that calories from fat, saturated fat,

cholesterol, dietary fiber, sugars,

vitamin A, vitamin C, calcium, and iron

also must be declared in the simplified

format when any are present in more

than insignificant amounts, as must any

added vitamins and minerals for which

Reference Daily Intakes (RDI) are

established if their addition were to be

allowed. Those provisions also do not

indicate that other nutrients for which

nutrition labeling is voluntary (e.g.,

sugar alcohol or thiamin) may also be

declared in the simplified format. FSIS

is redesignating sections 317.309(g) and

381.409(g) as 317.309(f) and 381.409(f),

respectively, revising the newly

designated paragraphs, and adding a

paragraph to specify the requirements

completely. This action provides

codified language that is consistent with

comparable FDA provisions at 21 CFR

101.9(f) and prevents misinterpretation

of the simplified format provisions.

FSIS is amending 9 CFR 317.313(q)(4)

and 381.414(q)(4) pertaining to

exemptions from the general principles

for nutrient content claims by correcting

the terminology for the products that are

not subject to the provisions in the

sections. Accordingly, the term

‘‘products for special dietary use’’ is

changed to read ‘‘infant formulas and

medical foods,’’ which is the

terminology employed by FDA in the

comparable provision in 21 CFR at

101.13(q)(4). Products for special dietary

use, as described in 21 CFR part 105,

include products such as hypoallergenic

products, products designed for weight

reduction or weight maintenance,

products for use in diets of diabetics,

and products used to regulate sodium

intake, all of which are subject to the

provisions of 9 CFR 317.313 and

381.413. To leave the terminology

uncorrected creates an apparent conflict

with provisions in the sections of the

nutrition labeling regulations pertaining

to nutrient content claims about calorie

content (9 CFR 317.360 and 381.460)

and sodium content (9 CFR 313.361 and

381.461), and label or labeling

statements relating to usefulness in

reducing or maintaining body weight (9

CFR 317.380 and 381.480).

At 9 CFR 317.345(a)(2) and

381.445(a)(2), FSIS set forth guidelines

for voluntary nutrition labeling of

single-ingredient, raw products that

specify that point-of-purchase materials

are not subject to any format

requirements if only nutrition

information, and not a nutrition claim,

is supplied on point-of-purchase

materials. FSIS specifically mentioned

that listing of Daily Reference Values,

which is a footnote, is voluntary but did

not specify that the listing of percent of

Daily Value is also a format

requirement. FSIS is making minor

editorial changes in 9 CFR 317.345(a)(2)

and 381.445(a)(2) to clarify this point

and is reordering some of the

information to improve readability.

In addition, at 9 CFR 317.362(f)(1) and

381.462(f)(2), FSIS used the following

statements as examples of declarations

of quantitative information for claims of

cholesterol free, low cholesterol, or

reduced cholesterol that compare the

level of cholesterol in an individual

food product with that of a reference

food: (e.g., ‘‘contains no cholesterol

compared with 30 mg in one serving of

‘reference food’; contains 11 g of fat per

serving’’ or ‘‘cholesterol lowered from

30 mg to 5 mg per serving; contains 13

g of fat per serving’’). FSIS is not

including in these amendments those

portions of the statements that disclose

fat contents, that is, ‘‘contains 11 grams

of fat per serving’’ and ‘‘contains 13 g

of fat per serving,’’ because FSIS does

not require such disclosure but, rather,

permits disclosure on an optional basis.

Executive Order 12866

This final rule has been determined to

be not significant for purposes of

Executive Order 12866 and therefore

has not been reviewed by the Office of

Management and Budget.

Executive Order 12778

This final rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. States and local

jurisdictions are preempted under the

Federal Meat Inspection Act (FMIA) and

the Poultry Products Inspection Act

(PPIA) from imposing any marking,

labeling, packaging, or ingredient

requirement on federally inspected meat

and poultry products that are in

addition to, or different than, those

imposed under the FMIA or PPIA.

States and local jurisdictions may,

however, exercise concurrent

jurisdiction over meat and poultry

products that are outside official

establishments for the purpose of

preventing the distribution of meat and

poultry products that are misbranded or

adulterated under the FMIA or PPIA, or,

in the case of imported articles, which

are not at such an establishment, after

their entry into the United States. Under

the FMIA and PPIA, States that

maintain meat and poultry inspection

programs must impose requirements

that are at least equal to those required

under the FMIA and PPIA. The States

may, however, impose more stringent

requirements on such State inspected

products and establishments.

No retroactive effect will be given to

this final rule. The administrative

procedures specified in 9 CFR 306.5 and

381.35 must be exhausted prior to any

judicial challenge of the application of

the provisions of this final rule, if the

challenge involves any decision of an

inspector relating to inspection services

provided under the FMIA or PPIA. The

administrative procedures specified in 9

CFR parts 335 and 381, subpart W, must

be exhausted prior to any judicial

challenge of the application of the

provisions of this final rule with respect

to labeling decisions.

Effect on Small Entities

The Administrator, FSIS, has made a

determination that this final rule will

not have a significant economic impact

on a substantial number of small

entities. This final rule simply codifies

into 9 CFR the 21 CFR provisions that

were previously cross-referenced in 9

CFR 317 and 381 pertaining to nutrition

labeling. In addition, small entities are

exempt from nutrition labeling

regulations, provided their products do

not make nutrition claims or nutrition

information.

List of Subjects

9 CFR Part 317

Food labeling, Food packaging,

Incorporation by reference, Meat

inspection.

9 CFR Part 381

Food labeling, Incorporation by

reference, Poultry and poultry products.

Final Rule

For the reasons discussed in the

preamble, FSIS is amending 9 CFR parts

317 and 381 of the Federal meat and

poultry products inspection regulations

as follows:

PART 317—LABELING, MARKING

DEVICES, AND CONTAINERS

1. The authority citation for part 317

continues to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.17,

2.55.
176 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

2. Section 317.300 is amended by

revising the section heading, paragraph

(a) and the first sentence of paragraph

(b) to read as follows:

§ 317.300 Nutrition labeling of meat or

meat food products.

(a) Nutrition labeling shall be

provided for all meat or meat food

products intended for human

consumption and offered for sale,

except single-ingredient, raw products,

in accordance with the requirements of

§ 317.309; except as exempted under

§ 317.400 of this subpart.

(b) Nutrition labeling may be

provided for single-ingredient, raw meat

or meat food products in accordance

with the requirements of §§ 317.309 and

317.345. * * *

3. Section 317.302 is amended by

adding the words ‘‘or meat food’’ after

the words ‘‘packaged meat’’ in

paragraph (a) and after the word ‘‘Meat’’

in the first sentence of paragraph (c).

4. Section 317.308 is amended by

adding the words ‘‘or meat food’’ after

the word ‘‘meat’’ in the section title and

after the word ‘‘meat’’ in the text.

5. Section 317.309 is amended by

changing the section reference in the

fifth sentence of paragraph (h)(2) from

‘‘317.309(b)’’ to ‘‘317.309(c)’’ and

revising paragraphs (a) through (g) to

read as follows:

§ 317.309 Nutrition label content.

(a) All nutrient and food component

quantities shall be declared in relation

to a serving as defined in this section.

(b)(1) The term ‘‘serving’’ or ‘‘serving

size’’ means an amount of food

customarily consumed per eating

occasion by persons 4 years of age or

older, which is expressed in a common

household measure that is appropriate

to the product. When the product is

specially formulated or processed for

use by infants or by toddlers, a serving

or serving size means an amount of food

customarily consumed per eating

occasion by infants up to 12 months of

age or by children 1 through 3 years of

age, respectively.

(2) Except as provided in paragraphs

(b)(8), (b)(12), and (b)(14) of this section

and for products that are intended for

weight control and are available only

through a weight-control or weightmaintenance program, serving size

declared on a product label shall be

determined from the ‘‘Reference

Amounts Customarily Consumed Per

Eating Occasion—General Food

Supply’’ (Reference Amount(s)) that

appear in § 317.312(b) using the

procedures described in this paragraph

(b). For products that are both intended

for weight control and available only

through a weight-control program, a

manufacturer may determine the serving

size that is consistent with the meal

plan of the program. Such products

must bear a statement, ‘‘for sale only

through the lll program’’ (fill in the

blank with the name of the appropriate

weight-control program, e.g., Smith’s

Weight Control), on the principal

display panel. However, the Reference

Amounts in § 317.312(b) shall be used

for purposes of evaluating whether

weight-control products that are

available only through a weight-control

program qualify for nutrition claims.

(3) The declaration of nutrient and

food component content shall be on the

basis of the product ‘‘as packaged’’ for

all products, except that singleingredient, raw products may be

declared on the basis of the product ‘‘as

consumed’’ as set forth in

§ 317.345(a)(1). In addition to the

required declaration on the basis of ‘‘as

packaged’’ for products other than

single-ingredient, raw products, the

declaration may also be made on the

basis of ‘‘as consumed,’’ provided that

preparation and cooking instructions are

clearly stated.

(4) For products in discrete units (e.g.,

hot dogs, and individually packaged

products within a multi-serving

package), and for products which

consist of two or more foods packaged

and presented to be consumed together

where the ingredient represented as the

main ingredient is in discrete units (e.g.,

beef fritters and barbecue sauce), the

serving size shall be declared as follows:

(i) If a unit weighs 50 percent or less

of the Reference Amount, the serving

size shall be the number of whole units

that most closely approximates the

Reference Amount for the product

category.

(ii) If a unit weighs more than 50

percent but less than 67 percent of the

Reference Amount, the manufacturer

may declare one unit or two units as the

serving size.

(iii) If a unit weighs 67 percent or

more but less than 200 percent of the

Reference Amount, the serving size

shall be one unit.

(iv) If a unit weighs 200 percent or

more of the Reference Amount, the

manufacturer may declare one unit as

the serving size if the whole unit can

reasonably be consumed at a single

eating occasion.

(v) For products that have Reference

Amounts of 100 grams (or milliliter) or

larger and are individual units within a

multi-serving package, if a unit contains

more than 150 percent but less than 200

percent of the Reference Amount, the

manufacturer may decide whether to

declare the individual unit as 1 or 2

servings.

(vi) For products which consist of two

or more foods packaged and presented

to be consumed together where the

ingredient represented as the main

ingredient is in discrete units (e.g., beef

fritters and barbecue sauce), the serving

size may be the number of discrete units

represented as the main ingredient plus

proportioned minor ingredients used to

make the Reference Amount for the

combined product as determined in

§ 317.312(c).

(vii) For packages containing several

individual single-serving containers,

each of which is labeled with all

required information including

nutrition labeling as specified in this

section (i.e., are labeled appropriately

for individual sale as single-serving

containers), the serving size shall be 1

unit.

(5) For products in large discrete units

that are usually divided for

consumption (e.g., pizza), for

unprepared products where the entire

contents of the package is used to

prepare large discrete units that are

usually divided for consumption (e.g.

pizza kit), and for products which

consist of two or more foods packaged

and presented to be consumed together

where the ingredient represented as the

main ingredient is a large discrete unit

usually divided for consumption, the

serving size shall be the fractional slice

of the ready-to-eat product (e.g., 1⁄8

quiche, 1⁄4 pizza) that most closely

approximates the Reference Amount for

the product category. The serving size

may be the fraction of the package used

to make the Reference Amount for the

unprepared product determined in

§ 317.312(d) or the fraction of the large

discrete unit represented as the main

ingredient plus proportioned minor

ingredients used to make the Reference

Amount of the combined product

determined in § 317.312(c). In

expressing the fractional slice,

manufacturers shall use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions that can be

generated by further division by 2 or 3.

(6) For nondiscrete bulk products

(e.g., whole roast beef, marinated beef

tenderloin, large can of chili), and for

products which consist of two or more

foods packaged and presented to be

consumed together where the ingredient

represented as the main ingredient is a

bulk product (e.g., roast beef and gravy),

the serving size shall be the amount in

household measure that most closely

approximates the Reference Amount for

the product category and may be the

amount of the bulk product represented

as the main ingredient plus

proportioned minor ingredients used to
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 177

make the Reference Amount for the

combined product determined in

§ 317.312(c).

(7) For labeling purposes, the term

‘‘common household measure’’ or

‘‘common household unit’’ means cup,

tablespoon, teaspoon, piece, slice,

fraction (e.g., 1⁄4 pizza), ounce (oz), or

other common household equipment

used to package food products (e.g., jar

or tray). In expressing serving size in

household measures, except as specified

in paragraphs (b)(7)(iv), (v), and (vi) of

this section, the following rules shall be

used:

(i) Cups, tablespoons, or teaspoons

shall be used wherever possible and

appropriate. Cups shall be expressed in

1⁄4- or 1⁄3-cup increments, tablespoons in

whole number of tablespoons for

quantities less than 1⁄4 cup but greater

than or equal to 2 tablespoons (tbsp), 1,

11⁄3, 11⁄2, or 1 2⁄3 tbsp for quantities less

than 2 tbsp but greater than or equal to

1 tbsp, and teaspoons in whole number

of teaspoons for quantities less than 1

tbsp but greater than or equal to 1

teaspoon (tsp), and in 1⁄4-tsp increments

for quantities less than 1 tsp.

(ii) If cups, tablespoons or teaspoons

are not applicable, units such as piece,

slice, tray, jar, and fraction shall be

used.

(iii) If cups, tablespoons and

teaspoons, or units such as piece, slice,

tray, jar, or fraction are not applicable,

ounces may be used. Ounce

measurements shall be expressed in 0.5-

ounce increments most closely

approximating the Reference Amount

with rounding indicated by the use of

the term ‘‘about’’ (e.g., about 2.5

ounces).

(iv) A description of the individual

container or package shall be used for

single-serving containers and meal-type

products and for individually packaged

products within multi-serving

containers (e.g., can, box, package, meal,

or dinner). A description of the

individual unit shall be used for other

products in discrete units (e.g., chop,

slice, link, or patty).

(v) For unprepared products where

the entire contents of the package is

used to prepare large discrete units that

are usually divided for consumption

(e.g., pizza kit), the fraction or portion

of the package may be used.

(vi) For products that consist of two

or more distinct ingredients or

components packaged and presented to

be consumed together (e.g., ham with a

glaze packet), the nutrition information

may be declared for each component or

as a composite. The serving size may be

provided in accordance with the

provisions of paragraphs (b)(4), (b)(5),

and (b)(6) of this section.

(vii) For nutrition labeling purposes, a

teaspoon means 5 milliliters (mL), a

tablespoon means 15 mL, a cup means

240 mL, and 1 oz in weight means 28

grams (g).

(viii) When a serving size, determined

from the Reference Amount in

§ 317.312(b) and the procedures

described in this section, falls exactly

half way between two serving sizes (e.g.,

2.5 tbsp), manufacturers shall round the

serving size up to the next incremental

size.

(8) A product that is packaged and

sold individually and that contains less

than 200 percent of the applicable

Reference Amount shall be considered

to be a single-serving container, and the

entire content of the product shall be

labeled as one serving, except for

products that have Reference Amounts

of 100 g (or mL) or larger, manufacturers

may decide whether a package that

contains more than 150 percent but less

than 200 percent of the Reference

Amount is 1 or 2 servings. Packages sold

individually that contain 200 percent or

more of the applicable Reference

Amount may be labeled as a singleserving if the entire content of the

package can reasonably be consumed at

a single-eating occasion.

(9) A label statement regarding a

serving shall be the serving size

expressed in common household

measures as set forth in paragraphs

(b)(2) through (b)(8) of this section and

shall be followed by the equivalent

metric quantity in parenthesis (fluids in

milliliters and all other foods in grams),

except for single-serving containers.

(i) For a single-serving container, the

parenthetical metric quantity, which

will be presented as part of the net

weight statement on the principal

display panel, is not required except

where nutrition information is required

on a drained weight basis according to

paragraph (b)(11) of this section.

However, if a manufacturer voluntarily

provides the metric quantity on

products that can be sold as singleservings, then the numerical value

provided as part of the serving size

declaration must be identical to the

metric quantity declaration provided as

part of the net quantity of contents

statement.

(ii) The gram or milliliter quantity

equivalent to the household measure

should be rounded to the nearest whole

number except for quantities that are

less than 5 g (mL). The gram (mL)

quantity between 2 and 5 g (mL) should

be rounded to the nearest 0.5 g (mL) and

the g (mL) quantity less than 2 g (mL)

should be expressed in 0.1-g (mL)

increments.

(iii) In addition, serving size may be

declared in ounce, in parenthesis,

following the metric measure separated

by a slash where other common

household measures are used as the

primary unit for serving size, e.g., 1 slice

(28 g/1 oz) for sliced bologna. The ounce

quantity equivalent to the metric

quantity should be expressed in 0.1-oz

increments.

(iv) If a manufacturer elects to use

abbreviations for units, the following

abbreviations shall be used: tbsp for

tablespoon, tsp for teaspoon, g for gram,

mL for milliliter, and oz for ounce.

(10) Determination of the number of

servings per container shall be based on

the serving size of the product

determined by following the procedures

described in this section.

(i) The number of servings shall be

rounded to the nearest whole number

except for the number of servings

between 2 and 5 servings and random

weight products. The number of

servings between 2 and 5 servings shall

be rounded to the nearest 0.5 serving.

Rounding should be indicated by the

use of the term ‘‘about’’ (e.g., about 2

servings; about 3.5 servings).

(ii) When the serving size is required

to be expressed on a drained solids basis

and the number of servings varies

because of a natural variation in unit

size (e.g., pickled pigs feet), the

manufacturer may state the typical

number of servings per container (e.g.,

usually 5 servings).

(iii) For random weight products, a

manufacturer may declare ‘‘varied’’ for

the number of servings per container

provided the nutrition information is

based on the Reference Amount

expressed in ounces. The manufacturer

may provide the typical number of

servings in parenthesis following the

‘‘varied’’ statement (e.g., varied

(approximately 8 servings per pound)).

(iv) For packages containing several

individual single-serving containers,

each of which is labeled with all

required information including

nutrition labeling as specified in this

section (i.e., are labeled appropriately

for individual sale as single-serving

containers), the number of servings shall

be the number of individual packages

within the total package.

(v) For packages containing several

individually packaged multi-serving

units, the number of servings shall be

determined by multiplying the number

of individual multi-serving units in the

total package by the number of servings

in each individual unit.

(11) The declaration of nutrient and

food component content shall be on the

basis of product as packaged or

purchased with the exception of
178 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

products that are packed or canned in

water, brine, or oil but whose liquid

packing medium is not customarily

consumed. Declaration of the nutrient

and food component content of

products that are packed in liquid

which is not customarily consumed

shall be based on the drained solids.

(12) Serving size for meal-type

products as defined in § 317.313(l) shall

be the entire content (edible portion

only) of the package.

(13) Another column of figures may

be used to declare the nutrient and food

component information in the same

format as required by § 317.309(e),

(i) Per 100 grams, 100 milliliters, or 1

ounce of the product as packaged or

purchased.

(ii) Per one unit if the serving size of

a product in discrete units in a multiserving container is more than one unit.

(14) If a product consists of

assortments of meat or meat food

products (e.g., variety packs) in the

same package, nutrient content shall be

expressed on the entire package

contents or on each individual product.

(15) If a product is commonly

combined with other ingredients or is

cooked or otherwise prepared before

eating, and directions for such

combination or preparations are

provided, another column of figures

may be used to declare the nutrient

contents on the basis of the product as

consumed for the product alone (e.g., a

cream soup mix may be labeled with

one set of Daily Values for the dry mix

(per serving), and another set for the

serving of the final soup when prepared

(e.g., per serving of cream soup mix and

1 cup of vitamin D fortified whole

milk)): Provided, That the type and

quantity of the other ingredients to be

added to the product by the user and the

specific method of cooking and other

preparation shall be specified

prominently on the label.

(c) The declaration of nutrition

information on the label or in labeling

of a meat or meat food product shall

contain information about the level of

the following nutrients, except for those

nutrients whose inclusion, and the

declaration of amounts, is voluntary as

set forth in this paragraph. No nutrients

or food components other than those

listed in this paragraph as either

mandatory or voluntary may be

included within the nutrition label.

Except as provided for in paragraph (f)

or (g) of this section, nutrient

information shall be presented using the

nutrient names specified and in the

following order in the formats specified

in paragraph (d) or (e) of this section.

(1) ‘‘Calories, total,’’ ‘‘Total calories,’’

or ‘‘Calories’’: A statement of the caloric

content per serving, expressed to the

nearest 5-calorie increment up to and

including 50 calories, and 10-calorie

increment above 50 calories, except that

amounts less than 5 calories may be

expressed as zero. Energy content per

serving may also be expressed in

kilojoule units, added in parenthesis

immediately following the statement of

the caloric content.

(i) Caloric content may be calculated

by the following methods. Where either

specific or general food factors are used,

the factors shall be applied to the actual

amount (i.e., before rounding) of food

components (e.g., fat, carbohydrate,

protein, or ingredients with specific

food factors) present per serving.

(A) Using specific Atwater factors

(i.e., the Atwater method) given in Table

13, page 25, ‘‘Energy Value of Foods—

Basis and Derivation,’’ by A. L. Merrill

and B. K. Watt, United States

Department of Agriculture (USDA),

Agriculture Handbook No. 74 (Slightly

revised February 1973), which is

incorporated by reference. Table 13 of

the ‘‘Energy Value of Foods—Basis and

Derivation,’’ Agriculture Handbook No.

74 is incorporated as it exists on the

date of approval. This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

It is available for inspection at the Office

of the Federal Register, suite 700, 800

North Capitol Street, NW., Washington,

DC, or at the office of the FSIS Docket

Clerk, Room 3171, South Building, 14th

and Independence Avenue, SW.,

Washington, DC. Copies of the

incorporation by reference are available

from the Product Assessment Division,

Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Room 329, West End Court

Building, Washington, DC 20250–3700;

(B) Using the general factors of 4, 4,

and 9 calories per gram for protein, total

carbohydrate, and total fat, respectively,

as described in USDA’s Agriculture

Handbook No. 74 (Slightly revised

February 1973), pages 9–11, which is

incorporated by reference. Pages 9–11,

Agriculture Handbook No. 74 is

incorporated as it exists on the date of

approval. This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

(The availability of this incorporation by

reference is given in paragraph

(c)(1)(i)(A) of this section.);

(C) Using the general factors of 4, 4,

and 9 calories per gram for protein, total

carbohydrate less the amount of

insoluble dietary fiber, and total fat,

respectively, as described in USDA’s

Agriculture Handbook No. 74 (Slightly

revised February 1973), pages 9–11,

which is incorporated by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. (The availability of this

incorporation by reference is given in

paragraph (c)(1)(i)(A) of this section.); or

(D) Using data for specific food factors

for particular foods or ingredients

approved by the Food and Drug

Administration (FDA) and provided in

parts 172 or 184 of 21 CFR, or by other

means, as appropriate.

(ii) ‘‘Calories from fat’’: A statement of

the caloric content derived from total fat

as defined in paragraph (c)(2) of this

section per serving, expressed to the

nearest 5-calorie increment, up to and

including 50 calories, and the nearest

10-calorie increment above 50 calories,

except that label declaration of ‘‘calories

from fat’’ is not required on products

that contain less than 0.5 gram of fat per

serving and amounts less than 5 calories

may be expressed as zero. This

statement shall be declared as provided

in paragraph (d)(5) of this section.

(iii) ‘‘Calories from saturated fat’’ or

‘‘Calories from saturated’’

(VOLUNTARY): A statement of the

caloric content derived from saturated

fat as defined in paragraph (c)(2)(i) of

this section per serving may be declared

voluntarily, expressed to the nearest 5-

calorie increment, up to and including

50 calories, and the nearest 10-calorie

increment above 50 calories, except that

amounts less than 5 calories may be

expressed as zero. This statement shall

be indented under the statement of

calories from fat as provided in

paragraph (d)(5) of this section.

(2) ‘‘Fat, total’’ or ‘‘Total fat’’: A

statement of the number of grams of

total fat per serving defined as total

lipid fatty acids and expressed as

triglycerides. Amounts shall be

expressed 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.

(i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A

statement of the number of grams of

saturated fat per 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 per serving if no claims are made

about fat or cholesterol content, and if

‘‘calories from saturated fat’’ is not

declared. Saturated 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
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 179

gram, the content shall be expressed as

zero.

(A) ‘‘Stearic Acid’’ (VOLUNTARY): A

statement of the number of grams of

stearic acid per serving may be declared

voluntarily, except that when a claim is

made about stearic acid, label

declaration shall be required. Stearic

acid content shall be indented under

saturated fat and expressed to the

nearest 0.5 (1⁄2)-gram increment below 5

grams and the nearest gram increment

above 5 grams. If the serving contains

less than 0.5 gram, the content shall be

expressed as zero.

(B) [Reserved]

(ii) ‘‘Polyunsaturated fat’’ or

‘‘Polyunsaturated’’ (VOLUNTARY): A

statement of the number of grams of

polyunsaturated fat per serving defined

as cis,cis-methylene-interrupted

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 product other than one that

meets the criteria in § 317.362(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.

(iii) ‘‘Monounsaturated fat’’ or

‘‘Monounsaturated’’ (VOLUNTARY): A

statement of the number of grams of

monounsaturated fat per 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 product other than one that

meets the criteria in § 317.362(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.

(3) ‘‘Cholesterol’’: A statement of the

cholesterol content per serving

expressed in milligrams to the nearest 5-

milligram increment, except that label

declaration of cholesterol information is

not required for products that contain

less than 2 milligrams of cholesterol per

serving and make no claim about fat,

fatty acids, or cholesterol content, or

such products may state the cholesterol

content as zero. If the product contains

2 to 5 milligrams of cholesterol per

serving, the content may be stated as

‘‘less than 5 milligrams.’’

(4) ‘‘Sodium’’: A statement of the

number of milligrams of sodium per

serving expressed as zero when the

serving contains less than 5 milligrams

of sodium, to the nearest 5-milligram

increment when the serving contains 5

to 140 milligrams of sodium, and to the

nearest 10-milligram increment when

the serving contains greater than 140

milligrams.

(5) ‘‘Potassium’’ (VOLUNTARY): A

statement of the number of milligrams

of potassium per serving may be

declared voluntarily, except that when a

claim is made about potassium content,

label declaration shall be required.

Potassium content shall be expressed as

zero when the serving contains less than

5 milligrams of potassium, to the nearest

5-milligram increment when the serving

contains 5 to 140 milligrams of

potassium, and to the nearest 10-

milligram increment when the serving

contains greater than 140 milligrams.

