[Federal Register Volume 60, Number 1 (Tuesday, January 3, 1995)]
[Rules and Regulations]
[Pages 174-217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32105]




[[Page 173]]

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Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Parts 317 and 381



Nutrition Labeling of Meat and Poultry Products; Final Rule

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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 94-029F]


Nutrition Labeling of Meat and Poultry Products; Codification

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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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 ingredients 
used to make the Reference Amount for the combined product as 
determined in Sec. 381.412(c).
    (vii) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving 
containers), the serving size shall be 1 unit.
    (5) For products in large discrete units that are usually divided 
for consumption (e.g., pizza, pan of poultry lasagna), for unprepared 
products where the entire contents of the package is used to prepare 
large discrete units that are usually divided for consumption (e.g., 
pizza kit), and for products which consist of two or more foods 
packaged and presented to be consumed together where the ingredient 
represented as the main ingredient is a large discrete unit usually 
divided for consumption, the serving size shall be the fractional slice 
of the ready-to-eat product (e.g., \1/8\ quiche, \1/4\ pizza) that most 
closely approximates the Reference Amount for the product category. The 
serving size may be the fraction of the package used to make the 
Reference Amount for the unprepared product determined in 
Sec. 381.412(d) or the fraction of the large discrete unit represented 
as the main ingredient plus proportioned minor ingredients used to make 
the Reference Amount of the combined product determined in 
Sec. 381.412(c). In expressing the fractional slice, manufacturers 
shall use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller fractions that 
can be generated by further division by 2 or 3.
    (6) For nondiscrete bulk products (e.g., whole turkey, turkey 
breast, ground poultry), and for products which consist of two or more 
foods packaged and presented to be consumed together where the 
ingredient represented as the main ingredient is a bulk product (e.g., 
turkey breast and gravy), the serving size shall be the amount in 
household measure that most closely approximates the Reference Amount 
for the product category and may be the amount of the bulk product 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product determined 
in Sec. 381.412(c).
    (7) For labeling purposes, the term ``common household measure'' or 
``common household unit'' means cup, tablespoon, teaspoon, piece, 
slice, fraction (e.g., \1/4\ pizza), ounce (oz), or other common 
household equipment used to package food products (e.g., jar 
[[Page 198]] 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., wing, 
slice, link, or patty).
    (v) For unprepared products where the entire contents of the 
package is used to prepare large discrete units that are usually 
divided for consumption (e.g., pizza kit), the fraction or portion of 
the package may be used.
    (vi) For products that consist of two or more distinct ingredients 
or components packaged and presented to be consumed together (e.g., 
chicken wings with a glaze packet), the nutrition information may be 
declared for each component or as a composite. The serving size may be 
provided in accordance with the provisions of paragraphs (b)(4), 
(b)(5), and (b)(6) of this section.
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 
oz in weight means 28 grams (g).
    (viii) When a serving size, determined from the Reference Amount in 
Sec. 381.412(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving size up to the next incremental 
size.
    (8) A product that is packaged and sold individually and that 
contains less than 200 percent of the applicable Reference Amount shall 
be considered to be a single-serving container, and the entire content 
of the product shall be labeled as one serving, except for products 
that have Reference Amounts of 100 g (or mL) or larger, manufacturers 
may decide whether a package that contains more than 150 percent but 
less than 200 percent of the Reference Amount is 1 or 2 servings. 
Packages sold individually that contain 200 percent or more of the 
applicable Reference Amount may be labeled as a 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 chicken roll. The 
ounce quantity equivalent to the metric quantity should be expressed in 
0.1-oz increments.
    (iv) If a manufacturer elects to use abbreviations for units, the 
following abbreviations shall be used: tbsp for tablespoon, tsp for 
teaspoon, g for gram, mL for milliliter, and oz for ounce.
    (10) Determination of the number of servings per container shall be 
based on the serving size of the product determined by following the 
procedures described in this section.
    (i) The number of servings shall be rounded to the nearest whole 
number except for the number of servings between 2 and 5 servings and 
random weight products. The number of servings between 2 and 5 servings 
shall be rounded to the nearest 0.5 serving. Rounding should be 
indicated by the use of the term ``about'' (e.g., about 2 servings; 
about 3.5 servings).
    (ii) When the serving size is required to be expressed on a drained 
solids basis and the number of servings varies because of a natural 
variation in unit size, the manufacturer may state the typical number 
of servings per container (e.g., usually 5 servings).
    (iii) For random weight products, a manufacturer may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the Reference Amount expressed in 
ounces. The manufacturer may provide the typical number of servings in 
parenthesis following the ``varied'' statement (e.g., varied 
(approximately 8 servings per pound)).
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving 
containers), the number of servings shall be the number of individual 
packages within the total package.
    (v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by 
multiplying the number of individual multi-serving units in the total 
package by the number of servings in each individual unit.
    (11) The declaration of nutrient and food component content shall 
be on the basis of product as packaged or purchased with the exception 
of products that are packed or canned in water, brine, or oil but whose 
liquid packing medium is not customarily consumed. Declaration of the 
nutrient and food component content of products that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (12) Serving size for meal-type products as defined in 
Sec. 381.413(l) shall [[Page 199]] be the entire content (edible 
portion only) of the package.
    (13) Another column of figures may be used to declare the nutrient 
and food component information in the same format as required by 
Sec. 381.409(e),
    (i) Per 100 grams, 100 milliliters, or 1 ounce of the product as 
packaged or purchased.
    (ii) Per one unit if the serving size of a product in discrete 
units in a multi-serving container is more than one unit.
    (14) If a product consists of assortments of poultry products 
(e.g., variety packs) in the same package, nutrient content shall be 
expressed on the entire package contents or on each individual product.
    (15) If a product is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare the nutrient contents on the basis of the product as 
consumed for the product alone (e.g., a cream soup mix may be labeled 
with one set of Daily Values for the dry mix (per serving), and another 
set for the serving of the final soup when prepared (e.g., per serving 
of cream soup mix and 1 cup of vitamin D fortified whole milk)): 
Provided, that the type and quantity of the other ingredients to be 
added to the product by the user and the specific method of cooking and 
other preparation shall be specified prominently on the label.
    (c) The declaration of nutrition information on the label or in 
labeling of a poultry product shall contain information about the level 
of the following nutrients, except for those nutrients whose inclusion, 
and the declaration of amounts, is voluntary as set forth in this 
paragraph. No nutrients or food components other than those listed in 
this paragraph as either mandatory or voluntary may be included within 
the nutrition label. Except as provided for in paragraph (f) or (g) of 
this section, nutrient information shall be presented using the 
nutrient names specified and in the following order in the formats 
specified in paragraph (d) or (e) of this section.
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero. Energy content per serving may also be 
expressed in kilojoule units, added in parenthesis immediately 
following the statement of the caloric content.
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,'' 
by A. L. Merrill and B. K. Watt, United States Department of 
Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised 
February 1973), which is incorporated by reference. Table 13 of the 
``Energy Value of Foods--Basis and Derivation,'' Agriculture Handbook 
No. 74 is incorporated as it exists on the date of approval. This 
incorporation by reference was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is 
available for inspection at the Office of the Federal Register, suite 
700, 800 North Capitol Street, NW., Washington, DC, or at the office of 
the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence 
Avenue, SW., Washington, DC. Copies of the incorporation by reference 
are available from the Product Assessment Division, Regulatory 
Programs, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Room 329, West End Court Building, Washington, DC 20250-
3700;
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), 
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture 
Handbook No. 74 is incorporated as it exists on the date of approval. 
This incorporation by reference was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
(The availability of this incorporation by reference is given in 
paragraph (c)(1)(i)(A) of this section.);
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA's Agriculture 
Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. (The availability of this incorporation by reference is given 
in paragraph (c)(1)(i)(A) of this section.); or
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of 21 CFR, or by other means, as 
appropriate.
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section 
per serving, expressed to the nearest 5-calorie increment, up to and 
including 50 calories, and the nearest 10-calorie increment above 50 
calories, except that label declaration of ``calories from fat'' is not 
required on products that contain less than 0.5 gram of fat per serving 
and amounts less than 5 calories may be expressed as zero. This 
statement shall be declared as provided in paragraph (d)(5) of this 
section.
    (iii) ``Calories from saturated fat'' or ``Calories from 
saturated'' (VOLUNTARY): A statement of the caloric content derived 
from saturated fat as defined in paragraph (c)(2)(i) of this section 
per serving may be declared voluntarily, expressed to the nearest 5-
calorie increment, up to and including 50 calories, and the nearest 10-
calorie increment above 50 calories, except that amounts less than 5 
calories may be expressed as zero. This statement shall be indented 
under the statement of calories from fat as provided in paragraph 
(d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat per serving defined as total lipid fatty acids and 
expressed as triglycerides. Amounts shall be expressed to the nearest 
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, 
the content shall be expressed as zero.
    (i) ``Saturated fat'' or ``Saturated'': A statement of the number 
of grams of saturated fat per serving defined as the sum of all fatty 
acids containing no double bonds, except that label declaration of 
