On April 22, 2025, Department of Health and Human Services (HHS) Secretary Robert Kennedy, Jr. announced the agency’s plan to “phase out” petroleum-based synthetic color additives. Though the announcement did not include any formal rulemaking or industry guidance documents, the agency described it as “a significant milestone in the administration’s broader initiative to Make America Healthy Again.” To read the full press release, click here.

Background on synthetic dyes

Color additives are defined by the Food and Drug Administration (FDA) as “a dye, pigment or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetic or to the human body.” Color additives are distinguished from food additives by the Federal Food, Drug and Cosmetic Act (FFDCA) and require pre-approval from the FDA before they can be used in food. Specifically, there are two types of color additives – naturally occurring and synthetic. Synthetic dyes are manmade, and the FDA requires that each batch of synthetic dye must be certified as safe for its approved purpose. Thus, all food in the US food supply that contains synthetic dyes has been certified by the FDA that the synthetic dye is safe at its approved level for its approved purpose. Synthetic dyes, which are the color additives targeted by this initiative, are typically petroleum-based. There are currently nine synthetic dyes that might be found in food today, and this initiative aims to phase all nine out of the food supply by the end of 2026.

FDA’s stated actions

Specifically, the phase out plan outlines six measures that the FDA will take:

• Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
• Initiating the process to revoke authorization for two synthetic food colorings – Citrus Red No. 2 and Orange B – within the coming months.
• Working with industry to eliminate six remaining 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.
• Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others.
• Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
• Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required.

National Standard and Timeline

The first measure FDA outlines in its phase out plan aims to establish both a national standard and timeline for the food industry to transition from synthetic dyes to natural alternatives. However, the FDA did not establish the national standard or timeline through this initiative, nor did it clarify how it plans to establish either. The FDA could promulgate rules that establish a national standard for color additives that are permitted in foods. If the function of formal rulemaking is utilized by the FDA, then a timeline for compliance, including both an effective date and compliance date, will accompany the rule. However, the FDA could choose to implement this initiative by publishing an industry guidance document. A guidance document describes the agency’s interpretation of, or policy on a regulatory issue, but it does not establish legally enforceable rights or responsibilities. 21 CFR § 10.115. FDA describes guidance documents as representing “FDA’s current thinking on matters, but they are not binding, so industry could also do things in a different way, as long as they comply with the statutes and regulations.” Thus, if FDA publishes a guidance document to explain the procedure for industry’s transition from synthetic to natural color additives it would not carry the force of law. This means that FDA would not have the authority to require that industry is compliant with the national standard or timeline established in the guidance. At this time, no announcement has been made regarding the direction FDA plans to take.

Revoking Citrus Red No. 2 and Orange B

Part 2 of the FDA phase out declares that the agency will initiate the process of revoking authorization for two synthetic dyes – Citrus Red No. 2 and Orange B. These are two of the nine authorized synthetic dyes, but they are two of the most rarely used. Specifically, Citrus Red No. 2 is only used for coloring the skins of oranges that are not intended or used for processing. Orange B may be safely used for coloring the casings or surfaces of frankfurters and sausages if the quantity of the color additive does not exceed 150 parts per million by weight of the finished food. However, both Citrus Red No. 2 and Orange B are rarely used in the US food supply anymore. In fact, FDA’s public reports on the certification of color additives shows that no batch of Orange B has been certified since before 2019, and that the last batch of Citrus Red No. 2 was certified in 2020.

To be used in food, the FFDCA requires all color additives to receive pre-market approval from the FDA. As part of the approval process, a Color Additive Petition that provides evidence that the substance is safe for the ways in which it will be used, must be submitted. Thus, under the FFDCA, the FDA only allows color additives for purposes and in doses that it deems safe. For example, Citrus Red No. 2 was only authorized to color the peel of oranges not intended for processing to increase the fruit’s aesthetic appeal to consumers. Additionally, Orange B was only approved for certain uses if its level in food does not exceed 150 parts per million by weight of the finished food.

The FDA did not clarify how the revocation will take place, but there are two ways it might go about revoking the authorization. This process either starts with a proposal submitted by the Secretary of HHS or through a petition by interested stakeholders seeking to revoke the color additive’s authorization. 21 USC § 379(d); 21 USC § 371(e). If a petition is submitted by stakeholders, it must show “reasonable grounds” for the review. 21 USC § 371(e). The FFDCA does not include language requiring the same evidential standard for proposals initiated by the Secretary. No matter if it was a Secretary initiated-proposal or a stakeholder petition, if either undergoes FDA review, then it will be published by the FDA and a public comment period will commence. Following its review, FDA will publish an order. It is unclear at this time whether Secretary Kennedy will submit a proposal himself or will choose to review a stakeholder petition.

Alternatively, a color additive’s authorization must be revoked if it is found to cause cancer in man or animals. This provision is called the Delaney Clause, and it was recently used to revoke FDA’s authorization of Red Dye No. 3’s use in food and ingested drugs. 21 USC § 379e(b)(5)(B). If utilizing the Delaney Clause, a petition will still have to be submitted and reviewed by the FDA. To learn more about the Delaney Clause, and how it was used with Red Dye No. 3, click here to read NALC article “FDA bans Red Dye No. 3.”

