[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.309]
[Page 185-204]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317_LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B_Nutrition Labeling
Sec. 317.309 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(1) The term ``serving'' or ``serving size'' means an amount of
food customarily consumed per eating occasion by persons 4 years of age
or older, which is expressed in a common household measure that is
appropriate to the product. When the product is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the ``Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply'' (Reference Amount(s)) that appear in Sec.
317.312(b) using the procedures described in this paragraph (b). For
products that are both intended for weight control and available only
through a weight-control program, a manufacturer may determine the
serving size that is consistent with the meal plan of the program. Such
products must bear a statement, ``for sale only through the ------
program'' (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display
panel. However, the Reference Amounts in Sec. 317.312(b) shall be used
for purposes of evaluating whether weight-control products that are
available only through a weight-control program qualify for nutrition
claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product ``as packaged'' for all products, except
that single-ingredient, raw products may be declared on the basis of the
product ``as consumed'' as set forth in Sec. 317.345(a)(1). In addition
to the required declaration on the basis of ``as packaged'' for products
other than single-ingredient, raw products, the declaration may also be
made on the basis of ``as consumed,'' provided that preparation and
cooking instructions are clearly stated.
(4) For products in discrete units (e.g., hot dogs, and individually
packaged products within a multi-serving package), and for products
which consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is in
discrete units (e.g., beef fritters and barbecue sauce), the serving
size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount, the
serving size shall be the number of whole units that most closely
approximates the
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Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent
of the Reference Amount, the manufacturer may declare one unit or two
units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or
milliliter) or larger and are individual units within a multi-serving
package, if a unit contains more than 150 percent but less than 200
percent of the Reference Amount, the manufacturer may decide whether to
declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., beef fritters and
barbecue sauce), the serving size may be the number of discrete units
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product as determined
in Sec. 317.312(c).
(vii) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza), for unprepared products where the entire
contents of the package is used to prepare large discrete units that are
usually divided for consumption (e.g. pizza kit), and for products which
consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is a
large discrete unit usually divided for consumption, the serving size
shall be the fractional slice of the ready-to-eat product (e.g., \1/8\
quiche, \1/4\ pizza) that most closely approximates the Reference Amount
for the product category. The serving size may be the fraction of the
package used to make the Reference Amount for the unprepared product
determined in Sec. 317.312(d) or the fraction of the large discrete
unit represented as the main ingredient plus proportioned minor
ingredients used to make the Reference Amount of the combined product
determined in Sec. 317.312(c). In expressing the fractional slice,
manufacturers shall use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller
fractions that can be generated by further division by 2 or 3.
(6) For nondiscrete bulk products (e.g., whole roast beef, marinated
beef tenderloin, large can of chili), and for products which consist of
two or more foods packaged and presented to be consumed together where
the ingredient represented as the main ingredient is a bulk product
(e.g., roast beef and gravy), the serving size shall be the amount in
household measure that most closely approximates the Reference Amount
for the product category and may be the amount of the bulk product
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product determined in
Sec. 317.312(c).
(7) For labeling purposes, the term ``common household measure'' or
``common household unit'' means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household
equipment used to package food products (e.g., jar or tray). In
expressing serving size in household measures, except as specified in
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following
rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1 \2/3\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
[[Page 187]]
teaspoons for quantities less than 1 tbsp but greater than or equal to 1
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1
tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce increments most
closely approximating the Reference Amount with rounding indicated by
the use of the term ``about'' (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and for individually packaged
products within multi-serving containers (e.g., can, box, package, meal,
or dinner). A description of the individual unit shall be used for other
products in discrete units (e.g., chop, slice, link, or patty).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., pizza kit), the fraction or portion of the package
may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g., ham
with a glaze packet), the nutrition information may be declared for each
component or as a composite. The serving size may be provided in
accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6)
of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz
in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 317.312(b) and the procedures described in this section, falls
exactly half way between two serving sizes (e.g., 2.5 tbsp),
manufacturers shall round the serving size up to the next incremental
size.
(8) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable Reference Amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving, except for products that
have Reference Amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the Reference Amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
Reference Amount may be labeled as a single-serving if the entire
content of the package can reasonably be consumed at a single-eating
occasion.
