The Food and Drug Administration (FDA) announced that it will ban Red No. 3 in food, drinks, and pharmaceutical products. Red No. 3 is a synthetic coloring frequently used in candies, desserts, and some drugs.
“The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition,” the FDA said in a constituent update.
In 2022, the FDA received a petition urging the agency to consider whether the Delaney Clause applied to the synthetic coloring. “The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism.”
Under the Delaney Clause, the FDA cannot authorize a food or color additive if it is linked to cancer in humans or animals.
The agency claims, however, that Red No. 3 does not cause cancer in humans.
“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals,” said Jim Jones, the FDA’s deputy director for human foods, as per NBC News. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”
Dr. Peter Lurie, President of the Center for Science in the Public Interest, said in a statement on the ban, “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. 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?”
Food manufacturers will have until January 15, 2027, to remove the dye from products, while drug manufacturers will have until January 18, 2028, to remove the substance. Imported foods must also comply with U.S. requirements.
