[Title 21 CFR A]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 101 - FOOD LABELING]
[Subpart A - General Provisions]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
2
1996-04-01
1996-04-01
false
General Provisions
A
Subpart A
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
FOOD FOR HUMAN CONSUMPTION
FOOD LABELING
Subpart A--General Provisions
Sec. 101.1 Principal display panel of package form food.
The term ``principal display panel'' as it applies to food in
package form and as used in this part, means the part of a label that is
most likely to be displayed, presented, shown, or examined under
customary conditions of display for retail sale. The principal display
panel shall be large enough to accommodate all the mandatory label
information required to be placed thereon by this part with clarity and
conspicuousness and without obscuring design, vignettes, or crowding.
Where packages bear alternate principal display panels, information
required to be placed on the principal display panel shall be duplicated
on each principal display panel. For the purpose of obtaining uniform
type size in declaring the quantity of contents for all packages of
substantially the same size, the term ``area of the principal display
panel'' means the area of the side or surface that bears the principal
display panel, which area shall be:
(a) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel side, the
product of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40
percent of the product of the height of the container times the
circumference;
(c) In the case of any otherwise shaped container, 40 percent of the
total surface of the container: Provided, however, That where such
container presents an obvious ``principal display panel'' such as the
top of a triangular or circular package of cheese, the area shall
consist of the entire top surface. In determining the area of the
principal display panel, exclude tops, bottoms, flanges at tops and
bottoms of cans, and shoulders and necks of bottles or jars. In the case
of cylindrical or nearly cylindrical containers, information required by
this part to appear on the principal display panel shall appear within
that 40 percent of the circumference which is most likely to be
displayed, presented, shown, or examined under customary conditions of
display for retail sale.
Sec. 101.2 Information panel of package form food.
(a) The term ``information panel'' as it applies to packaged food
means that part of the label immediately contiguous and to the right of
the principal display panel as observed by an individual facing the
principal display panel with the following exceptions:
(1) If the part of the label immediately contiguous and to the right
of the principal display panel is too small
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to accommodate the necessary information or is otherwise unusable label
space, e.g., folded flaps or can ends, the panel immediately contiguous
and to the right of this part of the label may be used.
(2) If the package has one or more alternate principal display
panels, the information panel is immediately contiguous and to the right
of any principal display panel.
(3) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package
of food pursuant to Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17,
subpart D of part 101, and part 105 of this chapter shall appear either
on the principal display panel or on the information panel, unless
otherwise specified by regulations in this chapter.
(c) All information appearing on the principal display panel or the
information panel pursuant to this section shall appear prominently and
conspicuously, but in no case may the letters and/or numbers be less
than one-sixteenth inch in height unless an exemption pursuant to
paragraph (f) of this section is established. The requirements for
conspicuousness and legibility shall include the specifications of
Secs. 101.105(h) (1) and (2) and 101.15.
(1) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a surface area that can
bear an information panel and/or an alternate principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in Sec. 101.1 is
less than 10 square inches.
(iii) The label information includes:
(a) Nutrition labeling in accordance with Sec. 101.9.
(b) A full list of ingredients in accordance with regulations in
this part and the policy expressed in Sec. 101.6.
(iv) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than three sixty-fourths inch in height.
(2) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a single ``obvious
principal display panel'' as this term is defined in Sec. 101.1 and has
no other available surface area for an information panel or alternate
principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in Sec. 101.1 is
less than 12 square inches and bears all labeling appearing on the
package.
(iii) The label information includes:
(a) Nutrition labeling in accordance with Sec. 101.9.
(b) A full list of ingredients in accordance with regulations in
this part and the policy expressed in Sec. 101.6.
(iv) The information required by paragraph (b) of this section
appears on the single, obvious principal display panel in accordance
with the provisions of this paragraph (c) except that the type size is
not less than one thirty-second inch in height.
(3) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a total surface area
available to bear labeling of less than 12 square inches.
(ii) The label information includes:
(a) Nutrition labeling in accordance with Sec. 101.9.
(b) A full list of ingredients in accordance with regulations in
this part and the policy expressed in Sec. 101.6.
(iii) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than one thirty-second inch in height.
(4)(i) Soft drinks packaged in bottles manufactured before October
31, 1975 shall be exempt from the requirements prescribed by this
section to the extent that information which is blown, lithographed, or
formed onto the surface of the bottle is exempt from the
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size and placement requirements of this section.
(ii) Soft drinks packaged in bottles shall be exempt from the size
and placement requirements prescribed by this section if all of the
following conditions are met:
(a) If the soft drink is packaged in a bottle bearing a paper,
plastic foam jacket, or foil label, or is packaged in a nonreusable
bottle bearing a label lithographed onto the surface of the bottle or is
packaged in metal cans, the product shall not be exempt from any
requirement of this section other than the exemptions created by
Sec. 1.24(a)(5) (ii) and (v) of this chapter and the label shall bear
all required information in the specified minimum type size, except the
label will not be required to bear the information required by
Sec. 101.5 if this information appears on the bottle closure or on the
lid of the can in a type size not less than one-sixteenth inch in
height, or if embossed on the lid of the can in a type size not less
than one-eighth inch in height.
(b) If the soft drink is packaged in a bottle which does not bear a
paper, plastic foam jacket or foil label, or is packaged in a reusable
bottle bearing a label lithographed onto the surface of the bottle:
(1) Neither the bottle nor the closure is required to bear nutrition
labeling in compliance with Sec. 101.9, except that any multiunit retail
package in which it is contained shall bear nutrition labeling if
required by Sec. 101.9; and any vending machine in which it is contained
shall bear nutrition labeling if nutrition labeling is not present on
the bottle or closure, if required by Sec. 101.9.
(2) All other information pursuant to this section shall appear on
the top of the bottle closure prominently and conspicuously in letters
and/or numbers no less than one thirty-second inch in height, except
that if the information required by Sec. 101.5 is placed on the side of
the closure in accordance with Sec. 1.24(a)(5)(ii) of this chapter, such
information shall appear in letters and/or numbers no less than one-
sixteenth inch in height.
(3) Upon the petition of any interested person demonstrating that
the bottle closure is too small to accommodate this information, the
Commissioner may by regulation establish an alternative method of
disseminating such information. Information appearing on the closure
shall appear in the following priority:
(i) The warning required by Sec. 100.130 of this chapter.
(ii) The statement of ingredients.
(iii) The name and address of the manufacturer, packer, or
distributor.
(iv) The statement of identity.
(5) Individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, are exempt from type-size requirements of
this paragraph, provided:
(i) The package has a total area of 3 square inches or less
available to bear labeling;
(ii) There is insufficient area on the package available to print
all required information in a type size of \1/16\ inch in height;
(iii) The label information includes a full list of ingredients in
accordance with regulations in this part and the policy expressed in
Sec. 101.6 of this chapter; and
(iv) The information required by paragraph (b) of this section
appears on the label in accordance with the provisions of this
paragraph, except that the type size is not less than \1/32\ inch in
height.
(d)(1) Except as provided by Sec. 101.9(j)(13) and (j)(17), all
information required to appear on the principal display panel or on the
information panel pursuant to this section shall appear on the same
panel unless there is insufficient space. In determining the sufficiency
of the available space, except as provided by Sec. 101.9(j)(17), any
vignettes, designs, and other nonmandatory label information shall not
be considered. If there is insufficient space for all of this
information to appear on a single panel, it may be divided between these
two panels except that the information required pursuant to any given
section or part shall all appear on the same panel. A food whose label
is required to bear the ingredient statement on the principal display
panel may bear all other information specified in paragraph (b) of this
section on the information panel.
[[Page 17]]
(2) Any food, not otherwise exempted in this section, if packaged in
a container consisting of a separate lid and body, and bearing nutrition
labeling pursuant to Sec. 101.9, and if the lid qualifies for and is
designed to serve as a principal display panel, shall be exempt from the
placement requirements of this section in the following respects:
(i) The name and place of business information required by
Sec. 101.5 shall not be required on the body of the container if this
information appears on the lid in accordance with this section.
(ii) The nutrition information required by Sec. 101.9 shall not be
required on the lid if this information appears on the container body in
accordance with this section.
(iii) The statement of ingredients required by Sec. 101.4 shall not
be required on the lid if this information appears on the container body
in accordance with this section. Further, the statement of ingredients
is not required on the container body if this information appears on the
lid in accordance with this section.
(e) All information appearing on the information panel pursuant to
this section shall appear in one place without other intervening
material.
(f) If the label of any package of food is too small to accommodate
all of the information required by Secs. 101.4, 101.5, 101.8, 101.9,
101.13, 101.17, subpart D of part 101, and part 105 of this chapter, the
Commissioner may establish by regulation an acceptable alternative
method of disseminating such information to the public, e.g., a type
size smaller than one-sixteenth inch in height, or labeling attached to
or inserted in the package or available at the point of purchase. A
petition requesting such a regulation, as an amendment to this paragraph
shall be submitted pursuant to part 10 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006,
Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58
FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995]
Sec. 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear
as one of its principal features a statement of the identity of the
commodity.
(b) Such statement of identity shall be in terms of:
(1) The name now or hereafter specified in or required by any
applicable Federal law or regulation; or, in the absence thereof,
(2) The common or usual name of the food; or, in the absence
thereof,
(3) An appropriately descriptive term, or when the nature of the
food is obvious, a fanciful name commonly used by the public for such
food.
(c) Where a food is marketed in various optional forms (whole,
slices, diced, etc.), the particular form shall be considered to be a
necessary part of the statement of identity and shall be declared in
letters of a type size bearing a reasonable relation to the size of the
letters forming the other components of the statement of identity;
except that if the optional form is visible through the container or is
depicted by an appropriate vignette, the particular form need not be
included in the statement. This specification does not affect the
required declarations of identity under definitions and standards for
foods promulgated pursuant to section 401 of the act.
(d) This statement of identity shall be presented in bold type on
the principal display panel, shall be in a size reasonably related to
the most prominent printed matter on such panel, and shall be in lines
generally parallel to the base on which the package rests as it is
designed to be displayed.
(e) Under the provisions of section 403(c) of the Federal Food,
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is
an imitation of another food unless its label bears, in type of uniform
size and prominence, the word ``imitation'' and, immediately thereafter,
the name of the food imitated.
(1) A food shall be deemed to be an imitation and thus subject to
the requirements of section 403(c) of the act if it is a substitute for
and resembles another food but is nutritionally inferior to that food.
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(2) A food that is a substitute for and resembles another food shall
not be deemed to be an imitation provided it meets each of the following
requirements:
(i) It is not nutritionally inferior to the food for which it
substitutes and which it resembles.
(ii) Its label bears a common or usual name that complies with the
provisions of Sec. 102.5 of this chapter and that is not false or
misleading, or in the absence of an existing common or usual name, an
appropriately descriptive term that is not false or misleading. The
label may, in addition, bear a fanciful name which is not false or
misleading.
(3) A food for which a common or usual name is established by
regulation (e.g., in a standard of identity pursuant to section 401 of
the act, in a common or usual name regulation pursuant to part 102 of
this chapter, or in a regulation establishing a nutritional quality
guideline pursuant to part 104 of this chapter), and which complies with
all of the applicable requirements of such regulation(s), shall not be
deemed to be an imitation.
(4) Nutritional inferiority includes: (i) Any reduction in the
content of an essential nutrient that is present in a measurable amount,
but does not include a reduction in the caloric or fat content provided
the food is labeled pursuant to the provisions of Sec. 101.9, and
provided the labeling with respect to any reduction in caloric content
complies with the provisions applicable to caloric content in part 105
of this chapter.
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or more
of the Daily Reference Value (DRV) of protein listed under
Sec. 101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) per
reference amount customarily consumed and 2 percent or more of the
Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv) per reference amount customarily consumed, except
that selenium, molybdenum, chromium, and chloride need not be
considered.
(iii) If the Commissioner concludes that a food is a substitute for
and resembles another food but is inferior to the food imitated for
reasons other than those set forth in this paragraph, he may propose
appropriate revisions to this regulation or he may propose a separate
regulation governing the particular food.
(f) A label may be required to bear the percentage(s) of a
characterizing ingredient(s) or information concerning the presence or
absence of an ingredient(s) or the need to add an ingredient(s) as part
of the common or usual name of the food pursuant to subpart B of part
102 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983;
58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995]
Effective Date Note: At 60 FR 67174, Dec. 28, 1995, in Sec. 101.3,
paragraph (e)(4)(ii) was revised, effective January 1, 1997. For the
convenience of the reader, the superseded text is set forth below.
Sec. 101.3 Identity labeling of food in packaged form.
* * * * *
(e) * * *
(4) * * *
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or more
of the Daily Reference Value (DRV) of protein listed under
Sec. 101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) and
the Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv).
* * * * *
Sec. 101.4 Food; designation of ingredients.
(a)(1) Ingredients required to be declared on the label or labeling
of a food, including foods that comply with standards of identity,
except those ingredients exempted by Sec. 101.100, shall be listed by
common or usual name in descending order of predominance by weight on
either the principal display panel or the information panel in
accordance with the provisions of Sec. 101.2.