saturated fat content information is not required for products that 
contain less than 0.5 gram of total fat per serving if no claims are 
made about fat or cholesterol content, and if ``calories from saturated 
fat'' is not declared. Saturated fat content shall be indented and 
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram 
increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of 
grams of stearic acid per serving may be declared voluntarily, except 
that when a claim is made about stearic acid, label declaration shall 
be required. Stearic acid content shall be indented under saturated fat 
and expressed to the [[Page 200]] 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. 381.462(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest 
gram increment above 5 grams. If the serving contains less than 0.5 
gram, the content shall be expressed as zero.
    (iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat per serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily, 
except that when polyunsaturated fat is declared, or when a claim about 
fatty acids or cholesterol is made on the label or in labeling of a 
product other than one that meets the criteria in Sec. 381.462(b)(1) 
for a claim for ``fat free,'' label declaration of monounsaturated fat 
is required. Monounsaturated fat content shall be indented and 
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram 
increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content per 
serving expressed in milligrams to the nearest 5-milligram increment, 
except that label declaration of cholesterol information is not 
required for products that contain less than 2 milligrams of 
cholesterol per serving and make no claim about fat, fatty acids, or 
cholesterol content, or such products may state the cholesterol content 
as zero. If the product contains 2 to 5 milligrams of cholesterol per 
serving, the content may be stated as ``less than 5 milligrams.''
    (4) ``Sodium'': A statement of the number of milligrams of sodium 
per serving expressed as zero when the serving contains less than 5 
milligrams of sodium, to the nearest 5-milligram increment when the 
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140 
milligrams.
    (5) ``Potassium'' (VOLUNTARY): A statement of the number of 
milligrams of potassium per serving may be declared voluntarily, except 
that when a claim is made about potassium content, label declaration 
shall be required. Potassium content shall be expressed as zero when 
the serving contains less than 5 milligrams of potassium, to the 
nearest 5-milligram increment when the serving contains 5 to 140 
milligrams of potassium, and to the nearest 10-milligram increment when 
the serving contains greater than 140 milligrams.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate per serving expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, or, if the serving contains less than 0.5 
gram, the content may be expressed as zero. Total carbohydrate content 
shall be calculated by subtraction of the sum of the crude protein, 
total fat, moisture, and ash from the total weight of the product. This 
calculation method is described in USDA's Agriculture Handbook No. 74 
(Slightly revised February 1973), pages 2 and 3, which is incorporated 
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is 
incorporated as it exists on the date of approval. This incorporation 
by reference was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of 
this incorporation by reference is given in paragraph (c)(1)(i)(A) of 
this section.).
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber per serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required, or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be 
expressed as zero.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber content shall 
be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the 
content may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber per serving may be declared 
voluntarily except when a claim is made on the label or in labeling 
about insoluble fiber, label declaration shall be required. Insoluble 
fiber content shall be indented under dietary fiber and expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, and if the serving contains less than 0.5 
gram, the content may be expressed as zero.
    (ii) ``Sugars'': A statement of the number of grams of sugars per 
serving, except that label declaration of sugars content is not 
required for products that contain less than 1 gram of sugars per 
serving if no claims are made about sweeteners, sugars, or sugar 
alcohol content. Sugars shall be defined as the sum of all free mono- 
and disaccharides (such as glucose, fructose, lactose, and sucrose). 
Sugars content shall be indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the 
content may be expressed as zero.
    (iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols per serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or sugars when sugar alcohols are present in the 
product, sugar alcohol content shall be declared. For nutrition 
labeling purposes, sugar alcohols are defined as the sum of saccharide 
derivatives in which a hydroxyl group replaces a ketone or aldehyde 
group and whose use in the food is listed by FDA (e.g., mannitol or 
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu 
of the term ``sugar alcohol,'' the name of the specific sugar alcohol 
(e.g., ``xylitol'') present in the product may be used in the nutrition 
label, provided that only one sugar alcohol is present in the product. 
Sugar alcohol content shall be indented and expressed to the nearest 
gram, except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the 
content may be expressed as zero. [[Page 201]] 
    (iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number 
of grams of other carbohydrate per serving may be declared voluntarily. 
Other carbohydrate shall be defined as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared (even if present), it 
shall be defined as the difference between total carbohydrate and the 
sum of dietary fiber and sugars. Other carbohydrate content shall be 
indented and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.
    (7) ``Protein'': A statement of the number of grams of protein per 
serving expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero. When the protein in products represented or purported to be for 
adults and children 4 or more years of age has a protein quality value 
that is a protein digestibility-corrected amino acid score of less than 
20 expressed as a percent, or when the protein in a product represented 
or purported to be for children greater than 1 but less than 4 years of 
age has a protein quality value that is a protein digestibility-
corrected amino acid score of less than 40 expressed as a percent, 
either of the following shall be placed adjacent to the declaration of 
protein content by weight: The statement ``not a significant source of 
protein,'' or a listing aligned under the column headed ``Percent Daily 
Value'' of the corrected amount of protein per serving, as determined 
in paragraph (c)(7)(ii) of this section, calculated as a percentage of 
the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as 
appropriate, for protein and expressed as percent of Daily Value. When 
the protein quality in a product as measured by the Protein Efficiency 
Ratio (PER) is less than 40 percent of the reference standard (casein) 
for a product represented or purported to be for infants, the statement 
``not a significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on 
the basis of the factor of 6.25 times the nitrogen content of the food 
as determined by appropriate methods of analysis in accordance with 
Sec. 381.409(h), except when the procedure for a specific food requires 
another factor.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be for infants or 
children under 4 years of age. When such a declaration is provided, it 
shall be placed on the label adjacent to the statement of grams of 
protein and aligned under the column headed ``Percent Daily Value,'' 
and expressed to the nearest whole percent. However, the percentage of 
the RDI for protein shall not be declared if the product is represented 
or purported to be for infants and the protein quality value is less 
than 40 percent of the reference standard.
    (ii) The corrected amount of protein (grams) per serving for 
products represented or purported to be for adults and children 1 or 
more years of age is equal to the actual amount of protein (grams) per 
serving multiplied by the amino acid score corrected for protein 
digestibility. If the corrected score is above 1.00, then it shall be 
set at 1.00. The protein digestibility-corrected amino acid score shall 
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in 
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert 
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is 
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report 
of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation,'' as published by the Food and Agriculture Organization of 
the United Nations/World Health Organization, is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the 
Office of the Federal Register, suite 700, 800 North Capitol Street, 
NW., Washington, DC, or at the office of the FSIS Docket Clerk, Room 
3171, South Building, 14th and Independence Avenue, SW., Washington, 
DC. Copies of the incorporation by reference are available from the 
Product Assessment Division, Regulatory Programs, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Room 329, West End 
Court Building, Washington, DC 20250-3700. For products represented or 
purported to be for infants, the corrected amount of protein (grams) 
per serving is equal to the actual amount of protein (grams) per 
serving multiplied by the relative protein quality value. The relative 
protein quality value shall be determined by dividing the subject 
product's protein PER value by the PER value for casein. If the 
relative protein value is above 1.00, it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, and the RDI for protein for children less than 
4 years of age, infants, pregnant women, and lactating women shall be 
16 grams, 14 grams, 60 grams, and 65 grams, respectively.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, calculated as 
a percent of the RDI and expressed as percent of Daily Value.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d) through (g) of this section, products 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women shall use the RDI's 
that are specified for the intended group. For products represented or 
purported to be for use by both infants and children under 4 years of 
age, the percent of Daily Value shall be presented by separate 
declarations according to paragraph (e) of this section based on the 
RDI values for infants from birth to 12 months of age and for children 
under 4 years of age. Similarly, the percent of Daily Value based on 
both the RDI values for pregnant women and for lactating women shall be 
declared separately on products represented or purported to be for use 
by both pregnant and lactating women. When such dual declaration is 
used on any label, it shall be included in all labeling, and equal 
prominence shall be given to both values in all such labeling. All 
other products shall use the RDI for adults and children 4 or more 
years of age.
    (ii) The declaration of vitamins and minerals as a percent of the 
RDI shall include vitamin A, vitamin C, calcium, and iron, in that 
order, and shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added, or when a 
claim is made about them. Other vitamins and minerals need not be 
declared if neither the nutrient nor the component is otherwise 
referred to on the label or in labeling or advertising and the vitamins 
and minerals are: [[Page 202]] 
    (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)................    2400
Potassium......................  ......do.......................    3500
Protein........................  grams (g)......................      50
------------------------------------------------------------------------

