HHS announces intent to phase out synthetic food dyes

Key takeaways:

• HHS plans to phase out nine artificial food dyes by next year.
• However, some measures may have “minimal impact,” an expert told Healio.
• Evidence on the health effects of the dyes is mixed.

The HHS secretary and FDA commissioner announced several measures to phase out petroleum-based synthetic dyes from the U.S. food supply by the end of next year while transitioning to new natural additives.

According to a press release, this plan will include:

• establishing a “national standard” and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives;
• initiating the process of revoking the authorization of two dyes — orange b and red citrus no. 2 — in the coming months;
• working with the food industry to eliminate the six remaining dyes — green no. 3, red no. 40, yellow no. 5, yellow no. 6, blue no. 1 and blue no. 2 — within the next year;
• authorizing four new natural color additives in the coming weeks while speeding up the review and approval of others;
• partnering with NIH to research how food additives impact children’s health and development; and
• requesting food companies remove red no. 3 earlier than the 2027 to 2028 deadlines previously requested.

“Four years from now, we’re going to have most of these products off the market or you will know about them when you go into a grocery store,” HHS Secretary Robert F. Kennedy Jr. said during a press conference.

FDA Commissioner Martin A. Makary, MD, MPH, said that removing these dyes from the food supply “is not a silver bullet that will instantly make America’s children healthy, but it is one important step.”

“For companies that are currently using petroleum-based red dye, try watermelon juice,” he added. “For companies that are combining petroleum-based yellow and red dyes together, try carrot juice.”

The FDA banned red no. 3 in January. The decision was made in response to a 2022 petition from the Center for Science in the Public Interest (CSPI) and 23 other organizations that asked the FDA to reevaluate the dye’s authorization after research indicated carcinogenic properties among rats exposed to high levels of it.

For now, manufacturers that use red no. 3 in food products have until Jan. 15, 2027, to update product formulations, and manufacturers that use the dye in ingested drugs have until Jan. 18, 2028, to comply with the ban.

Thomas Galligan, PhD, principal scientist for food additives and supplements at CSPI, told Healio that HHS’ plan for the other dyes is unclear.

“They didn’t announce any new regulations with the exception of orange b and citrus red no. 2, which they intend to phase out … which I assume would be through regulations,” Galligan said.

Galligan added that orange b and citrus red no. 2 “are very uncommon.”

“They’ve all but been abandoned by the food industry. It’s a very minimal impact,” he said. “As for the food dyes that are commonly used, it sounds like they’re just asking food companies to stop using them even though the FDA has the authority to ban them outright. It doesn’t sound like the agency is going to do that. I don’t see any real action yet.”

Kennedy said there is no formal agreement between the FDA and food companies to phase out the dyes, but they have “an understanding.” According to reporting by The New York Times, no food companies have publicly said they would agree to the demands.

Makary said that the FDA hopes to phase out food dyes “without any statutory or regulatory changes.”

However, “we are exploring every tool in the toolbox to make sure this gets done very quickly,” he said.

Evidence on food dyes

Makary said during the press conference that a number of studies have tied petroleum-based synthetic dyes to adverse health outcomes, including neurobehavioral issues like hyperactivity, inattentiveness and aggressive behavior, as well as ADHD, obesity, cancer, genomic disruption, diabetes, insulin resistance, gastrointestinal issues and allergic reactions.

“We know very clearly that some children have adverse behavioral reactions,” Galligan said. “There are 27 human clinical trials where kids who have been directly dosed with these dyes exhibit behavioral problems.”

Fatima Cody Stanford, MD, MPH, MPA, MBA, MACP, FAAP, FAHA, FAMWA, FTOS, an associate professor of medicine and pediatrics at Harvard Medical School and Healio Primary Care Peer Perspective Board member, said “some studies, including those reviewed by the European Food Safety Authority, suggest a possible link between certain dyes and behavioral effects in children,” but the literature is mixed.

“While some studies suggest potential adverse effects, others do not find significant risks at the levels typically consumed,” she told Healio.

As for the other health outcomes, Galligan said he is “not familiar with evidence that suggests food dyes cause any sort of metabolic health effects [like] obesity or diabetes.”

A ‘broken’ system

Galligan said the fact that petroleum-based synthetic dyes — which he said are purely used as a marketing tool to make food look more appealing — were not phased out sooner “points to a broader issue, which is that the FDA’s food chemical regulatory system is broken.”

“The FDA historically has not done a good job over the last decades at reassessing the safety of the chemicals that are already in our food,” he said. “These food dyes were authorized by the FDA decades ago, and this new evidence has emerged over time since those approvals went into effect. The FDA has seemingly never reassessed it fully.”

Stanford noted that the dyes have passed stringent FDA safety evaluations, and current evidence on their effects “is not definitive enough to mandate an immediate phase-out.”

“Synthetic dyes are cost-effective and provide consistent results, which are important for food manufacturers. Phasing them out could increase production costs and affect product availability,” she said. “The food industry has traditionally relied on these dyes for their stability and vivid colors, making transitioning to natural alternatives potentially challenging and expensive.”

However, according to Stanford, “a gradual transition toward natural alternatives could be beneficial given consumer preferences and emerging research.”

“This would allow time for industry adaptation and further research to clarify health impacts,” she said.

For more information:

Thomas Galligan, PhD, can be reached at cspinews@cspinet.org.

Fatima Cody Stanford, MD, MPH, MPA, MBA, MACP, FAAP, FAHA, FAMWA, FTOS, can be reached at primarycare@healio.com.

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