A PPENDIX A: D EFINITIONS OF N UTRIENT C ONTENT C LAIMS
9. A PPENDIX A: D EFINITIONS OF N UTRIENT C ONTENT C LAIMS
Content Claims (“Free,” “Low,” “Reduced/Less”)
Free Low Reduced/Less Comments
Synonyms for
For “Free”, “Very Low”, or “Low”, “Free” “Zero”,
Synonyms for
Synonyms for
must indicate if food meets a “No”,“Without”,
“Low”:
“Reduced/Less”:
definition without benefit of special “Trivial Source
“Little”, (“Few”
“Lower”
processing, alteration, formulation of”, “Dietarily
for Calories),
(“Fewer” for
or reformulation; e.g., “broccoli, a Insignificant
“Contains a
Calories)
fat-free food” or “celery, a low Source of”
Small Amount
of”, “Low Source
“Modified” may
calorie food”
of”
be used
Definitions for
in statement of
“Free” for meals
identity
and main dishes are the stated
Definitions for
values per
meals and main
labeled serving
dishes are same
but are not
as for individual
defined for
foods on a per
calories
100 g basis
Definitions of Nutrient Content Claims
Nutrient Free Low Reduced/Less Comments
Calories Less than 5 cal
“Light” or “Lite”: if 50% or more of per RACC and
40 cal or less per
At least 25%
RACC (and per
fewer calories per
the calories are from fat, fat must be
21 CFR 101.60(b) per labeled
50g if RACC is
RACC than an
reduced by at least 50% per RACC.
serving (b)(1) small) (b)(2) appropriate
If less than 50% of calories are from
reference food
fat, fat must be reduced at least 50%
Meals and main
(for meals and
or calories reduced at least 1/3 per
dishes: 120 cal or
main dishes, at
RACC 21 CFR 101.56(b)
less per 100 g least 25% fewer (b)(3) calories per 100 g)
“Light” or “Lite” meal or main dish
Reference food
product meets definition for “Low
may not be “Low
Calorie” or “Low Fat” meal and is
Calorie
labeled to indicate which definition is
Uses term
met 21 CFR 101.56(d)
“Fewer rather
For dietary supplements: Calorie
than “Less
claims can only be made when the
(b)(4) & (5)
reference product is greater than 40 calories per serving 21 CFR
101.60(a)(4)
A F O O D L A B E L I N G G U I D E 87
Definitions of Nutrient Content Claims continued
Nutrient Free Low Reduced/Less Comments
Total Fat
Less than 0.5 g
3 g or less per
At least 25% less
“__% Fat Free”: may be used if food
21 CFR 101.62(b) RACC and per
meets the requirements for “Low Fat” labeled serving
RACC (and per
fat per RACC
21 CFR 101.62(b)(6) (or for meals and
50 g if RACC is
than an
small) (b)(2) appropriate
100% Fat Free: food must be “Fat main dishes, less
reference food
Meals and main
Free”
(b)(6)(iii)
than 0.5 g per
(or for meals and
dishes: 3 g or less
labeled serving)
main dishes, at
“Light”—see previous Calorie
per 100 g and
(b)(1)
least 25% less fat
comments
not more than
per 100 g) (b)(4)
(5) For dietary supplements: total fat ingredient that is
Contains no
30% of calories
claims cannot be made for products fat or understood
from fat
(b)(3)
that are 40 calories or less per serving to contain fat,
Reference food
21 CFR 101.62(a)(4) except noted
may not be “Low
Fat”
below (*).
Nutrient Free Low Reduced/Less Comments
Saturated Fat
Less than 0.5 g
1 g or less per
At least 25% less
Next to all saturated fat claims, must
21 CFR 101.62(c) saturated fat and
declare the amount of cholesterol if 2 less than 0.5 g
RACC and 15%
saturated fat per
mg or more per RACC; and the trans fatty acids
or less of calories
RACC than an
amount of total fat if more than 3g per RACC and
from saturated
appropriate
per RACC (or 0.5 g or more of total main dishes, less
fat (c)(2) reference food
(or for meals and
fat per RACC for “Saturated Fat
Meals and main
than 0.5 g
main dishes, at
Free”) (or for meals and main dishes,
dishes: 1 g or less
saturated fat and
least 25% less
per labeled serving)
per 100g and less
trans fatty acids
saturated fat per
CFR 101.62(c) per labeled
than 10% of
100 g) (c)(4)
calories from
serving) (c)(1) (5)
For dietary supplements: saturated fat Contains no
saturated fat
claims cannot be made for products ingredient that is
(c)(3)t
Reference food
that are 40 calories or less per serving understood to
may not be “Low
21 CFR 101.62(a)(4) contain saturated fat except as noted below (*)
Saturated Fat”
88 G U I D A N C E F O R I N D U S T R Y
Definitions of Nutrient Content Claims continued
Nutrient Free Low Reduced/Less Comments
Cholesterol Less than 2 mg
20 mg or less per
At least 25% less
Cholesterol claims only allowed
21 CFR 101.62(d) per RACC and
when food contains 2 g or less per labeled
RACC (and per
cholesterol per
saturated fat per RACC; or for meals serving (or for
50 g of food if
RACC than an
and main dish products, per labeled meals and main
RACC is small)
appropriate
serving size for “Free” claims or per dishes, less than
(d)(2) reference food
(or for meals and
100 g for “Low” and “Reduced/Less”
Meals and main
2 mg per labeled
main dishes, at
claims
dishes: 20 mg or
serving)
least 25% less
less per 100 g
Must declare the amount of total fat
cholesterol per
Contains no (d)(3) 100 g) (d)(4) & next to cholesterol claim when fat ingredient that
exceeds 13 g per RACC and labeled
contains serving (or per 50 g of food if RACC cholesterol except
is small), or when the fat exceeds as noted below
Reference food
may not be “Low
19.5 g per labeled serving for main
(*) (d)(1) Cholesterol”
dishes or 26g for meal products For dietary supplements: cholesterol
claims cannot be made for products that are 40 calories or less per serving
Nutrient Free Low Reduced/Less Comments
Sodium Less than 5 mg
140 mg or less
At least 25% less
“Light” (for sodium reduced 21 CFR
21 CFR 101.61 per RACC and
products): if food is “Low Calorie” per labeled
per RACC (and
sodium per
and “Low Fat” and sodium is reduced serving (or for
per 50 g if RACC
RACC than an
by at least 50%. 21 CFR 101.56(c)(1) meals and main
is small) (b)(4) appropriate
reference food
“Light in Sodium”: if sodium is dishes, less than
Meals and main
(or for meals and
dishes: 140 mg or
reduced by at least 50% per RACC.