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on products in the following format, except 
on products on which dual columns of nutrition information are declared 
as provided for in paragraph (e) of this section, on those products on 
which the simplified format is permitted to be used as provided for in 
paragraph (f) of this section, on products for infants and children 
less than 4 years of age as provided for in Sec. 381.500(c), and on 
products in packages that have a total surface area available to bear 
labeling of 40 or less square inches as provided for in paragraph (g) 
of this section.
    (i) The nutrition information shall be set off in a box by use of 
hairlines and shall be all black or one color type, printed on a white 
or other neutral contrasting background whenever practical.
    (ii) All information within the nutrition label shall utilize:
    (A) A single easy-to-read type style,
    (B) Upper and lower case letters,
    (C) At least one point leading (i.e., space between two lines of 
text) except that at least four points leading shall be utilized for 
the information required by paragraphs (d)(7) and (d)(8) of this 
section, and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), 
and (d)(8) of this section shall be in type size no smaller than 8 
point. Except for the heading ``Nutrition Facts,'' the information 
required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and 
all other information contained within the nutrition label shall be in 
type size no smaller than 6 point. When provided, the information 
described in paragraph (d)(10) of this section shall also be in type no 
smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) 
of this section (i.e., ``Nutrition Facts,'' ``Amount Per Serving,'' and 
``% Daily Value*''), the names of all nutrients that are not indented 
according to requirements of paragraph (c) of this section (i.e., 
Calories, Total fat, Cholesterol, Sodium, Potassium, Total 
carbohydrate, and Protein), and the percentage amounts required by 
paragraph (d)(7)(ii) of this section shall be highlighted by bold or 
extra bold type or other highlighting (reverse printing is not 
permitted as a form of highlighting) that prominently distinguishes it 
from other information. No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text 
shall separate ``Amount Per Serving'' from the calorie statements 
required in paragraph (d)(5) of this section and shall separate each 
nutrient and its corresponding percent of Daily Value required in 
paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient 
and percent of Daily Value above and below it.
    (2) The information shall be presented under the identifying 
heading of ``Nutrition Facts'' which shall be set in a type size larger 
than all other print size in the nutrition label and, except for labels 
presented according to the format provided for in paragraph (d)(11) of 
this section, unless impractical, shall be set the full width of the 
information provided under paragraph (d)(7) of this section.
    (3) Information on serving size shall immediately follow the 
heading. Such information shall include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(9) of this section. [[Page 203]] 
    (ii) ``Servings Per Container'': The number of servings per 
container, except that this statement is not required on single-serving 
containers as defined in paragraph (b)(8) of this section.
    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar.
    (5) Information on calories shall immediately follow the heading 
``Amount Per Serving'' and shall be declared in one line, leaving 
sufficient space between the declaration of ``Calories'' and ``Calories 
from fat'' to allow clear differentiation, or, if ``Calories from 
saturated fat'' is declared, in a column with total ``Calories'' at the 
top, followed by ``Calories from fat'' (indented), and ``Calories from 
saturated fat'' (indented).
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar. The position of this column heading shall allow for 
a list of nutrient names and amounts as described in paragraph (d)(7) 
of this section to be to the left of, and below, this column heading. 
The column heading ``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' 
may be substituted for ``% Daily Value.''
    (7) Except as provided for in paragraph (g) of this section, and 
except as permitted by Sec. 381.500(d)(2), nutrient information for 
both mandatory and any voluntary nutrients listed in paragraph (c) of 
this section that are to be declared in the nutrition label, except 
vitamins and minerals, shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of 
this section, shall be given in a column and followed immediately by 
the quantitative amount by weight for that nutrient appended with a 
``g'' for grams or ``mg'' for milligrams.
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% Daily Value'' established in 
paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column 
described in paragraph (d)(7)(i) of this section for which a DRV has 
been established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, 
Iron 4%) or may be listed in two columns, except that when more than 
four vitamins and minerals are declared, they may be declared 
vertically with percentages listed under the column headed ``% Daily 
Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath 
the list of vitamins and minerals and shall be separated from that list 
by a hairline.
    (i) The footnote shall state: Percent Daily Values are based on a 
2,000 calorie diet. Your daily values may be higher or lower depending 
on your calorie needs.

------------------------------------------------------------------------
                                      Calories       2,000       2,500  
------------------------------------------------------------------------
Total fat........................  Less than....  65 g        80 g      
Saturated fat....................  Less than....  20 g        25 g      
Cholesterol......................  Less than....  300 mg      300 mg    
Sodium...........................  Less than....  2400 mg     2400 mg   
Total carbohydrate...............  .............  300 g       375 g     
Dietary fiber....................  .............  25 g        30 g      
------------------------------------------------------------------------

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and value of 65 g in the column headed ``2,500.''
    (iii) If potassium is declared in the column described in paragraph 
(d)(7)(i) of this section, potassium shall be listed under sodium and 
the DRV established in paragraph (c)(9) of this section shall be 
inserted on the same line in the numeric columns.
    (iv) The abbreviations established in paragraph (g)(2) of this 
section may be used within the footnote.
    (10) Caloric conversion information on a per-gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9), separated from that information by a 
hairline. This information may be presented horizontally (i.e., 
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically 
in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in 
paragraph (d)(9) of this section, the information required in paragraph 
(d)(9) may be moved to the right of the column required in paragraph 
(d)(7)(ii) of this section and set off by a line that distinguishes it 
and sets it apart from the percent of Daily Value information. The 
caloric conversion information provided for in paragraph (d)(10) of 
this section may be presented beneath either side or along the full 
length of the nutrition label.
    (ii) If the space beneath the mandatory declaration of iron is not 
adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set 
off by a line that distinguishes it and sets it apart from the percent 
of Daily Value information given to the left. The caloric conversion 
information provided for in paragraph (d)(10) of this section may be 
presented beneath either side or along the full length of the nutrition 
label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 inches) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of iron, 
the nutrition label may be presented in a tabular display in which the 
footnote required by paragraph (d)(9) of the section is given to the 
far right of the label, and additional vitamins and minerals beyond the 
four that are required (i.e., vitamin A, vitamin C, calcium, and iron) 
are arrayed horizontally following declarations of the required 
vitamins and minerals.
    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section:

