Contains Nonbinding Recommendations
16
percent of Daily Value of this (these) nutrient (nutrients).” Alternatively, except as provided in
21 CFR 101.9(f), if vitamin D, calcium, iron, or potassium is present in amounts less than 2
percent of the RDI, label declaration of the nutrient(s) is not required if the statement “Not a
significant source of (listing the vitamins or minerals omitted)” is placed at the bottom of the
table of nutrient values (21 CFR 101.9(c)(8)(iii)).
When any other nutrient listed in Figure 2 is added to a food as a nutrient supplement or when a
claim is made about it (therefore triggering mandatory declaration), the declaration must include
the amount per serving, expressed as percent DV, unless otherwise stated as both the quantitative
amount by weight and percent DV (21 CFR 101.9(c)(8)(ii)). Any nutrient (except folic acid) that
is voluntarily declared must be declared as a percent of the RDI (21 CFR 101.9(c)(8)(ii)) but
declaring the quantitative amount by weight is voluntary (81 FR 33742 at 33947-48). The
quantitative amount of folic acid must always be declared (21 CFR 101.9(c)(8)(ii)). You must
use the appropriate RDI, depending on which population group your food is represented or
purported to be for (21 CFR 101.9(c)(8)(i)).
Zeros following the decimal points may be dropped, and additional levels of significance may be
used when the number of decimal places indicated is not sufficient to express lower amounts
(e.g., the RDI for zinc is given in whole milligrams, but the quantitative amount may be declared
in tenths of a milligram) (21 CFR 101.9(c)(8)(iii)). The phrase “levels of significance” refers to
the degree of accuracy when rounding nutrients for purposes of declaring quantitative amounts
of vitamins and minerals on the label. For example, the RDIs for some vitamins and minerals
are small numerical values, and nutrients with an RDI of less than 5 (i.e. thiamin, riboflavin,
vitamin B
6
, vitamin B
12
, copper, and manganese) would not be able to be declared on the
Supplement Facts label if they contain less than 2 percent of the RDI and the amount is declared
to the nearest mg or mcg. In such situations, manufacturers could declare the quantitative
amounts to the nearest hundredth of a mg or mcg per serving, provided that such a level of
specificity does not represent a greater level of precision in the amount of the nutrient present
than can be scientifically supported. These rounding recommendations are explained in further
detail in FDA’s guidance for industry entitled “Nutrition and Supplement Facts Labels:
Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of
Quantitative Amounts of Vitamins and Minerals” (Ref. 3).
VII.D How Do the Nutrient Requirements for Supplement Facts Labels Differ?
Both the content and format of the Supplement Facts label have been updated to correspond to
the Nutrition Facts label, wherever possible. However, there are still some differences between
the two. On the Supplement Facts label, information on calories and serving size was not made
more prominent through increased type size, as it has been on the Nutrition Facts label. While
the percentage of the RDI for protein for foods purported to be for infants through 12 months of
age is allowed on Nutrition Facts labels, this declaration must be omitted for Supplement Facts
labels (21 CFR 101.36(b)(2)(iii)).
In addition, the new ordering for vitamins and minerals on the Supplement Facts label is as
follows: vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin,
vitamin B6, folate and folic acid, vitamin B12, biotin, pantothenic acid, choline, calcium, iron,