FDA Officially Bans Red Dye No. 3, Citing Cancer Risks in Animals

Landmark Decision Targets Popular Additive Used in Candy, Snacks, and Drinks

The U.S. Food and Drug Administration (FDA) announced a ban on Red Dye No. 3, a commonly used artificial food coloring linked to cancer in animals. The move, effective January 15, 2025, follows years of advocacy from public health groups and increasing scrutiny over food safety regulations.

Red Dye No. 3: What You Need to Know

Red Dye No. 3, also known as erythrosine or FD&C Red No. 3, has been used for over five decades in foods such as bubblegum, candy, cakes, and frozen desserts. While the dye enhances the aesthetic appeal of many products, studies have shown that high doses of the coloring caused thyroid cancer in male rats.

Although the FDA maintains that no evidence links Red Dye No. 3 to cancer in humans at typical consumption levels, the agency is moving forward with the ban under the Delaney Clause—a federal law prohibiting additives found to cause cancer in humans or animals at any dose.

“The Delaney Clause is clear; the FDA cannot authorize a food or color additive if it has been shown to cause cancer,” said Jim Jones, the FDA’s deputy commissioner for human foods.

Timeline for the Ban

The FDA has set a timeline for phasing out the dye. Red Dye No. 3 must be eliminated from food products by mid-January 2027 and from ingested drugs by 2028. While the dye is less widely used compared to other artificial colorings, it remains a key ingredient in brightly colored candies and snacks targeted at children.

Public Health Advocates Applaud, Industry Pushes Back

Public health organizations have long criticized the use of Red Dye No. 3, arguing it should have been banned decades ago. The Center for Science in the Public Interest, a nonprofit group, filed a petition in 2022 urging the FDA to remove the dye from the list of approved additives.

“We’re not surprised the FDA has asserted that the risk is small, given how long this chemical has been allowed on the market,” said Peter Lurie, president of the organization and a former FDA official. “Congress made it clear years ago that this kind of additive—one that causes cancer in animals—should not be in the U.S. food supply.”

However, the International Association of Color Manufacturers has defended the dye, stating, “Red Dye No. 3 is safe for its intended uses.” The group also warned that removing the additive could increase production costs, potentially leading to higher prices for consumers.

A Turning Point in Food Safety Policy

The FDA’s decision reflects a growing shift toward more precautionary measures in regulating food additives. The ban aligns the U.S. with countries like Japan, China, and members of the European Union, where Red Dye No. 3 has already been prohibited.

Consumer demand for natural ingredients may accelerate the transition to safer alternatives like beet juice, red cabbage, or paprika. These natural colorings offer additional nutritional benefits while avoiding the health risks associated with artificial additives.

The Bigger Picture: Food Safety in Focus

The FDA’s action comes at a pivotal time for U.S. food policy. President-elect Donald Trump’s pick for health secretary, Robert F. Kennedy Jr., has been vocal about regulating potentially harmful chemicals in food and drinks. Bipartisan lawmakers and social media influencers have also amplified the call for stricter oversight of additives in consumer products.

As more information emerges about the potential risks of artificial additives, this ban may pave the way for tighter regulations on other controversial substances.

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