
After ignoring legislative directives and a deep well of scientific data over the last 33 years, the U.S. Food and Drug Administration (FDA) has belatedly banned the continued use of Food, Drug & Cosmetic (FD&C) red dye no. 3 in food, including dietary supplements (effective January 15, 2027) and ingested drugs (effective January 18, 2028). This action comes more than three decades after scientists discovered links between red dye no. 3 and cancer in animals.
Red dye no. 3 is a petroleum-based color additive chemically known as erythrosine. Approved for use in food in 1907, red dye no. 3 gives food and beverages a bright red color. In 1990, the FDA banned its use in cosmetics and topical drugs based on evidence it caused cancer in rats. In 1992 the agency announced it intended to revoke its use in food and ingested drugs for the same reason; the agency failed to do so for the next 33 years.
“This is welcome news, but incredibly late in coming. For more than 30 years, the FDA has had an obligation to take this action under the Delaney Clause, but it continued to allow this non-essential chemical colorant to remain in candy, desserts and other food products,” said Betsy Lehrfeld, President of Citizens for Health.
What is the Delaney Clause?
The Delaney Clause, enacted in 1960, is a provision of the Food, Drug and Cosmetic Act (FD&C Act) that prohibits the FDA from approving color additives that cause cancer in humans or animals. Studies in the 1980s found that red dye no. 3 caused thyroid cancer in male rats.
Over teh years the FDA has maintained, and continues to assert in announcing the ban, that the mechanism by which red dye no. 3 causes cancer in male rats does not occur in humans. Further, the FDA contends, ‘claims that the use of the FD&C red dye no. 3 in food and ingested drugs puts people at risk are not supported by the available scientific evidence.’
“Citizens for Health believes the FDA has long disregarded its responsibility with respect to color additives by substituting its judgment for the plain text of applicable law. For more than 30 years, the FDA has known that red dye no. 3 causes cancer in rats. The FDA has no authority to decide not to enforce the Delaney Clause. The FD&C says American consumers should be protected from any color additive that causes cancer in humans or animals. The Delaney Clause does not permit the FDA to use its own judgment as to whether ‘available scientific evidence’ shows a color additive poses a risk of harm to humans. Congress itself, in passing the Delaney Clause, made the decision about risk: consumers should not be subjected to any risk from color additives that cause cancer in animals.”
Take Action Today
Act now and contact your Congress member asking them to require FDA to undertake a review of all approved color additives to ensure that the protections provided to American consumers and families by the Delaney Clause are enforced.