Eliminate Six Remaining Synthetic Dyes

The third measure aims for the FDA to work with industry to eliminate six synthetic dyes from the food supply by the end of 2026. There are currently nine synthetic dyes that might be found in food. However, the FDA is seeking to revoke authorization for Citrus Red No. 2 and Orange B, and the FDA earlier this year revoked the authorization for Red Dye No. 3 in food and ingested drugs – the compliance date of which is not until 2027 for food and 2028 for drugs. The FDA claims it will work with industry to voluntarily remove the remaining 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. In the press conference announcing the phase out plan, Secretary Kennedy stated that there was an “understanding” between FDA and food manufacturers for the voluntarily elimination of the six remaining synthetic dyes – though no formal agreement has been published, nor were any food industry representatives present at the event.

The alleged willingness of food industry might have something to do with the movement of this issue on a state level. California and West Virginia have banned foods containing certain food additives from being sold in their state. Additionally, California, West Virginia, Virginia, and Utah have passed legislation banning school meals from containing certain food additives. This state level inconsistency might have led to a desire by industry for federal movement on the color additive conversation. Specifically, FDA Commissioner Marty Makary, MD, MPH, stated in the press conference that food companies “want to do this,” and that they particularly “don’t want to deal with patchwork of 30 different state plans.”

Authorize Four New Natural Dyes

The fourth measure outlined in FDA’s plan is to authorize four new natural color additives – calcium phosphate, galdieria extract blue, gardenia blue, and butterfly pea flower extract. Along with stating it will “fast track” the authorization of these four, the FDA also stated that it would issue guidance and provide regulatory flexibilities to industries. Each of these four already has a Color Additive Petition requesting authorization that the FDA is reviewing.

• Calcium phosphate is a chemical compound which produces a white color. Its petition is seeking authorization for calcium phosphate’s use in poultry, icing, white chocolate candy melts, doughnut sugar, and sugar for coated candies.
• Galdeieria extract blue is derived from the unicellular red algae, Galdieria sulphuraria. It’s seeking authorization for use in beverages; breakfast cereals; chewing gum; confections and frostings; dairy product analogs; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and filings; hard candy and cough drops; milk products; processed fruits and fruit juices; processed vegetables and vegetable juices; and soft candy.
• Gardenia blue is derived from the fruit of the cap jasmine, gardina jasminoides, a flowering shrub native to southern China. Its petition is seeking authorization to be used in sport drinks; flavored or enhanced, noncarbonated water; fruit drinks and aides; ready-to-drink tea; hard candy; and soft candy.
• Butterfly pea flower extract is derived from a purple flower and typically produces a blue color that can take on different hues depending on the pH of the additive. This natural dye is already approved for certain uses, but the current petition is seeking to expand authorization for use in ready-to-eat cereals; crackers and snack mixes; and chips.

To begin the approval process, a color additive petition must first be submitted. The FDA will evaluate the color additive based on the best science available to determine if there is a reasonable certainty of no harm to consumers. Specifically, the FDA will consider the composition and properties of the substance; amount that would typically be consumed; immediate and long-term health effects; and availability of analytical methods of determining its purity and acceptable levels of impurities. The FDA states that this evaluation will determine an appropriate level of use that includes a safety margin. This means that the maximum quantity of dye allowed in foods is a level much lower than what is known to cause an adverse effect in consumers.

Partner with the National Institutes of Health

The fifth portion of FDA’s phase out plan states that FDA will partner with the National Institute of Health (NIH) to conduct comprehensive research on the effect food additives might have on children’s health and development. The concern that synthetic dyes cause developmental issues in children has helped to drive most of the current interest in removing synthetic dyes from the food supply. However, this is not a new concern and is something that the FDA has examined before. On its website, the FDA addresses the issue stating that “the totality of scientific evidence shows that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them.” Specifically, a 2011 Food Advisory Committee concluded that no link between children’s consumption of synthetic dyes and adverse behavior effects had been established. However, FDA declares a commitment to assessing emerging science and for that reason will partner with NIH to further study the issue.

Remove Red Dye No. 3 Sooner

The last of the stated measures requests that food companies remove Red Dye No. 3 sooner than the compliance deadline previously required. In January 2025, FDA officially revoked the color additive authorization for the use of Red Dye No. 3 in food and ingested drugs. The final determination required compliance for food manufacturers by January 15, 2027, and for drug manufacturers by January 15, 2028. The phase out plan aims for industry to eliminate the six remaining synthetic dyes by the end of 2026, and the FDA is asking industry to move their removal of Red Dye No. 3 in alignment with the plan. The agency has not made any action to expedite the compliance date – at this point, FDA is only requesting that industry comply sooner.

Conclusion

The FDA recently announced its six-pronged initiative to “phase out” synthetic food dyes from the food supply. This initiative does not create formal rulemaking but emphasizes FDA’s intention to work with industry to eliminate the presence of these color additives. As the agency continues to implement this plan, more information including guidance documents for industry and petitions for color additive revocation might be published. To stay up to date on this issue, click here to subscribe to NALC’s biweekly newsletter “The Feed.”

To learn more about the federal regulation of color additives, click here to read NALC article “FDA’s Color Additive Regulations and the Skittles Litigation”

To learn more about 2024 state proposals to ban food additives, click here to read NALC article “Update on Proposed Food Additive Bans”

To review enacted a few of the 2025 state enacted proposals relating to food additives, click here to read NALC article “Food Law in the States – 2025 Update”