[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: 9CFR317.362]



[Page 224-229]

 

                  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. 317.362  Nutrient content claims for fat, fatty acids, and cholesterol content.



    (a) General requirements. A claim about the level of fat, fatty 

acid, and cholesterol in a product may only be made on the label or in 

labeling of products if:

    (1) The claim uses one of the terms defined in this section in 

accordance with the definition for that term;

    (2) The claim is made in accordance with the general requirements 

for nutrient content claims in Sec. 317.313; and

    (3) The product for which the claim is made is labeled in accordance 

with Sec. 317.309.

    (b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,'' 

``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial source 

of fat,'' ``negligible source of fat,'' or ``dietarily insignificant 

source of fat'' may be used on the label or in labeling of products, 

provided that:

    (i) The product contains less than 0.5 gram (g) of fat per reference 

amount customarily consumed and per labeled serving size or, in the case 

of a meal-type product or a main-dish product, less than 0.5 g of fat 

per labeled serving size;

    (ii) The product contains no added ingredient that is a fat or is 

generally understood by consumers to contain fat unless the listing of 

the ingredient in the ingredients statement is followed by an asterisk 

that refers to the statement below the list of ingredients, which 

states: ``Adds a trivial amount of fat,'' ``adds a negligible amount of 

fat,'' or ``adds a dietarily insignificant amount of fat''; and

    (iii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

the fat content, it is labeled to clearly refer to all products of its 

type and not merely to the particular brand to which the label attaches.

    (2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount 

of fat,'' ``low source of fat,'' or ``little fat'' may be used on the 

label and in labeling of products, except meal-type products as defined 

in Sec. 317.313(l) and main-dish products as defined in Sec. 

317.313(m), provided that:

    (i)(A) The product has a reference amount customarily consumed 

greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g 

or less of fat per reference amount customarily consumed; or

    (B) The product has a reference amount customarily consumed of 30 g 

or less or 2 tbsp or less and contains 3 g or less of fat per reference 

amount customarily consumed and per 50 g (for dehydrated products that 

must be reconstituted before typical consumption with water or a diluent 

containing an insignificant amount, as defined in Sec. 317.309(f)(1), 

of all nutrients per reference amount customarily consumed, the per-50-g 

criterion refers to the ``as prepared'' form).

    (ii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

the fat content, it is labeled to clearly refer to all products of its 

type and not merely to the particular brand to which the label attaches.

    (3) The terms defined in paragraph (b)(2) of this section may be 

used on the label or in labeling of a meal-type product as defined in 

Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 

provided that:

    (i) The product contains 3 g or less of total fat per 100 g of 

product and not more than 30 percent of calories from fat; and

    (ii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

the fat content, it is labeled to clearly refer to all products of its 

type and not merely to the particular brand to which the label attaches.

    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 

``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 

label or in labeling of products, except meal-type products as defined 

in Sec. 317.313(l) and main-dish products as defined in Sec. 

317.313(m), provided that:

    (i) The product contains at least 25 percent less fat per reference 

amount customarily consumed than an appropriate reference product as 

described in Sec. 317.313(j)(1); and



[[Page 225]]



    (ii) As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the fat differs between the two products are declared in 

immediate proximity to the most prominent such claim (e.g., ``reduced 

fat--50 percent less fat than our regular `product' ''); and

    (B) Quantitative information comparing the level of fat in the 

product per labeled serving size with that of the reference product that 

it replaces is declared adjacent to the most prominent claim or to the 

nutrition information (e.g., ``fat content has been reduced from 8 g to 

4 g per serving'').

    (iii) Claims described in paragraph (b)(4) of this section may not 

be made on the label or in labeling of a product if the nutrient content 

of the reference product meets the definition for ``low fat.''

    (5) The terms defined in paragraph (b)(4) of this section may be 

used on the label or in labeling of a meal-type product as defined in 

Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 

provided that:

    (i) The product contains at least 25 percent less fat per 100 g of 

product than an appropriate reference product as described in Sec. 

317.313(j)(1); and

    (ii) As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the fat differs between the two products are declared in 

immediate proximity to the most prominent such claim (e.g., ``reduced 

fat `product', 33 percent less fat per 3 oz than our regular `product' 

''); and

    (B) Quantitative information comparing the level of fat in the 

product per specified weight with that of the reference product that it 

replaces is declared adjacent to the most prominent such claim or to the 

nutrition information (e.g., ``fat content has been reduced from 8 g per 

3 oz to 5 g per 3 oz'').

