[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.313]

[Page 203-206]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
 
                      Subpart B--Nutrition Labeling
 
Sec. 317.313  Nutrient content claims; general principles.

    (a) This section applies to meat or meat food products that are 
intended for human consumption and that are offered for sale.
    (b) A claim which, expressly or by implication, characterizes the 
level of a nutrient (nutrient content claim) of the type required in 
nutrition labeling pursuant to Sec. 317.309, may not be made on a label 
or in labeling of that product unless the claim is made in accordance 
with the applicable provisions in this subpart.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the product, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the product or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount (e.g., 
``high in oat bran''); or
    (ii) Suggests that the product, because of its nutrient content, may 
be useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be made 
on products intended specifically for use by infants and children less 
than 2 years of age unless the claim is specifically provided for in 
subpart B of this part.
    (4) Reasonable variations in the spelling of the terms defined in 
applicable provisions in this subpart and their synonyms are permitted 
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
    (c) Information that is required or permitted by Sec. 317.309 to be 
declared in nutrition labeling, and that appears as part of the 
nutrition label, is not a nutrient content claim and is not subject to 
the requirements of this section. If such information is declared 
elsewhere on the label or in labeling, it is a nutrient content claim 
and is subject to the requirements for nutrient content claims.
    (d) A ``substitute'' product is one that may be used interchangeably 
with another product that it resembles, i.e., that it is 
organoleptically, physically, and functionally (including shelf life) 
similar to, and that it is not nutritionally inferior to unless it is 
labeled as an ``imitation.''
    (1) If there is a difference in performance characteristics that 
materially limits the use of the product, the product may still be 
considered a substitute if the label includes a disclaimer adjacent to 
the most prominent claim as defined in paragraph (j)(2)(iii) of this 
section, informing the consumer of such difference (e.g., ``not 
recommended for frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec. 317.2(h) for the net quantity 
of contents statement, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 317.400(d)(2).
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a product implies that the product differs from other products 
of the same type by virtue of its having a lower amount of the nutrient, 
only products that have been specially processed, altered, formulated, 
or reformulated so as to lower the amount of the nutrient in the 
product, remove the nutrient from the product, or not include the 
nutrient in the product, may bear such a claim (e.g., ``low sodium beef 
noodle soup'').
    (2) Any claim for the absence of a nutrient in a product, or that a 
product is low in a nutrient when the product has not been specially 
processed, altered,

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formulated, or reformulated to qualify for that claim shall indicate 
that the product inherently meets the criteria and shall clearly refer 
to all products of that type and not merely to the particular brand to 
which the labeling attaches (e.g., ``lard, a sodium free food'').
    (f) A nutrient content claim shall be in type size and style no 
larger than two times that of the statement of identity and shall not be 
unduly prominent in type style compared to the statement of identity.
    (g) Labeling information required in Secs. 317.313, 317.354, 
317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not 
otherwise specified, is required to be in letters and/or numbers no less 
than \1/16\ inch in height, except as permitted by Sec. 317.400(d)(2).
    (h) [Reserved]
    (i) Except as provided in Sec. 317.309 or in paragraph (q)(3) of 
this section, the label or labeling of a product may contain a statement 
about the amount or percentage of a nutrient if:
    (1) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is consistent with a 
definition for a claim, as provided in subpart B of this part, for the 
nutrient that the label addresses. Such a claim might be, ``less than 10 
g of fat per serving;''
    (2) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is not consistent with such 
a definition, but the label carries a disclaimer adjacent to the 
statement that the product is not ``low'' in or a ``good source'' of the 
nutrient, such as ``only 200 milligrams (mg) sodium per serving, not a 
low sodium product.'' The disclaimer must be in easily legible print or 
type and in a size no less than required by Sec. 317.2(h) for the net 
quantity of contents, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 317.400(d)(2);
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the product and it is not false or misleading 
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec. 317.362(b)(6).
    (j) A product may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
product. These statements shall be known as ``relative claims'' and 
include ``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' 
claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the product must be compared to an amount of 
nutrient in an appropriate reference product as specified in this 
paragraph (j).
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference product may be a dissimilar product within a product category 
that can generally be substituted for one another in the diet or a 
similar product.
    (B) For ``light,'' ``reduced,'' and ``added'' claims, the reference 
product shall be a similar product, and
    (ii)(A) For ``light'' claims, the reference product shall be 
representative of the type of product that includes the product that 
bears the claim. The nutrient value for the reference product shall be 
representative of a broad base of products of that type; e.g., a value 
in a representative, valid data base; an average value determined from 
the top three national (or regional) brands, a market basket norm; or, 
where its nutrient value is representative of the product type, a market 
leader. Firms using such a reference nutrient value as a basis for a 
claim, are required to provide specific information upon which the 
nutrient value was derived, on request, to consumers and appropriate 
regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' and 
``more'' claims, the reference product may be the same as that provided 
for ``light'' in paragraph (j)(1)(ii)(A) of this section or it may be 
the manufacturer's regular product, or that of another manufacturer, 
that has been offered for sale to the public on a regular basis for a