(9) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(8) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to paragraph
(b)(11) of this section. However, if a manufacturer voluntarily provides
the metric quantity on products that can be sold as single-servings,
then the numerical value provided as part of the serving size
declaration must be identical to the metric quantity declaration
provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between 2
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL)
quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce, in
parenthesis, following the metric measure separated by a slash where
other common household measures are used as the primary unit for serving
size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity
equivalent to the metric
[[Page 188]]
quantity should be expressed in 0.1-oz increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, and oz for ounce.
(10) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term ``about'' (e.g., about 2 servings;
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size (e.g., pickled pigs feet), the manufacturer may
state the typical number of servings per container (e.g., usually 5
servings).
(iii) For random weight products, a manufacturer may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the Reference Amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the ``varied'' statement (e.g., varied
(approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the number of servings shall be the number of individual packages within
the total package.
(v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by multiplying
the number of individual multi-serving units in the total package by the
number of servings in each individual unit.
(11) The declaration of nutrient and food component content shall be
on the basis of product as packaged or purchased with the exception of
products that are packed or canned in water, brine, or oil but whose
liquid packing medium is not customarily consumed. Declaration of the
nutrient and food component content of products that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(12) The serving size for meal-type products and main-dish products
as defined in Sec. 317.313(l) and Sec. 317.313(m) in single-serving
containers will be the entire edible content of the package. Serving
size for meal-type products and main-dish products in multi-serve
containers will be based on the reference amount applicable to the
product in Sec. 317.312(b) if the product is listed in Sec.
317.312(b). Serving size for meal-type products and main-dish products
in multi-serve containers that are not listed in Sec. 317.312(b) will
be based on the reference amount according to Sec. 317.312(c), (d), and
(e).
(13) Another column of figures may be used to declare the nutrient
and food component information in the same format as required by Sec.
317.309(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as
packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete units
in a multi-serving container is more than one unit.
(14) If a product consists of assortments of meat or meat food
products (e.g., variety packs) in the same package, nutrient content
shall be expressed on the entire package contents or on each individual
product.
(15) If a product is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare the nutrient contents on the basis of the product as
consumed for the product alone (e.g., a cream soup mix may be labeled
with one set of Daily Values for the dry mix (per serving), and another
set for the serving of the final soup when prepared (e.g., per serving
of cream soup mix and 1 cup of vitamin D fortified whole milk)):
Provided, That the type and quantity of
[[Page 189]]
the other ingredients to be added to the product by the user and the
specific method of cooking and other preparation shall be specified
prominently on the label.
(c) The declaration of nutrition information on the label or in
labeling of a meat or meat food product shall contain information about
the level of the following nutrients, except for those nutrients whose
inclusion, and the declaration of amounts, is voluntary as set forth in
this paragraph. No nutrients or food components other than those listed
in this paragraph as either mandatory or voluntary may be included
within the nutrition label. Except as provided for in paragraph (f) or
(g) of this section, nutrient information shall be presented using the
nutrient names specified and in the following order in the formats
specified in paragraph (d) or (e) of this section.
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parenthesis immediately following
the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,''
by A. L. Merrill and B. K. Watt, United States Department of Agriculture
(USDA), Agriculture Handbook No. 74 (Slightly revised February 1973),
which is incorporated by reference. Table 13 of the ``Energy Value of
Foods--Basis and Derivation,'' Agriculture Handbook No. 74 is
incorporated as it exists on the date of approval. This incorporation by
reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for
inspection at the office of the FSIS Docket Clerk, Room 3171, South
Building, 14th and Independence Avenue, SW., Washington, DC, or 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. Copies of the incorporation by
reference are available from the Product Assessment Division, Regulatory
Programs, Food Safety and Inspection Service, U.S. Department of
Agriculture, Room 329, West End Court Building, Washington, DC 20250-
3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973),
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture
Handbook No. 74 is incorporated as it exists on the date of approval.
This incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(The availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA's Agriculture Handbook
No. 74 (Slightly revised February 1973), pages 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. (The availability of this incorporation by reference is given
in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of 21 CFR, or by other means, as
appropriate.
(ii) ``Calories from fat'': A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section
per serving, expressed to the nearest 5-calorie increment, up to
[[Page 190]]
and including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of ``calories from fat'' is not
required on products that contain less than 0.5 gram of fat per serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section.
