[Title 21 CFR D]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 101 - FOOD LABELING]
[Subpart D - Specific Requirements for Nutrient Content Claims]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  2
  1996-04-01
  1996-04-01
  false
  
  D
  Subpart D
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
    FOOD FOR HUMAN CONSUMPTION
    FOOD LABELING
  


      Subpart D--Specific Requirements for Nutrient Content Claims

    Source: 58 FR 2413, Jan. 6, 1993, unless otherwise noted.



Sec. 101.54  Nutrient content claims for ``good source,'' ``high,'' and ``more.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a food in 
relation to the Reference Daily Intake (RDI) established for that 
nutrient in Sec. 101.9(c)(8)(iv) or Daily Reference Value (DRV) 
established for that nutrient in Sec. 101.9(c)(9), (excluding total 
carbohydrates) may only be made on the label or in labeling of the 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; and
    (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.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label or in the 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 to characterize the level of any substance that is 
not a vitamin or mineral, provided that the food contains 20 percent or 
more of the RDI or the DRV

[[Page 91]]

per reference amount customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label and 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 product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., the serving of broccoli in this product is 
high in vitamin C).
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling of 
foods except meal products as described in Sec. 101.13(l) main dish 
products as described in Sec. 101.13(m), and dietary supplements of 
vitamins or minerals to characterize the level of any substance that is 
not a vitamin or mineral, provided that the food contains 10 to 19 
percent of the RDI or the DRV per reference amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label and in the labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in 101.13(m), provided 
that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., the serving of sweet potatoes in this 
product is a ``good source'' of fiber).
    (d) ``Fiber'' claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, that is, that the product is high 
in fiber, a good source of fiber, or that the food contains ``more'' 
fiber, and the food is not ``low'' in total fat as defined in 
Sec. 101.62(b)(2) or, in the case of a meal product, as defined in 
Sec. 101.13(l), or main dish product, as defined in Sec. 101.13(m), is 
not ``low'' in total fat as defined in Sec. 101.62(b)(3), then the label 
shall disclose the level of total fat per labeled serving.
    (2) The disclosure shall appear in immediate proximity to such 
claim, be in a type size no less than one-half the size of the claim and 
precede the referral statement required in Sec. 101.13(g) (e.g., 
``contains [x amount] of total fat per serving. See [appropriate panel] 
for nutrition information'').
    (e) ``More'' claims. (1) A relative claim using the terms ``more,'' 
``fortified,'' ``enriched,'' ``added,'' and ``extra'' may be used on the 
label or in labeling of foods to describe the level of protein, 
vitamins, minerals,

[[Page 92]]

dietary fiber, or potassium except as limited by Sec. 101.13(j)(1)(i) 
and 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 to characterize the level of any substance that is 
not a vitamin or mineral, provided that:
    (i) The food contains at least 10 percent more of the RDI for 
vitamins or minerals or of the DRV for protein, dietary fiber, or 
potassium (expressed as a percent of the Daily Value) per reference 
amount customarily consumed than an appropriate reference food; and
    (ii) Where the claim is based on a nutrient that has been added to 
the food, that fortification is in accordance with the policy on 
fortification of foods in Sec. 104.20 of this chapter; and
    (iii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percentage (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than white 
bread''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per 
serving; (this product) 3.5 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.
    (2) A relative claim using the terms ``more,'' ``fortified,'' 
``enriched,'' ``added,'' and ``extra'' may be used on the label or in 
labeling to describe the level of protein, vitamins, minerals, dietary 
fiber or potassium, except as limited in Sec. 101.13(j)(1)(i), in meal 
products as defined in Sec. 101.13(l) or main dish products as defined 
in Sec. 101.13(m), provided that:
    (i) The food contains at least 10 percent more of the RDI for 
vitamins or minerals or of the DRV for protein, dietary fiber, or 
potassium (expressed as a percent of the Daily Value) per 100 g of food 
than an appropriate reference food.
    (ii) Where the claim is based on a nutrient that has been added to 
the food, that fortification is in accordance with the policy on 
fortification of foods in Sec. 104.20 of this chapter; and
    (iii) As required in Sec. 101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percentage (or 
fraction) that the nutrient was increased relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 oz than 
does `X brand of product'''), 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., ``The fiber content of `X brand of product' is 2 g per 3 
oz. This product contains 4.5 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 59 
FR 394, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5, 
1995; 61 FR 11731, Mar. 22, 1996]



Sec. 101.56  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the term ``light'' or 
``lite'' to describe a food may only be made on the label or in labeling 
of the 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; and
    (3) The food is labeled in accordance with Sec. 101.9 or 
Sec. 101.10, where applicable.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on 
the label or in the labeling of foods, except meal products as defined 
in Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), 
without further qualification, provided that:
    (1) If the food derives 50 percent or more of its calories from fat, 
its fat content is reduced by 50 percent or more per reference amount 
customarily consumed compared to an appropriate reference food as 
specified in Sec. 101.13(j)(1); or
    (2) If the food derives less than 50 percent of its calories from 
fat:
    (i) The number of calories is reduced by at least one-third (33 1/3 
percent) per reference amount customarily consumed compared to an 
appropriate reference food; or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the reference food that it 
resembles or for which it substitutes as specified in Sec. 101.13(j)(1); 
and
    (3) As required in Sec. 101.13(j)(2) for relative claims:
    (i) The identity of the reference food and the percent (or fraction) 
that the calories and the fat were reduced are declared in immediate 
proximity to the most prominent such claim, (e.g., ``1/3 fewer calories 
and 50 percent less fat than our regular cheese cake'');
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference food that it replaces (e.g., ``lite cheesecake--200 calories, 
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat 
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; and
    (iii) If the labeled food contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.

