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

Food and Drug Administration announced last week That it would revoke the authorization of FD&C Red No. 3 in foods and ingestible drugs under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. Red No. 3, a synthetic food dye, gives products such as candy, frosting and frozen desserts their bright, cherry red color.

The decision comes after a 2022 petition and a study showing cancer in male rats exposed to high levels of the dye. Although the cancer-causing mechanism is specific to mice and not to humans, the Delaney Clause prohibits the FDA from approving an additive that causes cancer in humans or animals, regardless of the level of exposure. .

“The Delaney Clause, enacted in 1960 as part of the color additive amendment to the FD&C Act, prohibits the FDA from authorizing a food additive if it causes cancer in humans or animals,” the agency wrote in January. Allows addition or addition of color.” 15 statement. “This is not the first time the agency has revoked a permit based on the Delaney Clause.”

In 2018, for example, the FDA withdrew approval for some artificial flavors—including benzophenone, ethyl acrylate, and eugenyl methyl ether—that mimic flavors like mint, cinnamon, and lemon in processed foods. used to do

Food and drug manufacturers that 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 victory after years of pushing for stricter monitoring of artificial colors because of their links to hyperactivity in children and possible carcinogenic properties. For example, the FDA banned Red No. 3 in cosmetics in 1990, stating that “high concentrations of the color additive may cause cancer in laboratory animals.” However, some experts say the FDA’s delayed action on Red No. 3 highlights larger systemic problems. The agency itself admits that “FD&C Red No. 3 is not as widely used in food and medicine as other certified dyes.”

Along with many other synthetic dyes still in regular use, the ban raises questions about the wide regulatory loophole.

According to Center for Science in the Public Interest (CSPI), last week’s ban is a step in the right direction, but “FDA and Congress have a long way to go to fix the broken food chemical regulatory system.” The organization claims that the FDA has failed to effectively monitor the safety of chemicals after they enter the market, prompting the agency to announce plans to develop a better framework for postmarket food chemical safety assessments in 2024. . Urgent concerns about artificial colors and additives currently on American grocery store shelves.

“All Americans deserve to eat food free of harmful nutrients,” said Thomas Gilligan, CSPI’s Principal Scientist for Additives and Supplements. Removing Red 3 and other unsafe, unnecessary food chemicals from our food supply is an important step to protect consumers. We hope to see action soon by the FDA and Congress to reform the broken federal regulatory systems that have allowed unsafe chemicals to enter and remain in our food supply for so long.

Many artificial food colors are still in use today, each with their own uses and controversies. Yellow 5 (Tartrazine), a lemon-yellow ajo dye, is one of the most widely used and recognized food dyes. Approved in the US, EU, Canada and beyond, it is found in dairy products, beverages, sweet candies and more. However, it is one of the artificial colors most often associated with negative reactions.

Yellow 6 — used in brightly colored treats like AirHeads, Jolly Ranchers and Skittles, as well as snacks like Cheetos and Doritos — adds a distinct orange-yellow color to products. Similarly, Blue 1 (Brilliant Blue) and Blue 2 (Indigo Carmine) are synthetic dyes that give candy, ice cream, beverages, and baked goods greenish-blue and royal blue, respectively. Green 3 (Fast Green FCF) is another artificial color used in food, medicine and cosmetics, which gives various products a blue-green shade.

Meanwhile, Red 40, one of the most controversial colors, has recently faced increased scrutiny. Children are most commonly exposed to Red 40 through cereal, juice, soda, and ice cream.

A major concern among food safety and public health experts is that the FDA relies on outdated studies—some more than 70 years old—to establish acceptable daily limits for artificial colors. New research offers evidence that may prompt a rethinking of these boundaries. For example, in 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) Published a report revealed that the seven most commonly used food dyes – Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5 and Yellow 6 – may contribute to neurobehavioral problems in some children or Can increase it.

The report highlights evidence linking artificial colors to hyperactivity, inattention, and impulsivity, particularly in children with ADHD. ADHD diagnoses among American children have increased from 6.1% to 10.2% over the past two decades, and while genetic factors play a role, environmental exposures, including food dyes, can increase susceptibility.

Human “challenge studies” show that artificial colors can trigger neurobehavioral effects in sensitive children. These studies typically involve removing dyes from children’s diets to establish a baseline, followed by reintroduction of controlled doses of dyes to measure behavioral changes. Animal research has also shown that dyes such as red 40, yellow 5 and yellow 6 affect brain activity, memory, learning and behavior – even at doses below current regulatory limits.

In particular, children are exposed to higher levels of artificial colors than adults, primarily through brightly colored foods such as cereals, juices and candy.

That’s one reason why, in September, California Governor Gavin Newsom signed into law a bill that would ban schools from serving foods containing six artificial food dyes, including Red 40.

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

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

The ban will come into effect from December 31, 2027. Other states, including New York, Maryland, Illinois and South Dakota, have considered banning Red 40, but none have yet enacted legislation.