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101.9 Nutrition labeling of food.

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[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.9]

[Page 19-46]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 101_FOOD LABELING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  101.9  Nutrition labeling of food.

    (a) Nutrition information relating to food shall be provided for all 
products intended for human consumption and offered for sale unless an 
exemption is provided for the product in paragraph (j) of this section.
    (1) When food is in package form, the required nutrition labeling 
information shall appear on the label in the format specified in this 
section.
    (2) When food is not in package form, the required nutrition 
labeling information shall be displayed clearly at the point of purchase 
(e.g., on a counter card, sign, tag affixed to the product, or some 
other appropriate device). Alternatively, the required information may 
be placed in a booklet, looseleaf binder, or other appropriate

[[Page 20]]

format that is available at the point of purchase.
    (3) Solicitation of requests for nutrition information by a 
statement ``For nutrition information write to ---------------------- '' 
on the label or in the labeling or advertising for a food, or providing 
such information in a direct written reply to a solicited or unsolicited 
request, does not subject the label or the labeling of a food exempted 
under paragraph (j) of this section to the requirements of this section 
if the reply to the request conforms to the requirements of this 
section.
    (4) If any vitamin or mineral is added to a food so that a single 
serving provides 50 percent or more of the Reference Daily Intake (RDI) 
for the age group for which the product is intended, as specified in 
paragraph (c)(8)(iv) of this section, of any one of the added vitamins 
or minerals, unless such addition is permitted or required in other 
regulations, e.g., a standard of identity or nutritional quality 
guideline, or is otherwise exempted by the Commissioner, the food shall 
be considered a food for special dietary use within the meaning of Sec.  
105.3(a)(1)(iii) of this chapter.
    (b) Except as provided in Sec.  101.9(h)(3), all nutrient and food 
component quantities shall be declared in relation to a serving as 
defined in this section.
    (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 food. When the food 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)(3), (b)(4), and (b)(6) 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 * 
* * *'' (reference amounts) that appear in Sec.  101.12(b) using the 
procedures described below. 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.  101.12(b) shall be used for purposes of evaluating whether 
weight-control products that are available only through a weight-control 
program qualify for nutrient content claims or health claims.
    (i) For products in discrete units (e.g., muffins, sliced products, 
such as sliced bread, or individually packaged products within a 
multiserving package) and for products which consist of two or more 
foods packaged and presented to be consumed together where the 
ingredient represented as the main ingredient is in discrete units 
(e.g., pancakes and syrup), the serving size shall be declared as 
follows:
    (A) 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;
    (B) 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;
    (C) If a unit weighs 67 percent or more, but less than 200 percent 
of the reference amount, the serving size shall be one unit;
    (D) 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.
    (E) For products that have reference amounts of 100 grams (g) (or 
milliliter (mL)) or larger and are individual units within a 
multiserving package, if a unit contains more than 150 percent but less 
than 200 percent of the reference amount, the manufacturer may

[[Page 21]]

decide whether to declare the individual unit as 1 or 2 servings.
    (F) The serving size for maraschino cherries shall be expressed as 1 
cherry with the parenthetical metric measure equal to the average weight 
of a medium size cherry.
    (G) The serving size for products that naturally vary in size (e.g., 
pickles, shellfish, whole fish, and fillet of fish) may be the amount in 
ounces that most closely approximates the reference amount for the 
product category. Manufacturers shall adhere to the requirements in 
paragraph (b)(5)(vi) of this section for expressing the serving size in 
ounces.
    (H) 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., pancakes and syrup), 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 determined in Sec.  101.12(f).
    (I) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec.  101.9 (that is, are 
labeled appropriately for individual sale as single-serving containers), 
the serving size shall be 1 unit.
    (ii) For products in large discrete units that are usually divided 
for consumption (e.g., cake, pie, pizza, melon, cabbage), 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., 
cake mix, 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 (e.g., prepared cake packaged with a can 
of frosting), the serving size shall be the fractional slice of the 
ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/
6 cabbage) that most closely approximates the reference amount for the 
product category, and may be the fraction of the package used to make 
the reference amount for the unprepared product determined in Sec.  
101.12(c) or the fraction of the large discrete unit represented as the 
main ingredient plus proportioned minor ingredients used to make the 
reference amount for the combined product determined in Sec.  101.12(f). 
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.
    (iii) For nondiscrete bulk products (e.g., breakfast cereal, flour, 
sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese 
kits), 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., peanut butter and jelly), 
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.  101.12(f).
    (3) The serving size for meal products and main dish products as 
defined in Sec.  101.13 (l) and (m) that comes in single-serving 
containers as defined in paragraph (b)(6) of this section shall be the 
entire content (edible portion only) of the package. Serving size for 
meal products and main dish products in multiserving containers shall be 
based on the reference amount applicable to the product in Sec.  
101.12(b) if the product is listed in Sec.  101.12(b). Serving size for 
meal products and main dish products in multiserving containers that are 
not listed in Sec.  101.12(b) shall be based on the reference amount 
according to Sec.  101.12(f).
    (4) A variety pack, such as a package containing several varieties 
of single-serving units as defined in paragraph (b)(2)(i) of this 
section, and a product having two or more compartments with each 
compartment containing a different food, shall provide nutrition 
information for each variety or food per serving size that is derived 
from the reference amount in Sec.  101.12(b) applicable for each variety 
or food and

