(The Center Square) – The U.S. Food and Drug Administration has revoked authorization for Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.
Safety concerns over potential cancer risks, linking the dye to cancer in laboratory animals, were the main driving force behind the petition started by the consumer advocacy group the Center for Science in the Public Interests.
CSPI argued that the use of the dye contradicted the FDA’s own research on carcinogenic potential.
However, the FDA stated in the announcement that “claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.” Officials cited a statute known as the Delaney Clause, which requires the FDA to ban any additive found to cause cancer in people or animals, for its new position.
“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, “But the truth is Congress made plain decades ago that this was exactly the type of chemical – one that causes cancer in animals – it was trying to keep out of the U.S. food supply,” said CSPI in a statement.
Manufacturers of FD&C Red No. 3 in food and ingested drugs will have until Jan. 15, 2027, or Jan. 18, 2028, to reformulate their products.
The National Confectioners Association stated that the FDA’s evaluation and risk assessment had concluded that Red No. 3 “meets the safety standard of a reasonable certainty of no harm required for a color additive.” The company noted that the FDA revoked the use of Red Dye 3 in food and drugs because of The Delaney Clause.
“Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” the association said in an email to The Center Square.
“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 rightful national regulatory decision maker and leader in food safety.”
Red No. 3, a synthetic dye commonly found in colored candies, baked goods, and medications, has been a topic of debate for decades. In 1990, the FDA banned its use in cosmetics after studies linked the dye to thyroid tumors in rats used to test it.
“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” said the FDA.
Meanwhile, the dye has managed to remain in use in food and pharmaceuticals due to the different regulatory standards and industry reliance on its bright, pinkish-red hue.
The FDA’s move to remove the dye comes as President-elect Donald Trump prepares to take office, bringing his new pick for the Department of Health and Human Services secretary, Robert F. Kennedy Jr., with him if he’s confirmed by the U.S. Senate.
Red No. 3 is one of the several synthetic dyes regulated by the FDA. Unlike Red No. 3, Red No.40, another widely used red dye, remains approved for use in the United States, although it faces scrutiny over the behavioral effects connected to children.
