FDA Bans Red Dye No. 3 in Food, Drinks, and Medicine
Have you ever wondered what makes that bright red color in certain foods, candy, and beverages? While it may look appealing, that red color can actually be a sign of artificial coloring - Red Dye No. 3.
What is Red Dye No. 3?
Red dye No. 3, also known as erythrosine or FD&C Red No. 3, is a synthetic food coloring agent derived from petroleum. It creates a bright cherry-red or watermelon-red hue to certain food, candy beverages, and medications.
This organoiodine compound, which is the disodium salt of 2,4,5,7-tetraiodofluorescein, was first approved for use in 1907.
Commonly found in items such as candies, ice cream, cake decorating gels, and some medications, erythrosine has been a subject of controversy due to studies linking it to potential health risks, including cancer in laboratory animals.
Red Dye No. 3 Banned
The U.S. Food and Drug Administration (FDA) announced on Wednesday a ban on the use of red dye No. 3 in food, drinks, and medications. This decision comes more than three decades after studies linked the synthetic coloring agent to cancer in animals.
The FDA's decision follows a petition filed in November 2022 by advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group.
Under the new regulations, manufacturers using red dye No. 3 in food products must reformulate by January 15, 2027, while those producing ingestible drugs have until January 18, 2028, to comply. The ban also applies to imported foods.
Positive Step Forward
Dr. Jerold Mande, an adjunct professor at Harvard University's T.H. Chan School of Public Health, called the FDA's decision "long overdue" and a small but positive step forward. He suggested it reflects a renewed commitment by the FDA to fulfill its responsibilities, despite challenges from the food industry.
The FDA's ban aligns with California's recent prohibition of the dye, issued in October 2023. The agency cited the Delaney Clause, which mandates the removal of any additive that poses cancer risks in animals or humans, as the legal basis for its decision.
While the dye has been banned in cosmetics and topical medications since 1990 due to its carcinogenic effects in rats, it remained approved for food use until now.
The FDA explained that the existing research indicated the carcinogenic mechanism observed in rats did not translate to humans, which had previously prevented them from revoking the dye's authorization in food.
As the food industry prepares to adapt to these new regulations, consumers can expect to see changes in the appearance of some familiar products in the coming years.