Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels

Contains Nonbinding Recommendations

Converting Units of Measure for Folate,

Niacin, and Vitamins A, D, and E on the

Nutrition and Supplement Facts Labels:

Guidance for Industry

Additional copies are available from:

Office of Nutrition and Food Labeling

Division of Nutrition Programs Staff, HFS-830

Center for Food Safety and Applied Nutrition

Food and Drug Administration

5001 Campus Drive

College Park, MD 20740

(Tel) 240-402-1450

https://www.fda.gov/FoodGuidances

You may submit electronic or written comments regarding this guidance at any time. Submit

electronic comments to https://www.regulations.gov. Submit written comments to the Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with docket number FDA-2016-D-

4484 and with the title of the guidance document.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition

August 2019

Contains Nonbinding Recommendations

Table of Contents

I. Introduction

II. Background

III. Conversion Factors

A. Folate

B. Niacin

C. Vitamin A

D. Vitamin D

E. Vitamin E

IV. Paperwork Reduction Act of 1995

V. References

Contains Nonbinding Recommendations

Converting Units of Measure for Folate,

Niacin, and Vitamins A, D, and E on the

Nutrition and Supplement Facts Labels:

Guidance for Industry

This guidance represents the current thinking of the Food and Drug Administration (FDA or we)

on this topic. It does not establish any rights for any person and is not binding on FDA or the

public. You can use an alternative approach if it satisfies the requirements of the applicable

statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible

for this guidance as listed on the title page.

I. Introduction

This guidance document provides step-by-step instructions to manufacturers of retail food

products marketed in the United States on how they may convert the previous units of measure

for certain nutrients to the new units in the updated Nutrition Facts label (81 FR 33742 at 33906-

33916 and § 101.9 (21 CFR 101.9)). This guidance document also provides conversion factors

that can be used for each of these nutrients and example

calculations for converting to the new

units of measure for conventional foods and dietary supplements. Lastly, this guidance document

provides information that can help manufacturers understand and comply with relevant labeling

requirements.

FDA’s guidance documents, including this guidance, do not establish legally enforceable

responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed

only as recommendations, unless specific regulatory or statutory requirements are cited. The use

of the word should in our guidance documents means that something is suggested or

recommended, but not required.

This guidance has been prepared by the Nutrition Programs Staff in the Office of Nutrition and Food Labeling,

Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

In the examples provided for conventional foods, the quantity of a nutrient is expressed per serving size, which, in

this guidance, refers to the serving size declaration on the Nutrition Facts label based on the reference amount

customarily consumed per eating occasion (RACC) for a specific food category (§ 101.12, Tables 1-2) and

applicable requirements set forth in § 101.9(b). For dietary supplements, the nutrient amount is expressed per

serving size.

Contains Nonbinding Recommendations

II. Background

In 2016, FDA amended the regulations for the nutrition labeling of conventional foods (§ 101.9)

and dietary supplements (§ 101.36) to include updated Daily Values (DV), as Reference Daily

Intakes (RDIs), for folate, niacin, vitamin A, vitamin D, and vitamin E. These RDIs are based on

the Dietary Reference Intakes (DRIs), specifically Recommended Dietary Allowances (RDAs)

published by the National Academy of Medicine (NAM, formerly known as the Institute of

Medicine (IOM)). Except for niacin, which had its unit of measure established in the 1989 RDA

as “Niacin Equivalent,” the other four nutrients have new units of measure associated with the

updated RDAs established by the NAM. While the unit of measurement for the RDI for niacin is

listed as Niacin Equivalents (i.e., mg NE) in § 101.9(c)(8)(iv), only the amount “mg” will

continue to be declared in labeling. The units of measure for these nutrients in the Nutrition Facts

label, described in § 101.9(c)(8)(iv), also pertain to the Supplement Facts label

(§ 101.36(b)(2)(ii)(B)). Table 1 shows the old (1993) and the current (2016) RDI’s established

for these five nutrients:

Table 1: RDIs for the Five Nutrients

Nutrient

1993 RDI

2016 RDI

Folate

400 micrograms (mcg)

400 micrograms DFE

(mcg DFE

)

Niacin

20 milligrams (mg)

16 milligrams NE

(mg)

Vitamin A

5,000 International Units (IU)

900 micrograms RAE

(mcg)

Vitamin D

400 International Units (IU)

20 micrograms (mcg)

Vitamin E

30 International Units (IU)

15 milligrams α-Tocopherol

(mg)

These RDIs are based on RDAs for adults and children ≥ 4 years of age (these RDIs were based on the

highest RDA for the adult male and/or adult female).

DFE = Dietary Folate Equivalents. “Folate” and “Folic Acid” must be used for purposes of declaration

in the labeling of conventional foods and dietary supplements. The declaration for folate must be in mcg

DFE (when expressed as a quantitative amount by weight in a conventional food or dietary supplement),

and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional

foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in

parentheses, as mcg of folic acid (see § 101.9(c)(8)(iv) (footnote 6)).