(iii) ``Calories from saturated fat'' or ``Calories from saturated''
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section per serving may be
declared voluntarily, expressed to the nearest 5-calorie increment, up
to and including 50 calories, and the nearest 10-calorie increment above
50 calories, except that amounts less than 5 calories may be expressed
as zero. This statement shall be indented under the statement of
calories from fat as provided in paragraph (d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat per serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram, the
content shall be expressed as zero.
(i) ``Saturated fat'' or ``Saturated'': A statement of the number of
grams of saturated fat per serving defined as the sum of all fatty acids
containing no double bonds, except that label declaration of saturated
fat content information is not required for products that contain less
than 0.5 gram of total fat per serving if no claims are made about fat
or cholesterol content, and if ``calories from saturated fat'' is not
declared. Saturated fat content shall be indented and expressed as grams
per serving to the nearest 0.5 (\1/2\)-gram increment below 5 grams and
to the nearest gram increment above 5 grams. If the serving contains
less than 0.5 gram, the content shall be expressed as zero.
(A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of grams
of stearic acid per serving may be declared voluntarily, except that
when a claim is made about stearic acid, label declaration shall be
required. Stearic acid content shall be indented under saturated fat and
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and
the nearest gram increment above 5 grams. If the serving contains less
than 0.5 gram, the content shall be expressed as zero.
(B) [Reserved]
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat per serving
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may
be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a product other than one that meets the
criteria in Sec. 317.362(b)(1) for a claim for ``fat free,'' label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram, the
content shall be expressed as zero.
(iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat per serving
defined as cis-monounsaturated fatty acids may be declared voluntarily,
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
product other than one that meets the criteria in Sec. 317.362(b)(1)
for a claim for ``fat free,'' label declaration of monounsaturated fat
is required. Monounsaturated fat content shall be indented and expressed
as grams per serving to the nearest 0.5 (\1/2\)-gram increment below 5
grams and to the nearest gram increment above 5 grams. If the serving
contains less than 0.5 gram, the content shall be expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content per
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not required
for products that contain less than 2 milligrams of cholesterol per
serving and make no claim about fat, fatty acids, or cholesterol
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content, or such products may state the cholesterol content as zero. If
the product contains 2 to 5 milligrams of cholesterol per serving, the
content may be stated as ``less than 5 milligrams.''
(4) ``Sodium'': A statement of the number of milligrams of sodium
per serving expressed as zero when the serving contains less than 5
milligrams of sodium, to the nearest 5-milligram increment when the
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140
milligrams.
(5) ``Potassium'' (VOLUNTARY): A statement of the number of
milligrams of potassium per serving may be declared voluntarily, except
that when a claim is made about potassium content, label declaration
shall be required. Potassium content shall be expressed as zero when the
serving contains less than 5 milligrams of potassium, to the nearest 5-
milligram increment when the serving contains 5 to 140 milligrams of
potassium, and to the nearest 10-milligram increment when the serving
contains greater than 140 milligrams.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate per serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, or, if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the product. This
calculation method is described in USDA's Agriculture Handbook No. 74
(Slightly revised February 1973), pages 2 and 3, which is incorporated
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated
as it exists on the date of approval. This incorporation by reference
was approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this
incorporation by reference is given in paragraph (c)(1)(i)(A) of this
section.)
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber per serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required, or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5 gram, the content may be expressed
as zero.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about insoluble
fiber, label declaration shall be required. Insoluble fiber content
shall be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(ii) ``Sugars'': A statement of the number of grams of sugars per
serving, except that label declaration of sugars content is not required
for products that contain less than 1 gram of sugars per serving if no
claims are made about sweeteners, sugars, or sugar alcohol content.
Sugars shall be defined as the sum of all free mono- and disaccharides
(such as glucose, fructose, lactose, and sucrose). Sugars content shall
be indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1
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gram'' may be used as an alternative, and if the serving contains less
than 0.5 gram, the content may be expressed as zero.
(iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols per serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
product, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of
the term ``sugar alcohol,'' the name of the specific sugar alcohol
(e.g., ``xylitol'') present in the product may be used in the nutrition
label, provided that only one sugar alcohol is present in the product.
Sugar alcohol content shall be indented and expressed to the nearest
gram, except that if a serving contains less than 1 gram, the statement
``Contains less then 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number
of grams of other carbohydrate per serving may be declared voluntarily.
