[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR104.20]
[Page 179-181]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 104--NUTRITIONAL QUALITY GUIDELINES FOR FOODS--Table of Contents
Subpart B--Fortification Policy
Sec. 104.20 Statement of purpose.
(a) The fundamental objective of this subpart is to establish a
uniform set of principles that will serve as a model for the rational
addition of nutrients to foods. The achievement and maintenance of a
desirable level of nutritional quality in the nation's food supply is an
important public health objective. The addition of nutrients to specific
foods can be an effective way of maintaining and improving the overall
nutritional quality of the food supply. However, random fortification of
foods could result in over- or underfortification in consumer diets and
create nutrient imbalances in the food supply. It could also result in
deceptive or misleading claims for certain foods. The Food and Drug
Administration does not encourage indiscriminate addition of nutrients
to foods, nor does it consider it appropriate to fortify fresh produce;
meat, poultry, or fish products; sugars; or snack foods such as candies
and carbonated beverages. To preserve a balance of nutrients in the
diet, manufacturers who elect to fortify foods are urged to utilize
these principles when adding nutrients to food. It is reasonable to
anticipate that the Reference Daily Intakes (RDI's) as delineated in
Sec. 101.9 of this chapter and
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in paragraph (d) of this section will be amended from time to time to
list additional nutrients and/or to change the levels of specific RDI's
as improved knowledge about human nutrient requirements and allowances
develops. The policy set forth in this section is based on U.S. dietary
practices and nutritional needs and may not be applicable in other
countries.
(b) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to correct a dietary insufficiency
recognized by the scientific community to exist and known to result in
nutritional deficiency disease if:
(1) Sufficient information is available to identify the nutritional
problem and the affected population groups, and the food is suitable to
act as a vehicle for the added nutrients. Manufacturers contemplating
using this principle are urged to contact the Food and Drug
Administration before implementing a fortification plan based on this
principle.
(2) The food is not the subject of any other Federal regulation for
a food or class of food that requires, permits, or prohibits nutrient
additions. (Other Federal regulations include, but are not limited to,
standards of identity promulgated under section 401 of the Federal Food,
Drug, and Cosmetic Act, nutritional quality guidelines established in
subpart C of this part, and common or usual name regulations established
in part 102 of this chapter.)
(c) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to restore such nutrient(s) to a
level(s) representative of the food prior to storage, handling, and
processing, when:
(1) The nutrient is shown by adequate scientific documentation to
have been lost in storage, handling, or processing in a measurable
amount equal to at least 2 percent of the Daily Reference Value (DRV) of
protein and of potassium and 2 percent of the Reference Daily Intake
(RDI) in a normal serving of the food.
(2) Good manufacturing practices and normal storage and handling
procedures cannot prevent the loss of such nutrient(s),
(3) All nutrients, including protein, iodine and vitamin D, that are
lost in a measurable amount are restored and all ingredients of the food
product that contribute nutrients are considered in determining
restoration levels; and
(4) The food is not the subject of any other Federal regulation that
requires or prohibits nutrient addition(s), or the food has not been
fortified in accordance with any other Federal regulation that permits
voluntary nutrient additions.
(d) A nutrient(s) listed in paragraph (d)(3) of this section may be
added to a food in proportion to the total caloric content of the food,
to balance the vitamin, mineral, and protein content if:
(1) A normal serving of the food contains at least 40 kilocalories
(that is, 2 percent of a daily intake of 2,000 kilocalories);
(2) The food is not the subject of any other Federal regulation for
a food or class of food that requires, permits, or prohibits nutrient
additions; and
(3) The food contains all of the following nutrients per 100
calories based on 2,000 calorie total intake as a daily standard:
------------------------------------------------------------------------
Amount
Nutrient Unit of measurement DRV or per 100
RDI1 calories
------------------------------------------------------------------------
Protein................... grams (g)................ 50 2.5
Vitamin A................. International Unit (IU).. 5,000 250
Vitamin C................. milligrams (mg).......... 60 3
Calcium................... g........................ 1 0.05
Iron...................... mg....................... 18 0.9
Vitamin D................. IU....................... 400 20
Vitamin E................. do....................... 30 1.5
Thiamin................... mg....................... 1.5 0.08
Riboflavin................ do....................... 1.7 0.09
Niacin.................... do....................... 20 1
Vitamin B6................ do....................... 2.0 0.1
Folate.................... micrograms ([mu]g)....... 400 20
Vitamin B12............... do....................... 6.0 0.3
Biotin.................... mg....................... 0.3 0.015
Pantothenic acid.......... do....................... 10 0.5
Phosphorus................ g........................ 1.0 0.05
Magnesium................. mg....................... 400 20
Zinc...................... do....................... 15 0.8
Iodine.................... [mu]g.................... 150 7.5
Copper.................... mg....................... 2.0 0.1
Potassium................. do....................... 3,500 175
------------------------------------------------------------------------
\1\ RDI's for adults and children 4 or more years of age.
(e) A nutrient(s) may appropriately be added to a food that replaces
traditional food in the diet to avoid nutritional inferiority in
accordance with Sec. 101.3(e)(2) of this chapter.
(f) Nutrient(s) may be added to foods as permitted or required by
applicable
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regulations established elsewhere in this chapter.
(g) A nutrient added to a food is appropriate only when the
nutrient:
(1) Is stable in the food under customary conditions of storage,
distribution, and use;
(2) Is physiologically available from the food;
(3) Is present at a level at which there is a reasonable assurance
that consumption of the food containing the added nutrient will not
result in an excessive intake of the nutrient, considering cumulative
amounts from other sources in the diet; and
(4) Is suitable for its intended purpose and is in compliance with
applicable provisions of the act and regulations governing the safety of
substances in food.
(h) Any claims or statements in the labeling of food about the
addition of a vitamin, mineral, or protein to a food shall be made only
if the claim or statement is not false or misleading and otherwise
complies with the act and any applicable regulations. The following
label claims are acceptable:
(1) The labeling claim ``fully restored with vitamins and minerals''
or ``fully restored with vitamins and minerals to the level of
unprocessed ------'' (the blank to be filled in with the common or usual
name of the food) may be used to describe foods fortified in accordance
with the principles established in paragraph (c) of the section.
(2) The labeling claim, ``vitamins and minerals (and ``protein''
when appropriate) added are in proportion to caloric content'' may be
used to describe food fortified in accordance with the principles
established in paragraph (d) of this section.
(3) When labeling claims are permitted, the term ``enriched,''
``fortified,'' ``added,'' or similar terms may be used interchangeably
to indicate the addition of one or more vitamins or minerals or protein
to a food, unless an applicable Federal regulation requires the use of
specific words or statements.
(i) It is inappropriate to make any claim or statement on a label or
in labeling, other than in a listing of the nutrient ingredients as part
of the ingredient statement, that any vitamin, mineral, or protein has
been added to a food to which nutrients have been added pursuant to
paragraph (e) of this section.
[45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993]