A widely used cherry-red food coloring additive faces nationwide restrictions as federal regulators take action on consumer safety concerns.
According to USA TODAY, the Food and Drug Administration has officially banned Red No. 3, a petroleum-based color additive, from food products and ingested drugs due to its potential carcinogenic effects observed in laboratory studies.
The regulatory change comes after advocates filed a color additive petition in 2022, citing research that linked the dye to cancer in male laboratory rats and behavioral issues in children. This decision marks a significant shift in food safety policy, as Red No. 3 has been one of nine synthetic dyes approved for use in food products in the United States.
The FDA's announcement provides manufacturers with a transition period. Food companies have until January 15, 2027, to reformulate their products. Drug manufacturers have received a slightly longer timeline: Compliance is required by January 18, 2028. These deadlines also apply to imported products entering the U.S. market.
California pioneered state-level restrictions by becoming the first state to ban Red No. 3, along with three other food additives, in 2023. The state further expanded its regulations in 2024 by prohibiting six FDA-approved artificial food dyes in public school food and beverages, though this particular measure did not include Red No. 3.
Several other states have shown interest in similar regulations, with Illinois and New York following California's lead. The Environmental Working Group reports that bills targeting Red No. 3 and other food dyes have been introduced in multiple states, including Maryland, Missouri, New Jersey, Pennsylvania, Rhode Island, South Dakota, Washington, and West Virginia.
The ban's reach extends far beyond a few products, affecting more than 3,000 items containing Red No. 3, according to the Environmental Working Group. The additive is commonly found in various consumer products, including candy, cakes, cupcakes, frozen desserts, and pharmaceutical items.
This decision builds upon previous restrictions, as the FDA had already banned Red No. 3 from cosmetics in 1990 based on similar cancer concerns. The current ban represents a more comprehensive approach to consumer protection, though the FDA notes important context about the research findings.
The agency's announcement addresses the scientific evidence, acknowledging that while high doses of Red No. 3 caused cancer in male lab rats, the mechanism behind this effect does not occur in humans. Moreover, typical human exposure levels are significantly lower than those used in the laboratory studies, and similar effects have not been observed in other animals or humans.
The U.S. ban aligns with international regulatory standards, as Red No. 3 is already prohibited in the European Union, Australia, and New Zealand. This global consensus highlights the growing awareness of potential risks associated with certain food additives.
Eight synthetic dyes remain approved for use in food products in the United States, including Blue No. 1, Blue No. 2, Green No. 3, Orange B, Red 40, Yellow 5, Yellow 6, and Citrus Red. These alternatives provide manufacturers with options as they work to reformulate their products within the established timeline.
The implementation period allows businesses time to adapt their manufacturing processes and develop new formulations while ensuring compliance with the updated regulations. This transition phase aims to minimize disruption to both domestic and international food supply chains.
The FDA's decision to ban Red No. 3 represents a significant shift in food safety regulation, affecting thousands of products across the American market. The ban, prompted by research showing carcinogenic effects in laboratory studies, gives manufacturers until early 2027 to reformulate food products and until 2028 for ingested drugs. This regulatory change aligns the United States with international standards while demonstrating a continued commitment to consumer safety through evidence-based policymaking.
