What is Red Dye 3 and why has the US FDA banned it in food and drinks?

In 2022, the Food and Drug Administration (FDA) approved a petition from consumer advocacy groups to prohibit the use of the dye in food and medicine.

Marshmallow Peeps candy, which had contained the dye Red No. 3 but removed it in 2024, is on display at a store in Lafayette, California, March 24, 2023 

FDA Bans Red Dye 3 Over Cancer Concerns in Lab Rats

The United States Food and Drug Administration (FDA) has officially banned Red Dye 3, a synthetic color additive used in foods, beverages, and medicines, after studies showed it causes cancer in lab rats. This decision follows a 2022 petition by consumer advocacy groups and comes 35 years after the dye was prohibited in cosmetics.

Regulatory Background

The FDA's decision is based on the Delaney Clause, a legal statute that mandates banning any food additive found to cause cancer in humans or animals. Despite evidence that the way Red Dye 3 induces cancer in rats does not apply to humans, the clause required its prohibition.

Red Dye 3, also known as erythrosine or FD&C Red No. 3, has been restricted for food use in Europe, Australia, and New Zealand, except for specific products like cocktail cherries. However, it remains a common ingredient in popular U.S. snacks such as Betty Crocker’s Red Decorating Icing and Brach’s Candy Corn.

Timeline for Compliance

Food manufacturers have until January 15, 2027, to reformulate products containing the dye, while drug manufacturers must comply by January 18, 2028.

Reactions to the Ban

• Consumer Advocacy Groups: The Center for Science in the Public Interest lauded the FDA's decision, calling it a step toward rectifying regulatory failures.
• Industry Response: The National Confectioners Association stated its commitment to adhering to FDA regulations, emphasizing the importance of science-based decision-making.
• Color Manufacturers: The International Association of Color Manufacturers expressed concern, highlighting that the cancer risk observed in rats may not translate to humans and advocating for updated scientific approaches to such assessments.

Broader Implications

The decision coincides with growing scrutiny of food additives under the Biden administration and prospective Health and Human Services Secretary Robert F. Kennedy Jr., who has expressed intentions to target additional food additives and ingredients. Kennedy has also advocated for removing synthetic dyes from cereals and raised controversial claims about seed oils, which nutrition experts have largely refuted.

This ban underscores ongoing efforts to align food safety regulations with evolving scientific understanding while balancing public health concerns with industry practices.