FDA Bans Red Dye No. 3 From Food, Beverages and Ingested Drugs, Citing Link to Cancer in Lab Rats
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The dye, chemically known as erythrosine, has been used since 1907 to give candies, drinks and other foods their vibrant red color. Andia/Universal Images Group via Getty ImagesAfter decades of debate, the Food and Drug Administration (FDA) has announced a ban on Red Dye No. 3, a synthetic food coloring thats been linked to cancer in male lab rats.The decision comes after a petition filed in 2022 by advocacy groups, including the Center for Science in the Public Interest (CSPI), and follows mounting state-level legislation, most notably a ban in California. The federal ban will take effect in 2027, giving manufacturers time to reformulate their products.This is wonderful news and long overdue, Melanie Benesh, vice president for government affairs at the Environmental Working Group, tells Andrew Jacobs and Teddy Rosenbluth of the New York Times. Red Dye 3 is the lowest of the low-hanging fruit when it comes to toxic food dyes that the FDA should be addressing.The petroleum-based dye, chemically known as erythrosine, has been approved for use since 1907 to give candies, drinks and other foods their vibrant red color. While its cosmetic use was banned in 1990 under the Delaney Clausea federal rule prohibiting additives that have been found to cause cancer in humans or animalsit has remained in food and ingested drugs.Now, the FDA is using the same rule to eliminate the dye from beverages, food and drugs. However, the agency noted that the findings tying Red Dye No. 3 to cancer are specific to male rats and not directly translatable to humans.Relevant exposure levels for humans are typically much lower than those that cause the effects shown in male rats, the agency writes. Studies in other animals and in humans did not show these effects.But consumer safety advocates have long criticized the use of Red Dye No. 3 in food while it has been banned in cosmetics and topical drugs. The dye is prohibited or severely restricted in many countries, including the European Union, Japan and Australia, yet it has remained a staple in several U.S. products.Red 3, like every food dye, only serves as a marketing tool for the food industry, Thomas Galligan, principal scientist for food additives and supplements at CSPI, tells NPRs Allison Aubrey. Its just there to make food look visually appealing so that consumers want to spend their money on it.Red Dye No. 3 is found in more than 9,200 U.S. food products, including popular candies, cereals and sodas, according to data from the U.S. Department of Agriculture cited by CSPI. Companies like Ferrara, which produces Brachs candies, and Just Born, the maker of Peeps, have already begun removing the dye from their products, while other companies have turned to alternatives like Red Dye No. 40 or natural colorants, from beets to turmeric.The FDAs decision follows a wave of state legislation targeting synthetic dyes. California banned Red Dye No. 3 in October 2023, alongside three other additives linked to health risks, and it has barred artificial dyes including Red Dye No. 40 from public school meals.California assemblymember Jesse Gabriel, who introduced the states 2023 bill, credited state-level efforts with spurring federal action.To me, this is a clear indication that our strategy of putting pressure on Washington and putting pressure on the FDA to look at these issues more closely, to step up to the plate and take their regulatory responsibility seriously, is working, Gabriel tells Berkeley Lovelace Jr. and Elizabeth Chuck of NBC News.But concerns about synthetic dyes extend beyond cancer risks. In 2012, a study concluded that, while such dyes are not a primary cause of hyperactivity and attention-related behaviors, they could exacerbate these symptoms in children. Then, in 2021, a study by the California Office of Environmental Health Hazard Assessment found that legal exposure limits for artificial dyes might not adequately protect childrens behavioral health.Despite these concerns, the FDA maintains that most children are not affected.The totality of scientific evidence indicates that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them, the agency wrote in a 2023 consumer update.For now, consumers worried about synthetic dyes can check product labels for ingredients like FD&C Red #3, red 3 or Red Dye No. 3. Highly processed foods, which are more likely to contain artificial colorings, may also warrant a second look for those aiming to reduce their exposure.Revoking the authorized use of Red No. 3 is an example of the FDA using its risk and science-based authority to review the safety of products in the marketplace, Sarah Gallo,senior vice president of product policy and federal affairs at the trade groupConsumer Brands Association, says in a statement to NBC News. 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.Advocates hope the FDA will adopt a more proactive approach to regulating additives. Speaking to CNNs Kristen Rogers, Galligan suggests the case of Red Dye No. 3 reflects broader challenges in food safety oversight. The FDA has a long way to go to reform the broken system that allowed Red 3 to remain in foods decades after it was shown to cause cancer when eaten by animals, he tells the publication.But the decision, Galligan adds, ends the regulatory paradox of Red 3.Get the latest stories in your inbox every weekday.Filed Under: California, Cancer, Food, Government, Health, Law, Medicine, US Government
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