The Food and Drug Administration has revoked the food use authorization of Red Dye No. 3, a dye that gives foods and drinks their bright-red color but which also is linked to cancer in animals.
The move follows a 2022 color additive petition from the Center for Science in the Public Interest and 23 other groups urging FDA to ban the dye.
The petition cited two two studies that "showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat-specific hormonal mechanism," FDA said in its announcement. However, "The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats."
The Delaney Clause of the Federal Food, Drug and Cosmetic Act, however, prohibits FDA authorization of a food or color additive found to induce cancer in humans or animals.
Manufacturers using the color additive in food have until Jan. 15, 2027, to reformulate products, and imported products must also comply with this requirement. FDA said the dye is not as widely used in food and drugs as other certified colors, and is primarily used in foods such as candy, cakes, cupcakes, cookies, frozen desserts and more.
Based on evidence from the 1980s showing Red 3 caused cancer in lab animals, FDA prohibited use of the dye in cosmetics and topical drugs in 1990. CSPI President Peter Lurie said this move ended the “regulatory paradox of Red 3.”
“We’re not surprised FDA has asserted that the risk is small, since it’s a chemical they failed to ban for years, and they want to reassure the public that the agency hasn’t been placing them at risk for decades,” Lurie said in a statement.
Food and drug industries used over 200,000 pounds of Red 3 in 2021, according to CSPI. The group urged consumers to avoid not just Red 3 but all numbered dyes, including Yellow 5 and Red 40, due to risk of cancer and adverse impacts on children’s behavior.
“If the incoming administration wants to protect children’s health, it should require companies to warn parents of the risks that all synthetic dyes pose to their children — right on the label of the package,” Lurie said.
CSPI urged the incoming Trump administration to support FDA’s announced efforts to develop an enhanced framework for post-market assessments of food chemicals.
This is one regulatory move that stands to survive the incoming Trump administration. Robert F. Kennedy Jr., who is nominated to lead the Department of Health and Human Services, has been critical of artificial dyes like Red 3.
Last year, California preempted the federal government by banning six chemical dyes, including Red 40, Yellow 5 and more, in school meals. Other countries either ban Red 3, or include restrictions like warning labels on products with the dye.
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