[[Page 93]]

    (4) A ``light'' claim may not be made on a food for which the 
reference food meets the definition of ``low fat'' and ``low calorie.''
    (c)(1)(i) A product for which the reference food contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the term ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference food; 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 sodium was reduced shall be declared in immediate proximity to 
the most prominent such claim (e.g., 50 percent less sodium than our 
regular soy sauce); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular 
soy sauce 1,000 mg 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.
    (2)(i) A product for which the reference food contains more than 40 
calories or more than 3 g fat per reference amount customarily consumed 
may use the term ``light in sodium'' or ``lite in sodium'' if it is 
reduced by 50 percent or more in sodium content compared to the 
reference food, provided that ``light'' or ``lite'' is presented in 
immediate proximity with ``in sodium'' and the entire term is presented 
in uniform type size, style, color, and prominence; 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 sodium was reduced shall be declared in immediate proximity to 
the most prominent such claim (e.g., 50 percent less sodium than our 
regular canned peas); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned 
peas 350 mg 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) Except for meal products as defined in Sec. 101.13(l) and main 
dish products as defined in Sec. 101.13(m), a ``light in sodium'' claim 
may not be made on a food for which the reference food meets the 
definition of ``low in sodium''.
    (d)(1) The terms ``light'' or ``lite'' 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 meets the definition of:
    (A) ``Low in calories'' as defined in Sec. 101.60(b)(3); or
    (B) ``Low in fat'' as defined in Sec. 101.62(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The term ``light in sodium'' or ``lite in sodium'' 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 the food meets the definition of ``low in sodium'' as 
defined in Sec. 101.61(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the term ``light'' or ``lite'' may not be used to refer to a 
food that is not reduced in fat by 50 percent, or, if applicable, in 
calories by 1/3 or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the food 
such as texture or color and the information (e.g., ``light in color'' 
or ``light in texture'') so stated, clearly conveys the nature of the 
product; and

[[Page 94]]

    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular food to reflect a 
physical or organoleptic attribute (e.g., light brown sugar, light corn 
syrup, or light molasses) to the point where it has become part of the 
statement of identity, such use of the term ``light'' shall not be 
considered a nutrient content claim subject to the requirements in this 
part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference food as described in Sec. 101.13(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec. 101.61(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition label of the food bearing the 
claim, or, if the nutrition label is on the information panel, it may 
appear elsewhere on the information panel in accordance with Sec. 101.2 
and the information required to accompany a relative claim shall appear 
on the label or labeling as specified in Sec. 101.13(j)(2).

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 60 
FR 17206, Apr. 5, 1995]



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

[[Page 95]]

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,'' ``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

[[Page 96]]

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

[[Page 97]]

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 (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section; 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)(4) 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
    (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]



Sec. 101.61  Nutrient content claims for the sodium content of foods.

    (a) General requirements. A claim about the level of sodium or salt 
in a food may only be made on the label or in the labeling of the 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; and
    (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.
    (b) ``Sodium content claims.'' (1) The terms ``sodium free,'' ``free 
of sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' 
``trivial source of sodium,'' ``negligible source of sodium,'' or 
``dietary insignificant source of sodium'' may be used on the label or 
in the labeling of foods, provided that:
    (i) The food contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving or, in the 
case of a meal product or a main dish product, less than 5 mg of sodium 
per labeled serving; and
    (ii) The food contains no ingredient that is sodium chloride or is 
generally understood by consumers to contain sodium, 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 sodium,'' ``adds a negligible amount 
of sodium'' or ``adds a dietarily insignificant amount of sodium;'' and
    (iii) As required in Sec. 101.13(e)(2) if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower the sodium content, it is labeled 
to disclose that sodium is not usually present in the food (e.g., ``leaf 
lettuce, a sodium free food'').
    (2) The terms ``very low sodium,'' or ``very low in sodium,'' may be 
used on the label or in labeling of foods, except meal products as 
defined in Sec. 101.13(l) and main

[[Page 98]]

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 contains 35 mg or 
less sodium 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 contains 35 mg or less sodium per 
reference amount customarily consumed and 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 the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium 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., ``potatoes, a very low-sodium 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) and main dish products as defined in Sec. 101.13(m), 
provided that:
    (i) The product contains 35 mg or less of sodium per 100 g of 
product; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium 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.
    (4) The terms ``low sodium,'' or ``low in sodium,'' ``little 
sodium,'' ``contains a small amount of sodium,'' or ``low source of 
sodium'' may be used on the label or in the 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 g or greater than 2 tablespoons and contains 140 mg or less 
sodium 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 contains 140 mg or less sodium per 
reference amount customarily consumed and 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); 
and
    (ii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium 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., ``fresh spinach, a low sodium food''); and
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in 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 product contains 140 mg or less sodium per 100 g; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium 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.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' 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) The food contains at least 25 percent less sodium per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec. 101.13(j)(1).
    (ii) As required for Sec. 101.13(j)(2) for relative claims:

[[Page 99]]

    (A) The identity of the reference food and the percent (or fraction) 
that the sodium differs from the labeled food are declared in immediate 
proximity to the most prominent such claim (e.g., ``reduced sodium ----
------, 50 percent less sodium than regular ----------''); and
    (B) Quantitative information comparing the level of the sodium in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sodium content has been lowered from 300 to 150 mg 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)(6) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low sodium.''
    (7) The terms defined in paragraph (b)(6) 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 less sodium 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 sodium differs from the reference food are declared in 
immediate proximity to the most prominent such claim (e.g., reduced 
sodium eggplant parmigiana dinner ``30 percent less sodium per oz (or 3 
oz) than our regular eggplant parmigiana dinner'').
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz 
to 150 mg 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)(7) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low sodium.''
    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers 
to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no salt,'' ``no salt added'' are potentially misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of foods only if the food is ``sodium free'' as defined in paragraph 
(b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of foods only if:
    (i) No salt is added during processing;
    (ii) The food that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the food is not sodium free, the statement, ``not a sodium 
free food'' or ``not for control of sodium in the diet'' appears 
adjacent to the nutrition label of the food bearing the claim, or, if 
the nutrition label is on the information panel, it may appear elsewhere 
on the information panel in accordance with Sec. 101.2.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a food intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the food and is not otherwise false and misleading.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 
FR 44032, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 
1995]



Sec. 101.62  Nutrient content claims for fat, fatty acid, and cholesterol content of foods.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a food may only be made on the label or in the 
labeling of foods 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 for fat, saturated fat, and 
cholesterol 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.
    (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 
foods, provided that:
    (i) The food contains less than 0.5 gram (g) of fat 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 fat per labeled 
serving; and
    (ii) The food 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 ingredient 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) As required in Sec. 101.13(e)(2), if the food meets these 
conditions without

