Broken up piece of red candy.
The Food and Drug Administration announced Wednesday it is banning the food dye Red No. 3. The agency had been reviewing a petition to ban the colorant since 2022 over safety concerns. The petroleum-based dye has been used for more than 50 years in thousands of products including candy, snack foods, and soda.
At issue was whether the dye is linked to cancer. Under a provision of a 1958 law called the Delaney Clause, "the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals," Jim Jones, deputy commissioner for human foods at the FDA, said in a statement. And there's evidence of cancer in lab rats exposed to high levels of Red No. 3, he added.
Questions about the dye's potential health effects go back decades. The FDA banned the use of the Red No. 3 in cosmetics and medicated ointments and lotions back in 1990. Research showed the dye could cause cancer in animals in high doses. But the agency concluded it was safe in the amounts used in food.
The agency says it has evaluated the safety of Red No. 3 "multiple times" since its original approval for use in food in 1969.
In Wednesday's announcement, the agency said it was banning the dye to comply with the law, but noted that the evidence for the dye's linked to cancer is mixed and "the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans." Human exposure levels to Red No. 3 "are typically much lower than those that cause the effects shown in male rats," it said, adding that studies in other animals and in humans did not show the same effects.
But the concern about use of the dye in food has grown. Last year, the state of California passed a law to ban Red No. 3 — the law is slated to take effect in 2027. Lawmakers in ten other states have introduced legislation to ban Red No. 3 in foods, according to the Center for Science in The Public Interest.
State actions like these put pressure on the FDA to make a decision on this issue. "Over the past few years, there have been an increasing number of state bills to ban certain additives and set limits for certain contaminants," a spokesperson for the FDA told NPR via email. "However, a strong national food safety system is not built state by state."
"Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA's guidance and safety standards. Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety."
As NPR reported last year, California's Environmental Protection Agency reviewed the research on synthetic dyes, and found evidence that when consumed in food they can negatively affect children's behavior. Out of about 25 studies, more than half pointed to an association with behavior.
"I think the evidence is compelling from those human studies that children's consumption of synthetic food dyes can contribute to increases in symptoms like inattention, hyperactivity in some children," Mark Miller, a scientist with California's EPA's Office of Environmental Health Hazard Assessment told NPR in 2023.
The FDA has said it will continue to examine the effects of color additives on children's behavior.
"The totality of scientific evidence shows that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them," wrote the authors of an FDA consumer update titled "How Safe Are Color Additives?" which was updated in 2023.
But the Center for Science in the Public Interest, which brought the Red No. 3 petition, says there's no reason to add synthetic dyes to food.
"Red 3, like every food dye, only serves as a marketing tool for the food industry," says Thomas Galligan, principal scientist for food additives and supplements at CSPI. "It's just there to make food look visually appealing so that consumers want to spend their money on it."
He points out that Red No. 3 is banned or severely restricted in many countries, including Australia, Japan and European Union countries.
His group has been urging the FDA to ban eight synthetic food dyes since 2008, including a group of red, blue, yellow and green dyes and a rarely used orange hue.
Red No. 3 has been singled out for a ban due to the evidence on cancer in animals. "It's very low-hanging fruit that the FDA really should have picked decades ago," Galligan told NPR in 2023.
Earlier this year, California Gov. Gavin Newsom signed a second law to ban a group of six other synthetic dyes in school meals.
The National Confectioners Association said in a statement about the FDA ban that consumers and the industry "want and expect a strong FDA."
"Food safety is the number one priority for U.S. confectionery companies and we will continue to follow and comply with FDA's guidance and safety standards," it said.
The food industry has shown that it can pivot to alternatives. For instance, when Kraft foods decided to take synthetic food dyes out of its mac and cheese products, it replaced them with colors from spices such as paprika and turmeric.
Edited by Jane Greenhalgh and Carmel Wroth
By submitting your comments, you hereby give AZPM the right to post your comments and potentially use them in any other form of media operated by this institution.