(6) ‘‘Carbohydrate, total’’ or ‘‘Total

carbohydrate’’: A statement of the

number of grams of total carbohydrate

per serving 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, or, if the serving contains

less than 0.5 gram, the content may be

expressed as zero. Total carbohydrate

content shall be calculated by

subtraction of the sum of the crude

protein, total fat, moisture, and ash from

the total weight of the product. This

calculation method is described in

USDA’s Agriculture Handbook No. 74

(Slightly revised February 1973), pages

2 and 3, which is incorporated by

reference. Pages 2 and 3, Agriculture

Handbook No. 74 is incorporated as it

exists on the date of approval. This

incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. (The

availability of this incorporation by

reference is given in paragraph

(c)(1)(i)(A) of this section.)

(i) ‘‘Dietary fiber’’: A statement of the

number of grams of total dietary fiber

per 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.

(A) ‘‘Soluble fiber’’ (VOLUNTARY): A

statement of the number of grams of

soluble dietary fiber per serving may be

declared voluntarily except when a

claim is made on the label or in labeling

about soluble fiber, label declaration

shall be required. Soluble fiber content

shall be indented under dietary fiber

and 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.

(B) ‘‘Insoluble fiber’’ (VOLUNTARY):

A statement of the number of grams of

insoluble dietary fiber per serving may

be declared voluntarily except when a

claim is made on the label or in labeling

about insoluble fiber, label declaration

shall be required. Insoluble fiber content

shall be indented under dietary fiber

and 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.

(ii) ‘‘Sugars’’: A statement of the

number of grams of sugars per serving,

except that label declaration of sugars

content is not required for products that

contain less than 1 gram of sugars per

serving if no claims are made about

sweeteners, sugars, or sugar alcohol

content. Sugars shall be defined as the

sum of all free mono- and disaccharides

(such as glucose, fructose, lactose, and

sucrose). Sugars content shall be

indented and 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.

(iii) ‘‘Sugar alcohol’’ (VOLUNTARY):

A statement of the number of grams of

sugar alcohols per serving may be

declared voluntarily on the label, except

that when a claim is made on the label

or in labeling about sugar alcohol or

sugars when sugar alcohols are present

in the product, sugar alcohol content

shall be declared. For nutrition labeling

purposes, sugar alcohols are defined as

the sum of saccharide derivatives in

which a hydroxyl group replaces a

ketone or aldehyde group and whose

use in the food is listed by FDA (e.g.,

mannitol or xylitol) or is generally

recognized as safe (e.g., sorbitol). In lieu

of the term ‘‘sugar alcohol,’’ the name of

the specific sugar alcohol (e.g.,

‘‘xylitol’’) present in the product may be

used in the nutrition label, provided
180 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

that only one sugar alcohol is present in

the product. Sugar alcohol content shall

be indented and expressed to the

nearest gram, except that if a serving

contains less than 1 gram, the statement

‘‘Contains less then 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.

(iv) ‘‘Other carbohydrate’’

(VOLUNTARY): A statement of the

number of grams of other carbohydrate

per serving may be declared voluntarily.

Other carbohydrate shall be defined as

the difference between total

carbohydrate and the sum of dietary

fiber, sugars, and sugar alcohol, except

that if sugar alcohol is not declared

(even if present), it shall be defined as

the difference between total

carbohydrate and the sum of dietary

fiber and sugars. Other carbohydrate

content shall be indented and 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.

(7) ‘‘Protein’’: A statement of the

number of grams of protein per serving

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 the

protein in products represented or

purported to be for adults and children

4 or more years of age has a protein

quality value that is a protein

digestibility-corrected amino acid score

of less than 20 expressed as a percent,

or when the protein in a product

represented or purported to be for

children greater than 1 but less than 4

years of age has a protein quality value

that is a protein digestibility-corrected

amino acid score of less than 40

expressed as a percent, either of the

following shall be placed adjacent to the

declaration of protein content by

weight: The statement ‘‘not a significant

source of protein,’’ or a listing aligned

under the column headed ‘‘Percent

Daily Value’’ of the corrected amount of

protein per serving, as determined in

paragraph (c)(7)(ii) of this section,

calculated as a percentage of the Daily

Reference Value (DRV) or Reference

Daily Intake (RDI), as appropriate, for

protein and expressed as percent of

Daily Value. When the protein quality

in a product as measured by the Protein

Efficiency Ratio (PER) is less than 40

percent of the reference standard

(casein) for a product represented or

purported to be for infants, the

statement ‘‘not a significant source of

protein’’ shall be placed adjacent to the

declaration of protein content. Protein

content may be calculated on the basis

of the factor of 6.25 times the nitrogen

content of the food as determined by

appropriate methods of analysis in

accordance with § 317.309(h), except

when the procedure for a specific food

requires another factor.

(i) A statement of the corrected

amount of protein per serving, as

determined in paragraph (c)(7)(ii) of this

section, calculated as a percentage of the

RDI or DRV for protein, as appropriate,

and expressed as percent of Daily Value,

may be placed on the label, except that

such a statement shall be given if a

protein claim is made for the product,

or if the product is represented or

purported to be for infants or children

under 4 years of age. When such a

declaration is provided, it shall be

placed on the label adjacent to the

statement of grams of protein and

aligned under the column headed

‘‘Percent Daily Value,’’ and expressed to

the nearest whole percent. However, the

percentage of the RDI for protein shall

not be declared if the product is

represented or purported to be for

infants and the protein quality value is

less than 40 percent of the reference

standard.

(ii) The corrected amount of protein

(grams) per serving for products

represented or purported to be for adults

and children 1 or more years of age is

equal to the actual amount of protein

(grams) per serving multiplied by the

amino acid score corrected for protein

digestibility. If the corrected score is

above 1.00, then it shall be set at 1.00.

The protein digestibility-corrected

amino acid score shall be determined by

methods given in sections 5.4.1, 7.2.1,

and 8 in ‘‘Protein Quality Evaluation,

Report of the Joint FAO/WHO Expert

Consultation on Protein Quality

Evaluation,’’ Rome, 1990, which is

incorporated by reference. Sections

5.4.1, 7.2.1, and 8 of the ‘‘Report of the

Joint FAO/WHO Expert Consultation on

Protein Quality Evaluation,’’ as

published by the Food and Agriculture

Organization of the United Nations/

World Health Organization, is

incorporated as it exists on the date of

approval. This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

It is available for inspection at the Office

of the Federal Register, suite 700, 800

North Capitol Street, NW., Washington,

DC, or at the office of the FSIS Docket

Clerk, Room 3171, South Building, 14th

and Independence Avenue, SW.,

Washington, DC. Copies of the

incorporation by reference are available

from the Product Assessment Division,

Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Room 329, West End Court

Building, Washington, DC 20250–3700.

For products represented or purported

to be for infants, the corrected amount

of protein (grams) per serving is equal

to the actual amount of protein (grams)

per serving multiplied by the relative

protein quality value. The relative

protein quality value shall be

determined by dividing the subject

product’s protein PER value by the PER

value for casein. If the relative protein

value is above 1.00, it shall be set at

1.00.

(iii) For the purpose of labeling with

a percent of the DRV or RDI, a value of

50 grams of protein shall be the DRV for

adults and children 4 or more years of

age, and the RDI for protein for children

less than 4 years of age, infants,

pregnant women, and lactating women

shall be 16 grams, 14 grams, 60 grams,

and 65 grams, respectively.

(8) Vitamins and minerals: A

statement of the amount per serving of

the vitamins and minerals as described

in this paragraph, calculated as a

percent of the RDI and expressed as

percent of Daily Value.

(i) For purposes of declaration of

percent of Daily Value as provided for

in paragraphs (d) through (g) of this

section, products represented or

purported to be for use by infants,

children less than 4 years of age,

pregnant women, or lactating women

shall use the RDI’s that are specified for

the intended group. For products

represented or purported to be for use

by both infants and children under 4

years of age, the percent of Daily Value

shall be presented by separate

declarations according to paragraph (e)

of this section based on the RDI values

for infants from birth to 12 months of

age and for children under 4 years of

age. Similarly, the percent of Daily

Value based on both the RDI values for

pregnant women and for lactating

women shall be declared separately on

products represented or purported to be

for use by both pregnant and lactating

women. When such dual declaration is

used on any label, it shall be included

in all labeling, and equal prominence

shall be given to both values in all such

labeling. All other products shall use

the RDI for adults and children 4 or

more years of age.

(ii) The declaration of vitamins and

minerals as a percent of the RDI shall

include vitamin A, vitamin C, calcium,

and iron, in that order, and shall
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 181

include any of the other vitamins and

minerals listed in paragraph (c)(8)(iv) of

this section when they are added, or

when a claim is made about them. Other

vitamins and minerals need not be

declared if neither the nutrient nor the

component is otherwise referred to on

the label or in labeling or advertising

and the vitamins and minerals are:

(A) Required or permitted in a

standardized food (e.g., thiamin,

riboflavin, and niacin in enriched flour)

and that standardized food is included

as an ingredient (i.e., component) in

another product; or

(B) Included in a product solely for

technological purposes and declared

only in the ingredients statement. The

declaration may also include any of the

other vitamins and minerals listed in

paragraph (c)(8)(iv) of this section when

they are naturally occurring in the food.

The additional vitamins and minerals

shall be listed in the order established

in paragraph (c)(8)(iv) of this section.

(iii) The percentages for vitamins and

minerals shall be expressed to the

nearest 2-percent increment up to and

including the 10-percent level, the

nearest 5-percent increment above 10

percent and up to and including the 50-

percent level, and the nearest 10-percent

increment above the 50-percent level.

Amounts of vitamins and minerals

present at less than 2 percent of the RDI

are not required to be declared in

nutrition labeling but may be declared

by a zero or by the use of an asterisk (or

other symbol) that refers to another

asterisk (or symbol) that is placed at the

bottom of the table and that is followed

by the statement ‘‘Contains less than 2

percent of the Daily Value of this (these)

nutrient (nutrients).’’ Alternatively, if

vitamin A, vitamin C, calcium, or iron

is present in amounts less than 2

percent of the RDI, label declaration of

the nutrient(s) is not required if the

statement ‘‘Not a significant source of

lll (listing the vitamins or minerals

omitted)’’ is placed at the bottom of the

table of nutrient values.

(iv) The following RDI’s and

nomenclature are established for the

following vitamins and minerals which

are essential in human nutrition:

Vitamin A, 5,000 International Units

Vitamin C, 60 milligrams

Calcium, 1.0 gram

Iron, 18 milligrams

Vitamin D, 400 International Units

Vitamin E, 30 International Units

Thiamin, 1.5 milligrams

Riboflavin, 1.7 milligrams

Niacin, 20 milligrams

Vitamin B6, 2.0 milligrams

Folate, 0.4 milligram

Vitamin B12, 6 micrograms

Biotin, 0.3 milligram

Pantothenic acid, 10 milligrams

Phosphorus, 1.0 gram

Iodine, 150 micrograms

Magnesium, 400 milligrams

Zinc, 15 milligrams

Copper, 2.0 milligrams

(v) The following synonyms may be

added in parenthesis immediately

following the name of the nutrient or

dietary component:

Vitamin C—Ascorbic acid

Thiamin—Vitamin B1

Riboflavin—Vitamin B2

Folate—Folacin

Calories—Energy

(vi) A statement of the percent of

vitamin A that is present as betacarotene may be declared voluntarily.

When the vitamins and minerals are

listed in a single column, the statement

shall be indented under the information

on vitamin A. When vitamins and

minerals are arrayed horizontally, the

statement of percent shall be presented

in parenthesis following the declaration

of vitamin A and the percent of Daily

Value of vitamin A in the product (e.g.,

‘‘Percent Daily Value: Vitamin A 50 (90

percent as beta-carotene)’’). When

declared, the percentages shall be

expressed in the same increments as are

provided for vitamins and minerals in

paragraph (c)(8)(iii) of this section.

(9) For the purpose of labeling with a

percent of the DRV, the following DRV’s

are established for the following food

components based on the reference

caloric intake of 2,000 calories:

Food component Unit of measurement DRV

Fat ...................... grams (g) ........... 65

Saturated fatty

acids.

do ....................... 20

Cholesterol ......... milligrams (mg) .. 300

Total carbohydrate.grams (g) ........... 300

Fiber ................... do ....................... 25

Sodium ............... milligrams (mg) .. 2,400

Potassium .......... do ....................... 3,500

Protein ................ grams (g) ........... 50

(d)(1) Nutrient information specified

in paragraph (c) of this section shall be

presented on products in the following

format, except on products on which

dual columns of nutrition information

are declared as provided for in

paragraph (e) of this section, on those

products on which the simplified format

is permitted to be used as provided for

in paragraph (f) of this section, on

products for infants and children less

than 4 years of age as provided for in

§ 317.400(c), and on products in

packages that have a total surface area

available to bear labeling of 40 or less

square inches as provided for in

paragraph (g) of this section.

(i) The nutrition information shall be

set off in a box by use of hairlines and

shall be all black or one color type,

printed on a white or other neutral

contrasting background whenever

practical.

(ii) All information within the

nutrition label shall utilize:

(A) A single easy-to-read type style,

(B) Upper and lower case letters,

(C) At least one point leading (i.e.,

space between two lines of text) except

that at least four points leading shall be

utilized for the information required by

paragraphs (d)(7) and (d)(8) of this

section, and

(D) Letters should never touch.

(iii) Information required in

paragraphs (d)(3), (d)(5), (d)(7), and

(d)(8) of this section shall be in type size

no smaller than 8 point. Except for the

heading ‘‘Nutrition Facts,’’ the

information required in paragraphs

(d)(4), (d)(6), and (d)(9) of this section

and all other information contained

within the nutrition label shall be in

type size no smaller than 6 point. When

provided, the information described in

paragraph (d)(10) of this section shall

also be in type no smaller than 6 point.

(iv) The headings required by

paragraphs (d)(2), (d)(4), and (d)(6) of

this section (i.e., ‘‘Nutrition Facts,’’

‘‘Amount per Serving,’’ and ‘‘% Daily

Value*’’), the names of all nutrients that

are not indented according to

requirements of paragraph (c) of this

section (i.e., Calories, Total fat,

Cholesterol, Sodium, Potassium, Total

carbohydrate, and Protein), and the

percentage amounts required by

paragraph (d)(7)(ii) of this section shall

be highlighted by bold or extra bold

type or other highlighting (reverse

printing is not permitted as a form of

highlighting) that prominently

distinguishes it from other information.

No other information shall be

highlighted.

(v) A hairline rule that is centered

between the lines of text shall separate

‘‘Amount Per Serving’’ from the calorie

statements required in paragraph (d)(5)

of this section and shall separate each

nutrient and its corresponding percent

of Daily Value required in paragraphs

(d)(7)(i) and (d)(7)(ii) of this section

from the nutrient and percent of Daily

Value above and below it.

(2) The information shall be presented

under the identifying heading of

‘‘Nutrition Facts’’ which shall be set in

a type size larger than all other print

size in the nutrition label and, except

for labels presented according to the

format provided for in paragraph (d)(11)

of this section, unless impractical, shall

be set the full width of the information
182 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

provided under paragraph (d)(7) of this

section.

(3) Information on serving size shall

immediately follow the heading. Such

information shall include:

(i) ‘‘Serving Size’’: A statement of the

serving size as specified in paragraph

(b)(9) of this section.

(ii) ‘‘Servings Per Container’’: The

number of servings per container,

except that this statement is not

required on single-serving containers as

defined in paragraph (b)(8) of this

section.

(4) A subheading ‘‘Amount Per

Serving’’ shall be separated from serving

size information by a bar.

(5) Information on calories shall

immediately follow the heading

‘‘Amount Per Serving’’ and shall be

declared in one line, leaving sufficient

space between the declaration of

‘‘Calories’’ and ‘‘Calories from fat’’ to

allow clear differentiation, or, if

‘‘Calories from saturated fat’’ is

declared, in a column with total

‘‘Calories’’ at the top, followed by

‘‘Calories from fat’’ (indented), and

‘‘Calories from saturated fat’’ (indented).

(6) The column heading ‘‘% Daily

Value,’’ followed by an asterisk (e.g., ‘‘%

Daily Value*’’), shall be separated from

information on calories by a bar. The

position of this column heading shall

allow for a list of nutrient names and

amounts as described in paragraph

(d)(7) of this section to be to the left of,

and below, this column heading. The

column headings ‘‘Percent Daily Value,’’

‘‘Percent DV,’’ or ‘‘% DV’’ may be

substituted for ‘‘% Daily Value.’’

(7) Except as provided for in

paragraph (g) of this section, and except

as permitted by § 317.400(d)(2), nutrient

information for both mandatory and any

voluntary nutrients listed in paragraph

(c) of this section that are to be declared

in the nutrition label, except vitamins

and minerals, shall be declared as

follows:

(i) The name of each nutrient, as

specified in paragraph (c) of this

section, shall be given in a column and

followed immediately by the

quantitative amount by weight for that

nutrient appended with a ‘‘g’’ for grams

or ‘‘mg’’ for milligrams.

(ii) A listing of the percent of the DRV

as established in paragraphs (c)(7)(iii)

and (c)(9) of this section shall be given

in a column aligned under the heading

‘‘% Daily Value’’ established in

paragraph (d)(6) of this section with the

percent expressed to the nearest whole

percent for each nutrient declared in the

column described in paragraph (d)(7)(i)

of this section for which a DRV has been

established, except that the percent for

protein may be omitted as provided in

paragraph (c)(7) of this section. The

percent shall be calculated by dividing

either the amount declared on the label

for each nutrient or the actual amount

of each nutrient (i.e., before rounding)

by the DRV for the nutrient, except that

the percent for protein shall be

calculated as specified in paragraph

(c)(7)(ii) of this section. The numerical

value shall be followed by the symbol

for percent (i.e., %).

(8) Nutrient information for vitamins

and minerals shall be separated from

information on other nutrients by a bar

and shall be arrayed horizontally (e.g.,

Vitamin A 4%, Vitamin C 2%, Calcium

15%, Iron 4%) or may be listed in two

columns, except that when more than

four vitamins and minerals are declared,

they may be declared vertically with

percentages listed under the column

headed ‘‘% Daily Value.’’

(9) A footnote, preceded by an

asterisk, shall be placed beneath the list

of vitamins and minerals and shall be

separated from that list by a hairline.

(i) The footnote shall state: Percent

Daily Values are based on a 2,000

calorie diet. Your daily values may be

higher or lower depending on your

calorie needs.

Calories: 2,000 2,500

Total fat .......................................... Less than ...................................... 65 g ............................................... 80 g

Saturated fat .................................. Less than ...................................... 20 g ............................................... 25 g

Cholesterol ..................................... Less than ...................................... 300 mg .......................................... 300 mg

Sodium ........................................... Less than ...................................... 2,400 mg ....................................... 2,400 mg

Total carbohydrate ......................... ....................................................... 300 g ............................................. 375 g

Dietary fiber ................................... ....................................................... 25 g ............................................... 30 g

(ii) If the percent of Daily Value is

given for protein in the Percent of Daily

Value column as provided in paragraph

(d)(7)(ii) of this section, protein shall be

listed under dietary fiber, and a value of

50 g shall be inserted on the same line

in the column headed ‘‘2,000’’ and

value of 65 g in the column headed

‘‘2,500.’’

(iii) If potassium is declared in the

column described in paragraph (d)(7)(i)

of this section, potassium shall be listed

under sodium and the DRV established

in paragraph (c)(9) of this section shall

be inserted on the same line in the

numeric columns.

(iv) The abbreviations established in

paragraph (g)(2) of this section may be

used within the footnote.

(10) Caloric conversion information

on a per-gram basis for fat,

carbohydrate, and protein may be

presented beneath the information

required in paragraph (d)(9), separated

from that information by a hairline. This

information may be presented

horizontally (i.e., ‘‘Calories per gram:

Fat 9, Carbohydrate 4, Protein 4’’) or

vertically in columns.

(11)(i) If the space beneath the

information on vitamins and minerals is

not adequate to accommodate the

information required in paragraph (d)(9)

of this section, the information required

in paragraph (d)(9) may be moved to the

right of the column required in

paragraph (d)(7)(ii) of this section and

set off by a line that distinguishes it and

sets it apart from the percent of Daily

Value information. The caloric

conversion information provided for in

paragraph (d)(10) of this section may be

presented beneath either side or along

the full length of the nutrition label.

(ii) If the space beneath the mandatory

declaration of iron is not adequate to

accommodate any remaining vitamins

and minerals to be declared or the

information required in paragraph (d)(9)

of this section, the remaining

information may be moved to the right

and set off by a line that distinguishes

it and sets it apart from the percent of

Daily Value information given to the

left. The caloric conversion information

provided for in paragraph (d)(10) of this

section may be presented beneath either

side or along the full length of the

nutrition label.

(iii) If there is not sufficient

continuous vertical space (i.e.,

approximately 3 inches) to

accommodate the required components

of the nutrition label up to and

including the mandatory declaration of

iron, the nutrition label may be

presented in a tabular display in which

the footnote required by paragraph

(d)(9) of the section is given to the far

right of the label, and additional

vitamins and minerals beyond the four

that are required (i.e., vitamin A,

vitamin C, calcium, and iron) are
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 183

arrayed horizontally following

declarations of the required vitamins

and minerals.

(12) The following sample label

illustrates the provisions of paragraph

(d) of this section:

BILLING CODE 3410–DM–P

BILLING CODE 3410–DM–C

(13)(i) Nutrition labeling on the outer

label of packages of meat or meat food

products that contain two or more

products in the same packages (e.g.,

variety packs) or of packages that are

used interchangeably for the same type

of food (e.g., meat salad containers) may

use an aggregate display.

(ii) Aggregate displays shall comply

with format requirements of paragraph
184 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

(d) of this section to the maximum

extent possible, except that the identity

of each food shall be specified to the

right of the ‘‘Nutrition Facts’’ title, and

both the quantitative amount by weight

(i.e., g/mg amounts) and the percent

Daily Value for each nutrient shall be

listed in separate columns under the

name of each food.

(14) When nutrition labeling appears

in a second language, the nutrition

information may be presented in a

separate nutrition label for each

language or in one nutrition label with

the information in the second language

following that in English. Numeric

characters that are identical in both

languages need not be repeated (e.g.,

‘‘Protein/Proteinas 2 g’’). All required

information must be included in both

languages.

(e) Nutrition information may be

presented for two or more forms of the

same product (e.g., both ‘‘raw’’ and

‘‘cooked’’) or for common combinations

of foods as provided for in paragraph (b)

of this section, or for different units

(e.g., per 100 grams) as provided for in

paragraph (b) of this section, or for two

or more groups for which RDI’s are

established (e.g., both infants and

children less than 4 years of age) as

provided for in paragraph (c)(8)(i) of this

section. When such dual labeling is

provided, equal prominence shall be

given to both sets of values. Information

shall be presented in a format consistent

with paragraph (d) of this section,

except that:

(1) Following the subheading of

‘‘Amount Per Serving,’’ there shall be

two or more column headings

accurately describing the forms of the

same product (e.g., ‘‘raw’’ and

‘‘roasted’’), the combinations of foods,

the units, or the RDI groups that are

being declared. The column

representing the product as packaged

and according to the label serving size

based on the Reference Amount in

§ 317.312(b) shall be to the left of the

numeric columns.

(2) When the dual labeling is

presented for two or more forms of the

same product, for combinations of

foods, or for different units, total

calories and calories from fat (and

calories from saturated fat, when

declared) shall be listed in a column

and indented as specified in paragraph

(d)(5) of this section with quantitative

amounts declared in columns aligned

under the column headings set forth in

paragraph (e)(1) of this section.

(3) Quantitative information by

weight required in paragraph (d)(7)(i) of

this section shall be specified for the

form of the product as packaged and

according to the label serving size based

on the Reference Amount in

§ 317.312(b).

(i) Quantitative information by weight

may be included for other forms of the

product represented by the additional

column(s) either immediately adjacent

to the required quantitative information

by weight for the product as packaged

and according to the label serving size

based on the Reference Amount in

§ 317.312(b) or as a footnote.

(A) If such additional quantitative

information is given immediately

adjacent to the required quantitative

information, it shall be declared for all

nutrients listed and placed immediately

following and differentiated from the

required quantitative information (e.g.,

separated by a comma). Such

information shall not be put in a

separate column.

(B) If such additional quantitative

information is given in a footnote, it

shall be declared in the same order as

the nutrients are listed in the nutrition

label. The additional quantitative

information may state the total nutrient

content of the product identified in the

second column or the nutrient amounts

added to the product as packaged for

only those nutrients that are present in

different amounts than the amounts

declared in the required quantitative

information. The footnote shall clearly

identify which amounts are declared.

Any subcomponents declared shall be

listed parenthetically after principal

components (e.g., 1⁄2 cup skim milk

contributes an additional 40 calories, 65

mg sodium, 6 g total carbohydrate (6 g

sugars), and 4 g protein).

(ii) Total fat and its quantitative

amount by weight shall be followed by

an asterisk (or other symbol) (e.g.,

‘‘Total fat (2 g)*’’) referring to another

asterisk (or symbol) at the bottom of the

nutrition label identifying the form(s) of

the product for which quantitative

information is presented.

(4) Information required in paragraphs

(d)(7)(ii) and (d)(8) of this section shall

be presented under the subheading ‘‘%

DAILY VALUE’’ and in columns

directly under the column headings set

forth in paragraph (e)(1) of this section.

(5) The following sample label

illustrates the provisions of paragraph

(e) of this section:

BILLING CODE 3410–DM–P
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 185

BILLING CODE 3410–DM–C

(f)(1) Nutrition information may be

presented in a simplified format as set

forth herein when any required

nutrients, other than the core nutrients

(i.e., calories, total fat, sodium, total

carbohydrate, and protein), are present

in insignificant amounts. An

insignificant amount shall be defined as

that amount that may be rounded to

zero in nutrition labeling, except that for

total carbohydrate, dietary fiber, sugars

and protein, it shall be an amount less

than 1 gram.

(2) The simplified format shall

include information on the following

nutrients:

(i) Total calories, total fat, total

carbohydrate, sodium, and protein;

(ii) Any of the following that are

present in more than insignificant

amounts: Calories from fat, saturated fat,

cholesterol, dietary fiber, sugars,

vitamin A, vitamin C, calcium, and iron;

and

(iii) Any vitamins and minerals listed

in paragraph (c)(8)(iv) of this section

when they are added in fortified or

fabricated foods.

(3) Other nutrients that are naturally

present in the product in more than

insignificant amounts may be
186 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

voluntarily declared as part of the

simplified format.

(4) Any required nutrient, other than

a core nutrient, that is present in an

insignificant amount may be omitted

from the tabular listing, provided that

the following statement is included at

the bottom of the nutrition label, ‘‘Not

a significant source of llll.’’ The

blank shall be filled in with the

appropriate nutrient or food component.

Alternatively, amounts of vitamins and

minerals present in insignificant

amounts may be declared by the use of

an asterisk (or symbol) that is placed at

the bottom of the table of nutrient

values and that is followed by the

statement ‘‘Contains less than 2 percent

of the Daily Value of this (these)

nutrient (nutrients).’’

