[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.13]
 
[Page 56-62]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                          SERVICES (CONTINUED)
 
PART 101--FOOD LABELING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 101.13  Nutrient content claims--general principles.
 
    (a) This section and the regulations in subpart D of this part apply
to foods
 
[[Page 57]]
 
that are intended for human consumption and that are offered for sale,
including conventional foods and dietary supplements.
    (b) A claim that expressly or implicitly characterizes the level of
a nutrient of the type required to be in nutrition labeling under
Sec. 101.9 or under Sec. 101.36 (that is, a nutrient content claim) 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 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'').
 
[[Page 58]]
 
    (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) [Reserved]
    (h)(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 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 bear a statement
disclosing that the nutrient exceeding the specified level is present in
the food as follows: ``See nutrition information for ____ content'' with
the blank filled in with the identity of the nutrient exceeding the
specified level, e.g., ``See nutrition information for fat content.''
    (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.
    (4)(i) The disclosure statement ``See nutrition information for ____
content'' 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 disclosure 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)(2), in which case the disclosure statement
may be in type of not less than one thirty-second of an inch.
    (ii) The disclosure 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 disclosure statement shall be adjacent to the claim on
each panel except for the panel that bears the nutrition information
where it may be omitted.
    (iii) If a single panel of a food label or labeling contains
multiple nutrient content claims or a single claim repeated several
times, a single disclosure statement may be made. The statement shall be
adjacent to the claim that is printed in the largest type on that panel.
    (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
 
[[Page 59]]
 
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,'' ``plus,''
``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
    (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
 
[[Page 60]]
 
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
(h)(4)(i) 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:
    (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,
 
[[Page 61]]
 
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 (h)(4)(i) 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 403(r)(2) of the act (e.g., 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)(i) 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.
    (ii) Percentage claims for dietary supplements. Under section
403(r)(2)(F) of the act, a statement that characterizes the percentage
level of a dietary ingredient for which a reference daily intake (RDI)
or daily reference value (DRV) has not been established may be made on
the label or in labeling of dietary supplements without a regulation
that specifically defines such a statement. All such claims shall be
accompanied by any disclosure statement required under paragraph (h) of
this section.
    (A) Simple percentage claims. Whenever a statement is made that
characterizes the percentage level of a dietary ingredient for which
there is no RDI or DRV, the statement of the actual amount of the
dietary ingredient per serving shall be declared next to the percentage
statement (e.g., ``40 percent omega-3 fatty acids, 10 mg per capsule'').
    (B) Comparative percentage claims. Whenever a statement is made that
characterizes the percentage level of a dietary ingredient for which
there is no RDI or DRV and the statement draws a
 
[[Page 62]]
 
comparison to the amount of the dietary ingredient in a reference food,
the reference food shall be clearly identified, the amount of that food
shall be identified, and the information on the actual amount of the
dietary ingredient in both foods shall be declared in accordance with
paragraph (j)(2)(iv) of this section (e.g., ``twice the omega-3 fatty
acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)'').
    (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 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 paragraph (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) 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; 61
FR 40332, Aug. 2, 1996; 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9,
1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 63 FR
26980, May 15, 1998]