FDA Bans Use of Red Dye No. 3

Last Updated: January 23, 2025

On January 15, 2025, the U.S. Food and Drug Administration (FDA) made an amendment to the color additive regulations which bans the use of FD&C Red No. 3 dye in food and medicines. FD&C Red No 3. is also known as Red Dye No. 3, Red Dye 3, and erythrosine and is a synthetic food dye that causes a bright red color. Red Dye No. 3 can be found in some medicines and many foods including candy, cakes, cupcakes, cookies, popsicles, and frosting.

Studies showed that high levels of FD&C Red No. 3 dye caused cancer in male laboratory rats. Although there has been no evidence of FD&C Red No. 3 causing cancer in humans, due to the Delaney clause the color additive cannot be used in food. The Delaney Clause states any food or color additive found to cause cancer in humans or animals must be banned. For more information regarding the health concerns relating to Red Dye No. 3, visit the FDA’s website, FD&C Red No. 3 | FDA .

The FDA will provide guidance and recommended alternatives to drug manufacturers that often use the color additive. These companies will have until January 18, 2028, to completely remove FD&C Red No 3 from their products.

FDA Revokes Use of FD&C Red No.3 in Foods and Drugs