[[Page 100]]

the benefit of special processing, alteration, formulation, or 
reformulation to lower fat content, it is labeled to disclose that fat 
is not usually present in the food (e.g., ``broccoli, a fat free 
food'').
    (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 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 g or greater than 2 tablespoons and contains 3 g or less of fat 
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 contains 3 g or less of fat per 
reference amount customarily consumed and per 50 g of food (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); 
and
    (ii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
fat 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., 
``frozen perch, a low fat 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 3 g or less of total fat per 100 g 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 
fat 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.
    (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 the 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) The food contains at least 25 percent less fat 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 fat differs between the two foods and are declared in immediate 
proximity to the most prominent such claim (e.g., ``reduced fat--50 
percent less fat than our regular brownies''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving with that of the reference food that it 
replaces (e.g.,

[[Page 101]]

``Fat content has been reduced from 8 g to 4 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.
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 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 less fat 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 fat differs between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced fat spinach 
souffle, ``33 percent less fat per 3 oz than our regular spinach 
souffle''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5 
g per 3 oz.'') is declared adjacent to the most prominent claim, to the 
nutrition label, or, if the nutrition label is located on the 
information panel, it may appear 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 in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low fat.''
    (6) The term ``------ percent fat free'' may be used on the label or 
in the labeling of foods, provided that:
    (i) The food 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 foods 
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.
    (c) ``Fatty acid content claims.'' The label or labeling of foods 
that bear claims with respect to the level of saturated fat shall 
disclose the level of total fat and cholesterol in the food in immediate 
proximity to such claim each time the claim is made and in type that 
shall be no less than one-half the size of the type used for the claim 
with respect to the level of saturated fat. Declaration of cholesterol 
content may be omitted when the food contains less than 2 milligrams 
(mg) of cholesterol per reference amount customarily consumed or in the 
case of a meal or main dish product less than 2 mg of cholesterol per 
labeled serving. Declaration of total fat may be omitted with the term 
defined in paragraph (c)(1) of this section when the food contains less 
than 0.5 g of total fat per reference amount customarily consumed or, in 
the case of a meal product or a main dish product, when the product 
contains less than 0.5 g of total fat per labeled serving. The 
declaration of total fat may be omitted with the terms defined in 
paragraphs (c)(2) through (c)(5) of this section when the food contains 
3 g or less of total fat per reference amount customarily consumed or in 
the case of a meal product or a main dish product, when the product 
contains 3 g or less of total fat per 100 g and not more than 30 percent 
calories from fat.
    (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 the labeling of foods, provided that:
    (i) The food contains less than 0.5 g of saturated fat and less than 
0.5 g trans fatty acid 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 saturated fat and less than 0.5 g trans fatty acid 
per labeled serving; and
    (ii) The food contains no ingredient that is generally understood by 
consumers to contain saturated fat 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 saturated fat,'' ``adds a negligible amount of 
saturated fat,'' or ``adds a dietarily insignificant amount of saturated 
fat;'' and
    (iii) As required in Sec. 101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower saturated fat content, it

[[Page 102]]

is labeled to disclose that saturated fat is not usually present in the 
food.
    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source of saturated 
fat,'' or ``a little saturated fat'' may be used on the label or in the 
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) The food contains 1 g or less of saturated fatty acids per 
reference amount

[[Page 103]]

customarily consumed and not more than 15 percent of calories from 
saturated fatty acids; and
    (ii) If a food 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 foods of its type and 
not merely to the particular brand to which the label attaches (e.g., 
``raspberries, a low saturated fat food'').
    (3) The terms defined in paragraph (c)(2) 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 product contains 1 g or less of saturated fatty acids 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 foods 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 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 less saturated fat 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 saturated fat differs between the two foods are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
saturated fat. Contains 50 percent less saturated fat than the national 
average for nondairy creamers''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 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.
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 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 less saturated fat 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 fat differs between the two foods are declared in 
immediate proximity to the most prominent such claim (e.g., reduced 
saturated fat Macaroni and Cheese, ``33 percent less saturated fat per 3 
oz than our regular Macaroni and Cheese'').
    (B) Quantitative information comparing the level of saturated fat in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Saturated fat content has been reduced from 2.5 g per 
3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label in 
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 (c)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 source of cholesterol,'' or ``dietarily insignificant 
source of cholesterol'' may be used on the label or in the labeling of 
foods, provided that:
    (i) For foods that contain 13 g or less of total fat per reference 
amount cutomarily consumed, per labeled serving, and per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (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), or, in the case of meal products, 26.0 g or less total 
fat per labeled serving, or, in the case of main dish products, 19.5 g 
or less total fat per labeled serving:
    (A) The food contains less than 2 mg of cholesterol per reference 
amount customarily consumed and per labeling serving or, in the case of 
a meal product or main dish product, less than 2 mg of cholesterol per 
labeled serving; and
    (B) The food contains no ingredient that is generally understood by 
consumers to contain cholesterol, 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 cholesterol,'' ``adds a negligible amount of 
cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol;'' and
    (C) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed or, in the case of a meal product 
or main dish product, 2 g or less of saturated fatty acids per labeled 
serving; and
    (D) As required in Sec. 101.13(e)(2), if the food contains less than 
2 mg of cholesterol per reference amount customarily consumed or in the 
case of a meal product or main dish product, less than 2 mg of 
cholesterol per labeled serving without the benefit of special 
processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to disclose that cholesterol is not 
usually present in the food (e.g., ``applesauce, a cholesterol-free 
food'').
    (ii) For food that contain more than 13 g of total fat per reference 
amount customarily consumed, per labeling serving, or per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (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), or in the case of a meal product, more than 26 g of 
total fat per labeled serving, or, in the case of a main dish product 
more than 19.5 g of total fat per labeled serving:
    (A) The food contains less than 2 mg of cholesterol per reference 
amount customarily consumed and per labeling serving or, in the case of 
a meal product or main dish product, less than 2 mg of cholesterol per 
labeled serving; and
    (B) The food contains no ingredient that is generally understood by 
consumers to contain cholesterol, 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 cholesterol,'' ``adds a negligible amount of 
cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol;'' and
    (C) The food contains 2 g or less of saturated fatty acids per 
reference amount cutomarily consumed or, in the case of a meal product 
or main dish product less than 2 g of saturated fatty acids per labeled 
serving; and
    (D) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding the referral 
statement required in Sec. 101.13(g) in type that shall be no less than 
one-half the size of the type used for such claim. If the claim appears 
on more than one panel, the disclosure shall be made on each panel 
except for the panel that bears nutrition labeling. If the claim appears 
more than once on a panel, the disclosure shall be made in immediate 
proximity to the claim that is printed in the largest type; and
    (E) As required in Sec. 101.13(e)(2), if the food contains less than 
2 mg of cholesterol per reference amount customarily consumed or in the 
case of a meal product or main dish product less than 2 mg of 
cholesterol per labeled serving without the benefit of special 
processing, alteration, formulation, or