For label declarations, except for folate, which must be declared in mcg DFE, the name of each nutrient,

as specified in § 101.9(c)(8)(iv), shall be given in a column and followed immediately by the quantitative

amount by weight for that nutrient appended with a “mg” for milligrams, or “mcg” for micrograms as

shown in § 101.9(d)(7)(i) and § 101.9(d)(12).

NE = Niacin Equivalents, 1 mg NE = 1 mg niacin = 60 mg tryptophan (see § 101.9(c)(8)(iv) (footnote

5)).

RAE = Retinol Activity Equivalents; 1 microgram RAE = 1 microgram retinol, 2 micrograms

supplemental β-carotene, 12 micrograms dietary β-carotene, or 24 micrograms dietary α-carotene, or 24

micrograms dietary β-cryptoxanthin (see § 101.9(c)(8)(iv) (footnote 3)).

1 mg α-tocopherol (label claim) = 1 mg α-tocopherol = 1 mg RRR-α-tocopherol = 2 mg all-rac-α-

tocopherol (see § 101.9(c)(8)(iv) (footnote 4)).

Contains Nonbinding Recommendations

III. Conversion Factors

A. Folate

The 2016 RDI for folate is based on the RDA of 400 mcg of dietary folate equivalents (DFE) for

men and women (Ref. 1). The term DFE was introduced by the NAM to take into account the

differences in bioavailability between the naturally occurring folates in the reduced

tetrahydrofolate form that are inherent components of conventional foods, and folic acid, the

fully oxidized monoglutamate synthetic form of the vitamin, used to fortify conventional foods

and often used as an ingredient in dietary supplements.

Because folic acid is 85 percent bioavailable, but naturally occurring folate is only about 50

percent bioavailable, folic acid is 1.7 (85 ÷ 50) times more bioavailable. Therefore, the DFE

folate is calculated as:

mcg DFE = mcg naturally occurring folate + (1.7 × mcg folic acid)

DFE is the unit of measure for the labeling of folate in the Nutrition Facts label

(§ 101.9(c)(8)(iv)) and the Supplement Facts label (§ 101.36(b)(2)(i)(B)). In addition, when folic

acid is added to conventional foods, folate must be declared as the percent DV folate based on

mcg DFE, in addition to the quantitative amount of folic acid in mcg in parentheses (§

101.9(c)(8)(vii)). Declaring the quantitative amount of folate in mcg DFE is optional. When folic

acid is added to dietary supplements the quantitative amount of folate must be declared by

weight in mcg DFE folate and the percent DV based on mcg DFE folate, in addition to the

quantitative amount by weight of folic acid in parentheses (§§ 101.36(b)(2) and 101.9(c)(8)(vii)).

Furthermore, for the Supplement Facts label, synthetic forms of folate other than folic acid (such

as calcium or glucosamine salts of L-5-methyl-tetrahydrofolate (L-5-MTHF)) may be added.

We do not intend to object to a manufacturer using its own established conversion factors for

such forms of folate, provided that the declaration is truthful and not misleading. Furthermore,

we would not expect a conversion factor for any synthetic form of folate to exceed 1.7

(comparable to folic acid), when reporting mcg DFE on the Supplement Facts label (81 FR

33742 at 33908-09).

The only form that can be added to conventional food is folic acid under § 172.345.

Contains Nonbinding Recommendations

Examples of Conversion from Naturally Occurring Folate, Folic Acid,

and Synthetic Folate to Dietary Folate Equivalents (DFE)

CONVENTIONAL FOODS

Example 1: A serving (85 g) of frozen spinach contains only naturally occurring folate (120

mcg)

Folate Conversion to mcg DFE

Folate (mcg DFE) = Naturally occurring folate (mcg per serving) × 1.0 (conversion factor for

naturally occurring folate)

Folate (mcg DFE) = 120 mcg × 1 = 120 mcg DFE

% DV Calculation

% DV = [Folate (mcg DFE) ÷ 2016 RDI for folate (mcg DFE)] × 100

% DV = (120 mcg DFE ÷ 400 mcg DFE) × 100 = 30%

Label Declaration

Declaring naturally occurring folate on a conventional food label is voluntary. If a manufacturer

wants to report naturally occurring folate, the label declaration must be as follows, except that

declaring the quantitative amount for folate in “mcg DFE” (e.g., 120 mcg DFE) is optional

(§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Folate 120 mcg DFE

30%

Contains Nonbinding Recommendations

Example 2: A serving (40 g) of ready-to-eat breakfast cereal contains only folic acid (200

mcg)

Folate Conversion to mcg DFE

Folate (mcg DFE) = Folic acid (mcg per serving) × 1.7 (conversion factor for folic acid)

Folate (mcg DFE) = 200 mcg × 1.7 = 340 mcg DFE

% DV Calculation

% DV = [Folate (mcg DFE) ÷ 2016 RDI for folate (mcg DFE)] × 100

% DV = (340 mcg DFE ÷ 400 mcg DFE) × 100 = 85%

Label Declaration

Declaring folic acid on a conventional food label is mandatory when folic acid is added or when

a claim is made about the nutrient (§ 101.9(c)(8)(iv) (footnote 6)). The label declaration must be

as follows, except that declaring the quantitative amount for folate in “mcg DFE” (e.g., 340 mcg

