Author: Emily Stone

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.” 

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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

On January 16, 2025, the Food and Drug Administration (FDA) revoked the color additive listing for use of Red Dye No. 3, a food dye that is used to color Brach’s Conversation Hearts and other popular candies. This decision was in response to a petition filed by the Center for Science in the Public Interest (CSPI) and other stakeholders to ban Red Dye No. 3 under the Delaney Clause of the Food, Drugs, and Cosmetics Act (FDCA). The Delaney Clause is a provision in the FDCA that deems any color additive found to cause cancer in man or animals as unsafe for any use that results in its ingestion. Specifically, the CSPI petition cited two studies that showed cancer in laboratory male rats exposed to high levels of Red Dye No. 3. Though the FDA did revoke the authorized uses for Red Dye No. 3 in food and ingested drugs to comply with the Delaney Clause, it maintains that available scientific information does not support that claim that ingested Red Dye No. 2 puts people at risk. 

Red Dye No. 3 is considered a “color additive” under the FDCA. Color additives are defined 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,” and are considered useful by the FDA for providing a color consistency that helps consumers identify food products on sight. To be used in food, drugs, cosmetics, or medical devices, the FDCA requires that color additives be approved by the FDA. This is done through a Color Additive Petition that provides evidence that the additive is safe for the ways in which it will be used. Once the petition is approved, a regulation identifying the conditions of use is published in the Federal Register. When a color additive’s regulation is published, it is considered “permanently listed,” however, per the FDA, it may “revoke or amend” the listings as needed. Here, the FDA is revoking the regulations formally found at 21 CFR §§ 74.303, 1303 authorizing the use of Red Dye No. 3 for coloring in foods and ingested drugs.

Though Red Dye No. 3 has been in commercial use since the early 1900s, it was not permanently listed until 1969. The current petition process for color additives was created under the Color Additive Amendments of 1960, and following the update, all additives that were previously in commercial use were reevaluated for safety. Specifically, the color additives were provisionally listed and could only be used on an interim basis until they were either permanently listed or terminated. Thus, Red Dye No. 3 was provisionally listed in 1960 and stayed under that classification until it was proved safe through the petition process in 1969 and permanently listed for use in food and ingested drugs. In 1990, the FDA revoked Red Dye No. 3’s authorization for use in cosmetics and topical drugs under the Delaney Clause. Following that revocation, the FDA announced it would also revoke Red Dye No. 3’s authorization under the Delaney Clause for use in food and ingested drugs, but it never followed through. According to the FDA, “the agency decided not to take action at that time, given the resources required to remove this authorization,” but maintained that “available data does not raise safety concerns for humans.”

State level bans 

The FDA banning Red Dye No. 3 follows several states proposing legislation that sought to ban food and color additives. Specifically, in October of 2023, California became the first state in the nation to ban the manufacture, distribution, and sale of foods and beverages containing certain color additives, including Red Dye No. 3. Following California’s passage of the law, several other states proposed food and color additive bans in 2024. Currently, at least six states have legislation introduced in their legislative sessions similar to California’s banning certain food or color additives. These states include New Jersey, Arkansas, Missouri, Oklahoma, New York, and Delaware. Additionally, in 2024, California passed the California School Food Safety Act prohibiting food with certain food and color additives from being sold in schools. So far, Texas, Hawaii, and Virginia have introduced similar legislation this session that seeks to ban the use of certain additives in food and beverages sold in schools. As most states are just beginning the 2025 legislative session, there might be more bills relating to these topics proposed in the coming months. 

Next Steps for the Federal Ban 

As the rule currently reads, food manufacturers who use Red Dye No. 3 in foods will have until January 15, 2027 to comply, while ingested drug manufacturers will have until January 18, 2028. The agency action banning Red Dye No. 3 was published in the last few days of the Biden administration. As such, its future under the Trump administration remains uncertain. The Trump administration has not spoken about its intentions regarding the issue, so the future of the Red Dye No. 3 ban remains unclear. Regardless, the conversation hearts are safe for this Valentine’s Day. To learn more about this issue, click here to read NALC article, “FDA bans Red Dye No. 3.” 

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Stone, Emily. “Be Mine: FDA bans food dye used in popular candies.” Southern Ag Today 5(7.5). February 14, 2025. Permalink

In their most recent legislative sessions, nine states – Alabama, Arizona, Florida, Kentucky, Michigan, New York, Pennsylvania, Tennessee, and Texas – considered legislation banning the manufacture, sale, or distribution of cell-cultured meat. Florida and Alabama both passed the legislation, and their governors signed it into law. In Kentucky, New York, Tennessee, and Texas the proposed bills did not make it out of committee before the session ended. Arizona’s bill made it further with HB2121 passing in the House of Representatives but failing in the Senate. The Pennsylvania and Michigan bills, whose legislative sessions are ongoing, were introduced following the passage of the Alabama and Florida bills and are each being considered in committee. 

Florida 

On May 1, 2024, Florida became the first state in the U.S. to ban cell-cultured meat. SB1084, an appropriations bill with a number of agriculture-related measures, included a provision outlawing the manufacturing for sale, selling, holding or offering for sale, or distribution of “cultivated meat.” The Florida law defines cultivated meat as “any meat or food product produced from cultured animal cells.” The violation of this law is deemed a misdemeanor of the second degree and a food establishment which violates the law will be subject to disciplinary actions. Additionally, a restaurant, store, or other business may have its license suspended if the owner or an employee is convicted of violating this law in connection with that business. The law does not ban research conducted on the production of cultivated meat. The law went into effect on July 1, 2024.

Alabama 

Similarly, on May 7, 2024, Alabama Governor Kay Ivey signed SB23 into law. This law prohibits the manufacturing, selling, holding or offering for sale, or distribution of any cultivated food product in Alabama. The law defines a cultivated food product as any food product produced from cultured animal cells. A violation of this law is considered a Class C misdemeanor, and establishments found to be in violation could have its food safety permit suspended. The law does not prohibit research of cultivated food products by a “federal, state, or local governmental entity or institution of higher education, or a person that is partnered with a governmental entity or institution of higher education.” SB23 goes into effect on October 1, 2024. 

Lawsuit against Florida  

On August 12, 2024, UPSIDE Foods, Inc. filed a complaint in the U.S. District Court for the Northern District of Florida challenging Florida’s ban on cell-cultured meat. UPSIDE is a California company that produces cultivated meat products grown from animal cells. UPSIDE was the first manufacturer of cell-cultured meat or poultry authorized by the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), who share the regulatory authority over cell-cultured meat, to sell its product in the U.S. 

In this complaint, UPSIDE argues that Florida’s cell-cultured meat ban is unconstitutional because it violates both the Supremacy Clause and the Commerce Clause of the U.S. Constitution. The complaint alleges that the Supremacy Clause, which gives priority to the Constitution and federal laws over any conflicting state laws, is violated because Florida’s ban is preempted by federal laws regulating meat and poultry products. Further, UPSIDE argues that the Commerce Clause, which grants Congress the authority to regulate commerce among the states, is violated by Florida’s ban because it discriminates against out-of-state producers of cultivated meat and benefits the interests of Florida’s agricultural industry. So far this is the only legal challenge brought against Florida’s cell-cultured meat ban, and no challenge has been made against Alabama’s. However, that might change when the Alabama law goes into effect on October 1, 2024. 

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Stone, Emily. “Cell Cultured Meat.” Southern Ag Today 4(37.5). September 13, 2024. Permalink