[[Page 205]]

substantial period of time in the same geographic area by the same 
business entity or by one entitled to use its trade name, provided the 
name of the competitor is not used on the labeling of the product. The 
nutrient values used to determine the claim when comparing a single 
manufacturer's product to the labeled product shall be either the values 
declared in nutrition labeling or the actual nutrient values, provided 
that the resulting labeling is internally consistent (i.e., that the 
values stated in the nutrition information, the nutrient values in the 
accompanying information, and the declaration of the percentage of 
nutrient by which the product has been modified are consistent and will 
not cause consumer confusion when compared), and that the actual 
modification is at least equal to the percentage specified in the 
definition of the claim.
    (2) For products bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
product and the percent (or fraction) of the amount of the nutrient in 
the reference product by which the nutrient has been modified, (e.g., 
``50 percent less fat than `reference product' '' or ``\1/3\ fewer 
calories than `reference product' ''); and
    (ii) This information shall be immediately adjacent to the most 
prominent claim in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, that is no less than that 
required by Sec. 317.2(h) for net quantity of contents, except where the 
size of the claim is less than two times the required size of the net 
quantity of contents statement, in which case the referral statement 
shall be no less than one-half the size of the claim, but no smaller 
than \1/16\-inch minimum height, except as permitted by 
Sec. 317.400(d)(2).
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the statement 
of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving size with 
that in the reference product; and
    (B) This statement shall appear adjacent to the most prominent claim 
or to the nutrition information.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the requirement for a ``low'' claim for that 
nutrient.
    (k) The term ``modified'' may be used in the statement of identity 
of a product that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``modified fat `product' 
''). This statement of identity must be immediately followed by the 
comparative statement such as ``contains 35 percent less fat than 
`reference product'.'' The label or labeling must also bear the 
information required by paragraph (j)(2) of this section in the manner 
prescribed.
    (l) For purposes of making a claim, a ``meal-type product'' shall be 
defined as a product that:
    (1) Makes a significant contribution to the diet by weighing at 
least 6 ounces, but no more than 12 ounces per serving (container), and
    (2) Contains ingredients from two or more of the following four food 
groups:
    (i) Bread, cereal, rice and pasta group,
    (ii) Fruits and vegetables group,
    (iii) Milk, yogurt, and cheese group, and
    (iv) Meat, poultry, fish, dry beans, eggs, and nuts group, and
    (3) Is represented as, or is in a form commonly understood to be a 
breakfast, lunch, dinner, meal, main dish, entree, or pizza. Such 
representations may be made either by statements, photographs, or 
vignettes.
    (m) [Reserved]

[[Page 206]]

    (n) Nutrition labeling in accordance with Sec. 317.309, shall be 
provided for any food for which a nutrient content claim is made.
    (o) Compliance with requirements for nutrient content claims shall 
be in accordance with Sec. 317.309(h).
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec. 317.312(b) through (e) shall be used in 
determining whether a product meets the criteria for a nutrient content 
claim. If the serving size declared on the product label differs from 
the reference amount customarily consumed, and the amount of the 
nutrient contained in the labeled serving does not meet the maximum or 
minimum amount criterion in the definition for the descriptor for that 
nutrient, the claim shall be followed by the criteria for the claim as 
required by Sec. 317.312(f) (e.g., ``very low sodium, 35 mg or less per 
55 grams'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size that 
is no less than that required by Sec. 317.2(h) for net quantity of 
contents, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the criteria statement shall be no less than one-half the size of the 
claim but no smaller than \1/16\-inch minimum height, except as 
permitted by Sec. 317.400(d)(2).
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by regulation 
and that appear as part of a brand name that was in use prior to 
November 27, 1991, may continue to be used as part of that brand name, 
provided they are not false or misleading under section 1(n) of the Act 
(21 U.S.C. 601(n)(1)).
    (2) [Reserved]
    (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. 317.309 may be made on 
the label or in the labeling of a food without a regulation authorizing 
such a claim for a specific vitamin or mineral.
    (4) The requirements of this section do not apply to infant formulas 
and medical foods, as described in 21 CFR 101.13(q)(4).
    (5) [Reserved]
    (6) Nutrient content claims that were part of the name of a product 
that was subject to a standard of identity as of November 27, 1991, are 
not subject to the requirements of paragraph (b) of this section whether 
or not they meet the definition of the descriptive term.
    (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 FSIS. 
Labeling applications requesting approval of such a claim may be 
submitted pursuant to Sec. 317.369.

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 
FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept. 
1, 1994; 60 FR 187, Jan. 3, 1995]