FDA bans red dye #3

The Food and Drug Administration has banned a controversial red dye of ingested foods and drugs that have been linked to cancer in animals.

The FDA has it decided to rescind its approval of FD&C Red No.3, also known simply as Red No.3, from food and drug supplies more than 30 years after the agency banned it from cosmetics.

The agency’s decision comes less than a week before President-elect Trump takes office where he and his pick Secretary of Health and Human ServicesRobert F. Kennedy Jr. is expected to do well promises to suppress on the use of artificial food dyes.

Network No. 3 was approved for permanent use in food and ingested drugs approximately 50 years ago and has been used as an artificial food coloring to give products such as candy, cakes, and ice cream a bright cherry red color.

The FDA’s ban on the dye comes two years after advocates petitioned the agency to have it removed from food products arguing that companies should use natural food coloring such as beets, red cabbage and black currants.

Studies cited in the petition show that high doses of the dye can cause cancer in male rats, but the FDA insists that Red No. 3 does not cause cancer in humans.

“Relevant exposure levels to FD&C Red No. 3 for humans are typically well below those that cause the effects shown in male rats,” the agency said in a statement.

Some consumer advocacy groups and lawmakers who have tried to pressure the agency to rescind its approval of the dye praised the FDA’s decision on Wednesday.

“The FDA is finally ending the regulatory paradox that Red 3 is illegal for use in lipstick but perfectly legal to feed to children in candy form,” said Peter G. Lurie, president of the Center for Science in the Public Interest, one of the organizations behind the 2022 petition to the FDA to end the use of the dye.

“The main purpose of food coloring is to make sweets, drinks and other processed foods more appealing,” he continued. “When the function is purely aesthetic, why accept any risk of cancer?”

The administration said it was removing the dye as a “matter of law” citing the Delany Clause, a federal law that prohibits the addition of any chemical to food that has been shown to cause cancer in humans or animals.

Food manufacturers using Red No. 3 will have until Jan. 15, 2027, to reformulate their products, while drugmakers have until Jan. 18, 2028, according to an FDA statement.

Food imported from other countries where Red No. 3 is still used in food, they will have to comply with the new US requirement.

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