BILLING CODE 3410-DM-P


[[Page 204]]

[GRAPHIC][TIFF OMITTED]TR03JA95.002



BILLING CODE 3410-DM-C
[[Page 205]]

    (13)(i) Nutrition labeling on the outer label of packages of 
poultry products that contain two or more products in the same packages 
(e.g., variety packs) or of packages that are used interchangeably for 
the same type of food (e.g., poultry salad containers) may use an 
aggregate display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified to the right of the 
``Nutrition Facts'' title, and both the quantitative amount by weight 
(i.e., g/mg amounts) and the percent Daily Value for each nutrient 
shall be listed in separate columns under the name of each food.
    (14) When nutrition labeling appears in a second language, the 
nutrition information may be presented in a separate nutrition label 
for each language or in one nutrition label with the information in the 
second language following that in English. Numeric characters that are 
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both 
languages.
    (e) Nutrition information may be presented for two or more forms of 
the same product (e.g., both ``raw'' and ``cooked'') or for common 
combinations of foods as provided for in paragraph (b) of this section, 
or for different units (e.g., per 100 grams) as provided for in 
paragraph (b) of this section, or for two or more groups for which 
RDI's are established (e.g., both infants and children less than 4 
years of age) as provided for in paragraph (c)(8)(i) of this section. 
When such dual labeling is provided, equal prominence shall be given to 
both sets of values. Information shall be presented in a format 
consistent with paragraph (d) of this section, except that:
    (1) Following the subheading of ``Amount Per Serving,'' there shall 
be two or more column headings accurately describing the forms of the 
same product (e.g., ``raw'' and ``roasted''), the combinations of 
foods, the units, or the RDI groups that are being declared. The column 
representing the product as packaged and according to the label serving 
size based on the Reference Amount in Sec. 381.412(b) shall be to the 
left of the numeric columns.
    (2) When the dual labeling is presented for two or more forms of 
the same product, for combinations of foods, or for different units, 
total calories and calories from fat (and calories from saturated fat, 
when declared) shall be listed in a column and indented as specified in 
paragraph (d)(5) of this section with quantitative amounts declared in 
columns aligned under the column headings set forth in paragraph (e)(1) 
of this section.
    (3) Quantitative information by weight required in paragraph 
(d)(7)(i) of this section shall be specified for the form of the 
product as packaged and according to the label serving size based on 
the Reference Amount in Sec. 381.412(b).
    (i) Quantitative information by weight may be included for other 
forms of the product represented by the additional column(s) either 
immediately adjacent to the required quantitative information by weight 
for the product as packaged and according to the label serving size 
based on the Reference Amount in Sec. 381.412(b) or as a footnote.
    (A) If such additional quantitative information is given 
immediately adjacent to the required quantitative information, it shall 
be declared for all nutrients listed and placed immediately following 
and differentiated from the required quantitative information (e.g., 
separated by a comma). Such information shall not be put in a separate 
column.
    (B) If such additional quantitative information is given in a 
footnote, it shall be declared in the same order as the nutrients are 
listed in the nutrition label. The additional quantitative information 
may state the total nutrient content of the product identified in the 
second column or the nutrient amounts added to the product as packaged 
for only those nutrients that are present in different amounts than the 
amounts declared in the required quantitative information. The footnote 
shall clearly identify which amounts are declared. Any subcomponents 
declared shall be listed parenthetically after principal components 
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg 
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
    (ii) Total fat and its quantitative amount by weight shall be 
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'') 
referring to another asterisk (or symbol) at the bottom of the 
nutrition label identifying the form(s) of the product for which 
quantitative information is presented.
    (4) Information required in paragraphs (d)(7)(ii) and (d)(8) of 
this section shall be presented under the subheading ``% DAILY VALUE'' 
and in columns directly under the column headings set forth in 
paragraph (e)(1) of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:

BILLING CODE 3410-DM-P


[[Page 206]]

[GRAPHIC][TIFF OMITTED]TR03JA95.003



BILLING CODE 3410-DM-C

     (f)(1) Nutrition information may be presented in a simplified 
format as set forth herein when any required nutrients, other than the 
core nutrients (i.e., calories, total fat, sodium, total carbohydrate, 
and protein), are present in insignificant amounts. An insignificant 
amount shall be defined as that amount that may be rounded to zero in 
nutrition labeling, except that for total carbohydrate, dietary fiber, 
sugars and protein, it shall be an amount less than 1 gram.
     (2) The simplified format shall include information on the 
following nutrients:
     (i) Total calories, total fat, total carbohydrate, sodium, and 
protein;
     (ii) Any of the following that are present in more than 
insignificant amounts: Calories from fat, saturated fat, cholesterol, 
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
     (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are added in fortified or fabricated foods.
     (3) Other nutrients that are naturally present in the product in 
more than insignificant amounts may be voluntarily declared as part of 
the simplified format.
     (4) Any required nutrient, other than a core nutrient, that is 
present in an insignificant amount may be omitted from the tabular 
listing, provided that the following statement is included at the 
bottom of the nutrition label, ``Not a significant source of 
________.'' The [[Page 207]] blank shall be filled in with the 
appropriate nutrient or food component. Alternatively, amounts of 
vitamins and minerals present in insignificant amounts may be declared 
by the use of an asterisk (or symbol) that is placed at the bottom of 
the table of nutrient values and that is followed by the statement 
``Contains less than 2 percent of the Daily Value of this (these) 
nutrient (nutrients).''
     (5) Except as provided for in paragraph (g) of this section and in 
Sec. 381.500(c) and (d), nutrient information declared in the 
simplified format shall be presented in the same manner as specified in 
paragraphs (d) or (e) of this section, except that the footnote 
required in paragraph (d)(9) of this section is not required. When the 
footnote is omitted, an asterisk shall be placed at the bottom of the 
label followed by the statement ``Percent Daily Values are based on a 
2,000 calorie diet'' and, if the term ``Daily Value'' is not spelled 
out in the heading, a statement that ``DV'' represents ``Daily Value.''
     (g) Foods in packages that have a total surface area available to 
bear labeling of 40 or less square inches may modify the requirements 
of paragraphs (c) through (f) of this section and Sec. 381.402(a) by 
one or more of the following means:
     (1)(i) Presenting the required nutrition information in a tabular 
or linear (i.e., string) fashion, rather than in vertical columns if 
the product has a total surface area available to bear labeling of less 
than 12 square inches, or if the product has a total surface area 
available to bear labeling of 40 or less square inches and the package 
shape or size cannot accommodate a standard vertical column or tabular 
display on any label panel. Nutrition information may be given in a 
linear fashion only if the package shape or size will not accommodate a 
tabular display.
     (ii) When nutrition information is given in a linear display, the 
nutrition information shall be set off in a box by the use of a 
hairline. The percent Daily Value is separated from the quantitative 
amount declaration by the use of parenthesis, and all nutrients, both 
principal components and subcomponents, are treated similarly. Bolding 
is required only on the title ``Nutrition Facts'' and is allowed for 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
     (2) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb

