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Wanted: Red or Alive. FDA Revokes Authorization for Use of Red No. 3 in Food and Drugs.

By Kit Yona, M.A. | Last updated on

First makeup, now food. Erythrosine, also known as FD&C Red No. 3, had its authorization for use in food and ingestible drugs revoked by the U.S. Food and Drug Administration (FDA) on Jan. 15, 2025. This comes some 35 years after it was banned from cosmetics, some foods, and topical drugs.

Why now? The FDA acted after a 2022 color additive petition from the Center for Science in the Public Interest that requested a review of FD&C Red No. 3. The Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) bans the addition of any carcinogenic additives.

FD&C Red No. 3 has been proven to cause cancer in rats. While increased cancer risk in humans hasn't been established, the law behind the Delaney Clause caused the FDA to act.

What's Saying Goodbye to FD&C Red No. 3

FD&C Red No. 3's days may have been numbered before the FDA chose to act. California banned FD&C Red No. 3 in 2023 and 10 other states had introduced legislation to do so by April 2024. Erythrosine is also restricted as a food additive in China, the United Kingdom, and the European Union. In the U.S., it's mostly been replaced by Allura Red AC, also known as FD&C Red 40.

If you're old enough to remember when pistachio shells were dyed red, that was FD&C Red No. 3. It was used to cover up blemishes and stains from when the pistachios were harvested and imported from Iran. California picked up production when Iranian products were embargoed in the 1980s. The state's better quality of nut and development of a harvesting method that didn't stain the shell made the red-dyed version unnecessary.

Manufacturers of food sold in the U.S. have until Jan. 15, 2027, to remove FD&C Red No. 3 from their products. The cherry-red dye is mostly used in candy and other sweets. This includes Brach's Candy Corn, certain types of Jelly Belly candies, icings used for cookies and cakes, and Strawberry Yoo-hoo.

Your next Shirley Temple will still look the same. Maraschino cherries in America have typically used FD&C Red 40 since 2010. Although, California has also banned Red Dye 40.

FD&C Red No. 3 must also be removed from ingestable medicines and drug supplements. While not prevalent, the dye can still be found in some cough syrups and gummy vitamins. Manufacturers must comply by Jan. 15, 2028. Some have already done so, such as Abbott pulling the dye from their Pediasure line.

While it won't be going into your body anymore, FD&C Red No. 3 isn't going to vanish entirely. It's still used in printer ink, as a biological stain, and to expose dental plaque.

Coloring Outside the Lines

With the FDA revoking authorization despite any proven threat to the health of humans, a lawsuit from an affected industry wouldn't be unexpected. For now, that doesn't seem to be the case. The National Confectioners Association has applauded the decision and indicated the chocolate and candy industry is happy to follow the FDA's guidelines.

Will FD&C Red No. 3 be missed? Most people won't even notice that it's been replaced by a different coloring agent. Test rats might be excited, though.

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