Leo Sher, M.D.

In May 2016, the U.S. Food and Drug Administration (FDA) announced regulations that require amendments to the existing supplement facts label, which uses units and conversions based on the 1968 Recommended Daily Allowances (RDA) (1).

Vitamin A has previously been reported in international units (IU). New labeling rules require reporting of vitamin A in the unit of mcg RAE (retinol activity equivalent) in order to account for the varying bioavailability of the forms. The conversion between Vitamin A IU and Vitamin A RAE takes into account whether the Vitamin A is coming from an animal source (retinol) or a plant source (carotenoids), or a combination. For an animal source: Vitamin A RAE = Vitamin A IU/3.33. For a plant source: Vitamin A RAE = Vitamin A IU/20.

New FDA regulations oblige that vitamin D be reported in mcg rather than IU. Vitamin D IUs may be listed voluntarily in parenthesis as well. 1 Vitamin D mcg = 40 Vitamin D IU.

New guidelines require that Vitamin E content be determined based on the source of vitamin E and that it be reported as mg alpha-tocopherol rather than in IU. Natural source – from food: Unit conversion: 1 mg alpha – tocopherol = 1.49 IU. Synthetic source – from supplement: Unit conversion: 1 mg alpha – tocopherol = 2.22 IU.

Before, all folates and folic acid were reported as mcg folic acid. New rules require that folates/folic acid be reported in Dietary Folate Equivalents (DFE) with mcg of folic acid in parentheses. 1 Folate DFE = [Food Folate mcg + (1.7 x Folic Acid mcg)]

New FDA rules require that niacin be reported as Niacin Equivalents (NE). Dietary niacin can come in several forms. The new unit accounts for tryptophan as a source of niacin. Niacin Equivalents = [niacin mg + (tryptophan mg / 60)].

According to “Food Labeling: Revision of the Nutrition and Supplement Facts Labels“ Final Rule issued by the FDA on May 27, 2016, companies were required to comply with the new rules by July 26, 2018, except that companies with less than $10 million in revenue from food products had an extra year to implement changes and were required to comply with the new rules by July 26, 2019 (1). In June 2017, the FDA proposed to extend the compliance dates to January 1, 2020, for manufacturers with $10 million or more in annual food sales and to January 1, 2021, for manufacturers with less than $10 million in annual food sales (2). On May 3, 2018, the FDA finalized that proposed rule (3).

References

1. Food and Drug Administration, HHS. Food Labeling: Revision of the Nutrition and Supplement Facts Labels. Final rule. Friday, May 27, 2016. URL: https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11867.pdf
2. Food and Drug Administration, HHS. Changes to the Nutrition Facts Label. URL: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm#dates
3. Food and Drug Administration, HHS. Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates. Final rule. Friday, May 4, 2018. URL: https://www.gpo.gov/fdsys/pkg/FR-2018-05-04/pdf/2018-09476.pdf