     (3) Omitting the footnote required in paragraph (d)(9) of this 
section and placing another asterisk at the bottom of the label 
followed by the statement ``Percent Daily Values are based on a 2,000 
calorie diet'' and, if the term ``Daily Value'' is not spelled out in 
the heading, a statement that ``DV'' represents ``Daily Value.''
* * * * *
     21. Section 381.412 is amended by redesignating paragraph (d) as 
(g), revising paragraph (a), and adding new paragraphs (d), (e), and 
(f) to read as follows: Sec. 381.412 Reference amounts customarily 
consumed per eating occasion.
     (a) The general principles followed in arriving at the reference 
amounts customarily consumed per eating occasion (Reference Amount(s)), 
as set forth in paragraph (b) of this section, are:
     (1) The Reference Amounts are calculated for persons 4 years of 
age or older to reflect the amount of food customarily consumed per 
eating occasion by persons in this population group. These Reference 
Amounts are based on data set forth in appropriate national food 
consumption surveys.
     (2) The Reference Amounts are calculated for an infant or child 
under 4 years of age to reflect the amount of food customarily consumed 
per eating occasion by infants up to 12 months of age or by children 1 
through 3 years of age, respectively. These Reference Amounts are based 
on data set forth in appropriate national food consumption surveys. 
Such Reference Amounts are to be used only when the product is 
specially formulated or processed for use by an infant or by a child 
under 4 years of age.
     (3) An appropriate national food consumption survey includes a 
large sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
     (4) To determine the amount of food customarily consumed per 
eating occasion, the mean, median, and mode of the consumed amount per 
eating occasion were considered.
     (5) When survey data were insufficient, FSIS took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
     (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
     (ii) Serving sizes recommended in comments;
     (iii) Serving sizes used by manufacturers and grocers; and
     (iv) Serving sizes used by other countries.
     (6) Because they reflect the amount customarily consumed, the 
Reference Amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.
     (7) The Reference Amount is based on the major intended use of the 
product (e.g., a mixed dish measurable with a cup as a main dish and 
not as a side dish).
     (8) The Reference Amounts for products that are consumed as an 
ingredient of other products, but that may also be consumed in the form 
in which they are purchased (e.g., ground poultry), are based on use in 
the form purchased.
     (9) FSIS sought to ensure that foods that have similar dietary 
usage, product characteristics, and customarily consumed amounts have a 
uniform Reference Amount.
* * * * *
     (d) If a product requires further preparation, e.g., cooking or 
the addition of water or other ingredients, and if paragraph (b) of 
this section provides a Reference Amount for the product in the 
prepared form, then the Reference Amount for the unprepared product 
shall be determined using the following rules:
    (1) Except as provided for in paragraph (d)(2) of this section, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the Reference Amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used 
to prepare one large discrete unit usually divided for consumption, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the Reference Amount for the prepared product as 
established in paragraph (b) of this section. [[Page 208]] 
    (e) The Reference Amount for an imitation or substitute product or 
altered product as defined in Sec. 381.413(d), such as a ``low 
calorie'' version, shall be the same as for the product for which it is 
offered as a substitute.
    (f) The Reference Amounts set forth in paragraphs (b) through (e) 
of this section shall be used in determining whether a product meets 
the criteria for nutritional claims. If the serving size declared on 
the product label differs from the Reference Amount, and the product 
meets the criteria for the claim only on the basis of the Reference 
Amount, the claim shall be followed by a statement that sets forth the 
basis on which the claim is made. That statement shall include the 
Reference Amount as it appears in paragraph (b) of this section 
followed, in parenthesis, by the amount in common household measure if 
the Reference Amount is expressed in measures other than common 
household measures.
* * * * *
    22. Section 381.413 is amended by revising paragraphs (b), (g), 
(i), (j), (k), (p), and (q)(4) and adding new paragraphs (c), (d), (e), 
and (f) to read as follows:


Sec. 381.413  Nutrient content claims; general principles.

