The Blubber

The U.S. Food and Drug Administration (FDA) has officially banned the use of red dye No. 3 in food and ingested drugs, more than three decades after scientists identified links between the dye and cancer in animal studies, the agency announced on Wednesday.

Red dye No. 3, a synthetic color additive derived from petroleum and chemically known as erythrosine, has been widely used to create a bright cherry-red hue in various foods and beverages.

This decision stems from a November 2022 petition submitted by advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, citing cancer risks. It also follows California’s October 2023 prohibition of the additive.

Manufacturers must reformulate food products containing red dye No. 3 by January 15, 2027, and ingested drugs by January 18, 2028, according to the FDA. These rules apply to both domestic production and imported goods.

“Today’s action by FDA is long overdue,” said Dr. Jerold Mande, a nutrition professor at Harvard T.H. Chan School of Public Health, via email. “It’s a small step in the right direction and hopefully signals a renewed effort by FDA to prioritize consumer safety despite challenges from the food industry.”

Ken Cook, president of the Environmental Working Group, hailed the decision as a “monumental victory for consumer health and safety” in a news release, crediting public health advocates for decades of persistent efforts.

Use and Phase-Out of Red Dye No. 3

Red dye No. 3 is present in numerous candy, food, and beverage products. However, many major brands have either avoided or already begun removing the additive. For instance, fewer than 10% of Ferrara’s products, such as Brach’s candies, still contain red dye No. 3, as the company began phasing it out in early 2023. Similarly, Just Born, the maker of PEEPS, stopped using the dye after Easter 2024.

Some companies have switched to red dye No. 40, a common alternative. While not as strongly linked to cancer in animals, red dye No. 40 has raised other concerns, including potential links to behavioral issues in children and accelerated tumor growth in mice. California banned red dye No. 40 in public schools in September due to these concerns.

Regulatory History of Red Dye No. 3

The Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act prohibits approving color additives that cause cancer in animals or humans when ingested. Despite this, red dye No. 3 has remained in use in food for decades. The FDA banned it in cosmetics and topical drugs in 1990 after studies showed it was carcinogenic at high doses in rats. However, the FDA maintained its authorization for food use, citing differences in how the dye’s cancer-causing mechanism operates in humans compared to rats.

The FDA has reassessed red dye No. 3 multiple times since its approval in 1969, relying on animal studies. While no direct link between the dye and cancer in humans has been established, the FDA’s update acknowledged that exposure levels for humans are much lower than those causing effects in lab rats.

Even so, Dr. Jennifer Pomeranz, a public health policy professor at NYU, emphasized that the Delaney Clause mandates removing additives linked to cancer in animals from the food supply. “The FDA’s decision to revoke authorization for red dye No. 3 is a matter of law,” the agency stated.