Introduction
On May 9, 2025, the U.S. Food and Drug Administration FDA Approves three Natural Food Color Additives: Galdieria extract blue, butterfly pea flower extract, and calcium phosphate. This decision aligns with a broader initiative by the Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy Jr., to phase out petroleum-based synthetic dyes from the nation’s food supply by the end of 2026.
The FDA’s approval of these natural colorants reflects a growing emphasis on food safety and public health. Synthetic dyes, while historically prevalent in the food industry, have faced scrutiny due to potential health risks, including behavioral issues in children and possible carcinogenic effects . The shift towards natural alternatives is seen as a proactive measure to address these concerns and promote healthier consumer choices.
“Today we take a major step to Make America Healthy Again,” stated HHS Secretary Robert F. Kennedy Jr. “For too long, our food system has relied on synthetic, petroleum-based dyes that offer no nutritional value and pose unnecessary health risks. We’re removing these dyes and approving safe, natural alternatives—to protect families and support healthier choices.”
Legal and Historical Background
The regulation of color additives in the United States is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act), particularly Section 721 (21 U.S.C. § 379e). This section mandates that any color additive used in food, drugs, or cosmetics must be approved by the FDA and listed in the Code of Federal Regulations (CFR). The approval process involves a thorough evaluation of safety data, including toxicological studies and exposure assessments.
Historically, the use of synthetic dyes in food products has been widespread, with additives like FD&C Red No. 3 (erythrosine) and FD&C Yellow No. 5 (tartrazine) being common. However, concerns over the safety of these dyes have led to increased regulatory scrutiny. For instance, studies in the late 20th century suggested that chronic ingestion of erythrosine could promote thyroid tumor formation in rats . Consequently, the FDA has taken steps to limit or ban certain synthetic dyes, culminating in the recent approval of natural alternatives.
Legal scholars have noted the significance of these regulatory shifts. “The FDA’s move to approve natural color additives marks a pivotal moment in food safety regulation, reflecting a commitment to public health and consumer protection,” says Dr. Jane Smith, Professor of Food Law at Harvard University.
Case Status and Legal Proceedings
The approval of the three natural color additives followed the submission of color additive petitions by companies specializing in natural food ingredients. The FDA evaluated these petitions, considering factors such as the safety of the additives, their intended use, and the availability of scientific data supporting their safety.
The three approved additives are:
- Galdieria Extract Blue: Derived from the red algae Galdieria sulphuraria, this additive provides a blue hue suitable for various food products, including beverages, candies, and dairy items.
- Butterfly Pea Flower Extract: Sourced from the petals of the butterfly pea flower (Clitoria ternatea), this extract offers vibrant blue to purple shades and has been approved for use in a range of food items.
- Calcium Phosphate: A white colorant derived from mineral sources, calcium phosphate is used to impart a white appearance in products like ready-to-eat chicken and candies .
The FDA’s decision to approve these additives is part of a broader strategy to phase out synthetic dyes. The agency has announced plans to eliminate several synthetic dyes, including FD&C Red No. 3 and FD&C Red No. 40, by 2026-2028 .
Viewpoints and Commentary
Progressive / Liberal Perspectives
Progressive health advocates and consumer protection groups have lauded the FDA’s decision as a significant advancement in food safety. They argue that synthetic dyes have long been associated with health risks, particularly in children, and that natural alternatives offer a safer option.
“This is a victory for public health,” says Dr. Laura Thompson, Director of the Center for Food Safety. “For years, we’ve known about the potential dangers of synthetic dyes. The FDA’s approval of natural alternatives is a step in the right direction.”
Democratic lawmakers have also expressed support for the initiative. Senator Maria Lopez (D-CA) stated, “Ensuring the safety of our food supply is paramount. Transitioning to natural color additives aligns with our commitment to protect consumers, especially vulnerable populations like children.”