[[Page 22]]

the procedures to convert the reference amount to serving size in 
paragraph (b)(2) of this section.
    (5) 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), fluid ounce (fl oz), or other 
common household equipment used to package food products (e.g., jar, 
tray). In expressing serving size in household measures, except as 
specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and 
(b)(5)(vii) of this section, the following rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate except for beverages. For beverages, a manufacturer may 
use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup increments. 
Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3, 2, or 3 
tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 
teaspoons.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not 
applicable, ounces may be used with an appropriate visual unit of 
measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2 
pickle). Ounce measurements shall be expressed in 0.5 oz increments most 
closely approximating the reference amount.
    (iv) A description of the individual container or package shall be 
used for single serving containers and for individually packaged 
products within multiserving containers (e.g., can, box, package). A 
description of the individual unit shall be used for other products in 
discrete units (e.g., piece, slice, cracker, bar).
    (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., cake mix, pizza kit), the fraction or portion of the 
package may be used.
    (vi) Ounces with an appropriate visual unit of measure, as described 
in paragraph (b)(5)(iii) of this section, may be used for products that 
naturally vary in size as provided for in paragraph (b)(2)(i)(G) of this 
section.
    (vii) As provided for in Sec.  101.9(h)(1), for products that 
consist of two or more distinct ingredients or components packaged and 
presented to be consumed together (e.g. dry macaroni and cheese mix, 
cake and muffin mixes with separate ingredient packages, pancakes and 
syrup), 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)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this 
section, or alternatively in ounces with an appropriate visual unit of 
measure, as described in paragraph (b)(5)(iii) of this section (e.g., 
declared as separate components: ``3 oz dry macaroni (84 g/about 2/3 
cup)'' and ``1 oz dry cheese mix (28 g/about 2 tbsp);'' declared as a 
composite value: ``4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry 
cheese mix)'').
    (viii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz 
means 30 mL, and 1 oz in weight means 28 g.
    (ix) When a serving size, determined from the reference amount in 
Sec.  101.12(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.
    (6) 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.
    (7) A label statement regarding a serving shall be the serving size 
expressed in common household measures

[[Page 23]]

as set forth in paragraphs (b)(2) through (b)(6) 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 Sec.  
101.9(b)(9). 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 and fluid 
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 bread. 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, oz for ounce, and fl oz for 
fluid ounce.
    (v) For products that only require the addition of water or another 
ingredient that contains insignificant amounts of nutrients in the 
amount added and that are prepared in such a way that there are no 
significant changes to the nutrient profile, the amount of the finished 
product may be declared in parentheses at the end of the serving size 
declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup 
prepared)).
    (vi) To promote uniformity in label serving sizes in household 
measures declared by different manufacturers, FDA has provided a 
guidance document entitled, ``Guidelines for Determining the Gram Weight 
of the Household Measure.'' The guidance document can be obtained from 
the Office of Nutritional Products, Labeling and Dietary Supplements 
(HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
    (8) 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., maraschino cherries, pickles), 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.
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec.  101.9 (that is, 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 
multiserving

[[Page 24]]

units, the number of servings shall be determined by multiplying the 
number of individual multiserving units in the total package by the 
number of servings in each individual unit.
    (9) The declaration of nutrient and food component content shall be 
on the basis of food as packaged or purchased with the exception of raw 
fish covered under Sec.  101.42 (see 101.44), packaged single-ingredient 
products that consist of fish or game meat as provided for in paragraph 
(j)(11) of this section, and of foods that are packed or canned in 
water, brine, or oil but whose liquid packing medium is not customarily 
consumed (e.g., canned fish, maraschino cherries, pickled fruits, and 
pickled vegetables). Declaration of nutrient and food component content 
of raw fish shall follow the provisions in Sec.  101.45. Declaration of 
the nutrient and food component content of foods that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (10) Another column of figures may be used to declare the nutrient 
and food component information:
    (i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as 
packaged or purchased;
    (ii) Per one unit if the serving size of a product in discrete units 
in a multiserving container is more than 1 unit;
    (iii) Per cup popped for popcorn in a multiserving container.
    (11) If a product is promoted on the label, labeling, or advertising 
for a use that differs in quantity by twofold or greater from the use 
upon which the reference amount in Sec.  101.12(b) was based (e.g., 
liquid cream substitutes promoted for use with breakfast cereals), the 
manufacturer shall provide a second column of nutrition information 
based on the amount customarily consumed in the promoted use, in 
addition to the nutrition information per serving derived from the 
reference amount in Sec.  101.12(b), except that nondiscrete bulk 
products that are used primarily as ingredients (e.g., flour, 
sweeteners, shortenings, oils), or traditionally used for multipurposes 
(e.g., eggs, butter, margarine), and multipurpose baking mixes are 
exempt from this requirement.
    (c) The declaration of nutrition information on the label and in 
labeling of a food 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 paragraphs (f) or (j) of this section, 
nutrient information shall be presented using the nutrient names 
specified and in the following order in the formats specified in 
paragraphs (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 parentheses 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, ``Energy Value of Foods--Basis and Derivation,'' by A. L. 
Merrill and B. K. Watt, United States Department of Agriculture (USDA) 
Handbook No. 74 (slightly revised, 1973), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is 
available from the Office of Nutritional Products, Labeling and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or may be inspected at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://

[[Page 25]]

www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.;
    (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 Handbook No. 74 (slightly revised 1973) pp. 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);
    (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 Handbook No. 74 
(slightly revised 1973) pp. 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;
    (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 this chapter, or by other means, as 
appropriate; or
    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised 1973) p. 10, 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).
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section in 
a 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 in a 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. Except as provided for in paragraph (f) of this section, if 
``Calories from fat'' is not required and, as a result, not declared, 
the statement ``Not a significant source of calories from fat'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size.
    (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 in a 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 in a 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 in a serving defined as the sum of all fatty 
acids containing no double bonds, except that label declaration of 
saturated fat content information is not required for products that 
contain less than 0.5 gram of total fat in a serving if no claims are 
made about fat, fatty acid, or cholesterol content, and if ``calories 
from saturated fat'' is not declared. Except as provided for in 
paragraph (f) of this section, if a statement of the saturated fat 
content is not required and, as a result, not declared, the statement 
``Not a significant source of saturated fat'' shall be placed at the 
bottom of the table of nutrient values. Saturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 gram (1/
2) gram increment below 5 grams and to the nearest gram increment above 
5 grams. If the serving contains less than 0.5 gram, the content shall 
be expressed as zero.
    (ii) ``Trans fat'' or ``Trans'': A statement of the number of grams 
of trans fat in a serving, defined as the sum of

