IACM Responds to Revocation of FD&C Red No. 3: FDA Confirms Color Additive Remains Safe for Human Consumption

Media Contact: Meredith Huddle
mhuddle@iacmcolor.org
202-293-5800

January 15, 2025

WASHINGTON – The International Association of Color Manufacturers (IACM) remains steadfast in its commitment to upholding the highest safety standards for color additives used in consumer products and firmly believes in evidence-based decision-making rooted in sound scientific assessments.

Today, the U.S. Food and Drug Administration (FDA) amended its color additive regulations to no longer allow for the use of FD&C Red No. 3 while also noting that “[t]he way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.” The FDA also states that “[s]tudies in other animals and 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.” The decision specifically removes approval for FD&C Red No. 3 in food and ingested drugs in response to a petition from a coalition of non-governmental organizations petition, despite the FDA’s acknowledgment that the color additive does not pose a risk to human health based on available scientific evidence.

In 1990, FDA denied a petition to expand authorized uses of FD&C Red No. 3 to cosmetics, dermal pharmaceutical applications, and lakes, citing the Delany Clause, which prohibits FDA from authorizing a food or color additive shown to be a carcinogen in humans or animals. 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. 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.

Notably, the FDA states that the revocations are due to the rigid language of the Delaney Clause and that otherwise, FD&C Red No. 3 meets the FDA’s safety standard and remains safe for use as a color additive:

“[w]e conclude that FD&C Red No. 3 meets the safety standard of a reasonable certainty of no harm required for a color additive…[h]owever, as a matter of law we must revoke the regulations authorizing the uses of FD&C Red No. 3 because it has been shown to induce cancer in male rats.”

Additionally, Jim Jones, Deputy Commissioner for Human Foods at the FDA, has underscored the limits of the Delaney Clause, noting that “evidence shows cancer in laboratory male rats exposed to high levels of [FD&C Red No. 3]. Importantly, the way that [FD&C Red No. 3] causes cancer in male rats does not occur in humans.”

FDA’s conclusion that FD&C Red No. 3 continues to be safe and does not pose a risk to public health under its conditions of intended use as a color is consistent with other global scientific and regulatory authoritative bodies, including the World Health Organization’s Joint Expert Committee on Food Additives (JECFA), which reconfirmed its safe use in 2018 and the European Food Safety Authority (EFSA), which reassessed the color in 2011. The color remains approved (as erythrosine) globally in countries including, but not limited to, China, Japan, Australia/New Zealand, Canada, and the European Union.