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In recent months, the FDA has accelerated its efforts to phase out petroleum-based food dyes, a move that could significantly impact food products in the United States. In this blog, Leatherhead’s regulatory experts provide an overview of these regulatory changes and offer guidance on how food manufacturers can adapt to ensure compliance.

Rapid developments in colour additive regulations

Since the beginning of 2025, the FDA has made several notable changes to colour additive regulations. One colour additive has been revoked, seven have been placed under review, and another has been proposed for removal. These changes are part of a broader “Make America Healthy Again” initiative, under which the phasing out of petroleum-based food dyes is included.

In January 2025, the FDA revoked the regulation permitting the use of FD&C Red #3, a petroleum-based dye. On September 17, the FDA proposed to revoke the regulation authorising the use of Orange B, citing its abandonment by the industry and its outdated status. Additionally, seven other petroleum-based dyes, including Fast Green FCF, Erythrosine, Allura Red, Tartrazine, Sunset Yellow, Brilliant Blue FCF, and Indigo Carmine, are now under FDA review.

Supporting the industry with natural alternatives

While phasing out petroleum-based dyes, the FDA has also supported the industry by approving new colour additives derived from natural sources.

In May 2025, calcium phosphate was approved for use in ready-to-eat chicken products, white candy melts, doughnuts, and sugar-coated candies. The same month saw the approval of galdieria extract blue, derived from unicellular red algae, for various food categories.

Additionally, butterfly pea flower extract and gardenia genipin blue have been approved for expanded use in multiple food products.

Three steps for food manufacturers

In navigating these regulatory changes, we recommend that food manufacturers:

  • Review product portfolios: Conduct an early review of product formulations to identify those containing petroleum-based dyes that may be impacted by the new regulations
  • Explore alternative colour solutions: Prioritise existing approved colours that fall outside the scope of the phase-out initiative
  • Stay informed: Keep abreast of FDA updates and consider participating in voluntary initiatives to remove petroleum-based dyes from products sold in schools by 2026 and more broadly by 2027

How Leatherhead Food Research can help

At Leatherhead Food Research, we provide Members with timely updates on regulatory developments related to colour additives, offering detailed insights into their specific uses across product categories. Our team closely monitors FDA actions aligned with national health initiatives and offers strategic guidance to help you anticipate changes, assess risks, and implement reformulations efficiently, ensuring your products remain compliant and aligned with evolving consumer expectations.

For more information and support, please contact our team at Leatherhead Food Research. We are here to help you navigate these regulatory changes and maintain your market edge.

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