Why Is Red Dye No. 3 Allowed in Food but Not in Cosmetics? The short answer: Bureaucracy, it seems. As the recent petition to the FDA puts it: “There is no scientific or public health justification for permitting the use of FD&C Red No. 3 dye in food while prohibiting [the dye] in cosmetics and externally applied drugs.”
Instead, it’s largely the result of complicated internal processes at the FDA. The list of color additives the agency allows in food, supplements, and ingested drugs (like pills and liquid medicine) is separate from the list for cosmetics and applied drugs (like prescription lotions). That means the FDA has had to make decisions about the safety of each type of use at different times.
The agency approved the use of Red Dye No. 3 in food and supplements before it approved its use in cosmetics. By the time the FDA had to make a decision about whether to permanently approve its use in cosmetics, in 1990, the agency had enough evidence from scientific studies to show that it caused cancer in lab rats. So the FDA then banned Red Dye No. 3 from all cosmetics. But at that point, the color was already on a permanently approved list for food.
So then what happened? At the time, the FDA said that it would “take steps” to ban it from food as well, but then … it didn’t. When CR asked the agency to explain its lack of action in 32 years, officials didn’t answer directly but wrote: “The FDA evaluates and approves color additives for certain uses, based on the most current science available at the time. Following our initial evaluation, our scientists continue to review relevant new information to determine whether there are safety questions and whether the use of such substance is no longer safe under the Federal Food, Drug, and Cosmetic Act.”
“Regardless of the reason why it’s taken this long, it’s absurd that it’s taken this long,” says Thomas Galligan, PhD, principal scientist for food additives and supplements at the CSPI and one of the authors of the group’s petition to the FDA. “In 32 years, there’s millions and millions of children who have been exposed to this chemical who didn’t need to be.”