(2) The descending order of predominance requirements of paragraph
(a)(1) of this section do not apply to ingredients present in amounts of
2 percent or less by weight when a listing of these ingredients is
placed at the end of the ingredient statement following an appropriate
quantifying statement, e.g.,
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``Contains ______ percent or less of ______,'' or ``Less than ______
percent of ______.'' The blank percentage within the quantifying
statement shall be filled in with a threshold level of 2 percent, or, if
desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No
ingredient to which the quantifying phrase applies may be present in an
amount greater than the stated threshold.
(b) The name of an ingredient shall be a specific name and not a
collective (generic) name, except that:
(1) Spices, flavorings, colorings and chemical preservatives shall
be declared according to the provisions of Sec. 101.22.
(2) An ingredient which itself contains two or more ingredients and
which has an established common or usual name, conforms to a standard
established pursuant to the Meat Inspection or Poultry Products
Inspection Acts by the U.S. Department of Agriculture, or conforms to a
definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the
statement of ingredients on the label of such food by either of the
following alternatives:
(i) By declaring the established common or usual name of the
ingredient followed by a parenthetical listing of all ingredients
contained therein in descending order of predominance except that, if
the ingredient is a food subject to a definition and standard of
identity established in subchapter B of this chapter that has specific
labeling provisions for optional ingredients, optional ingredients may
be declared within the parenthetical listing in accordance with those
provisions.
(ii) By incorporating into the statement of ingredients in
descending order of predominance in the finished food, the common or
usual name of every component of the ingredient without listing the
ingredient itself.
(3) Skim milk, concentrated skim milk, reconstituted skim milk, and
nonfat dry milk may be declared as ``skim milk'' or ``nonfat milk''.
(4) Milk, concentrated milk, reconstituted milk, and dry whole milk
may be declared as ``milk''.
(5) Bacterial cultures may be declared by the word ``cultured''
followed by the name of the substrate, e.g., ``made from cultured skim
milk or cultured buttermilk''.
(6) Sweetcream buttermilk, concentrated sweetcream buttermilk,
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may
be declared as ``buttermilk''.
(7) Whey, concentrated whey, reconstituted whey, and dried whey may
be declared as ``whey''.
(8) Cream, reconstituted cream, dried cream, and plastic cream
(sometimes known as concentrated milk fat) may be declared as ``cream''.
(9) Butteroil and anhydrous butterfat may be declared as
``butterfat''.
(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may
be declared as ``eggs''.
(11) Dried egg whites, frozen egg whites, and liquid egg whites may
be declared as ``egg whites''.
(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be
declared as ``egg yolks''.
(13) [Reserved]
(14) Each individual fat and/or oil ingredient of a food intended
for human consumption shall be declared by its specific common or usual
name (e.g., ``beef fat'', ``cottonseed oil'') in its order of
predominance in the food except that blends of fats and/or oils may be
designated in their order of predominance in the foods as ``----
shortening'' or ``blend of ---- oils'', the blank to be filled in with
the word ``vegetable'', ``animal'', ``marine'', with or without the
terms ``fat'' or ``oils'', or combination of these, whichever is
applicable if, immediately following the term, the common or usual name
of each individual vegetable, animal, or marine fat or oil is given in
parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed
oil)''. For products that are blends of fats and/or oils and for foods
in which fats and/or oils constitute the predominant ingredient, i.e.,
in which the combined weight of all fat and/or oil ingredients equals or
exceeds the weight of the most predominant ingredient that is not a fat
or oil, the listing of the common or usual names of such fats and/or
oils in parentheses shall be in
[[Page 20]]
descending order of predominance. In all other foods in which a blend of
fats and/or oils is used as an ingredient, the listing of the common or
usual names in parentheses need not be in descending order of
predominance if the manufacturer, because of the use of varying
mixtures, is unable to adhere to a constant pattern of fats and/or oils
in the product. If the fat or oil is completely hydrogenated, the name
shall include the term ``hydrogenated'', or if partially hydrogenated,
the name shall include the term ``partially hydrogenated''. If each fat
and/or oil in a blend or the blend is completely hydrogenated, the term
``hydrogenated'' may precede the term(s) describing the blend, e.g.,
``hydrogenated vegetable oil (soybean, cottonseed, and palm oils)'',
rather than preceding the name of each individual fat and/or oil; if the
blend of fats and/or oils is partially hydrogenated, the term
``partially hydrogenated'' may be used in the same manner. Fat and/or
oil ingredients not present in the product may be listed if they may
sometimes be used in the product. Such ingredients shall be identified
by words indicating that they may not be present, such as ``or'', ``and/
or'', ``contains one or more of the following:'', e.g., ``vegetable oil
shortening (contains one or more of the following: cottonseed oil, palm
oil, soybean oil)''. No fat or oil ingredient shall be listed unless
actually present if the fats and/or oils constitute the predominant
ingredient of the product, as defined in this paragraph (b)(14).
(15) When all the ingredients of a wheat flour are declared in an
ingredient statement, the principal ingredient of the flour shall be
declared by the name(s) specified in Secs. 137.105, 137.200, 137.220 and
137.225 of this chapter, i.e., the first ingredient designated in the
ingredient list of flour, or bromated flour, or enriched flour, or self-
rising flour is ``flour'', ``white flour'', ``wheat flour'', or ``plain
flour''; the first ingredient designated in the ingredient list of durum
flour is ``durum flour''; the first ingredient designated in the
ingredient list of whole wheat flour, or bromated whole wheat flour is
``whole wheat flour'', ``graham flour'', or ``entire wheat flour''; and
the first ingredient designated in the ingredient list of whole durum
wheat flour is ``whole durum wheat flour''.
(16) Ingredients that act as leavening agents in food may be
declared in the ingredient statement by stating the specific common or
usual name of each individual leavening agent in parentheses following
the collective name ``leavening'', e.g., ``leavening (baking soda,
monocalcium phosphate, and calcium carbonate)''. The listing of the
common or usual name of each individual leavening agent in parentheses
shall be in descending order of predominance: Except, That if the
manufacturer is unable to adhere to a constant pattern of leavening
agents in the product, the listing of individual leavening agents need
not be in descending order of predominance. Leavening agents not present
in the product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as ``or'', ``and/or'', ``contains one or more of
the following:''.
(17) Ingredients that act as yeast nutrients in foods may be
declared in the ingredient statement by stating the specific common or
usual name of each individual yeast nutrient in parentheses following
the collective name ``yeast nutrients'', e.g., ``yeast nutrients
(calcium sulfate and ammonium phosphate)''. The listing of the common or
usual name of each individual yeast nutrient in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of yeast nutrients in the
product, the listing of the common or usual names of individual yeast
nutrients need not be in descending order of predominance. Yeast
nutrients not present in the product may be listed if they are sometimes
used in the product. Such ingredients shall be identified by words
indicating that they may not be present, such as ``or'', ``and/or'', or
``contains one or more of the following:''.
(18) Ingredients that act as dough conditioners may be declared in
the ingredient statement by stating the specific common or usual name of
each individual dough conditioner in parentheses following the
collective name ``dough conditioner'', e.g., ``dough
[[Page 21]]
conditioners (L-cysteine, ammonium sulfate)''. The listing of the common
or usual name of each dough conditioner in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of dough conditioners in the
product, the listing of the common or usual names of individual dough
conditioners need not be in descending order of predominance. Dough
conditioners not present in the product may be listed if they are
sometimes used in the product. Such ingredients shall be identified by
words indicating that they may not be present, such as ``or'', ``and/
or'', or ``contains one or more of the following:''.
(19) Ingredients that act as firming agents in food (e.g., salts of
calcium and other safe and suitable salts in canned vegetables) may be
declared in the ingredient statement, in order of predominance
appropriate for the total of all firming agents in the food, by stating
the specific common or usual name of each individual firming agent in
descending order of predominance in parentheses following the collective
name ``firming agents''. If the manufacturer is unable to adhere to a
constant pattern of firming agents in the food, the listing of the
individual firming agents need not be in descending order of
predominance. Firming agents not present in the product may be listed if
they are sometimes used in the product. Such ingredients shall be
identified by words indicating that they may not be present, such as
``or'', ``and/or'', ``contains one or more of the following:''.
(20) For purposes of ingredient labeling, the term ``sugar'' shall
refer to sucrose, which is obtained from sugar cane or sugar beets in
accordance with the provisions of Sec. 184.1854 of this chapter.
(21) [Reserved]
(22) Wax and resin ingredients on fresh produce when such produce is
held for retail sale, or when held for other than retail sale by packers
or repackers shall be declared collectively by the phrase ``coated with
food-grade animal-based wax, to maintain freshness'' or the phrase
``coated with food-grade vegetable-, petroleum-, beeswax-, and/or
shellac-based wax or resin, to maintain freshness'' as appropriate. The
terms ``food-grade'' and ``to maintain freshness'' are optional. The
term ``lac-resin'' may be substituted for the term ``shellac.''
(c) When water is added to reconstitute, completely or partially, an
ingredient permitted by paragraph (b) of this section to be declared by
a class name, the position of the ingredient class name in the
ingredient statement shall be determined by the weight of the
unreconstituted ingredient plus the weight of the quantity of water
added to reconstitute that ingredient, up to the amount of water needed
to reconstitute the ingredient to single strength. Any water added in
excess of the amount of water needed to reconstitute the ingredient to
single strength shall be declared as ``water'' in the ingredient
statement.
(d) When foods characterized on the label as ``nondairy'' contain a
caseinate ingredient, the caseinate ingredient shall be followed by a
parenthetical statement identifying its source. For example, if the
manufacturer uses the term ``nondairy'' on a creamer that contains
sodium caseinate, it shall include a parenthetical term such as ``a milk
derivative'' after the listing of sodium caseinate in the ingredient
list.
(e) If the percentage of an ingredient is included in the statement
of ingredients, it shall be shown in parentheses following the name of
the ingredient and expressed in terms of percent by weight. Percentage
declarations shall be expressed to the nearest 1 percent, except that
where ingredients are present at levels of 2 percent or less, they may
be grouped together and expressed in accordance with the quantifying
guidance set forth in paragraph (a)(2) of this section.
(f) Except as provided in Sec. 101.100, ingredients that must be
declared on labeling because there is no label for the food, including
foods that comply with standards of identity, shall be listed
prominently and conspicuously by common or usual name in the manner
prescribed by paragraph (b) of this section.
[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978;
43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr.
25, 1990; 58 FR 2875, Jan. 6, 1993]
[[Page 22]]
Sec. 101.5 Food; name and place of business of manufacturer, packer, or distributor.
(a) The label of a food in packaged form shall specify conspicuously
the name and place of business of the manufacturer, packer, or
distributor.
(b) The requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporation, only by the actual corporate name, which may be preceded or
followed by the name of the particular division of the corporation. In
the case of an individual, partnership, or association, the name under
which the business is conducted shall be used.
(c) Where the food is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that
reveals the connection such person has with such food; such as
``Manufactured for --------------'', ``Distributed by --------------'',
or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street
address, city, State, and ZIP code; however, the street address may be
omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP code shall apply
only to consumer commodity labels developed or revised after the
effective date of this section. In the case of nonconsumer packages, the
ZIP code shall appear either on the label or the labeling (including
invoice).
(e) If a person manufactures, packs, or distributes a food at a
place other than his principal place of business, the label may state
the principal place of business in lieu of the actual place where such
food was manufactured or packed or is to be distributed, unless such
statement would be misleading.
Sec. 101.8 Labeling of food with number of servings.
(a) The label of any package of a food that bears a representation
as to the number of servings contained in such package shall bear in
immediate conjunction with such statement, and in the same size type as
is used for such statement, a statement of the net quantity (in terms of
weight, measure, or numerical count) of each such serving; however, such
statement may be expressed in terms that differ from the terms used in
the required statement of net quantity of contents (for example cups,
tablespoons) when such differing term is common to cookery and describes
a constant quantity. Such statement shall not be misleading in any
particular. Where nutrition labeling information is required in
accordance with the provisions of Sec. 101.9, however, the statement of
the net quantity of each serving shall be consistent with the
requirements for serving size expression set forth in that section
(e.g., 10 1-cup (240 milliliters) servings). A statement of the number
of units in a package is not in itself a statement of the number of
servings.
(b) If there exists a voluntary product standard promulgated
pursuant to the procedures found in 15 CFR part 10 by the Department of
Commerce, quantitatively defining the meaning of the term ``serving''
with respect to a particular food, then any label representation as to
the number of servings in such packaged food shall correspond with such
quantitative definition. (Copies of published standards are available
upon request from the National Bureau of Standards, Department of
Commerce, Washington, DC 20234.)
[42 FR 14308, Mar. 15, 1977, as amended at 58 FR 2291, Jan. 6, 1993]
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 23]]
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 24]]
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 25]]
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 in whole number of tablespoons for quantities less than 1/4
cup but greater than or equal to 2 tablespoons (tbsp), 1, 1 1/3, 1 1/2,
or 1 2/3 tbsp for quantities less than 2 tbsp but greater than or equal
to 1 tbsp, and teaspoons in whole number of teaspoons for quantities
less than 1 tbsp but greater than or equal to 1 teaspoon (tsp), and in
1/4-tsp increments for quantities less than 1 tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If 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
[[Page 26]]
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 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
guideline entitled, ``Guidelines for Determining the Gram Weight of the
Household Measure.'' The guideline can be obtained from the Office of
Food Labeling (HFS-150), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
(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
[[Page 27]]
of individual packages within the total package.