[[Page 104]]

reformulation to lower cholesterol content, it is labeled to disclose 
that cholesterol is not usually present in the food (e.g., ``canola oil, 
a cholesterol-free food, contains 14 g of fat per serving''); or
    (F) If the food contains less than 2 mg of cholesterol per reference 
amount customarily consumed or in the case of a meal product or main 
dish product less than 2 mg of cholesterol per labeled serving only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec. 101.13(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 margarine, 
contains 100 percent less cholesterol than butter''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Contains no cholesterol compared with 30 mg 
cholesterol in one serving of butter. Contains 13 g of fat 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.
    (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 
the 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) For foods that have a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and contain 13 g or less 
of total fat per reference amount customarily consumed and per labeled 
serving:
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches (e.g., ``low fat cottage 
cheese, a low cholesterol food.'').
    (ii) For foods that have a reference amount customarily consumed of 
30 g or less or 2 tablespoons or less and contain 13 g or less of total 
fat per reference amount customarily consumed, per labeled serving, and 
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);
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed and 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);
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches (e.g., ``low fat cottage 
cheese, a low cholesterol food'').
    (iii) For foods that have a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and contain more than 13 
g of total fat

[[Page 105]]

per reference amount customarily consumed or per labeled serving,
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding the referral 
statement required in Sec. 101.13(g) in type that shall be no less than 
one-half the size of the type used for such claim. If the claim appears 
on more than one panel, the disclosure shall be made on each panel 
except for the panel that bears nutrition labeling. If the claim is made 
more than once on a panel, the disclosure shall be made in immediate 
proximity to the claim that is printed in the largest type; and
    (D) As required in Sec. 101.13(e)(2), if the food 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 foods of that type

[[Page 106]]

and not merely to the particular brand to which the label attaches; or
    (E) If the food contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec. 101.13(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 
peanut butter sandwich crackers, contains 83 percent less cholesterol 
than our regular peanut butter sandwich crackers''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat 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.
    (iv) For foods that have a reference amount customarily consumed of 
30 g or less or 2 tablespoons or less and contain more than 13 g of 
total fat per reference amount customarily consumed, per labeled 
serving, or 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),
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed and 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),
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding the referral 
statement required in Sec. 101.13(g) in type that shall be no less than 
one-half the size of the type used for such claim. If the claim appears 
on more than one panel, the disclosure shall be made on each panel 
except for the panel that bears nutrition labeling. If the claim is made 
more than once on a panel, the disclosure shall be made in immediate 
proximity to the claim that is printed in the largest type; and
    (D) As required in Sec. 101.13(e)(2), if the food 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 foods of that type and not merely to the 
particular brand to which the label attaches; or
    (E) If the food contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec. 101.13(d) that has a 
significant (i.e., 5 percent or more of a national or regional market) 
market share. As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 
peanut butter sandwich crackers, contains 83 percent less cholesterol 
than our regular peanut butter sandwich crackers''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat 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.
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label and in labeling of meal products as defined in 
Sec. 101.13(l) or a main dish product as defined in Sec. 101.13(m) 
provided that the product meets the requirements of paragraph (d)(2) of 
this section except that the determination as to whether paragraph 
(d)(2)(i) or (d)(2)(iii) of this section applies to the product will be 
made only on the basis of whether the meal product contains 26 g or less 
of total fat per labeled serving or the main dish product contain 19.5 g 
or less of total fat per labeled serving, the requirement in paragraphs 
(d)(2)(i)(A) and (d)(2)(iii)(A) of this section shall be limited to 20 
mg of cholesterol per 100 g, and the requirement in paragraphs 
(d)(2)(i)(B) and (d)(2)(iii)(B) of this section shall be modified to 
require that the food contain 2 g or less of saturated fat per 100 g 
rather than per reference amount customarily consumed.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 
``lower in cholesterol'' except as limited by Sec. 101.13(j)(1)(i) may 
be used on the label or in labeling of foods or foods that substitute 
for those foods as specified in Sec. 101.13(d), excluding meal products 
as defined in Sec. 101.13(l) and main dish products as defined in 
Sec. 101.13(m), provided that:
    (i) For foods that contain 13 g or less of total fat per reference 
amount customarily consumed, per labeled serving, and per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (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):
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant (i.e., 
5 percent or more) market share; and
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim; and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving; 
[reference product] 30 mg cholesterol 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

[[Page 107]]

information panel in accordance with Sec. 101.2.
    (ii) For foods that contain more than 13 g of total fat per 
reference amount customarily consumed, per labeled serving, or per 50 g 
if the reference amount customarily consumed is 30 g or less or 2 
tablespoons or less (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):
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant (i.e., 
5 percent or more of a national or regional market) market share;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding the referral 
statement required in Sec. 101.13(g) in type that shall be no less than 
one-half the size of the type used for such claim. If the claim appears 
on more than one panel, the disclosure shall be made on each panel 
except for the panel that bears nutrition labeling. If the claim is made 
more than once on a panel, the disclosure shall be made in immediate 
proximity to the claim that is printed in the largest type; and
    (D) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 ----------------); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving. 
Contains 13 g of fat 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 (d)(4) of this section may not 
be made on the label or in labeling of a food if the nutrient content of 
the reference food 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 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) For meal products that contain 26.0 g or less of total fat per 
labeled serving or for main dish products that contain 19.5 g or less of 
total fat per labeled serving;
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant (e.g., 
5 percent or more of a national or regional market) market share;
    (B) The food contains 2 g or less of saturated fatty acids per 100 
g; and
    (C) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food, 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 per 3 oz than --------.''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Cholesterol content has been reduced from 35 mg per 3 
oz to 25 mg 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.
    (ii) For meal products that contain more than 26.0 g of total fat 
per labeled

