WASHINGTON — The US Food and Drug Administration no longer will allow the use of Red No. 3 in food and ingested drugs. Red No. 3, a synthetic food dye, gives food and beverages a bright, cherry-red color and often is used in candy, cakes, cupcakes, cookies, frozen desserts, frostings, icings and certain ingested drugs, according to the FDA.

Manufacturers who use Red No. 3 in food and ingested drugs will have until Jan. 15, 2027, or Jan. 18, 2028, respectively, to reformulate their products, according to the FDA.

The FDA noted the Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits authorization of a food additive or a color additive if it has been found to induce cancer in humans or animals. The FDA’s ruling came in response to a 2022 color additive petition that cited, among other data and information, that two studies showed cancer in laboratory male rats exposed to high levels of Red No. 3 due to a rat-specific hormonal mechanism.

“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” the FDA said Jan. 15. “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. Studies in other animals and in humans did not show these effects. 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.”

The Center for Science in the Public Interest, Washington, was one of the groups that filed the 2022 color additive petition.

“The US Food and Drug Administration is finally banning the food dye Red 3 from use in foods, beverages, oral drugs and dietary supplements, addressing a decades-long regulatory failure,” the CSPI said Jan. 15. “Red 3 has been banned from use in topical drugs and cosmetics since 1990, when the FDA itself determined that the dye causes cancer when eaten by animals. Because the FDA failed to uphold its legal obligation to fully ban cancer-causing additives, Red 3 remained permitted in foods, supplements and oral drugs more than 34 years later. That changed on Jan. 16, 2025, thanks to a color additive petition filed by CSPI in 2022.”

A California law already bans the sale of foods containing Red No. 3 in that state, beginning Jan. 1, 2027, leading some in the food industry to hope the FDA acted to avoid a patchwork of state laws.

“Food safety is the No. 1 priority for US confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” the National Confectioners Association, Washington, said Jan. 15. “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 FDA is the rightful national regulatory decision maker and leader in food safety.”