The FDA today (Jan. 15) gave notice it is revoking the authorization for the use of FD&C Red No. 3, responding to a 2022 color additive petition from the Center for Science in the Public Interest (CSPI) and 23 other signatories. The ban will go into effect Jan. 15, 2027, and Jan. 18, 2028.
Despite the two-year wait, the ban rested on a simple “matter of law.” The 1960 Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) stated that no chemical additive can be used for food if it’s found to induce cancer in humans or animals.
There was a considerable body of evidence that Red 3 caused cancer in lab rats, but the FDA said that mechanism does not occur in humans, and the amounts used in the tests were extraordinarily high.
Nevertheless, the FDA itself banned its use from cosmetics in 1990 but did not prohibit it in food. It’s also been connected to hyperactivity in children.
Red 3, also known as erythrosine, is restricted as a food additive in the European Union, China and the United Kingdom and its use is limited in Australia and New Zealand. Jim Jones, FDA’s Deputy Commissioner for Human Foods, told a senate hearing on Dec. 5 an agency decision on banning Red 3 would be coming soon.
CSPI and the other supporters on the petition – including Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Consumer Reports and Environmental Working Group – have been relentless in pressuring the FDA to act. Perhaps the final straw was the California legislature’s ban of the colorant, along with three other additives, effective Jan. 1, 2027.
In the past, Red 3 was used in hundreds of food products, but its use has been waning as a ban looked likely, consumer fear increased and natural replacement colors emerged. Today’s FDA announcement acknowledged it’s still used in some as candies, cakes and cupcakes, cookies, frozen desserts and frostings and icings, as well as certain ingested drugs.