(v) For packages containing several individually packaged
multiserving 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 Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be inspected at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.;
[[Page 28]]
(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 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 in the same type size. 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.
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat in a serving
defined as cis,cis-methylene-interrupted
[[Page 29]]
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.
(iii) ``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 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
[[Page 30]]
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 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.
[[Page 31]]
(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, 2200 Wilson Blvd.,
suite 400, Arlington, VA 22201-3301, or may be inspected at the Office
of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(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.
(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-150), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be inspected at the Office of the
[[Page 32]]
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
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 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).'' 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
[[Page 33]]
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:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--either Folic acid or Folacin may be used.
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 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 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) 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
[[Page 34]]
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'' 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 ``mg'' for milligrams as shown in paragraph (d)(12) of this
section.
(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
[[Page 35]]
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 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.
[[Page 36]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.351
[[Page 37]]
(12) The following sample label illustrates the provisions of
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR01JA93.352
[[Page 38]]
(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.
[GRAPHIC] [TIFF OMITTED] TR01JA93.353
(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
[[Page 39]]
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 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:
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[GRAPHIC] [TIFF OMITTED] TR01JA93.354
(f) The declaration of nutrition information may be presented in the
simplified format set forth herein when a food product contains
insignificant amounts of seven or more of the following: Calories, total
fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary
fiber, sugars, protein,
[[Page 41]]
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.''
(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 chosenshipping 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
[[Page 42]]
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, 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, 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., 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 Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(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-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204.
(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,
[[Page 43]]
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 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 Food Labeling
(HFS-150), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(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.
[[Page 44]]
(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 manufacturer, packer, or
distributor 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 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
[[Page 45]]
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.'' 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
(E) Such labeling shall not include the footnote specified in
paragraph (d)(9) of this section.
(6) Dietary supplements of vitamins or minerals that have an RDI as
established in paragraph (c)(8)(iv) of this section or a DRV as
established in paragraph (c)(9) of this section shall be labeled in
compliance with Sec. 101.36, except that dietary supplements of vitamins
or minerals in food in conventional form (e.g., breakfast cereals), of
herbs, and of other similar nutritional substances shall conform to the
labeling of this section.
(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
[[Page 46]]
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 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.
[[Page 47]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.355
(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] TR01JA93.356
(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
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
[[Page 48]]
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.
(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 a balanced diet of ordinary foods cannot supply adequate
amounts of nutrients.
(3) 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.
(4) 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.
(5) That the food has dietary properties when such properties are of
no significant value or need in human nutrition.
(6) That a natural vitamin in a food is superior to an added or
synthetic vitamin or to differentiate in any way between vitamins
naturally present from those added.
[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]
Effective Date Notes: 1. At 60 FR 67174, Dec. 28, 1995, in
Sec. 101.9, paragraph (c)(8)(iv) was revised, effective January 1, 1997.
For the convenience of the reader, the superseded text is set forth
below.
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(8) * * *
(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 milligrams.
Vitamin B12, 6.0 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.
* * * * *
2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.9, in paragraph
(c)(8)(v) the entry which read ``Folate--Folacin'' was revised to read
as set forth above in the text, effective April 19, 1996.
[[Page 49]]
Sec. 101.10 Nutrition labeling of restaurant foods.
Nutrition labeling in accordance with Sec. 101.9 shall be provided
upon request for any restaurant food or meal for which a nutrient
content claim (as defined in Sec. 101.13 or in subpart D of this part)
or a health claim (as defined in Sec. 101.14 and permitted by a
regulation in subpart E of this part) is made (except on menus). Except:
That information on the nutrient amounts that are the basis for the
claim (e.g., ``low fat,'' this meal provides less than 10 grams of fat)
may serve as the functional equivalent of complete nutrition information
as described in Sec. 101.9. Nutrient levels may be determined by
nutrient data bases, cookbooks, or analyses or by other reasonable bases
that provide assurance that the food or meal meets the nutrient
requirements for the claim. Presentation of nutrition labeling may be in
various forms, including those provided in Sec. 101.45 and other
reasonable means.
[58 FR 2410, Jan. 6, 1993; 58 FR 17341, Apr. 2, 1993]
Sec. 101.11 Saccharin and its salts; retail establishment notice.
Each retail establishment (except restaurants) that sells food that
contains saccharin shall display the following notice in the locations
set forth in paragraph (b) of this section:
[GRAPHIC] [TIFF OMITTED] TR01JA93.357
Each notice shall be displayed prominently, in a manner highly visible
to consumers (e.g., not shielded by other store signs or merchandise
displays) and set up to reduce the likelihood
[[Page 50]]
that a notice will be torn, defaced, or removed.
(a) The notice shall be printed in a combination of red and black
ink on white card stock and be at least 11 by 14 inches. The background
of the bold heading, ``Saccharin Notice,'' and the boxed warning
statement shall be bright red and the lettering, white. The remaining
background shall be white with black ink. All lettering shall be in
gothic typeface.
(b) Except as provided in paragraph (c) of this section, each retail
establishment that sells food that contains saccharin shall display a
notice in each of the following three locations:
(1) Near the entrance to the retail establishment and arranged so
that consumers are likely to see the notice upon entering.
(2) Centrally located in the area of the retail establishment in
which soft drinks containing saccharin are displayed. If there is more
than one such place, then in the area where the greatest quantity of
diet soft drinks are displayed.
(3) In the area in the establishment in which the largest quantity
of saccharin-containing foods (including saccharin sold in package form
as a sugar substitute) are displayed, other than the area where diet
soft drinks are displayed.
(c) The following are exceptions to the requirements set forth in
paragraph (b) of this section:
(1) A retail establishment with 3,200 square feet or less of floor
space shall display at least one notice. The notice shall be located
near the entrance to the retail establishment and arranged so that
consumers are likely to see the notice upon entering.
(2) A retail establishment with more than 3,200 but less than 10,000
square feet of floor space shall display at least two notices. The first
notice shall be located near the entrance to the retail establishment
and arranged so that consumers are likely to see the notice upon
entering. The second notice shall be centrally located in the area of
the retail establishment in which soft drinks containing saccharin are
displayed. If there is more than one such place, then in the area where
the greatest quantity of diet soft drinks are displayed. If diet soft
drinks are not sold, then in the area of the establishment in which the
largest quantity of saccharin-containing foods (including saccharin sold
in package form as a sugar substitute) are displayed.
(3) A large retail establishment, e.g., department store, whose
primary business consists of selling nonfood items (i.e., the proportion
of food sold is extremely small compared to other items) shall display
at least one notice. The notice shall be located in the area of the
establishment in which foods containing saccharin are displayed. If
there is more than one such area, then a notice shall be displayed in
each area.
(d) Each manufacturer of saccharin-containing food who customarily
delivers his products directly to retail establishments shall make
available at least three notices to each retail establishment in which
his products are sold. Each manufacturer shall also arrange to supply
additional notices to a retail establishment that asks for them.
(e) Manufacturers who do not customarily deliver their saccharin-
containing food products directly to retail establishments may fulfill
their obligation to provide notices either in the manner set forth in
paragraph (d) of this section or by participating in, and performing the
actions required by, a trade association coordinated program that meets
the following requirements:
(1) The coordinating association shall have filed notice of the
program with the Food and Drug Administration, including the
association's name, mailing address, telephone number, and contact
person.
(2) Each manufacturer participating in the program shall file notice
of its participation with the coordinating association, including its
name, mailing address, telephone number, and contact person.
(3) The association shall ensure that retail establishment notices,
in the form specified in this section, are readily available to
participating manufacturers.
(4) The association shall take affirmative steps to coordinate with
retail establishments, their trade associations,
[[Page 51]]
and the trade press to disseminate information about the applicable
requirements of the Saccharin Study and Labeling Act and these
regulations, the existence of the association coordinated program, and
the availability of notices through the program.
(5) Each manufacturer shall, in consultation with the association,
communicate with its contacts in the distributional chain to inform them
of the applicable requirements of the Saccharin Study and Labeling Act
and these regulations, and the continued availability of notices.
(6) Each manufacturer shall ensure that notices are promptly
provided on request to any retail establishment carrying its products.
(7) The association shall consult with participating manufacturers
concerning the implementation and progress of the program and shall
disseminate information to facilitate the conduct of the program based
on such consultations or consultation with the Food and Drug
Administration.
(8) The association shall, on request, permit the Food and Drug
Administration to have access to the participation notices filed by
manufacturers, samples showing the form of retail establishment notices
made available, and typical communication materials used by the
association in the course of the program.
[43 FR 8795, Mar. 3, 1978]
Sec. 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug
Administration (FDA) considered in arriving at the reference amounts
customarily consumed per eating occasion (reference amounts) which are
set forth in paragraph (b) of this section, are that:
(1) FDA calculated the reference amounts for persons 4 years of age
or older to reflect the amount of food customarily consumed per eating
occasion by persons in this population group. These reference amounts
are based on data set forth in appropriate national food consumption
surveys.
(2) FDA calculated the reference amounts for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These reference amounts are based
on data set forth in appropriate national food consumption surveys. Such
reference amounts are to be used only when the food is specially
formulated or processed for use by an infant or by a child under 4 years
of age.
(3) An appropriate national food consumption survey includes a large
sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating
occasion, FDA considered the mean, median, and mode of the consumed
amount per eating occasion.
(5) When survey data were insufficient, FDA took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
reference amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The reference amount is based on the major intended use of the
food (e.g., milk as a beverage and not as an addition to cereal).
(8) The reference amounts for products that are consumed as an
ingredient of other foods, but that may also be consumed in the form in
which they are purchased (e.g., butter), are based on use in the form
purchased.
(9) FDA sought to ensure that foods that have similar dietary usage,
product characteristics, and customarily consumed amounts have a uniform
reference amount.
[[Page 52]]
(b) The following reference amounts shall be used as the basis for
determining serving sizes for specific products:
Table 1.--Reference Amounts Customarily Consumed Per Eating Occasion:
Infant and Toddler Foods 1,2,3,4
------------------------------------------------------------------------
Product category Reference amount Label statement5
------------------------------------------------------------------------
Cereals, dry instant........ 15 g................ ------ cup (------
g)
Cereals, prepared, ready-to- 110 g............... ------ cup(s) (------
serve. g)
Other cereal and grain 7 g for infants and ------ cup(s) (------
products, dry ready-to-eat, 20 g for toddlers g) for ready-to-
e.g., ready-to-eat cereals, for ready-to-eat eat cereals; ------
cookies, teething biscuits, cereals; 7 g for piece(s) (------ g)
and toasts. all others. for others
Dinners, desserts, fruits, 15 g................ ------ tbsp(s)
vegetables or soups, dry (------ g); ------
mix. cup(s) (------ g)
Dinners, desserts, fruits, 110 g............... ------ cup(s) (------
vegetables or soups, ready- g); ------ cup(s)
to-serve, junior type. (------ mL)
Dinners, desserts, fruits, 60 g................ ------ cup(s) (------
vegetables or soups, ready- g); ------ cup(s)
to-serve, strained type. (------ mL)
Dinners, stews or soups for 170 g............... ------ cup(s) (------
toddlers, ready-to-serve. g); ------ cup(s)
(------ mL)
Fruits for toddlers, ready- 125 g............... ------ cup(s) (------
to-serve. g)
Vegetables for toddlers, 70 g................ ------ cup(s) (------
ready-to- serve. g)
Eggs/egg yolks, ready-to- 55 g................ ------ cup(s) (------
serve. g)
Juices, all varieties....... 120 mL.............. 4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
cereal) is the amount required to make the reference amount of the
prepared form. Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\Copies of the list of products for each product category are
available from the Office of Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for frozen novelties).
Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion:
General Food Supply1,2,3,4
------------------------------------------------------------------------
Product category Reference amount Label statement5
------------------------------------------------------------------------
Bakery products:
Biscuits, croissants, 55 g................ ------ piece(s) (----
bagels, tortillas, soft -- g)
bread sticks, soft
pretzels, corn bread,
hush puppies.
Breads (excluding sweet 50 g................ ------ piece(s) (----
quick type), rolls. -- g) for sliced
bread and distinct
pieces (e.g.,
rolls); 2 oz (56 g/
------ inch slice)
for unsliced bread
Bread sticks--see .................... ....................
crackers.
Toaster pastries--see .................... ....................
coffee cakes.
Brownies................ 40 g................ ------ piece(s) (----
-- g) for distinct
pieces; fractional
slice (------ g)
for bulk
Cakes, heavy weight 125 g............... ------ piece(s) (----
(cheese cake; pineapple -- g) for distinct
upside-down cake; pieces (e.g.,
fruit, nut, and sliced or
vegetable cakes with individually
more than or equal to packaged products);
35 percent of the ------ fractional
finished weight as slice (------ g)
fruit, nuts, or for large discrete
vegetables or any of units
these combined)6.
Cakes, medium weight 80 g................ ------ piece(s) (----
(chemically leavened -- g) for distinct
cake with or without pieces (e.g.,
icing or filling except cupcake); ------
those classified as fractional slice (--
light weight cake; ---- g) for large
fruit, nut, and discrete units
vegetable cake with
less than 35 percent of
the finished weight as
fruit, nuts, or
vegetables or any of
these combined; light
weight cake with icing;
Boston cream pie;
cupcake; eclair; cream
puff)7.
