From the deep red tint in fruit punch to the bright green hue of mint toothpaste, color additives are a quiet but ...

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 In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...

FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed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

Industry groups representing drugmakers have expressed support for a US Food and Drug Administration’s (FDA) draft guidance that would make it easier to replace color additives in drugs, though they ...