* * * * *
    (b) A claim which, expressly or by implication, characterizes the 
level of a nutrient (nutrient content claim) of the type required in 
nutrition labeling pursuant to Sec. 381.409, may not be made on a label 
or in labeling of that product unless the claim is made in accordance 
with the applicable provisions in this subpart.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the product, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the product or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount 
(e.g., ``high in oat bran''); or
    (ii) Suggests that the product, because of its nutrient content, 
may be useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be 
made on products intended specifically for use by infants and children 
less than 2 years of age unless the claim is specifically provided for 
in subpart Y of this part.
    (4) Reasonable variations in the spelling of the terms defined in 
applicable provisions in this subpart and their synonyms are permitted 
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
    (c) Information that is required or permitted by Sec. 381.409 to be 
declared in nutrition labeling, and that appears as part of the 
nutrition label, is not a nutrient content claim and is not subject to 
the requirements of this section. If such information is declared 
elsewhere on the label or in labeling, it is a nutrient content claim 
and is subject to the requirements for nutrient content claims.
    (d) A ``substitute'' product is one that may be used 
interchangeably with another product that it resembles, i.e., that it 
is organoleptically, physically, and functionally (including shelf 
life) similar to, and that it is not nutritionally inferior to unless 
it is labeled as an ``imitation.''
    (1) If there is a difference in performance characteristics that 
materially limits the use of the product, the product may still be 
considered a substitute if the label includes a disclaimer adjacent to 
the most prominent claim as defined in paragraph (j)(2)(iii) of this 
section, informing the consumer of such difference (e.g., ``not 
recommended for frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec. 381.121(c) for the net 
quantity of contents statement, except where the size of the claim is 
less than two times the required size of the net quantity of contents 
statement, in which case the disclaimer statement shall be no less than 
one-half the size of the claim but no smaller than \1/16\-inch minimum 
height, except as permitted by Sec. 381.500(d)(2).
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a product implies that the product differs from other products 
of the same type by virtue of its having a lower amount of the 
nutrient, only products that have been specially processed, altered, 
formulated, or reformulated so as to lower the amount of the nutrient 
in the product, remove the nutrient from the product, or not include 
the nutrient in the product, may bear such a claim (e.g., ``low sodium 
chicken noodle soup'').
    (2) Any claim for the absence of a nutrient in a product, or that a 
product is low in a nutrient when the product has not been specially 
processed, altered, formulated, or reformulated to qualify for that 
claim shall indicate that the product inherently meets the criteria and 
shall clearly refer to all products of that type and not merely to the 
particular brand to which the labeling attaches (e.g., ``chicken breast 
meat, a low sodium food'').
    (f) A nutrient content claim shall be in type size and style no 
larger than two times that of the statement of identity and shall not 
be unduly prominent in type style compared to the statement of 
identity.
    (g) Labeling information required in Secs. 381.413, 381.454, 
381.456, 381.460, 381.461, 381.462, and 381.480, whose type size is not 
otherwise specified, is required to be in letters and/or numbers no 
less than \1/16\ inch in height, except as permitted by 
Sec. 381.500(d)(2).
    (h) [Reserved]
    (i) Except as provided in Sec. 381.409 or in paragraph (q)(3) of 
this section, the label or labeling of a product may contain a 
statement about the amount or percentage of a nutrient if:
    (1) The use of the statement on the product implicitly 
characterizes the level of the nutrient in the product and is 
consistent with a definition for a claim, as provided in subpart Y of 
this part, for the nutrient that the label addresses. Such a claim 
might be, ``less than 10 g of fat per serving;''
    (2) The use of the statement on the product implicitly 
characterizes the level of the nutrient in the product and is not 
consistent with such a definition, but the label carries a disclaimer 
adjacent to the statement that the product is not ``low'' in or a 
``good source'' of the nutrient, such as ``only 200 milligrams (mg) 
sodium per serving, not a low sodium product.'' The disclaimer must be 
in easily legible print or type and in a size no less than required by 
Sec. 381.121(c) for the net quantity of contents, except where the size 
of the claim is less than two times the required size of the net 
quantity of contents statement, in which case the disclaimer statement 
shall be no less than one-half the size of the claim but no smaller 
than \1/16\-inch minimum height, except as permitted by 
Sec. 381.500(d)(2);
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the product and it is not false or misleading 
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec. 381.462(b)(6).
    (j) A product may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient [[Page 209]] in a 
reference product. These statements shall be known as ``relative 
claims'' and include ``light,'' ``reduced,'' ``less'' (or ``fewer''), 
and ``more'' claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the product must be compared to an amount of 
nutrient in an appropriate reference product as specified in this 
paragraph (j).
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference product may be a dissimilar product within a product category 
that can generally be substituted for one another in the diet or a 
similar product.
    (B) For ``light,'' ``reduced,'' and ``added'' claims, the reference 
product shall be a similar product, and
    (ii)(A) For ``light'' claims, the reference product shall be 
representative of the type of product that includes the product that 
bears the claim. The nutrient value for the reference product shall be 
representative of a broad base of products of that type; e.g., a value 
in a representative, valid data base; an average value determined from 
the top three national (or regional) brands, a market basket norm; or, 
where its nutrient value is representative of the product type, a 
market leader. Firms using such a reference nutrient value as a basis 
for a claim, are required to provide specific information upon which 
the nutrient value was derived, on request, to consumers and 
appropriate regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' 
and ``more'' claims, the reference product may be the same as that 
provided for ``light'' in paragraph (j)(1)(ii)(A) of this section or it 
may be the manufacturer's regular product, or that of another 
manufacturer, that has been offered for sale to the public on a regular 
basis for a substantial period of time in the same geographic area by 
the same business entity or by one entitled to use its trade name, 
provided the name of the competitor is not used on the labeling of the 
product. The nutrient values used to determine the claim when comparing 
a single manufacturer's product to the labeled product shall be either 
the values declared in nutrition labeling or the actual nutrient 
values, provided that the resulting labeling is internally consistent 
(i.e., that the values stated in the nutrition information, the 
nutrient values in the accompanying information, and the declaration of 
the percentage of nutrient by which the product has been modified are 
consistent and will not cause consumer confusion when compared), and 
that the actual modification is at least equal to the percentage 
specified in the definition of the claim.
    (2) For products bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
product and the percent (or fraction) of the amount of the nutrient in 
the reference product by which the nutrient has been modified, (e.g., 
``50 percent less fat than `reference product''' or ``\1/3\ fewer 
calories than `reference product'''); and
    (ii) This information shall be immediately adjacent to the most 
prominent claim in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, that is no less than that 
required by Sec. 381.121(c) for net quantity of contents, except where 
the size of the claim is less than two times the required size of the 
net quantity of contents statement, in which case the referral 
statement shall be no less than one-half the size of the claim, but no 
smaller than \1/16\-inch minimum height, except as permitted by 
Sec. 381.500(d)(2).
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the 
statement of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving size with 
that in the reference product; and
    (B) This statement shall appear adjacent to the most prominent 
claim or to the nutrition information.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a product if the nutrient content 
of the reference product meets the requirement for a ``low'' claim for 
that nutrient.
    (k) The term ``modified'' may be used in the statement of identity 
of a product that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``modified fat 
`product'''). This statement of identity must be immediately followed 
by the comparative statement such as ``contains 35 percent less fat 
than `reference product'.'' The label or labeling must also bear the 
information required by paragraph (j)(2) of this section in the manner 
prescribed.
* * * * *
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec. 381.412(b) through (e) shall be used in 
determining whether a product meets the criteria for a nutrient content 
claim. If the serving size declared on the product label differs from 
the reference amount customarily consumed, and the amount of the 
nutrient contained in the labeled serving does not meet the maximum or 
minimum amount criterion in the definition for the descriptor for that 
nutrient, the claim shall be followed by the criteria for the claim as 
required by Sec. 381.412(f) (e.g., ``very low sodium, 35 mg or less per 
55 grams'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size that 
is no less than that required by Sec. 381.121(c) for net quantity of 
contents, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the criteria statement shall be no less than one-half the size of the 
claim but no smaller than 1/16-inch minimum height, except as permitted 
by Sec. 381.500(d)(2).
    (q) * * *
    (4) The requirements of this section do not apply to infant 
formulas and medical foods, as described in 21 CFR 101.13(q)(4).
* * * * *
    22. Section 381.445 is amended by revising the section reference in 
paragraph (c) from ``Sec. 381.409(g)'' to ``Sec. 381.409(f)'' and by 
revising paragraph (a)(2) introductory text, (a)(2)(ii) and (a)(2)(iii) 
to read as follows: Sec. 381.445 Guidelines for voluntary nutrition 
labeling of single-ingredient, raw products.
    (a) * * *
    (2) A retailer may choose to provide nutrition information at the 
point-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) * * * [[Page 210]] 
    (ii) The listing of percent of Daily Value for the nutrients 
(except vitamins and minerals specified in Sec. 381.409(c)(8)) and 
footnote required by Sec. 381.409(d)(9) may be omitted; and
    (iii) The point-of-purchase materials are not subject to any of the 
format requirements.
* * * * *
    23. Section 381.454 is revised to read as follows:


Sec. 381.454  Nutrient content claims for ``good source,'' ``high,'' 
and ``more.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a product in 
relation to the Reference Daily Intake (RDI) or Daily Reference Value 
(DRV), established for that nutrient (excluding total carbohydrate) in 
Sec. 381.409(c), may only be made on the label or in labeling of the 
product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec. 381.409.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label or in labeling of 
products, except meal-type products as defined in Sec. 381.413(l), 
provided that the product contains 20 percent or more of the RDI or the 
DRV per reference amount customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of broccoli in this meal is 
high in vitamin C'').
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling 
of products, except meal-type products as described in Sec. 381.413(l), 
provided that the product contains 10 to 19 percent of the RDI or the 
DRV per reference amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of sweet potatoes in this 
meal is a good source of fiber'').
    (d) Fiber claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, i.e., that the product is high 
in fiber, a good source of fiber, or that the product contains ``more'' 
fiber, and the product is not ``low'' in total fat as defined in 
Sec. 381.462(b)(2) or, in the case of a meal-type product, is not 
``low'' in total fat as defined in Sec. 381.462(b)(3), then the 
labeling shall disclose the level of total fat per labeled serving size 
(e.g., ``contains 12 grams (g) of fat per serving''); and
    (2) The disclosure shall appear in immediate proximity to such 
claim and be in a type size no less than one-half the size of the 
claim.
    (e) ``More'' claims. (1) A relative claim using the terms ``more'' 
and ``added'' may be used on the label or in labeling to describe the 
level of protein, vitamins, minerals, dietary fiber, or potassium in a 
product, except meal-type products as defined in Sec. 381.413(l), 
provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per reference amount 
customarily consumed than an appropriate reference product as described 
in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than `reference 
product'''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 1 g per serving; `this product' contains 4 g per serving'').
    (2) A relative claim using the terms ``more'' and ``added'' may be 
used on the label or in labeling to describe the level of protein, 
vitamins, minerals, dietary fiber, or potassium in meal-type products 
as defined in Sec. 381.413(l), provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per 100 g of product than 
an appropriate reference product as described in Sec. 381.413(j)(1); 
and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 ounces 
(oz) than does `reference product'''), and
    (B) Quantitative information comparing the level of the nutrient in 
the meal-type product per specified weight with that of the reference 
product that it replaces is declared adjacent to the most prominent 
claim or to the nutrition information (e.g., ``fiber content of 
`reference product' is 2 g per 3 oz; `this product' contains 5 g per 3 
oz'').
    24. Section 381.456 is revised to read as follows:


Sec. 381.456  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the terms ``light'' or 
``lite'' to describe a product may only be made on the label or in 
labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec. 381.409.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used 
on the label or in labeling of products, except meal-type products as 
defined in Sec. 381.413(l), without further qualification, provided 
that:
    (1) If the product derives 50 percent or more of its calories from 
fat, its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to an appropriate reference 
product as described in Sec. 381.413(j)(1); or
    (2) If the product derives less than 50 percent of its calories 
from fat:
    (i) The number of calories is reduced by at least one-third (33\1/
3\ percent) per reference amount customarily consumed compared to an 
appropriate reference product as described in Sec. 381.413(j)(1); or 
[[Page 211]] 
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (3) As required in Sec. 381.413(j)(2) for relative claims:
    (i) The identity of the reference product and the percent (or 
fraction) that the calories and the fat were reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``\1/3\ 
fewer calories and 50 percent less fat than the market leader''); and
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference product that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
    (iii) If the labeled product contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.
    (4) A ``light'' claim may not be made on a product for which the 
reference product meets the definition of ``low fat'' and ``low 
calorie.''
    (c)(1)(i) A product for which the reference product contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the terms ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference product; and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., ``lite `this product'--500 milligrams (mg) sodium 
per serving; regular `reference product'--1,000 mg sodium per 
serving'').
    (2)(i) A product for which the reference product contains more than 
40 calories or more than 3 g fat per reference amount customarily 
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if 
it is reduced by 50 percent or more in sodium content compared to the 
reference product, provided that ``light'' or ``lite'' is presented in 
immediate proximity with ``in sodium'' and the entire term is presented 
in uniform type size, style, color, and prominence; and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., or ``lite `this product'--170 mg sodium per serving; 
regular `reference product'--350 mg per serving'').
    (3) Except for meal-type products as defined in Sec. 381.413(l), a 
``light in sodium'' claim may not be made on a product for which the 
reference product meets the definition of ``low in sodium.''
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in labeling of a meal-type product as defined in Sec. 381.413(l), 
provided that:
    (i) The product meets the definition of:
    (A) ``Low in calories'' as defined in Sec. 381.460(b)(3); or
    (B) ``Low in fat'' as defined in Sec. 381.462(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that the product meets the definition of 
``low in sodium'' as defined in Sec. 381.461(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (3) The terms ``light'' or ``lite'' may be used in the brand name 
of a product to describe the sodium content, provided that:
    (i) The product is reduced by 50 percent or more in sodium content 
compared to the reference product;
    (ii) A statement specifically stating that the product is ``light 
in sodium'' or ``lite in sodium'' appears:
    (A) Contiguous to the brand name; and
    (B) In uniform type size, style, color, and prominence as the 
product name; and
    (iii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim; and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the terms ``light'' or ``lite'' may not be used to refer to a 
product that is not reduced in fat by 50 percent, or, if applicable, in 
calories by \1/3\ or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the 
product such as texture or color and the information (e.g., ``light in 
color'' or ``light in texture'') so stated, clearly conveys the nature 
of the product; and
    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular product to 
reflect a physical or organoleptic attribute to the point where it has 
become part of the statement of identity, such use of the term 
``light'' shall not be considered a nutrient content claim subject to 
the requirements in this part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference product as described in Sec. 381.413(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec. 381.461(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition information and the information 
required to accompany a relative claim shall appear on the label or 
labeling as specified in Sec. 381.413(j)(2).
    25. Section 381.460 is revised to read as follows:


Sec. 381.460  Nutrient content claims for calorie content.

    (a) General requirements. A claim about the calorie or sugar 
content of a product may only be made on the label or in labeling of 
the product if:
[[Page 212]]

    (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. 381.413; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec. 381.409.
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietarily insignificant source of calories'' may be 
used on the label or in labeling of products, provided that:
    (i) The product contains less than 5 calories per reference amount 
customarily consumed and per labeled serving size; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in 
calories'' may be used on the label or in labeling of products, except 
meal-type products as defined in Sec. 381.413(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does 
not provide more than 40 calories per reference amount customarily 
consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and does not provide more than 40 calories 
per reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains 120 calories or less per 100 g of product; 
and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower 
in calories'' may be used on the label or in labeling of products, 
except meal-type products as defined in Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
lower calorie `product'--``33 \1/3\ percent fewer calories than our 
regular `product'''); and
    (B) Quantitative information comparing the level of calories in the 
product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``calorie content has been reduced 
from 150 to 100 calories per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of products if the reference 
product meets the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent fewer calories per 100 
g of product than an appropriate reference product as described in 
Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``calorie reduced `product', 25% less calories per ounce (oz) (or 3 oz) 
than our regular `product'''); and
    (B) Quantitative information comparing the level of calories in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 
110 calories per 3 oz to 80 calories per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of products if the reference 
product meets the definition for ``low calorie.''
    (c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free 
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably 
be expected to be regarded by consumers as terms that represent that 
the product contains no sugars or sweeteners, e.g., ``sugar free,'' or 
``no sugar,'' as indicating a product which is low in calories or 
significantly reduced in calories. Consequently, except as provided in 
paragraph (c)(2) of this section, a product may not be labeled with 
such terms unless:
    (i) The product contains less than 0.5 g of sugars, as defined in 
Sec. 381.409(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 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. 381.409(c)(6)(ii), or 
any other ingredient that contains sugars that functionally substitute 
for added sugars is added during processing or packaging; [[Page 213]] 
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice;
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as the use of enzymes, 
except where the intended functional effect of the process is not to 
increase the sugars content of a product, and a functionally 
insignificant increase in sugars results;
    (iv) The product that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the product is not ``low 
calorie'' or ``calorie reduced'' (unless the product meets the 
requirements for a ``low'' or ``reduced calorie'' product) and that 
directs consumers' attention to the nutrition panel for further 
information on sugar and calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a product, including products intended specifically for 
infants and children less than 2 years of age, is unsweetened or 
contains no added sweeteners in the case of a product that contains 
apparent substantial inherent sugar content, e.g., juices.
    (4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may 
be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less sugars per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``this 
product contains 25 percent less sugar than our regular product''); and
    (B) Quantitative information comparing the level of the sugar in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``sugar content has been lowered from 
8 g to 6 g per serving'').
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less sugars per 100 g 
of product than an appropriate reference product as described in 
Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., 
``reduced sugar `product'--25% less sugar than our regular 
`product'''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``sugar content has been reduced from 
17 g per 3 oz to 13 g per 3 oz'').

    26. Section 381.461 is revised to read as follows:


Sec. 381.461  Nutrient content claims for the sodium content.

    (a) General requirements. A claim about the level of sodium in a 
product may only be made on the label or in labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec. 381.409.
    (b) Sodium content claims. (1) The terms ``sodium free,'' ``free of 
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial 
source of sodium,'' ``negligible source of sodium,'' or ``dietarily 
insignificant source of sodium'' may be used on the label or in 
labeling of products, provided that:
    (i) The product contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a meal-type product, less than 5 mg of sodium per 
labeled serving size;
    (ii) The product contains no ingredient that is sodium chloride or 
is generally understood by consumers to contain sodium unless the 
listing of the ingredient in the ingredients statement is followed by 
an asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible 
amount of sodium'' or ``adds a dietarily insignificant amount of 
sodium;'' and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``very low sodium'' or ``very low in sodium'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 381.413(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and 
contains 35 mg or less sodium per reference amount customarily 
consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains 140 mg or less sodium per 100 g of 
product; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' 
may be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less sodium per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(l); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) [[Page 214]] 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. 381.413(l), provided that:
    (i) The product contains at least 25 percent less sodium per 100 g 
of product than an appropriate reference product as described in 
Sec. 381.413(j)(l); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., 
``reduced sodium `product'--30% less sodium per 3 oz than our `regular 
product'''); and
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in labeling of products if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt 
refers to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no salt,'' ``no salt added'' are potentially 
misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of products only if the product is ``sodium free'' as defined in 
paragraph (b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of products only if:
    (i) No salt is added during processing;
    (ii) The product that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the product is not sodium free, the statement ``not a 
sodium free product'' or ``not for control of sodium in the diet'' 
appears adjacent to the nutrition information of the product bearing 
the claim.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a product intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the product and is not false or otherwise misleading.