(5) Except as provided for in

paragraph (g) of this section and in

§ 317.400(c) and (d), nutrient

information declared in the simplified

format shall be presented in the same

manner as specified in paragraphs (d) or

(e) of this section, except that the

footnote required in paragraph (d)(9) of

this section is not required. When the

footnote is omitted, an asterisk shall be

placed at the bottom of the label

followed by the statement ‘‘Percent

Daily Values are based on a 2,000

calorie diet’’ and, if the term ‘‘Daily

Value’’ is not spelled out in the heading,

a statement that ‘‘DV’’ represents ‘‘Daily

Value.’’

(g) Foods in packages that have a total

surface area available to bear labeling of

40 or less square inches may modify the

requirements of paragraphs (c) through

(f) of this section and § 317.302(a) by

one or more of the following means:

(1)(i) Presenting the required nutrition

information in a tabular or linear (i.e.,

string) fashion, rather than in vertical

columns if the product has a total

surface area available to bear labeling of

less than 12 square inches, or if the

product has a total surface area available

to bear labeling of 40 or less square

inches and the package shape or size

cannot accommodate a standard vertical

column or tabular display on any label

panel. Nutrition information may be

given in a linear fashion only if the

package shape or size will not

accommodate a tabular display.

(ii) When nutrition information is

given in a linear display, the nutrition

information shall be set off in a box by

the use of a hairline. The percent Daily

Value is separated from the quantitative

amount declaration by the use of

parenthesis, and all nutrients, both

principal components and

subcomponents, are treated similarly.

Bolding is required only on the title

‘‘Nutrition Facts’’ and is allowed for

nutrient names for ‘‘Calories,’’ ‘‘Total

fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total

carbohydrate,’’ and ‘‘Protein.’’

(2) Using any of the following

abbreviations:

Serving size—Serv size

Servings per container—Servings

Calories from fat—Fat cal

Calories from saturated fat—Sat fat cal

Saturated fat—Sat fat

Monounsaturated fat—Monounsat fat

Polyunsaturated fat—Polyunsat fat

Cholesterol—Cholest

Total carbohydrate—Total carb

Dietary fiber—Fiber

Soluble fiber—Sol fiber

Insoluble fiber—Insol fiber

Sugar alcohol—Sugar alc

Other carbohydrate—Other carb

(3) Omitting the footnote required in

paragraph (d)(9) of this section and

placing another asterisk at the bottom of

the label followed by the statement

‘‘Percent Daily Values are based on a

2,000 calorie diet’’ and, if the term

‘‘Daily Value’’ is not spelled out in the

heading, a statement that ‘‘DV’’

represents ‘‘Daily Value.’’

(4) Presenting the required nutrition

information on any other label panel.

* * * * *

6. Section 317.312 is amended by

redesignating paragraph (d) as (g),

correcting the spelling of the word

‘‘Nationwide’’ in footnote 1 of Table 2

in paragraph (b), revising paragraph (a),

and adding new paragraphs (d), (e), and

(f) to read as follows:

§ 317.312 Reference amounts

customarily consumed per eating

occasion.

(a) The general principles followed in

arriving at the reference amounts

customarily consumed per eating

occasion (Reference Amount(s)), as set

forth in paragraph (b) of this section,

are:

(1) The Reference Amounts are

calculated for persons 4 years of age or

older to reflect the amount of food

customarily consumed per eating

occasion by persons in this population

group. These Reference Amounts are

based on data set forth in appropriate

national food consumption surveys.

(2) The Reference Amounts are

calculated for an infant or child under

4 years of age to reflect the amount of

food customarily consumed per eating

occasion by infants up to 12 months of

age or by children 1 through 3 years of

age, respectively. These Reference

Amounts are based on data set forth in

appropriate national food consumption

surveys. Such Reference Amounts are to

be used only when the product is

specially formulated or processed for

use by an infant or by a child under 4

years of age.

(3) An appropriate national food

consumption survey includes a large

sample size representative of the

demographic and socioeconomic

characteristics of the relevant

population group and must be based on

consumption data under actual

conditions of use.

(4) To determine the amount of food

customarily consumed per eating

occasion, the mean, median, and mode

of the consumed amount per eating

occasion were considered.

(5) When survey data were

insufficient, FSIS took various other

sources of information on serving sizes

of food into consideration. These other

sources of information included:

(i) Serving sizes used in dietary

guidance recommendations or

recommended by other authoritative

systems or organizations;

(ii) Serving sizes recommended in

comments;

(iii) Serving sizes used by

manufacturers and grocers; and

(iv) Serving sizes used by other

countries.

(6) Because they reflect the amount

customarily consumed, the Reference

Amount and, in turn, the serving size

declared on the product label are based

on only the edible portion of food, and

not bone, seed, shell, or other inedible

components.

(7) The Reference Amount is based on

the major intended use of the product

(e.g., a mixed dish measurable with a

cup as a main dish and not as a side

dish).

(8) The Reference Amounts for

products that are consumed as an

ingredient of other products, but that

may also be consumed in the form in

which they are purchased (e.g., ground

beef), are based on use in the form

purchased.

(9) FSIS sought to ensure that foods

that have similar dietary usage, product

characteristics, and customarily

consumed amounts have a uniform

Reference Amount.

* * * * *

(d) If a product requires further

preparation, e.g., cooking or the

addition of water or other ingredients,

and if paragraph (b) of this section

provides a Reference Amount for the

product in the prepared form, then the

Reference Amount for the unprepared

product shall be determined using the

following rules:

(1) Except as provided for in

paragraph (d)(2) of this section, the

Reference Amount for the unprepared

product shall be the amount of the
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 187

unprepared product required to make

the Reference Amount for the prepared

product as established in paragraph (b)

of this section.

(2) For products where the entire

contents of the package is used to

prepare one large discrete unit usually

divided for consumption, the Reference

Amount for the unprepared product

shall be the amount of the unprepared

product required to make the fraction of

the large discrete unit closest to the

Reference Amount for the prepared

product as established in paragraph (b)

of this section.

(e) The Reference Amount for an

imitation or substitute product or

altered product as defined in

§ 317.313(d), such as a ‘‘low calorie’’

version, shall be the same as for the

product for which it is offered as a

substitute.

(f) The Reference Amounts set forth in

paragraphs (b) through (e) of this section

shall be used in determining whether a

product meets the criteria for nutritional

claims. If the serving size declared on

the product label differs from the

Reference Amount, and the product

meets the criteria for the claim only on

the basis of the Reference Amount, the

claim shall be followed by a statement

that sets forth the basis on which the

claim is made. That statement shall

include the Reference Amount as it

appears in paragraph (b) of this section

followed, in parentheses, by the amount

in common household measure if the

Reference Amount is expressed in

measures other than common household

measures.

* * * * *

7. Section 317.313 is amended by

revising paragraphs (a), (b), (g), (i), (j),

(k), (p), and (q)(4) and adding new

paragraphs (c), (d), (e), and (f) to read as

follows:

§ 317.313 Nutrient content claims; general

principles.

(a) This section applies to meat or

meat food products that are intended for

human consumption and that are

offered for sale.

(b) A claim which, expressly or by

implication, characterizes the level of a

nutrient (nutrient content claim) of the

type required in nutrition labeling

pursuant to § 317.309, may not be made

on a label or in labeling of that product

unless the claim is made in accordance

with the applicable provisions in this

subpart.

(1) An expressed nutrient content

claim is any direct statement about the

level (or range) of a nutrient in the

product, e.g., ‘‘low sodium’’ or

‘‘contains 100 calories.’’

(2) An implied nutrient content claim

is any claim that:

(i) Describes the product or an

ingredient therein in a manner that

suggests that a nutrient is absent or

present in a certain amount (e.g., ‘‘high

in oat bran’’); or

(ii) Suggests that the product, because

of its nutrient content, may be useful in

maintaining healthy dietary practices

and is made in association with an

explicit claim or statement about a

nutrient (e.g., ‘‘healthy, contains 3

grams (g) of fat’’).

(3) Except for claims regarding

vitamins and minerals described in

paragraph (q)(3) of this section, no

nutrient content claims may be made on

products intended specifically for use

by infants and children less than 2 years

of age unless the claim is specifically

provided for in subpart B of this part.

(4) Reasonable variations in the

spelling of the terms defined in

applicable provisions in this subpart

and their synonyms are permitted

provided these variations are not

misleading (e.g., ‘‘hi’’ or ‘‘lo’’).

(c) Information that is required or

permitted by § 317.309 to be declared in

nutrition labeling, and that appears as

part of the nutrition label, is not a

nutrient content claim and is not subject

to the requirements of this section. If

such information is declared elsewhere

on the label or in labeling, it is a

nutrient content claim and is subject to

the requirements for nutrient content

claims.

(d) A ‘‘substitute’’ product is one that

may be used interchangeably with

another product that it resembles, i.e.,

that it is organoleptically, physically,

and functionally (including shelf life)

similar to, and that it is not nutritionally

inferior to unless it is labeled as an

‘‘imitation.’’

(1) If there is a difference in

performance characteristics that

materially limits the use of the product,

the product may still be considered a

substitute if the label includes a

disclaimer adjacent to the most

prominent claim as defined in

paragraph (j)(2)(iii) of this section,

informing the consumer of such

difference (e.g., ‘‘not recommended for

frying’’).

(2) This disclaimer shall be in easily

legible print or type and in a size no less

than that required by § 317.2(h) for the

net quantity of contents statement,

except where the size of the claim is less

than two times the required size of the

net quantity of contents statement, in

which case the disclaimer statement

shall be no less than one-half the size of

the claim but no smaller than 1⁄16-inch

minimum height, except as permitted by

§ 317.400(d)(2).

(e)(1) Because the use of a ‘‘free’’ or

‘‘low’’ claim before the name of a

product implies that the product differs

from other products of the same type by

virtue of its having a lower amount of

the nutrient, only products that have

been specially processed, altered,

formulated, or reformulated so as to

lower the amount of the nutrient in the

product, remove the nutrient from the

product, or not include the nutrient in

the product, may bear such a claim (e.g.,

‘‘low sodium beef noodle soup’’).

(2) Any claim for the absence of a

nutrient in a product, or that a product

is low in a nutrient when the product

has not been specially processed,

altered, formulated, or reformulated to

qualify for that claim shall indicate that

the product inherently meets the criteria

and shall clearly refer to all products of

that type and not merely to the

particular brand to which the labeling

attaches (e.g., ‘‘lard, a sodium free

food’’).

(f) A nutrient content claim shall be

in type size and style no larger than two

times that of the statement of identity

and shall not be unduly prominent in

type style compared to the statement of

identity.

(g) Labeling information required in

§§ 317.313, 317.354, 317.356, 317.360,

317.361, 317.362, and 317.380, whose

type size is not otherwise specified, is

required to be in letters and/or numbers

no less than 1⁄16 inch in height, except

as permitted by § 317.400(d)(2).

(h) [Reserved]

(i) Except as provided in § 317.309 or

in paragraph (q)(3) of this section, the

label or labeling of a product may

contain a statement about the amount or

percentage of a nutrient if:

(1) The use of the statement on the

product implicitly characterizes the

level of the nutrient in the product and

is consistent with a definition for a

claim, as provided in subpart B of this

part, for the nutrient that the label

addresses. Such a claim might be, ‘‘less

than 10 g of fat per serving;’’

(2) The use of the statement on the

product implicitly characterizes the

level of the nutrient in the product and

is not consistent with such a definition,

but the label carries a disclaimer

adjacent to the statement that the

product is not ‘‘low’’ in or a ‘‘good

source’’ of the nutrient, such as ‘‘only

200 milligrams (mg) sodium per serving,

not a low sodium product.’’ The

disclaimer must be in easily legible

print or type and in a size no less than

required by § 317.2(h) for the net

quantity of contents, except where the

size of the claim is less than two times
188 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

the required size of the net quantity of

contents statement, in which case the

disclaimer statement shall be no less

than one-half the size of the claim but

no smaller than 1⁄16-inch minimum

height, except as permitted by

§ 317.400(d)(2);

(3) The statement does not in any way

implicitly characterize the level of the

nutrient in the product and it is not

false or misleading in any respect (e.g.,

‘‘100 calories’’ or ‘‘5 grams of fat’’), in

which case no disclaimer is required.

(4) ‘‘Percent fat free’’ claims are not

authorized by this paragraph. Such

claims shall comply with

§ 317.362(b)(6).

(j) A product may bear a statement

that compares the level of a nutrient in

the product with the level of a nutrient

in a reference product. These statements

shall be known as ‘‘relative claims’’ and

include ‘‘light,’’ ‘‘reduced,’’ ‘‘less’’ (or

‘‘fewer’’), and ‘‘more’’ claims.

(1) To bear a relative claim about the

level of a nutrient, the amount of that

nutrient in the product must be

compared to an amount of nutrient in an

appropriate reference product as

specified in this paragraph (j).

(i)(A) For ‘‘less’’ (or ‘‘fewer’’) and

‘‘more’’ claims, the reference product

may be a dissimilar product within a

product category that can generally be

substituted for one another in the diet

or a similar product.

(B) For ‘‘light,’’ ‘‘reduced,’’ and

‘‘added’’ claims, the reference product

shall be a similar product, and

(ii)(A) For ‘‘light’’ claims, the

reference product shall be

representative of the type of product

that includes the product that bears the

claim. The nutrient value for the

reference product shall be

representative of a broad base of

products of that type; e.g., a value in a

representative, valid data base; an

average value determined from the top

three national (or regional) brands, a

market basket norm; or, where its

nutrient value is representative of the

product type, a market leader. Firms

using such a reference nutrient value as

a basis for a claim, are required to

provide specific information upon

which the nutrient value was derived,

on request, to consumers and

appropriate regulatory officials.

(B) For relative claims other than

‘‘light,’’ including ‘‘less’’ and ‘‘more’’

claims, the reference product may be the

same as that provided for ‘‘light’’ in

paragraph (j)(1)(ii)(A) of this section or

it may be the manufacturer’s regular

product, or that of another

manufacturer, that has been offered for

sale to the public on a regular basis for

a substantial period of time in the same

geographic area by the same business

entity or by one entitled to use its trade

name, provided the name of the

competitor is not used on the labeling

of the product. The nutrient values used

to determine the claim when comparing

a single manufacturer’s product to the

labeled product shall be either the

values declared in nutrition labeling or

the actual nutrient values, provided that

the resulting labeling is internally

consistent (i.e., that the values stated in

the nutrition information, the nutrient

values in the accompanying

information, and the declaration of the

percentage of nutrient by which the

product has been modified are

consistent and will not cause consumer

confusion when compared), and that the

actual modification is at least equal to

the percentage specified in the

definition of the claim.

(2) For products bearing relative

claims:

(i) The label or labeling must state the

identity of the reference product and the

percent (or fraction) of the amount of

the nutrient in the reference product by

which the nutrient has been modified,

(e.g., ‘‘50 percent less fat than ‘reference

product’ ’’ or ‘‘1⁄3 fewer calories than

‘reference product’ ’’); and

(ii) This information shall be

immediately adjacent to the most

prominent claim in easily legible

boldface print or type, in distinct

contrast to other printed or graphic

matter, that is no less than that required

by § 317.2(h) for net quantity of

contents, except where the size of the

claim is less than two times the required

size of the net quantity of contents

statement, in which case the referral

statement shall be no less than one-half

the size of the claim, but no smaller

than 1⁄16-inch minimum height, except

as permitted by § 317.400(d)(2).

(iii) The determination of which use

of the claim is in the most prominent

location on the label or labeling will be

made based on the following factors,

considered in order:

(A) A claim on the principal display

panel adjacent to the statement of

identity;

(B) A claim elsewhere on the

principal display panel;

(C) A claim on the information panel;

or

(D) A claim elsewhere on the label or

labeling.

(iv) The label or labeling must also

bear:

(A) Clear and concise quantitative

information comparing the amount of

the subject nutrient in the product per

labeled serving size with that in the

reference product; and

(B) This statement shall appear

adjacent to the most prominent claim or

to the nutrition information.

(3) A relative claim for decreased

levels of a nutrient may not be made on

the label or in labeling of a product if

the nutrient content of the reference

product meets the requirement for a

‘‘low’’ claim for that nutrient.

(k) The term ‘‘modified’’ may be used

in the statement of identity of a product

that bears a relative claim that complies

with the requirements of this part,

followed immediately by the name of

the nutrient whose content has been

altered (e.g., ‘‘modified fat ‘product’ ’’).

This statement of identity must be

immediately followed by the

comparative statement such as

‘‘contains 35 percent less fat than

‘reference product’.’’ The label or

labeling must also bear the information

required by paragraph (j)(2) of this

section in the manner prescribed.

* * * * *

(p)(1) Unless otherwise specified, the

reference amount customarily

consumed set forth in § 317.312(b)

through (e) shall be used in determining

whether a product meets the criteria for

a nutrient content claim. If the serving

size declared on the product label

differs from the reference amount

customarily consumed, and the amount

of the nutrient contained in the labeled

serving does not meet the maximum or

minimum amount criterion in the

definition for the descriptor for that

nutrient, the claim shall be followed by

the criteria for the claim as required by

§ 317.312(f) (e.g., ‘‘very low sodium, 35

mg or less per 55 grams’’).

(2) The criteria for the claim shall be

immediately adjacent to the most

prominent claim in easily legible print

or type and in a size that is no less than

that required by § 317.2(h) for net

quantity of contents, except where the

size of the claim is less than two times

the required size of the net quantity of

contents statement, in which case the

criteria statement shall be no less than

one-half the size of the claim but no

smaller than 1⁄16-inch minimum height,

except as permitted by § 317.400(d)(2).

(q) * * *

(4) The requirements of this section

do not apply to infant formulas and

medical foods, as described in 21 CFR

101.13(q)(4).

* * * * *

8. Section 317.345 is amended by

revising the section reference in

paragraph (c) from ‘‘§ 317.309(g)’’ to

‘‘§ 317.309(f)’’ and revising paragraphs

(a)(2) introductory text, (a)(2)(ii) and

(a)(2)(iii) to read as follows:
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 189

§ 317.345 Guidelines for voluntary

nutrition labeling of single-ingredient, raw

products.

(a) * * *

(2) A retailer may choose to provide

nutrition information at the point-ofpurchase, such as by posting a sign, or

by making the information readily

available in brochures, notebooks, or

leaflet form in close proximity to the

food. The nutrition labeling information

may also be supplemented by a video,

live demonstration, or other media. If a

nutrition claim is made on point-ofpurchase materials all of the

requirements of the mandatory nutrition

labeling program apply. However, if

only nutrition information—and not a

nutrition claim—is supplied on pointof-purchase materials:

(i) * * *

(ii) The listing of percent of Daily

Value for the nutrients (except vitamins

and minerals specified in

§ 317.309(c)(8)) and footnote required by

§ 317.309(d)(9) may be omitted; and

(iii) The point-of-purchase materials

are not subject to any of the format

requirements.

* * * * *

9. Section 317.354 is revised to read

as follows:

§ 317.354 Nutrient content claims for

‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’

(a) General requirements. Except as

provided in paragraph (e) of this

section, a claim about the level of a

nutrient in a product in relation to the

Reference Daily Intake (RDI) or Daily

Reference Value (DRV) established for

that nutrient (excluding total

carbohydrate) in § 317.309(c), may only

be made on the label or in labeling of

the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 317.313;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 317.309.

(b) ‘‘High’’ claims. (1) The terms

‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source

of’’ may be used on the label or in

labeling of products, except meal-type

products as defined in § 317.313(l),

provided that the product contains 20

percent or more of the RDI or the DRV

per reference amount customarily

consumed.

(2) The terms defined in paragraph

(b)(1) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains a food that

meets the definition of ‘‘high’’ in

paragraph (b)(1) of this section; and

(ii) The label or labeling clearly

identifies the food that is the subject of

the claim (e.g., ‘‘the serving of broccoli

in this meal is high in vitamin C’’).

(c) ‘‘Good Source’’ claims. (1) The

terms ‘‘good source,’’ ‘‘contains,’’ or

‘‘provides’’ may be used on the label or

in labeling of products, except mealtype products as described in

§ 317.313(l), provided that the product

contains 10 to 19 percent of the RDI or

the DRV per reference amount

customarily consumed.

(2) The terms defined in paragraph

(c)(1) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains a food that

meets the definition of ‘‘good source’’ in

paragraph (c)(1) of this section; and

(ii) The label or labeling clearly

identifies the food that is the subject of

the claim (e.g., ‘‘the serving of sweet

potatoes in this meal is a good source of

fiber’’).

(d) Fiber claims. (1) If a nutrient

content claim is made with respect to

the level of dietary fiber, i.e., that the

product is high in fiber, a good source

of fiber, or that the product contains

‘‘more’’ fiber, and the product is not

‘‘low’’ in total fat as defined in

§ 317.362(b)(2) or, in the case of a mealtype product, is not ‘‘low’’ in total fat as

defined in § 317.362(b)(3), then the

labeling shall disclose the level of total

fat per labeled serving size (e.g.,

‘‘contains 12 grams (g) of fat per

serving’’); and

(2) The disclosure shall appear in

immediate proximity to such claim and

be in a type size no less than one-half

the size of the claim.

(e) ‘‘More’’ claims. (1) A relative claim

using the terms ‘‘more’’ and ‘‘added’’

may be used on the label or in labeling

to describe the level of protein,

vitamins, minerals, dietary fiber, or

potassium in a product, except mealtype products as defined in § 317.313(l),

provided that:

(i) The product contains at least 10

percent more of the RDI or the DRV for

protein, vitamins, minerals, dietary

fiber, or potassium (expressed as a

percent of the Daily Value) per reference

amount customarily consumed than an

appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the nutrient is greater relative to the

RDI or DRV are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘contains 10 percent more of

the Daily Value for fiber than ‘reference

product’ ’’); and

(B) Quantitative information

comparing the level of the nutrient in

the product per labeled serving size

with that of the reference product that

it replaces is declared adjacent to the

most prominent claim or to the nutrition

information (e.g., ‘‘fiber content of

‘reference product’ is 1 g per serving;

‘this product’ contains 4 g per serving’’).

(2) A relative claim using the terms

‘‘more’’ and ‘‘added’’ may be used on

the label or in labeling to describe the

level of protein, vitamins, minerals,

dietary fiber, or potassium in meal-type

products as defined in § 317.313(l),

provided that:

(i) The product contains at least 10

percent more of the RDI or the DRV for

protein, vitamins, minerals, dietary

fiber, or potassium (expressed as a

percent of the Daily Value) per 100 g of

product than an appropriate reference

product as described in § 317.313(j)(1);

and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the nutrient is greater relative to the

RDI or DRV are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘contains 10 percent more of

the Daily Value for fiber per 3 ounces

(oz) than does ‘reference product’ ’’),

and

(B) Quantitative information

comparing the level of the nutrient in

the meal-type product per specified

weight with that of the reference

product that it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., ‘‘fiber

content of ‘reference product’ is 2 g per

3 oz; ‘this product’ contains 5 g per 3

oz’’).

10. Section 317.356 is revised to read

as follows:

§ 317.356 Nutrient content claims for

‘‘light’’ or ‘‘lite.’’

(a) General requirements. A claim

using the terms ‘‘light’’ or ‘‘lite’’ to

describe a product may only be made on

the label or in labeling of the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 317.313;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 317.309.

(b) ‘‘Light’’ claims. The terms ‘‘light’’

or ‘‘lite’’ may be used on the label or in
190 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

labeling of products, except meal-type

products as defined in § 317.313(l),

without further qualification, provided

that:

(1) If the product derives 50 percent

or more of its calories from fat, its fat

content is reduced by 50 percent or

more per reference amount customarily

consumed compared to an appropriate

reference product as described in

§ 317.313(j)(1); or

(2) If the product derives less than 50

percent of its calories from fat:

(i) The number of calories is reduced

by at least one-third (331⁄3 percent) per

reference amount customarily

consumed compared to an appropriate

reference product as described in

§ 317.313(j)(1); or

(ii) Its fat content is reduced by 50

percent or more per reference amount

customarily consumed compared to the

appropriate reference product as

described in § 317.313(j)(1); and

(3) As required in § 317.313(j)(2) for

relative claims:

(i) The identity of the reference

product and the percent (or fraction)

that the calories and the fat were

reduced are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘1⁄3 fewer calories and 50

percent less fat than the market leader’’);

and

(ii) Quantitative information

comparing the level of calories and fat

content in the product per labeled

serving size with that of the reference

product that it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., ‘‘lite

‘this product’—200 calories, 4 grams (g)

fat; regular ‘reference product’—300

calories, 8 g fat per serving’’); and

(iii) If the labeled product contains

less than 40 calories or less than 3 g fat

per reference amount customarily

consumed, the percentage reduction for

that nutrient need not be declared.

(4) A ‘‘light’’ claim may not be made

on a product for which the reference

product meets the definition of ‘‘low

fat’’ and ‘‘low calorie.’’

(c)(1)(i) A product for which the

reference product contains 40 calories

or less and 3 g fat or less per reference

amount customarily consumed may use

the terms ‘‘light’’ or ‘‘lite’’ without

further qualification if it is reduced by

50 percent or more in sodium content

compared to the reference product; and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium was reduced are

declared in immediate proximity to the

most prominent such claim (e.g., ‘‘50

percent less sodium than the market

leader’’); and

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference product it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., ‘‘lite

‘this product’—500 milligrams (mg)

sodium per serving; regular ‘reference

product’—1,000 mg sodium per

serving’’).

(2)(i) A product for which the

reference product contains more than 40

calories or more than 3 g fat per

reference amount customarily

consumed may use the terms ‘‘light in

sodium’’ or ‘‘lite in sodium’’ if it is

reduced by 50 percent or more in

sodium content compared to the

reference product, provided that ‘‘light’’

or ‘‘lite’’ is presented in immediate

proximity with ‘‘in sodium’’ and the

entire term is presented in uniform type

size, style, color, and prominence; and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium was reduced are

declared in immediate proximity to the

most prominent such claim (e.g., ‘‘50

percent less sodium than the market

leader’’); and

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference product it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., or

‘‘lite ‘this product’—170 mg sodium per

serving; regular ‘reference product’—

350 mg per serving’’).

(3) Except for meal-type products as

defined in § 317.313(l), a ‘‘light in

sodium’’ claim may not be made on a

product for which the reference product

meets the definition of ‘‘low in

sodium.’’

(d)(1) The terms ‘‘light’’ or ‘‘lite’’ may

be used on the label or in labeling of a

meal-type product as defined in

§ 317.313(l), provided that:

(i) The product meets the definition

of:

(A) ‘‘Low in calories’’ as defined in

§ 317.360(b)(3); or

(B) ‘‘Low in fat’’ as defined in

§ 317.362(b)(3); and

(ii)(A) A statement appears on the

principal display panel that explains

whether ‘‘light’’ is used to mean ‘‘low

fat,’’ ‘‘low calories,’’ or both (e.g., ‘‘Light

Delight, a low fat meal’’); and

(B) The accompanying statement is no

less than one-half the type size of the

‘‘light’’ or ‘‘lite’’ claim.

