[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.60]

[Page 104-107]
 
                        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 D_Specific Requirements for Nutrient Content Claims
 
Sec.  101.60  Nutrient content claims for the calorie content of foods.

    (a) General requirements. A claim about the calorie or sugar content 
of a food may only be made on the label or in the labeling of a food 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.  101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.9, Sec.  101.10, or Sec.  101.36, as applicable; and
    (4) For dietary supplements, claims regarding calories 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 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).
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietarily insignificant source of calories'' may be used on the label 
or in the labeling of foods, provided that:
    (i) The food contains less than 5 calories per reference amount 
customarily consumed and per labeled serving.
    (ii) As required in Sec.  101.13(e)(2), if the food meets this 
condition without the benefit of special processing, alteration, 
formulation, or reformulation to lower the caloric content, it is 
labeled to disclose that calories are not usually present in the food 
(e.g., ``cider vinegar, a calorie free food'').
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in calories'' 
may be used on the label or in labeling of foods, except meal products 
as defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and does not provide 
more than 40 calories per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and does not provide more than 40 calories 
per reference amount customarily consumed and, except for sugar 
substitutes, 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).
    (ii) If a food meets these conditions without the benefit of special 
processing, alteration, formulation, or reformulation to vary the 
caloric content, it is labeled to clearly refer to all foods of its type 
and not merely to the particular brand to which the label attaches 
(e.g., ``celery, a low calorie food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec.  
101.13(l) or main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) The product contains 120 calories or less per 100 g; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,''

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``fewer calories,'' ``lower calorie,'' or ``lower in calories'' may be 
used on the label or in the labeling of foods, except as limited by 
Sec.  101.13(j)(1)(i) and except meal products as defined in Sec.  
101.13(l) and main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) The food contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference food 
as described in Sec.  101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the calories differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced calorie 
cupcakes ``33 1/3 percent fewer calories than regular cupcakes''); and
    (B) Quantitative information comparing the level of the nutrient per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``Calorie content has been reduced from 150 to 100 calories per 
serving.'') is declared 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.
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or labeling of foods if the reference food meets 
the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent fewer calories per 100 g 
of food than an appropriate reference food as described in Sec.  
101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the calories differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., Larry's Reduced 
Calorie Lasagna, ``25 percent fewer calories per oz (or 3 oz) than our 
regular Lasagna''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Calorie content has been reduced from 108 calories per 
3 oz to 83 calories per 3 oz.'') is declared 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.
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or labeling of food if the reference food meets the 
definition for ``low calorie.''
    (c) Sugar content claims--(1) Use of terms such as ``sugar free,'' 
``free of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar.'' Consumers may 
reasonably be expected to regard terms that represent that the food 
contains no sugars or sweeteners e.g., ``sugar free,'' or ``no sugar,'' 
as indicating a product which is low in calories or significantly 
reduced in calories. Consequently, except as provided in paragraph 
(c)(2) of this section, a food may not be labeled with such terms 
unless:
    (i) The food contains less than 0.5 g of sugars, as defined in Sec.  
101.9(c)(6)(ii), per reference amount customarily consumed and per 
labeled serving or, in the case of a meal product or main dish product, 
less than 0.5 g of sugars per labeled serving; and
    (ii) The food contains no ingredient that is a sugar or that is 
generally understood by consumers to contain sugars unless the listing 
of the ingredient in the ingredient statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which states 
``adds a trivial amount of sugar,'' ``adds a negligible amount of 
sugar,'' or ``adds a dietarily insignificant amount of sugar;'' and
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs

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(b)(2), (b)(3), (b)(4), or (b)(5) of this section, or, if a dietary 
supplement, it meets the definition in paragraph (b)(2) of this section 
for ``low calorie'' but is prohibited by Sec. Sec.  101.13(b)(5) and 
101.60(a)(4) from bearing the claim; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie food,'' ``not a low calorie 
food,'' or ``not for weight control.''
    (2) The terms ``no added sugar,'' ``without added sugar,'' or ``no 
sugar added'' may be used only if:
    (i) No amount of sugars, as defined in Sec.  101.9(c)(6)(ii), or any 
other ingredient that contains sugars that functionally substitute for 
added sugars is added during processing or packaging; and
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice; and
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as the use of enzymes, 
except where the intended functional effect of the process is not to 
increase the sugars content of a food, and a functionally insignificant 
increase in sugars results; and
    (iv) The food that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the food is not ``low 
calorie'' or ``calorie reduced'' (unless the food meets the requirements 
for a ``low'' or ``reduced calorie'' food) and that directs consumers' 
attention to the nutrition panel for further information on sugar and 
calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a food, including foods intended specifically for infants 
and children less than 2 years of age, is unsweetened or contains no 
added sweeteners in the case of a food that contains apparent 
substantial inherent sugar content, e.g., juices.
    (4) The claims provided for in paragraph (c)(1) and (c)(2) of this 
section may be used on labels or in labeling of dietary supplements of 
vitamins or minerals that are intended specifically for use by infants 
and children less than 2 years of age.
    (5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be 
used on the label or in labeling of foods, except meal products as 
defined in Sec.  101.13(l), main dish products as defined in Sec.  
101.13(m), and dietary supplements of vitamins or minerals, provided 
that:
    (i) The food contains at least 25 percent less sugar per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec.  101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sugar differs between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., ``these corn flakes 
contain 25 percent less sugar than our sugar coated corn flakes''); and
    (B) Quantitative information comparing the level of the sugar in the 
product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per 
serving.'') is declared 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.
    (6) The terms defined in paragraph (c)(5) of this section may be 
used on the label or in the labeling of a meal product as defined in 
Sec.  101.13(l) and a main dish product as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent less sugars per 100 g of 
food than an appropriate reference food as described in Sec.  
101.13(j)(1), and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sugars differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced sweet and sour 
shrimp dinner, ``25 percent less sugar per 3 oz than our regular sweet 
and sour shrimp dinner''); and

[[Page 107]]

    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz to 
13 g per 3 oz.'') is declared 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.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 
FR 44031, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 
1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881, Sept. 23, 1997]