(WASHINGTON) -- The U.S. Food and Drug Administration is moving to ban the use of Red No. 3 dye in food products.
The agency said Wednesday it is amending its color additive regulations to no longer allow the use of Red No. 3 in food, beverages and ingested drugs, in response to a 2022 petition from health groups and activists.
FD&C Red No. 3, also known as Red 3, is a synthetic food dye that gives foods and drinks a bright, cherry-red color. It is primarily used in foods such as candy, cakes and cupcakes, cookies, frozen desserts, frosting and icings, and some ingested drugs.
At least two studies have shown that high levels of the food dye were linked to cancer in rats. However, the link between the dye and cancer does not occur in humans, the FDA says.
While studies in other animals and humans did not show this link of cancer, an FDA regulation prohibits the agency to authorize color additive found to induce cancer in humans or animals, pushing the agency to revoke the food dye's authorization.
Food manufacturers will have until 2027 to reformulate their products while drugmakers will have until 2028.
FDA Commissioner Robert Califf was asked at a Senate hearing in December why the dye had not been banned. He said the FDA hasn't been given the resources to do the kind of post-market monitoring of substances done in Europe, where it has been largely banned since 1994. The FDA also banned the use of Red 3 in cosmetics in 1990.
"We have repeatedly asked for better funding for chemical safety ... Please look at our request for funding for the people who do this work, remember that when we do ban something, it will go to court, and if we don't have the scientific evidence … we will lose in court," Califf said at the hearing.
Red 40, another synthetic food dye used to achieve a bright crimson color in condiments and candy, will remain available for use. Some studies have also shown Red 40 is a carcinogen in animals.
Red No. 3 was first approved by the FDA in 1969 and had been reviewed "multiple times" since then, according to the agency.
ABC News' Kelly McCarthy contributed to this report.