FDA bans FD&C Red No. 3 in food, drugsFDA bans FD&C Red No. 3 in food, drugs

The U.S. Food and Drug Administration is repealing color additive regulations that allow the use of FD&C Red No. 3 (Red 3) in foods (including dietary supplements) and ingested drugs.

The decision comes after the Center for Science in the Public Interest (CSPI) and others in a petition provided evidence showing the additive brings about cancer in male rats, according to a document scheduled to be published in the Federal Register on Thursday, Jan. 16.

Per the document, FDA is revoking the authorized uses in food and ingested drugs of Red 3 in the color additive regulations. Red 3 is a synthetic food dye responsible for the “bright, cherry-red color,” and it has been predominantly used in such food products as candy, cakes and cupcakes, as well as certain ingested drugs, FDA said.

Manufacturers who use Red 3 in food and ingested drugs will have until Jan. 15, 2027, or Jan. 18, 2028, respectively, to redevelop their products, FDA announced.

In October 2022, CSPI and 23 other groups and scientists filed a petition with FDA to remove Red 3 from the list of approved color additives in foods, dietary supplements and oral medicines. The petition characterized Red 3 as a “carcinogen” with widespread exposure to children and urged the agency to “take immediate action to prohibit” its use.

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According to CSPI, FDA prohibited Red 3 from use in cosmetics and topical drugs in 1990, based on evidence from the 1980s that the dye caused cancer in laboratory animals. And though FDA said it would “take steps” to prohibit it from foods and ingested drugs, it didn’t do so until now, the public advocacy group said.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” CSPI president Peter Lurie, M.D., said in a news release. “The primary purpose of food dyes is to make candy, drinks and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?”

In a Jan. 15 constituent update announcing it was revoking the authorization for use of Red 3, FDA acknowledged the petitioners cited studies that showed cancer in male lab rats exposed to high levels of Red 3. But the same risks from Red 3 aren’t applicable to humans, the public health agency maintained.

“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,” FDA asserted in the constituent update. “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.”

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Nonetheless, FDA announced it was revoking the authorization of Red 3 based on the so-called Delaney Clause of the Federal Food, Drug & Cosmetic Act. That clause, the agency explained, bars FDA authorization of a food additive or color additive if it has been found to cause cancer in animals or humans.

The National Confectioners Association released a statement in response to the FDA news.

“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 trade association said. "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.” 

Sarah Gallo, senior vice president of product policy and federal affairs with the Consumer Brands Association, formerly known as the Grocery Manufacturers Association and which represents the CPG (consumer packaged goods) industry, issued a similar statement.

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“Food safety is the number one priority for the makers of America’s trusted household brands. Revoking the authorized use of Red No 3 is an example of the FDA using its risk and science-based authority to review the safety of products in the marketplace," Gallo said. "Food and beverage companies will continue to follow the latest science and comply with all food safety regulations to ensure safe and available choices for consumers.”

According to FDA estimates, Red 3 is not as predominant in food and drugs compared to other certified colors.

“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.”