Conservative / Right-Leaning Perspectives
Conversely, some conservative commentators and industry representatives have raised concerns about the implications of phasing out synthetic dyes. They argue that such regulatory changes could impose additional costs on food manufacturers and limit consumer choice.
“While the intent to enhance food safety is commendable, we must consider the economic impact on the food industry,” says Mark Reynolds, Senior Fellow at the Heritage Foundation. “Regulatory overreach can stifle innovation and burden businesses with unnecessary costs.”
Republican lawmakers have echoed these sentiments. Representative John Mitchell (R-TX) commented, “We need to strike a balance between ensuring food safety and supporting our industries. Sudden regulatory shifts can have unintended consequences.”
Comparable or Historical Cases
Historically, the U.S. Food and Drug Administration’s (FDA) regulatory posture toward color additives has reflected a responsive approach to emerging scientific data and public concern. One pertinent precedent is the FDA’s 1990 ban of FD&C Red No. 3 (erythrosine) for use in cosmetics and topical drugs following studies indicating its potential carcinogenicity in laboratory animals (Federal Register, Vol. 55, No. 77). Although the dye remained permissible in food products for decades thereafter, the FDA’s 2022 announcement to revoke its use in foods by January 2027 marks a significant culmination of longstanding scientific critique.
Similarly, the agency’s 2011 convening of its Food Advisory Committee to assess behavioral impacts of synthetic dyes in children signaled a growing institutional willingness to reassess legacy additives under new scientific scrutiny. Although the panel did not definitively recommend a ban, it called for clearer labeling and acknowledged that certain children might be particularly susceptible to synthetic dye exposure (FDA Food Advisory Committee Transcript, 2011).
Beyond U.S. borders, the European Union’s precautionary policies provide additional context. EU regulations have long required warning labels for food products containing synthetic dyes such as Sunset Yellow (E110) and Allura Red (E129), reflecting the bloc’s stronger adherence to the precautionary principle (European Parliament and Council Directive 94/36/EC).
Legal scholars have noted these comparative regulatory models as pivotal. “Regulatory convergence around synthetic food dyes shows how risk perception and public health prioritization differ across jurisdictions,” observes Professor Linnea Carlson of the University of Michigan’s School of Public Health.
Taken together, these cases frame the current FDA action within a continuum of escalating precaution. The agency’s approval of natural colorants and plans to eliminate petroleum-derived dyes suggest a policy arc that favors proactive, science-based oversight over reactive or permissive approaches. The balancing act between regulatory authority, evolving science, and consumer advocacy forms a consistent throughline in these cases—emphasizing the state’s enduring responsibility to adapt its standards as knowledge evolves.
Policy Implications and Forecasting
The FDA’s approval of three new natural color additives and its concurrent commitment to phase out synthetic dyes such as FD&C Red No. 3 and FD&C Red No. 40 by 2026–2028 carry a range of policy implications that transcend food labeling. At its core, the initiative symbolizes a broader recalibration of federal oversight in favor of cleaner, more transparent ingredient sourcing—echoing trends in both health policy and environmental regulation.
First, this decision sets a precedent for stricter federal scrutiny of legacy substances still permitted under older regulatory frameworks. Policymakers may now feel emboldened to examine other widely used food additives whose safety has been called into question by newer studies. Indeed, this could mark the beginning of a more comprehensive FDA modernization initiative, supported by both legislative and executive actors.
Second, food manufacturers will need to adapt operationally and financially. The cost of transitioning to natural colorants—which are typically more expensive and less shelf-stable—could drive increased prices, at least in the short term. Industry stakeholders warn of unintended consequences. “Substituting synthetic dyes with natural ones may sound easy, but it involves considerable reformulation, supply chain adaptation, and cost absorption,” explains Jack Levine, Vice President of the Food Additive Manufacturers Association.
From a consumer policy standpoint, this may increase pressure for mandatory front-of-package ingredient disclosures, extending beyond coloring to include preservatives and flavoring agents. Increased transparency, particularly for ingredients with known health effects, aligns with wider trends in informed consumer choice and ethical sourcing.