(2)(i) The terms ‘‘light in sodium’’ or

‘‘lite in sodium’’ may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that the product meets the

definition of ‘‘low in sodium’’ as

defined in § 317.361(b)(5)(i); and

(ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in sodium’’

are presented in uniform type size,

style, color, and prominence.

(3) The term ‘‘light’’ or ‘‘lite’’ may be

used in the brand name of a product to

describe the sodium content, provided

that:

(i) The product is reduced by 50

percent or more in sodium content

compared to the reference product;

(ii) A statement specifically stating

that the product is ‘‘light in sodium’’ or

‘‘lite in sodium’’ appears:

(A) Contiguous to the brand name;

and

(B) In uniform type size, style, color,

and prominence as the product name;

and

(iii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium was reduced are

declared in immediate proximity to the

most prominent such claim; and

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference product it replaces is declared

adjacent to the most prominent claim or

to the nutrition information.

(e) Except as provided in paragraphs

(b) through (d) of this section, the terms

‘‘light’’ or ‘‘lite’’ may not be used to refer

to a product that is not reduced in fat

by 50 percent, or, if applicable, in

calories by 1⁄3 or, when properly

qualified, in sodium by 50 percent

unless:

(1) It describes some physical or

organoleptic attribute of the product

such as texture or color and the

information (e.g., ‘‘light in color’’ or

‘‘light in texture’’) so stated, clearly

conveys the nature of the product; and

(2) The attribute (e.g., ‘‘color’’ or

‘‘texture’’) is in the same style, color,

and at least one-half the type size as the

word ‘‘light’’ and in immediate

proximity thereto.

(f) If a manufacturer can demonstrate

that the word ‘‘light’’ has been

associated, through common use, with a

particular product to reflect a physical

or organoleptic attribute to the point

where it has become part of the

statement of identity, such use of the

term ‘‘light’’ shall not be considered a

nutrient content claim subject to the

requirements in this part.

(g) The term ‘‘lightly salted’’ may be

used on a product to which has been

added 50 percent less sodium than is

normally added to the reference product
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 191

as described in § 317.313(j)(1)(i)(B) and

(j)(1)(ii)(B), provided that if the product

is not ‘‘low in sodium’’ as defined in

§ 317.361(b)(4), the statement ‘‘not a low

sodium food,’’ shall appear adjacent to

the nutrition information and the

information required to accompany a

relative claim shall appear on the label

or labeling as specified in

§ 317.313(j)(2).

11. Section 317.360 is revised to read

as follows:

§ 317.360 Nutrient content claims for

calorie content.

(a) General requirements. A claim

about the calorie or sugar content of a

product may only be made on the label

or in labeling of the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 317.313;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 317.309.

(b) Calorie content claims. (1) The

terms ‘‘calorie free,’’ ‘‘free of calories,’’

‘‘no calories,’’ ‘‘zero calories,’’ ‘‘without

calories,’’ ‘‘trivial source of calories,’’

‘‘negligible source of calories,’’ or

‘‘dietarily insignificant source of

calories’’ may be used on the label or in

labeling of products, provided that:

(i) The product contains less than 5

calories per reference amount

customarily consumed and per labeled

serving size; and

(ii) If the product meets this condition

without the benefit of special

processing, alteration, formulation, or

reformulation to lower the caloric

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(2) The terms ‘‘low calorie,’’ ‘‘few

calories,’’ ‘‘contains a small amount of

calories,’’ ‘‘low source of calories,’’ or

‘‘low in calories’’ may be used on the

label or in labeling of products, except

meal-type products as defined in

§ 317.313(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 grams (g) or greater than 2

tablespoons (tbsp) and does not provide

more than 40 calories per reference

amount customarily consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and does not

provide more than 40 calories per

reference amount customarily

consumed and per 50 g (for dehydrated

products that must be reconstituted

before typical consumption with water

or a diluent containing an insignificant

amount, as defined in § 317.309(f)(1), of

all nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form).

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the caloric

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(3) The terms defined in paragraph

(b)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains 120 calories

or less per 100 g of product; and

(ii) If the product meets this condition

without the benefit of special

processing, alteration, formulation, or

reformulation to lower the calorie

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which it

attaches.

(4) The terms ‘‘reduced calorie,’’

‘‘reduced in calories,’’ ‘‘calorie

reduced,’’ ‘‘fewer calories,’’ ‘‘lower

calorie,’’ or ‘‘lower in calories’’ may be

used on the label or in labeling of

products, except meal-type products as

defined in § 317.313(l), provided that:

(i) The product contains at least 25

percent fewer calories per reference

amount customarily consumed than an

appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the calories differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., lower calorie ‘product’—

‘‘331⁄3 percent fewer calories than our

regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of calories in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘calorie content has

been reduced from 150 to 100 calories

per serving’’).

(iii) Claims described in paragraph

(b)(4) of this section may not be made

on the label or in labeling of products

if the reference product meets the

definition for ‘‘low calorie.’’

(5) The terms defined in paragraph

(b)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent fewer calories per 100 g of

product than an appropriate reference

product as described in § 317.313(j)(1);

and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the calories differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘calorie reduced ‘product’,

25% less calories per ounce (oz) (or 3

oz) than our regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of calories in the

product per specified weight with that

of the reference product that it replaces

is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘calorie content has

been reduced from 110 calories per 3 oz

to 80 calories per 3 oz’’).

(iii) Claims described in paragraph

(b)(5) of this section may not be made

on the label or in labeling of products

if the reference product meets the

definition for ‘‘low calorie.’’

(c) Sugar content claims. (1) Terms

such as ‘‘sugar free,’’ ‘‘free of sugar,’’

‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without

sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of

sugar,’’ ‘‘negligible source of sugar,’’ or

‘‘dietarily insignificant source of sugar’’

may reasonably be expected to be

regarded by consumers as terms that

represent that the product contains no

sugars or sweeteners, e.g., ‘‘sugar free,’’

or ‘‘no sugar,’’ as indicating a product

which is low in calories or significantly

reduced in calories. Consequently,

except as provided in paragraph (c)(2) of

this section, a product may not be

labeled with such terms unless:

(i) The product contains less than 0.5

g of sugars, as defined in

§ 317.309(c)(6)(ii), per reference amount

customarily consumed and per labeled

serving size or, in the case of a mealtype product, less than 0.5 g of sugars

per labeled serving size;

(ii) The product contains no

ingredient that is a sugar or that is

generally understood by consumers to

contain sugars unless the listing of the

ingredient in the ingredients statement

is followed by an asterisk that refers to

the statement below the list of

ingredients, which states: ‘‘Adds a

trivial amount of sugar,’’ ‘‘adds a

negligible amount of sugar,’’ or ‘‘adds a

dietarily insignificant amount of sugar;’’

and

(iii)(A) It is labeled ‘‘low calorie’’ or

‘‘reduced calorie’’ or bears a relative

claim of special dietary usefulness
192 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

labeled in compliance with paragraphs

(b)(2), (b)(3), (b)(4), or (b)(5) of this

section; or

(B) Such term is immediately

accompanied, each time it is used, by

either the statement ‘‘not a reduced

calorie product,’’ ‘‘not a low calorie

product,’’ or ‘‘not for weight control.’’

(2) The terms ‘‘no added sugar,’’

‘‘without added sugar,’’ or ‘‘no sugar

added’’ may be used only if:

(i) No amount of sugars, as defined in

§ 317.309(c)(6)(ii), or any other

ingredient that contains sugars that

functionally substitute for added sugars

is added during processing or

packaging;

(ii) The product does not contain an

ingredient containing added sugars such

as jam, jelly, or concentrated fruit juice;

(iii) The sugars content has not been

increased above the amount present in

the ingredients by some means such as

the use of enzymes, except where the

intended functional effect of the process

is not to increase the sugars content of

a product, and a functionally

insignificant increase in sugars results;

(iv) The product that it resembles and

for which it substitutes normally

contains added sugars; and

(v) The product bears a statement that

the product is not ‘‘low calorie’’ or

‘‘calorie reduced’’ (unless the product

meets the requirements for a ‘‘low’’ or

‘‘reduced calorie’’ product) and that

directs consumers’ attention to the

nutrition panel for further information

on sugar and calorie content.

(3) Paragraph (c)(1) of this section

shall not apply to a factual statement

that a product, including products

intended specifically for infants and

children less than 2 years of age, is

unsweetened or contains no added

sweeteners in the case of a product that

contains apparent substantial inherent

sugar content, e.g., juices.

(4) The terms ‘‘reduced sugar,’’

‘‘reduced in sugar,’’ ‘‘sugar reduced,’’

‘‘less sugar,’’ ‘‘lower sugar,’’ or ‘‘lower

in sugar’’ may be used on the label or

in labeling of products, except mealtype products as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent less sugars per reference amount

customarily consumed than an

appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sugars differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘this product contains 25

percent less sugar than our regular

product’’); and

(B) Quantitative information

comparing the level of the sugar in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sugar content has

been lowered from 8 g to 6 g per

serving’’).

(5) The terms defined in paragraph

(c)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent less sugars per 100 g of product

than an appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sugars differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced sugar ‘product’—

25% less sugar than our regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of the nutrient in

the product per specified weight with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sugar content has

been reduced from 17 g per 3 oz to 13

g per 3 oz’’).

12. Section 317.361 is revised to read

as follows:

§ 317.361 Nutrient content claims for the

sodium content.

(a) General requirements. A claim

about the level of sodium in a product

may only be made on the label or in

labeling of the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 317.313;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 317.309.

(b) Sodium content claims. (1) The

terms ‘‘sodium free,’’ ‘‘free of sodium,’’

‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without

sodium,’’ ‘‘trivial source of sodium,’’

‘‘negligible source of sodium,’’ or

‘‘dietarily insignificant source of

sodium’’ may be used on the label or in

labeling of products, provided that:

(i) The product contains less than 5

milligrams (mg) of sodium per reference

amount customarily consumed and per

labeled serving size or, in the case of a

meal-type product, less than 5 mg of

sodium per labeled serving size;

(ii) The product contains no

ingredient that is sodium chloride or is

generally understood by consumers to

contain sodium unless the listing of the

ingredient in the ingredients statement

is followed by an asterisk that refers to

the statement below the list of

ingredients, which states: ‘‘Adds a

trivial amount of sodium,’’ ‘‘adds a

negligible amount of sodium’’ or ‘‘adds

a dietarily insignificant amount of

sodium’’; and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(2) The terms ‘‘very low sodium’’ or

‘‘very low in sodium’’ may be used on

the label or in labeling of products,

except meal-type products as defined in

§ 317.313(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 grams (g) or greater than 2

tablespoons (tbsp) and contains 35 mg

or less sodium per reference amount

customarily consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and contains 35

mg or less sodium per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 317.309(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form); and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(3) The terms defined in paragraph

(b)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains 35 mg or less

of sodium per 100 g of product; and

(ii) If the product meets this condition

without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 193

to the particular brand to which the

label attaches.

(4) The terms ‘‘low sodium,’’ ‘‘low in

sodium,’’ ‘‘little sodium,’’ ‘‘contains a

small amount of sodium,’’ or ‘‘low

source of sodium’’ may be used on the

label and in labeling of products, except

meal-type products as defined in

§ 317.313(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 g or greater than 2 tbsp and

contains 140 mg or less sodium per

reference amount customarily

consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and contains 140

mg or less sodium per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 317.309(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form); and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(5) The terms defined in paragraph

(b)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains 140 mg or

less sodium per 100 g of product; and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(6) The terms ‘‘reduced sodium,’’

‘‘reduced in sodium,’’ ‘‘sodium

reduced,’’ ‘‘less sodium,’’ ‘‘lower

sodium,’’ or ‘‘lower in sodium’’ may be

used on the label or in labeling of

products, except meal-type products as

defined in § 317.313(l), provided that:

(i) The product contains at least 25

percent less sodium per reference

amount customarily consumed than an

appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced sodium ‘product’,

50 percent less sodium than regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of sodium in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sodium content has

been lowered from 300 to 150 mg per

serving’’).

(iii) Claims described in paragraph

(b)(6) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

sodium.’’

(7) The terms defined in paragraph

(b)(6) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent less sodium per 100 g of

product than an appropriate reference

product as described in § 317.313(j)(1);

and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced sodium

‘product’—30% less sodium per 3 oz

than our ‘regular product’ ’’); and

(B) Quantitative information

comparing the level of sodium in the

product per specified weight with that

of the reference product that it replaces

is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sodium content has

been reduced from 220 mg per 3 oz to

150 mg per 3 oz’’).

(iii) Claims described in paragraph

(b)(7) of this section may not be made

on the label or in labeling of products

if the nutrient content of the reference

product meets the definition for ‘‘low

sodium.’’

(c) The term ‘‘salt’’ is not synonymous

with ‘‘sodium.’’ Salt refers to sodium

chloride. However, references to salt

content such as ‘‘unsalted,’’ ‘‘no salt,’’

‘‘no salt added’’ are potentially

misleading.

(1) The term ‘‘salt free’’ may be used

on the label or in labeling of products

only if the product is ‘‘sodium free’’ as

defined in paragraph (b)(1) of this

section.

(2) The terms ‘‘unsalted,’’ ‘‘without

added salt,’’ and ‘‘no salt added’’ may be

used on the label or in labeling of

products only if:

(i) No salt is added during processing;

(ii) The product that it resembles and

for which it substitutes is normally

processed with salt; and

(iii) If the product is not sodium free,

the statement, ‘‘not a sodium free

product’’ or ‘‘not for control of sodium

in the diet’’ appears adjacent to the

nutrition information of the product

bearing the claim.

(3) Paragraph (c)(2) of this section

shall not apply to a factual statement

that a product intended specifically for

infants and children less than 2 years of

age is unsalted, provided such statement

refers to the taste of the product and is

not false or otherwise misleading.

13. Section 317.362 is revised to read

as follows:

§ 317.362 Nutrient content claims for fat,

fatty acids, and cholesterol content.

(a) General requirements. A claim

about the level of fat, fatty acid, and

cholesterol in a product may only be

made on the label or in labeling of

products if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 317.313;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 317.309.

(b) Fat content claims. (1) The terms

‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ ‘‘zero

fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ ‘‘trivial

source of fat,’’ ‘‘negligible source of fat,’’

or ‘‘dietarily insignificant source of fat’’

may be used on the label or in labeling

of products, provided that:

(i) The product contains less than 0.5

gram (g) of fat per reference amount

customarily consumed and per labeled

serving size or, in the case of a mealtype product, less than 0.5 g of fat per

labeled serving size;

(ii) The product contains no added

ingredient that is a fat or is generally

understood by consumers to contain fat

unless the listing of the ingredient in the

ingredients statement is followed by an

asterisk that refers to the statement

below the list of ingredients, which

states: ‘‘Adds a trivial amount of fat,’’

‘‘adds a negligible amount of fat,’’ or

‘‘adds a dietarily insignificant amount of

fat’’; and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the fat content, it

is labeled to clearly refer to all products

of its type and not merely to the
194 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

particular brand to which the label

attaches.

(2) The terms ‘‘low fat,’’ ‘‘low in fat,’’

‘‘contains a small amount of fat,’’ ‘‘low

source of fat,’’ or ‘‘little fat’’ may be used

on the label and in labeling of products,

except meal-type products as defined in

§ 317.313(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 g or greater than 2 tablespoons

(tbsp) and contains 3 g or less of fat per

reference amount customarily

consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and contains 3

g or less of fat per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 317.309(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form).

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the fat content, it

is labeled to clearly refer to all products

of its type and not merely to the

particular brand to which the label

attaches.

(3) The terms defined in paragraph

(b)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains 3 g or less of

total fat per 100 g of product and not

more than 30 percent of calories from

fat; and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the fat content, it

is labeled to clearly refer to all products

of its type and not merely to the

particular brand to which the label

attaches.

(4) The terms ‘‘reduced fat,’’ ‘‘reduced

in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ ‘‘lower

fat,’’ or ‘‘lower in fat’’ may be used on

the label or in labeling of products,

except meal-type products as defined in

§ 317.313(l), provided that:

(i) The product contains at least 25

percent less fat per reference amount

customarily consumed than an

appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the fat differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced fat—50 percent

less fat than our regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of fat in the product

per labeled serving size with that of the

reference product that it replaces is

declared adjacent to the most prominent

claim or to the nutrition information

(e.g., ‘‘fat content has been reduced from

8 g to 4 g per serving’’).

(iii) Claims described in paragraph

(b)(4) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

fat.’’

(5) The terms defined in paragraph

(b)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent less fat per 100 g of product

than an appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the fat differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced fat ‘product’, 33

percent less fat per 3 oz than our regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of fat in the product

per specified weight with that of the

reference product that it replaces is

declared adjacent to the most prominent

such claim or to the nutrition

information (e.g., ‘‘fat content has been

reduced from 8 g per 3 oz to 5 g per 3

oz’’).

(iii) Claims described in paragraph

(b)(5) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

fat.’’

(6) The term ‘‘lll percent fat free’’

may be used on the label or in labeling

of products, provided that:

(i) The product meets the criteria for

‘‘low fat’’ in paragraph (b)(2) or (b)(3) of

this section;

(ii) The percent declared and the

words ‘‘fat free’’ are in uniform type

size; and

(iii) A ‘‘100 percent fat free’’ claim

may be made only on products that

meet the criteria for ‘‘fat free’’ in

paragraph (b)(1) of this section, that

contain less than 0.5 g of fat per 100 g,

and that contain no added fat.

(iv) A synonym for ‘‘lll percent fat

free’’ is ‘‘lll percent lean.’’

(c) Fatty acid content claims. (1) The

terms ‘‘saturated fat free,’’ ‘‘free of

saturated fat,’’ ‘‘no saturated fat,’’ ‘‘zero

saturated fat,’’ ‘‘without saturated fat,’’

‘‘trivial source of saturated fat,’’

‘‘negligible source of saturated fat,’’ or

‘‘dietarily insignificant source of

saturated fat’’ may be used on the label

or in labeling of products, provided that:

(i) The product contains less than 0.5

g of saturated fat and less than 0.5 g

trans fatty acids per reference amount

customarily consumed and per labeled

serving size or, in the case of a mealtype product, less than 0.5 g of saturated

fat and less than 0.5 g trans fatty acids

per labeled serving size;

(ii) The product contains no

ingredient that is generally understood

by consumers to contain saturated fat

unless the listing of the ingredient in the

ingredients statement is followed by an

asterisk that refers to the statement

below the list of ingredients, which

states: ‘‘Adds a trivial amount of

saturated fat,’’ ‘‘adds a negligible

amount of saturated fat,’’ or ‘‘adds a

dietarily insignificant amount of

saturated fat;’’ and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower saturated fat

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(2) The terms ‘‘low in saturated fat,’’

‘‘low saturated fat,’’ ‘‘contains a small

amount of saturated fat,’’ ‘‘low source of

saturated fat,’’ or ‘‘a little saturated fat’’

may be used on the label or in labeling

of products, except meal-type products

as defined in § 317.313(l), provided that:

(i) The product contains 1 g or less of

saturated fat per reference amount

customarily consumed and not more

than 15 percent of calories from

saturated fat; and

(ii) If the product meets these

conditions without benefit of special

processing, alteration, formulation, or

reformulation to lower saturated fat

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(3) The terms defined in paragraph

(c)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains 1 g or less of

saturated fat per 100 g and less than 10

percent calories from saturated fat; and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower saturated fat
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 195

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(4) The terms ‘‘reduced saturated fat,’’

‘‘reduced in saturated fat,’’ ‘‘saturated

fat reduced,’’ ‘‘less saturated fat,’’

‘‘lower saturated fat,’’ or ‘‘lower in

saturated fat’’ may be used on the label

or in labeling of products, except mealtype products as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent less saturated fat per reference

amount customarily consumed than an

appropriate reference product as

described in § 317.313(j)(1); and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the saturated fat differs between the

two products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced saturated fat

‘product’, contains 50 percent less

saturated fat than the national average

for ‘product’ ’’); and

(B) Quantitative information

comparing the level of saturated fat in

the product per labeled serving size

with that of the reference product that

it replaces is declared adjacent to the

most prominent claim or to the nutrition

information (e.g., ‘‘saturated fat reduced

from 3 g to 1.5 g per serving’’).

(iii) Claims described in paragraph

(c)(4) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

saturated fat.’’

(5) The terms defined in paragraph

(c)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains at least 25

percent less saturated fat per 100 g of

product than an appropriate reference

product as described in § 317.313(j)(1);

and

(ii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the saturated fat differs between the

two products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced saturated fat

‘product’,’’ ‘‘50 percent less saturated fat

than our regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of saturated fat in

the product per specified weight with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘saturated fat content

has been reduced from 2.5 g per 3 oz to

1.5 g per 3 oz’’).

(iii) Claims described in paragraph

(c)(5) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

saturated fat.’’

(d) Cholesterol content claims. (1) The

terms ‘‘cholesterol free,’’ ‘‘free of

cholesterol,’’ ‘‘zero cholesterol,’’

‘‘without cholesterol,’’ ‘‘no cholesterol,’’

‘‘trivial source of cholesterol,’’

‘‘negligible source of cholesterol,’’ or

‘‘dietarily insignificant source of

cholesterol’’ may be used on the label or

in labeling of products, provided that:

(i) The product contains less than 2

milligrams (mg) of cholesterol per

reference amount customarily

consumed and per labeled serving size

or, in the case of a meal-type product as

defined in § 317.313(l), less than 2 mg

of cholesterol per labeled serving size;

(ii) The product contains no

ingredient that is generally understood

by consumers to contain cholesterol,

unless the listing of the ingredient in the

ingredients statement is followed by an

asterisk that refers to the statement

below the list of ingredients, which

states: ‘‘Adds a trivial amount of

cholesterol,’’ ‘‘adds a negligible amount

of cholesterol,’’ or ‘‘adds a dietarily

insignificant amount of cholesterol’’;

(iii) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed or, in the case of

a meal-type product as defined in

§ 317.313(l), 2 g or less of saturated fat

per labeled serving size; and

(iv) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower cholesterol

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which it

attaches; or

(v) If the product meets these

conditions only as a result of special

processing, alteration, formulation, or

reformulation, the amount of cholesterol

is reduced by 25 percent or more from

the reference product it replaces as

described in § 317.313(j)(1) and for

which it substitutes as described in

§ 317.313(d) that has a significant (e.g.,

5 percent or more of a national or

regional market) market share. As

required in § 317.313(j)(2) for relative

claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol was reduced are

declared in immediate proximity to the

most prominent such claim (e.g.,

‘‘cholesterol free ‘product’, contains 100

percent less cholesterol than ‘reference

product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘contains no

cholesterol compared with 30 mg in one

serving of ‘reference product’ ’’).

(2) The terms ‘‘low in cholesterol,’’

‘‘low cholesterol,’’ ‘‘contains a small

amount of cholesterol,’’ ‘‘low source of

cholesterol,’’ or ‘‘little cholesterol’’ may

be used on the label or in labeling of

products, except meal-type products as

defined in § 317.313(l), provided that:

(i)(A) If the product has a reference

amount customarily consumed greater

than 30 g or greater than 2 tbsp:

(1) The product contains 20 mg or less

of cholesterol per reference amount

customarily consumed; and

(2) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed; or

(B) If the product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less:

(1) The product contains 20 mg or less

of cholesterol per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 317.309(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form); and

(2) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed.

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower cholesterol

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches; or

(iii) If the product contains 20 mg or

less of cholesterol only as a result of

special processing, alteration,

formulation, or reformulation, the

amount of cholesterol is reduced by 25

percent or more from the reference

product it replaces as described in

§ 317.313(j)(1) and for which it

substitutes as described in § 317.313(d)

that has a significant (e.g., 5 percent or

more of a national or regional market)

market share. As required in

§ 317.313(j)(2) for relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol has been reduced
196 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

are declared in immediate proximity to

the most prominent such claim (e.g.,

‘‘low cholesterol ‘product’, contains 85

percent less cholesterol than our regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘cholesterol lowered

from 30 mg to 5 mg per serving’’).

(3) The terms defined in paragraph

(d)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product contains 20 mg or less

of cholesterol per 100 g of product;

(ii) The product contains 2 g or less

of saturated fat per 100 g of product; and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower cholesterol

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(4) The terms ‘‘reduced cholesterol,’’

‘‘reduced in cholesterol,’’ ‘‘cholesterol

reduced,’’ ‘‘less cholesterol,’’ ‘‘lower

cholesterol,’’ or ‘‘lower in cholesterol’’

may be used on the label or in labeling

of products or products that substitute

for those products as specified in

§ 317.313(d), excluding meal-type

products as defined in § 317.313(l),

provided that:

(i) The product has been specifically

formulated, altered, or processed to

reduce its cholesterol by 25 percent or

more from the reference product it

replaces as described in § 317.313(j)(1)

and for which it substitutes as described

in § 317.313(d) that has a significant

(e.g., 5 percent or more of a national or

regional market) market share;

(ii) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed; and

(iii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol has been reduced

are declared in immediate proximity to

the most prominent such claim (e.g.,

‘‘25 percent less cholesterol than

‘reference product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘cholesterol lowered

from 55 mg to 30 mg per serving’’).

(iv) Claims described in paragraph

(d)(4) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

cholesterol.’’

(5) The terms defined in paragraph

(d)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 317.313(l),

provided that:

(i) The product has been specifically

formulated, altered, or processed to

reduce its cholesterol by 25 percent or

more from the reference product it

replaces as described in § 317.313(j)(1)

and for which it substitutes as described

in § 317.313(d) that has a significant

(e.g., 5 percent or more of a national or

regional market) market share;

(ii) The product contains 2 g or less

of saturated fat per 100 g of product; and

(iii) As required in § 317.313(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol has been reduced

are declared in immediate proximity to

the most prominent such claim (e.g.,

‘‘25% less cholesterol than ‘reference

product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per specified weight with that

of the reference product that it replaces

is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘cholesterol content

has been reduced from 35 mg per 3 oz

to 25 mg per 3 oz).

(iv) Claims described in paragraph

(d)(5) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

cholesterol.’’

(e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims.

(1) The term ‘‘lean’’ may be used on the

label or in labeling of a product,

provided that the product contains less

than 10 g of fat, 4.5 g or less of saturated

fat, and less than 95 mg of cholesterol

per 100 g of product and per reference

amount customarily consumed for

individual foods, and per 100 g of

product and per labeled serving size for

meal-type products as defined in

§ 317.313(l).