    27. Section 381.462 is revised to read as follows:


Sec. 381.462  Nutrient content claims for fat, fatty acids, and 
cholesterol content. '

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a product may only be made on the label or in 
labeling of products if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 381.413; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec. 381.409.
    (b) Fat content claims. (1) The terms ``fat free,'' ``free of 
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial 
source of fat,'' ``negligible source of fat,'' or ``dietarily 
insignificant source of fat'' may be used on the label or in labeling 
of products, provided that:
    (i) The product contains less than 0.5 gram (g) of fat per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a 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 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. 381.413(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g 
or less of fat per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 3 g or less of fat per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains 3 g or less of total fat per 100 g of 
product and not more than 30 percent of calories from fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 
label or in labeling of products, except meal-type products as defined 
in Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference product as 
described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two [[Page 215]] products 
are declared in immediate proximity to the most prominent such claim 
(e.g., ``reduced fat--50 percent less fat than our regular 
`product'''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fat content has been reduced from 8 
g to 4 g per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low fat.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less fat per 100 g of 
product than an appropriate reference product as described in 
Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat `product', 33 percent less fat per 3 oz than our regular 
`product'''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent such claim or to 
the nutrition information (e.g., ``fat content has been reduced from 8 
g per 3 oz to 5 g per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low fat.''
    (6) The term ``____________ 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. 381.413(l), provided that:
    (i) The product contains 1 g or less of saturated fat per reference 
amount customarily consumed and not more than 15 percent of calories 
from saturated fat; and
    (ii) If the product meets these conditions without benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products 
of its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains 1 g or less of saturated fat per 100 g and 
less than 10 percent calories from saturated fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products 
of its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 
saturated fat,'' or ``lower in saturated fat'' may be used on the label 
or in labeling of products, except meal-type products as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', contains 50 percent less saturated 
fat than the national average for `product'''); and
    (B) Quantitative information comparing the level of saturated fat 
in the product per labeled serving size with that of the reference 
product that it replaces is declared adjacent to the most prominent 
claim or to the nutrition information (e.g., ``saturated fat reduced 
from 3 g to 1.5 g per serving'').
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
saturated fat.''
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains at least 25 percent less saturated fat per 
100 g of product than an appropriate reference product as described in 
Sec. 381.413(j)(1); and
    (ii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', 50 percent less saturated fat than 
our regular `product'''); and
    (B) Quantitative information comparing the level of saturated fat 
in the product per specified weight with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``saturated fat content 
[[Page 216]] 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. 381.413(l), 
less than 2 mg of cholesterol per labeled serving size;
    (ii) The product contains no ingredient that is generally 
understood by consumers to contain cholesterol, unless the listing of 
the ingredient in the ingredients statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of cholesterol,'' ``adds a negligible 
amount of cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol'';
    (iii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed or, in the case of a meal-type 
product as defined in Sec. 381.413(l), 2 g or less of saturated fat per 
labeled serving size; and
    (iv) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches; 
or
    (v) If the product meets these conditions only as a result of 
special processing, alteration, formulation, or reformulation, the 
amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``cholesterol free 
`product', contains 100 percent less cholesterol than `reference 
product'''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``contains no cholesterol compared 
with 30 mg in one serving of `reference product''').
    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 
``contains a small amount of cholesterol,'' ``low source of 
cholesterol,'' or ``little cholesterol'' may be used on the label or in 
labeling of products, except meal-type products as defined in 
Sec. 381.413(l), provided that:
    (i)(A) If the product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed; and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; or
    (B) If the product has a reference amount customarily consumed of 
30 g or less or 2 tbsp or less:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in 
Sec. 381.409(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed.
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches; or
    (iii) If the product contains 20 mg or less of cholesterol only as 
a result of special processing, alteration, formulation, or 
reformulation, the amount of cholesterol is reduced by 25 percent or 
more from the reference product it replaces as described in 
Sec. 381.413(j)(1) and for which it substitutes as described in 
Sec. 381.413(d) that has a significant (e.g., 5 percent or more of a 
national or regional market) market share. As required in 
Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``low 
cholesterol `product', contains 85 percent less cholesterol than our 
regular `product'''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5 
mg per serving'').
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product contains 20 mg or less of cholesterol per 100 g of 
product;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' 
or ``lower in cholesterol'' may be used on the label or in labeling of 
products or products that substitute for those products as specified in 
Sec. 381.413(d), excluding meal-type products as defined in 
Sec. 381.413(l), provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed; and
    (iii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25 
percent less cholesterol than `reference product'''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30 
mg per serving''). [[Page 217]] 
    (iv) Claims described in paragraph (d)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
cholesterol.''
    (5) The terms defined in paragraph (d)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 381.413(l), provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 381.413(j)(1) and 
for which it substitutes as described in Sec. 381.413(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) As required in Sec. 381.413(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25% less 
cholesterol than `reference product'''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol content has been reduced 
from 35 mg per 3 oz to 25 mg per 3 oz).
    (iv) Claims described in paragraph (d)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
cholesterol.''
    (e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may 
be used on the label or in labeling of a product, provided that the 
product contains less than 10 g of fat, 4.5 g or less of saturated fat, 
and less than 95 mg of cholesterol per 100 g of product and per 
reference amount customarily consumed for individual foods, and per 100 
g of product and per labeled serving size for meal-type products as 
defined in Sec. 381.413(l).
    (2) The term ``extra lean'' may be used on the label or in labeling 
of a product, provided that the product contains less than 5 g of fat, 
less than 2 g of saturated fat, and less than 95 mg of cholesterol per 
100 g of product and per reference amount customarily consumed for 
individual foods, and per 100 g of product and per labeled serving size 
for meal-type products as defined in Sec. 381.413(l).
    28. Section 381.463 is amended by revising the section reference in 
paragraphs (b)(2) and (b)(3) from ``Sec. 381.409(g)(1)'' to 
``Sec. 381.409(f)(1).''
    29. Section 381.469 is amended by removing the word ``rule'' from 
the third sentence of paragraph (m)(5).
    30. Section 381.480 is amended by revising paragraphs (e) and (f) 
to read as follows:


Sec. 381.480  Label statements relating to usefulness in reducing or 
maintaining body weight.

* * * * *
    (e) ``Label terms suggesting usefulness as low calorie or reduced 
calorie foods''. (1) Except as provided in paragraphs (e)(2) and (e)(3) 
of this section, a product may be labeled with terms such as ``diet,'' 
``dietetic,'' ``artificially sweetened,'' or ``sweetened with 
nonnutritive sweetener'' only if the claim is not false or misleading, 
and the product is labeled ``low calorie'' or ``reduced calorie'' or 
bears another comparative calorie claim in compliance with the 
applicable provisions in this subpart.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the product is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other product that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free'' and ``no added sugar''. Criteria for the use of 
the terms ``sugar free'' and ``no added sugar'' are provided for in 
Sec. 381.460(c).
    31. Section 381.500 is amended by removing the word ``food'' after 
the word ``poultry'' in paragraph (a) introductory text; by revising 
the words ``Products produced'' in paragraph (a)(1) introductory text 
to the words ``Food products produced''; by revising the section 
reference in paragraph (c)(2)(iii) from ``Sec. 381.409(e)'' to 
``Sec. 381.409(d)(6)''; and by revising the words ``at 21 CFR 
101.9(d)(9)'' in paragraph (c)(2)(v) to the words ``in 
Sec. 381.409(d)(9)''.

    Done at Washington, DC, on December 22, 1994.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 94-32105 Filed 12-30-94; 8:45 am]
BILLING CODE 3410-DM-P