FDA Finally Bans Red Dye #3 After 30+ Years of Harm

The Brief

The FDA has banned Red 3, a dye linked to cancer in lab rats, from foods and ingested drugs by 2027.
The decision follows a 2022 petition by health advocates and cites the Delaney Clause on cancer-causing additives.
Some manufacturers already use alternatives like beet juice and natural pigments.

WASHINGTON - The Food and Drug Administration has ruled to ban the dye called Red 3 from the nation’s food supply, nearly 35 years after it was barred from cosmetics because of potential cancer risk.

What we don't know:

It's not clear whether the ban will face legal challenges from food manufacturers because evidence hasn’t determined that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested that's a risk.

"When we do ban something, it will go to court," he told members of Congress on Dec. 5. "And if we don't have the scientific evidence, we will lose in court."

What is red dye No. 3?

Dig deeper:

The dye is known as erythrosine, FD&C Red No. 3 or Red 3. The ban removes it from the list of approved color additives in foods, dietary supplements and oral medicines, such as cough syrups. More than three decades ago, the FDA declined to authorize use of Red 3 in cosmetics and externally applied drugs because a study showed it caused cancer when eaten by rats.

Red 3 is banned for food use in Europe, Australia and New Zealand except in certain kinds of cherries. The dye will be banned in California starting in January 2027.

What they're saying:

"The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs," said Jim Jones, the FDA's deputy commissioner for human foods. "Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans."

Consumer advocates praised the decision.

"This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy," said Dr. Peter Lurie, director of the group Center for Science in the Public Interest, which led the petition effort.

The other side:

The International Association of Color Manufacturers defends the dye, saying that it is safe in levels typically consumed by humans. The group points to research by scientific committees operated by the United Nations and the World Health Organization, including a 2018 review that reaffirmed the safety of Red 3 in food.
Dye to be phased out by 2027

What's next:

Food manufacturers will have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same. Other countries still allow for certain uses of the dye, but imported foods must meet the new U.S. requirement.
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