(2) The term ‘‘extra lean’’ may be used

on the label or in labeling of a product,

provided that the product contains less

than 5 g of fat, less than 2 g of saturated

fat, and less than 95 mg of cholesterol

per 100 g of product and per reference

amount customarily consumed for

individual foods, and per 100 g of

product and per labeled serving size for

meal-type products as defined in

§ 317.313(l).

§ 317.363 [Amended]

14. Section 317.363 is amended by

revising the section reference in

paragraphs (b)(2) introductory text and

(b)(3) introductory text from

‘‘§ 317.309(g)(1)’’ to ‘‘§ 317.309(f)(1).’’

§ 317.369 [Amended]

15. Section 317.369 is amended by

adding the word ‘‘meat’’ before the

words ‘‘food products’’ in the last

sentence of paragraph (k)(5)

introductory text; by replacing the word

‘‘preceding’’ in paragraph (k)(5)(i)(A)

with the word ‘‘proceeding’’; and by

replacing the word ‘‘application’’ in the

second sentence of paragraph (k)(5)(i)(B)

with the word ‘‘applicant’’.

16. Section 317.380 is amended by

revising paragraphs (e) and (f) to read as

follows:

§ 317.380 Label statements relating to

usefulness in reducing or maintaining body

weight.

* * * * *

(e) ‘‘Label terms suggesting usefulness

as low calorie or reduced calorie foods’’.

(1) Except as provided in paragraphs

(e)(2) and (e)(3) of this section, a

product may be labeled with terms such

as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially

sweetened,’’ or ‘‘sweetened with

nonnutritive sweetener’’ only if the

claim is not false or misleading, and the

product is labeled ‘‘low calorie’’ or

‘‘reduced calorie’’ or bears another

comparative calorie claim in

compliance with the applicable

provisions in this subpart.

(2) Paragraph (e)(1) of this section

shall not apply to any use of such terms

that is specifically authorized by

regulation governing a particular food,

or, unless otherwise restricted by

regulation, to any use of the term ‘‘diet’’

that clearly shows that the product is

offered solely for a dietary use other

than regulating body weight, e.g., ‘‘for

low sodium diets.’’

(3) Paragraph (e)(1) of this section

shall not apply to any use of such terms

on a formulated meal replacement or

other product that is represented to be

of special dietary use as a whole meal,

pending the issuance of a regulation

governing the use of such terms on

foods.

(f) ‘‘Sugar free’’ and ‘‘no added

sugar’’. Criteria for the use of the terms

‘‘sugar free’’ and ‘‘no added sugar’’ are

provided for in § 317.360(c).

§ 317.400 [Amended]

17. Section 317.400 is amended by

adding the words ‘‘meat or’’ before the

words ‘‘meat food products’’ in

paragraph (a) introductory text; by

revising the section reference in
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 197

paragraph (c)(2)(iii) from ‘‘§ 317.309(e)’’

to ‘‘§ 317.309(d)(6)’’; and by revising the

words ‘‘at 21 CFR 101.9(d)(9)’’ in

paragraph (c)(2)(v) to the words ‘‘in

§ 317.309(d)(9).’’

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

18. The authority citation for part 381

continues to read as follows:

Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21

U.S.C. 451–470; 7 CFR 2.17, 2.55.

§ 381.400 [Amended]

19. Section 381.400 is amended by

adding the words ‘‘intended for human

consumption and offered for sale’’ after

the words ‘‘poultry products’’ in

paragraph (a).

20. Section 381.409 is amended by

revising the section reference in the fifth

sentence of paragraph (h)(2) from

‘‘§ 381.409(b)’’ to ‘‘§ 381.409(c)’’ and

revising paragraphs (a) through (g) to

read as follows:

§ 381.409 Nutrition label content.

(a) All nutrient and food component

quantities shall be declared in relation

to a serving as defined in this section.

(b)(1) The term ‘‘serving’’ or ‘‘serving

size’’ means an amount of food

customarily consumed per eating

occasion by persons 4 years of age or

older, which is expressed in a common

household measure that is appropriate

to the product. When the product is

specially formulated or processed for

use by infants or by toddlers, a serving

or serving size means an amount of food

customarily consumed per eating

occasion by infants up to 12 months of

age or by children 1 through 3 years of

age, respectively.

(2) Except as provided in paragraphs

(b)(8), (b)(12), and (b)(14) of this section

and for products that are intended for

weight control and are available only

through a weight-control or weightmaintenance program, the serving size

declared on a product label shall be

determined from the ‘‘Reference

Amounts Customarily Consumed Per

Eating Occasion—General Food

Supply’’ (Reference Amount(s)) that

appear in § 381.412(b) using the

procedures described in this paragraph

(b). For products that are both intended

for weight control and available only

through a weight-control program, a

manufacturer may determine the serving

size that is consistent with the meal

plan of the program. Such products

must bear a statement, ‘‘for sale only

through the lll program’’ (fill in the

blank with the name of the appropriate

weight-control program, e.g., Smith’s

Weight Control), on the principal

display panel. However, the Reference

Amounts in § 381.412(b) shall be used

for purposes of evaluating whether

weight-control products that are

available only through a weight-control

program qualify for nutrition claims.

(3) The declaration of nutrient and

food component content shall be on the

basis of the product ‘‘as packaged’’ for

all products, except that singleingredient, raw products may be

declared on the basis of the product ‘‘as

consumed’’ as set forth in

§ 381.445(a)(1). In addition to the

required declaration on the basis of ‘‘as

packaged’’ for products other than

single ingredient, raw products, the

declaration may also be made on the

basis of ‘‘as consumed,’’ provided that

preparation and cooking instructions are

clearly stated.

(4) For products in discrete units (e.g.,

chicken wings, and individually

packaged products within a multiserving package), and for products

which consist of two or more foods

packaged and presented to be consumed

together where the ingredient

represented as the main ingredient is in

discrete units (e.g., chicken wings and

barbecue sauce), the serving size shall

be declared as follows:

(i) If a unit weighs 50 percent or less

of the Reference Amount, the serving

size shall be the number of whole units

that most closely approximates the

Reference Amount for the product

category.

(ii) If a unit weighs more than 50

percent but less than 67 percent of the

Reference Amount, the manufacturer

may declare one unit or two units as the

serving size.

(iii) If a unit weighs 67 percent or

more but less than 200 percent of the

Reference Amount, the serving size

shall be one unit.

(iv) If a unit weighs 200 percent or

more of the Reference Amount, the

manufacturer may declare one unit as

the serving size if the whole unit can

reasonably be consumed at a single

eating occasion.

(v) For products that have Reference

Amounts of 100 grams (or milliliter) or

larger and are individual units within a

multi-serving package, if a unit contains

more than 150 percent but less than 200

percent of the Reference Amount, the

manufacturer may decide whether to

declare the individual unit as 1 or 2

servings.

(vi) For products which consist of two

or more foods packaged and presented

to be consumed together where the

ingredient represented as the main

ingredient is in discrete units (e.g.,

chicken wings and barbecue sauce), the

serving size may be the number of

discrete units represented as the main

ingredient plus proportioned minor

ingredients used to make the Reference

Amount for the combined product as

determined in § 381.412(c).

(vii) For packages containing several

individual single-serving containers,

each of which is labeled with all

required information including

nutrition labeling as specified in this

section (i.e., are labeled appropriately

for individual sale as single-serving

containers), the serving size shall be 1

unit.

(5) For products in large discrete units

that are usually divided for

consumption (e.g., pizza, pan of poultry

lasagna), for unprepared products where

the entire contents of the package is

used to prepare large discrete units that

are usually divided for consumption

(e.g., pizza kit), and for products which

consist of two or more foods packaged

and presented to be consumed together

where the ingredient represented as the

main ingredient is a large discrete unit

usually divided for consumption, the

serving size shall be the fractional slice

of the ready-to-eat product (e.g., 1⁄8

quiche, 1⁄4 pizza) that most closely

approximates the Reference Amount for

the product category. The serving size

may be the fraction of the package used

to make the Reference Amount for the

unprepared product determined in

§ 381.412(d) or the fraction of the large

discrete unit represented as the main

ingredient plus proportioned minor

ingredients used to make the Reference

Amount of the combined product

determined in § 381.412(c). In

expressing the fractional slice,

manufacturers shall use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions that can be

generated by further division by 2 or 3.

(6) For nondiscrete bulk products

(e.g., whole turkey, turkey breast,

ground poultry), and for products which

consist of two or more foods packaged

and presented to be consumed together

where the ingredient represented as the

main ingredient is a bulk product (e.g.,

turkey breast and gravy), the serving

size shall be the amount in household

measure that most closely approximates

the Reference Amount for the product

category and may be the amount of the

bulk product represented as the main

ingredient plus proportioned minor

ingredients used to make the Reference

Amount for the combined product

determined in § 381.412(c).

(7) For labeling purposes, the term

‘‘common household measure’’ or

‘‘common household unit’’ means cup,

tablespoon, teaspoon, piece, slice,

fraction (e.g., 1⁄4 pizza), ounce (oz), or

other common household equipment

used to package food products (e.g., jar
198 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

or tray). In expressing serving size in

household measures, except as specified

in paragraphs (b)(7)(iv), (v), and (vi) of

this section, the following rules shall be

used:

(i) Cups, tablespoons, or teaspoons

shall be used wherever possible and

appropriate. Cups shall be expressed in

1⁄4- or 1⁄3-cup increments, tablespoons in

whole number of tablespoons for

quantities less than 1⁄4 cup but greater

than or equal to 2 tablespoons (tbsp), 1,

11⁄3, 11⁄2, or 12⁄3 tbsp for quantities less

than 2 tbsp but greater than or equal to

1 tbsp, and teaspoons in whole number

of teaspoons for quantities less than 1

tbsp but greater than or equal to 1

teaspoon (tsp), and in 1⁄4-tsp increments

for quantities less than 1 tsp.

(ii) If cups, tablespoons or teaspoons

are not applicable, units such as piece,

slice, tray, jar, and fraction shall be

used.

(iii) If cups, tablespoons and

teaspoons, or units such as piece, slice,

tray, jar, or fraction are not applicable,

ounces may be used. Ounce

measurements shall be expressed in 0.5-

ounce increments most closely

approximating the Reference Amount

with rounding indicated by the use of

the term ‘‘about’’ (e.g., about 2.5

ounces).

(iv) A description of the individual

container or package shall be used for

single-serving containers and meal-type

products and for individually packaged

products within multi-serving

containers (e.g., can, box, package, meal,

or dinner). A description of the

individual unit shall be used for other

products in discrete units (e.g., wing,

slice, link, or patty).

(v) For unprepared products where

the entire contents of the package is

used to prepare large discrete units that

are usually divided for consumption

(e.g., pizza kit), the fraction or portion

of the package may be used.

(vi) For products that consist of two

or more distinct ingredients or

components packaged and presented to

be consumed together (e.g., chicken

wings with a glaze packet), the nutrition

information may be declared for each

component or as a composite. The

serving size may be provided in

accordance with the provisions of

paragraphs (b)(4), (b)(5), and (b)(6) of

this section.

(vii) For nutrition labeling purposes, a

teaspoon means 5 milliliters (mL), a

tablespoon means 15 mL, a cup means

240 mL, and 1 oz in weight means 28

grams (g).

(viii) When a serving size, determined

from the Reference Amount in

§ 381.412(b) and the procedures

described in this section, falls exactly

half way between two serving sizes (e.g.,

2.5 tbsp), manufacturers shall round the

serving size up to the next incremental

size.

(8) A product that is packaged and

sold individually and that contains less

than 200 percent of the applicable

Reference Amount shall be considered

to be a single-serving container, and the

entire content of the product shall be

labeled as one serving, except for

products that have Reference Amounts

of 100 g (or mL) or larger, manufacturers

may decide whether a package that

contains more than 150 percent but less

than 200 percent of the Reference

Amount is 1 or 2 servings. Packages sold

individually that contain 200 percent or

more of the applicable Reference

Amount may be labeled as a singleserving if the entire content of the

package can reasonably be consumed at

a single-eating occasion.

(9) A label statement regarding a

serving shall be the serving size

expressed in common household

measures as set forth in paragraphs

(b)(2) through (b)(8) of this section and

shall be followed by the equivalent

metric quantity in parenthesis (fluids in

milliliters and all other foods in grams),

except for single-serving containers.

(i) For a single-serving container, the

parenthetical metric quantity, which

will be presented as part of the net

weight statement on the principal

display panel, is not required except

where nutrition information is required

on a drained weight basis according to

paragraph (b)(11) of this section.

However, if a manufacturer voluntarily

provides the metric quantity on

products that can be sold as single

servings, then the numerical value

provided as part of the serving size

declaration must be identical to the

metric quantity declaration provided as

part of the net quantity of contents

statement.

(ii) The gram or milliliter quantity

equivalent to the household measure

should be rounded to the nearest whole

number except for quantities that are

less than 5 g (mL). The gram (mL)

quantity between 2 and 5 g (mL) should

be rounded to the nearest 0.5 g (mL) and

the g (mL) quantity less than 2 g (mL)

should be expressed in 0.1-g (mL)

increments.

(iii) In addition, serving size may be

declared in ounce, in parenthesis,

following the metric measure separated

by a slash where other common

household measures are used as the

primary unit for serving size, e.g., 1 slice

(28 g/1 oz) for sliced chicken roll. The

ounce quantity equivalent to the metric

quantity should be expressed in 0.1-oz

increments.

(iv) If a manufacturer elects to use

abbreviations for units, the following

abbreviations shall be used: tbsp for

tablespoon, tsp for teaspoon, g for gram,

mL for milliliter, and oz for ounce.

(10) Determination of the number of

servings per container shall be based on

the serving size of the product

determined by following the procedures

described in this section.

(i) The number of servings shall be

rounded to the nearest whole number

except for the number of servings

between 2 and 5 servings and random

weight products. The number of

servings between 2 and 5 servings shall

be rounded to the nearest 0.5 serving.

Rounding should be indicated by the

use of the term ‘‘about’’ (e.g., about 2

servings; about 3.5 servings).

(ii) When the serving size is required

to be expressed on a drained solids basis

and the number of servings varies

because of a natural variation in unit

size, the manufacturer may state the

typical number of servings per container

(e.g., usually 5 servings).

(iii) For random weight products, a

manufacturer may declare ‘‘varied’’ for

the number of servings per container

provided the nutrition information is

based on the Reference Amount

expressed in ounces. The manufacturer

may provide the typical number of

servings in parenthesis following the

‘‘varied’’ statement (e.g., varied

(approximately 8 servings per pound)).

(iv) For packages containing several

individual single-serving containers,

each of which is labeled with all

required information including

nutrition labeling as specified in this

section (i.e., are labeled appropriately

for individual sale as single-serving

containers), the number of servings shall

be the number of individual packages

within the total package.

(v) For packages containing several

individually packaged multi-serving

units, the number of servings shall be

determined by multiplying the number

of individual multi-serving units in the

total package by the number of servings

in each individual unit.

(11) The declaration of nutrient and

food component content shall be on the

basis of product as packaged or

purchased with the exception of

products that are packed or canned in

water, brine, or oil but whose liquid

packing medium is not customarily

consumed. Declaration of the nutrient

and food component content of

products that are packed in liquid

which is not customarily consumed

shall be based on the drained solids.

(12) Serving size for meal-type

products as defined in § 381.413(l) shall
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 199

be the entire content (edible portion

only) of the package.

(13) Another column of figures may

be used to declare the nutrient and food

component information in the same

format as required by § 381.409(e),

(i) Per 100 grams, 100 milliliters, or 1

ounce of the product as packaged or

purchased.

(ii) Per one unit if the serving size of

a product in discrete units in a multiserving container is more than one unit.

(14) If a product consists of

assortments of poultry products (e.g.,

variety packs) in the same package,

nutrient content shall be expressed on

the entire package contents or on each

individual product.

(15) If a product is commonly

combined with other ingredients or is

cooked or otherwise prepared before

eating, and directions for such

combination or preparations are

provided, another column of figures

may be used to declare the nutrient

contents on the basis of the product as

consumed for the product alone (e.g., a

cream soup mix may be labeled with

one set of Daily Values for the dry mix

(per serving), and another set for the

serving of the final soup when prepared

(e.g., per serving of cream soup mix and

1 cup of vitamin D fortified whole

milk)): Provided, that the type and

quantity of the other ingredients to be

added to the product by the user and the

specific method of cooking and other

preparation shall be specified

prominently on the label.

(c) The declaration of nutrition

information on the label or in labeling

of a poultry product shall contain

information about the level of the

following nutrients, except for those

nutrients whose inclusion, and the

declaration of amounts, is voluntary as

set forth in this paragraph. No nutrients

or food components other than those

listed in this paragraph as either

mandatory or voluntary may be

included within the nutrition label.

Except as provided for in paragraph (f)

or (g) of this section, nutrient

information shall be presented using the

nutrient names specified and in the

following order in the formats specified

in paragraph (d) or (e) of this section.

(1) ‘‘Calories, total,’’ ‘‘Total calories,’’

or ‘‘Calories’’: A statement of the caloric

content per serving, expressed to the

nearest 5-calorie increment up to and

including 50 calories, and 10-calorie

increment above 50 calories, except that

amounts less than 5 calories may be

expressed as zero. Energy content per

serving may also be expressed in

kilojoule units, added in parenthesis

immediately following the statement of

the caloric content.

(i) Caloric content may be calculated

by the following methods. Where either

specific or general food factors are used,

the factors shall be applied to the actual

amount (i.e., before rounding) of food

components (e.g., fat, carbohydrate,

protein, or ingredients with specific

food factors) present per serving.

(A) Using specific Atwater factors

(i.e., the Atwater method) given in Table

13, page 25, ‘‘Energy Value of Foods—

Basis and Derivation,’’ by A. L. Merrill

and B. K. Watt, United States

Department of Agriculture (USDA),

Agriculture Handbook No. 74 (Slightly

revised February 1973), which is

incorporated by reference. Table 13 of

the ‘‘Energy Value of Foods—Basis and

Derivation,’’ Agriculture Handbook No.

74 is incorporated as it exists on the

date of approval. This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

It is available for inspection at the Office

of the Federal Register, suite 700, 800

North Capitol Street, NW., Washington,

DC, or at the office of the FSIS Docket

Clerk, Room 3171, South Building, 14th

and Independence Avenue, SW.,

Washington, DC. Copies of the

incorporation by reference are available

from the Product Assessment Division,

Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Room 329, West End Court

Building, Washington, DC 20250–3700;

(B) Using the general factors of 4, 4,

and 9 calories per gram for protein, total

carbohydrate, and total fat, respectively,

as described in USDA’s Agriculture

Handbook No. 74 (Slightly revised

February 1973), pages 9–11, which is

incorporated by reference. Pages 9–11,

Agriculture Handbook No. 74 is

incorporated as it exists on the date of

approval. This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

(The availability of this incorporation by

reference is given in paragraph

(c)(1)(i)(A) of this section.);

(C) Using the general factors of 4, 4,

and 9 calories per gram for protein, total

carbohydrate less the amount of

insoluble dietary fiber, and total fat,

respectively, as described in USDA’s

Agriculture Handbook No. 74 (Slightly

revised February 1973), pages 9–11,

which is incorporated by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. (The availability of this

incorporation by reference is given in

paragraph (c)(1)(i)(A) of this section.); or

(D) Using data for specific food factors

for particular foods or ingredients

approved by the Food and Drug

Administration (FDA) and provided in

parts 172 or 184 of 21 CFR, or by other

means, as appropriate.

(ii) ‘‘Calories from fat’’: A statement of

the caloric content derived from total fat

as defined in paragraph (c)(2) of this

section per serving, expressed to the

nearest 5-calorie increment, up to and

including 50 calories, and the nearest

10-calorie increment above 50 calories,

except that label declaration of ‘‘calories

from fat’’ is not required on products

that contain less than 0.5 gram of fat per

serving and amounts less than 5 calories

may be expressed as zero. This

statement shall be declared as provided

in paragraph (d)(5) of this section.

(iii) ‘‘Calories from saturated fat’’ or

‘‘Calories from saturated’’

(VOLUNTARY): A statement of the

caloric content derived from saturated

fat as defined in paragraph (c)(2)(i) of

this section per serving may be declared

voluntarily, expressed to the nearest 5-

calorie increment, up to and including

50 calories, and the nearest 10-calorie

increment above 50 calories, except that

amounts less than 5 calories may be

expressed as zero. This statement shall

be indented under the statement of

calories from fat as provided in

paragraph (d)(5) of this section.

(2) ‘‘Fat, total’’ or ‘‘Total fat’’: A

statement of the number of grams of

total fat per serving defined as total

lipid fatty acids and expressed as

triglycerides. Amounts shall be

expressed 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.

(i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A

statement of the number of grams of

saturated fat per 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 per serving if no claims are made

about fat or cholesterol content, and if

‘‘calories from saturated fat’’ is not

declared. Saturated 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.

(A) ‘‘Stearic Acid’’ (VOLUNTARY): A

statement of the number of grams of

stearic acid per serving may be declared

voluntarily, except that when a claim is

made about stearic acid, label

declaration shall be required. Stearic

acid content shall be indented under

saturated fat and expressed to the
200 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

nearest 0.5 (1⁄2)-gram increment below 5

grams and the nearest gram increment

above 5 grams. If the serving contains

less than 0.5 gram, the content shall be

expressed as zero.

(B) [Reserved]

(ii) ‘‘Polyunsaturated fat’’ or

‘‘Polyunsaturated’’ (VOLUNTARY): A

statement of the number of grams of

polyunsaturated fat per serving defined

as cis,cis-methylene-interrupted

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 product other than one that

meets the criteria in § 381.462(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.

(iii) ‘‘Monounsaturated fat’’ or

‘‘Monounsaturated’’ (VOLUNTARY): A

statement of the number of grams of

monounsaturated fat per 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 product other than one that

meets the criteria in § 381.462(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.

(3) ‘‘Cholesterol’’: A statement of the

cholesterol content per serving

expressed in milligrams to the nearest 5-

milligram increment, except that label

declaration of cholesterol information is

not required for products that contain

less than 2 milligrams of cholesterol per

serving and make no claim about fat,

fatty acids, or cholesterol content, or

such products may state the cholesterol

content as zero. If the product contains

2 to 5 milligrams of cholesterol per

serving, the content may be stated as

‘‘less than 5 milligrams.’’

(4) ‘‘Sodium’’: A statement of the

number of milligrams of sodium per

serving expressed as zero when the

serving contains less than 5 milligrams

of sodium, to the nearest 5-milligram

increment when the serving contains 5

to 140 milligrams of sodium, and to the

nearest 10-milligram increment when

the serving contains greater than 140

milligrams.

(5) ‘‘Potassium’’ (VOLUNTARY): A

statement of the number of milligrams

of potassium per serving may be

declared voluntarily, except that when a

claim is made about potassium content,

label declaration shall be required.

Potassium content shall be expressed as

zero when the serving contains less than

5 milligrams of potassium, to the nearest

5-milligram increment when the serving

contains 5 to 140 milligrams of

potassium, and to the nearest 10-

milligram increment when the serving

contains greater than 140 milligrams.

(6) ‘‘Carbohydrate, total’’ or ‘‘Total

carbohydrate’’: A statement of the

number of grams of total carbohydrate

per serving 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, or, if the serving contains

less than 0.5 gram, the content may be

expressed as zero. Total carbohydrate

content shall be calculated by

subtraction of the sum of the crude

protein, total fat, moisture, and ash from

the total weight of the product. This

calculation method is described in

USDA’s Agriculture Handbook No. 74

(Slightly revised February 1973), pages

2 and 3, which is incorporated by

reference. Pages 2 and 3, Agriculture

Handbook No. 74 is incorporated as it

exists on the date of approval. This

incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. (The

availability of this incorporation by

reference is given in paragraph

(c)(1)(i)(A) of this section.).

(i) ‘‘Dietary fiber’’: A statement of the

number of grams of total dietary fiber

per 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.

(A) ‘‘Soluble fiber’’ (VOLUNTARY): A

statement of the number of grams of

soluble dietary fiber per serving may be

declared voluntarily except when a

claim is made on the label or in labeling

about soluble fiber, label declaration

shall be required. Soluble fiber content

shall be indented under dietary fiber

and 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.

(B) ‘‘Insoluble fiber’’ (VOLUNTARY):

A statement of the number of grams of

insoluble dietary fiber per serving may

be declared voluntarily except when a

claim is made on the label or in labeling

about insoluble fiber, label declaration

shall be required. Insoluble fiber content

shall be indented under dietary fiber

and 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.

(ii) ‘‘Sugars’’: A statement of the

number of grams of sugars per serving,

except that label declaration of sugars

content is not required for products that

contain less than 1 gram of sugars per

serving if no claims are made about

sweeteners, sugars, or sugar alcohol

content. Sugars shall be defined as the

sum of all free mono- and disaccharides

(such as glucose, fructose, lactose, and

sucrose). Sugars content shall be

indented and 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.

(iii) ‘‘Sugar alcohol’’ (VOLUNTARY):

A statement of the number of grams of

sugar alcohols per serving may be

declared voluntarily on the label, except

that when a claim is made on the label

or in labeling about sugar alcohol or

sugars when sugar alcohols are present

in the product, sugar alcohol content

shall be declared. For nutrition labeling

purposes, sugar alcohols are defined as

the sum of saccharide derivatives in

which a hydroxyl group replaces a

ketone or aldehyde group and whose

use in the food is listed by FDA (e.g.,

mannitol or xylitol) or is generally

recognized as safe (e.g., sorbitol). In lieu

of the term ‘‘sugar alcohol,’’ the name of

the specific sugar alcohol (e.g.,

‘‘xylitol’’) present in the product may be

used in the nutrition label, provided

that only one sugar alcohol is present in

the product. Sugar alcohol content shall

be indented and 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.
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 201

(iv) ‘‘Other carbohydrate’’

(VOLUNTARY): A statement of the

number of grams of other carbohydrate

per serving may be declared voluntarily.

Other carbohydrate shall be defined as

the difference between total

carbohydrate and the sum of dietary

fiber, sugars, and sugar alcohol, except

that if sugar alcohol is not declared

(even if present), it shall be defined as

the difference between total

carbohydrate and the sum of dietary

fiber and sugars. Other carbohydrate

content shall be indented and 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.