[[Page 108]]

serving or for main dish products that contain more than 19.5 g of total 
fat per labeled serving:
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec. 101.13(j)(1) and for which it 
substitutes as specified in Sec. 101.13(d) that has a significant (e.g., 
5 percent or more of a national or regional market) market share.
    (B) The food contains 2 g or less of saturated fatty acids per 100 
g;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding the referral 
statement required in Sec. 101.13(g) in type that shall be no less than 
one-half the size of the type used for such claim. If the claim appears 
on more than one panel the disclosure shall be made on each panel except 
for the panel that bears nutrition labeling. If the claim is made more 
than once on a panel, the disclosure shall be made in immediate 
proximity to the claim that is printed in the largest type; and
    (D) As required in Sec. 101.13(j)(2) for relative claims:
    (1) The identity of the reference food 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 ------------); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz of 
product.'') 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 (d)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food 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 foods except meal products as 
defined in Sec. 101.13(l) and main dish products as defined in 
Sec. 101.13(m) provided that the food is a seafood or game meat product 
and as packaged contains less than 10 g total fat, 4.5 g or less 
saturated fat, and less than 95 mg cholesterol per reference amount 
customarily consumed and per 100 g;
    (2) The term defined in paragraph (e)(1) of this section may be used 
on the label or in the labeling of meal products as defined in 
Sec. 101.13(l) or main dish products as defined in Sec. 101.13(m) 
provided that the food contains less than 10 g total fat, 4.5 g or less 
saturated fat, and less than 95 mg cholesterol per 100 g and per labeled 
serving;
    (3) The term ``extra lean'' may be used on the label or in the 
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 the food 
is a discrete seafood or game meat product and as packaged contains less 
than 5 g total fat, less than 2 g saturated fat, and less than 95 mg 
cholesterol per reference amount customarily consumed and per 100 g; and
    (4) The term defined in paragraph (e)(3) of this section may be used 
on the label or in labeling of meal products as defined in 
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m) 
provided that the food contains less than 5 g of fat, less than 2 g of 
saturated fat, and less than 95 mg of cholesterol per 100 g and per 
labeled serving.
    (f) Misbranding. Any label or labeling containing any statement 
concerning fat, fatty acids, or cholesterol that is not in conformity 
with this section shall be deemed to be misbranded under sections 
201(n), 403(a), and 403(r) of the Federal Food, Drug, and Cosmetic Act.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, Apr. 2, 1993, as amended 
at 58 FR 44032, Aug. 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394, 
Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995]



Sec. 101.65  Implied nutrient content claims and related label statements.

    (a) General requirements. An implied nutrient content claim can only 
be

[[Page 109]]

made on the label and in labeling of the food if:
    (1) The claim uses one of the terms described 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; and
    (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.
    (b) Label statements that are not implied claims. Certain label 
statements about the nature of a product are not nutrient content claims 
unless such statements are made in a context that would make them an 
implied claim under Sec. 101.13(b)(2). The following types of label 
statements are generally not implied nutrient content claims and, as 
such, are not subject to the requirements of Sec. 101.13 and this 
section:
    (1) A claim that a specific ingredient or food component is absent 
from a product, provided that the purpose of such claim is to facilitate 
avoidance of the substances because of food allergies (see Sec. 105.62 
of this chapter), food intolerance, religious beliefs, or dietary 
practices such as vegetarianism or other nonnutrition related reason, 
e.g., ``100 percent milk free;''
    (2) A claim about a substance that is nonnutritive or that does not 
have a nutritive function, e.g., ``contains no preservatives,'' ``no 
artificial colors;''
    (3) A claim about the presence of an ingredient that is perceived to 
add value to the product, e.g., ``made with real butter,'' ``made with 
whole fruit,'' or ``contains honey,'' except that claims about the 
presence of ingredients other than vitamins or minerals or that are 
represented as a source of vitamins and minerals are not allowed on 
labels or in labeling of dietary supplements of vitamins and minerals 
that are not in conventional food form.
    (4) A statement of identity for a food in which an ingredient 
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' ``oat 
bran,'' ``vitamin C 60 mg tablet'').
    (5) A statement of identity that names as a characterizing 
ingredient, an ingredient associated with a nutrient benefit (e.g., 
``corn oil margarine,'' ``oat bran muffins,'' or ``whole wheat 
bagels''), unless such claim is made in a context in which label or 
labeling statements, symbols, vignettes, or other forms of communication 
suggest that a nutrient is absent or present in a certain amount; and
    (6) A label statement made in compliance with a specific provision 
of part 105 of this chapter, solely to note that a food has special 
dietary usefulness relative to a physical, physiological, pathological, 
or other condition, where the claim identifies the special diet of which 
the food is intended to be a part.
    (c) Particular implied nutrient content claims. (1) Claims about the 
food or an ingredient therein that suggest that a nutrient or an 
ingredient is absent or present in a certain amount (e.g., ``high in oat 
bran'') are implied nutrient content claims and must comply with 
paragraph (a) of this section.
    (2) The phrases ``contains the same amount of [nutrient] as a 
[food]'' and ``as much [nutrient] as a [food]'' may be used on the label 
or in the labeling of foods, provided that the amount of the nutrient in 
the reference food is enough to qualify that food as a ``good source'' 
of that nutrient, and the labeled food, on a per serving basis, is an 
equivalent, good source of that nutrient (e.g., ``as much fiber as an 
apple,'' ``Contains the same amount of Vitamin C as an 8 oz glass of 
orange juice.'').
    (3) Claims may be made that a food contains or is made with an 
ingredient that is known to contain a particular nutrient, or is 
prepared in a way that affects the content of a particular nutrient in 
the food, if the finished food is either ``low'' in or a ``good source'' 
of the nutrient that is associated with the ingredient or type of 
preparation. If a more specific level is claimed (e.g., ``high in ------
----''), that level of the nutrient must be present in the food. For 
example, a claim that a food contains oat bran is a claim that it is a 
good source of dietary fiber; that a food is made only with vegetable 
oil is a claim that it is low in saturated fat; and that a food contains 
no oil is a claim that it is fat free.
    (d) General nutritional claims. (1) Claims about a food that suggest 
that the food because of its nutrient content may be useful in 
maintaining healthy dietary practices and that are made in association 
with an explicit claim or

