FDA Moves To Ban Red Dye 3
The Food and Drug Administration (FDA) announced it has banned the use of Red Dye 3 (Red No. 3) in food and beverage due to its potential to cause cancer.
The FDA has revoked the authorization to use the synthetic dye using a 1958 provision, the Delaney Clause, prohibiting the use of any carcinogenic food additives from the Food, Drug and Cosmetic Act.
Food makers using the synthetic dye have two years to reformulate their products, according to the FDA, and imported food will also need to comply with the directive by that time. Common foods that use the synthetic coloring are candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings.
The FDA did concede that Red No. 3 is “not as widely used in food and drugs when compared to other certified colors,” but the food coloring has been shown in studies to cause cancer in male rats.
The dye has already been banned almost completely in Europe, Australia and New Zealand.
The news was initially teased in a Biden White House Fact Sheet yesterday, explaining the administration’s food system investments. Similar rumors had surfaced in December during a U.S. Senate health committee meeting. At the time, FDA deputy commissioner for human foods Jim Jones said that a petition calling for a Red Dye 3 ban was being reviewed by the authorization board.
Various industry groups have applauded the decision, with the Environmental Working Group (EWG) calling it a “monumental victory.”
“For years, Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids,” said EWG president and co-founder Ken Cook in a statement. “This ban sends a strong message that protecting the health of Americans – especially vulnerable children – must always take priority over the narrow interests of the food industry.”
Food safety advocate and co-founder of Yuka Julie Chapon said the rule was “about time.”
“The FDA’s decision is a step forward, but we must continue to push for stronger regulations – dozens of risky additives are still allowed in the U.S.,” she said.
The National Confectioners Association (NCA) had a more tempered response to the decision, saying that “the conversation around state-level proposals that seek to ban certain FDA-approved food additives has been filled with myths pushed by unqualified voices and lacking facts.”
The trade group’s public statement went on to note that Indiana, Maryland, South Dakota, Washington and West Virginia had all rejected laws that would ban certain food additives because the “proposals lack scientific basis.”
“We are in firm agreement that science-based evaluation of food additives is needed – and we follow and will continue to follow regulatory guidance from the authorities in this space, because consumer safety is our chief responsibility and priority,” said NCA president and CEO John Downs. “Usurping FDA’s authority does nothing but create a state-by-state patchwork of inconsistent state requirements that increase food costs, create confusion around food safety, and erode consumer confidence in our food supply.”
California was one of the first states to implement legal barriers to certain food additives. The California Food Safety Act was passed in October 2023, which effectively banned common food additives like Red Dye 3, among others. The state followed that up in September 2024 by banning Blue 1, Blue 2, Green 3, Red 40, Yellow 5 and Yellow 6 from school meal products.
At the beginning of the month, California Governor Gavin Newsom announced an executive order that would investigate the adverse health impacts of synthetic food colorings along with ultra-processed foods.
