Feds Finally Ban Controversial Food Dye

Red is often used to make foods and medicines look more vibrant. Trouble is, a widely used red food dye has been linked to serious health risks—but its days now appear to be at an end.

A synthetic food dye commonly added to candy and sweets is being pulled from the market. This week, the Food and Drug Administration officially removed its authorization of Red No. 3 from use in foods and ingested drugs. The dye has been linked to cancer in rats and other potential health issues in children.

The FDA announced its removal of Red No. 3 from the market in an update released on Wednesday. In explaining its decision, the agency cited an existing regulation that prohibits potentially carcinogenic additives from being used in food. Companies that rely on Red No. 3 will be given up to three years to remove it from their products.

Red No. 3 is derived from petroleum and has been around since the early 1900s. As the name suggests, it’s used to give foods a bright, cherry-red color. The dye has historically been most commonly used in cakes, candy, cookies, icing, and some oral medications.

Over the years, however, some scientists and public health advocates have cast doubt on the dye’s safety. Starting in the 1980s, studies found that high levels of Red No. 3 appeared to cause the formation of thyroid tumors in male lab rats. In 1990, the FDA banned Red No. 3 from use in cosmetic products and some foods such as ice cream, citing this research. But the FDA has never endorsed the idea that Red No. 3 is a likely cancer risk in humans, even now.

In its latest announcement, the agency stated that the cancers tied to Red No. 3 found in these earlier studies were the result of a specific hormonal mechanism found only in rats. The rats were also exposed to levels of Red No. 3 that were much higher than the doses people are regularly exposed to through food. The agency went on to blankly add that “the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”

Both in the 1990s and now, the FDA’s rationale for removing Red No. 3 comes from a specific provision added to the Federal Food, Drug, and Cosmetic Act (the set of laws that govern how the FDA regulates the safety of foods and drugs) in 1960, known as the Delaney Clause. The clause explicitly bans the FDA from authorizing food or color additives that have been shown to cause cancer in either animals or people.

In 2022, various consumer health and environmental groups petitioned the FDA to review whether the Delaney Clause should be invoked for Red No. 3 based on earlier rat studies. The FDA has now determined that it should be and that Red No. 3 should be wholly banned as a result.

While Red No. 3 may not cause cancer in people, there are other potential reasons why it shouldn’t be in our food. Some studies have found a link between Red No. 3 and increased hyperactivity in children, especially in children with attention-deficit/hyperactivity disorder (ADHD), for instance—research that prompted officials in California to ban its use within the state in 2023. Many other countries around the world have enacted their own bans or restrictions of Red No. 3.

The FDA’s ban is certainly welcome news to the consumer organizations that have led the charge against Red No. 3.

“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,” said Peter G. Lurie, president of the Center for Science in the Public Interest, a food industry watchdog that participated in the 2022 FDA petition, in a statement. “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?”

It will take some time for Red No. 3 to be permanently pulled from the market. The FDA will give food manufacturers until January 2027 to remove it from their products, and drug manufacturers until January 2028.