DFE) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Note that when the Daily Value is presented on the Nutrition Facts label, this figure is rounded to 90% in

accordance with § 101.9(c)(8)(iii). Similar differences between the “DV Calculation” and the % Daily Value in the

partial “Nutrition Facts” mockups below result from this rounding provision. For dietary supplements, the

applicable rounding requirements differ, and the percentages based on RDIs shall be expressed to the nearest whole

percent (§ 101.36(b)(2)(iii)(C)).

Nutrition Facts

% Daily Value

Folate 340 mcg DFE (200 mcg folic acid)

90%

Contains Nonbinding Recommendations

Example 3: A serving (30 g) of enriched wheat flour contains a combination of naturally

occurring folate (5 mcg) and folic acid (50 mcg)

Folate Conversion to mcg DFE

Folate (mcg DFE) = [Naturally occurring folate (mcg per serving) × 1 (conversion factor for

naturally occurring folate] + [folic acid (mcg per serving) × 1.7 (conversion factor for folic acid)]

Folate (mcg DFE) = (5 mcg × 1) + (50 mcg × 1.7) = 90 mcg DFE

% DV Calculation

% DV = [Folate (mcg DFE) ÷ 2016 RDI for folate (mcg DFE)] × 100

% DV = (90 mcg DFE ÷ 400 mcg DFE) × 100 = 23%

Label Declaration

When a food ingredient is enriched (e.g., enriched wheat flour that is an ingredient in a loaf of

bread), the vitamins and minerals in the enriched ingredient are not required to be declared in a

food’s Nutrition Facts label (§ 101.9(c)(8)(ii)(A)-(B)). On the other hand, if enrichment nutrients

are added separately from the wheat flour as ingredients to another food, those nutrients (e.g.,

thiamin, riboflavin, niacin, iron, and folic acid) must be declared on the Nutrition Facts label (§

101.9(c)(8)(ii)).

Nutrition Facts

% Daily Value

Folate 90 mcg DFE (50 mcg folic acid)

25%

According to the standards of identity, enriched flour must contain in each pound 2.9 mg of thiamin, 1.8 mg of

riboflavin, 24 mg of niacin, 0.7 mg of folic acid, and 20 mg of iron (§ 137.165(a)). In this example, the folic acid

amount was calculated to conform to the standards of identity of enriched flour in which 1 pound = 453.6 g (Ref. 2)

and assuming a 30 g serving size yielded 46.296 mcg of folic acid per serving. This value was rounded to 50 mcg of

folic acid (recommended increment of nearest 5 mcg per serving (Ref. 3)). For standards of identity of other

enriched products, see 21 CFR Parts 136 and 137.

Contains Nonbinding Recommendations

DIETARY SUPPLEMENTS

Example 4: A dietary supplement contains only folic acid (400 mcg per serving)

Folate Conversion to mcg DFE

Folate (mcg DFE) = Folic acid (mcg per serving) × 1.7 (conversion factor for folic acid)

Folate (mcg DFE) = 400 mcg × 1.7 = 680 mcg DFE

% DV Calculation

% DV = [Folate (mcg DFE) ÷ 2016 RDI for folate (mcg DFE)] × 100

% DV = (680 mcg DFE ÷ 400 mcg DFE) × 100 = 170%

Label Declaration

Supplement Facts

% Daily Value

Folate 680 mcg DFE (400 mcg folic acid)

170%

Contains Nonbinding Recommendations

Example 5: A dietary supplement contains only synthetic folate (as calcium L-5-MTHF,

200 mcg per serving)

Folate Conversion to mcg DFE

Folate (mcg DFE) = Synthetic folate (mcg per serving) × 1.7 (conversion factor for synthetic

folate

)

Folate (mcg DFE) = 200 mcg × 1.7 = 340 mcg DFE

% DV Calculation

% DV = [Folate (mcg DFE) ÷ 2016 RDI for folate (mcg DFE)] × 100

% DV = (340 mcg DFE ÷ 400 mcg DFE) × 100 = 85%

Label Declaration

For synthetic folate (e.g., calcium L-5- MTHF) the 1.7 conversion factor was used as an example. If a

manufacturer uses its own established conversion factors, we would not expect the conversion factor to exceed 1.7

(comparable to folic acid), when declaring mcg DFE on the Supplement Facts label (81 FR 33742 at 33908-33909).

