In a significant move, the Food and Drug Administration (FDA) has decided to revoke the authorization of Red 3, a common food coloring agent, due to its potential carcinogenic effects observed in laboratory animals. The decision comes after months of deliberation and is rooted in legal requirements that mandate the removal of additives shown to cause cancer in animals. While the FDA had previously maintained that evidence did not conclusively apply to humans, the agency was compelled to act under the Delaney Clause. This legislation strictly prohibits any additive linked to cancer in either humans or animals. The ban will be phased out gradually, with food manufacturers having until January 2027 to cease using the dye.
In the crisp, golden hues of autumn, the FDA made an announcement that will reshape the food industry. On Wednesday, officials declared the revocation of Red 3’s authorization as a food additive, citing concerns about its link to cancer in laboratory animals. For months, the FDA has signaled this decision, driven by the Delaney Clause, which explicitly states that the agency cannot approve any food or color additive found to cause cancer in humans or animals. The law left the FDA with no choice but to take action.
The petition for this ban was initiated by the Center for Science in the Public Interest and several other organizations in 2022. California’s subsequent ban on the dye in 2023 further fueled the movement. Dr. Peter Lurie, president of the Center for Science in the Public Interest, questioned the necessity of such dyes, emphasizing that their primary role is purely aesthetic, raising doubts about the justification for accepting any associated health risks.
Beyond cancer concerns, there are growing worries about artificial food dyes potentially causing hyperactivity in children. A review by California’s Environmental Protection Agency in 2021 concluded that synthetic food dyes could impact neurobehavior in some children. Critics have also pointed out that the FDA’s regulatory approach to food additives may allow concerning ingredients to enter the market through loopholes.
Red 3, known by various names like erythrosine or E 127 internationally, has been used in numerous products ranging from candies like Jelly Belly’s Candy Corn and Tootsie’s Dubble Bubble ball gum to drinks such as Ensure’s creamy peach nutrition shake. Despite its widespread use, the dye will now be phased out over the next few years, marking a significant shift in the food industry.
From a journalist's perspective, this decision highlights the ongoing tension between aesthetics and safety in the food industry. It underscores the importance of rigorous testing and regulation to protect public health. As we move forward, it will be crucial to balance innovation with safety, ensuring that the foods we consume are both appealing and harmless.