Nutrition Labeling of Meat and Poultry Products; Codification

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

Secs. 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 cross-referenced 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 [[Page 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.

[[Page 176]] 2. Section 317.300 is amended by revising the section

heading, paragraph (a) and the first sentence of paragraph (b) to read

as follows:

Sec. 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

Sec. 317.309; except as exempted under Sec. 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

Secs. 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:

Sec. 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 weight-maintenance

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

Sec. 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 ______

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 Sec. 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 single-ingredient, raw products may be declared on the basis of

the product ``as consumed'' as set forth in Sec. 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 Sec. 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 Sec. 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 Sec. 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 [[Page 177]] make the Reference Amount for the

combined product determined in Sec. 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, 1\1/3\, 1\1/2\, 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

Sec. 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 single-serving 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 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 [[Page 178]] 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

Sec. 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

Sec. 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 multi-serving 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 [[Page 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 Sec. 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 Sec. 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 [[Page 180]] 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

Sec. 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 [[Page 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 ______ (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

beta-carotene 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 Sec. 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 [[Page 182]] 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 Sec. 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 ................. 300 g........... 375 g

carbohydrate.

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 [[Page 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

[GRAPHIC][TIFF OMITTED]TR03JA95.000

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 [[Page 184]] (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 Sec. 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 Sec. 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 Sec. 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

[[Page 185]]

[GRAPHIC][TIFF OMITTED]TR03JA95.001

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 [[Page 186]] 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

________.'' 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

Sec. 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 Sec. 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:

Sec. 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

[[Page 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 Sec. 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:

Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Secs. 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

Sec. 317.400(d)(2).

(h) [Reserved]

(i) Except as provided in Sec. 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

Sec. 317.2(h) for the net quantity of contents, except where the size

of the claim is less than two times [[Page 188]] 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

Sec. 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 Sec. 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 Sec. 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

Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 ``Sec. 317.309(g)'' to ``Sec. 317.309(f)'' and

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

(a)(2)(iii) to read as follows: [[Page 189]]

Sec. 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-of-purchase, 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-of-purchase 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 point-of-purchase materials:

(i) * * *

(ii) The listing of percent of Daily Value for the nutrients

(except vitamins and minerals specified in Sec. 317.309(c)(8)) and

footnote required by Sec. 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:

Sec. 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

Sec. 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 Sec. 317.313; and

(3) The product for which the claim is made is labeled in

accordance with Sec. 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 Sec. 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

Sec. 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 meal-type products as described in Sec. 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

Sec. 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

Sec. 317.362(b)(2) or, in the case of a meal-type product, is not

``low'' in total fat as defined in Sec. 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 meal-type products as defined in Sec. 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 Sec. 317.313(j)(1); and

(ii) As required in Sec. 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 Sec. 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 Sec. 317.313(j)(1);

and

(ii) As required in Sec. 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:

Sec. 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 Sec. 317.313; and

(3) The product for which the claim is made is labeled in

accordance with Sec. 317.309.

(b) ``Light'' claims. The terms ``light'' or ``lite'' may be used

on the label or in [[Page 190]] labeling of products, except meal-type

products as defined in Sec. 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 Sec. 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 (33\1/

3\ percent) per reference amount customarily consumed compared to an

appropriate reference product as described in Sec. 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 Sec. 317.313(j)(1); and

(3) As required in Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 317.313(l),

provided that:

(i) The product meets the definition of:

(A) ``Low in calories'' as defined in Sec. 317.360(b)(3); or

(B) ``Low in fat'' as defined in Sec. 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

Sec. 317.313(l), provided that the product meets the definition of

``low in sodium'' as defined in Sec. 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 Sec. 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 [[Page 191]] as described in Sec. 317.313(j)(1)(i)(B)

and (j)(1)(ii)(B), provided that if the product is not ``low in

sodium'' as defined in Sec. 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 Sec. 317.313(j)(2).

11. Section 317.360 is revised to read as follows:

Sec. 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 Sec. 317.313; and

(3) The product for which the claim is made is labeled in

accordance with Sec. 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 Sec. 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

Sec. 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

Sec. 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 Sec. 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 Sec. 317.313(j)(1); and

(ii) As required in Sec. 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'--``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

Sec. 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

Sec. 317.313(j)(1); and

(ii) As required in Sec. 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

Sec. 317.309(c)(6)(ii), per reference amount customarily consumed and

per labeled serving size or, in the case of a meal-type 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

[[Page 192]] 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 Sec. 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 meal-type

products as defined in Sec. 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 Sec. 317.313(j)(1); and

(ii) As required in Sec. 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

Sec. 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

Sec. 317.313(j)(1); and

(ii) As required in Sec. 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:

Sec. 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 Sec. 317.313; and

(3) The product for which the claim is made is labeled in

accordance with Sec. 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 Sec. 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

Sec. 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

Sec. 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 [[Page 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 Sec. 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

Sec. 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

Sec. 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 Sec. 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 Sec. 317.313(j)(1); and

(ii) As required in Sec. 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

Sec. 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

Sec. 317.313(j)(1); and

(ii) As required in Sec. 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:

Sec. 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 Sec. 317.313; and

(3) The product for which the claim is made is labeled in

accordance with Sec. 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 meal-type 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 [[Page 194]] 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 Sec. 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

Sec. 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

Sec. 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 Sec. 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 Sec. 317.313(j)(1); and

(ii) As required in Sec. 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

Sec. 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

Sec. 317.313(j)(1); and

(ii) As required in Sec. 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 ``______ 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 ``______ percent fat free'' is ``______ 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 meal-type 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

Sec. 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

Sec. 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 [[Page 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 meal-type products as defined in

Sec. 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 Sec. 317.313(j)(1); and

(ii) As required in Sec. 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

Sec. 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

Sec. 317.313(j)(1); and

(ii) As required in Sec. 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 Sec. 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 Sec. 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 Sec. 317.313(j)(1) and

for which it substitutes as described in Sec. 317.313(d) that has a

significant (e.g., 5 percent or more of a national or regional market)

market share. As required in Sec. 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

Sec. 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

Sec. 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

Sec. 317.313(j)(1) and for which it substitutes as described in

Sec. 317.313(d) that has a significant (e.g., 5 percent or more of a

national or regional market) market share. As required in

Sec. 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 [[Page 196]] 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

Sec. 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

Sec. 317.313(d), excluding meal-type products as defined in

Sec. 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 Sec. 317.313(j)(1) and

for which it substitutes as described in Sec. 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 Sec. 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

Sec. 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 Sec. 317.313(j)(1) and

for which it substitutes as described in Sec. 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 Sec. 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 Sec. 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 Sec. 317.313(l).

Sec. 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

``Sec. 317.309(g)(1)'' to ``Sec. 317.309(f)(1).''

Sec. 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:

Sec. 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

Sec. 317.360(c).

Sec. 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 [[Page 197]] paragraph

(c)(2)(iii) from ``Sec. 317.309(e)'' to ``Sec. 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 Sec. 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.

Sec. 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 ``Sec. 381.409(b)'' to

``Sec. 381.409(c)'' and revising paragraphs (a) through (g) to read as

follows:

Sec. 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 weight-maintenance

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

Sec. 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 ______

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 Sec. 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 single-ingredient, raw products may be declared on the basis of

the product ``as consumed'' as set forth in Sec. 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 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., 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

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