FDA Announces Plan to Phase Out Petroleum-Based Food Dyes

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a plan to phase out petroleum-based food dyes by the end of 2026. The announcement follows a string of state legislative actions and proposals related to synthetic food dyes. In addition to the phase out plan, the agency will accelerate review and approval of “natural alternatives” to petroleum-based food dyes in the coming weeks.

Why Is FDA Asking the Food Industry To Remove Petroleum-Based Food Dyes?

In announcing the FDA’s plan, FDA Commissioner Marty Makary noted that there are “growing concerns of doctors and parents” about the role petroleum-based dyes may play in childhood diseases.¹ In particular, the announcement highlighted rising rates of childhood diabetes, obesity, depression and ADHD as diseases exacerbated, in part, by the consumption of petroleum-based food dyes.

What Color Additives Are Impacted by the FDA’s Announcement?

The FDA’s phase out plan identifies six petroleum-based color additives currently used by food manufacturers:²

• 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
• FD&C Blue No. 2

The FDA also plans to ask food manufacturers to remove Red No. 3 sooner than the 2027-2028 deadline previously set.³ However, the FDA did not provide a new deadline during the announcement.

When Does the FDA Expect Industry To Make Changes?

The FDA asks that food manufacturers remove the above-listed color additives by the end of 2026.

How Is the FDA Planning To Implement These Changes?

The FDA’s announcement does not include changes to underlying federal statutes, nor does it include the immediate revocation of all of the FDA’s regulations authorizing the impacted color additives (excepting Citrus Red No. 2 and Orange B). There is also no formal agreement between the FDA and the industry. Instead, the FDA is first leaning on the industry to make changes and, if the industry does not comply, Commissioner Makary has indicated that “there are a number of tools at our disposal.” Commissioner Makary further stated that the FDA intends to start in a “friendly way … without any statutory or regulatory changes” but is “exploring every tool in the regulatory toolbox to ensure this gets done.”

The FDA announced six action items to implement the phase out plan:

1. Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives
2. Initiating the process to revoke authorization for Citrus Red No. 2 and Orange B—two color additives no longer used by food manufacturers⁴—within the coming months
3. Working with the 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
4. Authorizing four new natural color additives in the coming weeks, while also accelerating the review and approval of others
5. Partnering with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development
6. Requesting food companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required

Apart from Citrus Red No. 2 and Orange B, the Agency currently does not plan on formally revoking authorization of the above-listed color additives from food products.⁵ Instead, the FDA is requesting that food manufacturers voluntarily remove the color additives from food by the end of 2026.

What Steps Might Food Manufacturers Consider Taking?

Food manufacturers may want to consider reviewing formulations to explore whether there are alternatives that would feasibly allow the removal of the specified color additives. Notably, the FDA also plans to fast-track the review of calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract, which, if authorized for use, could provide additional alternatives to petroleum-based food dyes.⁶

Are Dietary Supplements and OTC Drugs Covered by the Phase Out Plan?

The FDA did not expressly address dietary supplements or drugs in the announcement or in the phase out plan. There is no reason to anticipate that dietary supplements are not going to be covered by the changes, as the underlying regulatory authorizations are the same. Additionally, during his remarks, Commissioner Makary mentioned the removal of synthetic dyes from “medications,” but stopped short of including OTC drugs in the phase out plan.