[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.362]

[Page 225-230]
 
                  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 226]]

    (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 227]]

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 228]]

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 229]]

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 230]]

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]