[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2007]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR317.313]



[Page 210-213]

 

                  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 Sec. Sec. 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 212]]



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 will be 

defined as a product that:

    (1) Makes a major contribution to the diet by:

    (i) Weighing at least 10 ounces per labeled serving; and

    (ii) Containing not less than three 40 gram 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;

    (B) Fruits and vegetables;

    (C) Milk, yogurt, and cheese;

    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:

    (E) These foods will not be sauces (except for foods in the four 

food groups in paragraph (l)(1)(ii)(A) through (D) of this section, that 

are in



[[Page 213]]



the sauces), gravies, condiments, relishes, pickles, olives, jams, 

jellies, syrups, breadings, or garnishes; and

    (2) Is represented as, or is in the form commonly understood to be, 

a breakfast, lunch, dinner, meal, or entre. Such representations may be 

made by statements, photographs, or vignettes.

    (m) For purposes of making a claim, a main-dish product will be 

defined as a food that:

    (1) Makes a major contribution to the meal by:

    (i) Weighing at least 6 ounces per labeled serving; and

    (ii) Containing not less than 40 grams of food, or combinations of 

foods, from two or more of the following four food groups, except as 

noted in paragraph (m)(1)(ii)(E) of this section.

    (A) Bread, cereal, rice, and pasta;

    (B) Fruits and vegetables;

    (C) Milk, yogurt, and cheese;

    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:

    (E) These foods will not be sauces (except for foods in the four 

food groups in paragraph (m)(l)(ii)(A) through (D) of this section, that 

are in the sauces), gravies, condiments, relishes, pickles, olives, 

jams, jellies, syrups, breadings, or garnishes; and

    (3) Is represented as, or is in a form commonly understood to be, a 

main dish (e.g., not a beverage or dessert). Such representations may be 

made by statements, photographs, or vignettes.

    (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; 69 FR 58801, Oct. 1, 2004]



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