5 mg per labeled
main dishes, at
less per 100g
serving
(b)(1)
least 25% less
CFR 101.56(c)(2)
(b)(5)
For meals and main dishes, “Light in Contains no
sodium per 100 g)
Sodium” meets definition for “Low in ingredient that is
“Very Low
Reference food
Sodium”: 35 mg
Sodium”
21 CFR 101.56(d)(2)
sodium chloride
may not be “Low
or less per RACC
or generally Sodium” (b)(6) “No Salt Added” and “Unsalted”
(and per 50 g if
understood to & (7) must declare “This is Not A Sodium
RACC is small).
contain sodium Free Food” on information panel if
For meals and
except as noted food is not “Sodium Free”
main dishes:
below (*)
21 CFR 101.61(c)(2) “Salt Free” must
35 mg or less per
“Lightly Salted”: 50% less sodium meet criterion for
100 g (b)(2) &
(3) than normally added to reference “Sodium Free”
food and if not “Low Sodium”, so (c)(1) labeled on information panel
21 CFR 101.56(g)
A F O O D L A B E L I N G G U I D E 89
Definitions of Nutrient Content Claims continued
Nutrient Free Low Reduced/Less Comments
Sugars “Sugar Free”:
Not Defined.
At least 25% less
“No Added Sugars” and “Without
21 CFR 101.60(c) Less than 0.5 g
sugars per RACC
Added Sugars” are allowed if no sugar
May not be used
or sugar containing ingredient is and per labeled
sugars per RACC
than an
added during processing. State if food serving (or for
appropriate
is not “Low” or “Reduced Calorie” meals and main
reference food
(or for meals and
(c)(2)
dishes, less than
main dishes, at
The terms “Unsweetened” and “No serving)
0.5 g per labeled
least 25% less
(c)(1) Added Sweeteners” remain as factual
sugar per 100g)
statements (c)(3) Contains no
May not use this
ingredient that is
claim on dietary
The claim does not refer to sugar
alcohols, which may be present. generally
a sugar or
supplements of
For dietary supplements: “Sugar understood to
vitamins and
minerals (c)(5) Free” and “No Added Sugar” may be contain sugars
& (6) used for vitamins and minerals except as noted
intended to be used by infants and below (*)
children less than 2 years of age. Disclose calorie
(c)(4)
profile (e.g., “Low Calorie”)
Notes: * Except if the ingredient listed in the ingredient statement has an asterisk that refers to footnote (e.g., “* adds a trivial amount of fat”).
• RACC = Reference Amounts Customarily Consumed. • Small RACC = Reference Amounts Customarily Consumed of 30 g or less or 2 tablespoons
or less (for dehydrated foods that are typically consumed when rehydrated with water or a diluent containing an insignificant amount, as defined in 21 CFR 101.9(f)(1), of all nutrients per RACC, the per 50 g criterion refers to the prepared form of the food).
• When levels exceed: 13 g Total Fat, 4 g Saturated Fat, 60 mg Cholesterol, and 480 mg Sodium per RACC, per labeled serving or, for foods with small RACC, per 50 g, a disclosure statement is required as part of claim (e.g., “See nutrition information for___content” with the blank filled in with nutrient(s) that exceed the prescribed levels).
• The term “light” may be used to describe a physical or organoleptic attribute of the food if it clearly conveys the nature of the product, e.g., “light in color,” “light in texture.” 21 CFR 101.56(e)
• If there has been a long history of use of the term “light” associated with a product it may continue to be used, e.g., “light corn syrup,” “light brown sugar.” 21 CFR 101.56(f)
90 G U I D A N C E F O R I N D U S T R Y