FDA bans red dye popular in candy, other ultraprocessed foods

Key takeaways:

• The ban is in response to a petition asking the agency to reevaluate the dye’s authorization due to an association with cancer in rats.
• This is the latest step in a recent flurry of FDA action in nutrition.

The FDA announced a ban on the controversial red dye no. 3, which gives food and drinks a bright, cherry red color and has also been associated with cancer in laboratory rats.

In a constituent update, the agency said it is revoking the dye’s authorization based on the Delaney Clause of the Federal Food, Drug and Cosmetic Act, which states the FDA cannot authorize a color or food additive that has been found to cause cancer in animals or humans. In 2018, the FDA similarly banned seven flavoring substances based on this clause.

The ban is a response to a 2022 petition from the Center for Science in the Public Interest (CSPI) and 23 other organizations. According to a statement from CSPI, the FDA banned red no. 3 from use in cosmetic products and topical drugs like lipstick and pain-relief ointments in 1990.

“The FDA decided (and promised) to take separate regulatory action to ban [red no. 3] from the food supply and other oral products,” the statement said. “More than three decades elapsed, and the FDA never took those critical next steps, failing to keep its promise and, more importantly, failing to protect consumers from this clearly unsafe additive.”

The petition cited evidence including two studies that indicated carcinogenic properties among male rats exposed to high levels of the dye.

According to the FDA’s release, this is “due to a rat specific hormonal mechanism,” and the way the dye caused cancer in the rats “does not occur in humans.” Plus, humans’ relevant exposure levels are usually much lower than what the rats received.

“Studies in other animals and in humans did not show these effects,” the FDA release added. “Claims that the use of [red no. 3] in food and in ingested drugs puts people at risk are not supported by the available scientific information.”

The FDA said that other certified colors are used more commonly than red no. 3, with its use being limited to frosting, candy, icing, cakes, frozen desserts, cookies, cupcakes and some ingested drugs. All manufacturers who use the dye in food products will have until Jan. 15, 2027, to update product formulations, whereas manufacturers using the dye in ingested drugs have a compliance date of Jan. 18, 2028.

The government’s actions — or inaction — to improve nutrition in the U.S. has been a hot topic recently. Robert F. Kennedy Jr., current nominee for Secretary of Health and Human Services for the incoming Trump administration who pledged to “make America healthy again,” has previously been critical of the FDA.

Early last month, head figures at the FDA were questioned about the agency’s role in the country’s obesity epidemic. But since then, it has taken some action.

For example, in late December, the FDA updated its definition of “healthy,” requiring food labels to abide by new rules to earn the designation. More recently, the agency proposed a rule requiring a new, simplified nutrition label on the front of most packaged foods that would offer consumers easily visible information about the presence of added sugar, sodium and saturated fat.

“Food should be a vehicle for wellness, not a contributor of chronic disease,” Jim Jones, FDA’s deputy commissioner for human foods, said in a Jan. 14 press release.

References:

• FDA removes 7 synthetic flavoring substances from food additives list. Available at: https://www.fda.gov/food/hfp-constituent-updates/fda-removes-7-synthetic-flavoring-substances-food-additives-list. Published Oct. 5, 2018. Accessed Jan. 15, 2025.
• Red 3: FDA finally bans cancer-causing food dye. Available at: https://www.cspinet.org/cspi-news/red-3-fda-finally-bans-cancer-causing-food-dye. Published Jan. 15, 2025. Accessed Jan. 15, 2025.