Supplement Facts

% Daily Value

Folate 340 mcg DFE

85%

Contains Nonbinding Recommendations

Example 6: A dietary supplement contains naturally occurring folate (50 mcg), folic acid

(100 mcg), and synthetic folate (as calcium L-5-MTHF, 150 mcg) per serving

Folate Conversion to mcg DFE

Folate (mcg DFE) = [Naturally occurring folate (mcg per serving) × 1 (conversion factor for

naturally occurring folate)] + [folic acid (mcg per serving) × 1.7 (conversion factor for folic

acid)] + [synthetic folate (mcg per serving) × 1.7 (conversion factor for synthetic folate

)]

Folate (mcg DFE) = (50 mcg × 1) + (100 mcg × 1.7) + (150 mcg × 1.7) = 475 mcg DFE

% DV Calculation

% DV = [Folate (mcg DFE) ÷ 2016 RDI for folate (mcg DFE)] × 100

% DV = (475 mcg DFE ÷ 400 mcg DFE) × 100 = 119%

Label Declaration

For synthetic folate (e.g., calcium L-5-MTHF) the 1.7 conversion factor was used as an example. If a manufacturer

uses its own established conversion factors, we would not expect the conversion factor to exceed 1.7 (comparable to

folic acid), when declaring mcg DFE on the Supplement Facts label (81 FR 33742 at 33908-33909).

Supplement Facts

% Daily Value

Folate 475 mcg DFE (100 mcg folic acid)

119%

Contains Nonbinding Recommendations

B. Niacin

The term niacin refers to nicotinamide (nicotinic acid amide-NAD), nicotinic acid (pyridine-3-

carboxylic acid), and derivatives that exhibit the biological activity of nicotinamide.

Furthermore, the amino acid tryptophan is available for conversion to NAD once protein

synthesis needs are met and thus can contribute to meeting the RDA for niacin (Ref. 1). The

tryptophan-to-niacin inter-conversion was considered previously in setting the RDA for niacin

(Ref. 4). Therefore, the RDA for niacin is expressed in Niacin Equivalents (NE), allowing for the

conversion of tryptophan to niacin (mean value of 60 mg tryptophan is equivalent to 1 mg of

niacin):

1 mg NE = 1 mg niacin

60 mg tryptophan

The NE can be estimated as follows:

mg NE = mg niacin + (mg tryptophan ÷ 60)

Contains Nonbinding Recommendations

Examples of Conversion from Niacin and Tryptophan to

Niacin Equivalents (NE)

CONVENTIONAL FOODS

Example 7: A serving (30 g) of macadamia nuts contains 1 mg niacin and 0 mg of

tryptophan

Niacin Conversion to mg NE

Niacin (mg NE) = [Niacin (mg per serving) × 1 (conversion factor from niacin to NE)] +

[tryptophan (mg per serving) ÷ 60 (conversion factor from tryptophan to NE)]

Niacin (mg NE) = (1 mg × 1) + (0 mg ÷ 60) = 1 mg NE

% DV Calculation

% DV = [Niacin (mg NE) ÷ 2016 RDI for niacin (mg NE)] × 100

% DV = (1 mg NE ÷ 16 mg NE) × 100 = 6%

Label Declaration

Declaring niacin on a conventional food label is voluntary. If a manufacturer wants to report

niacin, the label declaration must be as follows, except that declaring the quantitative amount for

niacin in “mg” (e.g., 1 mg) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Niacin 1 mg

Contains Nonbinding Recommendations

Example 8: A serving (85 g) of canned tuna contains 5 mg niacin and 300 mg of tryptophan

Niacin Conversion to mg NE

Niacin (mg NE) = [Niacin (mg per serving) × 1 (conversion factor from niacin to NE)] +

[tryptophan (mg per serving) ÷ 60 (conversion factor from tryptophan to NE)]

Niacin (mg NE) = (5 mg × 1) + (300 mg ÷ 60) = 10 mg NE

% DV Calculation

% DV = [Niacin (mg NE) ÷ 2016 RDI for niacin (mg NE)] × 100

% DV = (10 mg NE ÷ 16 mg NE) × 100 = 63%

Label Declaration

Declaring niacin on a conventional food label is voluntary. If a manufacturer wants to report

niacin, the label declaration must be as follows, except that declaring the quantitative amount for

niacin in “mg” (e.g., 10 mg) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Niacin 10 mg

60%

Contains Nonbinding Recommendations

DIETARY SUPPLEMENTS

Example 9: A dietary supplement contains 14 mg of niacin and 0 mg of tryptophan per

serving

Niacin Conversion to mg NE

Niacin (mg NE) = [Niacin (mg per serving) × 1 (conversion factor from niacin to NE)] +

[tryptophan (mg per serving) ÷ 60 (conversion factor from tryptophan to NE)]

Niacin (mg NE) = (14 mg niacin × 1) + (0 mg tryptophan ÷ 60) = 14 mg NE

% DV Calculation

% DV = [Niacin (mg NE) ÷ 2016 RDI for niacin (mg NE)] × 100

% DV = (14 mg NE ÷ 16 mg NE) ×100 = 88

Label Declaration

Supplement Facts

% Daily Value

Niacin 14 mg

88%

Contains Nonbinding Recommendations

Example 10: A dietary supplement contains 14 mg of niacin and 240 mg of tryptophan per

serving

Niacin Conversion to mg NE

Niacin (mg NE) = [Niacin (mg per serving) × 1 (conversion factor from niacin to NE)] +