[[Page 26]]

all unsaturated fatty acids that contain one or more isolated (i.e., 
nonconjugated) double bonds in a trans configuration, except that label 
declaration of trans fat content information is not required for 
products that contain less than 0.5 gram of total fat in a serving if no 
claims are made about fat, fatty acid or cholesterol content. The word 
``trans'' may be italicized to indicate its Latin origin. Trans fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (1/2)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content, when declared, shall be expressed as zero. Except as provided 
for in paragraph (f) of this section, if a statement of the trans fat 
content is not required and, as a result, not declared, the statement 
``Not a significant source of trans fat'' shall be placed at the bottom 
of the table of nutrient values.
    (iii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat in a serving 
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may 
be declared voluntarily, except that when monounsaturated fat is 
declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a food other than one that meets the 
criteria in Sec.  101.62(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat in a serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily 
except that when polyunsaturated fat is declared, or when a claim about 
fatty acids or cholesterol is made on the label or in labeling of a food 
other than one that meets the criteria in Sec.  101.62(b)(1) for a claim 
for ``fat free,'' label declaration of monounsaturated fat is required. 
Monounsaturated fat content shall be indented and expressed as grams per 
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the 
nearest gram increment above 5 grams. If the serving contains less than 
0.5 gram, the content shall be expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content in a 
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 cholesterol in a 
serving and make no claim about fat, fatty acids, or cholesterol 
content, or such products may state the cholesterol content as zero. 
Except as provided for in paragraph (f) of this section, if cholesterol 
content is not required and, as a result, not declared, the statement 
``Not a significant source of cholesterol'' shall be placed at the 
bottom of the table of nutrient values in the same type size. If the 
food 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 in 
a specified serving of food 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 in a specified serving of food 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 less than or equal to 140 milligrams of potassium, and to the 
nearest 10-milligram increment when the serving contains more than 140 
milligrams.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate in a serving expressed to 
the nearest gram, except that if a serving contains

[[Page 27]]

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 food. This calculation method is described in A. L. Merrill and B. 
K. Watt, ``Energy Value of Foods--Basis and Derivation,'' USDA Handbook 
74 (slightly revised 1973) pp. 2 and 3, 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).
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber in a serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be expressed 
as zero. Except as provided for in paragraph (f) of this section, if 
dietary fiber content is not required and as a result, not declared, the 
statement ``Not a significant source of dietary fiber'' shall be placed 
at the bottom of the table of nutrient values in the same type size.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a 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 in a serving may be declared 
voluntarily except that 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 in a 
serving, except that label declaration of sugars content is not required 
for products that contain less than 1 gram of sugars in a serving if no 
claims are made about sweeteners, sugars, or sugar alcohol content. 
Except as provided for in paragraph (f) of this section, if a statement 
of the sugars content is not required and, as a result, not declared, 
the statement ``Not a significant source of sugars'' shall be placed at 
the bottom of the table of nutrient values in the same type size. 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 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.
    (iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols in a 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 
food, 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 food may be used in the nutrition 
label provided that only one sugar alcohol is present in the food. Sugar 
alcohol content shall be indented and expressed to the nearest

[[Page 28]]

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 carbohydrates may be declared voluntarily. Other 
carbohydrates 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 in a 
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 foods 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 food 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 food as measured by the Protein Efficiency Ratio (PER) is 
less than 40 percent of the reference standard (casein) for a food 
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 the appropriate method of analysis as given in the 
``Official Methods of Analysis of the AOAC International'' (formerly the 
Association of Official Analytical Chemists), 15th Ed. (1990), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, except when the official procedure for a specific food requires 
another factor. Copies may be obtained from AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
inspected at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
    (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 use by 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 food is represented or 
purported to be for use by infants and the protein quality value is less 
than 40 percent of the reference standard.

[[Page 29]]

    (ii) The ``corrected amount of protein (gram) per serving'' for 
foods represented or purported for adults and children 1 or more years 
of age is equal to the actual amount of protein (gram) 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 8.00 in ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation,'' Rome, 1990, except that when official AOAC 
procedures described in section (c)(7) of this paragraph require a 
specific food factor other than 6.25, that specific factor shall be 
used. 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 by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-800), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or may be inspected at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. For foods represented or purported 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 food 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 Daily 
Reference Value (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), (e), and (f) of this section, foods 
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 foods 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 foods 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 foods 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 as a 
nutrient supplement, 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 food; or
    (B) Included in a food solely for technological purposes and 
declared only in

[[Page 30]]

the ingredient 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)'' or ``Contains < 2 percent of the Daily 
Value of this (these) nutrient (nutrients).'' Alternatively, except as 
provided for in paragraph (f) of this section, 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. 
Either statement shall be in the same type size as nutrients that are 
indented.
    (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, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams

    (v) The following synonyms may be added in parentheses immediately 
following the name of the nutrient or dietary component:

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folic acid or Folacin.
Alternatively, folic acid or folacin may be listed without parentheses 
in place of folate.

    (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 DV of 
vitamin A in the food (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:

------------------------------------------------------------------------
                                        Unit of
         Food component               measurement             DRV
------------------------------------------------------------------------
Fat.............................  gram (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

[[Page 31]]

presented on foods in the following format, as shown in paragraph 
(d)(12) of this section, except on foods on which dual columns of 
nutrition information are declared as provided for in paragraph (e) of 
this section, on those food products on which the simplified format is 
required to be used as provided for in paragraph (f) of this section, on 
foods for infants and children less than 4 years of age as provided for 
in paragraph (j)(5) of this section, and on foods in small or 
intermediate-sized packages as provided for in paragraph (j)(13) of this 
section. In the interest of uniformity of presentation, FDA urges that 
the nutrition information be presented using the graphic specifications 
set forth in appendix B to part 101.
    (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) Except as provided for in paragraph (c)(2)(ii) of this section, 
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 as 
shown in paragraph (d)(12), 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,'' ``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 Daily Value required in paragraphs (d)(7)(i) 
and (d)(7)(ii) of this section from the nutrient and percent Daily Value 
above and below it, as shown in paragraph (d)(12) of this section.
    (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, as shown in 
paragraph (d)(12) of this section.
    (3) Information on serving size shall immediately follow the heading 
as shown in paragraph (d)(12) of this section. Such information shall 
include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(7) 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)(6) of this section or on other 
food containers when this information is stated in the net quantity of 
contents declaration.
    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar as shown in paragraph (d)(12) of this 
section.
    (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''

[[Page 32]]

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 as shown in paragraph (d)(12) of this section. 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 (j)(13) of this section, 
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 a ``mg'' for milligrams as shown in paragraph (d)(12) of 
this section. The symbol ``<'' may be used in place of ``less than.''
    (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 as shown in paragraph (d)(12) 
of this section, except that when more than four vitamins and minerals 
are declared, they may be declared vertically with percentages listed 
under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath the 
list of vitamins and minerals and shall be separated from that list by a 
hairline.
    (i) The footnote shall state:
    Percent Daily Values are based on a 2,000 calorie diet.
    Your daily values may be higher or lower depending on your calorie 
needs.

