The US Food and Drug Administration (FDA) officially banned the use of Red Dye No. 3, also known as erythrosine, in food products and orally ingested medications due to evidence linking it to cancer in laboratory rats. Manufacturers of food products have until January 15, 2027, to remove the dye from their offerings, while drug manufacturers must comply by January 18, 2028, USA Today reported.
The decision came after years of scrutiny and debate over the safety of Red No. 3, particularly concerning its potential impact on children and its alleged link to cancer. In 2022, the Center for Science in the Public Interest (CSPI) and other health advocacy groups filed a petition urging the FDA to revoke authorization for Red No. 3 due to safety concerns, CBS News reported.
Studies showed that high doses of Red Dye No. 3 can induce tumors in male rats. The FDA cited these findings as the basis for the ban, stating that evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3, Parents reported.
The ban comes nearly 35 years after it was barred from cosmetics following studies that found tumors linked to the dye in lab rats, NBC News reported.
Health advocates long warned of the risks associated with Red No. 3. "The agency cannot authorize additives linked to cancer in humans or animals," said Jim Jones, the FDA's Deputy Commissioner for Human Foods, according to a report by La Opinión.
"Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids," stated Ken Cook, president of the Environmental Working Group, Real Simple reported.
Manufacturers are now required to reformulate their products to eliminate Red Dye No. 3. Companies involved in making ingested drugs, such as dietary supplements, will have an additional year to comply with the ban, Business Insider reported.
The FDA's decision aligns the US with international standards in public health protection. Red No. 3 was long banned in the European Union, Australia, and New Zealand, reflecting a global trend toward stricter regulations on artificial colorants, BBC News reported.
Industry groups expressed their commitment to complying with the FDA's decision. "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," stated the National Confectioners Association, Reuters reported.
Despite the ban, some experts note that harmful exposure levels for humans are much lower than those that caused cancer in rats. "People's levels of exposure are usually much lower, and studies conducted in other animals and in people have not shown the same effects," the FDA noted, according to CBS News.
Concerns have also been raised about the potential impact of Red Dye No. 3 on children's behavior. "Synthetic food colorants, including Red Dye No. 3, can impact neurobehavior in some children," a 2021 review by California's Environmental Protection Agency concluded, raising concerns about its effects on behavior, Parents reported.
Manufacturers are increasingly turning to natural alternatives to replace Red Dye No. 3. In place of Red No. 3, manufacturers are using natural alternatives such as beet juice, carmine, and pigments from foods like purple sweet potato and red cabbage, The Guardian reported.
The FDA's ban on Red Dye No. 3 is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of any food additive found to induce cancer in humans or animals at any dose. "The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals," Jim Jones stated, according to CBS News.
The article was written with the assistance of a news analysis system.