FDA Bans Red Dye No. 3 in Food and Medications: A Major Step for Consumer Health.
The U.S. Food and Drug Administration (FDA) has taken a historic step in safeguarding public health by banning red dye No. 3 in food products and ingestible medications. This move follows decades of research linking the synthetic colorant to potential cancer risks in animals. The decision, which was announced on Wednesday, is expected to impact a range of food and beverage products, including candies and snacks that use the vibrant cherry-red dye, also known as erythrosine.
The ban comes after a petition filed in November 2022 by advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, calling attention to the carcinogenic concerns surrounding the dye. The decision also aligns with California's recent move to ban red dye No. 3, which took effect in October 2023.
FDA's Timely Action to Protect Consumers
Manufacturers now have until January 15, 2027, to reformulate food products and until January 18, 2028, to comply for ingestible drugs. This shift reflects a growing concern over the safety of synthetic additives in consumer goods.
Dr. Jerold Mande, an adjunct professor of nutrition at Harvard University, commended the FDA’s action, calling it “long overdue” and a step in the right direction. He expressed hope that the decision signals a renewed commitment by the FDA to act in the public’s best interest, despite challenges from the food industry.
Ken Cook, cofounder and president of the Environmental Working Group, celebrated the move as a “monumental victory” for consumer health, noting that this decision would not have been possible without decades of advocacy from public health leaders like Michael Jacobson.
Dye No. 3's Prevalence and Industry Response
Red dye No. 3 has been commonly used in numerous food items, especially candy, but several major manufacturers had already started phasing out its use. For example, Ferrara, the maker of Brach’s candies, reduced its use of the dye in early 2023, and Just Born, the company behind PEEPS, confirmed it would cease using the dye by Easter 2024.
However, alternatives such as red dye No. 40, which has not shown the same cancer risks, have been more widely used in the industry. Some states, including California, have taken additional action, banning red dye No. 40 from food products sold in public schools due to concerns over its potential link to behavioral issues in children.
The Importance of Health and Safety in Food Regulations
Dr. Thomas Galligan from the Center for Science in the Public Interest expressed relief that the regulatory “paradox” surrounding red dye No. 3 has ended. However, he emphasized that the FDA must continue its work to improve the regulatory process, ensuring that harmful additives are not allowed to linger in the food supply.
As a result of this ruling, the U.S. food regulations now align more closely with European standards, where red dye No. 3 has been prohibited since 1994, except for specific products like maraschino cherries. Pomeranz, a food regulation expert, highlighted Europe’s precautionary approach to food safety, a model the U.S. may follow moving forward.
Future Steps and Consumer Awareness
The FDA’s action signals a growing awareness of the risks posed by artificial additives and their long-term health implications. As the ban progresses, it is important for consumers to stay informed. Red dye No. 3 can be found on product labels under names like “red 3” or “FD&C Red #3.” If you're looking to avoid this dye, reading ingredient lists and choosing whole foods over ultraprocessed options is a prudent approach.
As the Center for Science in the Public Interest advises, parents should consider avoiding all synthetic food dyes, including red No. 40 and yellow No. 5, to protect their children’s health.