------------------------------------------------------------------------
                                      Calories:       2,000      2,500
------------------------------------------------------------------------
Total fat........................  Less than             65 g       80 g
Saturated fat....................  Less than             20 g       25 g
Cholesterol......................  Less than           300 mg     300 mg
Sodium...........................  Less than         2,400 mg   2,400 mg
Total carbohydrate...............  ...............      300 g      375 g
Dietary fiber....................  ...............       25 g       30 g
------------------------------------------------------------------------

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and a 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 (j)(13)(ii)(B) 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

[[Page 33]]

paragraph (d)(9) of this section, separated from that information by a 
hairline. This information may be presented horizontally as shown in 
paragraph (d)(12) of this section (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 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 nutrients and 
the percent DV 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 in) 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 as shown 
below.
[GRAPHIC] [TIFF OMITTED] TR11JY03.000


[[Page 34]]


    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR11JY03.001

    (13)(i) Nutrition labels on the outer label of packages of products 
that contain two or more separately packaged foods that are intended to 
be eaten individually (e.g., variety packs of cereals or snack foods) or 
of packages that are used interchangeably for the same type of food 
(e.g., round ice cream containers) may use an aggregate display.
    (ii) Aggregate displays shall comply with the format requirements of 
paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately under 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. The following 
sample label illustrates an aggregate display.

[[Page 35]]

[GRAPHIC] [TIFF OMITTED] TR11JY03.002

    (14) In accordance with Sec.  101.15(c)(2), when nutrition labeling 
must appear 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 food (e.g., both ``as purchased'' and ``as prepared'') or for 
common combinations of food as provided for in paragraph (h)(4) of this 
section, for different units (e.g., slices of bread or 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 shown in paragraph (e)(5) 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 food (e.g., ``Mix'' and ``Baked''), the combinations of food, 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

[[Page 36]]

amount in Sec.  101.12(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 food, for combinations of food, 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.  101.12(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.  101.12(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:

[[Page 37]]

[GRAPHIC] [TIFF OMITTED] TR11JY03.003

    (f) The declaration of nutrition information may be presented in the 
simplified format set forth herein when a food product contains 
insignificant amounts of eight or more of the following: Calories, total 
fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, 
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron; 
except that for foods intended for children less than 2 years of age to 
which Sec.  101.9(j)(5)(i) applies, nutrition information may be 
presented in the simplified format when a food product contains 
insignificant amounts of six or more of the following: Calories, total 
fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin 
A, vitamin C, calcium, and iron.
    (1) An ``insignificant amount'' shall be defined as that amount that 
allows a declaration of zero in nutrition labeling, except that for 
total carbohydrate, dietary fiber, and protein, it shall be an amount 
that allows a declaration of ``less than 1 gram.''
    (2) The simplified format shall include information on the following 
nutrients:
    (i) Total calories, total fat, total carbohydrate, protein, and 
sodium;
    (ii) Calories from fat and any other nutrients identified in 
paragraph (f) of this section that are present in the food in more than 
insignificant amounts; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are required to be added as a nutrient supplement 
to foods for which a standard of identity exists.
    (iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this 
section voluntarily added to the food as nutrient supplements.
    (3) Other nutrients that are naturally present in the food in more 
than insignificant amounts may be voluntarily declared as part of the 
simplified format.
    (4) If any nutrients are declared as provided in paragraphs 
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the 
simplified format or if any nutrition claims are made on the label or in 
labeling, the statement ``Not a significant source of ------'' (with the 
blank filled in with the name(s) of any nutrient(s) identified in Sec.  
101.9(f) and calories from fat that are present in insignificant 
amounts) shall be included at the bottom of the nutrition label.
    (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this 
section, 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.''

[[Page 38]]

    (g) Compliance with this section shall be determined as follows:
    (1) A collection of primary containers or units of the same size, 
type, and style produced under conditions as nearly uniform as possible, 
designated by a common container code or marking, or in the absence of 
any common container code or marking, a day's production, constitutes a 
``lot.''
    (2) The sample for nutrient analysis shall consist of a composite of 
12 subsamples (consumer units), taken 1 from each of 12 different 
randomly chosen shipping cases, to be representative of a lot. Unless a 
particular method of analysis is specified in paragraph (c) of this 
section, composites shall be analyzed by appropriate methods as given in 
the ``Official Methods of Analysis of the AOAC International,'' 15th Ed. 
(1990), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) or 1 CFR part 51 or, if no AOAC method is available or 
appropriate, by other reliable and appropriate analytical procedures. 
The availability of this incorporation by reference is given in 
paragraph (c)(7) of this section.
    (3) Two classes of nutrients are defined for purposes of compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient is 
added to a food, the total amount of such nutrient in the final food 
product is subject to class II requirements unless the same nutrient is 
also added.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated 
or monounsaturated fat, or potassium shall be deemed to be misbranded 
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) unless it meets the following requirements:
    (i) Class I vitamin, mineral, protein, dietary fiber, or potassium. 
The nutrient content of the composite is at least equal to the value for 
that nutrient declared on the label.
    (ii) Class II vitamin, mineral, protein, total carbohydrate, dietary 
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or 
potassium. The nutrient content of the composite is at least equal to 80 
percent of the value for that nutrient declared on the label. Provided, 
That no regulatory action will be based on a determination of a nutrient 
value that falls below this level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
    (5) A food with a label declaration of calories, sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 403(a) of the act if the nutrient content of 
the composite is greater than 20 percent in excess of the value for that 
nutrient declared on the label. Provided, That no regulatory action will 
be based on a determination of a nutrient value that falls above this 
level by a factor less than the variability generally recognized for the 
analytical method used in that food at the level involved.
    (6) Reasonable excesses of a vitamin, mineral, protein, total 
carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or 
monounsaturated fat, or potassium over labeled amounts are acceptable 
within current good manufacturing practice. Reasonable deficiencies of 
calories, sugars, total fat, saturated fat, trans fat, cholesterol, or 
sodium under labeled amounts are acceptable within current good 
manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of serving size.
    (8) Compliance with the provisions set forth in paragraphs (g)(1) 
through (g)(6) of this section may be provided by use of an FDA approved 
data base that has been computed following FDA guideline procedures and 
where food samples have been handled in accordance with current good 
manufacturing practice to prevent nutrition loss. FDA approval of a data 
base shall not be considered granted until the Center for Food Safety 
and Applied Nutrition has agreed to all aspects of the data base in 
writing. The approval will be granted where a clear need is presented 
(e.g., raw produce and seafood). Approvals will be in effect for a 
limited time, e.g.,