[tryptophan (mg per serving) ÷ 60 (conversion factor from tryptophan to NE)]

Niacin (mg NE) = (14 mg niacin × 1) + (240 mg tryptophan ÷ 60) = 18 mg NE

% DV Calculation

% DV = [Niacin (mg NE) ÷ 2016 RDI for niacin (mg NE)] × 100

% DV = (18 mg NE ÷ 16 mg NE) × 100 = 113%

Label Declaration

Supplement Facts

% Daily Value

Niacin 18 mg

113%

Contains Nonbinding Recommendations

C. Vitamin A

The previous RDI for vitamin A was expressed in International Units (IU), a measurement based

on the biological activity or effect, where one IU of vitamin A activity had been defined as equal

to 0.30 mcg of all-trans-retinol or 0.60 mcg of all-trans-β-carotene (Ref. 4). However, IU does

not reflect the carotene:retinol equivalence ratio (81 FR 33742 at 33913). The new unit of

measure, RAE, considers the vitamin A activity of β-carotene in supplements to be half the

activity of pre-formed retinol, and the vitamin A activity of dietary β-carotene to be one-sixth of

the β-carotene in supplements (Ref. 5). Furthermore, carotenoids, such as β-carotene, added to

food is assumed to have the same bioconversion as those naturally occurring in foods (12:1)

(Ref. 6). For the other dietary provitamin A carotenoids, β-cryptoxanthin and α-carotene, the

RAE is set at 24 based on a vitamin A activity approximately half of that for β-carotene (Ref. 5).

1 mcg RAE = 1 mcg pre-formed vitamin A (retinol)

2 mcg supplemental β-carotene

12 mcg dietary β-carotene

24 mcg of other dietary provitamin A carotenoids

(α-carotene or β-cryptoxanthin)

See § 101.9(c)(8)(iv) (footnote 3).

FDA recommends that manufacturers apply the conversion factors listed in Table 2 to convert

the amount of pre-formed retinol and provitamin A carotenoids directly from mcg to mcg RAE.

Table 2. Conversion factors from pre-formed retinol and provitamin A carotenoids expressed in

mcg to vitamin A (mcg RAE)

From (mcg)

Conversion to Vitamin A (mcg RAE)

Pre-formed retinol 1

Supplemental

β-carotene ÷ 2

Provitamin A carotenoids: α-

carotene or β-cryptoxanthin

÷ 4

Dietary

β-carotene ÷ 12

Provitamin A carotenoids:

α-carotene or β-cryptoxanthin

÷ 24

The conversion factors for the supplemental form should be applied only to those supplements containing purified

provitamin A carotenoids in oil. For supplements containing provitamin A carotenoids from a food source, their

respective “dietary conversion factor” should be applied.

Contains Nonbinding Recommendations

Even though a conversion factor for supplemental α-carotene or β-cryptoxanthin had not been explicitly stated in

the NAM report (Ref. 5), FDA is providing a suggested conversion factor of 4:1 based on the extension of the

rationale and the observation that the vitamin A activity of dietary β-cryptoxanthin and α-carotene is approximately

half of that for β-carotene (Refs. 7-8) to the supplemental forms of these two provitamin A carotenoids.

Contains Nonbinding Recommendations

There is no direct conversion factor from the vitamin A declared on labels in IU to mcg RAE,

only individual conversion factors for provitamin A carotenoids and pre-formed vitamin A

(Table 3). Therefore, manufacturers may apply the individual conversion factors listed in Table 3

only when the food product is not a mixture of provitamin A carotenoids and/or pre-formed

retinol or when the proportion of the individual pre-formed vitamin A and provitamin A

carotenoids are known.

Table 3. Conversion factors from vitamin A (IU) to Vitamin A (mcg RAE)

From

Source

Conversion to mcg RAE

Pre-formed vitamin A (retinol)

0.30

Supplemental β-carotene

0.30

Vitamin A (IU) Dietary β-carotene 0.05

Dietary provitamin A carotenoids

α-carotene or β-cryptoxanthin

0.025

We considered the historical application for the conversion factor of supplemental β-carotene, in which 1 IU = 0.6

mcg of β-carotene (Ref. 4), followed by a second step conversion from mcg to vitamin A expressed as mcg RAE (1

mcg RAE = 2 micrograms supplemental β-carotene) (Ref. 5).

