Quick summary
• The FDA has announced a ban on Red No. 3, a synthetic food dye linked to cancer in lab animals, effective January 2027 for food products and January 2028 for dietary supplements.
• Red No. 3, found in over 9,200 products, including candies, cereals, and beverages, has been under scrutiny since the 1980s due to its carcinogenic risks.
• The decision follows decades of advocacy by groups like the Center for Science in the Public Interest (CSPI) and states like California, which already banned the dye.
• Advocacy leaders, such as Dr. Peter Lurie of CSPI, praised the move, noting the dye’s previous ban in cosmetics under the Delaney Clause, a law prohibiting carcinogenic additives.
• The Consumer Brands Association and other food industry groups pledged compliance with the new regulations, emphasizing their commitment to food safety.
• Advocacy groups hope the FDA will next address other artificial dyes, such as Red No. 40, and their potential impacts on children’s behavior and health.
• The decision precedes President-elect Donald Trump’s inauguration, with Robert F. Kennedy Jr. set to oversee the FDA, possibly signaling more regulatory changes for food additives.
The U.S. Food and Drug Administration (FDA) announced Wednesday its decision to ban Red No. 3, a synthetic dye used in thousands of food products, beverages, and dietary supplements. This marks the culmination of decades of pressure from consumer advocacy groups, researchers, and lawmakers over the dye’s potential health risks.
The FDA’s decision stems from studies dating back to the 1980s that linked the dye to cancer in laboratory animals. “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,” said Jim Jones, the FDA’s deputy commissioner for human foods. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
Red No. 3, approved for food use in 1907, is made from petroleum and is known for its bright red hue, often seen in candies, cereals, fruit cocktail cherries, and strawberry milkshakes. According to the Center for Science in the Public Interest (CSPI), more than 9,200 food items currently contain the dye.
Dr. Peter Lurie, president of CSPI, highlighted the significance of the FDA’s move: “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.”
Compliance deadlines and industry impact
Food manufacturers have until January 15, 2027, to reformulate their products, while makers of dietary supplements have an additional year. Several U.S. states, including California, have already taken action to ban or restrict the use of Red No. 3. Globally, the dye has been banned or severely restricted in countries such as Australia, Japan, and members of the European Union.
In California, Assemblymember Jesse Gabriel, who championed state-level bans, welcomed the FDA’s decision: “To me, this is a clear indication that our strategy of putting pressure on Washington and the FDA to take their regulatory responsibilities seriously is working.”
The Consumer Brands Association, a trade group representing food companies, pledged to comply with the ban. Sarah Gallo, senior vice president of product policy and federal affairs, noted: “Food and beverage companies will continue to follow the latest science and comply with all food safety regulations to ensure safe and available choices for consumers.”
Advocacy groups like the Environmental Working Group (EWG) expressed hope that the FDA will broaden its scrutiny of artificial dyes. “This is a big win for consumers, that this cancer-causing chemical is finally going to be out of the food supply,” said Melanie Benesh, vice president for government affairs at EWG. “This is certainly an important positive step forward.”
Research has also raised questions about artificial dyes’ potential effects on children’s behavior. While the FDA reviewed these concerns in 2011 and found no causal relationship, a 2021 review by California’s Environmental Protection Agency concluded that synthetic food dyes “can impact neurobehavior in some children.”
Food manufacturers have until January 2027 to comply with the new rules, with dietary supplement producers receiving an additional year.
As the food industry adjusts to this regulatory change, public health advocates remain hopeful that further scrutiny of artificial food dyes will follow. Melanie Benesh of the Environmental Working Group highlighted the importance of consumer awareness and advocacy: “The FDA, I think, is feeling that pressure from consumers who are worried about what is in their food. This is certainly an important positive step forward.”
The decision comes as President-elect Donald Trump’s administration prepares to take office, with Robert F. Kennedy Jr., a vocal critic of certain food additives, set to oversee the FDA. His leadership could bring additional changes to the regulation of artificial dyes and other additives in the future.
To see what food chemicals the FDA should ban next, visit Environmental Working Group.
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