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.” This article will assess where the phase out plan sits roughly two months after its announcement.
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 (FDCA) 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 outlined 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.
Industry “phase out”
The third prong of FDA’s six-pronged phase out plan was to work with industry to eliminate 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 by the end of 2026. While many were skeptical of the voluntary nature of this plan, in the two months since the announcement, several food companies have announced their intentions to remove synthetic dyes from their food portfolios. For example, Kraft Heinz, General Mills, Conagra Brands, Nestle USA, PepsiCo, and Tyson Foods have all announced their commitment to removing synthetic dyes from their products.
Part of the reason for the skepticism was that though HHS Secretary Kennedy stated that there was an “understanding” between FDA and food manufacturers at the phase out plan’s press conference, no formal agreement was published, nor was any food industry representative present at the event. Part of the 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, Delaware, Louisiana, Tennessee, West Virginia, Virginia, and Utah have passed legislation banning school meals from containing certain food additives. Texas and Louisiana have passed legislation requiring disclosure labels on foods containing certain listed food additives – important to note that at the time of writing this article the Louisiana bill has not yet been signed by its governor. 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.”
New Color Additives
The fourth prong of the phase out plan has also seen movement in the past two months. In May, the FDA announced its approval of three new natural color additives. These color additives occur naturally and are not man made, but even natural color additives must be approved as safe for their intended use by the FDA before they can be used in foods. 21 § USC 379e. Here, the FDA has approved Galdieria extract blue, butterfly pea flower extract, and calcium phosphate. Galdieria extract blue produces a blue color and is derived from the unicellular red algae Galdieria sulphuraria. Butterfly pea flower extract is also a blue color and it can be used to produce shades of blue like bright blues, intense purple, and natural greens. Calcium phosphate is a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
Additionally, as part of the six-pronged plan, FDA stated that it would fast track the authorization of four new natural dyes – the three approved here, and gardenia blue. The FDA also said it would accelerate the review and approval of other natural dyes and would issue guidance to industry. So far, the FDA has not published a guidance, nor made any announcements about the approval of gardenia blue or other natural dyes.
Partnership with NIH
The fifth prong in FDA’s phase out plan was to partner with the National Institutes of Health (NIH) to conduct comprehensive research on the effect food additives might have on the health and development of children. NIH is a federal agency housed in the Department of Health and Human Services and is primarily responsible for conducting and supporting federal medical research. On May 9, 2025, the FDA announced the creation of a joint research initiative with the NIH, titled the Nutrition Regulatory Science Program. This program will implement a nutrition research agenda that provides “critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier.” Specifically, the initiative highlighted the following questions it will aim to answer:
- How and why can ultra-processed foods harm people’s health?
- How might certain food additives affect metabolic health and possibly contribute to chronic disease?
- What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?
This joint initiative will mirror the FDA and NIH’s Tobacco Regulatory Science Program in structure and collaboration with FDA providing expertise in regulatory science and NIH providing the infrastructure for research. FDA states that the initiative will bring together experts in chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry, but is committed to conducting research that is “fair, independent and free of conflicts of interest.”
Remaining prongs
In the past two months, there has been no movement yet on the remaining three prongs of the FDA’s phase out plant. First, the FDA has not published an industry guidance document, promulgated formal rulemaking, nor posted any further documents regarding a national standard and timeline. Second, the FDA has not publicly announced that it has initiated the process for revoking Citrus Red No. 2 or Orange B. Last, though no company who has publicly committed to removing synthetic color additives from its food portfolio specifically mentioned Red Dye 3, it can likely be assumed that it is included under the board definition most are using to describe FD&C dyes.
Conclusion
In only two months, the FDA has moved extraordinarily fast on accomplishing portions of its six-pronged phase-out plan. With an administration that has stated its commitment to “restor[ing] the focus on the ‘F’ in FDA,” it can be assumed that food-related policies will continue to be a priority. For up-to-date information on FDA announcements, click here to subscribe to NALC’s bi-weekly newsletter “The Feed.” To learn more about the phase out plan, click here to read NALC article “FDA Announces Plan to ‘Phase Out’ Synthetic Dyes.” To learn more about other FDA updates, click here to read “FDA Updates: June 2025.”
Stone, Emily. “Two Months In: Assessing the Movement on FDA’s Plan to “Phase Out” Synthetic Dyes.” Southern Ag Today 5(27.5). July 4, 2025. Permalink
