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On April 22, 2025, Department of Health and Human Services (HHS) Secretary Robert Kennedy, Jr. announced the agency\u2019s plan to \u201cphase out\u201d petroleum-based synthetic color additives. Though the announcement did not include any formal rulemaking or industry guidance documents, the agency described it as \u201ca significant milestone in the administration\u2019s broader initiative to Make America Healthy Again.\u201d To read the full press release, click here<\/a>.<\/p>\n Background on synthetic dyes <\/strong><\/p>\n Color additives are defined<\/a> by the Food and Drug Administration (FDA) as \u201ca 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.\u201d 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 \u2013 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.<\/p>\n FDA\u2019s stated actions<\/strong><\/p>\n Specifically, the phase out plan outlines six measures that the FDA will take:<\/p>\n National Standard and Timeline <\/strong><\/p>\n 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\u2019s interpretation of, or policy on a regulatory issue, but it does not establish legally enforceable rights or responsibilities. 21 CFR \u00a7 10.115<\/a>. FDA describes<\/a> guidance documents as representing \u201cFDA\u2019s 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.\u201d Thus, if FDA publishes a guidance document to explain the procedure for industry\u2019s 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.<\/p>\n Revoking Citrus Red No. 2 and Orange B<\/strong><\/p>\n Part 2 of the FDA phase out declares that the agency will initiate the process of revoking authorization for two synthetic dyes \u2013 Citrus Red No. 2<\/a> and Orange B<\/a>. 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\u2019s public reports<\/a> 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.<\/p>\n 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\u2019s 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.<\/p>\n 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\u2019s authorization. 21 USC \u00a7 379(d)<\/a>; 21 USC \u00a7 371(e)<\/a>. If a petition is submitted by stakeholders, it must show \u201creasonable grounds\u201d for the review. 21 USC \u00a7 371(e).<\/a> 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.<\/p>\n Alternatively, a color additive\u2019s 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\u2019s authorization of Red Dye No. 3\u2019s use in food and ingested drugs. 21 USC \u00a7 379e(b)(5)(B)<\/a>. 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<\/a> to read NALC article \u201cFDA bans Red Dye No. 3.\u201d<\/p>\n Eliminate Six Remaining Synthetic Dyes <\/strong><\/p>\n 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 \u2013 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 \u2013 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 \u2013 from the food supply. In the press conference<\/a> announcing the phase out plan, Secretary Kennedy stated that there was an \u201cunderstanding\u201d between FDA and food manufacturers for the voluntarily elimination of the six remaining synthetic dyes \u2013 though no formal agreement has been published, nor were any food industry representatives present at the event.<\/p>\n The alleged willingness of food industry might have something to do with the movement of this issue on a state level. California<\/a> and West Virginia<\/a> have banned foods containing certain food additives from being sold in their state. Additionally, California<\/a>, West Virginia<\/a>, Virginia<\/a>, and Utah<\/a> 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<\/a> in the press conference that food companies \u201cwant to do this,\u201d and that they particularly \u201cdon\u2019t want to deal with patchwork of 30 different state plans.\u201d<\/p>\n Authorize Four New Natural Dyes <\/strong><\/p>\n The fourth measure outlined in FDA\u2019s plan is to authorize four new natural color additives \u2013 calcium phosphate, galdieria extract blue, gardenia blue, and butterfly pea flower extract. Along with stating it will \u201cfast track\u201d 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.<\/p>\n 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<\/a> 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.<\/p>\n Partner with the National Institutes of Health <\/strong><\/p>\n The fifth portion of FDA\u2019s 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\u2019s 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<\/a>, the FDA addresses the issue stating that \u201cthe 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.\u201d Specifically, a 2011 Food Advisory Committee<\/a> concluded that no link between children\u2019s 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.<\/p>\n Remove Red Dye No. 3 Sooner <\/strong><\/p>\n 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<\/a> 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 \u2013 at this point, FDA is only requesting that industry comply sooner.<\/p>\n Conclusion <\/strong><\/p>\n The FDA recently announced its six-pronged initiative to \u201cphase out\u201d synthetic food dyes from the food supply. This initiative does not create formal rulemaking but emphasizes FDA\u2019s 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<\/a> to subscribe to NALC\u2019s biweekly newsletter \u201cThe Feed.\u201d<\/p>\n \u00a0<\/p>\n To learn more about the federal regulation of color additives, click here<\/a> to read NALC article \u201cFDA\u2019s Color Additive Regulations and the Skittles Litigation\u201d<\/p>\n To learn more about 2024 state proposals to ban food additives, click here<\/a> to read NALC article \u201cUpdate on Proposed Food Additive Bans\u201d<\/p>\n\n
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