Other carbohydrate shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it shall
be defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars. Other carbohydrate content shall be indented
and expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less
than 1 gram'' may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
(7) ``Protein'': A statement of the number of grams of protein per
serving expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less
than 1 gram'' may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero. When the
protein in products represented or purported to be for adults and
children 4 or more years of age has a protein quality value that is a
protein digestibility-corrected amino acid score of less than 20
expressed as a percent, or when the protein in a product represented or
purported to be for children greater than 1 but less than 4 years of age
has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 40 expressed as a percent, either of the
following shall be placed adjacent to the declaration of protein content
by weight: The statement ``not a significant source of protein,'' or a
listing aligned under the column headed ``Percent Daily Value'' of the
corrected amount of protein per serving, as determined in paragraph
(c)(7)(ii) of this section, calculated as a percentage of the Daily
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate,
for protein and expressed as percent of Daily Value. When the protein
quality in a product as measured by the Protein Efficiency Ratio (PER)
is less than 40 percent of the reference standard (casein) for a product
represented or purported to be for infants, the statement ``not a
significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by appropriate methods of analysis in accordance with Sec.
317.309(h), except when the procedure for a specific food requires
another factor.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for infants or
children under 4 years of age. When such a declaration is provided, it
[[Page 193]]
shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed ``Percent Daily Value,'' and
expressed to the nearest whole percent. However, the percentage of the
RDI for protein shall not be declared if the product is represented or
purported to be for infants and the protein quality value is less than
40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for
products represented or purported to be for adults and children 1 or
more years of age is equal to the actual amount of protein (grams) per
serving multiplied by the amino acid score corrected for protein
digestibility. If the corrected score is above 1.00, then it shall be
set at 1.00. The protein digestibility-corrected amino acid score shall
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report
of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation,'' as published by the Food and Agriculture Organization of
the United Nations/World Health Organization, is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the
office of the FSIS Docket Clerk, Room 3171, South Building, 14th and
Independence Avenue, SW., Washington, DC, or 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. Copies of the incorporation by reference are available
from the Product Assessment Division, Regulatory Programs, Food Safety
and Inspection Service, U.S. Department of Agriculture, Room 329, West
End Court Building, Washington, DC 20250-3700. For products represented
or purported to be for infants, the corrected amount of protein (grams)
per serving is equal to the actual amount of protein (grams) per serving
multiplied by the relative protein quality value. The relative protein
quality value shall be determined by dividing the subject product's
protein PER value by the PER value for casein. If the relative protein
value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI,
a value of 50 grams of protein shall be the DRV for adults and children
4 or more years of age, and the RDI for protein for children less than 4
years of age, infants, pregnant women, and lactating women shall be 16
grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d) through (g) of this section, products
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For products represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the RDI
values for infants from birth to 12 months of age and for children under
4 years of age. Similarly, the percent of Daily Value based on both the
RDI values for pregnant women and for lactating women shall be declared
separately on products represented or purported to be for use by both
pregnant and lactating women. When such dual declaration is used on any
label, it shall be included in all labeling, and equal prominence shall
be given to both values in all such labeling. All other products shall
use the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and
[[Page 194]]
minerals listed in paragraph (c)(8)(iv) of this section when they are
added, or when a claim is made about them. Other vitamins and minerals
need not be declared if neither the nutrient nor the component is
otherwise referred to on the label or in labeling or advertising and the
vitamins and minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and
declared only in the ingredients statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement ``Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients).'' Alternatively, if vitamin A, vitamin C,
calcium, or iron is present in amounts less than 2 percent of the RDI,
label declaration of the nutrient(s) is not required if the statement
``Not a significant source of ------ (listing the vitamins or minerals
omitted)'' is placed at the bottom of the table of nutrient values.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams
(v) The following synonyms may be added in parenthesis immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent of
Daily Value of vitamin A in the product (e.g., ``Percent Daily Value:
Vitamin A 50 (90 percent as beta-carotene)''). When declared, the
percentages shall be expressed in the same increments as are provided
for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Food component Unit of measurement DRV
------------------------------------------------------------------------
Fat................................... grams (g)............... 65
Saturated fatty acids................. do...................... 20
Cholesterol........................... milligrams (mg)......... 300
Total carbohydrate.................... grams (g)............... 300
Fiber................................. do...................... 25
Sodium................................ milligrams (mg)......... 2,400
Potassium............................. do...................... 3,500
[[Page 195]]
Protein............................... grams (g)............... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on products in the following format, except
on products on which dual columns of nutrition information are declared
as provided for in paragraph (e) of this section, on those products on
which the simplified format is permitted to be used as provided for in
paragraph (f) of this section, on products for infants and children less
than 4 years of age as provided for in Sec. 317.400(c), and on products
in packages that have a total surface area available to bear labeling of
40 or less square inches as provided for in paragraph (g) of this
section.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section,
and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and
(d)(8) of this section shall be in type size no smaller than 8 point.
