FDA Label Changes for Vitamins A, D and E

Posted on October 18, 2018

The U.S. Food and Drug Administration (FDA) now requires that manufacturers change their product labels from international units (IU) to metric units of measurement — micrograms (mcg) or milligrams (mg). This comes as a result of the FDA’s final rule, “Food Labeling: Revision of the Nutrition Supplement Facts Labels,” published on May 27, 2016.

Pharmacies can expect to start seeing these label changes come through on all over-the-counter (OTC) fat-soluble vitamin A, D and E products. We understand that this change can be difficult when trying to determine the metric equivalent for IUs. For a safer transition to metric labeling, Safecor Health will begin including both the IU and metric measurements on its labels, when possible.

For any questions or concerns regarding this new regulation, please contact a Safecor Health representative at 800.447.1006 or quality@safecorhealth.com.

How to make your pharmacy compliant with FDA requirements