[[Page 53]]
Cakes, light weight 55 g................ ------ piece(s) (----
(angel food, chiffon, -- g) for distinct
or sponge cake without pieces (e.g.,
icing or filling)8. sliced or
individually
packaged products);
------ fractional
slice (------ g)
for large discrete
units
Coffee cakes, crumb 55 g................ ------ piece(s) (----
cakes, doughnuts, -- g) for sliced
Danish, sweet rolls, bread and distinct
sweet quick type pieces (e.g.,
breads, muffins, doughnut); 2 oz (56
toaster pastries. g/visual unit of
measure) for bulk
products (e.g.,
unsliced bread)
Cookies................. 30 g................ ------ piece(s) (----
-- g)
Crackers that are 15 g................ ------ piece(s) (----
usually not used as -- g)
snack, melba toast,
hard bread sticks, ice
cream cones9.
Crackers that are 30 g................ ------ piece(s) (----
usually used as snacks. -- g)
Croutons................ 7 g................. ------ tbsp(s)
(------ g); ------
cup(s) (------ g);
------ piece(s)
(------ g) for
large pieces
French toast, pancakes, 110 g prepared for ------ piece(s) (----
variety mixes. french toast and -- g); ------
pancakes; 40 g dry cup(s) (------ g)
mix for variety for dry mix
mixes.
Grain-based bars with or 40 g................ ------ piece(s) (----
without filling or -- g)
coating, e.g.,
breakfast bars, granola
bars, rice cereal bars.
Ice cream cones--see .................... ....................
crackers.
Pies, cobblers, fruit 125 g............... ------ piece(s) (----
crisps, turnovers, --g) for distinct
other pastries. pieces; ------
fractional slice (--
---- g) for large
discrete units
Pie crust............... 1/6 of 8 inch crust; 1/6 of 8 inch crust
1/8 of 9 inch crust. (------ g); 1/8 of
9 inch crust (------
g)
Pizza crust............. 55 g................ ------ fractional
slice (------ g)
Taco shells, hard....... 30 g................ ------ shell(s) (----
-- g)
Waffles................. 85 g................ ------ piece(s) (----
-- g)
Beverages:
Carbonated and 240 mL.............. 8 fl oz (240 mL)
noncarbonated
beverages, wine
coolers, water.
Coffee or tea, flavored 240 mL prepared..... 8 fl oz (240 mL)
and sweetened.
Cereal and Other Grain
Products:
Breakfast cereals (hot 1 cup prepared; 40 g ------ cup(s) (------
cereal type), hominy plain dry cereal; g)
grits. 55 g flavored,
sweetened dry
cereal.
Breakfast cereals, ready- 15 g................ ------ cup(s) (------
to-eat, weighing less g)
than 20 g per cup,
e.g., plain puffed
cereal grains.
Breakfast cereals, ready- 30 g................ ------ cup(s) (------
to-eat weighing 20 g or g)
more but less than 43 g
per cup; high fiber
cereals containing 28 g
or more of fiber per
100 g.
Breakfast cereals, ready- 55 g................ ------ piece(s) (----
to-eat, weighing 43 g -- g) for large
or more per cup; distinct pieces
biscuit types. (e.g., biscuit
type);------ cup(s)
(------ g) for all
others
Bran or wheat germ...... 15 g................ ------ tbsp(s)
(------ g); ------
cup(s) (------ g)
Flours or cornmeal...... 30 g................ ------ tbsp(s)
(------ g); ------
cup(s) (------ g)
Grains, e.g., rice, 140 g prepared; 45 g ------ cup(s) (------
barley, plain. dry. g)
Pastas, plain........... 140 g prepared; 55 g ------ cup(s) (------
dry. g); ------
piece(s) (------ g)
for large pieces
(e.g., large shells
or lasagna noodles)
or 2 oz (56 g/
visual unit of
measure) for dry
bulk products
(e.g., spaghetti)
Pastas, dry, ready-to- 25 g................ ------ cup(s) (------
eat, e.g., fried canned g)
chow mein noodles.
Starches, e.g., 10 g................ ------ tbsp (------
cornstarch, potato g)
starch, tapioca, etc..
Stuffing................ 100 g............... ------ cup(s) (------
g)
Dairy Products and
Substitutes:
Cheese, cottage......... 110 g............... ------ cup (------
g)
Cheese used primarily as 55 g................ ------ cup (------
ingredients, e.g., dry g)
cottage cheese, ricotta
cheese.
[[Page 54]]
Cheese, grated hard, 5 g................. ------ tbsp (------
e.g., Parmesan, Romano. g)
Cheese, all others 30 g................ ------ piece(s) (----
except those listed as -- g) for distinct
separate categories-- pieces;------
includes cream cheese tbsp(s) (------ g)
and cheese spread. for cream cheese
and cheese spread;
1 oz (28 g/visual
unit of measure)
for bulk
Cheese sauce--see sauce
category.
Cream or cream 15 mL............... 1 tbsp (15 mL)
substitutes, fluid.
Cream or cream 2 g................. ------ tsp (------
substitutes, powder. g)
Cream, half & half...... 30 mL............... 2 tbsp (30 mL)
Eggnog.................. 120 mL.............. 1/2 cup (120 mL); 4
fl oz (120 mL)
Milk, condensed, 30 mL............... 2 tbsp (30 mL)
undiluted.
Milk, evaporated, 30 mL............... 2 tbsp (30 mL)
undiluted.
Milk, milk-based drinks, 240 mL.............. 1 cup (240 mL); 8 fl
e.g., instant oz (240 mL)
breakfast, meal
replacement, cocoa.
Shakes or shake 240 mL.............. 1 cup (240 mL); 8 fl
substitutes, e.g., oz (240 mL)
dairy shake mixes,
fruit frost mixes.
Sour cream.............. 30 g................ ------ tbsp (------
g)
Yogurt.................. 225 g............... ------ cup (------
g)
Desserts:
Ice cream, ice milk, 1/2 cup-includes the ------ piece(s) (----
frozen yogurt, sherbet: volume for coatings -- g) for
all types, bulk and and wafers for the individually
novelties (e.g., bars, novelty type wrapped or packaged
sandwiches, cones). varieties. products; 1/2 cup
(------ g) for
others
Frozen flavored and 85 g................ ------ piece(s) (----
sweetened ice and pops, -- g) for
frozen fruit juices: individually
all types, bulk and wrapped or packaged
novelties (e.g., bars, products; ------
cups). cup(s) (------ g)
for others
Sundae.................. 1 cup............... 1 cup (------ g)
Custards, gelatin or 1/2 cup............. ------ piece(s) (----
pudding. -- g) for distinct
unit (e.g.,
individually
packaged products);
1/2 cup (------ g)
for bulk
Dessert Toppings and
Fillings:
Cake frostings or icings 35 g................ ------ tbsp(s)
(------ g)
Other dessert toppings, 2 tbsp.............. 2 tbsp (------ g); 2
e.g., fruits, syrups, tbsp (30 mL)
spreads, marshmallow
cream, nuts, dairy and
nondairy whipped
toppings.
Pie fillings............ 85 g................ ------ cup(s) (------
g)
Egg and Egg Sustitutes:
Egg mixtures, e.g., egg 110 g............... ------ piece(s) (----
foo young, scrambled -- g) for discrete
eggs, omelets. pieces; ------
cup(s) (------ g)
Eggs (all sizes)9....... 50 g................ 1 large, medium,
etc. (------ g)
Egg substitutes......... An amount to make 1 ------ cup(s) (------
large (50 g) egg. g); ------ cup(s)
(------ mL)
Fats and Oils:
Butter, margarine, oil, 1 tbsp.............. 1 tbsp (------ g); 1
shortening. tbsp (15 mL)
Butter replacement, 2 g................. ------ tsp(s) (------
powder. g)
Dressings for salads.... 30 g................ ------ tbsp (------
g); ------ tbsp
(------ mL)
Mayonnaise, sandwich 15 g................ ------ tbsp (------
spreads, mayonnaise- g)
type dressings.
Spray types............. 0.25 g.............. About ------ seconds
spray (------ g)
Fish, Shellfish, Game
Meats10, and Meat or
Poultry Substitutes:
Bacon substitutes, 15 g................ ------ piece(s) (----
canned anchovies,11 -- g) for discrete
anchovy pastes, caviar. pieces; ------
tbsp(s) (------ g)
for others
Dried, e.g., jerky...... 30 g................ ------ piece(s) (----
-- g)
Entrees with sauce, 140 g cooked........ ------ cup(s) (------
e.g., fish with cream g); 5 oz (140 g/
sauce, shrimp with visual unit of
lobster sauce. measure) if not
measurable by cup
Entrees without sauce, 85 g cooked; 110 g ------ piece(s) (----
e.g., plain or fried uncooked12. -- g) for discrete
fish and shellfish, pieces; ------
fish and shellfish cake. cup(s) (------ g);
------ oz (------ g/
visual unit of
measure) if not
measurable by cup13
[[Page 55]]
Fish, shellfish or game 55 g................ ------ piece(s) (----
meat10, canned11. -- g) for discrete
pieces; ------
cup(s) (------ g);
2 oz (56 g/------
cup) for products
that are difficult
to measure the g
weight of cup
measure (e.g.,
tuna); 2 oz (56 g/--
---- pieces) for
products that
naturally vary in
size (e.g.,
sardines)
Substitute for luncheon 55 g................ ------ piece(s) (----
meat, meat spreads, -- g) for distinct
Canadian bacon, pieces (e.g.,
sausages and slices, links); ----
frankfurters. -- cup(s) (------
g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Smoked or pickled11 55 g................ ------ piece(s) (----
fish, shellfish, or -- g) for distinct
game meat10; fish or pieces (e.g.,
shellfish spread. slices, links) or --
---- cup(s) (------
g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Substitutes for bacon
bits--see miscellaneous
category.
Fruits and Fruit Juices:
Candied or pickled11.... 30 g................ ------ piece(s) (----
-- g)
Dehydrated fruits--see .................... ....................
snacks category.
Dried................... 40 g................ ------ piece(s) (----
-- g) for large
pieces (e.g.,
dates, figs,
prunes); ------
cup(s) (------ g)
for small pieces
(e.g., raisins)
Fruits for garnish or 4 g................. 1 cherry (------ g)
flavor, e.g.,
maraschino cherries11.
Fruit relishes, e.g., 70 g................ ------ cup(s) (------
cranberry sauce, g)
cranberry relish.
Fruits used primarily as 30 g................ See footnote 13
ingredients, avocado.
Fruits used primarily as 55 g................ ------ piece(s) (----
ingredients, others -- g) for large
(cranberries, lemon, fruits; ------
lime). cup(s) (------ g)
for small fruits
measurable by cup13
Watermelon.............. 280 g............... See footnote 13
All other fruits (except 140 g............... ------ piece(s) (----
those listed as -- g) for large
separate categories), pieces (e.g.,
fresh, canned, or strawberries,
frozen. prunes, apricots,
etc.); ------
cup(s) (------ g)
for small pieces
(e.g., blueberries,
raspberries,
etc.)13
Juices, nectars, fruit 240 mL.............. 8 fl oz (240 mL)
drinks.
Juices used as 5 mL................ 1 tsp (5 mL)
ingredients, e.g.,
lemon juice, lime juice.
Legumes:
Bean cake (tofu)11, 85 g................ ------ piece(s) (----
tempeh. -- g) for discrete
pieces; 3 oz (84 g/
visual unit of
measure) for bulk
products
Beans, plain or in sauce 130 g for beans in ------ cup (------
sauce or canned in g)
liquid and refried
beans prepared; 90
g for others
prepared; 35 g dry.
Miscellaneous Category:
Baking powder, baking 1 g................. ------ tsp (------
soda, pectin. g)
Baking decorations, 1 tsp or 4 g if not ------ piece(s) (----
e.g., colored sugars measurable by -- g) for discrete
and sprinkles for teaspoon. pieces;1 tsp (------
cookies, cake g)
decorations.
Batter mixes, bread 30 g................ ------ tbsp(s)
crumbs. (------ g);------
cup(s) (------ g)
Cooking wine............ 30 mL............... 2 tbsp (30 mL)
Dietary supplements not The maximum amount ------ tablet(s),
in conventional food recommended, as ------ capsule(s),
form.. appropriate, on the ------ packet(s), --
label for ---- tsp(s) (------
consumption per g), etc.
eating occasion or,
in the absence of
recommendations, 1
unit, e.g., tablet,
capsule, packet,
teaspoonful, etc..
Drink mixers (without Amount to make 240 ------ fl oz (------
alcohol). mL drink (without mL)
ice).
Chewing gum9............ 3 g................. ------ piece(s) (----
-- g)
[[Page 56]]
Meat, poultry and fish Amount to make one ------ tsp(s) (------
coating mixes, dry; reference amount of g); ------ tbsp(s)
seasoning mixes, dry, final dish. (------ g)
e.g., chili seasoning
mixes, pasta salad
seasoning mixes.
Salad and potato 7 g................. ------ tbsp(s)
toppers, e.g., salad (------ g)
crunchies, salad
crispins, substitutes
for bacon bits.