Except for the heading ``Nutrition Facts,'' the information required in
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other
information contained within the nutrition label shall be in type size
no smaller than 6 point. When provided, the information described in
paragraph (d)(10) of this section shall also be in type no smaller than
6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and
``% Daily Value*''), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate,
and Protein), and the percentage amounts required by paragraph
(d)(7)(ii) of this section shall be highlighted by bold or extra bold
type or other highlighting (reverse printing is not permitted as a form
of highlighting) that prominently distinguishes it from other
information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall
separate ``Amount Per Serving'' from the calorie statements required in
paragraph (d)(5) of this section and shall separate each nutrient and
its corresponding percent of Daily Value required in paragraphs
(d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent
of Daily Value above and below it.
(2) The information shall be presented under the identifying heading
of ``Nutrition Facts'' which shall be set in a type size larger than all
other print size in the nutrition label and, except for labels presented
according to the format provided for in paragraph (d)(11) of this
section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section.
(3) Information on serving size shall immediately follow the
heading. Such information shall include:
(i) ``Serving Size'': A statement of the serving size as specified
in paragraph (b)(9) of this section.
(ii) ``Servings Per Container'': The number of servings per
container, except that this statement is not required on single-serving
containers as defined in paragraph (b)(8) of this section.
(4) A subheading ``Amount Per Serving'' shall be separated from
serving size information by a bar.
(5) Information on calories shall immediately follow the heading
``Amount Per Serving'' and shall be declared in one line, leaving
sufficient space between the declaration of ``Calories'' and ``Calories
from fat'' to allow clear differentiation, or, if ``Calories from
saturated fat'' is declared, in a column with total ``Calories'' at the
top, followed by ``Calories from fat'' (indented), and ``Calories from
saturated fat'' (indented).
(6) The column heading ``% Daily Value,'' followed by an asterisk
(e.g.,
[[Page 196]]
``% Daily Value*''), shall be separated from information on calories by
a bar. The position of this column heading shall allow for a list of
nutrient names and amounts as described in paragraph (d)(7) of this
section to be to the left of, and below, this column heading. The column
headings ``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be
substituted for ``% Daily Value.''
(7) Except as provided for in paragraph (g) of this section, and
except as permitted by Sec. 317.400(d)(2), nutrient information for
both mandatory and any voluntary nutrients listed in paragraph (c) of
this section that are to be declared in the nutrition label, except
vitamins and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of this
section, shall be given in a column and followed immediately by the
quantitative amount by weight for that nutrient appended with a ``g''
for grams or ``mg'' for milligrams.
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established in
paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column described
in paragraph (d)(7)(i) of this section for which a DRV has been
established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns, except that when more than
four vitamins and minerals are declared, they may be declared vertically
with percentages listed under the column headed ``% Daily Value.''
(9) A footnote, preceded by an asterisk, shall be placed beneath the
list of vitamins and minerals and shall be separated from that list by a
hairline.
(i) The footnote shall state: Percent Daily Values are based on a
2,000 calorie diet. Your daily values may be higher or lower depending
on your calorie needs.
----------------------------------------------------------------------------------------------------------------
Calories: 2,000 2,500
----------------------------------------------------------------------------------------------------------------
Total fat............................ Less than.............. 65 g................... 80 g
Saturated fat........................ Less than.............. 20 g................... 25 g
Cholesterol.......................... Less than.............. 300 mg................. 300 mg
Sodium............................... Less than.............. 2,400 mg............... 2,400 mg
Total carbohydrate................... ....................... 300 g.................. 375 g
Dietary fiber........................ ....................... 25 g................... 30 g
----------------------------------------------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
``2,000'' and value of 65 g in the column headed ``2,500.''
