The U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced their intentions to phase out all petroleum-based, synthetic dyes from the nation’s food supply, via a voluntary effort with industry cooperation.

There is no legal requirement to remove synthetic food dyes from the nation’s food supply at this time. FDA will rely on working with and not against the industry to remove dyes on a voluntary basis, said FDA Commissioner Marty Makary, MD, MPH, at a press conference yesterday. “There are a number of tools at our disposal … let’s start in a friendly way and see if we can do this without any statutory or regulatory changes, but we are exploring every tool within the toolbox to make sure this gets done very quickly,” he said.

The FDA will establish a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.

It will revoke authorization for two synthetic food colorings, Citrus Red No. 2 and Orange B, within the coming months.

The agency will also work with industry to eliminate six remaining synthetic dyes from the food supply by the end of next year, which include:

• FD&C Green No. 3
• FD&C Red No. 40
• FD&C Yellow No. 5
• FD&C Yellow No. 6
• FD&C Blue No. 1
• FD&C Blue No. 2

In the coming weeks, the agency will authorize four new natural color additives and accelerate the review and approval process for others. It will partner with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.

Finally, the agency will request that food companies remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent,” said HHS Secretary Robert F. Kennedy, Jr. “These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

FDA is fast-tracking reviews of calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract, and other natural alternatives to synthetic food dyes. The agency is also taking steps to issue guidance and provide regulatory flexibilities to industries.

“Today, the FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children, as they already do in Europe and Canada,” said FDA Commissioner Marty Makary, MD, MPH. “We have a new epidemic of childhood diabetes, obesity, depression, and ADHD. Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children.”

While the synthetic, petroleum-based dyes subject to this ban have been subject to FDA safety reviews as a form of premarket approval, limited research has found that, in animals, many of them have carcinogenic effects. Red No. 3, for instance, was declared by the FDA to be an animal carcinogen in 1990, leading to a ban on the additive in cosmetics, though the ingredient remained in use in food products until now.

In 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) reviewed evidence, which included 27 human clinical trials, and found that the seven most widely used synthetic food dyes can cause or exacerbate neurobehavioral problems in some children.

State Government Bans

While FDA is working with industry to phase out a select handful of synthetic dyes from the food supply on a voluntary basis, legislators at the state level on both sides of the political aisle are pursuing direct bans on these dyes and other additives. These state laws, which have variances that would require companies to produce different products for different states, would have considerably higher costs of compliance than a national standard established by the federal government, observers note.

California and West Virginia have each passed respective bans on synthetic food dyes and other food additives, while 23 other states currently have legislation on the docket seeking bans on a similar range of ingredients, per the Environmental Working Group.  

The Consumer Brands Association, a trade association representing the manufacturers of consumer packaged goods, maintained that the synthetic, petroleum-based dyes FDA is working to phase out are safe. It also expressed enthusiasm that FDA is taking a lead on the issue amid legislative efforts at the state level.

“The ingredients used in America’s food supply have been rigorously studied following an objective science and risk-based evaluation process and have been demonstrated to be safe,” the association stated. “Removing these safe ingredients does not change the consumer packaged goods industry’s commitment to providing safe, affordable and convenient product choices to consumers. As we increase the use of alternative ingredients, food and beverage companies will not sacrifice science or the safety of our products. Earlier this year, we urged HHS and FDA to follow the same rigor and we encourage the administration to prioritize research that is objective, peer reviewed and relevant to human health and safety. Consumer Brands has long asked HHS and FDA to reestablish themselves as the country’s leading regulatory authority and we appreciate that the administration has reasserted their leadership in response to the myriad of state activity in the food regulation space. A state patchwork of differing laws creates confusion for consumers, limits access to everyday goods, deters innovation, and increases costs at the grocery store.”

Bryan Hitchcock, chief science and technology officer at Institute of Food Technologists, expressed similar sentiment. While ongoing food dye safety evaluations, usage recommendations, and approvals by global regulatory and standards organizations support the use of petroleum-based synthetic dyes, and there is “a lack of scientific consensus to support such a move,” “additional research is needed to better understand the impact of artificial food dyes on specific subgroups, including various life stages including pregnancy, birth to 24 months, and aging. It is important to have a clear regulatory framework at the national level, and it is clear the FDA is elevating their engagement at a fast pace to, in part, satisfy consumer desire for a healthier food system. Leveraging science to understand complex and nuanced issues must play a prominent role in creating that healthier food framework.”

Hitchcock noted that at IFT’s annual event, IFT First, which takes place in Chicago in July, strategies to reformulate products over the next two years with alternative ingredient solutions will be a central focus.

Will an ‘Understanding Be Enough?

Peter G. Lurie, MD, MPH, president and executive director for Center for Science in the Public Interest expressed in a statement that expecting the food industry to comply with the agency on a voluntary basis is a “fool’s errand.”

“It’s disappointing that Secretary Kennedy and Commissioner Makary would hold a press conference to announce the elimination of food dyes, only for reporters to learn that the only real regulatory moves here are to move to ban two rarely used dyes, Citrus Red 2 and Orange B, ‘within the coming months.’”

Lurie expressed little hope in the “unspecified ‘understanding’ with some unspecified fraction of the food industry to eliminate dyes” FDA announced. “We wish Kennedy and Makary well in getting these unnecessary and harmful dyes out of the food supply and hope they succeed. Perhaps the food industry will seek to avoid a vindictive president’s wrath. But history tells us that relying on voluntary food industry compliance has all-too-often proven to be a fool’s errand.”