FDA Bans Red Food Dye No. 3 in Foods, Medications

Credit: Adobe Stock/Anna

The U.S. Food and Drug Administration (FDA) is taking steps to ban the use of FD&C Red No. 3, a bright red synthetic dye, in food and ingested drugs, according to a statement from the agency.

FD&C Red No. 3 is mostly used in products like candies, baked goods, frostings, frozen desserts and certain medications. However, the dye is not as commonly used as some other food colors.

This decision is based on the Delaney Clause, a law from 1958 that forbids the FDA from approving any food or color additive if it has been shown to cause cancer in animals or humans. This action responds to a 2022 petition, which cited studies demonstrating that high doses of FD&C Red No. 3 caused cancer in male rats.

However, the FDA says the way the dye caused cancer in rats does not apply to humans, and studies have not found the same effects in people or other animals. They added that human exposures to FD&C Red No. 3 are at much lower levels than those tested in rats.

Companies that currently use the dye will need to reformulate food products by January 2027 and ingested drugs by January 2028. While other countries still allow the dye in certain products, all food imported to the U.S. must meet these new regulations.

This is not the first time the FDA has used the Delaney Clause to revoke the approval of an additive. In October 2018, the FDA banned certain synthetic flavors under this law, prohibiting a total of 7 synthetic flavoring substances and flavor enhancers.