by Keka Araújo
January 16, 2025
The additive is banned in most countries outside of the United States.
On Jan. 15, the U.S. Food and Drug Administration (FDA) announced the revocation of FD&C Red No. 3 for use in food and ingested drugs. The decision, rooted in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), highlights the FDA’s commitment to ensuring public health and safety through regulatory oversight of color additives.
The synthetic dye, also known internationally as erythrosine, is widely used for its vibrant cherry-red hue in candies, baked goods, frozen desserts, and certain medications. To comply with the updated regulations, manufacturers must reformulate their products for food items by January 15, 2027, and for drugs by January 18, 2028.
The Delaney Clause: Protecting Public Health
Enacted in 1960, the Delaney Clause is a cornerstone of the FD&C Act’s color additive amendment. It prohibits the FDA from approving any food or color additive that induces cancer in humans or animals, regardless of dose.
In 2022, a coalition of consumer advocacy groups — including the Center for Science in the Public Interest, Environmental Defense Fund, and Consumer Reports — petitioned the FDA to revoke the approval of FD&C Red No. 3. They cited two studies showing cancer in male rats exposed to high doses of the dye.
Although the mechanism causing cancer in rats does not apply to humans, the Delaney Clause mandates a strict zero-tolerance approach. FDA Commissioner Robert M. Califf, M.D., emphasized the agency’s adherence to this legal framework, stating, “Today’s action reflects our commitment to following the science and prioritizing public health.”
The Science Behind FD&C Red No. 3
FD&C Red No. 3 has been scrutinized since its initial approval in 1969. While the rat studies cited in the petition highlighted risks at high exposure levels, research involving humans and other animals has not demonstrated similar effects.
“This decision is not about immediate human risk,” said Susan T. Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “It’s about ensuring compliance with the law and maintaining public confidence in the safety of the food supply.”
Chemicals are essential in food production, enhancing safety, nutritional value, and shelf life. Substances like salt (sodium chloride) and Vitamin C (ascorbic acid) are prime examples of chemicals with dual scientific and common names. While chemicals like FD&C Red No. 3 serve functional purposes, their safety must be rigorously evaluated.
Petition Details and Advocacy Efforts
A coalition of 23 organizations and individuals, including the Children’s Advocacy Institute, Public Citizen, and Breast Cancer Prevention Partners, submitted the 2022 petition to revoke FD&C Red No. 3. The petition underscored Red No. 3’s potential carcinogenicity. It invoked the Delaney Clause to challenge its continued use in food and drugs.
The petition also highlighted the FDA’s inconsistent approach to the dye. In 1990, the FDA banned its use in cosmetics and topical drugs due to carcinogenic findings, yet it allowed its use in food and ingested drugs to persist.
“The FDA’s decision is a victory for science-backed advocacy,” said a Center for Science in the Public Interest representative. “It demonstrates that regulatory systems can work to prioritize public health.”
Industry Implications
The revocation of FD&C Red No. 3 presents significant challenges for manufacturers, particularly those in the food and pharmaceutical sectors. The dye has been a staple in creating visually appealing products, such as brightly colored candies, cakes, and frostings. Its absence will require companies to find alternatives that meet FDA safety and certification standards.
Red No. 3 remains authorized internationally under erythrosine in countries like Canada and parts of Europe. However, products imported to the U.S. must comply with domestic regulations.
“This decision underscores the need for manufacturers to stay proactive in monitoring regulatory changes,” Califf said.
FDA’s Commitment to Chemical Oversight
The FDA’s decision reflects its broader regulatory framework for managing chemicals in food. Pre-market approval processes require manufacturers to demonstrate that additives are safe for their intended use. Post-market reviews, however, are equally critical in reassessing safety as new data emerges.
Pre-Market Approval Process
Before a substance like FD&C Red No. 3 can be used, the FDA extensively evaluates its safety. These include studying consumption patterns, manufacturing processes, and toxicological data. Only additives meeting strict standards for composition and purity are authorized.
Post-Market Review Framework
The FDA is also modernizing its post-market review framework to address emerging safety concerns. “We are working to develop systems that prioritize chemicals for reassessment based on risk,” said Mayne.
Recent examples include the FDA reassessing per- and poly-fluoroalkyl substances (PFAS) in food packaging and brominated vegetable oil. The agency’s ongoing surveillance helps ensure that the U.S. food supply remains among the safest in the world.
Public and Industry Reaction
Consumer groups have lauded the FDA’s decision, calling it a long-overdue step toward safer food practices. Advocates have urged the agency to apply similar scrutiny to other additives.
Meanwhile, industry leaders have expressed concerns about the logistical challenges of reformulating products. Smaller manufacturers, in particular, may have difficulty sourcing alternatives within the given timeline.
Transparency and Future Plans
The FDA aims to enhance transparency around its regulatory processes. The agency seeks to foster collaboration between consumer advocates, industry leaders, and lawmakers through public meetings, webinars, and stakeholder engagements.
“We’re committed to maintaining public trust,” said Mayne. “That includes sharing information openly and engaging all stakeholders in the regulatory process.”
The FDA has outlined plans for a unified Human Foods Program to strengthen its oversight of food chemical safety. The initiative will include routine surveillance to detect potential safety concerns and prioritize substances for in-depth review based on risk.
Looking Ahead
Manufacturers have three years to reformulate food products and four years to reformulate drugs ingested. With alternative dyes like FD&C Red No. 40 widely available, many expect the industry to adapt swiftly, though the transition may present temporary challenges.
For consumers, the revocation of FD&C Red No. 3 serves as a reminder of the complexities of food safety regulation. While the scientific findings behind the decision are specific to rats, the FDA’s adherence to the Delaney Clause reinforces its commitment to protecting public health.
To stay informed about the FDA’s regulatory updates and developments, visit FDA.gov.
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