On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a plan to phase out all petroleum-based synthetic dyes from the nation’s food supply.¹ The plan is part of the current administration’s Make America Healthy Again initiative.

Previously, the FDA announced that it was banning FD&C Red No. 3, a popular petroleum-based food and drug coloring, due to studies showing that it caused cancer in male rats, which rendered it unsafe under the Delaney Clause. We previously discussed the FDA’s ban on Red No. 3 here.

The plan to remove all petroleum-based synthetic dyes from the nation’s food supply stems from studies linking these dyes to a variety of health effects, including behavioral and cognitive problems in children. However, it remains unclear whether the health effects linked to these dyes were caused by the dyes.

The new HHS and FDA proposal¹ includes the following specific goals and plans:

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

Notably, the plan includes expediting the removal of previously banned Red No. 3 from food and ingested drugs. The FDA’s January 2025 Order had required food and ingested drug manufacturers who use Red No. 3 to reformulate their products by January 15, 2027, or January 18, 2028, respectively.

The FDA also noted its intent to fast-track four natural color additives, including calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract. Three of these additives, Galdieria extract blue (a blue color), Butterfly pea flower extract (a blue color that can achieve a range of shades, including purple and green), and Calcium phosphate (a white color), were approved. These natural additives may be used in specific types of products, so manufacturers should review the FDA’s guidance.

Key Takeaways

• The FDA plans to phase out all petroleum-based synthetic dyes from the nation’s food supply.
• Although an Order was already in place to remove Red No. 3 from food and ingested drugs by January 15, 2027, and January 18, 2028, respectively, the FDA’s new plan includes expediting the removal of Red No. 3 from products prior to the 2027-2028 timeline. 
• The FDA approved three new natural color additives: Galdieria extract blue (blue), Butterfly pea flower extract (blue, green, and purple), and Calcium phosphate (white).

We are continuing to monitor updates and developments in this area. If you have questions related to the FDA’s ban on petroleum-based food dyes, please contact the authors.

Cozen O’Connor’s Food & Beverage team provides comprehensive legal services to the food and beverage industry. Our attorneys represent clients operating at every point along the supply chain and involving all product lines — from produce to snack foods to pet foods and from alcoholic spirits to dietary supplements.

¹ To date, there is no Order or legislation officially banning the remaining synthetic dyes, outside of Red No. 3. However, HHS and the FDA are relying on a mutual understanding with the food industry to begin removing these dyes from their products.