As announced on January 15, 2025, the Food and Drug Administration is banning the use of FD&C Red No. 3 in any food product or drugs that are ingested. What foods does this affect? Any food or ingested drug that has a bright, cherry-red color. Food examples include candy, cakes and cupcakes, cookies, frozen desserts, and frosting or icings.
Two studies have shown cancer in laboratory male rats when exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. There are no scientific studies that have shown the relationship of consuming FD&C No. 3 causing cancer in humans or other animals. According to the Delaney Clause, if any food additive or color additive is proven to induce cancer in humans or animals, it cannot be used.
Manufacturers using FD&C Red No. 3 must reformulate their products by January 15, 2027 or January 18, 2028 based on sales. Imported foods into the U.S. must comply with FDA regulations and not contain this ingredient. Examples of colors to replace FD&C Red No. 3 may include red beet extract or paprika extract.
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