The FDA has announced that it will revoke authorization for the use of the synthetic food dye FD&C Red No. 3 in foods effective January 2027 and in ingested drugs effective January 2028 in response to a color additive petition filed by consumer advocacy groups in 2022. The petition cited two studies that linked exposure to high levels of FD&C Red No. 3 to thyroid cancer in male lab rats due to a rat-specific hormonal mechanism and requested that the agency review whether the Delaney Clause applied. The Delaney Clause was enacted in 1960 as part of the Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and prohibits FDA authorization of food additives or color additives that have been found to induce cancer in humans or animals.
The FDA emphasized that the revocation is occurring as a matter of law and not due to safety concerns about human consumption of FD&C Red No. 3. The announcement noted that the way FD&C Red No. 3 causes cancer in male rats does not occur in humans and that exposure levels to the color additive for humans are typically much lower than those that caused the effects in male rats. The agency also explained that “studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”
In 1990, the FDA revoked provisional authorization for the use of FD&C Red No. 3 in topical drugs and cosmetics under the Delaney Clause following a petition for permanent authorization. But the agency had not acted to revoke the color additive’s permanent authorization for use in foods and ingested drugs due to the resources required to remove that authorization and the agency’s lack of safety concerns for humans based on the available data.
In a post on its website, the Center for Science in the Public Interest, which led the petition effort, stated that the “long-delayed ban is a win for public health” and finally addresses “a decades-long regulatory failure.”
In a response to the ban, the International Association of Color Manufacturers (IACM) defended the safety of FD&C Red No. 3 and highlighted the FDA’s acknowledgement that the color additive does not pose a risk to humans based on the available scientific evidence. “When the Delaney Clause was introduced in the late 1950s, it was believed that even one molecule of a substance could cause cancer and pose a risk,” the IACM statement says. “However, science has advanced significantly in the past three decades, and it is now a well-accepted principle that test animals fed additives in high concentrations may produce increased incidences of tumors, but that does not necessarily indicate that the same effects will pertain to humans.”
David Schoneker, president of Black Diamond Regulatory Consulting, a consulting firm specializing in regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries, referred to the ban as “a Delaney Clause debacle.” He called for the FDA to pressure Congress to change the Delaney Clause to allow for a scientific risk assessment approach to determine whether there is actually a risk to human safety when animal studies show links to cancer.
“FDA said very clearly that this revocation of the approval of FD&C Red No. 3 doesn’t mean there’s any safety concern for humans with the use of this material,” says Schoneker. “But unfortunately, the Delaney Clause, which is extremely outdated and antiquated, doesn’t take any modern risk assessment concepts into consideration. It doesn’t give FDA the flexibility to use good science in decision making.”
The FDA’s announcement cited an additional instance where the agency revoked an authorization based on the Delaney Clause. In 2018, the agency revoked 6 synthetic flavors in response to a food additive petition. In that instance, the agency stated, “Although we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, the FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use.”
This week's announcement comes just days before the agency is set to change hands under the incoming Trump administration. Robert F. Kennedy Jr., President-elect Trump’s nominee for Secretary of Health and Human Services, has been critical of the FDA’s food safety policies and has spoken out against food dyes.