(7) ‘‘Protein’’: A statement of the

number of grams of protein per serving

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 the

protein in products represented or

purported to be for adults and children

4 or more years of age has a protein

quality value that is a protein

digestibility-corrected amino acid score

of less than 20 expressed as a percent,

or when the protein in a product

represented or purported to be for

children greater than 1 but less than 4

years of age has a protein quality value

that is a protein digestibility-corrected

amino acid score of less than 40

expressed as a percent, either of the

following shall be placed adjacent to the

declaration of protein content by

weight: The statement ‘‘not a significant

source of protein,’’ or a listing aligned

under the column headed ‘‘Percent

Daily Value’’ of the corrected amount of

protein per serving, as determined in

paragraph (c)(7)(ii) of this section,

calculated as a percentage of the Daily

Reference Value (DRV) or Reference

Daily Intake (RDI), as appropriate, for

protein and expressed as percent of

Daily Value. When the protein quality

in a product as measured by the Protein

Efficiency Ratio (PER) is less than 40

percent of the reference standard

(casein) for a product represented or

purported to be for infants, the

statement ‘‘not a significant source of

protein’’ shall be placed adjacent to the

declaration of protein content. Protein

content may be calculated on the basis

of the factor of 6.25 times the nitrogen

content of the food as determined by

appropriate methods of analysis in

accordance with § 381.409(h), except

when the procedure for a specific food

requires another factor.

(i) A statement of the corrected

amount of protein per serving, as

determined in paragraph (c)(7)(ii) of this

section, calculated as a percentage of the

RDI or DRV for protein, as appropriate,

and expressed as percent of Daily Value,

may be placed on the label, except that

such a statement shall be given if a

protein claim is made for the product,

or if the product is represented or

purported to be for infants or children

under 4 years of age. When such a

declaration is provided, it shall be

placed on the label adjacent to the

statement of grams of protein and

aligned under the column headed

‘‘Percent Daily Value,’’ and expressed to

the nearest whole percent. However, the

percentage of the RDI for protein shall

not be declared if the product is

represented or purported to be for

infants and the protein quality value is

less than 40 percent of the reference

standard.

(ii) The corrected amount of protein

(grams) per serving for products

represented or purported to be for adults

and children 1 or more years of age is

equal to the actual amount of protein

(grams) per serving multiplied by the

amino acid score corrected for protein

digestibility. If the corrected score is

above 1.00, then it shall be set at 1.00.

The protein digestibility-corrected

amino acid score shall be determined by

methods given in sections 5.4.1, 7.2.1,

and 8 in ‘‘Protein Quality Evaluation,

Report of the Joint FAO/WHO Expert

Consultation on Protein Quality

Evaluation,’’ Rome, 1990, which is

incorporated by reference. Sections

5.4.1, 7.2.1, and 8 of the ‘‘Report of the

Joint FAO/WHO Expert Consultation on

Protein Quality Evaluation,’’ as

published by the Food and Agriculture

Organization of the United Nations/

World Health Organization, is

incorporated as it exists on the date of

approval. This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

It is available for inspection at the Office

of the Federal Register, suite 700, 800

North Capitol Street, NW., Washington,

DC, or at the office of the FSIS Docket

Clerk, Room 3171, South Building, 14th

and Independence Avenue, SW.,

Washington, DC. Copies of the

incorporation by reference are available

from the Product Assessment Division,

Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Room 329, West End Court

Building, Washington, DC 20250–3700.

For products represented or purported

to be for infants, the corrected amount

of protein (grams) per serving is equal

to the actual amount of protein (grams)

per serving multiplied by the relative

protein quality value. The relative

protein quality value shall be

determined by dividing the subject

product’s protein PER value by the PER

value for casein. If the relative protein

value is above 1.00, it shall be set at

1.00.

(iii) For the purpose of labeling with

a percent of the DRV or RDI, a value of

50 grams of protein shall be the DRV for

adults and children 4 or more years of

age, and the RDI for protein for children

less than 4 years of age, infants,

pregnant women, and lactating women

shall be 16 grams, 14 grams, 60 grams,

and 65 grams, respectively.

(8) Vitamins and minerals: A

statement of the amount per serving of

the vitamins and minerals as described

in this paragraph, calculated as a

percent of the RDI and expressed as

percent of Daily Value.

(i) For purposes of declaration of

percent of Daily Value as provided for

in paragraphs (d) through (g) of this

section, products represented or

purported to be for use by infants,

children less than 4 years of age,

pregnant women, or lactating women

shall use the RDI’s that are specified for

the intended group. For products

represented or purported to be for use

by both infants and children under 4

years of age, the percent of Daily Value

shall be presented by separate

declarations according to paragraph (e)

of this section based on the RDI values

for infants from birth to 12 months of

age and for children under 4 years of

age. Similarly, the percent of Daily

Value based on both the RDI values for

pregnant women and for lactating

women shall be declared separately on

products represented or purported to be

for use by both pregnant and lactating

women. When such dual declaration is

used on any label, it shall be included

in all labeling, and equal prominence

shall be given to both values in all such

labeling. All other products shall use

the RDI for adults and children 4 or

more years of age.

(ii) The declaration of vitamins and

minerals as a percent of the RDI shall

include vitamin A, vitamin C, calcium,

and iron, in that order, and shall

include any of the other vitamins and

minerals listed in paragraph (c)(8)(iv) of

this section when they are added, or

when a claim is made about them. Other

vitamins and minerals need not be

declared if neither the nutrient nor the

component is otherwise referred to on

the label or in labeling or advertising

and the vitamins and minerals are:
202 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

(A) Required or permitted in a

standardized food (e.g., thiamin,

riboflavin, and niacin in enriched flour)

and that standardized food is included

as an ingredient (i.e., component) in

another product; or

(B) Included in a product solely for

technological purposes and declared

only in the ingredients statement. The

declaration may also include any of the

other vitamins and minerals listed in

paragraph (c)(8)(iv) of this section when

they are naturally occurring in the food.

The additional vitamins and minerals

shall be listed in the order established

in paragraph (c)(8)(iv) of this section.

(iii) The percentages for vitamins and

minerals shall be expressed to the

nearest 2-percent increment up to and

including the 10-percent level, the

nearest 5-percent increment above 10

percent and up to and including the 50-

percent level, and the nearest 10-percent

increment above the 50-percent level.

Amounts of vitamins and minerals

present at less than 2 percent of the RDI

are not required to be declared in

nutrition labeling but may be declared

by a zero or by the use of an asterisk (or

other symbol) that refers to another

asterisk (or symbol) that is placed at the

bottom of the table and that is followed

by the statement ‘‘Contains less than 2

percent of the Daily Value of this (these)

nutrient (nutrients).’’ Alternatively, if

vitamin A, vitamin C, calcium, or iron

is present in amounts less than 2

percent of the RDI, label declaration of

the nutrient(s) is not required if the

statement ‘‘Not a significant source of

llll (listing the vitamins or

minerals omitted)’’ is placed at the

bottom of the table of nutrient values.

(iv) The following RDI’s and

nomenclature are established for the

following vitamins and minerals which

are essential in human nutrition:

Vitamin A, 5,000 International Units

Vitamin C, 60 milligrams

Calcium, 1.0 gram

Iron, 18 milligrams

Vitamin D, 400 International Units

Vitamin E, 30 International Units

Thiamin, 1.5 milligrams

Riboflavin, 1.7 milligrams

Niacin, 20 milligrams

Vitamin B6, 2.0 milligrams

Folate, 0.4 milligram

Vitamin B12, 6 micrograms

Biotin, 0.3 milligram

Pantothenic acid, 10 milligrams

Phosphorus, 1.0 gram

Iodine, 150 micrograms

Magnesium, 400 milligrams

Zinc, 15 milligrams

Copper, 2.0 milligrams

(v) The following synonyms may be

added in parenthesis immediately

following the name of the nutrient or

dietary component:

Vitamin C—Ascorbic acid

Thiamin—Vitamin B1

Riboflavin—Vitamin B2

Folate—Folacin

Calories—Energy

(vi) A statement of the percent of

vitamin A that is present as betacarotene may be declared voluntarily.

When the vitamins and minerals are

listed in a single column, the statement

shall be indented under the information

on vitamin A. When vitamins and

minerals are arrayed horizontally, the

statement of percent shall be presented

in parenthesis following the declaration

of vitamin A and the percent of Daily

Value of vitamin A in the product (e.g.,

‘‘Percent Daily Value: Vitamin A 50 (90

percent as beta-carotene)’’). When

declared, the percentages shall be

expressed in the same increments as are

provided for vitamins and minerals in

paragraph (c)(8)(iii) of this section.

(9) For the purpose of labeling with a

percent of the DRV, the following DRV’s

are established for the following food

components based on the reference

caloric intake of 2,000 calories:

Food component Unit of measurement DRV

Fat ...................... grams (g) ........... 65

Saturated fatty

acids.

......do ................. 20

Cholesterol ......... milligrams (mg) .. 300

Total carbohydrate.grams (g) ........... 300

Fiber ................... ......do ................. 25

Sodium ............... milligrams (mg) .. 2400

Potassium .......... ......do ................. 3500

Protein ................ grams (g) ........... 50

(d)(1) Nutrient information specified

in paragraph (c) of this section shall be

presented on products in the following

format, except on products on which

dual columns of nutrition information

are declared as provided for in

paragraph (e) of this section, on those

products on which the simplified format

is permitted to be used as provided for

in paragraph (f) of this section, on

products for infants and children less

than 4 years of age as provided for in

§ 381.500(c), and on products in

packages that have a total surface area

available to bear labeling of 40 or less

square inches as provided for in

paragraph (g) of this section.

(i) The nutrition information shall be

set off in a box by use of hairlines and

shall be all black or one color type,

printed on a white or other neutral

contrasting background whenever

practical.

(ii) All information within the

nutrition label shall utilize:

(A) A single easy-to-read type style,

(B) Upper and lower case letters,

(C) At least one point leading (i.e.,

space between two lines of text) except

that at least four points leading shall be

utilized for the information required by

paragraphs (d)(7) and (d)(8) of this

section, and

(D) Letters should never touch.

(iii) Information required in

paragraphs (d)(3), (d)(5), (d)(7), and

(d)(8) of this section shall be in type size

no smaller than 8 point. Except for the

heading ‘‘Nutrition Facts,’’ the

information required in paragraphs

(d)(4), (d)(6), and (d)(9) of this section

and all other information contained

within the nutrition label shall be in

type size no smaller than 6 point. When

provided, the information described in

paragraph (d)(10) of this section shall

also be in type no smaller than 6 point.

(iv) The headings required by

paragraphs (d)(2), (d)(4), and (d)(6) of

this section (i.e., ‘‘Nutrition Facts,’’

‘‘Amount Per Serving,’’ and ‘‘% Daily

Value*’’), the names of all nutrients that

are not indented according to

requirements of paragraph (c) of this

section (i.e., Calories, Total fat,

Cholesterol, Sodium, Potassium, Total

carbohydrate, and Protein), and the

percentage amounts required by

paragraph (d)(7)(ii) of this section shall

be highlighted by bold or extra bold

type or other highlighting (reverse

printing is not permitted as a form of

highlighting) that prominently

distinguishes it from other information.

No other information shall be

highlighted.

(v) A hairline rule that is centered

between the lines of text shall separate

‘‘Amount Per Serving’’ from the calorie

statements required in paragraph (d)(5)

of this section and shall separate each

nutrient and its corresponding percent

of Daily Value required in paragraphs

(d)(7)(i) and (d)(7)(ii) of this section

from the nutrient and percent of Daily

Value above and below it.

(2) The information shall be presented

under the identifying heading of

‘‘Nutrition Facts’’ which shall be set in

a type size larger than all other print

size in the nutrition label and, except

for labels presented according to the

format provided for in paragraph (d)(11)

of this section, unless impractical, shall

be set the full width of the information

provided under paragraph (d)(7) of this

section.

(3) Information on serving size shall

immediately follow the heading. Such

information shall include:

(i) ‘‘Serving Size’’: A statement of the

serving size as specified in paragraph

(b)(9) of this section.
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 203

(ii) ‘‘Servings Per Container’’: The

number of servings per container,

except that this statement is not

required on single-serving containers as

defined in paragraph (b)(8) of this

section.

(4) A subheading ‘‘Amount Per

Serving’’ shall be separated from serving

size information by a bar.

(5) Information on calories shall

immediately follow the heading

‘‘Amount Per Serving’’ and shall be

declared in one line, leaving sufficient

space between the declaration of

‘‘Calories’’ and ‘‘Calories from fat’’ to

allow clear differentiation, or, if

‘‘Calories from saturated fat’’ is

declared, in a column with total

‘‘Calories’’ at the top, followed by

‘‘Calories from fat’’ (indented), and

‘‘Calories from saturated fat’’ (indented).

(6) The column heading ‘‘% Daily

Value,’’ followed by an asterisk (e.g., ‘‘%

Daily Value*’’), shall be separated from

information on calories by a bar. The

position of this column heading shall

allow for a list of nutrient names and

amounts as described in paragraph

(d)(7) of this section to be to the left of,

and below, this column heading. The

column heading ‘‘Percent Daily Value,’’

‘‘Percent DV,’’ or ‘‘% DV’’ may be

substituted for ‘‘% Daily Value.’’

(7) Except as provided for in

paragraph (g) of this section, and except

as permitted by § 381.500(d)(2), nutrient

information for both mandatory and any

voluntary nutrients listed in paragraph

(c) of this section that are to be declared

in the nutrition label, except vitamins

and minerals, shall be declared as

follows:

(i) The name of each nutrient, as

specified in paragraph (c) of this

section, shall be given in a column and

followed immediately by the

quantitative amount by weight for that

nutrient appended with a ‘‘g’’ for grams

or ‘‘mg’’ for milligrams.

(ii) A listing of the percent of the DRV

as established in paragraphs (c)(7)(iii)

and (c)(9) of this section shall be given

in a column aligned under the heading

‘‘% Daily Value’’ established in

paragraph (d)(6) of this section with the

percent expressed to the nearest whole

percent for each nutrient declared in the

column described in paragraph (d)(7)(i)

of this section for which a DRV has been

established, except that the percent for

protein may be omitted as provided in

paragraph (c)(7) of this section. The

percent shall be calculated by dividing

either the amount declared on the label

for each nutrient or the actual amount

of each nutrient (i.e., before rounding)

by the DRV for the nutrient, except that

the percent for protein shall be

calculated as specified in paragraph

(c)(7)(ii) of this section. The numerical

value shall be followed by the symbol

for percent (i.e., %).

(8) Nutrient information for vitamins

and minerals shall be separated from

information on other nutrients by a bar

and shall be arrayed horizontally (e.g.,

Vitamin A 4%, Vitamin C 2%, Calcium

15%, Iron 4%) or may be listed in two

columns, except that when more than

four vitamins and minerals are declared,

they may be declared vertically with

percentages listed under the column

headed ‘‘% Daily Value.’’

(9) A footnote, preceded by an

asterisk, shall be placed beneath the list

of vitamins and minerals and shall be

separated from that list by a hairline.

(i) The footnote shall state: Percent

Daily Values are based on a 2,000

calorie diet. Your daily values may be

higher or lower depending on your

calorie needs.

Calories 2,000 2,500

Total fat . Less than . 65 g 80 g

Saturated

fat.

Less than . 20 g 25 g

Cholesterol.Less than . 300 mg 300 mg

Sodium .. Less than . 2400 mg 2400 mg

Total carbohydrate................... 300 g 375 g

Dietary

fiber.

.................. 25 g 30 g

(ii) If the percent of Daily Value is

given for protein in the Percent of Daily

Value column as provided in paragraph

(d)(7)(ii) of this section, protein shall be

listed under dietary fiber, and a value of

50 g shall be inserted on the same line

in the column headed ‘‘2,000’’ and

value of 65 g in the column headed

‘‘2,500.’’

(iii) If potassium is declared in the

column described in paragraph (d)(7)(i)

of this section, potassium shall be listed

under sodium and the DRV established

in paragraph (c)(9) of this section shall

be inserted on the same line in the

numeric columns.

(iv) The abbreviations established in

paragraph (g)(2) of this section may be

used within the footnote.

(10) Caloric conversion information

on a per-gram basis for fat,

carbohydrate, and protein may be

presented beneath the information

required in paragraph (d)(9), separated

from that information by a hairline. This

information may be presented

horizontally (i.e., ‘‘Calories per gram:

Fat 9, Carbohydrate 4, Protein 4’’) or

vertically in columns.

(11)(i) If the space beneath the

information on vitamins and minerals is

not adequate to accommodate the

information required in paragraph (d)(9)

of this section, the information required

in paragraph (d)(9) may be moved to the

right of the column required in

paragraph (d)(7)(ii) of this section and

set off by a line that distinguishes it and

sets it apart from the percent of Daily

Value information. The caloric

conversion information provided for in

paragraph (d)(10) of this section may be

presented beneath either side or along

the full length of the nutrition label.

(ii) If the space beneath the mandatory

declaration of iron is not adequate to

accommodate any remaining vitamins

and minerals to be declared or the

information required in paragraph (d)(9)

of this section, the remaining

information may be moved to the right

and set off by a line that distinguishes

it and sets it apart from the percent of

Daily Value information given to the

left. The caloric conversion information

provided for in paragraph (d)(10) of this

section may be presented beneath either

side or along the full length of the

nutrition label.

(iii) If there is not sufficient

continuous vertical space (i.e.,

approximately 3 inches) to

accommodate the required components

of the nutrition label up to and

including the mandatory declaration of

iron, the nutrition label may be

presented in a tabular display in which

the footnote required by paragraph

(d)(9) of the section is given to the far

right of the label, and additional

vitamins and minerals beyond the four

that are required (i.e., vitamin A,

vitamin C, calcium, and iron) are

arrayed horizontally following

declarations of the required vitamins

and minerals.

(12) The following sample label

illustrates the provisions of paragraph

(d) of this section:

BILLING CODE 3410–DM–P
204 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

BILLING CODE 3410–DM–C
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 205

(13)(i) Nutrition labeling on the outer

label of packages of poultry products

that contain two or more products in the

same packages (e.g., variety packs) or of

packages that are used interchangeably

for the same type of food (e.g., poultry

salad containers) may use an aggregate

display.

(ii) Aggregate displays shall comply

with format requirements of paragraph

(d) of this section to the maximum

extent possible, except that the identity

of each food shall be specified to the

right of the ‘‘Nutrition Facts’’ title, and

both the quantitative amount by weight

(i.e., g/mg amounts) and the percent

Daily Value for each nutrient shall be

listed in separate columns under the

name of each food.

(14) When nutrition labeling appears

in a second language, the nutrition

information may be presented in a

separate nutrition label for each

language or in one nutrition label with

the information in the second language

following that in English. Numeric

characters that are identical in both

languages need not be repeated (e.g.,

‘‘Protein/Proteinas 2 g’’). All required

information must be included in both

languages.

(e) Nutrition information may be

presented for two or more forms of the

same product (e.g., both ‘‘raw’’ and

‘‘cooked’’) or for common combinations

of foods as provided for in paragraph (b)

of this section, or for different units

(e.g., per 100 grams) as provided for in

paragraph (b) of this section, or for two

or more groups for which RDI’s are

established (e.g., both infants and

children less than 4 years of age) as

provided for in paragraph (c)(8)(i) of this

section. When such dual labeling is

provided, equal prominence shall be

given to both sets of values. Information

shall be presented in a format consistent

with paragraph (d) of this section,

except that:

(1) Following the subheading of

‘‘Amount Per Serving,’’ there shall be

two or more column headings

accurately describing the forms of the

same product (e.g., ‘‘raw’’ and

‘‘roasted’’), the combinations of foods,

the units, or the RDI groups that are

being declared. The column

representing the product as packaged

and according to the label serving size

based on the Reference Amount in

§ 381.412(b) shall be to the left of the

numeric columns.

(2) When the dual labeling is

presented for two or more forms of the

same product, for combinations of

foods, or for different units, total

calories and calories from fat (and

calories from saturated fat, when

declared) shall be listed in a column

and indented as specified in paragraph

(d)(5) of this section with quantitative

amounts declared in columns aligned

under the column headings set forth in

paragraph (e)(1) of this section.

(3) Quantitative information by

weight required in paragraph (d)(7)(i) of

this section shall be specified for the

form of the product as packaged and

according to the label serving size based

on the Reference Amount in

§ 381.412(b).

(i) Quantitative information by weight

may be included for other forms of the

product represented by the additional

column(s) either immediately adjacent

to the required quantitative information

by weight for the product as packaged

and according to the label serving size

based on the Reference Amount in

§ 381.412(b) or as a footnote.

(A) If such additional quantitative

information is given immediately

adjacent to the required quantitative

information, it shall be declared for all

nutrients listed and placed immediately

following and differentiated from the

required quantitative information (e.g.,

separated by a comma). Such

information shall not be put in a

separate column.

(B) If such additional quantitative

information is given in a footnote, it

shall be declared in the same order as

the nutrients are listed in the nutrition

label. The additional quantitative

information may state the total nutrient

content of the product identified in the

second column or the nutrient amounts

added to the product as packaged for

only those nutrients that are present in

different amounts than the amounts

declared in the required quantitative

information. The footnote shall clearly

identify which amounts are declared.

Any subcomponents declared shall be

listed parenthetically after principal

components (e.g., 1⁄2 cup skim milk

contributes an additional 40 calories, 65

mg sodium, 6 g total carbohydrate (6 g

sugars), and 4 g protein).

(ii) Total fat and its quantitative

amount by weight shall be followed by

an asterisk (or other symbol) (e.g.,

‘‘Total fat (2 g)*’’) referring to another

asterisk (or symbol) at the bottom of the

nutrition label identifying the form(s) of

the product for which quantitative

information is presented.

(4) Information required in paragraphs

(d)(7)(ii) and (d)(8) of this section shall

be presented under the subheading ‘‘%

DAILY VALUE’’ and in columns

directly under the column headings set

forth in paragraph (e)(1) of this section.

(5) The following sample label

illustrates the provisions of paragraph

(e) of this section:

BILLING CODE 3410–DM–P
206 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

BILLING CODE 3410–DM–C

(f)(1) Nutrition information may be

presented in a simplified format as set

forth herein when any required

nutrients, other than the core nutrients

(i.e., calories, total fat, sodium, total

carbohydrate, and protein), are present

in insignificant amounts. An

insignificant amount shall be defined as

that amount that may be rounded to

zero in nutrition labeling, except that for

total carbohydrate, dietary fiber, sugars

and protein, it shall be an amount less

than 1 gram.

(2) The simplified format shall

include information on the following

nutrients:

(i) Total calories, total fat, total

carbohydrate, sodium, and protein;

(ii) Any of the following that are

present in more than insignificant

amounts: Calories from fat, saturated fat,

cholesterol, dietary fiber, sugars,

vitamin A, vitamin C, calcium, and iron;

and

(iii) Any vitamins and minerals listed

in paragraph (c)(8)(iv) of this section

when they are added in fortified or

fabricated foods.

(3) Other nutrients that are naturally

present in the product in more than

insignificant amounts may be

voluntarily declared as part of the

simplified format.

(4) Any required nutrient, other than

a core nutrient, that is present in an

insignificant amount may be omitted

from the tabular listing, provided that

the following statement is included at

the bottom of the nutrition label, ‘‘Not

a significant source of llll.’’ The
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 207

blank shall be filled in with the

appropriate nutrient or food component.

Alternatively, amounts of vitamins and

minerals present in insignificant

amounts may be declared by the use of

an asterisk (or symbol) that is placed at

the bottom of the table of nutrient

values and that is followed by the

statement ‘‘Contains less than 2 percent

of the Daily Value of this (these)

nutrient (nutrients).’’

(5) Except as provided for in

paragraph (g) of this section and in

§ 381.500(c) and (d), nutrient

information declared in the simplified

format shall be presented in the same

manner as specified in paragraphs (d) or

(e) of this section, except that the

footnote required in paragraph (d)(9) of

this section is not required. When the

footnote is omitted, an asterisk shall be

placed at the bottom of the label

followed by the statement ‘‘Percent

Daily Values are based on a 2,000

calorie diet’’ and, if the term ‘‘Daily

Value’’ is not spelled out in the heading,

a statement that ‘‘DV’’ represents ‘‘Daily

Value.’’

(g) Foods in packages that have a total

surface area available to bear labeling of

40 or less square inches may modify the

requirements of paragraphs (c) through

(f) of this section and § 381.402(a) by

one or more of the following means:

(1)(i) Presenting the required nutrition

information in a tabular or linear (i.e.,

string) fashion, rather than in vertical

columns if the product has a total

surface area available to bear labeling of

less than 12 square inches, or if the

product has a total surface area available

to bear labeling of 40 or less square

inches and the package shape or size

cannot accommodate a standard vertical

column or tabular display on any label

panel. Nutrition information may be

given in a linear fashion only if the

package shape or size will not

accommodate a tabular display.

(ii) When nutrition information is

given in a linear display, the nutrition

information shall be set off in a box by

the use of a hairline. The percent Daily

Value is separated from the quantitative

amount declaration by the use of

parenthesis, and all nutrients, both

principal components and

subcomponents, are treated similarly.

Bolding is required only on the title

‘‘Nutrition Facts’’ and is allowed for

nutrient names for ‘‘Calories,’’ ‘‘Total

fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total

carbohydrate,’’ and ‘‘Protein.’’

(2) Using any of the following

abbreviations:

Serving size—Serv size

Servings per container—Servings

Calories from fat—Fat cal

Calories from saturated fat—Sat fat cal

Saturated fat—Sat fat

Monounsaturated fat—Monounsat fat

Polyunsaturated fat—Polyunsat fat

Cholesterol—Cholest

Total carbohydrate—Total carb

Dietary fiber—Fiber

Soluble fiber—Sol fiber

Insoluble fiber—Insol fiber

Sugar alcohol—Sugar alc

Other carbohydrate—Other carb

(3) Omitting the footnote required in

paragraph (d)(9) of this section and

placing another asterisk at the bottom of

the label followed by the statement

‘‘Percent Daily Values are based on a

2,000 calorie diet’’ and, if the term

‘‘Daily Value’’ is not spelled out in the

heading, a statement that ‘‘DV’’

represents ‘‘Daily Value.’’

* * * * *

21. Section 381.412 is amended by

redesignating paragraph (d) as (g),

revising paragraph (a), and adding new

paragraphs (d), (e), and (f) to read as

follows: § 381.412 Reference amounts

customarily consumed per eating

occasion.

(a) The general principles followed in

arriving at the reference amounts

customarily consumed per eating

occasion (Reference Amount(s)), as set

forth in paragraph (b) of this section,

are:

(1) The Reference Amounts are

calculated for persons 4 years of age or

older to reflect the amount of food

customarily consumed per eating

occasion by persons in this population

group. These Reference Amounts are

based on data set forth in appropriate

national food consumption surveys.

(2) The Reference Amounts are

calculated for an infant or child under

4 years of age to reflect the amount of

food customarily consumed per eating

occasion by infants up to 12 months of

age or by children 1 through 3 years of

age, respectively. These Reference

Amounts are based on data set forth in

appropriate national food consumption

surveys. Such Reference Amounts are to

be used only when the product is

specially formulated or processed for

use by an infant or by a child under 4

years of age.

(3) An appropriate national food

consumption survey includes a large

sample size representative of the

demographic and socioeconomic

characteristics of the relevant

population group and must be based on

consumption data under actual

conditions of use.

