American regulatory authorities on Wednesday banned an additive called red dye no. 3 from the nation’s food supply, nearly 35 years after it was banned in cosmetics because of its potential cancer risk.
U.S. Food and Drug Administration (FDA) officials approved a petition in 2022, filed by about two dozen food safety and health advocates, calling on the agency to revoke authorization of a substance that gives some candy, snacks and maraschino cherries a bright red hue.
The agency said it was taking the action as a “legal matter” because some studies found the dye caused cancer in lab rats. Officials cited a law known as the Delaney Clause, which requires the FDA to ban any additive found to cause cancer in humans or animals.
The dye is known as erythrosine, FD&C Red No. 3 or Row 3. The ban removes it from the list of approved color additives in food, nutritional supplements and oral medicines, such as cough syrup. More than three decades ago, the FDA refused to approve the use of Red 3 in cosmetics and topical medications because a study showed it caused cancer when eaten by rats.
“FDA is taking actions that will remove approval for use of FD&C Red No. 3 in foods and drugs that are consumed,” said Jim Jones, FDA’s deputy commissioner for human foods. “Evidence shows cancer in male laboratory rats exposed to high levels of FD&C Red No. 3. Importantly, the way FD&C Red No. 3 causes cancer in male rats does not appear in humans.”
Food manufacturers will have until January 2027 to remove the dye from their products, while manufacturers of consumable drugs will have until January 2028 to do the same. Other countries still allow certain uses of dyes, but imported foods must comply a new American requirement.
Consumer rights defenders praised the decision.
“This is a welcome but long overdue action by the FDA: removing the unsustainable double standard under which Red 3 was banned from lipsticks but allowed in candy,” said Dr. Peter Lurie, group director of the Center for Science in Public. Interest (CSPI), which led the petition.
American regulators have banned the red color additive no. 3 in all food products after a study linked it to cancer in lab rats. The dye was banned in cosmetics 30 years ago, but is still used in cereals, candy and other packaged foods.
Health Canada announced Wednesday that it has concluded that erythrosine, or FD&C Order No. 3 does not pose a health risk to the general Canadian population at the levels specified in List of permitted food colors.
“If new scientific data becomes available showing that FD&C Red No. 3 poses a risk to human health as an ingredient in foods or drugs, Health Canada will take steps to mitigate that risk, including, if necessary, no longer allowing its use as a colorant in food and medicine,” the department said in an email to CBC News.
The FDA filed a claim for the color
It is unclear whether the ban will face legal challenges from food manufacturers because evidence has not found that the dye causes cancer when consumed by humans. At the hearing in December, FDA Commissioner Dr. Robert Califf suggested that this was a risk.
“When we ban something, it will go to court,” he told members of Congress on December 5. “And if we don’t have scientific evidence, we will lose in court.”
When the FDA refused to allow Red 3 in cosmetics and topical medications in 1990, the color additive was already allowed in foods and medications that are consumed. Because research at the time showed that the way the dye causes cancer in rats does not apply to humans, “FDA has not taken steps to revoke the food authorization of Red No. 3,” the agency said on its website.
Health advocates have been asking the FDA to reconsider that decision for years, including a 2022 petition led by CSPI. In November, nearly two dozen members of Congress sent a letter demanding FDA officials ban Order 3.
Lawmakers cited the Delaney Clause and said the measure was especially important to protect children, who consume more dye based on body weight than adults, lawmakers said.
“The FDA should act quickly to protect the nation’s youth from this harmful dye, which is used only to impart a bright red color to foods and beverages,” the letter said. “No aesthetic reason could justify the use of carcinogens in our food supply.”
Row 3 is banned for food use in Europe, Australia and New Zealand except in certain types of cherries. The dye will be banned in California starting January 2027.
The International Association of Paint Manufacturers defends the dye, saying it is safe in the amounts commonly consumed by humans. The group points to research by scientific committees run by the United Nations and the World Health Organization, including a 2018 review that reaffirmed the safety of Red 3 in food.
Some food manufacturers have already reformulated products to remove Red 3. They use beet juice instead; lipstick, a dye made from insects; and pigments from foods such as purple sweet potatoes, radishes and red cabbage, according to Sensient Food Colors, a St. Louis-based supplier of food colors and flavors. Louis.
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