Salt, salt substitutes, 1 g................. ------ tsp(s) (------
seasoning salts (e.g., g);------ piece(s)
garlic salt). (------ g) for
discrete pieces
(e.g., individually
packaged products)
Spices, herbs (other 1/4 tsp or 0.5 g if 1/4 tsp (------ g);
than dietary not measurable by ------ piece(s)
supplements). teaspoon. (------ g) if not
measurable by
teaspoons (e.g.,
bay leaf)
Mixed Dishes:
Measurable with cup, 1 cup.............. 1 cup (------ g)
e.g., casseroles, hash,
macaroni and cheese,
pot pies, spaghetti
with sauce, stews, etc..
Not measurable with cup, 140 g, add 55 g for ------ piece(s) (----
e.g., burritos, egg products with gravy -- g) for discrete
rolls, enchiladas, or sauce topping, pieces; ------
pizza, pizza rolls, e.g., enchilada fractional slice (--
quiche, all types of with cheese sauce, ---- g) for large
sandwiches. crepe with white discrete units
sauce14.
Nuts and Seeds:
Nuts, seeds, and 30 g................ ------ piece(s) (----
mixtures, all types: -- g) for large
sliced, chopped, pieces (e.g.,
slivered, and whole. unshelled nuts);----
-- tbsp(s) (------
g) ;------ cup(s)
(------ g) for
small pieces (e.g.,
peanuts, sunflower
seeds)
Nut and seed butters, 2 tbsp.............. 2 tbsp (------ g)
pastes, or creams.
Coconut, nut and seed 15 g................ ------ tbsp(s)
flours. (------ g); ------
cup (------ g)
Potatoes and Sweet Potatoes/
Yams:
French fries, hash 70 g prepared; 85 g ------ piece(s) (----
browns, skins, or for frozen -- g) for large
pancakes. unprepared french distinct pieces
fries. (e.g., patties,
skins); 2.5 oz (70
g/------ pieces)
for prepared fries;
3 oz (84 g/------
pieces) for
unprepared fries
Mashed, candied, 140 g............... ------ piece(s) (----
stuffed, or with sauce. -- g) for discrete
pieces (e.g.,
stuffed potato);
------ cup(s)
(------ g)
Plain, fresh, canned, or 110 g for fresh or ------ piece(s) (----
frozen. frozen; 125 g for -- g) for discrete
vacuum packed; 160 pieces;------
g for canned in cup(s) (------ g)
liquid. for sliced or
chopped products
Salads:
Gelatin salad........... 120 g............... ------ cup (------
g)
Pasta or potato salad... 140 g............... ------ cup(s) (------
g)
All other salads, e.g., 100 g............... ------ cup(s) (------
egg, fish, shellfish, g)
bean, fruit, or
vegetable salads.
Sauces, Dips, Gravies and
Condiments:
Barbecue sauce, 2 tbsp.............. 2 tbsp (------ g); 2
hollandaise sauce, tbsp (30 mL)
tartar sauce, other
sauces for dipping
(e.g., mustard sauce,
sweet and sour sauce),
all dips (e.g., bean
dips, dairy-based dips,
salsa).
Major main entree 125 g............... ------ cup (------
sauces, e.g., spaghetti g); ------ cup (----
sauce. -- mL)
Minor main entree sauces 1/4 cup............. 1/4 cup (------ g);
(e.g., pizza sauce, 1/4 cup (60 mL)
pesto sauce), other
sauces used as toppings
(e.g., gravy, white
sauce, cheese sauce),
cocktail sauce.
Major condiments, e.g., 1 tbsp.............. 1 tbsp (------ g); 1
catsup, steak sauce, tbsp (15 mL)
soy sauce, vinegar,
teriyaki sauce,
marinades.
Minor condiments, e.g., 1 tsp............... 1 tsp (------ g); 1
horseradish, hot tsp (5 mL)
sauces, mustards,
worcestershire sauce.
[[Page 57]]
Snacks:
All varieties, chips, 30 g................ ------ cup(s) (------
pretzels, popcorns, g) for small
extruded snacks, fruit- pieces (e.g.,
based snacks (e.g., popcorn) ------
fruit chips,) grain- piece(s) (------ g)
based snack mixes. for large pieces
(e.g., large
pretzels; pressed
dried fruit sheet);
1 oz (28 g/visual
unit of measure)
for bulk products
(e.g., potato
chips)
Soups:
All varieties........... 245 g............... ------ cup (------
g); ------ cup (----
-- mL)
Sugars and Sweets:
Baking candies (e.g., 15 g................ ------ piece(s) (----
chips). -- g) for large
pieces; ------
tbsp(s) (------ g)
for small pieces; 1/
2 oz (14 g/visual
unit of measure)
for bulk products
Hard candies, breath 2 g................. ------ piece(s) (----
mints. -- g)
Hard candies, roll-type, 5 g................. ------ piece(s) (----
mini-size in dispenser -- g)
packages.
Hard candies, others.... 15 g................ ------ piece(s) (----
-- g) for large
pieces;------
tbsp(s) (------ g)
for ``mini-size''
candies measurable
by tablespoon; 1/2
oz (14 g/visual
unit of measure)
for bulk products
All other candies....... 40 g................ ------ piece(s) (----
-- g); 1 1/2 oz (42
g/visual unit of
measure) for bulk
products
Confectioner's sugar.... 30 g................ ------ cup (------
g)
Honey, jams, jellies, 1 tbsp.............. 1 tbsp (------ g); 1
fruit butter, molasses. tbsp (15 mL)
Marshmallows............ 30 g................ ------ cup(s) (------
g) for small
pieces; ------
piece(s) (------ g)
for large pieces
Sugar................... 4 g................. ------ tsp (------
g) ; ------
piece(s) (------ g)
for discrete pieces
(e.g., sugar cubes,
individually
packaged products)
Sugar substitutes....... An amount equivalent ------ tsp(s) (------
to one reference g) for solids; ----
amount for sugar in -- drop(s) (------
sweetness. g) for liquid;
------ piece(s)
(------ g) (e.g.,
individually
packaged products)
Syrups.................. 30 mL for syrups 2 tbsp (30 mL) for
used primarily as syrups used
an ingredient primarily as an
(e.g., light or ingredient; 1/4 cup
dark corn syrup); (60 mL) for all
60 mL for all others
others.
Vegetables:
Vegetables primarily 4 g................. ------ piece(s) (----
used for garnish or -- g); ------
flavor, e.g., pimento, tbsp(s) (------ g)
parsley. for chopped
products
Chili pepper, green 30 g................ ------ piece(s) (----
onion. -- g)13; ------
tbsp(s) (------ g);
------ cup(s)
(------ g) for
sliced or chopped
products
All other vegetables 85 g for fresh or ------ piece(s) (----
without sauce: fresh, frozen; 95 g for -- g) for large
canned, or frozen. vacuum packed; 130 pieces (e.g.,
g for canned in brussel sprouts); --
liquid, cream-style ---- cup(s) (------
corn, canned or g) for small pieces
stewed tomatoes, (e.g., cut corn,
pumpkin, or winter green peas); 3 oz
squash. (84 g/visual unit
of measure) if not
measurable by cup13
All other vegetables 110 g............... ------ piece(s) (----
with sauce: fresh, -- g) for large
canned, or frozen. pieces (e.g.,
brussel sprouts); --
---- cup(s) (------
g) for small pieces
(e.g., cut corn,
green peas); 4 oz
(112 g/visual unit
of measure) if not
measurable by cup
Vegetable juice......... 240 mL.............. 8 fl oz (240 mL)
Olives11................ 15 g................ ------ piece(s) (----
-- g); ------
tbsp(s) (------ g)
for sliced products
Pickles, all types11.... 30 g................ 1 oz (28 g/visual
unit of measure)
Pickle relishes......... 15 g................ ------ tbsp (------
g)
Vegetable pastes, e.g., 30 g................ ------ tbsp (------
tomato paste. g)
[[Page 58]]
Vegetable sauces or 60 g................ ------ cup (------
purees, e.g, tomato g); ------ cup (----
sauce, tomato puree. -- mL)
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
customarily consumed per eating occasion and were primarily derived
from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
Surveys conducted by the U.S. Department of Argiculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
mixes; concentrates; dough; batter; fresh and frozen pasta) is the
amount required to make the reference amount of the prepared form.
Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are
available from the Office of Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for ice cream bars). The
guidance provided is for the label statement of products in ready-to-
serve or almost ready-to-serve form. The guidance does not apply to
the products which require further preparation for consumption (e.g.,
dry mixes, concentrates) unless specifically stated in the product
category, reference amount, or label statement column that it is for
these forms of the product. For products that require further
preparation, manufacturers must determine the label statement
following the rules in Sec. 101.9(b) using the reference amount
determined according to Sec. 101.12(c).
\6\ Includes cakes that weigh 10 g or more per cubic inch.
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than
10 g per cubic inch.
\8\ Includes cakes that weigh less than 4 g per cubic inch.
\9\ Label serving size for ice cream cones and eggs of all sizes will be
1 unit. Label serving size of all chewing gums that weigh more than
the reference amount that can reasonably be consumed at a single-
eating occasion will be 1 unit.
\10\ 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, geese, ostrich, etc.
\11\ If packed or canned in liquid, the reference amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed (e.g., canned chopped clam in juice).
\12\ The reference amount for the uncooked form does not apply to raw
fish in Sec. 101.45 or to single-ingredient products that consist of
fish or game meat as provided for in Sec. 101.9(b)(j)(11).
\13\ For raw fruit, vegetables, and fish, manufacturers should follow
the label statement for the serving size specified in Appendices A and
B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
Nutrition Labeling; and Identification of the 20 Most Frequently
Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial
Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6,
1992).
\14\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
(c) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a reference amount for the product in the prepared but
not the unprepared form, then the reference amount for the unprepared
product shall be determined using the following rules:
(1) Except as provided for in paragraph (c)(2) of this section, the
reference amount for the unprepared product shall be the amount of the
unprepared product required to make the reference amount for the
prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to
prepare one large discrete unit usually divided for consumption, the
reference amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the reference amount for the prepared product as
established in paragraph (b) of this section.
(d) The reference amount for an imitation or substitute food or
altered food, such as a ``low calorie'' version, shall be the same as
for the food for which it is offered as a substitute.
(e) If a food is modified by incorporating air (aerated), and
thereby the density of the food is lowered by 25 percent or more in
weight than that of an appropriate reference regular food as described
in Sec. 101.13(j)(1)(ii)(A), and the reference amount of the regular
food is in grams, the manufacturer may determine the reference amount of
the aerated food by adjusting for the difference in density of the
aerated food relative to the density of the appropriate reference food
provided that the manufacturer will show FDA detailed protocol and
records of all data that were used to determine the density-adjusted
reference amount for the aerated food. The reference amount for the
aerated food shall be rounded to
[[Page 59]]
the nearest 5-g increment. Such products shall bear a descriptive term
indicating that extra air has been incorporated (e.g., whipped,
aerated). The density-adjusted reference amounts described in paragraph
(b) of this section may not be used for cakes except for cheese cake.
The differences in the densities of different types of cakes having
different degrees of air incorporation have already been taken into
consideration in determining the reference amounts for cakes in
Sec. 101.12(b). In determining the difference in density of the aerated
and the regular food, the manufacturer shall adhere to the following:
(1) The regular and the aerated product must be the same in size,
shape, and volume. To compare the densities of products having nonsmooth
surfaces (e.g., waffles), manufacturers shall use a device or method
that ensures that the volumes of the regular and the aerated products
are the same.
(2) Sample selections for the density measurements shall be done in
accordance with the provisions in Sec. 101.9(e).
(3) Density measurements of the regular and the aerated products
shall be conducted by the same trained operator using the same
methodology (e.g., the same equipment, procedures, and techniques) under
the same conditions.
(4) Density measurements shall be replicated a sufficient number of
times to ensure that the average of the measurements is representative
of the true differences in the densities of the regular and the
``aerated'' products.
(f) For products that have no reference amount listed in paragraph
(b) of this section for the unprepared or the prepared form of the
product and that consist of two or more foods packaged and presented to
be consumed together (e.g., peanut putter and jelly, cracker and cheese
pack, pancakes and syrup, cake and frosting), the reference amount for
the combined product shall be determined using the following rules:
(1) For bulk products (e.g., peanut butter and jelly), the reference
amount for the combined product shall be the reference amount, as
established in paragraph (b) of this section, for the ingredient that is
represented as the main ingredient plus proportioned amounts of all
minor ingredients.
(2) For products where the ingredient represented as the main
ingredient is one or more discrete units (e.g., cracker and cheese pack,
pancakes and syrup, cake and frosting), the reference amount for the
combined product shall be either the number of small discrete units or
the fraction of the large discrete unit that is represented as the main
ingredient that is closest to the reference amount for that ingredient
as established in paragraph (b) of this section plus proportioned
amounts of all minor ingredients.
(3) If the reference amounts are in compatible units, they shall be
summed (e.g., the reference amount for equal volumes of peanut butter
and jelly for which peanut butter is represented as the main ingredient
would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly).
If the reference amounts are in incompatible units, the weights of the
appropriate volumes should be used (e.g., 110 grams (g) pancakes plus
the gram weight of the proportioned amount of syrup).
