The Food and Drug Administration announced Wednesday that it would revoke authorization of Red Dye No. 3 in food and ingested drugs, following pressure from a 2022 color additive petition.
The synthetic dye, also known as erythrosine, is used to give products a very bright color. The 2022 petition cited concerns about the toxicity and carcinogenicity of the red dye in animal studies. While the FDA did not find similar reactions in humans, it moved to classify the dye as unsafe for consumption.
Red Dye No. 3 is used in varied food products and candies, including Pez, some red icing, and strawberry-flavored milk. The FDA’s decision hinges on a portion of the 1938 Food, Drug, and Cosmetic Act known as the Delaney Clause, which prevents the FDA from authorizing a food or color additive if it has been found to cause cancer in either humans or animals.
“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” Jim Jones, the FDA’s deputy commissioner for human foods, said in a statement. “The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals.”
Still, Jones emphasized that the mechanism by which the dye causes cancer in rats does not translate to humans.
The Center for Science in the Public Interest spearheaded the petition to the agency in 2022 to ban the additive.
“After decades of delay, the FDA has finally followed the clear dictates of the law and banned a purely cosmetic color additive that never made a nutritional contribution to the food supply,” Peter Lurie, president of CSPI, said in a statement to CQ Roll Call. “Our question is: what took you so long?”
Food manufacturers will have until Jan. 15, 2027, and drug manufacturers will have until Jan. 18, 2028, to reformulate their products without Red Dye No. 3. Imported foods would be subject to the same requirements.
The FDA moved to ban Red Dye No. 3 from cosmetics in 1990 after studies came out showing its carcinogenic effects in rats.
“Today is a great day for parents across the country. Red Dye 3 is a known animal carcinogen and has been shown to have long-lasting neurobehavioral effects on children. Moreover, it’s been banned for use in cosmetic products for over 30 years. Simply put, this chemical certainly has no place in products that are on grocery store shelves,” said House Energy and Commerce ranking member Frank Pallone Jr., D-N.J.
Rep. Rosa DeLauro, D-Conn., ranking member of the House Appropriations Committee, welcomed the FDA’s decision, underscoring that the dye has already been banned in cosmetic products for nearly 30 years.
“Much work remains to be done, but the American public will be safer now that we are removing this dye from our foods, supplements, and drugs,” she said in a statement.
Pallone and DeLauro issued a joint statement calling for a ban on the additive last week, and DeLauro led a letter calling on FDA to finalize a ban in November.
Sen. Tommy Tuberville, R-Ala., a co-founder of the new Make America Healthy Again caucus, had pressed the FDA to bar Red Dye No. 3 and Red Dye No. 40, another controversial red dye, in the food supply during a Senate Health, Education, Labor and Pensions Committee hearing in December.
“I hope the FDA feels a responsibility to humans,” Tuberville said at the hearing.
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