[[Page 110]]

statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'') 
are implied nutrient content claims covered by this paragraph.
    (2) The term ``healthy'' or any derivative of the term ``healthy,'' 
such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'' may be 
used on the label or in labeling of a food, other than raw, single 
ingredient seafood or game meat products, main dish products as defined 
in Sec. 101.13(m), and meal products as defined in Sec. 101.13(l), as an 
implied nutrient content claim to denote foods that are useful in 
constructing a diet that is consistent with dietary recommendations 
provided that:
    (i) The food meets the definition of ``low'' for fat and saturated 
fat;
    (ii)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and, before January 1, 
1998, contains 480 milligrams (mg) sodium or less per reference amount 
customarily consumed, and per labeled serving; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, before January 1, 1998, contains 480 
mg sodium or less 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);
    (C)(1) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, after January 1, 1998, 
contains 360 mg sodium or less per reference amount customarily 
consumed, and per labeled serving; or
    (2) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, after January 1, 1998, contains 360 
mg sodium or less 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);
    (iii) Cholesterol is not present at a level exceeding the disclosure 
level as described in Sec. 101.13(h);
    (iv) The food, other than a raw fruit or vegetable, contains at 
least 10 percent of the Reference Daily Intake (RDI) or Daily Reference 
Value (DRV) per reference amount customarily consumed of vitamin A, 
vitamin C, calcium, iron, protein, or fiber;
    (v) Where compliance with paragraph (d)(2)(iv) of this section is 
based on a nutrient that has been added to the food, that fortification 
is in accordance with the policy on fortification of foods in 
Sec. 104.20 of this chapter; and
    (vi) The food complies with definitions and declaration requirements 
established in part 101 of this chapter for any specific nutrient 
content claim on the label or in labeling.
    (3) The term ``healthy'' or its derivatives may be used on the label 
or in labeling of raw, single ingredient seafood or game meat as an 
implied nutrient content claim provided that:
    (i) The food contains less than 5 g total fat, less than 2 g 
saturated fat, and less than 95 mg cholesterol per reference amount 
customarily consumed and per 100 g;
    (ii)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, before January 1, 1998, 
contains 480 mg sodium or less per reference amount customarily 
consumed, and per labeled serving; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, before January 1, 1998, contains 480 
mg sodium or less 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);
    (C)(1) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, after January 1, 1998, 
contains 360 mg sodium or less per reference amount customarily 
consumed, and per labeled serving; or
    (2) The food has a reference amount customarily consumed of 30 g or 
less or

[[Page 111]]

2 tablespoons or less and, after January 1, 1998, contains 360 mg sodium 
or less 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);
    (iii) The food contains at least 10 percent of the RDI or DRV per 
reference amount customarily consumed of vitamin A, vitamin C, calcium, 
iron, protein, or fiber;
    (iv) Where compliance with paragraph (d)(3)(iii) of this section is 
based on a nutrient that has been added to the food, that fortification 
is in accordance with the policy on fortification of foods in 
Sec. 104.20 of this chapter; and
    (v) The food complies with definitions and declaration requirements 
established in this part for any specific nutrient content claim on the 
label or in labeling.
    (4) The term ``healthy'' or its derivatives may be used on the label 
or in labeling of main dish products, as defined in Sec. 101.13(m), and 
meal products, as defined in Sec. 101.13(l) as an implied nutrient 
content claim provided that:
    (i) The food meets the definition of ``low'' for fat and saturated 
fat;
    (ii)(A) Before January 1, 1998, sodium is not present at a level 
exceeding 600 mg per labeled serving, or
    (B) After January 1, 1998, sodium is not present at a level 
exceeding 480 mg per labeled serving;
    (iii) Cholesterol is not present at a level exceeding 90 mg per 
labeled serving;
    (iv) The food contains at least 10 percent of the RDI or DRV per 
labeled serving of two (for main dish products) or three (for meal 
products) of the following nutrients--vitamin A, vitamin C, calcium, 
iron, protein, or fiber;
    (v) Where compliance with paragraph (d)(4)(iv) of this section is 
based on a nutrient that has been added to the food, that fortification 
is in accordance with the policy on fortification of foods in 
Sec. 104.20 of this chapter; and
    (vi) The food complies with definitions and declaration requirements 
established in this part for any specific nutrient content claim on the 
label or in labeling.

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59 
FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6, 
1994]



Sec. 101.67  Use of nutrient content claims for butter.

    (a) Claims may be made to characterize the level of nutrients, 
including fat, in butter if:
    (1) The claim complies with the requirements of Sec. 101.13 and with 
the requirements of the regulations in this subpart that define the 
particular nutrient content claim that is used and how it is to be 
presented. In determining whether a claim is appropriate, the 
calculation of the percent fat reduction in milkfat shall be based on 
the 80 percent milkfat requirement provided by the statutory standard 
for butter (21 U.S.C. 321a);
    (2) The product contains cream or milk, including milk constituents 
(including, but not limited to, whey, casein, modified whey, and salts 
of casein), or both, with or without added salt, with or without safe 
and suitable colorings, with or without nutrients added to comply with 
paragraph (a)(3) of this section, and with or without safe and suitable 
bacterial cultures. The product may contain safe and suitable 
ingredients to improve texture, prevent syneresis, add flavor, extend 
shelf life, improve appearance, and add sweetness. The product may 
contain water to replace milkfat although the amount of water in the 
product shall be less than the amount of cream, milk, or milk 
constituents;
    (3) The product is not nutritionally inferior, as defined in 
Sec. 101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and
    (4) If the product would violate 21 U.S.C. 321a but for the nutrient 
content claim that characterizes the level of nutrients, that claim 
shall be an explicit claim that is included as part of the common or 
usual name of the product.
    (b) Deviations from the ingredient provisions of 21 U.S.C. 321a must 
be the minimum necessary to achieve similar performance characteristics 
as butter as produced under 21 U.S.C. 321a, or the