(g) The reference amounts set forth in paragraphs (b) through (f) of
this section shall be used in determining whether a product meets the
criteria for nutrient content claims, such as ``low calorie,'' and for
health claims. If the serving size declared on the product label differs
from the reference amount, and the product meets the criteria for the
claim only on the basis of the reference amount, the claim shall be
followed by a statement that sets forth the basis on which the claim is
made. That statement shall include the reference amount as it appears in
paragraph (b) of this section followed, in parenthesis, by the amount in
common household measure if the reference amount is expressed in
measures other than common household measures (e.g., for a beverage,
``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').
(h) The Commissioner of Food and Drugs, either on his or her own
initiative or in response to a petition submitted pursuant to part 10 of
this chapter, may issue a proposal to establish or amend a reference
amount in paragraph (b) of this section. A petition to
[[Page 60]]
establish or amend a reference amount shall include:
(1) Objective of the petition;
(2) A description of the product;
(3) A complete sample product label including nutrition label, using
the format established by regulation;
(4) A description of the form (e.g., dry mix, frozen dough) in which
the product will be marketed;
(5) The intended dietary uses of the product with the major use
identified (e.g., milk as a beverage and chips as a snack);
(6) If the intended use is primarily as an ingredient in other
foods, list of foods or food categories in which the product will be
used as an ingredient with information on the prioritization of the use;
(7) The population group for which the product will be offered for
use (e.g., infants, children under 4 years of age);
(8) The names of the most closely related products (or in the case
of foods for special dietary use and imitation or substitute foods, the
names of the products for which they are offered as substitutes);
(9) The suggested reference amount (the amount of edible portion of
food as consumed, excluding bone, seed, shell, or other inedible
components) for the population group for which the product is intended
with full description of the methodology and procedures that were used
to determine the suggested reference amount. In determining the
reference amount, general principles and factors in paragraph (a) of
this section should be followed.
(10) The suggested reference amount shall be expressed in metric
units. Reference amounts for fluids shall be expressed in milliliters.
Reference amounts for other foods shall be expressed in grams except
when common household units such as cups, tablespoons, and teaspoons,
are more appropriate or are more likely to promote uniformity in serving
sizes declared on product labels. For example, common household measures
would be more appropriate if products within the same category differ
substantially in density, such as frozen desserts.
(i) In expressing the reference amounts in milliliters, the
following rules shall be followed:
(A) For volumes greater than 30 milliliters (mL), the volume shall
be expressed in multiples of 30 mL.
(B) For volumes less than 30 mL, the volume shall be expressed in
milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e.,
5, 10, or 15 mL.
(ii) In expressing the reference amounts in grams, the following
general rules shall be followed:
(A) For quantities greater than 10 g, the quantity shall be
expressed in the nearest 5-g increment.
(B) For quantities less than 10 g, exact gram weights shall be used.
(11) A petition to create a new subcategory of food with its own
reference amount shall include the following additional information:
(i) Data that demonstrate that the new subcategory of food will be
consumed in amounts that differ enough from the reference amount for the
parent category to warrant a separate reference amount. Data must
include sample size; and the mean, standard deviation, median, and modal
consumed amount per eating occasion for the petitioned product and for
other products in the category, excluding the petitioned product. All
data must be derived from the same survey data.
(ii) Documentation supporting the difference in dietary usage and
product characteristics that affect the consumption size that
distinguishes the petitioned product from the rest of the products in
the category.
(12) A claim for categorical exclusion under Sec. 25.24 of this
chapter or an environmental assessment under Sec. 25.31 of this chapter;
and
(13) In conducting research to collect or process food consumption
data in support of the petition, the following general guidelines should
be followed.
(i) Sampled population selected should be representative of the
demographic and socioeconomic characteristics of the target population
group for which the food is intended.
(ii) Sample size (i.e., number of eaters) should be large enough to
give reliable estimates for customarily consumed amounts.
(iii) The study protocol should identify potential biases and
describe how potential biases are controlled for or, if
[[Page 61]]
not possible to control, how they affect interpretation of results.
(iv) The methodology used to collect or process data should be fully
documented and should include: study design, sampling procedures,
materials used (e.g., questionnaire, and interviewer's manual),
procedures used to collect or process data, methods or procedures used
to control for unbiased estimates, and procedures used to correct for
nonresponse.
(14) A statement concerning the feasibility of convening
associations, corporations, consumers, and other interested parties to
engage in negotiated rulemaking to develop a proposed rule consistent
with the Negotiated Rulemaking Act (5 U.S.C. 561).
[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at
59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994]
Sec. 101.13 Nutrient content claims--general principles.
(a) This section and the regulations in subpart D of this part apply
to foods that are intended for human consumption and that are offered
for sale, including foods in conventional food form and dietary
supplements of vitamins, minerals, herbs, and other similar nutritional
substances (dietary supplements).
(b) A claim that expressly or implicitly characterizes the level of
a nutrient (nutrient content claim) of the type required in nutrition
labeling under Sec. 101.9, with the exception of such claims on
restaurant menus, may not be made on the label or in labeling of foods
unless the claim is made in accordance with this regulation and with the
applicable regulations in subpart D of this part or in part 105 or part
107 of this chapter.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the food, e.g., ``low
sodium'' or ``contains 100 calories.''
(2) An implied nutrient content claim is any claim that:
(i) Describes the food or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount (e.g.,
``high in oat bran''); or
(ii) Suggests that the food, because of its nutrient content, may be
useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
``healthy, contains 3 grams (g) of fat'').
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient content claims may be made
on food intended specifically for use by infants and children less than
2 years of age unless the claim is specifically provided for in parts
101, 105, or 107 of this chapter.
(4) Reasonable variations in the spelling of the terms defined in
part 101 and their synonyms are permitted provided these variations are
not misleading (e.g., ``hi'' or ``lo'').
(5) For dietary supplements, claims for calories, fat, saturated
fat, and cholesterol may not be made on products that meet the criteria
in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''
claims, except, in the case of calorie claims, when an equivalent amount
of a similar dietary supplement (e.g., another protein supplement) that
the labeled food resembles and for which it substitutes, normally
exceeds the definition for ``low calorie'' in Sec. 101.60(b)(2).
(c) Information that is required or permitted by Sec. 101.9 or
Sec. 101.36, as applicable, to be declared in nutrition labeling, and
that appears as part of the nutrition label, is not a nutrient content
claim and is not subject to the requirements of this section. If such
information is declared elsewhere on the label or in labeling, it is a
nutrient content claim and is subject to the requirements for nutrient
content claims.
(d) A ``substitute'' food is one that may be used interchangeably
with another food that it resembles, i.e., that it is organoleptically,
physically, and functionally (including shelf life) similar to, and that
it is not nutritionally inferior to unless it is labeled as an
``imitation.''
(1) If there is a difference in performance characteristics that
materially limits the use of the food, the food may still be considered
a substitute if the label includes a disclaimer adjacent to the most
prominent claim as defined in
[[Page 62]]
paragraph (j)(2)(iii) of this section, informing the consumer of such
difference (e.g., ``not recommended for frying'').
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 101.105(i) for the net
quantity of contents statement, except where the size of the claim is
less than two times the required size of the net quantity of contents
statement, in which case the disclaimer shall be no less than one-half
the size of the claim but no smaller than one-sixteenth of an inch,
unless the package complies with Sec. 101.2(c)(5), in which case the
disclaimer may be in type of not less than one thirty-second of an inch.
(e)(1) Because the use of a ``free'' or ``low'' claim before the
name of a food implies that the food differs from other foods of the
same type by virtue of its having a lower amount of the nutrient, only
foods that have been specially processed, altered, formulated, or
reformulated so as to lower the amount of the nutrient in the food,
remove the nutrient from the food, or not include the nutrient in the
food, may bear such a claim (e.g., ``low sodium potato chips'').
(2) Any claim for the absence of a nutrient in a food, or that a
food is low in a nutrient when the food has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the food inherently meets the criteria and
shall clearly refer to all foods of that type and not merely to the
particular brand to which the labeling attaches (e.g., ``corn oil, a
sodium-free food'').
(f) A nutrient content claim shall be in type size no larger than
two times the statement of identity and shall not be unduly prominent in
type style compared to the statement of identity.
(g) The label or labeling of a food for which a nutrient content
claim is made shall contain prominently and in immediate proximity to
such claim, the following referral statement: ``See --------------------
------------ for nutrition information'' with the blank filled in with
the identity of the panel on which nutrition labeling is located, except
that when such a claim appears on the panel that bears nutrition
information the referral statement may be omitted.
(1) The referral statement ``See [appropriate panel] for nutrition
information'' shall be in easily legible boldface print or type, in
distinct contrast to other printed or graphic matter, and in a size no
less than that required by Sec. 101.105(i) for the net quantity of
contents statement, except where the size of the claim is less than two
times the required size of the net quantity of contents statement, in
which case the referral statement shall be no less than one-half the
size of the claim but no smaller than one-sixteenth of an inch, unless
the package complies with Sec. 101.2(c)(5), in which case the referral
statement may be in type of not less than one thirty-second of an inch.
(2) The referral statement shall be immediately adjacent to the
nutrient content claim and may have no intervening material other than,
if applicable, other information in the statement of identity or any
other information that is required to be presented with the claim under
this section (e.g., see paragraph (j)(2) of this section) or under a
regulation in subpart D of this part (e.g., see Secs. 101.54 and
101.62). If the nutrient content claim appears on more than one panel of
the label, the referral statement shall be adjacent to the claim on each
panel except for the panel that bears the nutrition information where it
may be omitted.
(3) If a single panel of a food label or labeling contains multiple
nutrient content claims or a single claim repeated several times, a
single referral statement may be made. The statement shall be adjacent
to the claim that is printed in the largest type on that panel.
(h) In place of the referral statement described in paragraph (g) of
this section,
(1) If a food, except a meal product as defined in Sec. 101.13(l), a
main dish product as defined in Sec. 101.13(m), or food intended
specifically for use by infants and children less than 2 years of age,
contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 milligrams
(mg) of cholesterol, or 480 mg of sodium per reference amount
customarily consumed, per labeled serving, or, for a
[[Page 63]]
food with a reference amount customarily consumed of 30 g or less or 2
tablespoons or less, per 50 g (for dehydrated foods that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50 g
criterion refers to the ``as prepared'' form), then that food must
disclose, as part of the referral statement, that the nutrient exceeding
the specified level is present in the food as follows: ``See
[appropriate panel] for information about [nutrient requiring
disclosure] and other nutrients,'' e.g., ``See side panel for
information about total fat and other nutrients.''
(2) If a food is a meal product as defined in Sec. 101.13(l), and
contains more than 26 g of fat, 8.0 g of saturated fat, 120 mg of
cholesterol, or 960 mg of sodium per labeled serving, then that food
must disclose, in accordance with the requirements as provided in
paragraph (h)(1) of this section, that the nutrient exceeding the
specified level is present in the food.
(3) If a food is a main dish product as defined in Sec. 101.13(m),
and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of
cholesterol, or 720 mg of sodium per labeled serving, then that food
must disclose, in accordance with the requirements as provided in
paragraph (h)(1) of this section, that the nutrient exceeding the
specified level is present in the food.
(i) Except as provided in Sec. 101.9 or Sec. 101.36, as applicable,
or in paragraph (q)(3) of this section, the label or labeling of a
product may contain a statement about the amount or percentage of a
nutrient if:
(1) The use of the statement on the food implicitly characterizes
the level of the nutrient in the food and is consistent with a
definition for a claim, as provided in subpart D of this part, for the
nutrient that the label addresses. Such a claim might be, ``less than 3
g of fat per serving;''
(2) The use of the statement on the food implicitly characterizes
the level of the nutrient in the food and is not consistent with such a
definition, but the label carries a disclaimer adjacent to the statement
that the food is not ``low'' in or a ``good source'' of the nutrient,
such as ``only 200 mg sodium per serving, not a low sodium food.'' The
disclaimer must be in easily legible print or type and in a size no less
than that required by Sec. 101.105(i) for the net quantity of contents
statement except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the disclaimer shall be no less than one-half the size of the claim but
no smaller than one-sixteenth of an inch unless the package complies
with Sec. 101.2(c)(5), in which case the disclaimer may be in type of
not less less than one thirty-second of an inch, or
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the food and it is not false or misleading in
any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which
case no disclaimer is required.
(4) ``Percent fat free'' claims are not authorized by this
paragraph. Such claims shall comply with Sec. 101.62(b)(6).
(j) A food may bear a statement that compares the level of a
nutrient in the food with the level of a nutrient in a reference food.
These statements shall be known as ``relative claims'' and include
``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the food must be compared to an amount of
nutrient in an appropriate reference food as specified below.
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference food may be a dissimilar food within a product category that
can generally be substituted for one another in the diet (e.g., potato
chips as reference for pretzels, orange juice as a reference for vitamin
C tablets) or a similar food (e.g., potato chips as reference for potato
chips, one brand of multivitamin as reference for another brand of
multivitamin).
(B) For ``light,'' ``reduced,'' ``added,'' ``extra,'' ``fortified,''
and ``enriched'' claims, the reference food shall be a similar food
(e.g., potato chips as a reference for potato chips, one brand of
multivitamin for another brand of multivitamin), and
[[Page 64]]
(ii)(A) For ``light'' claims, the reference food shall be
representative of the type of food that includes the product that bears
the claim. The nutrient value for the reference food shall be
representative of a broad base of foods of that type; e.g., a value in a
representative, valid data base; an average value determined from the
top three national (or regional) brands, a market basket norm; or, where
its nutrient value is representative of the food type, a market leader.
