The FDA banned Red Dye No. 3 from cosmetics in 1990. Why are we still eating it?

In a landmark decision this month, California became the first state to follow in the footsteps of the European Union and ban the usage of Red Dye No. 3, as well as several other chemical additives, in food and beverage products. The dye — which is present in hundreds of candies, as well as snack foods like Hostess’ Ding Dongs, Peeps and even PediaSure Grow & Gain Kids’ Ready-to-Drink strawberry shake — has been banned from cosmetic use since 1990. 

Yet despite studies linking its consumption to cancer, as well as increased hyperactivity in children, California’s ban is controversial because it means that the state is essentially an island in terms of how the usage of Red Dye No. 3 is regulated. This is prompting public health advocates and some science work groups, including the Center for Science in the Public Interest (CSPI), to call on the Food and Drug Administration to reassess whether Red Dye No. 3 is actually truly safe for regular consumption. 

“If the data were strong enough to ban Red 3 in cosmetics and external drugs 30 years ago, they’re surely strong enough to ban it today in foods, oral drugs, and dietary supplements,” asserts CSPI president Peter Lurie in a statement. 

As the pressure for the FDA to investigate continues to mount, here’s what you need to know about Red Dye No. 3 and the California ban. 

What is Red Dye No. 3? 

Erythrosine,which you’ll see on some ingredients lists as “FD&C Red No. 3,” is a synthetic dye made from petroleum. It gives snacks, candies and beverages a bright, fire-engine red red color. It was first approved for use in food in 1907, one year after the Food and Drug Administration was founded. 

What are the safety concerns that come with consuming Red Dye No. 3? 

The health and safety concerns surrounding the consumption of Red Dye No. 3 vary in scope and severity. There have been reports of some individuals experiencing sensitivity or allergic reactions — including hives, itching, swelling and difficulty breathing — to the additive, though the American Academy of Allergy, Asthma and Immunology classifies these instances as rare. 

Research has linked hyperactivity and the consumption of food dyes in children and, more alarmingly, some studies showed that rats that consumed high doses of Erythrosine saw an increased incidence of thyroid tumors.

Who regulates the usage of Red Dye No. 3 in the United States? 

The Food and Drug Administration (FDA) is in charge of regulating the usage of ingredients like Red Dye No. 3 — though their stance on the additive has stagnated over the last three decades. As the New York Times and Associated Press reported in January 1990, the FDA banned many uses of Red Dye No. 3 “saying studies had shown that very high doses of the color additive can cause cancer in laboratory animals.” 

“The action prevents further use of the dye in some cosmetics, drugs and foods,” the report continued. “But because the risk is considered small, the agency said consumers could continue to use existing supplies of products that already contain the dye.” 

At the time, the agency said it would work towards extending the ban to foodstuffs, but that promise never materialized. However, as NPR reported on Monday, pressure is mounting for the agency to reevaluate its stance on Red Dye No. 3 in light of California’s new ban. Some of this pressure is actually from food manufacturers, like Christopher Gindlesperger of the National Confectioners Association, who are concerned that the mismatch in state and federal regulations will create confusion in the production and distribution processes. 

“I think it’s FDA’s call, and it’s time for the FDA to lean into the discussion, have a solid review, evaluate all of the available science, conduct their own research and provide the guidance that the food companies in this country need,”  Gindlesperger said. 

Is Red Dye No. 3 actually banned in Europe? 

One of the catalyzing arguments for banning Red Dye No. 3 — as well as Potassium Bromate, Brominated Vegetable Oil and Propyl Paraben — in California is that those ingredients are already banned in Europe, which means that manufacturers often already produce and distribute to different versions of the same snack product based on the market in which they are selling it. 

“Why are these toxic chemicals in our food?” said Susan Little, the Environmental Working Group’s Governmental Affairs Senior Advocate for California, in a statement earlier this year. “We know they are harmful and that children are likely eating more of these chemicals than adults. It makes no sense that the same products food manufacturers sell in California are sold in the EU but without these toxic chemicals.” 

As Little indicated, Red Dye No. 3 is banned except for use in a few specific brands of candied cherries. There are several other color additives, including Yellow Dye Nos. 5 and 6 and Red Dye No. 40, that are not fully banned in the EU, however foods containing them are required to bear a warning label stating: “May have an adverse effect on activity and attention in children.” 

No such warning label is required in the United States. 

What’s next for Red Dye No. 3 in the United States? 

When speaking with The New York Times, Assemblyman Jesse Gabriel, a Democrat who represents a district near Los Angeles, said that the purpose of the California bill was really twofold. 

“The primary purpose of this bill was to protect kids and families and consumers in the state of California,” he said. “But a secondary purpose here was to send a message to Washington that the FDA process is broken, and hopefully to spur momentum in Washington D.C. for real, significant change.”

However, whether the FDA will earnestly reevaluate the usage of Red Dye No. 3 anytime soon remains to be seen. In a statement, the agency simply said that it “evaluates and regulates ingredients added to food to ensure that the authorized use of these ingredients is safe. This includes the four ingredients included in the California bill.”