The Food and Drug Administration announced Wednesday that it had decided to revoke Red 3’s approval to be added to foods over concerns about how the food coloring has been linked to cancer in laboratory animals.
FDA officials have been telegraphing the decision for months. Although the agency has long said it doesn’t think the evidence that Red 3 causes cancer applies to humans, officials say their hand was forced by a law requiring the agency to remove additives that are carcinogenic in animals.
“The Delaney Clause is clear; the FDA cannot approve a food additive or color additive if it has been found to cause cancer in humans or animals. There is evidence that cancer occurs in male laboratory rats exposed to high levels of FD&C Red No. 3” , said Jim Jones, FDA deputy commissioner for human nutrition, referring to the law.
A notice on the FDA’s website states that using Red 3 in food or medicine “puts people at risk and is not supported by the available scientific information.”
Hundreds of food brands, including products ranging from candy and fruit cups to snack chips and tomato sauce, have once contained Red 3, according to databases maintained by the U.S. Department of Agriculture and the nonprofit Environmental Working Group, as well as nutrition labels. published by food companies.
Wednesday’s decision follows 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 a 2023 California initiative to ban the food coloring, which is already banned for use in cosmetics.
“The primary purpose of food colorings is to make sweets, drinks and other processed foods more attractive. If the function is purely aesthetic, why accept any risk of cancer?” said dr. Peter Lurie, president of the Center for Science in the Public Interest, said in a statement.
Although the group has highlighted Red 3’s link to cancer in efforts to ban the additive, it is concerns about another health problem – the possibility that artificial food dyes could cause hyperactivity in children – that are driving the opposition to this and another dye has sparked. called Red40 used in many American food products.
An influential review by California’s Environmental Protection Agency of studies on synthetic food dyes, including Red 3, concluded in 2021 that dyes “may influence neurobehavior in some children.”
What foods and drinks contain Red 3?
Red 3 has been approved by countries around the world for use in at least some foods, according to the International Association of Color Manufacturers, under other names such as erythrosine or E 127. In Europe, Red 3 is only permitted for use in cocktail cherries and candied cherries.
In the US, 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 blast flavors. Other foods also use Red 3, such as Del Monte cherry mix fruit cups, MorningStar Farms vegetarian bacon strips and Pillsbury’s birthday cake cookie dough.
Several drinks also rely on Red 3, including Secure’s creamy peach nutrition shake and Nesquik’s low-fat strawberry milk.
On Wednesday, the candy industry pledged in a statement to comply with FDA guidelines and safety standards. Industry groups have called on the agency to step up regulation of food additives, citing concerns that a vacuum left by the 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 said for years that the FDA is the rightful national regulatory decision-maker and leader in food safety,” the National Confections Association statement said.
Robert F. Kennedy Jr.President-elect Donald Trump’s pick to lead the federal department that will oversee the FDA has been critical of the agency for not taking steps to curb the use of certain food additives.
Kennedy and his allies did just that also called up tightening the FDA’s approach to regulating food additives, which critics have derided as a “loophole” that provides access to ingredients. That process is separate from artificial colors like Red 3 and Red 40, which must jump through steep hurdles to gain FDA approval and are carefully tested for purity before being used on the market.