Firms using such a reference nutrient value as a basis for a claim, are
required to provide specific information upon which the nutrient value
was derived, on request, to consumers and appropriate regulatory
officials.
(B) For relative claims other than ``light,'' including ``less'' and
``more'' claims, the reference food may be the same as that provided for
``light'' in paragraph (j)(1)(ii)(A) of this section, or it may be the
manufacturer's regular product, or that of another manufacturer, that
has been offered for sale to the public on a regular basis for a
substantial period of time in the same geographic area by the same
business entity or by one entitled to use its trade name. The nutrient
values used to determine the claim when comparing a single
manufacturer's product to the labeled product shall be either the values
declared in nutrition labeling or the actual nutrient values, provided
that the resulting label is internally consistent to (i.e., that the
values stated in the nutrition information, the nutrient values in the
accompanying information and the declaration of the percentage of
nutrient by which the food has been modified are consistent and will not
cause consumer confusion when compared), and that the actual
modification is at least equal to the percentage specified in the
definition of the claim.
(2) For foods bearing relative claims:
(i) The label or labeling must state the identity of the reference
food and the percentage (or fraction) of the amount of the nutrient in
the reference food by which the nutrient in the labeled food differs
(e.g., ``50 percent less fat than (reference food)'' or ``1/3 fewer
calories than (reference food)''),
(ii) This information shall be immediately adjacent to the most
prominent claim. The type size shall be in accordance with paragraph
(g)(1) of this section.
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement
of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving with that in
the reference food; and
(B) This statement shall appear adjacent to the most prominent claim
or to the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a food if the nutrient content of
the reference food meets the requirement for a ``low'' claim for that
nutrient (e.g., 3 g fat or less).
(k) The term ``modified'' may be used in the statement of identity
of a food that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., ``Modified fat
cheesecake''). This statement of identity must be immediately followed
by the comparative statement such as ``Contains 35 percent less fat than
----------.'' The label or labeling must also bear the information
required by paragraph (j)(2) of this section in the manner prescribed.
(l) For purposes of making a claim, a ``meal product shall be
defined as a food that:
[[Page 65]]
(1) Makes a major contribution to the total diet by:
(i) Weighing at least 10 ounces (oz) per labeled serving; and
(ii) Containing not less than three 40-g portions of food, or
combinations of foods, from two or more of the following four food
groups, except as noted in paragraph (l)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta group;
(B) Fruits and vegetables group;
(C) Milk, yogurt, and cheese group;
(D) Meat, poultry, fish, dry beans, eggs, and nuts group; except
that;
(E) These foods shall not be sauces (except for foods in the above
four food groups that are in the sauces), gravies, condiments, relishes,
pickles, olives, jams, jellies, syrups, breadings or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a
breakfast, lunch, dinner, or meal. Such representations may be made
either by statements, photographs, or vignettes.
(m) For purposes of making a claim, a ``main dish product'' shall be
defined as a food that:
(1) Makes a major contribution to a meal by
(i) Weighing at least 6 oz per labeled serving; and
(ii) Containing not less than 40 g of food, or combinations of
foods, from each of at least two of the following four food groups,
except as noted in paragraph (m)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta group;
(B) Fruits and vegetables group;
(C) Milk, yogurt, and cheese group;
(D) Meat, poultry, fish, dry beans, eggs, and nuts groups; except
that:
(E) These foods shall not be sauces (except for foods in the above
four food groups that are in the sauces) gravies, condiments, relishes,
pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a
main dish (e.g, not a beverage or a dessert). Such representations may
be made either by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10,
or Sec. 101.36, as applicable, shall be provided for any food for which
a nutrient content claim is made.
(o) Except as provided in Sec. 101.10, compliance with requirements
for nutrient content claims in this section and in the regulations in
subpart D of this part, will be determined using the analytical
methodology prescribed for determining compliance with nutrition
labeling in Sec. 101.9.
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 101.12(b) through (f) shall be used in
determining whether a product meets the criteria for a nutrient content
claim. If the serving size declared on the product label differs from
the reference amount customarily consumed, and the amount of the
nutrient contained in the labeled serving does not meet the maximum or
minimum amount criterion in the definition for the descriptor for that
nutrient, the claim shall be followed by the criteria for the claim as
required by Sec. 101.12(g) (e.g., ``very low sodium, 35 mg or less per
240 milliliters (8 fl oz.)'').
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size in
accordance with paragraph (g)(1) of this section.
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation
and that are contained in the brand name of a specific food product that
was the brand name in use on such food before October 25, 1989, may
continue to be used as part of that brand name for such product,
provided that they are not false or misleading under section 403(a) of
the Federal Food, Drug, and Cosmetic Act (the act). However, foods
bearing such claims must comply with section 403(f), (g), and (h) of the
act;
(2) A soft drink that used the term ``diet'' as part of its brand
name before October 25, 1989, and whose use of that term was in
compliance with Sec. 105.66 of this chapter as that regulation appeared
in the Code of Federal Regulations on that date, may continue to use
that term as part of its brand name, provided that its use of the term
is not false or misleading under section 403(a) of the act. Such claims
are exempt from the requirements of section
[[Page 66]]
403(r)(2) of the act (e.g., the referral statement also required by
Sec. 101.13(g) and the disclosure statement also required by
Sec. 101.13(h)). Soft drinks marketed after October 25, 1989, may use
the term ``diet'' provided they are in compliance with the current
Sec. 105.66 of this chapter and the requirements of Sec. 101.13.
(3) A statement that describes the percentage of a vitamin or
mineral in the food, including foods intended specifically for use by
infants and children less than 2 years of age, in relation to a
Reference Daily Intake (RDI) as defined in Sec. 101.9 may be made on the
label or in labeling of a food without a regulation authorizing such a
claim for a specific vitamin or mineral unless such claim is expressly
prohibited by regulation under section 403(r)(2)(A)(vi) of the act.
(4) The requirements of this section do not apply to:
(i) Infant formulas subject to section 412(h) of the act; and
(ii) Medical foods defined by section 5(b) of the Orphan Drug Act.
(5) A nutrient content claim used on food that is served in
restaurants (except on menus) or other establishments in which food is
served for immediate human consumption or which is sold for sale or use
in such establishments shall comply with the requirements of this
section and the appropriate definition in subpart D of this part, except
that:
(i) Such claim is exempt from the requirements for disclosure
statements in paragraphs (g) and (h) of this section and
Secs. 101.54(d), 101.62(c), (d)(1)(ii)(D), (d)(2)(iii)(C), (d)(3),
(d)(4)(ii)(C), and (d)(5)(ii)(C); and
(ii) In lieu of analytical testing, compliance may be determined
using a reasonable basis for concluding that the food that bears the
claim meets the definition for the claim. This reasonable basis may
derive from recognized data bases for raw and processed foods, recipes,
and other means to compute nutrient levels in the foods or meals and may
be used provided reasonable steps are taken to ensure that the method of
preparation adheres to the factors on which the reasonable basis was
determined (e.g., types and amounts of ingredients, cooking
temperatures, etc.). Firms making claims on foods based on this
reasonable basis criterion are required to provide to appropriate
regulatory officials on request the specific information on which their
determination is based and reasonable assurance of operational adherence
to the preparation methods or other basis for the claim; and
(iii) A term or symbol that may in some contexts constitute a claim
under this section may be used, provided that the use of the term or
symbol does not characterize the level of a nutrient, and a statement
that clearly explains the basis for the use of the term or symbol is
prominently displayed and does not characterize the level of a nutrient.
For example, a term such as ``lite fare'' followed by an asterisk
referring to a note that makes clear that in this restaurant ``lite
fare'' means smaller portion sizes than normal; or an item bearing a
symbol referring to a note that makes clear that this item meets the
criteria for the dietary guidance established by a recognized dietary
authority would not be considered a nutrient content claim under
Sec. 101.13.
(6) Nutrient content claims that were part of the common or usual
names of foods that were subject to a standard of identity on November
8, 1990, are not subject to the requirements of paragraphs (b), (g), and
(h) of this section or to definitions in subpart D of this part.
(7) Implied nutrient content claims may be used as part of a brand
name, provided that the use of the claim has been authorized by the Food
and Drug Administration. Petitions requesting approval of such a claim
may be submitted under Sec. 101.69(o).
(8) The term ``fluoridated,'' ``fluoride added'' or ``with added
fluoride'' may be used on the label or in labeling of bottled water that
contains added fluoride.
[58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, Apr. 2, 1993, as amended
at 58 FR 44030, Aug. 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051,
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR 11731, Mar. 22, 1996]
Sec. 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following
definitions apply:
[[Page 67]]
(1) Health claim means any claim made on the label or in labeling of
a food, including a dietary supplement, that expressly or by
implication, including ``third party'' references, written statements
(e.g., a brand name including a term such as ``heart''), symbols (e.g.,
a heart symbol), or vignettes, characterizes the relationship of any
substance to a disease or health-related condition. Implied health
claims include those statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
presented, that a relationship exists between the presence or level of a
substance in the food and a disease or health-related condition.
(2) Substance means a specific food or component of food, regardless
of whether the food is in conventional food form or a dietary supplement
that includes vitamins, minerals, herbs, or other similar nutritional
substances.
(3) Nutritive value means a value in sustaining human existence by
such processes as promoting growth, replacing loss of essential
nutrients, or providing energy.
(4) Dietary supplement means a food, not in conventional food form,
that supplies a component to supplement the diet by increasing the total
dietary intake of that component.
(5) Disqualifying nutrient levels means the levels of total fat,
saturated fat, cholesterol, or sodium in a food above which the food
will be disqualified from making a health claim. These levels are 13.0
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of
cholesterol, or 480 mg of sodium, per reference amount customarily
consumed, per label serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tablespoons or less,
per 50 g. For dehydrated foods that must have water added to them prior
to typical consumption, the per 50-g criterion refers to the as prepared
form. Any one of the levels, on a per reference amount customarily
consumed, a per label serving size or, when applicable, a per 50 g
basis, will disqualify a food from making a health claim unless an
exception is provided in subpart E of this part, except that:
(i) The levels for a meal product as defined in Sec. 101.13(l) are
26.0 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg
of sodium per label serving size, and
(ii) The levels for a main dish product as defined in
Sec. 101.13(m) are 19.5 g of fat, 6.0 g of saturated fat, 90 mg of
cholesterol, or 720 mg of sodium per label serving size.
(6) Disease or health-related condition means damage to an organ,
part, structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health leading to
such dysfunctioning (e.g., hypertension); except that diseases resulting
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not
included in this definition (claims pertaining to such diseases are
thereby not subject to Sec. 101.14 or Sec. 101.70).
(b) Eligibility. For a substance to be eligible for a health claim:
(1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an
identified U.S. population subgroup (e.g., the elderly) is at risk, or,
alternatively, the petition submitted by the proponent of the claim
otherwise explains the prevalence of the disease or health-related
condition in the U.S. population and the relevance of the claim in the
context of the total daily diet and satisfies the other requirements of
this section.
(2) If the substance is to be consumed as a component of a
conventional food at decreased dietary levels, the substance must be a
nutrient listed in 21 U.S.C. 343(q)(1)(C) or (q)(1)(D), or one that the
Food and Drug Administration (FDA) has required to be included in the
label or labeling under 21 U.S.C. 343(q)(2)(A); or
(3) If the substance is to be consumed at other than decreased
dietary levels:
(i) The substance must, regardless of whether the food is in
conventional food form or dietary supplement form, contribute taste,
aroma, or nutritive value, or any other technical effect listed in
Sec. 170.3(o) of this chapter, to the food and must retain that
attribute when consumed at levels that are necessary to justify a claim;
and
(ii) The substance must be a food or a food ingredient or a
component of a
[[Page 68]]
food ingredient whose use at the levels necessary to justify a claim has
been demonstrated by the proponent of the claim, to FDA's satisfaction,
to be safe and lawful under the applicable food safety provisions of the
Federal Food, Drug, and Cosmetic Act.
(c) Validity requirement. FDA will promulgate regulations
authorizing a health claim only when it determines, based on the
totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent
with generally recognized scientific procedures and principles), that
there is significant scientific agreement, among experts qualified by
scientific training and experience to evaluate such claims, that the
claim is supported by such evidence.
(d) General health claim labeling requirements. (1) When FDA
determines that a health claim meets the validity requirements of
paragraph (c) of this section, FDA will propose a regulation in subpart
E of this part to authorize the use of that claim. If the claim pertains
to a substance not provided for in Sec. 101.9 or Sec. 101.36, FDA will
propose amending that regulation to include declaration of the
substance.
