On April 22, 2025, the U.S. Department of Health and Human Services Secretary, Robert F. Kennedy, Jr., announced that the U.S. Food and Drug Administration (FDA) will begin to phase out all petroleum-based synthetic dyes from the U.S. food supply. This action is part of the current administration’s Make America Healthy Again initiative and is based on reports of health concerns of dietary exposure of artificial dyes in food being associated with adverse effects in adults and children.
Overview
The multi-step phase out process will include the following activities by the FDA:
1.) A national standard and timeline will be established for the food industry to move from petrochemical-based dyes to natural alternatives.
2.)The process to revoke authorization for two synthetic food colorings will begin immediately with the final ban to be effective in the coming months.
- The dyes affected are Citrus Red No. 2 and Orange B.
3.) The FDA will work with the food industry to eliminate six additional synthetic dyes from the food supply. This removal will occur by the end of 2026.
- The dyes affected are 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
4.) Authorization for four new natural color additives is expected in the coming weeks. The FDA is also accelerating the review and approval of additional natural color additives.
- The color additives to be approved are calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract.
5.) The FDA will work with the National Institutes of Health (NIH) to conduct comprehensive research on how food additives impact children’s health and development.
- The goal of this work is to enhance nutrition and food-related research to better inform regulatory decisions.
6.) An additional request is that food companies remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required. This deadline was a removal from food products by the end of 2027 and in pharmaceuticals by the end of 2028.
Future Outlook?
Although no formal legislation was passed officially banning the substances, the HHS and the FDA have a “mutual understanding” with the food industry that the dyes will be progressively removed. As part of this voluntary agreement with the food manufacturers, the FDA is asking the companies to use natural ingredients like those used in the EU and Canada. The FDA is also planning to issue guidance and provide regulatory flexibilities to affected industries.
Published April 24, 2025
This article was generated with the assistance of Artificial Intelligence.