FDA Bans Red No. 3 Food Dye, Citing Health Concerns

WASHINGTON – The U.S. Food and Drug Administration has announced a ban on the use of Red No. 3 dye in food, beverages, and ingested drugs, citing concerns over its potential health risks.

The dye has been in use since its approval in 1969.

The decision follows years of advocacy from health groups and is rooted in studies linking high doses of the dye to cancer in lab animals. Although the FDA noted no confirmed connection between Red No. 3 and cancer in humans, federal law prohibits the use of additives that may induce cancer in humans or animals.

Red No. 3, commonly used to create a bright cherry-red hue in candies, cakes, cookies, and frosting, has already been banned in cosmetics since 1990. The dye was largely prohibited in Europe beginning in 1994.

Food manufacturers have until 2027 to reformulate products containing the dye, while drugmakers have until 2028. 

The FDA’s action does not affect Red No. 40, a similar dye that will remain in use despite studies indicating it may also pose risks in animals.