[[Page 112]]

food will be deemed to be adulterated under section 402(b) of the act. 
The performance characteristics (e.g., physical properties, organoleptic 
characteristics, functional properties, shelf life) of the product shall 
be similar to butter as produced under 21 U.S.C. 321a. If there is a 
significant difference in performance characteristics (that materially 
limits the uses of the product compared to butter,) the label shall 
include a statement informing the consumer of such difference (e.g., if 
appropriate, ``not recommended for baking purposes''). Such statement 
shall comply with the requirements of Sec. 101.13(d). The modified 
product shall perform at least one of the principal functions of butter 
substantially as well as butter as produced under 21 U.S.C. 321a.
    (c)(1) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of this part.
    (2) Safe and suitable ingredients added to improve texture, prevent 
syneresis, add flavor, extend shelf life, improve appearance, or add 
sweetness and water added to replace milkfat shall be identified with an 
asterisk in the ingredient statement. The statement ``*Ingredients not 
in regular butter'' shall immediately follow the ingredient statement in 
the same type size.

[58 FR 2455, Jan. 6, 1993]



Sec. 101.69  Petitions for nutrient content claims.

    (a) This section pertains to petitions for claims, expressed or 
implied, that:
    (1) Characterize the level of any nutrient which is of the type 
required to be in the label or labeling of food by section 403(q)(1) or 
(q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and
    (2) That are not exempted under section 403(r)(5)(A) through 
(r)(5)(C) of the act from the requirements for such claims in section 
403(r)(2).
    (b) Petitions included in this section are:
    (1) Petitions for a new (heretofore unauthorized) nutrient content 
claim;
    (2) Petitions for a synonymous term (i.e., one that is consistent 
with a term defined by regulation) for characterizing the level of a 
nutrient; and
    (3) Petitions for the use of an implied claim in a brand name.
    (c) An original and one copy of the petition to be filed under the 
provisions of section 403(r)(4) of the act shall be submitted, or the 
petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. Petitioners interested in submitting a 
disk should contact FDA's Center for Food Safety and Applied Nutrition 
for details. If any part of the material submitted is in a foreign 
language, it shall be accompanied by an accurate and complete English 
translation. The petition shall state the petitioner's post office 
address to which published notices as required by section 403 of the act 
may be sent.
    (d) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of the Food and 
Drug Administration. However, any reference to unpublished information 
furnished by a person other than the applicant will not be considered 
unless use of such information is authorized (with the understanding 
that such information may in whole or part be subject to release to the 
public) in a written statement signed by the person who submitted it. 
Any reference to published information should be accompanied by reprints 
or photostatic copies of such references.
    (e) If nonclinical laboratory studies are included in a petition 
submitted under section 403(r)(4) of the act, the petition shall 
include, with respect to each nonclinical study contained in the 
petition, either a statement that the study has been, or will be, 
conducted in compliance with the good laboratory practice regulations as 
set forth in part 58 of this chapter or, if any such study was not 
conducted in compliance with such regulations, a brief statement of the 
reason for the noncompliance.
    (f) If clinical investigations are included in a petition submitted 
under section 403(r)(4) of the act, the petition shall include a 
statement regarding each such clinical investigation relied upon in the 
petition that the study either was conducted in compliance with

[[Page 113]]

the requirements for institutional review set forth in part 56 of this 
chapter or was not subject to such requirements in accordance with 
Sec. 56.104 or Sec. 56.105 of this chapter, and that it was conducted in 
compliance with the requirements for informed consent set forth in part 
50 of this chapter.
    (g) The availability for public disclosure of petitions submitted to 
the agency under this section will be governed by the rules specified in 
Sec. 10.20(j) of this chapter.
    (h) All petitions submitted under this section shall include either 
a claim for a categorical exclusion under Sec. 25.24 of this chapter or 
an environmental assessment under Sec. 25.31 of this chapter.
    (i) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application from 
the petitioner, the present petition may incorporate it by specific 
reference to the earlier petition.
    (j) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (k) The petition shall include a statement signed by the person 
responsible for the petition, that to the best of his knowledge, it is a 
representative and balanced submission that includes unfavorable 
information, as well as favorable information, known to him pertinent to 
the evaluation of the petition.
    (l) All applicable provisions of part 10--Administrative Practices 
and Procedures, may be used by the Commissioner of Food and Drugs, the 
petitioner or any outside party with respect to any agency action on the 
petition.
    (m)(1) Petitions for a new nutrient content claim shall include the 
following data and be submitted in the following form.
    ------------
    (Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Food Labeling (HFS-150)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, -- submits this petition under section 403(r)(4) of 
the Federal Food, Drug, and Cosmetic Act (the act) with respect to 
(statement of the claim and its proposed use).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the descriptive term and the nutrient 
that the term is intended to characterize with respect to the level of 
such nutrient. The statement should address why the use of the term as 
proposed will not be misleading. The statement should provide examples 
of the nutrient content claim as it will be used on labels or labeling, 
as well as the types of foods on which the claim will be used. The 
statement shall specify the level at which the nutrient must be present 
or what other conditions concerning the food must be met for the use of 
the term in labels or labeling to be appropriate, as well as any factors 
that would make the use of the term inappropriate.
    B. A detailed explanation, supported by any necessary data, of why 
use of the food component characterized by the claim is of importance in 
human nutrition by virtue of its presence or absence at the levels that 
such claim would describe. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed, and why such benefit is not available through the use of 
existing terms defined by regulation under section 403(r)(2)(A)(i) of 
the act. If the claim is intended for a specific group within the 
population, the analysis should specifically address nutritional needs 
of such group, and should include scientific data sufficient for such 
purpose.
    C. Analytical data that shows the amount of the nutrient that is the 
subject of the claim and that is present in the types of foods for which 
the claim is intended. The assays should be performed on representative 
samples using the Association of Official Analytical Chemists 
International (AOAC International) methods where available. If no AOAC 
International method is available, the petitioner shall submit the assay 
method used, and data establishing the validity of the method for 
assaying the nutrient in the particular food. The validation data should 
include a statistical analysis of the analytical and product 
variability.
    D. A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption and of any corresponding changes in 
nutrient intake. The latter item shall specifically address the intake 
of nutrients that have beneficial and negative consequences in the total 
diet. If the claim is intended for a specific group within the 
population, the above analysis shall specifically address the dietary 
practices of such group and shall include data sufficient to

