Will California’s Ban on Red Dye No. 3 Prompt More Action?

Oct. 27, 2023 — California Assemblymember Jesse Gabriel admits it. The issue wasn’t on his radar when a coalition of advocates approached him to talk about the need to remove dangerous additives from the food supply.

Gabriel, a Democrat from the San Fernando Valley, also admits he hasn’t always been the healthiest eater, but now, as the father of three young sons, “you start to think about these things. You want to do right by your kids.”

“I will confess, at first I was a little bit skeptical,” he said. As he looked over the data, he was astonished. “It seems crazy to me that there were these chemicals that were banned not only in the 27 nations of the European Union but really in dozens of countries around the world, based on strong scientific evidence they are linked with significant health harms.”

As he walked others in the Assembly through the science, he picked up bipartisan support for the bill he and his colleagues introduced. On Oct. 7, California Gov. Gavin Newsom signed the California Food Safety Act, making California the first state to prohibit the manufacture, sale, or distribution of any food product containing Red Dye No. 3 as well as three other chemicals: potassium bromate, brominated vegetable oil, and propyl paraben.

It takes effect in 2027.

California, New York, FDA?

Now, New York has proposed similar legislation, Senate Bill S6055A and Assembly Bill A6424, currently in early stages. Advocates for phasing out Red Dye No. 3 and other harmful additives hope these state-based developments will spur the FDA to finally take similar action and respond to a petition requesting the ban of Red Dye No. 3. 

It’s been just over a year since the Center for Science in the Public Interest, the Environmental Working Group, and 22 other organizations filed that petition with the FDA, asking the agency to ban Red Dye No. 3 in foods and supplements. 

“We anticipate this new law [in California] will have national impacts,” said Thomas Galligan, PhD, principal scientist for food additives and supplements for the Center for Science in the Public Interest, a nonprofit advocacy group that seeks to make foods healthier. “It certainly mounts more pressure on the FDA for them to respond [to the 2022 petition].”

The FDA did acknowledge receipt of the petition, which the agency filed on Nov. 15, Galligan said, but he said they missed the 180-day deadline – May 14, 2023 — to respond.

The FDA has not responded to requests for comment about when the agency would act on the petition or about why it has taken so long. 

Meanwhile, some companies have taken the initiative, removing Red Dye No. 3 from products even before the legal deadline or setting a deadline for when it will be removed. The maker of Peeps, the marshmallow treat favored at Easter, said it will no longer use the dye after Easter 2024. But one industry group balks at the new law, contending that it will create confusion and said waiting on the FDA decision would be best.

Chronology of Concern

Concerns about the health effects of Red Dye No. 3 can be traced to the 1990s, when research found that it causes thyroid cancer in rats and the FDA agreed the evidence was robust enough to “firmly establish” the link between the dye and thyroid cancer in rats. 

That finding alone obliges the FDA to act, Galligan of the Center for Science in the Public Interest said, citing what’s known as the Delaney Clause. Incorporated into the federal Food, Drug and Cosmetic Act by the Food Additives Amendment of 1958, the clause requires the FDA to ban any food additives found to cause or induce cancer in either animals or people. 

“The FDA acknowledged in 1990 that Red Dye No. 3 causes cancer in animals,” Galligan said. “By our assessment of the evidence there have not been further studies since the 1990 one to refute the FDA’s prior conclusion.”

The FDA banned Red Dye No. 3 in cosmetics and externally applied drugs, but not in foods and supplements. Since the 1990 investigations, much other research has linked the additive with health issues:

A 2021 report by the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment found that consumption of synthetic food dyes can result in hyperactivity and other neurobehavioral problems in some children. The percentage of American children and teens diagnosed with attention deficit hyperactivity disorder (ADHD) has increased from about 6.1% to 10.2% in the past 2 decades. The report was issued after a comprehensive 2-year evaluation of seven synthetic food dyes approved by the FDA, including Red Dye No. 3. Results were also published in the journal Environmental Health.  In a 2012 review of the research on all U.S. approved dyes, researchers concluded that “all of the currently used dyes should be removed from the food supply and replaced, if at all, by safer colorings.” 

The American Academy of Pediatrics issued a policy statement in 2018 on food additives and child health, concluding that substantial improvements to the food additives regulatory system are urgently needed. Among other actions, it calls for strengthening or replacing the FDA’s GRAS  (“generally recognized as safe”) determination process, which allows a product “generally recognized as safe” to skip the premarket review and FDA approval process.

Where Is Red Dye No. 3 Found?

The Environmental Working Group maintains a database, Food Scores, which grades products on nutrition, food additives, and processing. Staff with the Center for Science in the Public Interest searched the EWG’s database and found 3,183 brand-name foods containing Red Dye No. 3. Also known as erythrosine, it’s made from petroleum.   

A partial list, and the scores, with 10 being worst:

Brach’s Classic Candy Corn, 10.Peeps Cookie Coop Kit, 5 Chicks, 10.Pediasure Grow and Gain Strawberry Shake, 9.Pez Strawberry (and other flavors), 8.Ring Pop Halloween variety bag, 10.Corso’s Valentine Sugar Cookies, 10.

According to EWG, it’s also in fruit packs, bubble gum, some cake mixes, and other foods. These brightly colored foods are often marketed to kids, said Tasha Stoiber, PhD, a senior scientist at EWG. “They’re celebration foods, and it’s mostly children who are eating these. The amount even in one serving of food can affect the most sensitive children. Not every child is affected the same; some are particularly sensitive.”

Red Dye No. 3 Substitute: Beet Powder

“Like any color additive, Red Dye No. 3 is not a crucial ingredient,” Galligan said. “It’s just there to make food visually appealing.” He and others point to the European Union, where Red Dye No. 3 and other additives are largely prohibited in foods. “The food industry has already worked through this in the European market,” Galligan said, so U.S. food suppliers could certainly do the same.

A common alternative to Red Dye No. 3, according to EWG, is beet powder, which may cost even less than the dye.   

Companies’ Efforts

Dunkin’ Donuts was a front runner, which announced in 2018 it was removing all artificial dyes from its products.

In a statement, Keith Domalewski, spokesperson for Just Born, said none of its Peeps candies will have Red Dye No. 3 after Easter 2024. Another of its products, Hot Tamales, no longer contains Red Dye No. 3, and an upgraded ingredient list is expected to appear on shelves soon.

Asked if the company considered making a Red Dye No. 3-free product for California and leaving it in the other products for other states, another spokesperson did not know.

But experts at both the Environmental Working Group and the Center for Science in the Public Interest said they doubted any company would do that — both because of costs and because replacing red dye with other color-enhancing products, such as beet powders, is relatively easy to do. “There are alternatives [to the dyes] and it makes sense to get rid of one that we know causes cancer,” Stoiber of the Environmental Working Group said.

Brach’s candy corn, made by Ferrara USA, also has a score of 10 due to Red Dye No. 3 content. A spokesperson did not immediately reply to questions about whether it will remove Red Dye No. 3 from its products.

Taking Exception

Not everyone is applauding the state-led efforts. In a statement released after the California bill was signed into law, the National Confectioners Association said: “Governor Newsom’s approval of this bill will undermine consumer confidence and create confusion around food safety. This law replaces a uniform national food safety system with a patchwork of inconsistent state requirements created by legislative fiat that will increase food costs.”

It continued: “This is a slippery slope that the FDA could prevent by engaging on this important topic. We should be relying on the scientific rigor of the FDA in terms of evaluating the safety of food ingredients and additives.”

In an op-ed published before the California bill was signed into law, Frank Yiannas, a former deputy commissioner of food policy and response at the FDA, called the proposed legislation “well-intended” but if enacted would “set a dangerous precedent on how food safety standards in our nation are best established.” State-by-state decisions, he wrote, would result in different regulatory standards “that would weaken our nation’s food system and food safety efforts.”

While he understands that many think the FDA isn’t moving fast enough on the decision, “this doesn’t mean we should bypass their authority.”

What’s Next?

California’s Gabriel said he’s gotten inquiries from legislators in other states interested in proposing similar legislation. He had two objectives in getting the legislation signed into law, he said. “The primary was to protect kids and families. The second was to send a message to Washington, DC, about the need for some real reforms in the FDA food safety process.”

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