On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a series of steps intended to eliminate all petroleum-based synthetic dyes from the US food supply by the end of 2026. Importantly, the proposed phase out of synthetic food dyes will depend on "voluntary" compliance from regulated industry. In this Legal Update, we review both FDA and state measures, as well as the implications surrounding them.
The specific measures announced by FDA in the press release include:
- Transition from petrochemical-based dyes: FDA will establish a national standard and timeline to encourage industry to voluntarily transition from synthetic dyes to natural alternatives.
- Revocation of authorization for two synthetic dyes: FDA announced that it would initiate a process to revoke the authorization of two lesser used synthetic color additives, Citrus Red No. 2 and Orange B.
- Work with industry to eliminate six remaining synthetic dyes: FDA seeks to eliminate use of 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 – by the end of 2026, on a "voluntary" basis.
- Authorize four new natural color additives: FDA stated at the April press conference that it would fast-track the review of four new natural color additives. Indeed, on May 9, 2025, the agency announced the granting of three new color additive petitions, for Galdieria extract blue, Butterfly pea flower extract, and Calcium phosphate.
- Partner with National Institutes of Health (NIH): FDA intends to partner with NIH to conduct comprehensive research on how food additives may impact children's health and development.
- Expediting removal of FD&C Red No. 3: FDA has requested that industry cease use of FD&C Red No. 3 even sooner than the 2027-2028 deadline required under the January 2025 order revoking use of this synthetic dye in foods and ingested drug products. Red No. 3 has been under particular scrutiny as studies have attempted to evaluate the potential link between the dye and certain cancer outcomes.
The joint FDA-HHS announcement in April is consistent with many previous statements from HHS Secretary Robert F. Kennedy Jr. regarding the potential impact of food ingredients on chronic disease and particularly childhood chronic disease, which is also a focus of the Trump Administration's "Make America Healthy Again Commission," established in February 2025.
State Efforts to Address Artificial Food Dyes
The federal announcement also aligns with numerous current and pending state initiatives to eliminate petroleum-based dyes in food products, particularly in school lunches:
- California: In 2023,California passed the California Food Safety Act (AB418), becoming the first U.S. state to enact a law banning FD&CRed No. 3 as well as other food dyes, including brominated vegetable oil, potassium bromate and propylparaben. This law will become effective on January 1, 2027. California has also banned certain food dyes from public school lunches under the state's School Food Safety Act.
- West Virginia: In March 2025, West Virginia enacted House Bill 2354 which prohibits certain the sale of any food product in the state that contains the dyes Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2 and Green 3.
- Virginia: Virginia Governor Glenn Youngkin signed identical bills, House Bill 1910 and Senate Bill 1289, prohibiting public elementary and secondary schools from serving lunches containing seven synthetic color additives, including FD&C Red No. 3. These laws will take effect July 1, 2027.
- Texas: In March of this year, Texas passed a law banning several food additives, including FD&C Red No. 3, from being used in free or reduced-price meals served in Texas public schools. That same month, the Texas Senate unanimously passed Senate Bill 25, which requires food manufacturers to add a "warning label" to any food products sold in Texas that contain any of a list of enumerated ingredients for any food product labels developed or copyrighted on or after January 1, 2027. Among the list of fifty ingredients is "certified food colors by the United States Food and Drug Administration," which includes all synthetic food dyes. If passed, the law would also require the warning label to state if an artificial color, chemical, or food additive is banned in Australia, Canada, the European Union, or the United Kingdom. Similar laws requiring warning labels are pending in Louisiana and Missouri.
- Louisiana: The Louisiana Senate introduced a bill that prohibits public schools and nonpublic schools that receive state funds from serving "ultra processed foods" containing chemical additives and artificial food coloring.
Implications of the FDA/HHS Announcement for Regulated Industry
In the absence of formal rulemaking from FDA – and the public evaluation of scientific data required to support a finding that synthetic food dyes can no longer be considered safe – the agency's announcement depends heavily on voluntary industry compliance. Although some food manufacturers have indicated a willingness to phase out synthetic food dyes in line with the FDA goals, it remains to be seen how widespread such efforts will be. Given the ongoing state legislative efforts, we expect that many food manufacturers will seek to reformulate their products to eliminate synthetic food dyes and/or substitute natural color additives.
The current federal and state focus on synthetic food dyes also raises a number of related issues for food manufacturers, which we will address in more detail in subsequent Client Alerts:
- Manufacturers' reformulation efforts should take into account the safety profile and performance of alternative color additives, as well as potential supply chain issues. All new color additives must first be approved by FDA for use in food or drugs. Challenges to reformulating may include finding suitable and cost-effective natural color additives.
- Without formal rulemaking from FDA, it likely that state laws will be the battleground for any potential challenges from regulated industry.
- The lack of unanimity among the federal and state laws may also lead to an increase in consumer class actions related to the safety and alleged health effects from the use of synthetic dyes.
- Reformulated products will also require review of labeling updates. Changes in marketing can reflect negatively on the prior products and inadvertently create risks for potential claims. For example, in late March, Texas Attorney General Ken Paxton launched an investigation of WK Kellogg Co. (Kellogg's), for alleged violations of consumer protection laws. In the press statement, AG Paxton claims that Kellogg's markets its cereals as "healthy" despite containing petroleum-based artificial food dyes, purportedly linked to hyperactivity, obesity, autoimmune disease, endocrine-related health problems, and cancer. Paxton also alleges that Kellogg's previously announced it would remove artificial food dyes and the preservative BHT from its products, but only did so for products sold in Canada and Europe, and not in the United States. Labeling updates should avoid usage of words like "safer" or "healthier," especially where comparative information may be limited.
We will continue to monitor federal and state actions on color additives. If you have additional questions and/or concerns regarding these issues and how they will affect your company or consumers, please contact one of the authors, so we can prepare you for any issues that may arise.
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