    (iii) Claims described in paragraph (b)(5) of this section may not 

be made on the label or in labeling of a product if the nutrient content 

of the reference product meets the definition for ``low fat.''

    (6) The term ``------ percent fat free'' may be used on the label or 

in labeling of products, provided that:

    (i) The product meets the criteria for ``low fat'' in paragraph 

(b)(2) or (b)(3) of this section;

    (ii) The percent declared and the words ``fat free'' are in uniform 

type size; and

    (iii) A ``100 percent fat free'' claim may be made only on products 

that meet the criteria for ``fat free'' in paragraph (b)(1) of this 

section, that contain less than 0.5 g of fat per 100 g, and that contain 

no added fat.

    (iv) A synonym for ``------ percent fat free'' is ``------ percent 

lean.''

    (c) Fatty acid content claims. (1) The terms ``saturated fat free,'' 

``free of saturated fat,'' ``no saturated fat,'' ``zero saturated fat,'' 

``without saturated fat,'' ``trivial source of saturated fat,'' 

``negligible source of saturated fat,'' or ``dietarily insignificant 

source of saturated fat'' may be used on the label or in labeling of 

products, provided that:

    (i) The product contains less than 0.5 g of saturated fat and less 

than 0.5 g trans fatty acids per reference amount customarily consumed 

and per labeled serving size or, in the case of a meal-type product or a 

main-dish product, less than 0.5 g of saturated fat and less than 0.5 g 

trans fatty acids per labeled serving size;

    (ii) The product contains no ingredient that is generally understood 

by consumers to contain saturated fat unless the listing of the 

ingredient in the ingredients statement is followed by an asterisk that 

refers to the statement below the list of ingredients, which states: 

``Adds a trivial amount of saturated fat,'' ``adds a negligible amount 

of saturated fat,'' or ``adds a dietarily insignificant amount of 

saturated fat;'' and

    (iii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

saturated fat content, it is labeled to clearly refer to all products of 

its type and not merely to the particular brand to which the label 

attaches.

    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 

``contains a small amount of saturated fat,'' ``low source



[[Page 226]]



of saturated fat,'' or ``a little saturated fat'' may be used on the 

label or in labeling of products, except meal-type products as defined 

in Sec. 317.313(l) and main-dish products as defined in Sec. 

317.313(m), provided that:

    (i) The product contains 1 g or less of saturated fat per reference 

amount customarily consumed and not more than 15 percent of calories 

from saturated fat; and

    (ii) If the product meets these conditions without benefit of 

special processing, alteration, formulation, or reformulation to lower 

saturated fat content, it is labeled to clearly refer to all products of 

its type and not merely to the particular brand to which the label 

attaches.

    (3) The terms defined in paragraph (c)(2) of this section may be 

used on the label or in labeling of a meal-type product as defined in 

Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 

provided that:

    (i) The product contains 1 g or less of saturated fat per 100 g and 

less than 10 percent calories from saturated fat; and

    (ii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

saturated fat content, it is labeled to clearly refer to all products of 

its type and not merely to the particular brand to which the label 

attaches.

    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 

fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 

saturated fat,'' or ``lower in saturated fat'' may be used on the label 

or in labeling of products, except meal-type products as defined in 

Sec. 317.313(l) and main-dish products as defined in Sec. 317.313(m), 

provided that:

    (i) The product contains at least 25 percent less saturated fat per 

reference amount customarily consumed than an appropriate reference 

product as described in Sec. 317.313(j)(1); and

    (ii) As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the saturated fat differs between the two products are 

declared in immediate proximity to the most prominent such claim (e.g., 

``reduced saturated fat `product', contains 50 percent less saturated 

fat than the national average for `product' ''); and

    (B) Quantitative information comparing the level of saturated fat in 

the product per labeled serving size with that of the reference product 

that it replaces is declared adjacent to the most prominent claim or to 

the nutrition information (e.g., ``saturated fat reduced from 3 g to 1.5 

g per serving'').

    (iii) Claims described in paragraph (c)(4) of this section may not 

be made on the label or in labeling of a product if the nutrient content 

of the reference product meets the definition for ``low saturated fat.''