[[Page 39]]

10 years, and will be eligible for renewal in the absence of significant 
changes in agricultural or industry practices. Approval requests shall 
be submitted in accordance with the provisions of Sec.  10.30 of this 
chapter. Guidance in the use of data bases may be found in the ``FDA 
Nutrition Labeling Manual--A Guide for Developing and Using Data 
Bases,'' available from the Office of Nutritional Products, Labeling and 
Dietary Supplements (HFS-800), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.
    (9) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section (e.g., to develop adequate nutrient 
profiles to comply with the requirements of paragraph (c) of this 
section), FDA may permit alternative means of compliance or additional 
exemptions to deal with the situation. Firms in need of such special 
allowances shall make their request in writing to the Center for Food 
Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740.
    (h) Products with separately packaged ingredients or foods, with 
assortments of food, or to which other ingredients are added by the user 
may be labeled as follows:
    (1) If a product consists of two or more separately packaged 
ingredients enclosed in an outer container or of assortments of the same 
type of food (e.g., assorted nuts or candy mixtures) in the same retail 
package, nutrition labeling shall be located on the outer container or 
retail package (as the case may be) to provide information for the 
consumer at the point of purchase. However, when two or more food 
products are simply combined together in such a manner that no outer 
container is used, or no outer label is available, each product shall 
have its own nutrition information, e.g., two boxes taped together or 
two cans combined in a clear plastic overwrap. When separately packaged 
ingredients or assortments of the same type of food are intended to be 
eaten at the same time, the nutrition information may be specified per 
serving for each component or as a composite value.
    (2) If a product consists of two or more separately packaged foods 
that are intended to be eaten individually and that are enclosed in an 
outer container (e.g., variety packs of cereals or snack foods), the 
nutrition information shall:
    (i) Be specified per serving for each food in a location that is 
clearly visible to the consumer at the point of purchase; and
    (ii) Be presented in separate nutrition labels or in one aggregate 
nutrition label with separate columns for the quantitative amount by 
weight and the percent Daily Value for each food.
    (3) If a package contains a variety of foods, or an assortment of 
foods, and is in a form intended to be used as a gift, the nutrition 
labeling shall be in the form required by paragraphs (a) through (f) of 
this section, but it may be modified as follows:
    (i) Nutrition information may be presented on the label of the outer 
package or in labeling within or attached to the outer package.
    (ii) In the absence of a reference amount customarily consumed in 
Sec.  101.12(b) that is appropriate for the variety or assortment of 
foods in a gift package, 1 ounce for solid foods, 2 fluid ounces for 
nonbeverage liquids (e.g., syrups), and 8 fluid ounces for beverages may 
be used as the standard serving size for purposes of nutrition labeling 
of foods subject to this paragraph. However, the reference amounts 
customarily consumed in Sec.  101.12(b) shall be used for purposes of 
evaluating whether individual foods in a gift package qualify for 
nutrient content claims or health claims.
    (iii) The number of servings per container may be stated as 
``varied.''
    (iv) Nutrition information may be provided per serving for 
individual foods in the package, or, alternatively, as a composite per 
serving for reasonable categories of foods in the package having similar 
dietary uses and similar significant nutritional characteristics. 
Reasonable categories of foods may be used only if accepted by FDA. In 
determining whether a proposed category is reasonable, FDA will consider 
whether

[[Page 40]]

the values of the characterizing nutrients in the foods proposed to be 
in the category meet the compliance criteria set forth in paragraphs 
(g)(3) through (g)(6) of this section. Proposals for such categories may 
be submitted in writing to the Office of Nutritional Products, Labeling 
and Dietary Supplements (HFS-800), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.
    (v) If a food subject to paragraph (j)(13) of this section because 
of its small size is contained in a gift package, the food need not be 
included in the determination of nutrition information under paragraph 
(h) of this section if it is not specifically listed in a promotional 
catalogue as being present in the gift package, and:
    (A) It is used in small quantities primarily to enhance the 
appearance of the gift package; or
    (B) It is included in the gift package as a free gift or promotional 
item.
    (4) If a food 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 nutrition information on the basis of the food as 
consumed in the format required in paragraph (e) of this section (e.g., 
a dry ready-to-eat cereal may be described with one set of Percent Daily 
Values for the cereal as sold (e.g., per ounce), and another set for the 
cereal and milk as suggested in the label (e.g., per ounce of cereal and 
1/2 cup of vitamin D fortified skim milk); and a cake mix may be labeled 
with one set of Percent Daily Values for the dry mix (per serving) and 
another set for the serving of the final cake when prepared): 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.
    (i) Except as provided in paragraphs (j)(13) and (j)(17) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec.  101.2.
    (j) The following foods are exempt from this section or are subject 
to special labeling requirements:
    (1)(i) Food offered for sale by a person who makes direct sales to 
consumers (e.g., a retailer) who has annual gross sales made or business 
done in sales to consumers that is not more than $500,000 or has annual 
gross sales made or business done in sales of food to consumers of not 
more than $50,000, Provided, That the food bears no nutrition claims or 
other nutrition information in any context on the label or in labeling 
or advertising. Claims or other nutrition information subject the food 
to the provisions of this section.
    (ii) For purposes of this paragraph, calculation of the amount of 
sales shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years, 
reasonable estimates must indicate that annual sales will not exceed the 
amounts specified. For foreign firms that ship foods into the United 
States, the business activities to be included shall be the total amount 
of food sales, as well as other sales to consumers, by the firm in the 
United States.
    (2) Food products which are:
    (i) Served in restaurants, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section;
    (ii) Served in other establishments in which food is served for 
immediate human consumption (e.g., institutional food service 
establishments, such as schools, hospitals, and cafeterias; 
transportation carriers, such as trains and airplanes; bakeries, 
delicatessens, and retail confectionery stores where there are 
facilities for immediate consumption on the premises; food service 
vendors, such as lunch wagons, ice cream shops, mall cookie counters, 
vending machines, and sidewalk carts where foods are generally consumed 
immediately where purchased or while the consumer is walking away, 
including similar foods sold from convenience stores; and food delivery 
systems or establishments where ready-to-eat foods are delivered to 
homes or offices), Provided, That the food bears no nutrition

