FDA to Phase Out Synthetic Food Dyes Over Health Concerns

The US Food and Drug Administration (FDA) plans to begin phasing out petroleum-based synthetic food dyes from the US food supply, citing health concerns linked to conditions such as attention-deficit/hyperactivity disorder (ADHD), obesity, and diabetes. The initiative was announced by FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy. 

The agency will start the process by revoking authorization for two synthetic dyes in the coming months and will work with the food industry to voluntarily remove six others by the end of next year. At the same time, the FDA plans to authorize four new natural color additives in the coming weeks and expedite the review of others.

“For the last 50 years, American children have increasingly been living in a toxic soup of synthetic chemicals,” Makary said during a press conference. “Taking petroleum-based food dyes out of the food supply is not a silver bullet that will instantly make America’s children healthy, but it is one important step.”

Although Kennedy and Makary asserted that there is a growing body of evidence connecting synthetic dyes to chronic childhood illnesses, many scientists say more research is needed. “The information available is so minuscule in the scheme of science that it is really difficult to make those generalizations,” says Emily Acri, Clinical Transplant Dietitian, Yale New Haven Hospital.

The FDA’s move reflects a broader shift toward ingredient transparency and reformulation. Makary says that transitioning from synthetic to natural dyes would not increase food prices and suggested alternatives such as watermelon juice, beet juice, and carrot juice.

The FDA also intends to partner with the National Institutes of Health to conduct further research on how food additives impact child health and development. “We have been conducting one of the world’s largest uncontrolled science experiments on our children without their consent,” says Makary.

The effort is part of Kennedy’s broader “Make America Healthy Again” initiative. He said the Department of Health and Human Services (HHS) had reached a mutual understanding with the food industry to eliminate artificial dyes, and he expects compliance to occur without the need for new regulations. Still, both he and Makary indicated that the agency is considering all available enforcement tools to ensure the transition.

The Consumer Brands Association (CBA), which represents major food producers such as PepsiCo and Kraft Heinz, submitted a proposal to HHS in March outlining steps to eliminate synthetic dyes from products. The document, obtained by Reuters, commits companies to prioritize dye-free formulations for new products and to begin removing dyes from existing items.

According to the proposal, dye-free versions of food products will be made available to schools by the end of the year. WK Kellogg says that it is already reformulating cereals served in schools and plans to stop launching new products with artificial dyes starting next year.

Scientific literature has highlighted several dyes of concern. Research on animals has shown potential links between dyes such as Red No. 3, Red No. 40, Blue No. 2, and Green No. 3 and increased cancer risk. Other studies suggest that dyes like Yellow No. 5 and No. 6 may be contaminated with carcinogens or cause toxic effects in human cells. In sensitive children, even low levels of Yellow No. 5 have been linked to irritability, restlessness, and sleep disturbances.