    (5) The terms defined in paragraph (c)(4) of this section may be 

used on the label or in labeling of a meal-type product as defined in 

Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 

provided that:

    (i) The product contains at least 25 percent less saturated fat per 

100 g of product than an appropriate reference product as described in 

Sec. 317.313(j)(1); and

    (ii) As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the saturated fat differs between the two products are 

declared in immediate proximity to the most prominent such claim (e.g., 

``reduced saturated fat `product','' ``50 percent less saturated fat 

than our regular `product' ''); and

    (B) Quantitative information comparing the level of saturated fat in 

the product per specified weight with that of the reference product that 

it replaces is declared adjacent to the most prominent claim or to the 

nutrition information (e.g., ``saturated fat content has been reduced 

from 2.5 g per 3 oz to 1.5 g per 3 oz'').

    (iii) Claims described in paragraph (c)(5) of this section may not 

be made on the label or in labeling of a product if the nutrient content 

of the reference product meets the definition for ``low saturated fat.''

    (d) Cholesterol content claims. (1) The terms ``cholesterol free,'' 

``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,'' 

``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible



[[Page 227]]



source of cholesterol,'' or ``dietarily insignificant source of 

cholesterol'' may be used on the label or in labeling of products, 

provided that:

    (i) The product contains less than 2 milligrams (mg) of cholesterol 

per reference amount customarily consumed and per labeled serving size 

or, in the case of a meal-type product as defined in Sec. 317.313(l) 

and main-dish product as defined in Sec. 317.313(m), less than 2 mg of 

cholesterol per labeled serving size;

    (ii) The product contains no ingredient that is generally understood 

by consumers to contain cholesterol, unless the listing of the 

ingredient in the ingredients statement is followed by an asterisk that 

refers to the statement below the list of ingredients, which states: 

``Adds a trivial amount of cholesterol,'' ``adds a negligible amount of 

cholesterol,'' or ``adds a dietarily insignificant amount of 

cholesterol'';

    (iii) The product contains 2 g or less of saturated fat per 

reference amount customarily consumed or, in the case of a meal-type 

product as defined in Sec. 317.313(l) and main-dish product as defined 

in Sec. 317.313(m), 2 g or less of saturated fat per labeled serving 

size; and

    (iv) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

cholesterol content, it is labeled to clearly refer to all products of 

its type and not merely to the particular brand to which it attaches; or

    (v) If the product meets these conditions only as a result of 

special processing, alteration, formulation, or reformulation, the 

amount of cholesterol is reduced by 25 percent or more from the 

reference product it replaces as described in Sec. 317.313(j)(1) and 

for which it substitutes as described in Sec. 317.313(d) that has a 

significant (e.g., 5 percent or more of a national or regional market) 

market share. As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the cholesterol was reduced are declared in immediate 

proximity to the most prominent such claim (e.g., ``cholesterol free 

`product', contains 100 percent less cholesterol than `reference 

product' ''); and

    (B) Quantitative information comparing the level of cholesterol in 

the product per labeled serving size with that of the reference product 

that it replaces is declared adjacent to the most prominent claim or to 

the nutrition information (e.g., ``contains no cholesterol compared with 

30 mg in one serving of `reference product' '').

    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 

``contains a small amount of cholesterol,'' ``low source of 

cholesterol,'' or ``little cholesterol'' may be used on the label or in 

labeling of products, except meal-type products as defined in Sec. 

317.313(l) and main-dish products as defined in Sec. 317.313(m), 

provided that:

    (i)(A) If the product has a reference amount customarily consumed 

greater than 30 g or greater than 2 tbsp:

    (1) The product contains 20 mg or less of cholesterol per reference 

amount customarily consumed; and

    (2) The product contains 2 g or less of saturated fat per reference 

amount customarily consumed; or

    (B) If the product has a reference amount customarily consumed of 30 

g or less or 2 tbsp or less:

    (1) The product contains 20 mg or less of cholesterol per reference 

amount customarily consumed and per 50 g (for dehydrated products that 

must be reconstituted before typical consumption with water or a diluent 

containing an insignificant amount, as defined in Sec. 317.309(f)(1), 

of all nutrients per reference amount customarily consumed, the per-50-g 

criterion refers to the ``as prepared'' form); and

    (2) The product contains 2 g or less of saturated fat per reference 

amount customarily consumed.