[[Page 41]]

claims or other nutrition information in any context on the label or in 
labeling or advertising. Claims or other nutrition information subject 
the food to the provisions of this section;
    (iii) Sold only in such facilities, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section;
    (iv) Used only in such facilities and not served to the consumer in 
the package in which they are received (e.g., foods that are not 
packaged in individual serving containers); or
    (v) Sold by a distributor who principally sells food to such 
facilities: Provided, That:
    (A) This exemption shall not be available for those foods that are 
manufactured, processed, or repackaged by that distributor for sale to 
any persons other than restaurants or other establishments that serve 
food for immediate human consumption, and
    (B) The manufacturer of such products is responsible for providing 
the nutrition information on the products if there is a reasonable 
possibility that the product will be purchased directly by consumers.
    (3) Food products that are:
    (i) Of the type of food described in paragraphs (j)(2)(i) and 
(j)(2)(ii) of this section,
    (ii) Ready for human consumption,
    (iii) Offered for sale to consumers but not for immediate human 
consumption,
    (iv) Processed and prepared primarily in a retail establishment, and
    (v) Not offered for sale outside of that establishment (e.g., ready-
to-eat foods that are processed and prepared on-site and sold by 
independent delicatessens, bakeries, or retail confectionery stores 
where there are no facilities for immediate human consumption; by in-
store delicatessen, bakery, or candy departments; or at self-service 
food bars such as salad bars), Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section.
    (4) Foods that contain insignificant amounts of all of the nutrients 
and food components required to be included in the declaration of 
nutrition information under paragraph (c) of this section, Provided, 
That the food bears no nutrition claims or other nutrition information 
in any context on the label or in labeling or advertising. Claims or 
other nutrition information subject the food to the provisions of this 
section. An insignificant amount of a nutrient or food component shall 
be that amount that allows a declaration of zero in nutrition labeling, 
except that for total carbohydrate, dietary fiber, and protein, it shall 
be an amount that allows a declaration of ``less than 1 gram.'' Examples 
of foods that are exempt under this paragraph include coffee beans 
(whole or ground), tea leaves, plain unsweetened instant coffee and tea, 
condiment-type dehydrated vegetables, flavor extracts, and food colors.
    (5)(i) Foods, other than infant formula, represented or purported to 
be specifically for infants and children less than 2 years of age shall 
bear nutrition labeling, except as provided in paragraph (j)(5)(ii) and 
except that such labeling shall not include calories from fat (paragraph 
(c)(1)(ii) of this section), calories from saturated fat ((c)(1)(iii)), 
saturated fat ((c)(2)(i)), polyunsaturated fat ((c)(2)(ii)), 
monounsaturated fat ((c)(2)(iii)), and cholesterol ((c)(3)).
    (ii) Foods, other than infant formula, represented or purported to 
be specifically for infants and children less than 4 years of age shall 
bear nutrition labeling, except that:
    (A) Such labeling shall not include declarations of percent of Daily 
Value for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber;
    (B) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns.
    (C) The heading ``Percent Daily Value'' required in paragraph (d)(6) 
of this section shall be placed immediately below the quantitative 
information by weight for protein;
    (D) Percent of Daily Value for protein, vitamins, and minerals shall 
be listed immediately below the heading ``Percent Daily Value''; and

[[Page 42]]

