Red is often used to make foods and medicines look more vibrant. The problem is, a widely used red food dye has been linked to serious health risks—but its days now seem to be over.

A synthetic food dye commonly added to candy and sweets has been pulled from the market. This week, the Food and Drug Administration officially revoked its approval of Red No. The dye has been linked to cancer in rats and other potential health issues in children.

The FDA Office has partnered its removal from 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 get it for their products.

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

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

In its latest announcement, the agency said that cancers tied to Red No. 3 found in these earlier studies is the result of a specific hormonal mechanism found only in rats. Rats were also exposed to levels of Red No. 3 times higher than the doses that humans are regularly exposed to through food. The agency continued blankly adding that “the way FD&C Red No. 3 caused cancer in male rats did not occur in humans.”

Both of the around the 1990s and now, the FDA’s reason for removing Red No. 3 from a specific provision added to the Federal Food, Drug, and Cosmetic Act (the set of laws that governs how the FDA regulates the safety of foods and drugs) in 1960, known as the Delaney Clause. The clause clearly prohibits the FDA from approving food additives or colors that have been shown to cause cancer in animals or humans.

In 2022, various consumer health and environmental groups asked the FDA to review whether the Delaney Clause should be used for Red No. 3 based on previous rat studies. The FDA has now decided that it should and that Red No. 3 should be completely banned as a result.

While Red No. 3 may not cause cancer in humans, there are other potential reasons why it should not be in our diet. Other studies have found a link between Red No. 3 and increasing hyperactivity in children, especially in children with attention-deficit/hyperactivity disorder (ADHD), for example—RESEARCH REVEALS prompting California officials to ban its use within the state by 2023. Many other countries around the world have implemented their own restrictions or restrictions on Red No. 3.

The FDA ban is good news to consumer organizations that have led the charge against Red No. 3.

“Finally, the FDA has ended the regulatory paradox of Red 3 being illegal for lipstick use, but perfectly legal to feed to children in candy form,” said Peter G. Lurie, president of the Center for Science at the The Public Interest, a food industry watchdog that participated in the 2022 petition to the FDA, in a statement. “The main purpose of food dyes is to make candy, drinks, and other processed foods more attractive. If function is purely aesthetic, why accept any risk of cancer?

It took some time for Red No. 3 to be permanently withdrawn from the market. The FDA has given food manufacturers until January 2027 to remove it from their products, and drug manufacturers until January 2028.