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 In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...

FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed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

While previous studies have revealed the effects of additives on a substance-by-substance basis, none have investigated the effects of these additives combined. However, in a recent study, researchers ...

Industry groups representing drugmakers have expressed support for a US Food and Drug Administration’s (FDA) draft guidance that would make it easier to replace color additives in drugs, though they ...