The FDA has banned the use of Red No. 3, a synthetic dye linked to cancer in animals, from the U.S. food supply. This decision comes after decades of advocacy from consumer groups and lawmakers, as well as state-level bans. Food manufacturers have until 2027 to comply, while drug makers have an additional year. The ban aligns with international restrictions and aims to remove potential health risks from consumer products.
The U.S. Food and Drug Administration (FDA) has officially banned the use of Red No. 3, a synthetic dye commonly used in foods and beverages, due to its links to cancer in laboratory animals. This decision marks a significant victory for consumer advocacy groups and lawmakers who have long campaigned against the dye's use. The ban will require food manufacturers to reformulate their products by January 2027, with drug makers having an additional year to comply. The move aligns the U.S. with other countries that have already restricted the dye.
The FDA's decision to ban Red No. 3 comes after a petition filed in 2022 by various consumer groups, including the Center for Science in the Public Interest (CSPI). The dye, which has been used in thousands of products like candies, cereals, and beverages, was linked to cancer in male laboratory rats. Under the Delaney Clause, the FDA is required to ban any additive found to cause cancer in humans or animals. "The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals," stated Jim Jones, the FDA's deputy director for human foods[1]. The ban will affect both domestic and imported foods, requiring compliance with the new regulations.
The ban on Red No. 3 is a result of years of advocacy from consumer groups and pressure from lawmakers. The dye had been banned in cosmetics since 1990, but its use in food persisted until now. "At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy," said Dr. Peter Lurie, president of the CSPI[2]. California led the way with a state-level ban in 2023, and other states have introduced similar legislation. The FDA's decision is seen as a response to growing public concern and state-level actions against synthetic dyes.
The food industry is now tasked with finding alternatives to Red No. 3. Some companies have already begun reformulating their products, using natural colorants like beet juice and carmine. Ferrara Candy Company, for example, has started phasing out the dye, with plans to eliminate it by the end of 2026[3]. The National Confectioners Association stated that food safety remains a top priority and that companies will comply with FDA regulations. The ban also highlights the potential for future scrutiny of other synthetic dyes, such as Red No. 40, which has been linked to behavioral issues in children.
The FDA's ban on Red No. 3 marks a pivotal moment in food safety regulation, aligning the U.S. with international standards and addressing long-standing health concerns. While the ban will require significant adjustments from food manufacturers, it is a step towards minimizing potential health risks associated with synthetic dyes. As the industry adapts to these changes, consumer advocacy groups continue to push for further scrutiny of other artificial colorants, keeping food safety at the forefront of public health discussions.
""At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy."" - Dr. Peter Lurie
""The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals."" - Jim Jones