The US Food and Drug Administration (FDA) announced that it will ban the use of Red Dye No. 3 in food products, invoking The Delaney Clause. Red Dye No. 3 can be found in candy, cakes and cupcakes, gum, cookies, frozen desserts, and frostings and icings. The dye reportedly is known to cause cancer in animals. 

Approved for use in 1907, the dye gives food and drink a "bright, cherry-red color," and has been banned in cosmetics and topical drugs since 1990. Australia, Japan, and certain EU countries already ban or restrict the dye's usage in food. Producers will have until January 15, 2027 to remove it from all products, and drug companies will have until Jan. 18, 2028. This includes foods imported to the US, which must comply with US requirements.

The National Confectioners Association (NCA) says that food safety is the number one priority for US confectionery companies, and it will continue to follow and comply with FDA’s guidance and safety standards. 

"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," says an NCA spokesperson.

"For years, our industry has been calling for more transparency, more funding, and more staff resources for the FDA to continue fulfilling its mission, and it’s time to put politics aside and work together to fund the FDA at levels that will allow it to continue its work," they add.

The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals, says FDA. In 2018, FDA revoked the authorization for certain synthetic flavors based on the clause, in response to a food additive petition.

"The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals," says Jim Jones, the FDA's deputy director for human foods. "Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3."

FDA will be publishing an official statement on January 16 entitled "Petition: Color Additive; Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD and C Red No. 3 in Food and Ingested Drugs." The unpublished PDF version of the statement can be found here.

"The Food and Drug Administration is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations," the statement says.