[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.61]
[Page 100-103]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 101_FOOD LABELING--Table of Contents
Subpart D_Specific Requirements for Nutrient Content Claims
Sec. 101.61 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:
[[Page 101]]
(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 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,
[[Page 102]]
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:
(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.
[[Page 103]]
(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]
Additives that reference this regulation: |