(4) To determine the amount of food

customarily consumed per eating

occasion, the mean, median, and mode

of the consumed amount per eating

occasion were considered.

(5) When survey data were

insufficient, FSIS took various other

sources of information on serving sizes

of food into consideration. These other

sources of information included:

(i) Serving sizes used in dietary

guidance recommendations or

recommended by other authoritative

systems or organizations;

(ii) Serving sizes recommended in

comments;

(iii) Serving sizes used by

manufacturers and grocers; and

(iv) Serving sizes used by other

countries.

(6) Because they reflect the amount

customarily consumed, the Reference

Amount and, in turn, the serving size

declared on the product label are based

on only the edible portion of food, and

not bone, seed, shell, or other inedible

components.

(7) The Reference Amount is based on

the major intended use of the product

(e.g., a mixed dish measurable with a

cup as a main dish and not as a side

dish).

(8) The Reference Amounts for

products that are consumed as an

ingredient of other products, but that

may also be consumed in the form in

which they are purchased (e.g., ground

poultry), are based on use in the form

purchased.

(9) FSIS sought to ensure that foods

that have similar dietary usage, product

characteristics, and customarily

consumed amounts have a uniform

Reference Amount.

* * * * *

(d) If a product requires further

preparation, e.g., cooking or the

addition of water or other ingredients,

and if paragraph (b) of this section

provides a Reference Amount for the

product in the prepared form, then the

Reference Amount for the unprepared

product shall be determined using the

following rules:

(1) Except as provided for in

paragraph (d)(2) of this section, the

Reference Amount for the unprepared

product shall be the amount of the

unprepared product required to make

the Reference Amount for the prepared

product as established in paragraph (b)

of this section.

(2) For products where the entire

contents of the package is used to

prepare one large discrete unit usually

divided for consumption, the Reference

Amount for the unprepared product

shall be the amount of the unprepared

product required to make the fraction of

the large discrete unit closest to the

Reference Amount for the prepared

product as established in paragraph (b)

of this section.
208 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

(e) The Reference Amount for an

imitation or substitute product or

altered product as defined in

§ 381.413(d), such as a ‘‘low calorie’’

version, shall be the same as for the

product for which it is offered as a

substitute.

(f) The Reference Amounts set forth in

paragraphs (b) through (e) of this section

shall be used in determining whether a

product meets the criteria for nutritional

claims. If the serving size declared on

the product label differs from the

Reference Amount, and the product

meets the criteria for the claim only on

the basis of the Reference Amount, the

claim shall be followed by a statement

that sets forth the basis on which the

claim is made. That statement shall

include the Reference Amount as it

appears in paragraph (b) of this section

followed, in parenthesis, by the amount

in common household measure if the

Reference Amount is expressed in

measures other than common household

measures.

* * * * *

22. Section 381.413 is amended by

revising paragraphs (b), (g), (i), (j), (k),

(p), and (q)(4) and adding new

paragraphs (c), (d), (e), and (f) to read as

follows:

§ 381.413 Nutrient content claims; general

principles.

* * * * *

(b) A claim which, expressly or by

implication, characterizes the level of a

nutrient (nutrient content claim) of the

type required in nutrition labeling

pursuant to § 381.409, may not be made

on a label or in labeling of that product

unless the claim is made in accordance

with the applicable provisions in this

subpart.

(1) An expressed nutrient content

claim is any direct statement about the

level (or range) of a nutrient in the

product, e.g., ‘‘low sodium’’ or

‘‘contains 100 calories.’’

(2) An implied nutrient content claim

is any claim that:

(i) Describes the product or an

ingredient therein in a manner that

suggests that a nutrient is absent or

present in a certain amount (e.g., ‘‘high

in oat bran’’); or

(ii) Suggests that the product, because

of its nutrient content, may be useful in

maintaining healthy dietary practices

and is made in association with an

explicit claim or statement about a

nutrient (e.g., ‘‘healthy, contains 3

grams (g) of fat’’).

(3) Except for claims regarding

vitamins and minerals described in

paragraph (q)(3) of this section, no

nutrient content claims may be made on

products intended specifically for use

by infants and children less than 2 years

of age unless the claim is specifically

provided for in subpart Y of this part.

(4) Reasonable variations in the

spelling of the terms defined in

applicable provisions in this subpart

and their synonyms are permitted

provided these variations are not

misleading (e.g., ‘‘hi’’ or ‘‘lo’’).

(c) Information that is required or

permitted by § 381.409 to be declared in

nutrition labeling, and that appears as

part of the nutrition label, is not a

nutrient content claim and is not subject

to the requirements of this section. If

such information is declared elsewhere

on the label or in labeling, it is a

nutrient content claim and is subject to

the requirements for nutrient content

claims.

(d) A ‘‘substitute’’ product is one that

may be used interchangeably with

another product that it resembles, i.e.,

that it is organoleptically, physically,

and functionally (including shelf life)

similar to, and that it is not nutritionally

inferior to unless it is labeled as an

‘‘imitation.’’

(1) If there is a difference in

performance characteristics that

materially limits the use of the product,

the product may still be considered a

substitute if the label includes a

disclaimer adjacent to the most

prominent claim as defined in

paragraph (j)(2)(iii) of this section,

informing the consumer of such

difference (e.g., ‘‘not recommended for

frying’’).

(2) This disclaimer shall be in easily

legible print or type and in a size no less

than that required by § 381.121(c) for

the net quantity of contents statement,

except where the size of the claim is less

than two times the required size of the

net quantity of contents statement, in

which case the disclaimer statement

shall be no less than one-half the size of

the claim but no smaller than 1⁄16-inch

minimum height, except as permitted by

§ 381.500(d)(2).

(e)(1) Because the use of a ‘‘free’’ or

‘‘low’’ claim before the name of a

product implies that the product differs

from other products of the same type by

virtue of its having a lower amount of

the nutrient, only products that have

been specially processed, altered,

formulated, or reformulated so as to

lower the amount of the nutrient in the

product, remove the nutrient from the

product, or not include the nutrient in

the product, may bear such a claim (e.g.,

‘‘low sodium chicken noodle soup’’).

(2) Any claim for the absence of a

nutrient in a product, or that a product

is low in a nutrient when the product

has not been specially processed,

altered, formulated, or reformulated to

qualify for that claim shall indicate that

the product inherently meets the criteria

and shall clearly refer to all products of

that type and not merely to the

particular brand to which the labeling

attaches (e.g., ‘‘chicken breast meat, a

low sodium food’’).

(f) A nutrient content claim shall be

in type size and style no larger than two

times that of the statement of identity

and shall not be unduly prominent in

type style compared to the statement of

identity.

(g) Labeling information required in

§§ 381.413, 381.454, 381.456, 381.460,

381.461, 381.462, and 381.480, whose

type size is not otherwise specified, is

required to be in letters and/or numbers

no less than 1⁄16 inch in height, except

as permitted by § 381.500(d)(2).

(h) [Reserved]

(i) Except as provided in § 381.409 or

in paragraph (q)(3) of this section, the

label or labeling of a product may

contain a statement about the amount or

percentage of a nutrient if:

(1) The use of the statement on the

product implicitly characterizes the

level of the nutrient in the product and

is consistent with a definition for a

claim, as provided in subpart Y of this

part, for the nutrient that the label

addresses. Such a claim might be, ‘‘less

than 10 g of fat per serving;’’

(2) The use of the statement on the

product implicitly characterizes the

level of the nutrient in the product and

is not consistent with such a definition,

but the label carries a disclaimer

adjacent to the statement that the

product is not ‘‘low’’ in or a ‘‘good

source’’ of the nutrient, such as ‘‘only

200 milligrams (mg) sodium per serving,

not a low sodium product.’’ The

disclaimer must be in easily legible

print or type and in a size no less than

required by § 381.121(c) for the net

quantity of contents, except where the

size of the claim is less than two times

the required size of the net quantity of

contents statement, in which case the

disclaimer statement shall be no less

than one-half the size of the claim but

no smaller than 1⁄16-inch minimum

height, except as permitted by

§ 381.500(d)(2);

(3) The statement does not in any way

implicitly characterize the level of the

nutrient in the product and it is not

false or misleading in any respect (e.g.,

‘‘100 calories’’ or ‘‘5 grams of fat’’), in

which case no disclaimer is required.

(4) ‘‘Percent fat free’’ claims are not

authorized by this paragraph. Such

claims shall comply with

§ 381.462(b)(6).

(j) A product may bear a statement

that compares the level of a nutrient in

the product with the level of a nutrient
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 209

in a reference product. These statements

shall be known as ‘‘relative claims’’ and

include ‘‘light,’’ ‘‘reduced,’’ ‘‘less’’ (or

‘‘fewer’’), and ‘‘more’’ claims.

(1) To bear a relative claim about the

level of a nutrient, the amount of that

nutrient in the product must be

compared to an amount of nutrient in an

appropriate reference product as

specified in this paragraph (j).

(i)(A) For ‘‘less’’ (or ‘‘fewer’’) and

‘‘more’’ claims, the reference product

may be a dissimilar product within a

product category that can generally be

substituted for one another in the diet

or a similar product.

(B) For ‘‘light,’’ ‘‘reduced,’’ and

‘‘added’’ claims, the reference product

shall be a similar product, and

(ii)(A) For ‘‘light’’ claims, the

reference product shall be

representative of the type of product

that includes the product that bears the

claim. The nutrient value for the

reference product shall be

representative of a broad base of

products of that type; e.g., a value in a

representative, valid data base; an

average value determined from the top

three national (or regional) brands, a

market basket norm; or, where its

nutrient value is representative of the

product type, a market leader. Firms

using such a reference nutrient value as

a basis for a claim, are required to

provide specific information upon

which the nutrient value was derived,

on request, to consumers and

appropriate regulatory officials.

(B) For relative claims other than

‘‘light,’’ including ‘‘less’’ and ‘‘more’’

claims, the reference product may be the

same as that provided for ‘‘light’’ in

paragraph (j)(1)(ii)(A) of this section or

it may be the manufacturer’s regular

product, or that of another

manufacturer, that has been offered for

sale to the public on a regular basis for

a substantial period of time in the same

geographic area by the same business

entity or by one entitled to use its trade

name, provided the name of the

competitor is not used on the labeling

of the product. The nutrient values used

to determine the claim when comparing

a single manufacturer’s product to the

labeled product shall be either the

values declared in nutrition labeling or

the actual nutrient values, provided that

the resulting labeling is internally

consistent (i.e., that the values stated in

the nutrition information, the nutrient

values in the accompanying

information, and the declaration of the

percentage of nutrient by which the

product has been modified are

consistent and will not cause consumer

confusion when compared), and that the

actual modification is at least equal to

the percentage specified in the

definition of the claim.

(2) For products bearing relative

claims:

(i) The label or labeling must state the

identity of the reference product and the

percent (or fraction) of the amount of

the nutrient in the reference product by

which the nutrient has been modified,

(e.g., ‘‘50 percent less fat than ‘reference

product’ ’’ or ‘‘1⁄3 fewer calories than

‘reference product’ ’’); and

(ii) This information shall be

immediately adjacent to the most

prominent claim in easily legible

boldface print or type, in distinct

contrast to other printed or graphic

matter, that is no less than that required

by § 381.121(c) for net quantity of

contents, except where the size of the

claim is less than two times the required

size of the net quantity of contents

statement, in which case the referral

statement shall be no less than one-half

the size of the claim, but no smaller

than 1⁄16-inch minimum height, except

as permitted by § 381.500(d)(2).

(iii) The determination of which use

of the claim is in the most prominent

location on the label or labeling will be

made based on the following factors,

considered in order:

(A) A claim on the principal display

panel adjacent to the statement of

identity;

(B) A claim elsewhere on the

principal display panel;

(C) A claim on the information panel;

or

(D) A claim elsewhere on the label or

labeling.

(iv) The label or labeling must also

bear:

(A) Clear and concise quantitative

information comparing the amount of

the subject nutrient in the product per

labeled serving size with that in the

reference product; and

(B) This statement shall appear

adjacent to the most prominent claim or

to the nutrition information.

(3) A relative claim for decreased

levels of a nutrient may not be made on

the label or in labeling of a product if

the nutrient content of the reference

product meets the requirement for a

‘‘low’’ claim for that nutrient.

(k) The term ‘‘modified’’ may be used

in the statement of identity of a product

that bears a relative claim that complies

with the requirements of this part,

followed immediately by the name of

the nutrient whose content has been

altered (e.g., ‘‘modified fat ‘product’ ’’).

This statement of identity must be

immediately followed by the

comparative statement such as

‘‘contains 35 percent less fat than

‘reference product’.’’ The label or

labeling must also bear the information

required by paragraph (j)(2) of this

section in the manner prescribed.

* * * * *

(p)(1) Unless otherwise specified, the

reference amount customarily

consumed set forth in § 381.412(b)

through (e) shall be used in determining

whether a product meets the criteria for

a nutrient content claim. If the serving

size declared on the product label

differs from the reference amount

customarily consumed, and the amount

of the nutrient contained in the labeled

serving does not meet the maximum or

minimum amount criterion in the

definition for the descriptor for that

nutrient, the claim shall be followed by

the criteria for the claim as required by

§ 381.412(f) (e.g., ‘‘very low sodium, 35

mg or less per 55 grams’’).

(2) The criteria for the claim shall be

immediately adjacent to the most

prominent claim in easily legible print

or type and in a size that is no less than

that required by § 381.121(c) for net

quantity of contents, except where the

size of the claim is less than two times

the required size of the net quantity of

contents statement, in which case the

criteria statement shall be no less than

one-half the size of the claim but no

smaller than 1/16-inch minimum

height, except as permitted by

§ 381.500(d)(2).

(q) * * *

(4) The requirements of this section

do not apply to infant formulas and

medical foods, as described in 21 CFR

101.13(q)(4).

* * * * *

22. Section 381.445 is amended by

revising the section reference in

paragraph (c) from ‘‘§ 381.409(g)’’ to

‘‘§ 381.409(f)’’ and by revising paragraph

(a)(2) introductory text, (a)(2)(ii) and

(a)(2)(iii) to read as follows: § 381.445

Guidelines for voluntary nutrition

labeling of single-ingredient, raw

products.

(a) * * *

(2) A retailer may choose to provide

nutrition information at the point-ofpurchase, such as by posting a sign, or

by making the information readily

available in brochures, notebooks, or

leaflet form in close proximity to the

food. The nutrition labeling information

may also be supplemented by a video,

live demonstration, or other media. If a

nutrition claim is made on point-ofpurchase materials all of the

requirements of the mandatory nutrition

labeling program apply. However, if

only nutrition information—and not a

nutrition claim—is supplied on pointof-purchase materials:

(i) * * *
210 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

(ii) The listing of percent of Daily

Value for the nutrients (except vitamins

and minerals specified in

§ 381.409(c)(8)) and footnote required by

§ 381.409(d)(9) may be omitted; and

(iii) The point-of-purchase materials

are not subject to any of the format

requirements.

* * * * *

23. Section 381.454 is revised to read

as follows:

§ 381.454 Nutrient content claims for

‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’

(a) General requirements. Except as

provided in paragraph (e) of this

section, a claim about the level of a

nutrient in a product in relation to the

Reference Daily Intake (RDI) or Daily

Reference Value (DRV), established for

that nutrient (excluding total

carbohydrate) in § 381.409(c), may only

be made on the label or in labeling of

the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 381.413;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 381.409.

(b) ‘‘High’’ claims. (1) The terms

‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source

of’’ may be used on the label or in

labeling of products, except meal-type

products as defined in § 381.413(l),

provided that the product contains 20

percent or more of the RDI or the DRV

per reference amount customarily

consumed.

(2) The terms defined in paragraph

(b)(1) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains a food that

meets the definition of ‘‘high’’ in

paragraph (b)(1) of this section; and

(ii) The label or labeling clearly

identifies the food that is the subject of

the claim (e.g., ‘‘the serving of broccoli

in this meal is high in vitamin C’’).

(c) ‘‘Good Source’’ claims. (1) The

terms ‘‘good source,’’ ‘‘contains,’’ or

‘‘provides’’ may be used on the label or

in labeling of products, except mealtype products as described in

§ 381.413(l), provided that the product

contains 10 to 19 percent of the RDI or

the DRV per reference amount

customarily consumed.

(2) The terms defined in paragraph

(c)(1) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains a food that

meets the definition of ‘‘good source’’ in

paragraph (c)(1) of this section; and

(ii) The label or labeling clearly

identifies the food that is the subject of

the claim (e.g., ‘‘the serving of sweet

potatoes in this meal is a good source of

fiber’’).

(d) Fiber claims. (1) If a nutrient

content claim is made with respect to

the level of dietary fiber, i.e., that the

product is high in fiber, a good source

of fiber, or that the product contains

‘‘more’’ fiber, and the product is not

‘‘low’’ in total fat as defined in

§ 381.462(b)(2) or, in the case of a mealtype product, is not ‘‘low’’ in total fat as

defined in § 381.462(b)(3), then the

labeling shall disclose the level of total

fat per labeled serving size (e.g.,

‘‘contains 12 grams (g) of fat per

serving’’); and

(2) The disclosure shall appear in

immediate proximity to such claim and

be in a type size no less than one-half

the size of the claim.

(e) ‘‘More’’ claims. (1) A relative claim

using the terms ‘‘more’’ and ‘‘added’’

may be used on the label or in labeling

to describe the level of protein,

vitamins, minerals, dietary fiber, or

potassium in a product, except mealtype products as defined in § 381.413(l),

provided that:

(i) The product contains at least 10

percent more of the RDI or the DRV for

protein, vitamins, minerals, dietary

fiber, or potassium (expressed as a

percent of the Daily Value) per reference

amount customarily consumed than an

appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the nutrient is greater relative to the

RDI or DRV are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘contains 10 percent more of

the Daily Value for fiber than ‘reference

product’ ’’); and

(B) Quantitative information

comparing the level of the nutrient in

the product per labeled serving size

with that of the reference product that

it replaces is declared adjacent to the

most prominent claim or to the nutrition

information (e.g., ‘‘fiber content of

‘reference product’ is 1 g per serving;

‘this product’ contains 4 g per serving’’).

(2) A relative claim using the terms

‘‘more’’ and ‘‘added’’ may be used on

the label or in labeling to describe the

level of protein, vitamins, minerals,

dietary fiber, or potassium in meal-type

products as defined in § 381.413(l),

provided that:

(i) The product contains at least 10

percent more of the RDI or the DRV for

protein, vitamins, minerals, dietary

fiber, or potassium (expressed as a

percent of the Daily Value) per 100 g of

product than an appropriate reference

product as described in § 381.413(j)(1);

and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the nutrient is greater relative to the

RDI or DRV are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘contains 10 percent more of

the Daily Value for fiber per 3 ounces

(oz) than does ‘reference product’ ’’),

and

(B) Quantitative information

comparing the level of the nutrient in

the meal-type product per specified

weight with that of the reference

product that it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., ‘‘fiber

content of ‘reference product’ is 2 g per

3 oz; ‘this product’ contains 5 g per 3

oz’’).

24. Section 381.456 is revised to read

as follows:

§ 381.456 Nutrient content claims for

‘‘light’’ or ‘‘lite.’’

(a) General requirements. A claim

using the terms ‘‘light’’ or ‘‘lite’’ to

describe a product may only be made on

the label or in labeling of the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 381.413;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 381.409.

(b) ‘‘Light’’ claims. The terms ‘‘light’’

or ‘‘lite’’ may be used on the label or in

labeling of products, except meal-type

products as defined in § 381.413(l),

without further qualification, provided

that:

(1) If the product derives 50 percent

or more of its calories from fat, its fat

content is reduced by 50 percent or

more per reference amount customarily

consumed compared to an appropriate

reference product as described in

§ 381.413(j)(1); or

(2) If the product derives less than 50

percent of its calories from fat:

(i) The number of calories is reduced

by at least one-third (331⁄3 percent) per

reference amount customarily

consumed compared to an appropriate

reference product as described in

§ 381.413(j)(1); or
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 211

(ii) Its fat content is reduced by 50

percent or more per reference amount

customarily consumed compared to the

appropriate reference product as

described in § 381.413(j)(1); and

(3) As required in § 381.413(j)(2) for

relative claims:

(i) The identity of the reference

product and the percent (or fraction)

that the calories and the fat were

reduced are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘1⁄3 fewer calories and 50

percent less fat than the market leader’’);

and

(ii) Quantitative information

comparing the level of calories and fat

content in the product per labeled

serving size with that of the reference

product that it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., ‘‘lite

‘this product’—200 calories, 4 grams (g)

fat; regular ‘reference product’—300

calories, 8 g fat per serving’’); and

(iii) If the labeled product contains

less than 40 calories or less than 3 g fat

per reference amount customarily

consumed, the percentage reduction for

that nutrient need not be declared.

(4) A ‘‘light’’ claim may not be made

on a product for which the reference

product meets the definition of ‘‘low

fat’’ and ‘‘low calorie.’’

(c)(1)(i) A product for which the

reference product contains 40 calories

or less and 3 g fat or less per reference

amount customarily consumed may use

the terms ‘‘light’’ or ‘‘lite’’ without

further qualification if it is reduced by

50 percent or more in sodium content

compared to the reference product; and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium was reduced are

declared in immediate proximity to the

most prominent such claim (e.g., ‘‘50

percent less sodium than the market

leader’’); and

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference product it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., ‘‘lite

‘this product’—500 milligrams (mg)

sodium per serving; regular ‘reference

product’—1,000 mg sodium per

serving’’).

(2)(i) A product for which the

reference product contains more than 40

calories or more than 3 g fat per

reference amount customarily

consumed may use the terms ‘‘light in

sodium’’ or ‘‘lite in sodium’’ if it is

reduced by 50 percent or more in

sodium content compared to the

reference product, provided that ‘‘light’’

or ‘‘lite’’ is presented in immediate

proximity with ‘‘in sodium’’ and the

entire term is presented in uniform type

size, style, color, and prominence; and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium was reduced are

declared in immediate proximity to the

most prominent such claim (e.g., ‘‘50

percent less sodium than the market

leader’’); and

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference product it replaces is declared

adjacent to the most prominent claim or

to the nutrition information (e.g., or

‘‘lite ‘this product’—170 mg sodium per

serving; regular ‘reference product’—

350 mg per serving’’).

(3) Except for meal-type products as

defined in § 381.413(l), a ‘‘light in

sodium’’ claim may not be made on a

product for which the reference product

meets the definition of ‘‘low in

sodium.’’

(d)(1) The terms ‘‘light’’ or ‘‘lite’’ may

be used on the label or in labeling of a

meal-type product as defined in

§ 381.413(l), provided that:

(i) The product meets the definition

of:

(A) ‘‘Low in calories’’ as defined in

§ 381.460(b)(3); or

(B) ‘‘Low in fat’’ as defined in

§ 381.462(b)(3); and

(ii)(A) A statement appears on the

principal display panel that explains

whether ‘‘light’’ is used to mean ‘‘low

fat,’’ ‘‘low calories,’’ or both (e.g., ‘‘Light

Delight, a low fat meal’’); and

(B) The accompanying statement is no

less than one-half the type size of the

‘‘light’’ or ‘‘lite’’ claim.

(2)(i) The terms ‘‘light in sodium’’ or

‘‘lite in sodium’’ may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that the product meets the

definition of ‘‘low in sodium’’ as

defined in § 381.461(b)(5)(i); and

(ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in sodium’’

are presented in uniform type size,

style, color, and prominence.

(3) The terms ‘‘light’’ or ‘‘lite’’ may be

used in the brand name of a product to

describe the sodium content, provided

that:

(i) The product is reduced by 50

percent or more in sodium content

compared to the reference product;

(ii) A statement specifically stating

that the product is ‘‘light in sodium’’ or

‘‘lite in sodium’’ appears:

(A) Contiguous to the brand name;

and

(B) In uniform type size, style, color,

and prominence as the product name;

and

(iii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium was reduced are

declared in immediate proximity to the

most prominent such claim; and

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference product it replaces is declared

adjacent to the most prominent claim or

to the nutrition information.

(e) Except as provided in paragraphs

(b) through (d) of this section, the terms

‘‘light’’ or ‘‘lite’’ may not be used to refer

to a product that is not reduced in fat

by 50 percent, or, if applicable, in

calories by 1⁄3 or, when properly

qualified, in sodium by 50 percent

unless:

(1) It describes some physical or

organoleptic attribute of the product

such as texture or color and the

information (e.g., ‘‘light in color’’ or

‘‘light in texture’’) so stated, clearly

conveys the nature of the product; and

(2) The attribute (e.g., ‘‘color’’ or

‘‘texture’’) is in the same style, color,

and at least one-half the type size as the

word ‘‘light’’ and in immediate

proximity thereto.

(f) If a manufacturer can demonstrate

that the word ‘‘light’’ has been

associated, through common use, with a

particular product to reflect a physical

or organoleptic attribute to the point

where it has become part of the

statement of identity, such use of the

term ‘‘light’’ shall not be considered a

nutrient content claim subject to the

requirements in this part.

(g) The term ‘‘lightly salted’’ may be

used on a product to which has been

added 50 percent less sodium than is

normally added to the reference product

as described in § 381.413(j)(1)(i)(B) and

(j)(1)(ii)(B), provided that if the product

is not ‘‘low in sodium’’ as defined in

§ 381.461(b)(4), the statement ‘‘not a low

sodium food,’’ shall appear adjacent to

the nutrition information and the

information required to accompany a

relative claim shall appear on the label

or labeling as specified in

§ 381.413(j)(2).

25. Section 381.460 is revised to read

as follows:

§ 381.460 Nutrient content claims for

calorie content.

(a) General requirements. A claim

about the calorie or sugar content of a

product may only be made on the label

or in labeling of the product if:
212 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 381.413;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 381.409.

(b) Calorie content claims. (1) The

terms ‘‘calorie free,’’ ‘‘free of calories,’’

‘‘no calories,’’ ‘‘zero calories,’’ ‘‘without

calories,’’ ‘‘trivial source of calories,’’

‘‘negligible source of calories,’’ or

‘‘dietarily insignificant source of

calories’’ may be used on the label or in

labeling of products, provided that:

(i) The product contains less than 5

calories per reference amount

customarily consumed and per labeled

serving size; and

(ii) If the product meets this condition

without the benefit of special

processing, alteration, formulation, or

reformulation to lower the caloric

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(2) The terms ‘‘low calorie,’’ ‘‘few

calories,’’ ‘‘contains a small amount of

calories,’’ ‘‘low source of calories,’’ or

‘‘low in calories’’ may be used on the

label or in labeling of products, except

meal-type products as defined in

§ 381.413(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 grams (g) or greater than 2

tablespoons (tbsp) and does not provide

more than 40 calories per reference

amount customarily consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and does not

provide more than 40 calories per

reference amount customarily

consumed and per 50 g (for dehydrated

products that must be reconstituted

before typical consumption with water

or a diluent containing an insignificant

amount, as defined in § 381.409(f)(1), of

all nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form).

