FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...

APP. FIVE ON YOUR HEALTH TONIGHT, THERE’S A FEDERAL BAN ON RED DYE. NUMBER THREE, THAT’S THE INGREDIENT THAT CREATES A BRIGHT CHERRY RED COLOR WHEN IT’S ADDED TO FOOD AND TO DRINKS AND TO DRUGS. BUT ...

The U.S. Food and Drug Administration has approved three new color additives from natural sources “that will expand the palette of available colors from natural sources for manufacturers to safely use ...

FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed drug product with one ...