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this
section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9), separated from that information by a
hairline. This information may be presented horizontally (i.e.,
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent of Daily
[[Page 197]]
Value information. The caloric conversion information provided for in
paragraph (d)(10) of this section may be presented beneath either side
or along the full length of the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set off
by a line that distinguishes it and sets it apart from the percent of
Daily Value information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 inches) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display in which the
footnote required by paragraph (d)(9) of the section is given to the far
right of the label, and additional vitamins and minerals beyond the four
that are required (i.e., vitamin A, vitamin C, calcium, and iron) are
arrayed horizontally following declarations of the required vitamins and
minerals.
(12) The following sample label illustrates the provisions of
paragraph (d) of this section:
[[Page 198]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.013
(13)(i) Nutrition labeling on the outer label of packages of meat or
meat food products that contain two or more products in the same
packages (e.g., variety packs) or of packages that are used
interchangeably for the same type of food (e.g., meat salad containers)
may use an aggregate display.
(ii) Aggregate displays shall comply with format requirements of
paragraph
[[Page 199]]
(d) of this section to the maximum extent possible, except that the
identity of each food shall be specified to the right of the ``Nutrition
Facts'' title, and both the quantitative amount by weight (i.e., g/mg
amounts) and the percent Daily Value for each nutrient shall be listed
in separate columns under the name of each food.
(14) When nutrition labeling appears in a second language, the
nutrition information may be presented in a separate nutrition label for
each language or in one nutrition label with the information in the
second language following that in English. Numeric characters that are
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both
languages.
(e) Nutrition information may be presented for two or more forms of
the same product (e.g., both ``raw'' and ``cooked'') or for common
combinations of foods as provided for in paragraph (b) of this section,
or for different units (e.g., per 100 grams) as provided for in
paragraph (b) of this section, or for two or more groups for which RDI's
are established (e.g., both infants and children less than 4 years of
age) as provided for in paragraph (c)(8)(i) of this section. When such
dual labeling is provided, equal prominence shall be given to both sets
of values. Information shall be presented in a format consistent with
paragraph (d) of this section, except that:
(1) Following the subheading of ``Amount Per Serving,'' there shall
be two or more column headings accurately describing the forms of the
same product (e.g., ``raw'' and ``roasted''), the combinations of foods,
the units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the Reference Amount in Sec. 317.312(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the
same product, for combinations of foods, or for different units, total
calories and calories from fat (and calories from saturated fat, when
declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the product
as packaged and according to the label serving size based on the
Reference Amount in Sec. 317.312(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the Reference Amount in Sec. 317.312(b) or as a footnote.
(A) If such additional quantitative information is given immediately
adjacent to the required quantitative information, it shall be declared
for all nutrients listed and placed immediately following and
differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'')
referring to another asterisk (or symbol) at the bottom of the nutrition
label identifying the form(s) of the product for which quantitative
information is presented.
[[Page 200]]
(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 201]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.014
(f)(1) Nutrition information may be presented in a simplified format
as set forth herein when any required nutrients, other than the core
nutrients
[[Page 202]]
(i.e., calories, total fat, sodium, total carbohydrate, and protein),
are present in insignificant amounts. An insignificant amount shall be
defined as that amount that may be rounded to zero in nutrition
labeling, except that for total carbohydrate, dietary fiber, sugars and
protein, it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the following
nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and
protein;
(ii) Any of the following that are present in more than
insignificant amounts: Calories from fat, saturated fat, cholesterol,
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in
more than insignificant amounts may be voluntarily declared as part of
the simplified format.
(4) Any required nutrient, other than a core nutrient, that is
present in an insignificant amount may be omitted from the tabular
listing, provided that the following statement is included at the bottom
of the nutrition label, ``Not a significant source of --------.'' The
blank shall be filled in with the appropriate nutrient or food
component. Alternatively, amounts of vitamins and minerals present in
insignificant amounts may be declared by the use of an asterisk (or
symbol) that is placed at the bottom of the table of nutrient values and
that is followed by the statement ``Contains less than 2 percent of the
Daily Value of this (these) nutrient (nutrients).''
(5) Except as provided for in paragraph (g) of this section and in
Sec. 317.400(c) and (d), nutrient information declared in the
simplified format shall be presented in the same manner as specified in
paragraphs (d) or (e) of this section, except that the footnote required
in paragraph (d)(9) of this section is not required. When the footnote
is omitted, an asterisk shall be placed at the bottom of the label
followed by the statement ``Percent Daily Values are based on a 2,000
calorie diet'' and, if the term ``Daily Value'' is not spelled out in
the heading, a statement that ``DV'' represents ``Daily Value.''