1 IU = 1.2 mcg of other provitamin A carotenoids.

CONVENTIONAL FOODS

Example of Conversion from Carotenoids (mcg) and Pre-Formed Retinol

(mcg) to

to Vitamin A, expressed in

Retinol Activity Equivalents (mcg RAE)

Example 11: A serving of a food that naturally contains 15 mcg of retinol, 4,800 mcg of β-

carotene, and 2,400 mcg of β-cryptoxanthin

Conversion from Carotenoids (mcg) and Pre-Formed Retinol (mcg) to Vitamin A (mcg RAE)

Vitamin A (mcg RAE) = [retinol (mcg per serving) x 1 (conversion factor for pre-formed

retinol)] + [β-carotene (mcg per serving) ÷ 12 (conversion factor for β-carotene)] + [β-

cryptoxanthin (mcg per serving) ÷ 24 (conversion factor for β-cryptoxanthin)]

Vitamin A (mcg RAE) = (15 × 1) + (4,800 ÷ 12) + (2,400 ÷ 24) = 515 mcg RAE

Contains Nonbinding Recommendations

% DV Calculation

% DV = [Vitamin A (mcg RAE) ÷ 2016 RDI for vitamin A (mcg RAE)] × 100

% DV = (515 mcg RAE ÷ 900 mcg RAE) × 100 = 57%

Label Declaration

Declaring vitamin A on a conventional food label is voluntary. If a manufacturer wants to report

vitamin A, the label declaration must be as follows, except that declaring the quantitative amount

for vitamin A in “mcg” (e.g., 515 mcg) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Vitamin A 515 mcg

60%

Example of Conversion from Vitamin A (IU) to Vitamin A, expressed in

Retinol

Activity Equivalents (mcg RAE)

Example 12: A serving (240 mL) of milk contains 500 IU of vitamin A

Vitamin A Conversion from IU to mcg RAE

Vitamin A (mcg RAE) = Vitamin (IU per serving) × 0.3 (conversion factor for pre-formed

retinol)

Vitamin A (mcg RAE) = 500 IU × 0.3 = 150 mcg RAE

% DV Calculation

% DV = [Vitamin A (mcg RAE) ÷ 2016 RDI for vitamin A (mcg RAE)] × 100

% DV = (150 mcg RAE ÷ 900 mcg RAE) × 100 = 17%

Contains Nonbinding Recommendations

Label Declaration

Declaring vitamin A on a conventional food label is voluntary. If a manufacturer wants to report

vitamin A, the label declaration must be as follows, except that declaring the quantitative amount

for vitamin A in “mcg” (e.g., 150 mcg) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Vitamin A 150 mcg

15%

DIETARY SUPPLEMENTS

Example 13: A dietary supplement contains 3,500 IU of vitamin A

(100% as purified β-

carotene in oil) per serving

Vitamin A Conversion from IU to mcg RAE

Vitamin A (mcg RAE) = Vitamin A (IU per serving) × 0.3 (conversion factor for supplemental

β-carotene)

Vitamin A (mcg RAE) = 3,500 IU × 0.3 = 1,050 mcg RAE

% DV Calculation

% DV = [Vitamin A (mcg RAE) ÷ 2016 RDI for vitamin A (mcg RAE)] × 100

% DV = (1,050 mcg RAE ÷ 900 mcg RAE) × 100 = 117%

Label Declaration

Supplement Facts

% Daily Value

Vitamin A 1,050 mcg

117%

Contains Nonbinding Recommendations

D. Vitamin D

Vitamin D, also known as calciferol, comprises a group of fat-soluble seco-sterols where the two

major forms are vitamin D

(ergocalciferol) and vitamin D

(cholecalciferol). One IU of vitamin

D has been previously defined as the activity of 0.025 mcg of cholecalciferol (Vitamin D

) in

bioassays with rats and chicks (Ref. 9):

1 mcg cholecalciferol = 40 IU vitamin D

Vitamin D is considered a nutrient of public health significance, and so mandatory declaration of

vitamin D is necessary to assist consumers in maintaining healthy dietary practices (81 FR 33742

at 33891). The required unit of measure for vitamin D is “mcg” for both conventional foods and

dietary supplements. It is also permissible to include the voluntary labeling of vitamin D in IU, in

parentheses, next to the mandatory declaration in mcg units (81 FR 33742 at 33912-33913). The

two major forms of vitamin D, vitamin D

(ergocalciferol) and vitamin D

(cholecalciferol), have

been reported to exhibit identical responses in the body (Ref. 9), so for the purpose of converting

from IU to mcg, we consider them to be bioequivalent. Table 4 shows the conversion factor from

IU to mcg of vitamin D.

Table 4. Conversion factor from IU to mcg of vitamin D

From

Source

Conversion to mcg Vitamin D

Vitamin D

(ergocalciferol)

0.025

Vitamin D (IU) Vitamin D

(cholecalciferol)

Vitamin D (ergocalciferol +

cholecalciferol)

Contains Nonbinding Recommendations

Examples of Conversion from IU to mcg Vitamin D

CONVENTIONAL FOODS

Example 14: A serving (240 mL) of milk that contains 100 IU of vitamin D

Vitamin D Conversion from IU to mcg

Vitamin D (mcg) = Vitamin D (IU per serving) × 0.025 (conversion factor for vitamin D)

