Red Dye No. 3 Banned from Food, Candy, and Medicine

US Regulators Take Action to Remove Dye from Food Supply

U.S. regulators on Wednesday banned 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.

Reason for Ban

Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some candies, snack cakes, and maraschino cherries a bright red hue.

Delaney Clause

The agency said it was taking the action as a “matter of law” because some studies have found that the dye caused cancer in lab rats. Officials cited a statute known as the Delaney Clause, which requires FDA to ban any additive found to cause cancer in people or animals.

History of Red 3

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.

Impact of the Ban

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.

Congressional Support

Consumer advocates praised the decision.

Quote from Dr. Peter Lurie

“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.

Uncertainty about Legal Challenges

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.

Quote from Dr. Robert Califf

“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.”

Timeline

When the FDA declined to allow Red 3 in cosmetics and topical drugs in 1990, the color additive was already permitted in foods and ingested drugs. Because research showed then that the way the dye causes cancer in rats does not apply to humans, “the FDA did not take action to revoke the authorization of Red No. 3 in food,” the agency has said on its website.

Future of Food Colorants

Some food manufacturers have already reformulated products to remove Red 3. In its place, they use beet juice; carmine, a dye made from insects; and pigments from foods such as purple sweet potato, radish, and red cabbage, according to Sensient Food Colors, a St. Louis-based supplier of food colors and flavorings.

Conclusion

The ban on Red 3 is a significant step towards ensuring the safety of food and medicine for consumers. While some may argue that the dye is safe in small quantities, the evidence from lab rats suggests that it poses a risk. The FDA’s decision to ban Red 3 is a necessary step towards protecting public health.

FAQs

Q: Why was Red 3 banned from food and medicine?

A: Red 3 was banned because some studies have found that it caused cancer in lab rats.

Q: What is the Delaney Clause?

A: The Delaney Clause is a statute that requires the FDA to ban any additive found to cause cancer in people or animals.

Q: How long do manufacturers have to remove Red 3 from their products?

A: Food manufacturers have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same.

Q: Is Red 3 banned in other countries?

A: 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.