The U.S. Food and Drug Administration (FDA) has announced its decision to revoke the authorization of FD&C Red Dye 3, a synthetic dye commonly used in food and ingested drugs. The decision comes amid concerns over its potential health risks.
In a constituent update published on its website today, the FDA said the decision is in response to a 2022 color additive petition that cited studies showing cancer development in male rats exposed to high levels of FD&C Red No. 3.
The agency clarified that the hormonal mechanism causing cancer in these rats does not occur in humans. Moreover, typical human exposure levels are significantly lower than those used in animal studies. Nonetheless, the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C) prohibits the FDA from authorizing a color additive found to induce cancer in humans or animals, leading to the revocation.
The Delaney Clause prohibits the FDA from approving any food additive found to cause cancer in humans or animals, regardless of exposure level. Enacted in 1958, it requires a zero-tolerance policy to ensure public safety.
FD&C Red Dye 3 is a food dye that gives a bright, cherry-red color and is commonly used in candies, frozen desserts, frostings, and certain ingested drugs. The FDA estimates that its usage is less prevalent compared to other certified colors.
According to the FDA memo, manufacturers using this dye in food products have until January 15, 2027, to reformulate their products, while those using it in ingested drugs have until January 18, 2028, to comply with the new regulations.
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