The U.S. Food and Drug Administration announced Wednesday that it has decided to revoke its authorization to add Red 3 to food due to concerns about a link between the food dye and cancer in laboratory animals.
FDA officials had telegraphed the decision months ago. While the agency has long said it does not believe the evidence that Red 3 causes cancer applies to humans, officials said their approach was prompted by a law requiring the agency to eliminate additives that cause cancer in animals.
“The Delaney Clause is clear; the FDA cannot approve a food additive or color additive if it is found to cause cancer in humans or animals. There is evidence that male laboratory rats exposed to high concentrations of FD&C Red No. 3 developed cancer ,” said Jim Jones, the FDA's deputy commissioner for human foods, referring to the law.
A post on the FDA website states that the use of Red 3 in food or drugs “puts people at risk, but available scientific information does not support this.”
Wednesday's decision stems from a petition filed in 2022 by the Center for Science in the Public Interest and a number of other groups calling for the additive to be removed from the market. Food brands have until January 2027 to stop using the dye.
The group also supports California's 2023 ban on food dyes, which are already banned from use in cosmetics.
“The primary purpose of food colorings is to make candies, beverages and other processed foods more appealing. Why accept any cancer risk when the function is purely aesthetic?” Dr. Peter Lurie, president of the Center for Science in the Public Interest, said in a statement.
While the group has highlighted Red 3's links to cancer in its push to ban the additive, concerns about another health issue – that artificial food dyes may cause ADHD in children – have fueled concerns about the dye and Another dye objection called red 40 Used in many American foods.
An influential review by the California Environmental Protection Agency into research on synthetic food dyes, including Red 3, concluded in 2021 that the colorants “may affect neurobehavior in some children.”
Robert F. Kennedy Jr., President-elect Donald Trump's appointee to head the federal agency that oversees the FDA, has been critical of the agency's failure to act to restrict the use of certain food additives.
Kennedy and his allies also called for Critics deride the tightening of FDA regulations on food additives as a “loophole” that allows related ingredients to exist.
This process differs from artificial colors like Red 3 and Red 40, which must jump steep hurdles to gain FDA authorization and undergo careful purity testing before being released to the market.
Hundreds of food brands contain Red 3 to some extent, according to a database maintained by the U.S. Department of Agriculture and the nonprofit Environmental Working Group, as well as nutrition labels revealed by food companies.
Countries around the world have authorized Red 3 for use in at least some foods under the name erythrosine or E 127, according to the International Color Manufacturers Association.
In the United States, Red 3 is used in some candies, including Jelly Belly's Candy Corn, Tootsie's Dubble Bubble ball gum, and Ring Pop's strawberry and berry flavors.
Red 3 is also used in other foods, such as Del Monte Cherry Mixed Fruit Cups, MorningStar Farms Vegan Bacon Strips and Pillsbury's Birthday Cake Cookie Dough.
Some drinks also rely on Red 3, including Ensure's Creamy Peach Nutritional Smoothie and Nesquik's Strawberry Low-Fat Milk.
