The Food and Drug Administration (FDA) announced it is revoking the use of Red Dye 3 in food and ingested drugs, citing compliance with the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.
The ban follows a 2022 petition raising concerns about the dye’s safety, though officials emphasize limited human risk.
The FDA established deadlines for manufacturers to take the necessary measures to comply with the new regulation.
Industry Compliance and Timeline
Companies using Red Dye 3 in food products must reformulate them by January 15, 2027, while those using it in ingested medicines have until January 18, 2028.
The dye, also known internationally as erythrosine, has primarily been used in products like candy, cakes, cookies, frozen desserts, frostings, and certain medications.
Despite its recognizable color, the FDA noted that Red No. 3 is less widely used than other synthetic dyes.
The FDA’s Decision to Ban Red Dye 3
Red Dye 3 is a synthetic petroleum dye that gives food and drinks a bright, cherry-red color. The FDA prohibited its use in cosmetics after demonstrating that it caused cancer in laboratory rats.
At the time, the FDA indicated that it would take steps to ban the dye in food, but it never did so until January 15, 2025, when it announced its ban on food and medicines.
The Delaney Clause, part of the 1960 Color Additives Amendment, bars FDA approval of any additive shown to induce cancer, regardless of exposure level.
The European Union has already banned Red Dye 3, which was recently prohibited in food sold in California starting in 2027 through legislation co-sponsored by Consumer Reports and the Environmental Working Group (EWG).
Confectionery Industry Responds
Following the FDA’s announcement of a ban on using red dye 3 in foods, the National Confectioners Association, the leading organization for the $48 billion U.S. confectionery industry, responded to the FDA’s decision.
“Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards. Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety.”
The NCA reiterated in its statement that its industry has been calling for more transparency, funding, and staff resources for the FDA to continue fulfilling its mission for years. The association said it’s time to put politics aside and work together to fund the FDA at levels allowing it to continue its work.
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Global Implications and U.S. Standards
While many countries still permit Red No. 3 for various uses, the FDA’s ruling reinforces strict U.S. standards. To enter the U.S. market, imported foods containing the dye must also comply with the updated regulations.
This is not the first time the FDA has revoked an additive’s approval under the Delaney Clause. In 2018, the agency prohibited certain synthetic flavors after a similar review prompted by a petition.
Consumer Reports Welcomes Ban on Red Dye 3
Consumer Reports (CR) applauded the FDA for banning Red Dye 3 in food and drugs in response to a petition submitted by food safety groups calling on the agency to prohibit the dangerous dye.
In 2022, CR signed a petition to the agency led by the Center for Science in the Public Interest calling for a ban on the dye, a known carcinogen linked to hyperactivity and other neurobehavioral effects in children.
“Red Dye 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available,” said Brian Ronholm, food policy director at Consumer Reports. “By banning the dye, the FDA will protect the public by encouraging manufacturers to switch to safer ingredients already used in products sold in Europe and numerous other countries.”
According to the Environmental Working Group (EWG), nearly 3,000 food products today contain Red Dye 3, including many artificially flavored and artificially colored candies marketed to children.
While Red Dye 3 poses risks to people of all ages, young children may be most vulnerable because of their small body weight and higher levels of exposure.
“Ensuring the safety of food additives remains a critical priority for the FDA,” the agency stated, urging manufacturers to transition to alternative formulations to meet the regulatory deadlines.