Vitamin D (mcg) = 100 IU × 0.025 = 2.5 mcg

% DV Calculation

% DV = [Vitamin D (mcg) ÷ 2016 RDI for vitamin D (mcg)] × 100

% DV = (2.5 mcg ÷ 20 mcg) × 100 = 13%

Label Declaration

Declaring vitamin D on a conventional food label is mandatory (§ 101.9(c)(8)(ii)). In addition,

FDA allows manufacturers to voluntarily declare the vitamin D in IU, in parentheses, next to the

mandatory declaration in mcg unit as follows:

Nutrition Facts

% Daily Value

Vitamin D 2.5 mcg (100 IU)

15%

Contains Nonbinding Recommendations

DIETARY SUPPLEMENTS

Example 15: A dietary supplement contains 1,000 IU of vitamin D per serving

Vitamin D Conversion from IU to mcg

Vitamin D (mcg) = Vitamin D (IU per serving) × 0.025 (conversion factor for vitamin D)

Vitamin D (mcg) = 1,000 IU × 0.025 = 25 mcg

% DV Calculation

% DV = [Vitamin D (mcg) ÷ 2016 RDI for vitamin D (mcg)] × 100

% DV = (25 mcg ÷ 20 mcg) × 100 = 125%

Label Declaration

Supplement Facts

% Daily Value

Vitamin D 25 mcg (1,000 IU)

125%

E. Vitamin E

The 2016 RDI for vitamin E is based on the RDA of α-tocopherol, the only form of vitamin E

that is maintained in the blood and has biological activity (Ref. 10). α-Tocopherol has eight

stereoisomers (RRR-, RSR-, RRS-, RSS-, SRR-, SSR-, SRS-, SSS-), but only RRR-α-tocopherol

occurs naturally in food. The synthetic form, all-rac-α-tocopherol, contains all eight

stereoisomers in equal amounts and is only present in fortified foods and supplements. The

vitamin E activity is limited to the 2R-stereoisomers that have a higher biological activity than

the 2S-stereoisomers. Therefore, the four 2R-stereoisomers: RRR- (naturally occurring form of

vitamin E) and the other three synthetic forms (RSR-, RRS-, and RSS-) of α-tocopherol were

considered when establishing the RDA for vitamin E. Table 5 shows the conversions factors

from mg to mg of vitamin E (label claim).

1 mg α-tocopherol (label claim) = 1 mg α-tocopherol

= 1 mg RRR-α-tocopherol

= 2 mg all-rac-α-tocopherol

Manufacturers should apply the conversion factors listed in Table 5 when converting natural and

synthetic vitamin E from mg to mg vitamin E (label claim).

Contains Nonbinding Recommendations

Table 5. Conversion factors from natural and synthetic vitamin E from mg to mg of vitamin E

(label claim)

From (mg)

Conversion to mg of α–Tocopherol (label claim)

RRR-α-Tocopherol 1

All-rac-α-Tocopherol ÷ 2

Manufacturers could also apply the conversion factors listed in Table 6 when converting natural

and synthetic vitamin E from IU to mg vitamin E (label claim).

Table 6. Conversion factors from IU to mg of vitamin E

From

Source

Conversion to mg

α-Tocopherol

(label claim)

Vitamin E

(IU)

Natural vitamin E (RRR-α-tocopherol) including its ester forms

(RRR-α-tocopheryl acetate and RRR-α-tocopheryl succinate)

0.67

Synthetic vitamin E (all-rac-α-tocopherol) including its ester

forms (all-rac-α-tocopheryl acetate and all rac-α-tocopheryl

succinate)

0.45

Contains Nonbinding Recommendations

Examples of Conversion From mg of Natural Vitamin E (RRR-α-tocopherol)

and Synthetic Vitamin E (all-rac-α-tocopherol) to mg Vitamin E (label claim)

CONVENTIONAL FOODS

Example 16: A serving (240 mL) of a fortified beverage contains 10 mg of natural vitamin

E (RRR-α-tocopherol) and 8 mg of added vitamin E

(synthetic all-rac-α-tocopherol)

Vitamin E Conversion

Vitamin E (mg) = [(Natural vitamin E (mg per serving) × 1 (conversion factor for RRR-α-

tocopherol)) + (synthetic vitamin E (mg per serving) ÷ 2 (conversion factor for synthetic all-rac-

α-tocopherol))]

Vitamin E (mg) = (10 mg × 1) + (8 mg ÷ 2) = 14 mg

% DV Calculation

% DV = [Vitamin E (mg) ÷ 2016 RDI for α-tocopherol (mg)] × 100

% DV = (14 mg ÷ 15 mg) × 100 = 93%

Label Declaration

Declaring vitamin E on a conventional food label when vitamin E is added to food is mandatory

because some of the vitamin E present is added as a nutrient supplement (§ 101.9(c)(8)(ii)). The

label declaration must be as follows, except that declaring the quantitative amount for vitamin E

in “mg” (e.g., 14 mg) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Vitamin E 14 mg

90%

The same calculation will apply for supplements containing both natural and synthetic forms of vitamin E.

There might be instances where the natural form (RRR-α-tocopherol) is added to food.

