The U.S. Food and Drug Administration announced Wednesday that it has decided to withdraw its authorization to add Red 3 to food due to concerns about a link between the food coloring and cancer in laboratory animals.
FDA officials had been telegraphing the decision for months. 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 remove 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 laboratory males exposed to high concentrations of FD&C Red No. 3 Rats get 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."
Hundreds of food brands, including products ranging from candy and fruit cups to snack chips and ketchup, have contained Red 3, according to databases maintained by the U.S. Department of Agriculture and the nonprofit Environmental Working Group, as well as nutritional labels. Food company disclosures.
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, drinks 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 Zhong said.
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 prompted concerns about this dye and another dye objections called red 40 Used in many American foods.
An influential review by the California Environmental Protection Agency into research into synthetic food dyes, including Red 3, concluded in 2021 that the colorants "may affect neurobehavior in some children." .
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 Europe, Red 3 is only allowed for cocktail cherries and candied cherries.
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 beverages also rely on Red 3, including Ensure's Creamy Peach Nutritional Smoothie and Nesquik's Strawberry Low-Fat Milk.
In a statement Wednesday, the candy industry committed to adhering to FDA guidance and safety standards. Industry groups have been calling on the agency to strengthen its oversight of food additives, citing concerns that the vacuum left by FDA's inaction could lead to a frustrating patchwork of state laws for national food brands.
"Our consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based national regulatory framework. We have been saying for years that the FDA is the legitimate national regulatory decision-maker and leader in food safety ” Statement from the National Confectionery Association.
Robert F. Kennedy Jr.The head of the federal department appointed by President-elect Donald Trump to oversee the FDA has been critical of the agency's failure to take action to restrict the use of certain food additives.
kennedy and his allies also called for Tightening FDA regulations on food additives, derided by critics as a "loophole" that allows related ingredients to exist. The 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 hitting the market.