[[Page 114]]

demonstrate that the dietary analysis is representative of such group.
    E. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (Indicate authority)
    (2) Within 15 days of receipt of the petition, the petitioner will 
be notified by letter of the date on which the petition was received by 
the agency. Such notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition), and the petitioner will 
subsequently be notified of the agency's decision to file or deny the 
petition; or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 100 days of the date of receipt of the petition, the 
Commissioner of Food and Drugs will notify the petitioner by letter that 
the petition has either been filed or denied. If denied, the 
notification shall state the reasons therefor. If filed, the date of the 
notification letter becomes the date of filing for the purposes of 
section 403(r)(4)(A)(i) of the act. A petition that has been denied 
shall not be made available to the public. A filed petition shall be 
available to the public as provided under paragraph (g) of this section.
    (4) Within 90 days of the date of filing the Commissioner of Food 
and Drugs will by letter of notification to the petitioner:
    (i) Deny the petition; or
    (ii) Inform the petitioner that a proposed regulation to provide for 
the requested use of the new term will be published in the Federal 
Register. The Commissioner of Food and Drugs will publish the proposal 
to amend the regulations to provide for the requested use of the 
nutrient content claim in the Federal Register within 90 days of the 
date of filing. The proposal will also announce the availability of the 
petition for public disclosure.
    (n)(1) Petitions for a synonymous term shall include the following 
data and be submitted in the following form.
    ------------
    (Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Food Labeling (HFS-150)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ------------ submits this petition under section 
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to (statement of the synonymous term and its proposed use in a 
nutrient content claim that is consistent with an existing term that has 
been defined under section 403(r)(2) of the act).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the synonymous descriptive term, the 
existing term defined by a regulation under section 403(r)(2)(A)(i) of 
the act with which the synonymous term is claimed to be consistent. The 
statement should address why the proposed synonymous term is consistent 
with the term already defined by the agency, and why the use of the 
synonymous term as proposed will not be misleading. The statement should 
provide examples of the nutrient content claim as it will be used on 
labels or labeling, as well as the types of foods on which the claim 
will be used. The statement shall specify whether any limitations not 
applicable to the use of the defined term are intended to apply to the 
use of the synonymous term.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed term is requested, including an explanation of 
whether the existing defined term is inadequate for the purpose of 
effectively characterizing the level of a nutrient. This item shall also 
state what nutritional benefit to the public will derive from use of the 
claim as proposed, and why such benefit is not available through the use 
of existing term defined by regulation. If the claim is intended for a 
specific group within the population, the analysis should specifically 
address nutritional needs of such group, and should include scientific 
data sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------

[[Page 115]]

    (Indicate authority)
    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition

[[Page 116]]

was received. Such notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition) and the petitioner will 
subsequently be notified of the agency's decision to grant the 
petitioner permission to use the proposed term or to deny the petition; 
or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 90 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
consequently denied, the Commissioner of Food and Drugs will notify the 
petitioner by letter of the agency's decision to grant the petitioner 
permission to use the proposed term, with any conditions or limitations 
on such use specified, or to deny the petition, in which case the letter 
shall state the reasons therefor. Failure of the petition to fully 
address the requirements of this section shall be grounds for denial of 
the petition.
    (4) As soon as practicable following the agency's decision to either 
grant or deny the petition, the Commissioner of Food and Drugs will 
publish a notice in the Federal Register informing the public of his 
decision. If the petition is granted the Food and Drug Administration 
will list, the approved synonymous term in the regulations listing terms 
permitted for use in nutrient content claims.
    (o)(1) Petitions for the use of an implied nutrient content claim in 
a brand name shall include the following data and be submitted in the 
following form:
    ------------
    (Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Food Labeling (HFS-150)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, -------------------------------- submits this 
petition under section 403(r)(4) of the Federal Food, Drug, and Cosmetic 
Act (the act) with respect to (statement of the implied nutrient content 
claim and its proposed use in a brand name).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the implied nutrient content claim, the 
nutrient the claim is intended to characterize, the corresponding term 
for characterizing the level of such nutrient as defined by a regulation 
under section 403(r)(2)(A)(i) of the act, and the brand name of which 
the implied claim is intended to be a part. The statement should address 
why the use of the brandname as proposed will not be misleading. It 
should address in particular what information is required to accompany 
the claim or other ways in which the claim meets the requirements of 
sections 201(n) and 403(a) of the act. The statement should provide 
examples of the types of foods on which the brand name will appear. It 
shall also include data showing that the actual level of the nutrient in 
the food qualifies the food to bear the corresponding term defined by 
regulation. Assay methods used to determine the level of a nutrient 
should meet the requirements stated under petition format item C in 
paragraph (k)(1) of this section.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed brand name is requested. This item shall also state 
what nutritional benefit to the public will derive from use of the brand 
name as proposed. If the branded product is intended for a specific 
group within the population, the analysis should specifically address 
nutritional needs of such group and should include scientific data 
sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition); or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) The Commissioner of Food and Drugs will publish a notice of the 
petition in the Federal Register announcing its availability to the 
public and seeking comment on the petition. The petition shall be 
available to the public to the extent provided under paragraph (g) of 
this section. The notice shall allow 30 days for comments.
    (4) Within 100 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
subsequently returned to the petitioner), the Commissioner of Food and 
Drugs will:
    (i) Notify the petitioner by letter of the agency's decision to 
grant the petitioner permission to use the proposed brand name if such 
use is not misleading, with any conditions or limitations on such use 
specified; or
    (ii) Deny the petition, in which case the letter shall state the 
reasons therefor. Failure of the petition to fully address the 
requirements of this section shall be grounds for denial of the 
petition. Should the Commissioner of Food and Drugs not notify the 
petitioner of his decision on the petition within 100 days, the petition 
shall be considered to be granted.
    (5) As soon as practicable following the granting of a petition, the 
Commissioner of Food and Drugs will publish a notice in the Federal 
Register informing the public of such fact.

(Information collection requirements in this section were approved by 
the Office of Management and Budget (OMB) and assigned OMB control 
number ------------)

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58 
FR 44033, Aug. 18, 1993]