The Food and Drug Administration (FDA) announced Wednesday that it is banning the use of Red No. 3, a synthetic dye commonly used to color food and beverages, after research linked it to cancer in animals. The decision marks a significant victory for consumer advocacy groups and lawmakers who have long argued that the dye poses health risks, particularly to children.
Red No. 3 is used in a wide range of food products, including candy, cereals, cherries in fruit cocktails, and strawberry-flavored milkshakes. According to the Center for Science in the Public Interest (CSPI), a food safety advocacy organization that petitioned the FDA in 2022 to ban the dye, it has been a pervasive ingredient in many processed foods. The CSPI and other advocacy groups have argued that there is compelling evidence that the dye, when consumed, may increase the risk of cancer and also have negative effects on children’s behavior.
The FDA’s decision to remove Red No. 3 from the food supply came after years of research and mounting pressure from consumer groups. The agency initially began investigating the potential risks of Red No. 3 in the 1980s, when studies found that high levels of the dye caused tumors in male rats. Despite this evidence, the dye continued to be approved for use in food products until now.
“Finally, the FDA is addressing the longstanding regulatory inconsistency where Red No. 3 has been banned from use in cosmetics since 1990, but still allowed in foods, often consumed by children,” said Dr. Peter Lurie, president of the CSPI. “This move removes an unnecessary hazard from the American food supply.”
The decision is also a significant moment for consumer health advocates who have lobbied for years to have the dye banned. The CSPI’s petition was supported by lawmakers who have argued that the FDA has been slow to act, despite the evidence linking Red No. 3 to cancer in laboratory animals.
Red No. 3, made from petroleum, has been in use since it was first approved by the FDA in 1907. While it has been restricted or banned in other countries such as Australia, Japan, and the European Union due to its potential health risks, the U.S. has continued to allow its use in food products.
Under the FDA’s new ruling, food manufacturers will be required to remove Red No. 3 from their products by January 15, 2027. Manufacturers of dietary supplements and other ingestible drugs will be given an additional year to comply with the new ban.
ADVERTISEMENT
Jim Jones, the FDA’s deputy director for human foods, emphasized the importance of the ban in a statement. “The FDA cannot authorize a food or color additive if it has been found to cause cancer in humans or animals,” he said. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
The CSPI welcomed the FDA’s decision but pointed out that the agency’s action came long after the initial research into Red No. 3’s potential health hazards. “It should have occurred more than three decades ago,” Dr. Lurie said. “But we are still grateful that it is finally happening.”
Despite the scientific evidence of health risks, some food manufacturers have continued to use Red No. 3, even as public concern about artificial food dyes has grown. The dye has been linked not only to cancer but also to behavioral issues in children, further raising concerns about its widespread use in products aimed at young consumers.
In response to the ban, some food companies are already planning to reformulate their products to remove Red No. 3. The FDA has indicated that the ban will not immediately affect products currently on shelves, but that companies will need to comply with the new regulation by the 2027 deadline. This change is expected to prompt widespread reformulation of products containing the dye.
Red No. 3 has faced criticism in the past for its inclusion in foods targeted toward children, with consumer groups calling for its removal from the market for years. The FDA’s action is a key moment in the ongoing battle over food additives and their potential health risks, particularly for children who are often the most vulnerable.
The ban also highlights the growing concerns over food safety and the role of food dyes in public health. With Red No. 3 now officially banned from use in food products, attention is likely to turn to other additives that have yet to be restricted or banned in the U.S., as consumer advocacy groups continue to push for stronger protections.
ADVERTISEMENT
As of now, Red No. 3 will remain banned from cosmetics, as it has been since 1990, but its use in food products has now been firmly prohibited, marking an important step forward for food safety and public health.