HHS and FDA Announce Plans to Phase Out Certified Colors

During a press conference, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary said that the agencies are looking to revoke authorization for two synthetic food dyes, Citrus Red No. 2 and Orange B, and to work with industry on a voluntary process to eliminate the six remaining dyes by the end of 2026. “We are going to get rid of the dyes and then one by one, we’re going to get rid of every ingredient and additive in food that we can legally address,” Secretary Kennedy said. 

The phase out of the certified colors will largely rely on voluntary efforts from the food industry. Secretary Kennedy said during the press conference that the phase out is based on an “understanding” with major food companies, though no formal agreement has been put in place and no members from the food industry participated in the event. Secretary Kennedy noted that many companies “want to” comply, motivated in part by a desire to avoid navigating a confusing patchwork of differing state legislation. 

Summary of Key Actions

During the press conference FDA released a document with six action items the agency is taking to remove synthetic dyes from the food supply. ¹

1. Transitioning to natural alternatives. FDA will establish a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
2.  Revoking authorization of two synthetic dyes. In the coming months, FDA will initiate the process to revoke authorization for two rarely used synthetic food colorings, Citrus Red No. 2 and Orange B. Citrus Red is only approved for coloring orange peels and Orange B is approved only for use in hot dog and sausage casings. 
3. Phasing-out six remaining certified colors. The agency will work with industry to eliminate the six remaining certified colors – Green No. 3, Red No. 40, Yellow Nos. 5 and 6, Blue Nos. 1 and 2 – from the food supply by the end of 2026. 
4. Authorizing new natural color additives. FDA is fast-tracking the review of four natural color additives – calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract – and accelerating the review and approval of other natural alternatives to synthetic food dyes. 
5. Expediting the deadline to remove Red No. 3. In January 2025, FDA issued an order revoking the authorization of Red No. 3 for use in food and ingested drugs, based on the Delaney Clause.² The order requires manufacturers who use Red No. 3 in food and ingested drugs to reformulate their products by January 15, 2027 and January 18, 2028, respectively. With the phase-out of synthetic dyes, FDA is now requesting food companies to remove Red No. 3 by the end of 2026, which is 15 days prior to the existing effective date. 
6. Partnering with NIH. FDA will partner with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development. This partnership in intended to advance nutrition science, inform future regulatory decisions, and strengthen FDA’s ability to develop evidence-based food policies. 

Procedure for Amending or Repealing Color Additive Regulations 

FDA did not provide any details on how it intends to revoke the color additive regulations for Orange B and Citrus Red No. 2. These color additives do not appear to be in current use. A review of the publicly available data on FDA certifications for color additives reveals FDA has not certified a batch of Orange B since prior to 2019 and last certified a batch for Citrus Red No. 2 in 2020. The agency statements suggest FDA intends to pursue rulemaking to formally revoke these authorizations. FDA could revoke the authorizations in response to a color additive petition seeking such a revocation, by issuing a proposed rule and going through rulemaking, or by taking some other action to support the revocation that would involve a shorter timeframe than traditional rulemaking. 

For the remaining colors, FDA appears to be relying on the industry to phase out the use of these colors by the end of 2026. As a voluntary process, there is no legal requirement for companies to cease using the remaining certified colors in the proposed timeframe. State laws banning the use of these certified colors become effective as early as August 2025 for use in school meals sold in West Virginia and for foods sold in West Virginia as of January 1, 2028.³ As a practical matter, the state laws will incentivize many companies to transition away from the use of certified colors to comply with the state laws. 

To the extent FDA is interested in establishing a binding requirement, the agency would need to engage in rulemaking that would revoke the color additive authorizations. The Federal Food, Drug, and Cosmetic Act (FFDCA) is prescriptive in the procedure that HHS and FDA are expected to follow when amending or repealing a color additive regulation. The statute provides HHS with the discretion to repeal a color additive regulation either by issuing a proposed rule through the formal rulemaking process, or by accepting a color additive petition for filing. In both instances, there is a public process where the proposed amendment to or repeal of the color additive regulation is published in the Federal Register. Importantly, the process envisioned by the FFDCA is data driven with information supporting revocation found in the color additive petition or in the FDA proposal to revoke the authorizations. Both of these pathways require FDA to build an administrative record that would support an agency finding the specific color additive no longer meets the reasonable certainty of no harm safety standard. The agency would need to present data demonstrating each color additive no longer can be considered safe. In the statement released during the press conference, Secretary Kennedy alleged certified colors present “measurable dangers to our children’s health and development” and Commissioner Makary said “we have a new epidemic of childhood diabetes, obesity, depression, and ADHD . . . and we should not be taking risks and do everything possible to safeguard the health of our children.” In the past when FDA has raised safety questions with the use of an ingredient, the agency has presented data supporting its concerns. For example, the agency provided a detailed assessment supporting its view that partially hydrogenated oils could no longer be considered generally recognized as safe (GRAS) because of their role in contributing dietary trans fat. FDA similarly provided a compelling case supporting its decision to revoke the color additive regulation for Red No. 3. The agency explained the data confirmed Red No. 3 has been shown to cause cancer in laboratory animals and its authorization must be revoked as a matter of law under the Delaney Clause. FDA also provided a compelling justification supporting its view the evidence of cancer in rats is “of limited relevance to humans.” 

FDA did not announce any recent reviews of the data during the press conference or provide scientific support for the alleged health effects. Indeed, we are not aware of data that establishes a causal connection to certified colors and the adverse health effects mentioned during the press conference. One of the advantages of the voluntary approach is that FDA can circumvent the challenges with building scientific support challenging the safety of the remaining certified colors if the use of the colors is phased out voluntarily by the industry or as a result of compliance with state laws.

Authored by Martin Hahn and Rebecca Popkin.