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Why Is Red Dye 3 Banned in Cosmetics But Allowed in Food?

Oct 19, 2023Oct 19, 2023

Food safety advocates recently petitioned the FDA for a ban decades after studies found high doses of the artificial color could cause cancer in rats. Here's what you need to know.

More than 30 years ago the Food and Drug Administration told the cosmetics industry that it could no longer use an artificial color called FD&C Red No. 3, also known as Red Dye No. 3 and Red Dye 3. That's because high doses of it had been found to cause cancer in animals.

At the time, though, the same ingredient remained approved for use in food—as it had been since 1907. And it's still allowed to this day. It's used in thousands of food products, including candy and drinks, as well as in medicine that children and adults take, sometimes daily.

Last month the Center for Science in the Public Interest (CSPI), a food and health watchdog group, sent a petition to the FDA urging the agency to prohibit Red Dye No. 3 in food, dietary supplements, and ingested drugs. Consumer Reports signed it, along with 20 other advocacy groups and three individuals.

Here's some background on this dangerous dye, and the strange reason we’re still eating and drinking Red Dye No. 3.

Erythosine—which you’ll see on some ingredients lists as "FD&C Red No. 3"—is a synthetic dye made from petroleum that gives foods and drinks a bright, cherry-red color. For decades, the FDA has been aware of multiple studies showing that it can cause cancer in animals. When lab rats were fed high doses of the dye over long periods, they developed tumors in their thyroids, the studies found.

The International Association of Color Manufacturers (IACM), an industry group, maintains that Red Dye No. 3 is safe at the levels that people typically consume, and that human studies are more relevant than lab-rat studies (like the ones that led the FDA to ban it in cosmetics). The group has stated that the findings associating the dye with behavioral problems are "based on insufficient evidence." In an email to CR, Meredith Huddle, IACM's communications director, also said that a 1987 study had found that even high doses of Red Dye No. 3 have "no effect" on humans because it's "poorly absorbed."

But considerable research suggests otherwise. For example, several studies have linked some artificial food dyes, including Red Dye No. 3, to hyperactivity and other neurobehavioral effects in children. Double-blind studies controlled their diets for several weeks at a time, first without any artificial color additives, and then with them, at different doses. Not all children were affected in noticeable ways, but the ones who seemed to be more sensitive to the dyes showed more inattentiveness, hyperactivity, and restlessness even with a small amount—just 1 mg a day—than when they had dye-free diets.

So many! According to a search on the Environmental Working Group's food database, there are over 2,900 food products that contain it. It's in a lot of artificially flavored and artificially colored candy, and some gumdrops, peppermints, and candy corn. Watch out for it, especially around Valentine's Day; it can be an ingredient in those iconic heart candies with sayings on them made by Spangler, Brach's, and other companies.

And it's in many other food and drinks, too. Some things that contain it might not be surprising—like the strawberry flavors of Nesquik, Pediasure, Ensure, and Yoo-hoo. But there are also others you might not expect, like the cherries in Dole fruit cups, Vigo saffron rice, Wise onion rings, and vegetarian bacon by Morningstar Farms.

It also shows up in some medications and supplements, such as cough syrup and gummy vitamins. In a great irony given its potential link to inattentiveness and hyperactivity in kids, Red Dye No. 3 is an inactive ingredient in Vyvanse, a medication often prescribed for attention deficit and hyperactivity disorder.

Food safety experts and advocates say that while it likely poses risks to people of all ages, young children may be the most vulnerable. "Young children are the ones that are most affected because of their small body weight and because they are exposed to much more of these dyes in food," says Tasha Stoiber, PhD, senior staff scientist at the Environmental Working Group.

That's concerning because a lot of the food and medicine that contain it are actively marketed to—and actively consumed by—little kids. According to the FDA's own estimates, American children ages 2 to 5 end up consuming twice as much Red Dye No. 3 as the general population on a body-weight basis.

Stoiber says that even small amounts of the dye can add up and pose a risk to kids "It's not inconceivable that you eat a few servings of something, and you reach the amount that has been shown to have these effects in studies of humans," she says.

Here's some good news: The FDA requires manufacturers to list Red Dye No. 3 as an ingredient on a food's label. So if you’re shopping for candy, you can always check for this coloring in the ingredients list ("FD&C Red No. 3") to see which products to avoid. Brightly colored, fruity-flavored candy tends to have it more often than other kinds.

It will also be listed in the "inactive ingredients" list on a medicine bottle, or you can look for "dye-free" versions of some medications.

Tell the FDA to ban the cancer-causing dye from food, medicine, and supplements, as it has for 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."

Red Dye No. 3 is the focus of the current petition to the FDA because there's now so much evidence of its harm, and because the FDA itself has already determined that it's a carcinogen. But food safety experts are also concerned about other artificial dyes, too. Studies of kids’ exposure to FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6 (PDF) have similarly shown neurobehavioral effects, for instance.

"In general, we would recommend omitting all of those [artificial dyes], on the basis of their impacts on the smallest children," says the EWG's Stoiber.

The petition to the FDA urges the agency to immediately take Red Dye No. 3 off its list of approved ingredients. When asked to comment on how the agency might respond, a spokesperson said the agency doesn't comment on pending petitions.

Food safety experts and advocates maintain that they’re merely resurfacing a determination that the agency itself made about this ingredient a long time ago.

"This petition is asking them to finally get around to doing what they said they were going to do 32 years ago, and ban Red 3 in food and ingested drugs and supplements," Galligan says. "In our opinion, this is a very open-and-shut case."

Lauren Kirchner

Lauren Kirchner is an investigative reporter on the special projects team at Consumer Reports. She has been with CR since 2022, covering product safety. She has previously reported on algorithmic bias, criminal justice, and housing for the Markup and ProPublica, and was a finalist for the Pulitzer Prize in Explanatory Reporting in 2017. Send her tips at [email protected] and follow her on Twitter @lkirchner.