The Biden administration announced the revocation of FD&C Red No. 3, a controversial food coloring long known for its cancer links, particularly in animal studies. The decision, which came on January 15, 2025, has been hailed as a significant step toward improving food safety in the United States.
Red Dye No. 3, or erythrosine, has been used in over 3,000 food products, from candies to cakes, and even medications. Despite being banned in cosmetics since 1990 due to evidence of thyroid cancer in male rats, the FDA continued to allow its use in food products. This was largely due to resistance from the food industry, particularly manufacturers of maraschino cherries, who relied on the dye to maintain the vivid red color of their products.
The decision to ban the dye follows a petition filed in 2022 by the Center for Science in the Public Interest (CSPI) and other advocacy groups, citing the “Delaney Clause.” This provision mandates the prohibition of any food coloring shown to cause cancer in animals or humans. The FDA acknowledged that while there is no direct evidence linking Red 3 to cancer in humans, the carcinogenic effects in rats, coupled with other neurobehavioral concerns, raised alarms about the safety of synthetic food dyes.
While the ban focuses primarily on cancer risks, other studies have found potential neurobehavioral effects of synthetic food dyes, such as Attention-Deficit/Hyperactivity Disorder (ADHD) in children. Research in California has shown that synthetic dyes may cause adverse effects on children’s brain function, impacting memory, learning, and activity levels. This is particularly concerning given that many of the products containing Red 3 are aimed at children, who may be more susceptible to these chemicals.
The United States’ delay in taking action on Red 3 stands in stark contrast to other countries. The European Union banned the use of the dye back in 1994, followed by similar moves in Japan, China, the UK, Australia, and New Zealand. This prolonged inaction in the US has been attributed to extensive lobbying by the food industry, with some experts calling it “hard to square” with the FDA’s mission to protect public health.
The ban has been welcomed by health advocates, with CSPI’s Thomas Galligan emphasizing that artificial dyes like Red 3 offer no nutritional value and only serve to make food look more appealing. With the decision now made, manufacturers will have until January 2027 to remove Red 3 from food products and until 2028 for medications.
As the US takes this important step toward improving food safety, experts hope it will be a catalyst for broader action on harmful chemicals in food, especially those that pose risks to children’s health. The move is also seen as an opportunity to reconsider the widespread use of synthetic additives that have raised concerns for decades.
