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FDA outlines six measures to phase out synthetic dyes

Colorful donuts and FDA logo
GRAPHIC COLLAGE BY AVANT FOOD MEDIA
BY: Annie Hollon

Annie Hollon

SILVER SPRING, MD — After announcing that food manufacturers have until January 2027 to reformulate products that include Red No. 3, the FDA decreed additional changes for manufacturers related to food dyes.

In partnership with the Department of Health and Human Services (HHS), the FDA announced several measures to phase out all petroleum-based synthetic dyes, starting with a national standard and timeline for manufacturers to pivot.

“Thirty states concerned about this very issue have introduced bills or laws with a patchwork of standards for food companies,” said Marty Makary, FDA commissioner, during an April 22 press conference. “So, the food industry, which has many good people, has asked for clarity.”

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FDA’s new measures

Among these measures is a push for food producers to remove Red No. 3 sooner than the 2027-28 deadline announced earlier this year.

In the weeks ahead, the agency is authorizing four new natural color additives: calcium phosphate, Galdieria extract blue, gardenia blue and butterfly pea flower extract. The FDA is also set to accelerate the review and approval process for other alternative ingredients.

Additionally, the agency is initiating the process to revoke the authorization of synthetic food colorings Citrus Red No. 2 and Orange B in the coming months and remove six synthetic dyes — 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 and FD&C Blue No. 2 — from the food supply by the end of next year.

Through a partnership with the National Institute of Health’s Nutrition Regulatory Science and Research Program, the FDA will conduct research on the impact of food additives on the health and development of children. This move supports the Trump administration’s Make America Healthy Again initiative.

“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,” Makary said.

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Insights from industry associations

Leaders from food industry associations such as the Consumer Brands Association (CBA) and Institute of Food Technologists (IFT) released statements following the FDA announcement.

“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,” said Melissa Hockstad, president and CEO of CBA. “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.”

Hockstad noted that the association urged the HHS and FDA earlier this year to prioritize objective, relevant research as well as regulate at the national level to avoid laws that vary from state to state.

“CBA 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 myriads of state activity in the food regulation space,” she said. “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 IFT, said that additional research is needed to understand the impact of artificial food dyes in certain subgroups.

“It is important to have a clear regulatory framework at the national level, and it is clear the FDA is elevating its engagement at a fast pace to, in part, satisfy consumer desire for a healthier food system,” Hitchcock said. “Leveraging science to understand complex and nuanced issues must play a prominent role in creating that healthier food framework.”

Earlier this year, the government agency extended the deadline for manufacturers to comply with the Food Traceability Rule by 30 months.

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