(g) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements of
paragraphs (c) through (f) of this section and Sec. 317.302(a) by one
or more of the following means:
(1)(i) Presenting the required nutrition information in a tabular or
linear (i.e., string) fashion, rather than in vertical columns if the
product has a total surface area available to bear labeling of less than
12 square inches, or if the product has a total surface area available
to bear labeling of 40 or less square inches and the package shape or
size cannot accommodate a standard vertical column or tabular display on
any label panel. Nutrition information may be given in a linear fashion
only if the package shape or size will not accommodate a tabular
display.
(ii) When nutrition information is given in a linear display, the
nutrition information shall be set off in a box by the use of a
hairline. The percent Daily Value is separated from the quantitative
amount declaration by the use of parenthesis, and all nutrients, both
principal components and subcomponents, are treated similarly. Bolding
is required only on the title ``Nutrition Facts'' and is allowed for
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,''
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
(2) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(3) Omitting the footnote required in paragraph (d)(9) of this
section and
[[Page 203]]
placing another asterisk at the bottom of the label followed by the
statement ``Percent Daily Values are based on a 2,000 calorie diet''
and, if the term ``Daily Value'' is not spelled out in the heading, a
statement that ``DV'' represents ``Daily Value.''
(4) Presenting the required nutrition information on any other label
panel.
(h) Compliance with this section shall be determined as follows:
(1) A production lot is a set of food production consumer units that
are from one production shift. Alternatively, a collection of consumer
units of the same size, type, and style produced under conditions as
nearly uniform as possible, designated by a common container code or
marking, constitutes a production lot.
(2) The sample for nutrient analysis shall consist of a composite of
a minimum of six consumer units, each from a production lot.
Alternatively, the sample for nutrient analysis shall consist of a
composite of a minimum of six consumer units, each randomly chosen to be
representative of a production lot. In each case, the units may be
individually analyzed and the results of the analyses averaged, or the
units would be composited and the composite analyzed. In both cases, the
results, whether an average or a single result from a composite, will be
considered by the Agency to be the nutrient content of a composite. All
analyses shall be performed by appropriate methods and procedures used
by the Department for each nutrient in accordance with the ``Chemistry
Laboratory Guidebook,'' or, if no USDA method is available and
appropriate for the nutrient, by appropriate methods for the nutrient in
accordance with the 1990 edition of the ``Official Methods of Analysis''
of the AOAC International, formerly Association of Official Analytical
Chemists, 15th ed., which is incorporated by reference, unless a
particular method of analysis is specified in Sec. 317.309(c), or, if
no USDA, AOAC, or specified method is available and appropriate, by
other reliable and appropriate analytical procedures as so determined by
the Agency. The ``Official Methods of Analysis'' is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC
International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is
also available for inspection 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.
(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, which would make the total amount of such nutrient subject
to Class I requirements.
(4) A product 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 1(n) of the Federal Meat Inspection Act (21
U.S.C. 601(n)(1)) 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 which falls below this level by an amount less than the
variability generally recognized for the analytical method used in that
product at the level involved, and inherent nutrient variation in a
product.
(5) A product with a label declaration of calories, sugars, total
fat, saturated
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fat, cholesterol, or sodium shall be deemed to be misbranded under
section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) 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 which falls above this level by an amount less than the
variability generally recognized for the analytical method used in that
product at the level involved, and inherent nutrient variation in a
product.
(6) The amount of a vitamin, mineral, protein, total carbohydrate,
dietary fiber, other carbohydrate, polyunsaturated or monounsaturated
fat, or potassium may vary over labeled amounts within good
manufacturing practice. The amount of calories, sugars, total fat,
saturated fat, cholesterol, or sodium may vary under labeled amounts
within good manufacturing practice.
(7) Compliance will be based on the metric measure specified in the
label statement of serving size.
(8) The management of the establishment must maintain records to
support the validity of nutrient declarations contained on product
labels. Such records shall be made available to the inspector or any
duly authorized representative of the Agency upon request.
(9) The compliance provisions set forth in paragraph (h) (1) through
(8) of this section shall not apply to single-ingredient, raw meat
(including ground beef) products, including those that have been
previously frozen, when nutrition labeling is based on the most current
representative data base values contained in USDA's National Nutrient
Data Bank or its published form, the Agriculture Handbook No. 8 series
available from the Government Printing Office.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088)
[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept.
10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR
58801, Oct. 1, 2004]