FDA bans red dye 3 in food, linking it to cancer in rats

Wednesday, the Food and Drug Administration banned use red dye No. 3 in food, drink and medicine more than three decades after synthetic dyes were first discovered to cause cancer in male lab rats.

The dye, a petroleum-based additive, was used to give candies, sodas and other products a lively cherry-red hue. Consumer advocates said the FDA’s decision to revoke approval was long overdue, given the agency’s 1990 decision to ban the chemical in cosmetics and topical medications.

Under federal regulations, the FDA cannot approve food additives that cause cancer in humans or animals.

“This is great news that has been long overdue,” said Melanie Benesh, vice president of government affairs at the Environmental Working Group, one of several organizations that petitioned the agency to take action on the allowance. “Red Dye 3 is the lowest of the low-hanging fruit when it comes to toxic food dyes that should be addressed by the FDA.”

From 2027, companies will have to start removing dye from their products. Imported foods sold in the United States would also have to remove this additive.

While the dye is still used in hundreds of products, many companies have switched to other food dyes, a move that gained momentum after California became the first state to ban Red 3 dye in 2023, along with three other food additives linked to diseases. The dye has also been linked to health problems in children.

In announcing the ban, the agency downplayed the risk to humans, saying researchers had found no similar cancer risk in studies on animals other than male rats. Claims that the apply of red dye No. 3 “in foods and drugs poses a risk to humans are not supported by available scientific information,” Jim Jones, FDA deputy commissioner for human foods, said in a statement.

Sarah Gallo, senior vice president for product policy and federal affairs at the Consumer Brands Association, a trade group, said food and beverage makers will follow the agency’s decision. “Withdrawal of the authorized apply of Red No. 3 is an example of FDA using its risk-based and science-based authority to review the safety of commercially available products,” she said.

First approved for apply in food in 1907, Red Dye No. 3 was banned in cosmetics in 1990 by U.S. regulators. Then, cited the FDA an industry study that found the chemical causes thyroid cancer in male rats, but was estimated to be may cause cancer in less than one in 100,000 people. Along with the ban on the apply of dyes in cosmetics, the agency he pledged to do the same with food.

It is already banned for apply in food in Europe, Australia and Up-to-date Zealand, with a notable exception: maraschino cherries.

Although many food manufacturers rely on natural food dyes, including those from beets, red cabbage and insects, red dye #3 can still be found in many consumer products such as candy corn, yellow rice, mashed potatoes AND nutritional cocktails for children. Consumers can find out whether a product contains dye on the U.S. Department of Agriculture website database of branded food products AND another created by the Environment Working Party.

Artificial food colors and additives are a major target of Robert F. Kennedy Jr., President-elect Donald J. Trump’s pick for health secretary, whose Senate confirmation hearings are expected to begin soon.

While health and consumer advocates praised the agency’s decision to ban Red Dye No. 3, they said the decades-long delay highlighted systemic flaws in federal oversight of food additives.

Thomas Galligan, chief scientist for food additives and supplements at Center for Science in the Public Interestconcluded that the agency’s lack of earlier action was partly a result of industry opposition to the ban, but also reflected chronic underfunding of food safety at the FDA

“The FDA has a track record of allowing unsafe chemicals to persist in our food long after evidence of harm has emerged,” he said. “One reason is that the agency lacks a hearty system for reassessing the safety of already approved chemicals.”

He added: “Much of the blame also falls on Congress for failing to provide the authority and resources that FDA needs to do its job to protect public health.”

According to the organization, more than 200,000 pounds of Red 3 were used in foods and drugs in 2021. The center recommends consumers avoid all numbered dyes, including Yellow 5 and Red 40, which are made from petroleum.

The FDA has admitted weakness in its oversight efforts. Last year the agency announced a reorganization their human food programs to better address safety and health challenges in food and agriculture.

Brian Ronholm, the company’s director of food policy Consumer Reportswhich filed a petition with the FDA last year calling for a ban on red dye No. 3, said dozens of other chemical food additives are still in the nation’s food supply.

“Many synthetic food colors are allowed in foods, but they have not been reviewed for safety by the FDA for decades, despite recent studies linking these chemicals to earnest health problems,” he said. “It is time for the FDA to keep up with the latest science and eliminate these harmful chemicals from our food.”