Skip to main content
News

FDA Revokes Red Dye No. 3 Authorizations Based on Delaney Clause, not Safety

FDA Building

The U.S. Food and Drug Administration (FDA) announced on January 15, 2025, that it is revoking the color additive authorizations for Red No. 3 in food and ingested drugs based on evidence showing that Red No. 3 is carcinogenic to male rats (but not humans or female rats). FDA’s announcement notes that the “Delaney Clause” of the Federal Food, Drug, and Cosmetic Act (FD&C Act) prevents the agency from authorizing an additive that has been found to cause cancer in humans or animals.

This action was taken in response to a 2022 color additive petition submitted by the Center for Science in the Public Interest, et. al. The petition requested that FDA review whether the Delaney Clause applied and cited two studies, among other data, that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism.

FDA pointed out in its announcement that, “The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.” The agency added that relevant human exposure levels to the dye are typically much lower than those that caused the effects shown in male rats. In addition, carcinogenicity of Red No. 3 has not been observed when female rats were tested, or when either sex of mice, gerbils, or dogs was tested.

While currently available scientific information does not support safety concerns regarding the use of Red No. 3, FDA felt it was required to make the decision based on the broad scope of the Delaney Clause, which was added to the FD&C Act over 60 years ago and has not been updated to reflect new scientific understandings of cancer.

The Federal Register announcement revoking the color additive listing for the use of FD&C Red No. 3 in food and ingested drugs can be found here. Manufacturers using Red No. 3 in food will be required to reformulate their products by January 15, 2027, while manufacturers using Red No. 3 in ingested drugs will need to reformulate by January 18, 2028.