Red dye No. 3 is no longer approved for use in foods and oral medications, according to a decision by the U.S. FDA. (Photo credit: Elva Etienne via Getty Images)
On Wednesday (January 15), the U.S. Food and Drug Administration (FDA) announced that red dye No. 3 will no longer be allowed in foods, beverages or oral medications such as cough syrups.
In its statement, the FDA cited the Delaney clause — part of the Federal Food, Drug, and Cosmetic Act — as the reason for its decision. The clause requires the FDA to remove food additives and colors that have been shown to cause cancer in humans or animals.
In this context, the word “or” is key. Red dye #3 has been linked to cancer in male lab rats in several studies, but these carcinogenic effects have not been observed in other animal species or in humans, the FDA noted.
Still, the rat study data led to a ban on the additive in cosmetics and topicals back in 1990, The Washington Post reported at the time. That decision followed a petition that urged the FDA to review those specific uses of the dye. The agency ultimately cited Delaney when it excluded the additive from cosmetics and topicals, and has now applied the same logic to foods and ingested medications.
In one experiment on rats, 70 male rats were fed very high doses of red dye #3, which amounted to 4% of their diet for their entire lives. Fifteen rats developed thyroid tumors, but most were noncancerous. No tumors were seen in male rats given lower doses of the dye, or in female rats given any dose. In fact, when the scientists experimented on mice instead of rats, they did not see tumors in either male or female rats.
Later studies showed that the tumors were caused by certain hormonal changes caused by the accumulation of red dye in male rats. However, this hormonal mechanism is only relevant for rats, the Post reports.
Overall, “the mechanism by which FD&C Red No. 3 causes cancer in male rats is not observed in humans,” the FDA emphasized in its statement. Moreover, “levels of exposure to FD&C Red No. 3 in humans are generally well below those that produce the effects observed in male rats.” Thus, the available evidence suggests that consuming Red No. 3 does not pose a risk to humans.
“However, it doesn't matter because under the Delaney ruling, the FDA mandates that if cancer is found in animals or humans, it must be removed from the food supply,” Jennifer Pomerantz, an associate professor of public health policy and management at New York University's School of Global Public Health, told CNN.
As a result, the FDA banned the dye's use “in accordance with law,” the statement said.
Red dye #3, also known as erythrosine, gives foods a rich cherry-red color. The FDA noted that the dye is found in some candies, cakes, cookies, and frozen desserts, among other foods, but it is not as common as many other food dyes.
According to a database compiled by the Environmental Working Group (EWG), a nonprofit consumer advocacy organization, the dye is found in some brands of fruit smoothies, lollipops, beef jerky and sweet corn flakes.
EWG, which has a sister lobbying organization called the EWG Action Fund, has been a vocal supporter of the ban on Red Dye No. 3. In 2022, it and other groups asked the FDA to review the use of the additive, urging the agency to take Delaney’s point seriously. (EWG has been criticized for exaggerating the dangers of various chemicals in the food supply and the environment.)
Sourse: www.livescience.com
