FDA Revokes Food Dye Red No. 3: Cancer Evidence in Male Rats, 'Human Risk Not Shown'

The U.S. Food and Drug Administration (FDA) has decided to revoke authorization for the use of the synthetic dye FD&C Red No. 3 (erythrosine) in food and oral drugs. The dye has been used to give a bright cherry color to candy, cakes and cupcakes, cookies, frozen desserts, frostings and more. The FDA estimates that its use is narrower than that of other certified color additives.

The basis is the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This clause prohibits the authorization of food and color additives that have been found to induce cancer in humans or animals. After reviewing a petition from the Center for Science in the Public Interest (CSPI) and others, the FDA identified two studies in which male rats exposed to high doses developed cancer, and determined that revocation is required under the law. Food manufacturers have about two years and drug makers about three years to comply, and imported foods must also meet the same standard.

The difference between a legal determination and a scientific risk assessment

The FDA explained that the cancer in the rats came from a hormonal mechanism specific to male rats, and that this mechanism does not occur in humans. Typical human exposure is far lower than the doses that produced effects in rats, and other animal and human studies have not observed the same effect. The FDA said that the claim that the dye is hazardous to humans is not supported by current scientific information. In other words, this action is not the result of a new risk assessment but the result of applying a legal rule under which an additive cannot be allowed once animal carcinogenicity is established. Some countries still permit certain uses of erythrosine.