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Jan. 27, 2025—In January 2025, the U.S. Food and Drug Administration (FDA) announced it would put a stop to the use of FD&C Red No. 3—also called Red Dye No. 3—in foods and in ingested drugs. Manufacturers have until 2027 to stop using FD&C Red No. 3 in foods and drinks and have until 2028 to stop using it in medicines.

Here are answers to some common questions about the ban.

Q. What is FD&C Red No. 3?

FD&C Red No. 3 is a synthetic color additive—sometimes called a food dye—that gives certain foods and beverages a vibrant red color. You might spot it among the ingredients in cakes, cookies, cupcakes, frostings, frozen desserts and candy. It's also used in some medicines taken by mouth.

Q. Why the ban?

The FDA ban was triggered by a 2022 petition about color additives, which asked FDA to review studies connecting the dye to cancer in rats.

A federal law called the Delany Clause bars FDA from allowing the use of a color additive if it has been shown to cause cancer in animals or people. Studies have found that male lab rats developed cancer after being exposed to high levels of FD&C Red No. 3.

Q. Does FD&C Red No. 3 cause cancer in humans?

FDA says that, according to current scientific evidence, FD&C Red. No. 3 does not cause cancer in humans and is safe to consume.

The laboratory rats were exposed to very high levels of the additive—much higher than what humans normally consume. And their cancers are linked to a rat-specific hormonal mechanism—meaning the same process does not happen in humans, says FDA.

Other studies of the effects of FD&C Red No. 3 on animals and humans did not show a link between its use and an increased cancer risk.

Q. Are color additives safe in general?

Color additives are safe for humans to consume when they are used properly, says FDA. FDA is responsible for making sure that additives, dyes and other substances added to foods, drugs and cosmetics are safe to use—and used appropriately. Before new products containing additives can be sold, they undergo a rigorous FDA safety review and approval process.

If you'd rather avoid color additives, check the ingredients label. Synthetic additives like FD&C Red No. 3 are listed there. Sometimes the name is shortened. For example, FD&C No. 3 might be listed as "Red 3."

Coloring from natural sources follows different rules. Foods with those colorings might say "artificial colors" or "color added" on the label instead.

Find information about smart, healthy food choices in our Nutrition health topic center.

Sources

• U.S. Food and Drug Administration. "Color Additives: Information for Consumers." https://www.fda.gov/food/food-ingredients-packaging/color-additives-information-consumers.
• U.S. Food and Drug Administration. "Color Additives Questions and Answers for Consumers." https://www.fda.gov/food/color-additives-information-consumers/color-additives-questions-and-answers-consumers.
• U.S. Food and Drug Administration. "FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs." https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.
• U.S. Food and Drug Administration. "FD&C Red No. 3." https://www.fda.gov/industry/color-additives/fdc-red-no-3.
• U.S. Food and Drug Administration. "How Safe Are Color Additives?" https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives.