FDA bans Red No. 3, but experts warn of ongoing gaps in food safety regulations

Food and Drug Administration Announced last week It will revoke the FD&C Red No. 3 in ingested foods and drugs under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. Red No. 3, an artificial food dye, gives products such as Dessertfrost and Frozen desserts Its color is bright and cherry red.

The decision follows a 2022 petition and studies showing cancer in male rats exposed to high levels of the dye. While the mechanism of causing cancer is limited to mice and does not occur in humans, the Delaney Clause prohibits the FDA from approving additives shown to cause cancer in humans or animals, regardless of exposure levels.

“The Delaney Clause, which was enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA licensure of a food additive or color additive if it is shown to cause cancer in humans or animals,” the agency wrote in a January 2019 statement. 15 statement. “This is not the first time the agency has revoked a permit based on Delaney’s condition.”

In 2018, for example, the US Food and Drug Administration withdrew authorization for certain artificial flavors — including benzophenone, ethyl acrylate, and eugenyl methyl ether — used to imitate flavors like mint. Cinnamon Citrus fruits in processed foods.

Food and drug manufacturers who use Red No. 3 in their products will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products.

Public health advocates see the announcement as a win after years of pushing for stricter oversight of synthetic dyes because of their link to hyperactivity in children and their carcinogenic properties. The US Food and Drug Administration, for example, Banned red color No. 3 in cosmetics In 1990, he reported that “high doses of the coloring additive can cause cancer in laboratory animals.” However, some experts see the FDA’s late action on Red No. 3 Highlights larger systemic problems. The agency itself admits that “FD&C Red No. 3 is not more widely used in food and drugs than other approved colors.”

With many other synthetic dyes still in regular use, the ban raises questions about broader regulatory gaps.

According to Center for Science in the Public Interest (CSPI), last week’s ban is a step in the right direction, but “the FDA and Congress have a long way to go to fix our broken food chemicals regulatory system.” The organization asserts that the US Food and Drug Administration has failed to effectively monitor the safety of chemicals after they are on the market, prompting the agency to announce plans to develop an enhanced framework for post-marketing safety assessments of food chemicals in 2024. However, this does not address immediate concerns Concerning the artificial dyes and additives currently on American grocery store shelves.

“All Americans deserve foods free of harmful food additives,” said Thomas Galligan, lead scientist for additives and dietary supplements at CSPI. “Removing Red 3 and other unsafe and unnecessary food chemicals from our food supply is a critical step to protect consumers. We hope to see the FDA and Congress act soon to fix the broken federal regulatory systems that have allowed unsafe chemicals to enter and remain in our food supply for a while.” Long.

Many synthetic food dyes are still in use today, each with their own applications and differences. Yellow 5 (Tartrazine), a lemon yellow azo dye, is among the most widely used and recognized food colorings. It’s approved in the US, EU, Canada and beyond, and is found in dairy products, beverages, desserts, confections, and more. However, it is also one of the synthetic dyes often associated with harmful reactions.

Yellow 6 — used in brightly colored foods like AirHeads, Jolly Ranchers and Skittles, as well as snacks like Cheetos and Doritos — adds a vibrant orange-yellow color to products. Likewise, Blue 1 (Brilliant Blue) and Blue 2 (Indigo Carmine) are synthetic dyes that give a teal and royal blue color, respectively, to candy, ice cream, beverages, and baked goods. Green 3 (Fast Green FCF) is another industrial dye used in food, pharmaceuticals and cosmetics, imparting a bluish-green shade to various products.

Meanwhile, Red 40, one of the most controversial dyes, has recently faced increased scrutiny. Children are most commonly exposed to Red 40 through cereals, juices, soft drinks, and ice cream.

One major concern among food safety and public health experts is that the FDA relies on outdated studies — some more than 70 years old — to set acceptable daily limits for synthetic dyes. More recent research provides evidence that may prompt a reconsideration of those limits. For example, in 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) Published a report It reveals that the seven most commonly used food dyes – Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, and Yellow 6 – can contribute to or exacerbate neurobehavioral problems in some children.

The report highlights evidence linking artificial dyes to hyperactivity, inattention and impulsivity, especially in children with ADHD. The incidence of ADHD diagnoses in children in the United States has risen from 6.1% to 10.2% over the past two decades, and while genetic factors play a role, environmental exposure, including food dyes, may increase susceptibility.

Human “challenge studies” have shown that synthetic dyes can lead to neurobehavioral effects in sensitive children. These studies typically involve removing dyes from a child’s diet to establish a baseline, followed by reintroducing controlled doses of dyes to measure behavioral changes. Animal research has also found that pigments such as Red 40, Yellow 5 and Yellow 6 affect brain activity, memory, learning and behavior – even at doses lower than current regulatory thresholds.

It is worth noting that children are exposed to higher levels of artificial dyes than adults, primarily through brightly colored foods such as cereals, juices and sweets.

That’s one reason California Governor Gavin Newsom, in September, signed a bill into law Preventing schools from serving food It contains six artificial food dyes, including red 40.

“Toxic dyes in food that put children at risk for hyperactivity and other neurobehavioral problems that interfere with learning have no place in our schools,” said Brian Runholm, director of food policy at Consumer Reports. He said at the time. “We have known for years that artificial food dyes put our health at risk, but the FDA has failed to take action to protect the public.”

“California’s landmark new law will help ensure that children are not exposed to harmful dyes in food in schools that can put their health at risk,” Ronholm continued.

This ban will go into effect on December 31, 2027. Other states, including New York, Maryland, Illinois and South Dakota, have considered bans on Red 40, but none have passed legislation yet.