The U.S. Food and Drug Administration (FDA) has officially banned the use of Red No. 3, also known as Erythrosine, in foods, dietary supplements, and ingested medicines.
This decision follows decades of scrutiny and mounting evidence linking the synthetic dye to cancer in laboratory animals.
Red No. 3, a petroleum-based color additive known for its bright cherry-red hue, has been a staple in candies, baked goods, and certain medications.
Despite being banned in cosmetics and topical drugs since 1990 due to potential carcinogenic risks, its continued use in food products has been a controversial subject for years.
Now, food manufacturers have until January 2027 to eliminate the dye from their products, while drug manufacturers have until January 2028 to comply.
The FDA’s move stems from the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the agency from classifying as safe any additive found to cause cancer in humans or animals.
Evidence cited in the FDA’s announcement points to studies where male lab rats exposed to high doses of Red No. 3 developed cancer. Although similar studies have not shown a direct link between the dye and cancer in humans, the agency determined that its continued use was no longer justifiable.
“This is a welcome, but long overdue, action from the FDA,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest (CSPI), one of the leading organizations behind a 2022 petition to ban the dye.
Dr. Lurie noted the inconsistency of allowing Red No. 3 in food products while banning it from cosmetics for more than three decades.
The dye’s removal will also apply to imported foods, ensuring compliance with U.S. safety standards.
Red No. 3 has already been banned or severely restricted in several other countries, including Australia, Japan, and those in the European Union. In the U.S., nearly 3,000 products, ranging from candies to dietary supplements, currently contain the dye.
Critics of Red No. 3 have long argued that its use in brightly colored foods disproportionately affects children.
Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Health, emphasized the risks, saying the dye has been linked to behavioral issues in children, including ADHD, in addition to its cancer concerns. “It’s been more than 30 years since it was banned in cosmetics due to carcinogenic evidence in lab rats. It was time for consistency between what we put on our skin and what we ingest.”
Food industry groups have signaled their readiness to comply with the new regulations.
The National Confectioners Association, representing major candy manufacturers, stated, “Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with the FDA’s guidance and safety standards.”
The association had previously opposed state-level bans, such as California’s 2022 law banning Red No. 3 and other additives, citing concerns over fragmented regulation. With the FDA now enforcing a national standard, industry leaders appear to support the change.
The FDA’s action reflects growing awareness of the risks associated with synthetic food additives.
Advocacy groups have applauded the decision but remain critical of the time it took to reach this point. “These dyes serve no nutritional purpose,” said Thomas Galligan from the CSPI. “They’re used to make food look more appealing, but at what cost?”
While the FDA maintains that existing data does not raise immediate safety concerns for humans, the agency’s decision marks a significant shift in U.S. food safety policy, aligning with global trends to prioritize consumer health over aesthetic appeal in food products.