September 19, 2019

September 18, 2019

Subscribe to Latest Legal News and Analysis

September 17, 2019

Subscribe to Latest Legal News and Analysis

September 16, 2019

Subscribe to Latest Legal News and Analysis

FDA Issues Guidance on Conversion Factors for Various Nutrients

FDA has issued Guidance for Industry (“Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels”) on how to declare certain vitamins and minerals whose recommended daily intakes (RDIs) changed when FDA issued its revisions to 21 CFR 101.9 in 2016.

While some changes to RDIs involved changes only to the quantitative amounts of nutrients (e.g., the RDI for Vitamin C increased from 60 mg to 90 mg under the 2016 final rule), other RDI changes were less straightforward.  For example, under the old Nutrition Facts regulation, the RDI for Vitamin A was 5,000 International Units, and under the 2016 final rule, the RDI changed to 900 micrograms “RAE.”  (RAE stands for “Retinol Activity Equivalents” in which 1 microgram RAE is equivalent to 1 microgram retinol, 2 micrograms supplemental β-carotene, 12 micrograms dietary β-carotene, or 24 micrograms of either dietary α-carotene or dietary β-cryptoxanthin.)  In other words, the new 2016 RDIs changed the way certain micronutrient values are quantified and expressed.

FDA’s guidance provides industry with conversion factors and examples of conversion calculations for folate, niacin, Vitamin A, Vitamin D, and Vitamin E in both conventional foods and dietary supplements.  The guidance will be useful in ensuring compliance with the new Nutrition Facts regulations that become mandatory for most businesses on January 1, 2020.

© 2019 Keller and Heckman LLP

TRENDING LEGAL ANALYSIS


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

202-434-4100