    (E) Such labeling shall not include the footnote specified in 
paragraph (d)(9) of this section.
    (6) Dietary supplements, except that such foods shall be labeled in 
compliance with Sec.  101.36.
    (7) Infant formula subject to section 412 of the act, as amended, 
except that such foods shall be labeled in compliance with part 107 of 
this chapter.
    (8) Medical foods as defined in section 5(b) of the Orphan Drug Act 
(21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to 
be consumed or administered enterally under the supervision of a 
physician and which is intended for the specific dietary management of a 
disease or condition for which distinctive nutritional requirements, 
based on recognized scientific principles, are established by medical 
evaluation. A food is subject to this exemption only if:
    (i) It is a specially formulated and processed product (as opposed 
to a naturally occurring foodstuff used in its natural state) for the 
partial or exclusive feeding of a patient by means of oral intake or 
enteral feeding by tube;
    (ii) It is intended for the dietary management of a patient who, 
because of therapeutic or chronic medical needs, has limited or impaired 
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or 
certain nutrients, or who has other special medically determined 
nutrient requirements, the dietary management of which cannot be 
achieved by the modification of the normal diet alone;
    (iii) It provides nutritional support specifically modified for the 
management of the unique nutrient needs that result from the specific 
disease or condition, as determined by medical evaluation;
    (iv) It is intended to be used under medical supervision; and
    (v) It is intended only for a patient receiving active and ongoing 
medical supervision wherein the patient requires medical care on a 
recurring basis for, among other things, instructions on the use of the 
medical food.
    (9) Food products shipped in bulk form that are not for distribution 
to consumers in such form and that are for use solely in the manufacture 
of other foods or that are to be processed, labeled, or repacked at a 
site other than where originally processed or packed.
    (10) Raw fruits, vegetables, and fish subject to section 403(q)(4) 
of the act, except that the labeling of such foods should adhere to 
guidelines in Sec.  101.45. This exemption is contingent on the food 
bearing no nutrition claims or other nutrition information in any 
context on the label or in labeling or advertising. Claims or other 
nutrition information subject the food to nutrition labeling in 
accordance with Sec.  101.45. The term fish includes freshwater or 
marine fin fish, crustaceans, and mollusks, including shellfish, 
amphibians, and other forms of aquatic animal life.
    (11) Packaged single-ingredient products that consist of fish or 
game meat (i.e., animal products not covered under the Federal Meat 
Inspection Act or the Poultry Products Inspection Act, such as flesh 
products from deer, bison, rabbit, quail, wild turkey, or ostrich) 
subject to this section may provide required nutrition information for a 
3-ounce cooked edible portion (i.e., on an ``as prepared'' basis), 
except that:
    (i) Such products that make claims that are based on values as 
packaged must provide nutrition information on an as packaged basis, and
    (ii) Nutrition information is not required for custom processed fish 
or game meats.
    (12) Game meats (i.e., animal products not covered under the Federal 
Meat Inspection Act or the Poultry Products Inspection Act, such as 
flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich) 
may provide required nutrition information on labeling in accordance 
with the provisions of paragraph (a)(2) of this section.
    (13)(i) Foods in small packages that have a total surface area 
available to bear labeling of less than 12 square inches, Provided, That 
the labels for these foods bear no nutrition claims or other nutrition 
information in any context on the label or in labeling or advertising. 
Claims or other nutrition information subject the food to the provisions 
of this section.
    (A) The manufacturer, packer, or distributor shall provide on the 
label of packages that qualify for and use this

[[Page 43]]

exemption an address or telephone number that a consumer can use to 
obtain the required nutrition information (e.g., ``For nutrition 
information, call 1-800-123-4567'').
    (B) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in type size no smaller than 6 point 
or all uppercase type of 1/16 inches minimum height, except that 
individual serving-size packages of food served with meals in 
restaurants, institutions, and on board passenger carriers, and not 
intended for sale at retail, may comply with Sec.  101.2(c)(5).
    (ii) 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) and (i) of this section by one or more of the 
following means:
    (A) Presenting the required nutrition information in a tabular or, 
as provided below, 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 label will not accommodate a 
tabular display.
    (1) The following sample label illustrates the tabular display.
    [GRAPHIC] [TIFF OMITTED] TR11JY03.004
    
    (2) The following sample label illustrates the linear display. When 
nutrition information is given in a linear fashion, bolding is required 
only on the title ``Nutrition Facts`` and is allowed voluntarily for the 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
[GRAPHIC] [TIFF OMITTED] TR11JY03.005

    (B) 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

[[Page 44]]

Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb

    (C) 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.''
    (D) Presenting the required nutrition information on any label 
panel.
    (14) Shell eggs packaged in a carton that has a top lid designed to 
conform to the shape of the eggs are exempt from outer carton label 
requirements where the required nutrition information is clearly 
presented immediately beneath the carton lid or in an insert that can be 
clearly seen when the carton is opened.
    (15) The unit containers in a multiunit retail food package where:
    (i) The multiunit retail food package labeling contains all 
nutrition information in accordance with the requirements of this 
section;
    (ii) The unit containers are securely enclosed within and not 
intended to be separated from the retail package under conditions of 
retail sale; and
    (iii) Each unit container is labeled with the statement ``This Unit 
Not Labeled For Retail Sale'' in type size not less than 1/16-inch in 
height, except that this statement shall not be required when the inner 
unit containers bear no labeling at all. The word ``individual'' may be 
used in lieu of or immediately preceding the word ``Retail'' in the 
statement.
    (16) Food products sold from bulk containers: Provided, That 
nutrition information required by this section be displayed to consumers 
either on the labeling of the bulk container plainly in view or in 
accordance with the provisions of paragraph (a)(2) of this section.
    (17) Foods in packages that have a total surface area available to 
bear labeling greater than 40 square inches but whose principal display 
panel and information panel do not provide sufficient space to 
accommodate all required information may use any alternate panel that 
can be readily seen by consumers for the nutrition label. The space 
needed for vignettes, designs, and other nonmandatory label information 
on the principal display panel may be considered in determining the 
sufficiency of available space on the principal display panel for the 
placement of the nutrition label. Nonmandatory label information on the 
information panel shall not be considered in determining the sufficiency 
of available space for the placement of the nutrition label.
    (18) Food products that are low-volume (that is, they meet the 
requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of 
this section); that, except as provided in paragraph (j)(18)(iv) of this 
section, are the subject of a claim for an exemption that provides the 
information required under paragraph (j)(18)(iv) of this section, that 
is filed before the beginning of the time period for which the exemption 
is claimed, and that is filed by a person, whether it is the 
manufacturer, packer, or distributor, that qualifies to claim the 
exemption under the requirements for average full-time equivalent 
employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and 
whose labels, labeling, and advertising do not provide nutrition 
information or make a nutrient content or health claim.
    (i) For food products first introduced into interstate commerce 
before May 8, 1994, the product shall be exempt for the period:
    (A) Between May 8, 1995, and May 7, 1996, if, for the period between 
May 8, 1994, and May 7, 1995, the person claiming the exemption employed 
fewer than an average of 300 full-time equivalent employees and fewer 
than 400,000 units of that product were sold in the United States; and
    (B) Between May 8, 1996, and May 7, 1997, if for the period between 
May 8, 1995, and May 7, 1996, the person claiming the exemption employed 
fewer than an average of 200 full-time equivalent employees and fewer 
than 200,000 units of that product were sold in the United States.
    (ii) For all other food products, the product shall be eligible for 
an exemption for any 12-month period if, for the

