The Food and Drug Administration on Wednesday said it’s banning red dye No. 3 from food because it could cause cancer.
Red dye No. 3 gives food and drinks a bright, cherry-red color. It is also known as erythrosine, or “Red 3,” and is found in cough syrups and other medicines.
Manufacturers of food and ingested drugs will have until Jan. 15, 2027, and Jan. 18, 2028, respectively, to remake their products without the substance, the FDA said.
Regulators revoked the dye’s authorization under a lever called the Delaney Clause, which lets regulators crack down on substances found to induce cancer in humans or animals.
“Today’s action by the FDA marks a monumental victory for consumer health and safety,” said Ken Cook, president and co-founder of the Environmental Working Group, a nonprofit that promotes health. “For years, Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids.”
The FDA’s decision follows a groundbreaking California law that banned red dye No. 3 and other food additives in 2023. The California ban takes effect in 2027, and other states are working to pass similar bans.
Red dye No. 3 is banned for most purposes in Europe, Australia and New Zealand, though is permitted in some types of cherries.
Many companies that use the dye have begun phasing it out.
Ferrara, which makes Brach’s candy, started its phase-out in early 2023, and Just Born, which makes Peeps sweets, started to ban it in 2024, according to multiple reports.
President-elect Donald Trump’s pick for health secretary, Robert F. Kennedy Jr., has spoken out against additives in the food supply, condemning cereal companies and others that use certain coloring in food given to U.S. customers but not foreign consumers.
The FDA banned red dye No. 3 in cosmetics years ago, but it was permitted in food because of a lack of evidence showing it had the same cancer-causing effects in humans as in rats.
However, the Delaney Clause argues in favor of a ban if cancer is found in humans or animals, so regulators said they “as a matter of law” after their latest review.
“The petitioners provided data demonstrating that this additive induces cancer in male rats,” the FDA said in its published order. “Therefore, FDA is revoking the authorized uses in food and ingested drugs of [Red No. 3] in the color additive regulations.”
A leading industry group, the National Confectioners Association, highlighted the lack of proven risk to humans, as opposed to rats, and pointed out the FDA was relying on a legal requirement. It said it appreciates the FDA taking a lead role, as states pursue patchwork bans around the country.
“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,” the NCA said. “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.”
Others were openly critical, saying the FDA caved to pressure without evidence the dye causes cancer in humans.
“The campaign against Red No. 3 has been a scientific empty vessel from the start,” said Stephen Kent, an analyst for the Consumer Choice Center. “Proponents of this ban will say that it’s not a big deal to have cereal, frozen treats and cupcakes be less colorful when public health is at stake, but they’ve failed to show evidence of harm and have instead relied on misinformation campaigns by social media influencers to frighten the public.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.