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the caloric

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(3) The terms defined in paragraph

(b)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains 120 calories

or less per 100 g of product; and

(ii) If the product meets this condition

without the benefit of special

processing, alteration, formulation, or

reformulation to lower the calorie

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which it

attaches.

(4) The terms ‘‘reduced calorie,’’

‘‘reduced in calories,’’ ‘‘calorie

reduced,’’ ‘‘fewer calories,’’ ‘‘lower

calorie,’’ or ‘‘lower in calories’’ may be

used on the label or in labeling of

products, except meal-type products as

defined in § 381.413(l), provided that:

(i) The product contains at least 25

percent fewer calories per reference

amount customarily consumed than an

appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the calories differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., lower calorie ‘product’—‘‘33

1⁄3 percent fewer calories than our

regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of calories in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘calorie content has

been reduced from 150 to 100 calories

per serving’’).

(iii) Claims described in paragraph

(b)(4) of this section may not be made

on the label or in labeling of products

if the reference product meets the

definition for ‘‘low calorie.’’

(5) The terms defined in paragraph

(b)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent fewer calories per 100 g of

product than an appropriate reference

product as described in § 381.413(j)(1);

and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the calories differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘calorie reduced ‘product’,

25% less calories per ounce (oz) (or 3

oz) than our regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of calories in the

product per specified weight with that

of the reference product that it replaces

is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘calorie content has

been reduced from 110 calories per 3 oz

to 80 calories per 3 oz’’).

(iii) Claims described in paragraph

(b)(5) of this section may not be made

on the label or in labeling of products

if the reference product meets the

definition for ‘‘low calorie.’’

(c) Sugar content claims. (1) Terms

such as ‘‘sugar free,’’ ‘‘free of sugar,’’

‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without

sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of

sugar,’’ ‘‘negligible source of sugar,’’ or

‘‘dietarily insignificant source of sugar’’

may reasonably be expected to be

regarded by consumers as terms that

represent that the product contains no

sugars or sweeteners, e.g., ‘‘sugar free,’’

or ‘‘no sugar,’’ as indicating a product

which is low in calories or significantly

reduced in calories. Consequently,

except as provided in paragraph (c)(2) of

this section, a product may not be

labeled with such terms unless:

(i) The product contains less than 0.5

g of sugars, as defined in

§ 381.409(c)(6)(ii), per reference amount

customarily consumed and per labeled

serving size or, in the case of a mealtype product, less than 0.5 g of sugars

per labeled serving size;

(ii) The product contains no

ingredient that is a sugar or that is

generally understood by consumers to

contain sugars unless the listing of the

ingredient in the ingredients statement

is followed by an asterisk that refers to

the statement below the list of

ingredients, which states: ‘‘Adds a

trivial amount of sugar,’’ ‘‘adds a

negligible amount of sugar,’’ or ‘‘adds a

dietarily insignificant amount of sugar;’’

and

(iii)(A) It is labeled ‘‘low calorie’’ or

‘‘reduced calorie’’ or bears a relative

claim of special dietary usefulness

labeled in compliance with paragraphs

(b)(2), (b)(3), (b)(4), or (b)(5) of this

section; or

(B) Such term is immediately

accompanied, each time it is used, by

either the statement ‘‘not a reduced

calorie product,’’ ‘‘not a low calorie

product,’’ or ‘‘not for weight control.’’

(2) The terms ‘‘no added sugar,’’

‘‘without added sugar,’’ or ‘‘no sugar

added’’ may be used only if:

(i) No amount of sugars, as defined in

§ 381.409(c)(6)(ii), or any other

ingredient that contains sugars that

functionally substitute for added sugars

is added during processing or

packaging;
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 213

(ii) The product does not contain an

ingredient containing added sugars such

as jam, jelly, or concentrated fruit juice;

(iii) The sugars content has not been

increased above the amount present in

the ingredients by some means such as

the use of enzymes, except where the

intended functional effect of the process

is not to increase the sugars content of

a product, and a functionally

insignificant increase in sugars results;

(iv) The product that it resembles and

for which it substitutes normally

contains added sugars; and

(v) The product bears a statement that

the product is not ‘‘low calorie’’ or

‘‘calorie reduced’’ (unless the product

meets the requirements for a ‘‘low’’ or

‘‘reduced calorie’’ product) and that

directs consumers’ attention to the

nutrition panel for further information

on sugar and calorie content.

(3) Paragraph (c)(1) of this section

shall not apply to a factual statement

that a product, including products

intended specifically for infants and

children less than 2 years of age, is

unsweetened or contains no added

sweeteners in the case of a product that

contains apparent substantial inherent

sugar content, e.g., juices.

(4) The terms ‘‘reduced sugar,’’

‘‘reduced in sugar,’’ ‘‘sugar reduced,’’

‘‘less sugar,’’ ‘‘lower sugar,’’ or ‘‘lower

in sugar’’ may be used on the label or

in labeling of products, except mealtype products as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent less sugars per reference amount

customarily consumed than an

appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sugars differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘this product contains 25

percent less sugar than our regular

product’’); and

(B) Quantitative information

comparing the level of the sugar in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sugar content has

been lowered from 8 g to 6 g per

serving’’).

(5) The terms defined in paragraph

(c)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent less sugars per 100 g of product

than an appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sugars differ between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced sugar ‘product’—

25% less sugar than our regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of the nutrient in

the product per specified weight with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sugar content has

been reduced from 17 g per 3 oz to 13

g per 3 oz’’).

26. Section 381.461 is revised to read

as follows:

§ 381.461 Nutrient content claims for the

sodium content.

(a) General requirements. A claim

about the level of sodium in a product

may only be made on the label or in

labeling of the product if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 381.413;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 381.409.

(b) Sodium content claims. (1) The

terms ‘‘sodium free,’’ ‘‘free of sodium,’’

‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without

sodium,’’ ‘‘trivial source of sodium,’’

‘‘negligible source of sodium,’’ or

‘‘dietarily insignificant source of

sodium’’ may be used on the label or in

labeling of products, provided that:

(i) The product contains less than 5

milligrams (mg) of sodium per reference

amount customarily consumed and per

labeled serving size or, in the case of a

meal-type product, less than 5 mg of

sodium per labeled serving size;

(ii) The product contains no

ingredient that is sodium chloride or is

generally understood by consumers to

contain sodium unless the listing of the

ingredient in the ingredients statement

is followed by an asterisk that refers to

the statement below the list of

ingredients, which states: ‘‘Adds a

trivial amount of sodium,’’ ‘‘adds a

negligible amount of sodium’’ or ‘‘adds

a dietarily insignificant amount of

sodium;’’ and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(2) The terms ‘‘very low sodium’’ or

‘‘very low in sodium’’ may be used on

the label or in labeling of products,

except meal-type products as defined in

§ 381.413(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 grams (g) or greater than 2

tablespoons (tbsp) and contains 35 mg

or less sodium per reference amount

customarily consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and contains 35

mg or less sodium per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 381.409(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form); and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(5) The terms defined in paragraph

(b)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains 140 mg or

less sodium per 100 g of product; and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the sodium

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(6) The terms ‘‘reduced sodium,’’

‘‘reduced in sodium,’’ ‘‘sodium

reduced,’’ ‘‘less sodium,’’ ‘‘lower

sodium,’’ or ‘‘lower in sodium’’ may be

used on the label or in labeling of

products, except meal-type products as

defined in § 381.413(l), provided that:

(i) The product contains at least 25

percent less sodium per reference

amount customarily consumed than an

appropriate reference product as

described in § 381.413(j)(l); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)
214 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

that the sodium differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced sodium ‘product’,

50 percent less sodium than regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of sodium in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sodium content has

been lowered from 300 to 150 mg per

serving’’).

(iii) Claims described in paragraph

(b)(6) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

sodium.’’

(7) The terms defined in paragraph

(b)(6) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent less sodium per 100 g of

product than an appropriate reference

product as described in § 381.413(j)(l);

and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the sodium differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced sodium

‘product’—30% less sodium per 3 oz

than our ‘regular product’ ’’); and

(B) Quantitative information

comparing the level of sodium in the

product per specified weight with that

of the reference product that it replaces

is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘sodium content has

been reduced from 220 mg per 3 oz to

150 mg per 3 oz’’).

(iii) Claims described in paragraph

(b)(7) of this section may not be made

on the label or in labeling of products

if the nutrient content of the reference

product meets the definition for ‘‘low

sodium.’’

(c) The term ‘‘salt’’ is not synonymous

with ‘‘sodium.’’ Salt refers to sodium

chloride. However, references to salt

content such as ‘‘unsalted,’’ ‘‘no salt,’’

‘‘no salt added’’ are potentially

misleading.

(1) The term ‘‘salt free’’ may be used

on the label or in labeling of products

only if the product is ‘‘sodium free’’ as

defined in paragraph (b)(1) of this

section.

(2) The terms ‘‘unsalted,’’ ‘‘without

added salt,’’ and ‘‘no salt added’’ may be

used on the label or in labeling of

products only if:

(i) No salt is added during processing;

(ii) The product that it resembles and

for which it substitutes is normally

processed with salt; and

(iii) If the product is not sodium free,

the statement ‘‘not a sodium free

product’’ or ‘‘not for control of sodium

in the diet’’ appears adjacent to the

nutrition information of the product

bearing the claim.

(3) Paragraph (c)(2) of this section

shall not apply to a factual statement

that a product intended specifically for

infants and children less than 2 years of

age is unsalted, provided such statement

refers to the taste of the product and is

not false or otherwise misleading.

27. Section 381.462 is revised to read

as follows:

§ 381.462 Nutrient content claims for fat,

fatty acids, and cholesterol content. ′

(a) General requirements. A claim

about the level of fat, fatty acid, and

cholesterol in a product may only be

made on the label or in labeling of

products if:

(1) The claim uses one of the terms

defined in this section in accordance

with the definition for that term;

(2) The claim is made in accordance

with the general requirements for

nutrient content claims in § 381.413;

and

(3) The product for which the claim

is made is labeled in accordance with

§ 381.409.

(b) Fat content claims. (1) The terms

‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ ‘‘zero

fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ ‘‘trivial

source of fat,’’ ‘‘negligible source of fat,’’

or ‘‘dietarily insignificant source of fat’’

may be used on the label or in labeling

of products, provided that:

(i) The product contains less than 0.5

gram (g) of fat per reference amount

customarily consumed and per labeled

serving size or, in the case of a mealtype product, less than 0.5 g of fat per

labeled serving size;

(ii) The product contains no added

ingredient that is a fat or is generally

understood by consumers to contain fat

unless the listing of the ingredient in the

ingredients statement is followed by an

asterisk that refers to the statement

below the list of ingredients, which

states: ‘‘Adds a trivial amount of fat,’’

‘‘adds a negligible amount of fat,’’ or

‘‘adds a dietarily insignificant amount of

fat’’; and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the fat content, it

is labeled to clearly refer to all products

of its type and not merely to the

particular brand to which the label

attaches.

(2) The terms ‘‘low fat,’’ ‘‘low in fat,’’

‘‘contains a small amount of fat,’’ ‘‘low

source of fat,’’ or ‘‘little fat’’ may be used

on the label and in labeling of products,

except meal-type products as defined in

§ 381.413(l), provided that:

(i)(A) The product has a reference

amount customarily consumed greater

than 30 g or greater than 2 tablespoons

(tbsp) and contains 3 g or less of fat per

reference amount customarily

consumed; or

(B) The product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less and contains 3

g or less of fat per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 381.409(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form).

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the fat content, it

is labeled to clearly refer to all products

of its type and not merely to the

particular brand to which the label

attaches.

(3) The terms defined in paragraph

(b)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains 3 g or less of

total fat per 100 g of product and not

more than 30 percent of calories from

fat; and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower the fat content, it

is labeled to clearly refer to all products

of its type and not merely to the

particular brand to which the label

attaches.

(4) The terms ‘‘reduced fat,’’ ‘‘reduced

in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ ‘‘lower

fat,’’ or ‘‘lower in fat’’ may be used on

the label or in labeling of products,

except meal-type products as defined in

§ 381.413(l), provided that:

(i) The product contains at least 25

percent less fat per reference amount

customarily consumed than an

appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the fat differs between the two
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 215

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced fat—50 percent

less fat than our regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of fat in the product

per labeled serving size with that of the

reference product that it replaces is

declared adjacent to the most prominent

claim or to the nutrition information

(e.g., ‘‘fat content has been reduced from

8 g to 4 g per serving’’).

(iii) Claims described in paragraph

(b)(4) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

fat.’’

(5) The terms defined in paragraph

(b)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent less fat per 100 g of product

than an appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the fat differs between the two

products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced fat ‘product’, 33

percent less fat per 3 oz than our regular

‘product’ ’’); and

(B) Quantitative information

comparing the level of fat in the product

per specified weight with that of the

reference product that it replaces is

declared adjacent to the most prominent

such claim or to the nutrition

information (e.g., ‘‘fat content has been

reduced from 8 g per 3 oz to 5 g per 3

oz’’).

(iii) Claims described in paragraph

(b)(5) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

fat.’’

(6) The term ‘‘llllll percent fat

free’’ may be used on the label or in

labeling of products, provided that:

(i) The product meets the criteria for

‘‘low fat’’ in paragraph (b)(2) or (b)(3) of

this section;

(ii) The percent declared and the

words ‘‘fat free’’ are in uniform type

size; and

(iii) A ‘‘100 percent fat free’’ claim

may be made only on products that

meet the criteria for ‘‘fat free’’ in

paragraph (b)(1) of this section, that

contain less than 0.5 g of fat per 100 g,

and that contain no added fat.

(iv) A synonym for ‘‘lll percent fat

free’’ is ‘‘lll percent lean.’’

(c) Fatty acid content claims. (1) The

terms ‘‘saturated fat free,’’ ‘‘free of

saturated fat,’’ ‘‘no saturated fat,’’ ‘‘zero

saturated fat,’’ ‘‘without saturated fat,’’

‘‘trivial source of saturated fat,’’

‘‘negligible source of saturated fat,’’ or

‘‘dietarily insignificant source of

saturated fat’’ may be used on the label

or in labeling of products, provided that:

(i) The product contains less than 0.5

g of saturated fat and less than 0.5 g

trans fatty acids per reference amount

customarily consumed and per labeled

serving size or, in the case of a mealtype product, less than 0.5 g of saturated

fat and less than 0.5 g trans fatty acids

per labeled serving size;

(ii) The product contains no

ingredient that is generally understood

by consumers to contain saturated fat

unless the listing of the ingredient in the

ingredients statement is followed by an

asterisk that refers to the statement

below the list of ingredients, which

states: ‘‘Adds a trivial amount of

saturated fat,’’ ‘‘adds a negligible

amount of saturated fat,’’ or ‘‘adds a

dietarily insignificant amount of

saturated fat;’’ and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower saturated fat

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(2) The terms ‘‘low in saturated fat,’’

‘‘low saturated fat,’’ ‘‘contains a small

amount of saturated fat,’’ ‘‘low source of

saturated fat,’’ or ‘‘a little saturated fat’’

may be used on the label or in labeling

of products, except meal-type products

as defined in § 381.413(l), provided that:

(i) The product contains 1 g or less of

saturated fat per reference amount

customarily consumed and not more

than 15 percent of calories from

saturated fat; and

(ii) If the product meets these

conditions without benefit of special

processing, alteration, formulation, or

reformulation to lower saturated fat

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(3) The terms defined in paragraph

(c)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains 1 g or less of

saturated fat per 100 g and less than 10

percent calories from saturated fat; and

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower saturated fat

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(4) The terms ‘‘reduced saturated fat,’’

‘‘reduced in saturated fat,’’ ‘‘saturated

fat reduced,’’ ‘‘less saturated fat,’’

‘‘lower saturated fat,’’ or ‘‘lower in

saturated fat’’ may be used on the label

or in labeling of products, except mealtype products as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent less saturated fat per reference

amount customarily consumed than an

appropriate reference product as

described in § 381.413(j)(1); and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the saturated fat differs between the

two products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced saturated fat

‘product’, contains 50 percent less

saturated fat than the national average

for ‘product’ ’’); and

(B) Quantitative information

comparing the level of saturated fat in

the product per labeled serving size

with that of the reference product that

it replaces is declared adjacent to the

most prominent claim or to the nutrition

information (e.g., ‘‘saturated fat reduced

from 3 g to 1.5 g per serving’’).

(iii) Claims described in paragraph

(c)(4) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

saturated fat.’’

(5) The terms defined in paragraph

(c)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains at least 25

percent less saturated fat per 100 g of

product than an appropriate reference

product as described in § 381.413(j)(1);

and

(ii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the saturated fat differs between the

two products are declared in immediate

proximity to the most prominent such

claim (e.g., ‘‘reduced saturated fat

‘product’, 50 percent less saturated fat

than our regular ‘product’ ’’); and

(B) Quantitative information

comparing the level of saturated fat in

the product per specified weight with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘saturated fat content
216 Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations

has been reduced from 2.5 g per 3 oz to

1.5 g per 3 oz’’).

(iii) Claims described in paragraph

(c)(5) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

saturated fat.’’

(d) Cholesterol content claims. (1) The

terms ‘‘cholesterol free,’’ ‘‘free of

cholesterol,’’ ‘‘zero cholesterol,’’

‘‘without cholesterol,’’ ‘‘no cholesterol,’’

‘‘trivial source of cholesterol,’’

‘‘negligible source of cholesterol,’’ or

‘‘dietarily insignificant source of

cholesterol’’ may be used on the label or

in labeling of products, provided that:

(i) The product contains less than 2

milligrams (mg) of cholesterol per

reference amount customarily

consumed and per labeled serving size

or, in the case of a meal-type product as

defined in § 381.413(l), less than 2 mg

of cholesterol per labeled serving size;

(ii) The product contains no

ingredient that is generally understood

by consumers to contain cholesterol,

unless the listing of the ingredient in the

ingredients statement is followed by an

asterisk that refers to the statement

below the list of ingredients, which

states: ‘‘Adds a trivial amount of

cholesterol,’’ ‘‘adds a negligible amount

of cholesterol,’’ or ‘‘adds a dietarily

insignificant amount of cholesterol’’;

(iii) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed or, in the case of

a meal-type product as defined in

§ 381.413(l), 2 g or less of saturated fat

per labeled serving size; and

(iv) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower cholesterol

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which it

attaches; or

(v) If the product meets these

conditions only as a result of special

processing, alteration, formulation, or

reformulation, the amount of cholesterol

is reduced by 25 percent or more from

the reference product it replaces as

described in § 381.413(j)(1) and for

which it substitutes as described in

§ 381.413(d) that has a significant (e.g.,

5 percent or more of a national or

regional market) market share. As

required in § 381.413(j)(2) for relative

claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol was reduced are

declared in immediate proximity to the

most prominent such claim (e.g.,

‘‘cholesterol free ‘product’, contains 100

percent less cholesterol than ‘reference

product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘contains no

cholesterol compared with 30 mg in one

serving of ‘reference product’ ’’).

(2) The terms ‘‘low in cholesterol,’’

‘‘low cholesterol,’’ ‘‘contains a small

amount of cholesterol,’’ ‘‘low source of

cholesterol,’’ or ‘‘little cholesterol’’ may

be used on the label or in labeling of

products, except meal-type products as

defined in § 381.413(l), provided that:

(i)(A) If the product has a reference

amount customarily consumed greater

than 30 g or greater than 2 tbsp:

(1) The product contains 20 mg or less

of cholesterol per reference amount

customarily consumed; and

(2) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed; or

(B) If the product has a reference

amount customarily consumed of 30 g

or less or 2 tbsp or less:

(1) The product contains 20 mg or less

of cholesterol per reference amount

customarily consumed and per 50 g (for

dehydrated products that must be

reconstituted before typical

consumption with water or a diluent

containing an insignificant amount, as

defined in § 381.409(f)(1), of all

nutrients per reference amount

customarily consumed, the per-50-g

criterion refers to the ‘‘as prepared’’

form); and

(2) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed.

(ii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower cholesterol

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches; or

(iii) If the product contains 20 mg or

less of cholesterol only as a result of

special processing, alteration,

formulation, or reformulation, the

amount of cholesterol is reduced by 25

percent or more from the reference

product it replaces as described in

§ 381.413(j)(1) and for which it

substitutes as described in § 381.413(d)

that has a significant (e.g., 5 percent or

more of a national or regional market)

market share. As required in

§ 381.413(j)(2) for relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol has been reduced

are declared in immediate proximity to

the most prominent such claim (e.g.,

‘‘low cholesterol ‘product’, contains 85

percent less cholesterol than our regular

‘product’’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘cholesterol lowered

from 30 mg to 5 mg per serving’’).

(3) The terms defined in paragraph

(d)(2) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product contains 20 mg or less

of cholesterol per 100 g of product;

(ii) The product contains 2 g or less

of saturated fat per 100 g of product; and

(iii) If the product meets these

conditions without the benefit of special

processing, alteration, formulation, or

reformulation to lower cholesterol

content, it is labeled to clearly refer to

all products of its type and not merely

to the particular brand to which the

label attaches.

(4) The terms ‘‘reduced cholesterol,’’

‘‘reduced in cholesterol,’’ ‘‘cholesterol

reduced,’’ ‘‘less cholesterol,’’ ‘‘lower

cholesterol,’’ or ‘‘lower in cholesterol’’

may be used on the label or in labeling

of products or products that substitute

for those products as specified in

§ 381.413(d), excluding meal-type

products as defined in § 381.413(l),

provided that:

(i) The product has been specifically

formulated, altered, or processed to

reduce its cholesterol by 25 percent or

more from the reference product it

replaces as described in § 381.413(j)(1)

and for which it substitutes as described

in § 381.413(d) that has a significant

(e.g., 5 percent or more of a national or

regional market) market share;

(ii) The product contains 2 g or less

of saturated fat per reference amount

customarily consumed; and

(iii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol has been reduced

are declared in immediate proximity to

the most prominent such claim (e.g.,

‘‘25 percent less cholesterol than

‘reference product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per labeled serving size with

that of the reference product that it

replaces is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘cholesterol lowered

from 55 mg to 30 mg per serving’’).
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules and Regulations 217

(iv) Claims described in paragraph

(d)(4) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

cholesterol.’’

(5) The terms defined in paragraph

(d)(4) of this section may be used on the

label or in labeling of a meal-type

product as defined in § 381.413(l),

provided that:

(i) The product has been specifically

formulated, altered, or processed to

reduce its cholesterol by 25 percent or

more from the reference product it

replaces as described in § 381.413(j)(1)

and for which it substitutes as described

in § 381.413(d) that has a significant

(e.g., 5 percent or more of a national or

regional market) market share;

(ii) The product contains 2 g or less

of saturated fat per 100 g of product; and

(iii) As required in § 381.413(j)(2) for

relative claims:

(A) The identity of the reference

product and the percent (or fraction)

that the cholesterol has been reduced

are declared in immediate proximity to

the most prominent such claim (e.g.,

‘‘25% less cholesterol than ‘reference

product’ ’’); and

(B) Quantitative information

comparing the level of cholesterol in the

product per specified weight with that

of the reference product that it replaces

is declared adjacent to the most

prominent claim or to the nutrition

information (e.g., ‘‘cholesterol content

has been reduced from 35 mg per 3 oz

to 25 mg per 3 oz).

(iv) Claims described in paragraph

(d)(5) of this section may not be made

on the label or in labeling of a product

if the nutrient content of the reference

product meets the definition for ‘‘low

cholesterol.’’

(e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims.

(1) The term ‘‘lean’’ may be used on the

label or in labeling of a product,

provided that the product contains less

than 10 g of fat, 4.5 g or less of saturated

fat, and less than 95 mg of cholesterol

per 100 g of product and per reference

amount customarily consumed for

individual foods, and per 100 g of

product and per labeled serving size for

meal-type products as defined in

§ 381.413(l).

(2) The term ‘‘extra lean’’ may be used

on the label or in labeling of a product,

provided that the product contains less

than 5 g of fat, less than 2 g of saturated

fat, and less than 95 mg of cholesterol

per 100 g of product and per reference

amount customarily consumed for

individual foods, and per 100 g of

product and per labeled serving size for

meal-type products as defined in

§ 381.413(l).

28. Section 381.463 is amended by

revising the section reference in

paragraphs (b)(2) and (b)(3) from

‘‘§ 381.409(g)(1)’’ to ‘‘§ 381.409(f)(1).’’

29. Section 381.469 is amended by

removing the word ‘‘rule’’ from the third

sentence of paragraph (m)(5).

30. Section 381.480 is amended by

revising paragraphs (e) and (f) to read as

follows:

§ 381.480 Label statements relating to

usefulness in reducing or maintaining body

weight.

* * * * *

(e) ‘‘Label terms suggesting usefulness

as low calorie or reduced calorie foods’’.

(1) Except as provided in paragraphs

(e)(2) and (e)(3) of this section, a

product may be labeled with terms such

as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially

sweetened,’’ or ‘‘sweetened with

nonnutritive sweetener’’ only if the

claim is not false or misleading, and the

product is labeled ‘‘low calorie’’ or

‘‘reduced calorie’’ or bears another

comparative calorie claim in

compliance with the applicable

provisions in this subpart.

(2) Paragraph (e)(1) of this section

shall not apply to any use of such terms

that is specifically authorized by

regulation governing a particular food,

or, unless otherwise restricted by

regulation, to any use of the term ‘‘diet’’

that clearly shows that the product is

offered solely for a dietary use other

than regulating body weight, e.g., ‘‘for

low sodium diets.’’

(3) Paragraph (e)(1) of this section

shall not apply to any use of such terms

on a formulated meal replacement or

other product that is represented to be

of special dietary use as a whole meal,

pending the issuance of a regulation

governing the use of such terms on

foods.

(f) ‘‘Sugar free’’ and ‘‘no added sugar’’.

Criteria for the use of the terms ‘‘sugar

free’’ and ‘‘no added sugar’’ are

provided for in § 381.460(c).

31. Section 381.500 is amended by

removing the word ‘‘food’’ after the

word ‘‘poultry’’ in paragraph (a)

introductory text; by revising the words

‘‘Products produced’’ in paragraph (a)(1)

introductory text to the words ‘‘Food

products produced’’; by revising the

section reference in paragraph (c)(2)(iii)

from ‘‘§ 381.409(e)’’ to

‘‘§ 381.409(d)(6)’’; and by revising the

words ‘‘at 21 CFR 101.9(d)(9)’’ in

paragraph (c)(2)(v) to the words ‘‘in

§ 381.409(d)(9)’’.

Done at Washington, DC, on December 22,

1994.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 94–32105 Filed 12–30–94; 8:45 am]

BILLING CODE 3410–DM–P