(2) When FDA has adopted a regulation in subpart E of this part
providing for a health claim, firms may make claims based on the
regulation in subpart E of this part, provided that:
(i) All label or labeling statements about the substance-disease
relationship that is the subject of the claim are based on, and
consistent with, the conclusions set forth in the regulations in subpart
E of this part;
(ii) The claim is limited to describing the value that ingestion (or
reduced ingestion) of the substance, as part of a total dietary pattern,
may have on a particular disease or health-related condition;
(iii) The claim is complete, truthful, and not misleading. Where
factors other than dietary intake of the substance affect the
relationship between the substance and the disease or health-related
condition, such factors may be required to be addressed in the claim by
a specific regulation in subpart E of this part;
(iv) All information required to be included in the claim appears in
one place without other intervening material, except that the principal
display panel of the label or labeling may bear the reference statement,
``See -------------- for information about the relationship between ----
---------- and ------------,'' with the blanks filled in with the
location of the labeling containing the health claim, the name of the
substance, and the disease or health-related condition (e.g., ``See
attached pamphlet for information about calcium and osteoporosis''),
with the entire claim appearing elsewhere on the other labeling,
Provided that, where any graphic material (e.g., a heart symbol)
constituting an explicit or implied health claim appears on the label or
labeling, the reference statement or the complete claim shall appear in
immediate proximity to such graphic material;
(v) The claim enables the public to comprehend the information
provided and to understand the relative significance of such information
in the context of a total daily diet; and
(vi) If the claim is about the effects of consuming the substance at
decreased dietary levels, the level of the substance in the food is
sufficiently low to justify the claim. To meet this requirement, if a
definition for use of the term ``low'' has been established for that
substance under this part, the substance must be present at a level that
meets the requirements for use of that term, unless a specific
alternative level has been established for the substance in subpart E of
this part. If no definition for ``low'' has been established, the level
of the substance must meet the level established in the regulation
authorizing the claim; or
(vii) If the claim is about the effects of consuming the substance
at other than decreased dietary levels, the level of the substance is
sufficiently high and in an appropriate form to justify the claim. To
meet this requirement, if a definition for use of the term ``high'' for
that substance has been established under this part, the substance must
be present at a level that meets the requirements for use of that term,
unless a specific alternative level has been established for the
substance in subpart
[[Page 69]]
E of this part. If no definition for ``high'' has been established
(e.g., where the claim pertains to a food either as a whole food or as
an ingredient in another food), the claim must specify the daily dietary
intake necessary to achieve the claimed effect, as established in the
regulation authorizing the claim; Provided That:
(A) Where the food that bears the claim meets the requirements of
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its
reference amount customarily consumed, and the labeled serving size
differs from that amount, the claim shall be followed by a statement
explaining that the claim is based on the reference amount rather than
the labeled serving size (e.g., ``Diets low in sodium may reduce the
risk of high blood pressure, a disease associated with many factors. A
serving of -------- ounces of this product conforms to such a diet.'').
(B) Where the food that bears the claim is sold in a restaurant
(except if the claim is made on a menu) or in other establishments in
which food that is ready for human consumption is sold, the food can
meet the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) of this
section if the firm that sells the food has a reasonable basis on which
to believe that the food that bears the claim meets the requirements of
paragraphs (d)(2)(vi) and (d)(2)(vii) of this section and provides that
basis upon request.
(3) Nutrition labeling shall be provided in the label or labeling of
any food for which a health claim is made in accordance with Sec. 101.9;
for restaurant foods, in accordance with Sec. 101.10; or for dietary
supplements of vitamins or minerals, in accordance with Sec. 101.36. The
requirements of the introductory text of paragraph (d)(3) of this
section are effective as of May 8, 1993, except:
(i)--(ii) [Reserved]
(iii) For dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances for which the requirements of paragraph
(d)(3) of this section will be effective July 5, 1994.
(e) Prohibited health claims. No expressed or implied health claim
may be made on the label or in labeling for a food, regardless of
whether the food is in conventional food form or dietary supplement
form, unless:
(1) The claim is specifically provided for in subpart E of this
part; and
(2) The claim conforms to all general provisions of this section as
well as to all specific provisions in the appropriate section of subpart
E of this part;
(3) None of the disqualifying levels identified in paragraph (a)(5)
of this section is exceeded in the food, unless specific alternative
levels have been established for the substance in subpart E of this
part; or unless FDA has permitted a claim despite the fact that a
disqualifying level of a nutrient is present in the food based on a
finding that such a claim will assist consumers in maintaining healthy
dietary practices, and, in accordance with the regulation in subpart E
of this part that makes such a finding, the label bears a referral
statement that complies with Sec. 101.13(h), highlighting the nutrient
that exceeds the disqualifying level;
(4) Except as provided in paragraph (e)(3) of this section, no
substance is present at an inappropriate level as determined in the
specific provision authorizing the claim in subpart E of this part;
(5) The label does not represent or purport that the food is for
infants and toddlers less than 2 years of age except if the claim is
specifically provided for in subpart E of this part; and
(6) Except for dietary supplements or where provided for in other
regulations in part 101, subpart E, the food contains 10 percent or more
of the Reference Daily Intake or the Daily Reference Value for vitamin
A, vitamin C, iron, calcium, protein, or fiber per reference amount
customarily consumed prior to any nutrient addition.
(f) The requirements of this section do not apply to:
(1) Infant formulas subject to section 412(h) of the Federal Food,
Drug, and Cosmetic Act, and
(2) Medical foods defined by section 5(b) of the Orphan Drug Act.
(g) Applicability. The requirements of this section apply to foods
intended for human consumption that are offered for sale, regardless of
whether the
[[Page 70]]
foods are in conventional food form or dietary supplement form.
[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58
FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31,
1994]
Sec. 101.15 Food; prominence of required statements.
(a) A word, statement, or other information required by or under
authority of the act to appear on the label may lack that prominence and
conspicuousness required by section 403(f) of the act by reason (among
other reasons) of:
(1) The failure of such word, statement, or information to appear on
the part or panel of the label which is presented or displayed under
customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on
two or more parts or panels of the label, each of which has sufficient
space therefor, and each of which is so designed as to render it likely
to be, under customary conditions of purchase, the part or panel
displayed;
(3) The failure of the label to extend over the area of the
container or package available for such extension, so as to provide
sufficient label space for the prominent placing of such word,
statement, or information;
(4) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
for any word, statement, design, or device which is not required by or
under authority of the act to appear on the label;
(5) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
to give materially greater conspicuousness to any other word, statement,
or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or
information appears, insufficient background contrast, obscuring designs
or vignettes, or crowding with other written, printed, or graphic
matter.
(b) No exemption depending on insufficiency of label space, as
prescribed in regulations promulgated under section 403 (e) or (i) of
the act, shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or
device which is not required by or under authority of the act to appear
on the label;
(2) The use of label space to give greater conspicuousness to any
word, statement, or other information than is required by section 403(f)
of the act; or
(3) The use of label space for any representation in a foreign
language.
(c)(1) All words, statements, and other information required by or
under authority of the act to appear on the label or labeling shall
appear thereon in the English language: Provided, however, That in the
case of articles distributed solely in the Commonwealth of Puerto Rico
or in a Territory where the predominant language is one other than
English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language,
all words, statements, and other information required by or under
authority of the act to appear on the label shall appear thereon in the
foreign language: Provided, however, That individual serving-size
packages of foods containing no more than 1\1/2\ avoirdupois ounces or
no more than 1\1/2\ fluid ounces served with meals in restaurants,
institutions, and passenger carriers and not intended for sale at retail
are exempt from the requirements of this paragraph (c)(2), if the only
representation in the foreign language(s) is the name of the food.
(3) If any article of labeling (other than a label) contains any
representation in a foreign language, all words, statements, and other
information required by or under authority of the act to appear on the
label or labeling shall appear on such article of labeling.
Sec. 101.17 Food labeling warning and notice statements.
(a) Self-pressurized containers. (1) The label of a food packaged in
a self-pressurized container and intended to be expelled from the
package under pressure shall bear the following warning:
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Warning--Avoid spraying in eyes. Contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120 deg. F.
Keep out of reach of children.
(2) In the case of products intended for use by children, the phrase
``except under adult supervision'' may be added at the end of the last
sentence in the warning required by paragraph (a)(1) of this section.
(3) In the case of products packaged in glass containers, the word
``break'' may be substituted for the word ``puncture'' in the warning
required by paragraph (a)(1) of this section.
(4) The words ``Avoid spraying in eyes'' may be deleted from the
warning required by paragraph (a)(1) of this section in the case of a
product not expelled as a spray.
(b) Self-pressurized containers with halocarbon or hydrocarbon
propellants. (1) In addition to the warning required by paragraph (a) of
this section, the label of a food packaged in a self-pressurized
container in which the propellant consists in whole or in part of a
halocarbon or a hydrocarbon shall bear the following warning:
Warning--Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
(2) The warning required by paragraph (b)(1) of this section is not
required for the following products:
(i) Products expelled in the form of a foam or cream, which contain
less than 10 percent propellant in the container.
(ii) Products in a container with a physical barrier that prevents
escape of the propellant at the time of use.
(iii) Products of a net quantity of contents of less than 2 ounces
that are designed to release a measured amount of product with each
valve actuation.
(iv) Products of a net quantity of contents of less than one-half
ounce.
(c) Self-pressurized containers with a chlorofluorocarbon
propellant. (1) In addition to the warning required by paragraphs (a)
and (b) of this section, the label on each package of a food in a self-
pressurized container in which the propellant consists in whole or in
part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon)
shall bear the following warning:
Warning--Contains a chlorofluorocarbon that may harm the public
health and environment by reducing ozone in the upper atmosphere.
(2) The warning required by paragraph (c)(1) of this section shall
appear on an appropriate panel with such prominence and conspicuousness
as to render it likely to be read and understood by ordinary individuals
under normal conditions of purchase. The warning may appear on a firmly
affixed tag, tape, card, or sticker or similar overlabeling attached to
the package. The warning shall comply in all other respects with
Sec. 101.2, e.g., type-size requirements.
(3) The warning required by paragraph (c)(1) of this section is
applicable only to self-pressurized containers that use
chlorofluorocarbons in whole or in part as a propellant to expel from
the container liquid or solid material different from the propellant,
but the warning is not applicable to the use of chlorofluorocarbon as a
stabilizer in food toppings and spreads.
(d) Protein products. (1) The label and labeling of any food product
in liquid, powdered, tablet, capsule, or similar forms that derives more
than 50 percent of its total caloric value from either whole protein,
protein hydrolysates, amino acid mixtures, or a combination of these,
and that is represented for use in reducing weight shall bear the
following warning:
Warning: Very low calorie protein diets (below 400 Calories per day)
may cause serious illness or death. Do Not Use for Weight Reduction in
Such Diets Without Medical Supervision. Not for use by infants,
children, or pregnant or nursing women.
(2) Products described in paragraph (d)(1) of this section are
exempt from the labeling requirements of that paragraph if the protein
products are represented as part of a nutritionally balanced diet plan
providing 400 or more Calories (kilocalories) per day and the label or
labeling of the product specifies the diet plan in detail or provides a
brief description of that diet plan and adequate information describing
where
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the detailed diet plan may be obtained and the label and labeling bear
the following statement:
Notice: For weight reduction, use only as directed in the
accompanying diet plan (the name and specific location in labeling of
the diet plan may be included in this statement in place of
``accompanying diet plan''). Do not use in diets supplying less than 400
Calories per day without medical supervision.
(3) The label and labeling of food products represented or intended
for dietery (food) supplementation that derive more than 50 percent of
their total caloric value from either whole protein, protein
hydrolysates, amino acid mixtures, or a combination of these, that are
represented specifically for purposes other than weight reduction; and
that are not covered by the requirements of paragraph (d) (1) and (2) of
this section; shall bear the following statement:
Notice: Use this product as a food supplement only. Do not use for
weight reduction.
(4) The provisions of this paragraph are separate from and in
addition to any labeling requirements promulgated by the Federal Trade
Commission for protein supplements.
(5) Protein products shipped in bulk form for use solely in the
manufacture of other foods and not for distribution to consumers in such
container are exempt from the labeling requirements of this paragraph.
(6) The warning and notice statements required by paragraphs (d)
(1), (2), and (3) of this section shall appear prominently and
conspicuously on the principal display panel of the package label and
any other labeling.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977;
49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984]
Sec. 101.18 Misbranding of food.
(a) Among representations in the labeling of a food which render
such food misbranded is a false or misleading representation with
respect to another food or a drug, device, or cosmetic.
(b) The labeling of a food which contains two or more ingredients
may be misleading by reason (among other reasons) of the designation of
such food in such labeling by a name which includes or suggests the name
of one or more but not all such ingredients, even though the names of
all such ingredients are stated elsewhere in the labeling.
(c) Among representations in the labeling of a food which render
such food misbranded is any representation that expresses or implies a
geographical origin of the food or any ingredient of the food except
when such representation is either:
(1) A truthful representation of geographical origin.
(2) A trademark or trade name provided that as applied to the
article in question its use is not deceptively misdescriptive. A
trademark or trade name composed in whole or in part of geographical
words shall not be considered deceptively misdescriptive if it:
(i) Has been so long and exclusively used by a manufacturer or
distributor that it is generally understood by the consumer to mean the
product of a particular manufacturer or distributor; or
(ii) Is so arbitrary or fanciful that it is not generally understood
by the consumer to suggest geographic origin.
(3) A part of the name required by applicable Federal law or
regulation.
(4) A name whose market significance is generally understood by the
consumer to connote a particular class, kind, type, or style of food
rather than to indicate geographical origin.