[[Page 45]]

preceding 12 months, the person claiming the exemption employed fewer 
than an average of 100 full-time equivalent employees and fewer than 
100,000 units of that product were sold in the United States, or in the 
case of a food product that was not sold in the 12-month period 
preceding the period for which exemption is claimed, fewer than 100,000 
units of such product are reasonably anticipated to be sold in the 
United States during the period for which exemption is claimed.
    (iii) If a person claims an exemption under paragraphs (j)(18)(i) or 
(j)(18)(ii) of this section for a food product and then, during the 
period of such exemption, the number of full-time equivalent employees 
of such person exceeds the appropriate number, or the number of food 
products sold in the United States exceeds the appropriate number, or, 
if at the end of the period of such exemption, the food product no 
longer qualifies for an exemption under the provisions of paragraphs 
(j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 
months from the date that the product was no longer qualified as a low-
volume product of a small business to comply with this section.
    (iv) A notice shall be filed with the Office of Nutritional 
Products, Labeling and Dietary Supplements (HFS-800), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740 and contain the following 
information, except that if the person is not an importer and has fewer 
than 10 full-time equivalent employees, that person does not have to 
file a notice for any food product with annual sales of fewer than 
10,000 total units:
    (A) Name and address of person requesting exemption. This should 
include a telephone number or FAX number that can be used to contact the 
person along with the name of a specific contact;
    (B) Names of the food products (including the various brand names) 
for which exemption is claimed;
    (C) Name and address of the manufacturer, distributor, or importer 
of the food product for which an exemption is claimed, if different than 
the person that is claiming the exemption;
    (D) The number of full-time equivalent employees. Provide the 
average number of full-time equivalent individuals employed by the 
person and its affiliates for the 12 months preceding the period for 
which a small business exemption is claimed for a product. The average 
number of full-time equivalent employees is to be determined by dividing 
the total number of hours of salary or wages paid to employees of the 
person and its affiliates by the number of hours of work in a year, 
2,080 hours (i.e., 40 hoursx52 weeks);
    (E) Approximate total number of units of the food product sold by 
the person in the United States in the 12-month period preceding that 
for which a small business exemption is claimed. Provide the approximate 
total number of units sold, or expected to be sold, in a 12-month period 
for each product for which an exemption is claimed. For products that 
have been in production for 1 year or more prior to the period for which 
exemption is claimed, the 12-month period is the period immediately 
preceding the period for which an exemption is claimed. For other 
products, the 12-month period is the period for which an exemption is 
claimed; and
    (F) The notice shall be signed by a responsible individual for the 
person who can certify the accuracy of the information presented in the 
notice. The individual shall certify that the information contained in 
the notice is a complete and accurate statement of the average number of 
full-time equivalent employees of this person and its affiliates and of 
the number of units of the product for which an exemption is claimed 
sold by the person. The individual shall also state that should the 
average number of full-time equivalent employees or the number of units 
of food products sold in the United States by the person exceed the 
applicable numbers for the time period for which exemption is claimed, 
the person will notify FDA of that fact and the date on which the number 
of employees or the number of products sold exceeded the standard.
    (v) FDA may by regulation lower the employee or units of food 
products requirements of paragraph (j)(18)(ii) of this section for any 
food product first

[[Page 46]]

introduced into interstate commerce after May 8, 2002, if the agency 
determines that the cost of compliance with such lower requirement will 
not place an undue burden on persons subject to it.
    (vi) For the purposes of this paragraph, the following definitions 
apply:
    (A) Unit means the packaging or, if there is no packaging, the form 
in which a food product is offered for sale to consumers.
    (B) Food product means food in any sized package which is 
manufactured by a single manufacturer or which bears the same brand 
name, which bears the same statement of identity, and which has similar 
preparation methods.
    (C) Person means all domestic and foreign affiliates, as defined in 
13 CFR 121.401, of the corporation, in the case of a corporation, and 
all affiliates, as defined in 13 CFR 121.401, of a firm or other entity, 
when referring to a firm or other entity that is not a corporation.
    (D) Full-time equivalent employee means all individuals employed by 
the person claiming the exemption. This number shall be determined by 
dividing the total number of hours of salary or wages paid directly to 
employees of the person and of all of its affiliates by the number of 
hours of work in a year, 2,080 hours (i.e., 40 hoursx52 weeks).
    (k) A food labeled under the provisions of this section shall be 
deemed to be misbranded under sections 201(n) and 403(a) of the act if 
its label or labeling represents, suggests, or implies:
    (1) That the food, because of the presence or absence of certain 
dietary properties, is adequate or effective in the prevention, cure, 
mitigation, or treatment of any disease or symptom. Information about 
the relationship of a dietary property to a disease or health-related 
condition may only be provided in conformance with the requirements of 
Sec.  101.14 and part 101, subpart E.
    (2) That the lack of optimum nutritive quality of a food, by reason 
of the soil on which that food was grown, is or may be responsible for 
an inadequacy or deficiency in the quality of the daily diet.
    (3) That the storage, transportation, processing, or cooking of a 
food is or may be responsible for an inadequacy or deficiency in the 
quality of the daily diet.
    (4) That a natural vitamin in a food is superior to an added or 
synthetic vitamin.

[58 FR 2175, Jan. 6, 1993, as amended at 58 FR 2227, 2533, Jan. 6, 1993; 
58 FR 17104, Apr. 1, 1993; 58 FR 17328-17331, Apr. 2, 1993; 58 FR 44048, 
44076, Aug. 18, 1993; 58 FR 59363, Nov. 9, 1993; 58 FR 60109, Nov. 15, 
1993; 59 FR 371, Jan. 4, 1994; 59 FR 62317, Dec. 5, 1994; 60 FR 17205, 
Apr. 5, 1995; 60 FR 30788, June 12, 1995; 60 FR 67174, Dec. 28, 1995; 61 
FR 8779, Mar. 5, 1996; 61 FR 14479, Apr. 2, 1996; 61 FR 40978, Aug. 7, 
1996; 62 FR 15342, Mar. 31, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 
14035, Mar. 24, 1998; 64 FR 12889, Mar. 16, 1999; 65 FR 56479, Sept. 19, 
2000; 66 FR 56035, Nov. 6, 2001; 70 FR 41502, July 11, 2005]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 101, Section 9


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