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Update, Jan. 15, 2025: This story has been revised to incorporate the latest developments regarding FDA policy. (Originally published Feb. 9, 2024.)
On Wednesday, the Food and Drug Administration officially prohibited FD&C Red No. 3, widely recognized as Red Dye 3, from being utilized within the American food supply. This decision followed sustained advocacy from various groups, urging the FDA to eliminate this additive from commonly consumed items such as candies and beverages.
Manufacturers of food and beverage products have until January 15, 2027, to comply with the ban, while pharmaceutical companies have until January 18, 2028.
The FDA’s action was influenced by a petition filed in 2022 by the Center for Science in the Public Interest, in collaboration with over twenty other organizations and experts. This petition referenced the Delaney Clause, a law mandating the ban of any food additive found to cause cancer in humans or animals. (Further details on this legislation can be found below.)
In a released statement, CSPI president Peter G. Lurie, MD, MPH, remarked, “Finally, the FDA is resolving the inconsistency of allowing Red 3 in food while banning it in cosmetics such as lipsticks. As food dyes serve primarily for visual appeal, it raises the question: why accept any risk of cancer?”
The National Confectioners Association also issued a statement, emphasizing their commitment to prioritizing food safety and adherence to FDA regulations.
Historically, the dye faced scrutiny three decades ago when the FDA banned its use in cosmetics due to studies indicating that high exposure levels could induce thyroid cancer in rats. Despite this, Red 3 remained permitted in food and medicines, featuring prominently on many product labels.
Since its introduction in 1907, Red 3 has gained widespread acceptance in the food sector. In October 2022, California became the pioneer state to declare a ban on Red 3 in food items, starting in 2027. Other states, including New York, Illinois, and Washington, have begun to consider legislation to abolish the use of Red 3. This synthetic dye has been under a near-total ban across the European Union since the early 1990s and faces similar prohibitions in Japan, China, the UK, Australia, and New Zealand.
Here’s an overview of Red Dye No. 3.
What is Red Dye 3?
Red Dye No. 3, also referred to as Erythrosine, is categorized as a coal tar dye, meaning it is a synthetic dye derived from petroleum, according to Homer Swei, PhD, who serves as the senior vice president for Healthy Living and Consumer Safety Science at the Environmental Working Group, an organization dedicated to promoting public health and ensuring consumer safety. Since its initial commercialization in the early 20th century, Red Dye 3 has gained widespread favor in the food and pharmaceutical sectors, valued for its vivid red color that enhances the visual appeal of drinks, sweets, and other processed foods.
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