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

Description

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.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5

Conventional Foods

Standard food products subject to nutrition labeling; General food labeling context; Standard food products requiring Nutrition Facts.

Foods

Carotenoid Vitamin A Precursors and Analogs in Foods

Dietary Supplements

Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.

Dietary Supplement

Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.

Conventional Food

Food marketed for general consumption, distinct from dietary supplements.; Comparison point for intake levels

Stakeholders

2

Manufacturers

Responsible for declaring acceptable market names on labels.

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Document Types

4

Nutrition Facts label

Consumers are prompted to review this to understand product composition.

Supplement Facts label

specific labeling for dietary supplements

Nutrition Facts

The label panel showing nutrient content like Total Fat and Saturated Fat.

Supplement Facts

Labeling panel where allergens may be declared.

Attributes

9

Dietary Folate Equivalents

New unit of measure (mcg DFE) for folate

International Unit

Previous unit of measure (IU) being converted

mcg RAE

Unit of measure for Vitamin A

Retinol Activity Equivalents

New unit of measure (mcg RAE) for Vitamin A; New unit of measure (mcg RAE) for vitamin A.

Niacin Equivalents

Unit of measure (mg NE) for niacin; The RDA for niacin is expressed in Niacin Equivalents (NE).; Unit of measure (mg NE) for niacin activity.

Reference Amount Customarily Consumed

The RACC for yogurt is 170 grams.

Conversion factor

Multipliers (1.0 or 1.7) used to calculate DFE

mcg DFE

Folate is expressed in Dietary Folate Equivalents (DFE).

International Units

Previous unit of measure for vitamin A activity.; Unit of measure being converted to mg

Technical Details

Substances

10

alpha-carotene

Provitamin A carotenoid.

Selenium

Essential trace element and catalyst used in manufacturing; Elemental impurity discussed for PDE calculation

Vitamin C

Nutrient required in infant formula but not by rats

Calcium

Solute measured in urine to calculate RSS

Carotenoid

Vitamin A Precursors and Analogs in Foods and Feeds

All-rac-a-tocopherol

Synthetic form of vitamin E

RRR-a-tocopherol

Naturally occurring form of vitamin E; Natural form of vitamin E

Ergocalciferol

Vitamin D2 form

Cholecalciferol

Vitamin D3 form

ẞ-carotene

Voluntary declaration of vitamin A source

Standards & References

External Standards

1

Dietary Reference Intakes

Standards established by the Institute of Medicine for healthy populations.

Specifications

7

Dietary Folate Equivalents

Unit of measure (mcg DFE) for folate declaration

Dietary Reference Intakes

Standards for nutrient intake established by the Institute of Medicine

2016 RDI for a-tocopherol

Reference Daily Intake used for % DV calculation

2016 RDI

Reference Daily Intake used for % DV calculations

2016 RDI for vitamin A

Reference Daily Intake of 900 mcg RAE.

2016 RDI for folate

Reference Daily Intake value of 400 mcg DFE used for % DV calculation; 400 mcg DFE used for % DV calculation.

2016 RDI for niacin

16 mg NE used for % DV calculation.; Reference Daily Intake used for % DV calculation.

Related CFR Sections (5)

21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
21CFR101.36§ 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.Read full regulation →
21CFR101.12§ 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that:Read full regulation →
21CFR172.345§ 172.345 Folic acid (folacin).
Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, may be safely used in food as a nutrient in accordance with the following prescribed conditions:Read full regulation →
21CFR137.165§ 137.165 Enriched flour.
Enriched flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for flour by § 137.105 , except that:Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded Dietary Supplements

5

Unapproved New Drugs

4

Failure to establish component specifications

3

Adulterated Dietary Supplements

3

Failure to establish and follow written procedures for quality control operations

2

Failure to establish product specifications

2

Unapproved New Drug

2

Misbranded dietary supplements

2

Misbranded foods

1

misbranded within the meaning of section 403(q) of the Act

1