Contains Nonbinding Recommendations

DIETARY SUPPLEMENTS

Example 17: A dietary supplement contains 20 mg of synthetic vitamin E (all-rac-α-

tocopherol) per serving

Vitamin E Conversion

Vitamin E (mg) = Synthetic vitamin E (mg per serving) ÷ 2 (conversion factor for synthetic all-

rac-α-tocopherol)

Vitamin E (mg) = 20 mg ÷ 2 = 10 mg

% DV Calculation

% DV = [Vitamin E (mg) ÷ 2016 RDI for α-tocopherol (mg)] × 100

% DV = (10 mg ÷ 15 mg) × 100 = 67%

Label Declaration

Supplement Facts

% Daily Value

Vitamin E 10 mg

67%

Contains Nonbinding Recommendations

Examples of Conversion from IU to mg Vitamin E

CONVENTIONAL FOODS

Example 18: A serving (1 tablespoon) of corn oil contains 3 IU of vitamin E

Vitamin E Conversion from IU to mg

Vitamin E (mg) = Vitamin E (IU per serving) × 0.67 (conversion factor for natural RRR-α-

tocopherol)

Vitamin E (mg) = 3 IU × 0.67 = 2.01 mg

% DV Calculation

% DV = [Vitamin E (mg) ÷ 2016 RDI for α-tocopherol (mg)] × 100

% DV = (2.01 mg ÷ 15 mg) × 100 = 13%

Label Declaration

Declaring vitamin E on a conventional food label is voluntary. If a manufacturer wants to report

vitamin E, the label declaration must be as follows, except that declaring the quantitative amount

for vitamin E in “mg” (e.g., 2 mg) is optional (§ 101.9(c)(8)(ii) and (c)(8)(iv)):

Nutrition Facts

% Daily Value

Vitamin E 2 mg

15%

Contains Nonbinding Recommendations

DIETARY SUPPLEMENTS

Example 19: A dietary supplement contains 35 IU of vitamin E per serving

Vitamin E Conversion from IU to mg

Vitamin E (mg) = Vitamin E (IU per serving) × 0.45 (conversion factor for synthetic all-rac-α-

tocopherol)

Vitamin E (mg) = 35 IU × 0.45 = 15.75 mg

% DV Calculation

% DV = [Vitamin E (mg) ÷ 2016 RDI for α-tocopherol (mg)] × 100

% DV = (15.75 mg ÷ 15 mg) × 100 = 105%

Label Declaration

Supplement Facts

% Daily Value

Vitamin E 16 mg

105%

Contains Nonbinding Recommendations

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA

regulations. These collections of information are subject to review by the Office of Management

and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The

collections of information in §§ 101.9 and 101.36 have been approved under OMB Control No.

0910-0813.

V. References

The following references are on display at the Dockets Management Staff, Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and are available for

viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday. References

marked with an (*) are also available electronically at https://www.regulations.gov. References

without asterisks are not on public display at https://www.regulations.gov because they have

asterisks are available for viewing only at the Dockets Management Staff. As of August 9, 2019,

FDA has verified the Web site address for the references it makes available as hyperlinks from

the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to

Non-FDA Web site references after August 9, 2019.

1. Institute of Medicine. "Dietary Reference Intakes for Thiamin, Riboflavin, Niacin,

Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline," Washington

D.C., National Academies Press; 1998.

2.* U.S. Department of Agriculture Agricultural Reserach Service, Nutrient Data Laboratory,

Beltsville, MD. "Measurement Conversion Tables," 2016. Retrieved from:

https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-

research-center/nutrient-data-laboratory/docs/measurement-conversion-tables/.

3.* U.S. Food and Drug Administration. "Nutrition and Supplement Facts Labels: Questions

and Answers Related to the Compliance Date, Added Sugars, and Declaration of

Quantitative Amounts of Vitamins and Minerals: Guidance for Industry," 2018.

Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/guidance-industry-nutrition-and-supplement-facts-labels-questions-and-

answers-related-compliance.

4. National Research Council. "Recommended Dietary Allowances, 10th Ed.," Washington

D.C., National Academies Press; 1989.

5. Institute of Medicine. "Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,

Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon,

Vanadium, and Zinc, Washington D.C., National Academies Press; 2001.

6. Institute of Medicine. "Dietary Reference Intakes: Essential Guide to Nutrient

Requirements," Washington D.C., National Academies Press; 2006.

7. Deuel H.J., Jr., Greenberg S.M., et al. "Stereochemical Configuration and Provitamin A

Activity; Neocryptoxanthin U." Arch Biochem. 1949;23:239-241.

Contains Nonbinding Recommendations

8. Bauernfeind J.C. "Carotenoid Vitamin A Precursors and Analogs in Foods and Feeds." J

Agric Food Chem. 1972;20:456-473.

9. Institute of Medicine. "Dietary Reference Intakes for Calcium and Vitamin D,"

Washington D.C., National Academies Press; 2011.

10. Institute of Medicine. "Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium,

and Carotenoids," Washington D.C., National Academies Press; 2000.