Anne Bredemann

Associate Editor

Loyola University Chicago School of Law, JD 2026

In January 2025, the U.S. Food and Drug Administration (FDA) announced a ban on the use of Red Dye No. 3 (erythrosine) in food and ingested drugs. The main concern regarding the dye is that it is a potential carcinogen; studies from the 1980s found laboratory rats which were fed Erythrosine developed thyroid cancer. According to the Environmental Working Group, there are approximately 2,900 food products currently in the market that contain the dye, such as cherry sodas, candies, and frosting (not to mention medicines and supplements). While the ban is a step in the right direction, it is far overdue and leaves questions about what should be done about other artificial dyes that remain in the market.

Despite the studies from the 1980s, it was not until last month –thirty years later– that the FDA revoked authorization of the food additive. Back in 2022, scientists submitted a petition to the FDA, citing concern that the Delaney Clause should apply in light of the health risks that Red Dye No. 3 poses. The Delaney Clause was first incorporated into the Federal Food, Drug and Cosmetic Act by the Food Additives Amendment of 1958. The clause requires the FDA to ban food additives which are found to cause or induce cancer in humans or animals as indicated by testing. Manufacturers have until January 2027 to reformulate their products to comply with the ban, meaning that Red Dye No. 3 will likely remain available for consumption for the next two years.

Red Dye No. 3 in other industries

Interestingly, Red Dye No. 3 has actually been banned for use in makeup and cosmetic products in the U.S. since 1990 in light of the known potential risks, such as cancer and thyroid disruption. Dr. Peter Lurie, a well-known health expert and advocate in food safety, has been a vocal critic for years about the dye and the discrepancies in how it is regulated in makeup and food. He is the president and executive director of the Center for Science in the Public Interest and was a guest on NPR earlier last month to discuss Red Dye No. 3 specifically. He remarked in the interview, “It feels great to see this finally take place, but the law is absolutely clear. Any additive that causes cancer in humans or animals is not supposed to be in the food supply, but somehow FDA has tolerated this, even after admitting that it caused cancer over three decades ago.”

Despite the findings in the rat studies, the FDA has apparently long maintained that Red No. 3 was not a risk for people given that the amount of dye used in the foods and medicines is generally less than the amounts that the rats were exposed to. But other studies since then have found that Red 3 and other petroleum-based dyes can contribute to learning and behavioral issues in children, such as ADHD.

In a Center for Science in the Public Interest press release from January 15, Dr. Lurie acknowledges the FDA’s downplaying of the risks, saying, “We’re not surprised FDA has asserted that the risk is small, since it’s a chemical they failed to ban for years.” Dr. Lurie suggests that the FDA is doing so “to reassure the public that the agency hasn’t been placing them at risk for decades,” despite Congress making it clear years ago that this was exactly the type of chemical that should not be available for consumption when it issued the Delaney Clause.

The future of artificial dyes

Critics argue that it is nonsensical for Red Dye No. 3 to have been banned in cosmetics such as lipstick because of its health risks but simultaneously available for children to consume in food such as Candy Corn. While Red Dye No. 3 is now banned in food products, other artificial dyes such as Red 40, Yellow 5, and Yellow 6 still remain approved for use. These dyes make up 90 percent of food dye in the U.S., and more than 36,000 food products sold in the U.S. contain Red 40. In response to these concerns, some states have taken action to ban certain food additives prior to the FDA ban. California, for example, issued a ban in 2024 on several other artificial dyes which are still FDA-approved.

While these are steps in the right direction, it is evident that more must be done at the federal level in order to protect Americans from hazardous chemicals in their food, since other synthetic dyes remain in use and Red Dye No. 3 will still be in circulation for the next two years. Consumers who wish to avoid synthetic dyes could do so by reading ingredient labels and choosing products that are colored naturally, with ingredients like turmeric. Hopefully, the federal government will continue working to get the dyes and other dangerous synthetic foods off shelves sooner.