    (ii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

cholesterol content, it is labeled to clearly refer to all products of 

its type and not merely to the particular brand to which the label 

attaches; or

    (iii) If the product contains 20 mg or less of cholesterol only as a 

result of special processing, alteration, formulation, or reformulation, 

the amount of cholesterol is reduced by 25 percent or more from the 

reference product it replaces as described in Sec. 317.313(j)(1) and



[[Page 228]]



for which it substitutes as described in Sec. 317.313(d) that has a 

significant (e.g., 5 percent or more of a national or regional market) 

market share. As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the cholesterol has been reduced are declared in 

immediate proximity to the most prominent such claim (e.g., ``low 

cholesterol `product', contains 85 percent less cholesterol than our 

regular `product' ''); and

    (B) Quantitative information comparing the level of cholesterol in 

the product per labeled serving size with that of the reference product 

that it replaces is declared adjacent to the most prominent claim or to 

the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5 

mg per serving'').

    (3) The terms defined in paragraph (d)(2) of this section may be 

used on the label or in labeling of a meal-type product as defined in 

Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 

provided that:

    (i) The product contains 20 mg or less of cholesterol per 100 g of 

product;

    (ii) The product contains 2 g or less of saturated fat per 100 g of 

product; and

    (iii) If the product meets these conditions without the benefit of 

special processing, alteration, formulation, or reformulation to lower 

cholesterol content, it is labeled to clearly refer to all products of 

its type and not merely to the particular brand to which the label 

attaches.

    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 

``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 

``lower in cholesterol'' may be used on the label or in labeling of 

products or products that substitute for those products as specified in 

Sec. 317.313(d), excluding meal-type products as defined in Sec. 

317.313(l) and main-dish products as defined in Sec. 317.313(m), 

provided that:

    (i) The product has been specifically formulated, altered, or 

processed to reduce its cholesterol by 25 percent or more from the 

reference product it replaces as described in Sec. 317.313(j)(1) and 

for which it substitutes as described in Sec. 317.313(d) that has a 

significant (e.g., 5 percent or more of a national or regional market) 

market share;

    (ii) The product contains 2 g or less of saturated fat per reference 

amount customarily consumed; and

    (iii) As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the cholesterol has been reduced are declared in 

immediate proximity to the most prominent such claim (e.g., ``25 percent 

less cholesterol than `reference product' ''); and

    (B) Quantitative information comparing the level of cholesterol in 

the product per labeled serving size with that of the reference product 

that it replaces is declared adjacent to the most prominent claim or to 

the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30 

mg per serving'').

    (iv) Claims described in paragraph (d)(4) of this section may not be 

made on the label or in labeling of a product if the nutrient content of 

the reference product meets the definition for ``low cholesterol.''

    (5) The terms defined in paragraph (d)(4) of this section may be 

used on the label or in labeling of a meal-type product as defined in 

Sec. 317.313(l) and main-dish product as defined in Sec. 317.313(m), 

provided that:

    (i) The product has been specifically formulated, altered, or 

processed to reduce its cholesterol by 25 percent or more from the 

reference product it replaces as described in Sec. 317.313(j)(1) and 

for which it substitutes as described in Sec. 317.313(d) that has a 

significant (e.g., 5 percent or more of a national or regional market) 

market share;

    (ii) The product contains 2 g or less of saturated fat per 100 g of 

product; and

    (iii) As required in Sec. 317.313(j)(2) for relative claims:

    (A) The identity of the reference product and the percent (or 

fraction) that the cholesterol has been reduced are declared in 

immediate proximity to the most prominent such claim (e.g., ``25% less 

cholesterol than `reference product' ''); and

    (B) Quantitative information comparing the level of cholesterol in 

the product per specified weight with that



[[Page 229]]



of the reference product that it replaces is declared adjacent to the 

most prominent claim or to the nutrition information (e.g., 

``cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 

3 oz).

    (iv) Claims described in paragraph (d)(5) of this section may not be 

made on the label or in labeling of a product if the nutrient content of 

the reference product meets the definition for ``low cholesterol.''

    (e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may be 

used on the label or in labeling of a product, provided that the product 

contains less than 10 g of fat, 4.5 g or less of saturated fat, and less 

than 95 mg of cholesterol per 100 g of product and per reference amount 

customarily consumed for individual foods, and per 100 g of product and 

per labeled serving size for meal-type products as defined in Sec. 

317.313(l) and main-dish products as defined in Sec. 317.313(m).

    (2) The term ``extra lean'' may be used on the label or in labeling 

of a product, provided that the product contains less than 5 g of fat, 

less than 2 g of saturated fat, and less than 95 mg of cholesterol per 

100 g of product and per reference amount customarily consumed for 

individual foods, and per 100 g of product and per labeled serving size 

for meal-type products as defined in Sec. 317.313(l) and main-dish 

products as defined in Sec. 317.313(m).



[60 FR 193, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004]