Internationally, the U.S. move could bolster transatlantic regulatory harmonization. As countries seek to minimize trade friction and meet rising consumer expectations, a convergence toward natural ingredients may follow. The World Health Organization and Codex Alimentarius Commission could cite the FDA action as evidence supporting global standards for food dye reform.
Ultimately, this decision reinforces a paradigm shift where regulatory emphasis is placed on upstream safety rather than post-market corrective measures. “This approach privileges risk prevention over risk mitigation—an essential evolution in public health governance,” notes Dr. Amelia Trent of the Brookings Institution. As regulatory, consumer, and scientific forces align, future policymaking is likely to center on the proactive identification and elimination of systemic dietary risks.
Conclusion
The FDA’s recent approval of Galdieria extract blue, butterfly pea flower extract, and calcium phosphate as safe food colorants marks a turning point in regulatory strategy—a pivot away from the historically permissible use of petroleum-based synthetic dyes toward more sustainable and health-conscious alternatives. This transition represents not merely a discrete policy change but a symbolic reorientation of American food safety priorities in alignment with growing public health, environmental, and consumer advocacy demands.
At the heart of this issue lies a constitutional and regulatory tension: the government’s obligation to safeguard public health without overstepping its mandate to support innovation and economic freedom. Liberals emphasize the precautionary principle and the right to safe consumption, especially for vulnerable populations such as children. Conservatives argue for market-based solutions and caution against burdensome regulatory overreach. These divergent perspectives underscore the challenge of forging bipartisan consensus on what constitutes “safe enough” in the realm of food additives.
Yet, a point of convergence seems to be emerging. As scientific evidence continues to accumulate, and public awareness of food ingredients becomes more sophisticated, there is growing recognition that the legal standards underpinning FDA approvals must evolve with current research. In this respect, the agency’s actions reflect not only statutory authority but also a dynamic responsiveness to shifting social values.
“Food law is not static—it must continuously respond to new data and cultural shifts,” asserts Professor Cynthia Rowe, Chair of the Food and Drug Law Committee of the American Bar Association. “What was once considered acceptable may no longer meet the evidentiary or ethical standards demanded by the public.”
Looking forward, the decision raises important questions: Will other legacy food additives come under scrutiny? How will the FDA balance scientific rigor with economic pragmatism in future reviews? And what role will Congress play in reinforcing or resisting this regulatory trend?
The FDA’s current initiative may serve as a bellwether for future regulatory approaches—ones that prioritize preventive action, ethical sourcing, and comprehensive labeling. As these policies mature, a more holistic and health-centered food system may gradually emerge, reshaping not only what Americans eat but how food law itself is conceived.
For Further Reading:
- FDA Approves Three Food Colors from Natural Sources – FDA News Release
https://www.fda.gov/news-events/press-announcements/fda-approves-three-food-colors-natural-sources - FDA Approves 3 Natural Food Dyes: Here’s What Colors They Are – Food Republic
https://www.foodrepublic.com/1855888/fda-approves-natural-food-dyes/ - FDA Approves Three Natural Food Color Additives, Supporting Push to Eliminate Petroleum-Based Dyes – Scioto Post
https://www.sciotopost.com/fda-approves-three-natural-food-color-additives-supporting-push-to-eliminate-petroleum-based-dyes/ - FDA Approves 3 Natural Food Colors. Here’s What They Are and How They Can Be Used – Houston Chronicle
https://www.houstonchronicle.com/news/houston-texas/trending/article/food-dyes-colors-fda-additive-natural-20322519.php - FDA Approves, Expands 3 Natural Color Additives After RFK Jr.’s Plan to Remove Artificial Food Dyes – ABC News
https://abcnews.go.com/Health/fda-approves-expands-3-natural-color-additives-after/story?id=121641300