FDA Revokes Authorization for Food Coloring Red 3 Due to Cancer Risks

On Wednesday, the Food and Drug Administration (FDA) made a significant decision to revoke the authorization for Red 3, a food coloring dye, due to concerns about its association with cancer in laboratory animals. Although FDA officials had previously stated that the evidence linking Red 3 to cancer did not apply to humans, they were compelled to act in accordance with a legal stipulation that mandates the removal of additives deemed carcinogenic in either humans or animals.

According to Jim Jones, the deputy commissioner for human foods at the FDA, the Delaney Clause prohibits the authorization of any food additive or color additive found to cause cancer. Despite the FDA's earlier position on human safety, studies showed that high levels of exposure to Red 3 could lead to cancer in male rats. The FDA acknowledged that the current scientific evidence does not support the continued use of Red 3, which has been a common ingredient in various food brands, from sweets to sauces.

The FDA's decision follows a petition from the Center for Science in the Public Interest and other organizations in 2022, which called for the ban of this additive. Food companies are now required to cease using Red 3 by January 2027, and similar efforts have been seen in California, where a ban on the dye has been proposed.

Proponents of the ban emphasize that food dyes primarily serve to enhance the visual appeal of processed foods, leading to questions about their necessity when there is a potential cancer risk involved. At the same time, concerns remain about artificial dyes like Red 3 and their possible links to hyperactivity in children, a topic that has garnered significant attention.

In the global context, Red 3 is allowed in some foods under different names in various countries, though in Europe, its use is restricted primarily to cocktail cherries. In the U.S., it can be found in several popular candies and other food products.

The candy industry has expressed its intention to comply with the FDA's guidance and maintain safety standards, while also advocating for a robust national regulatory framework from the FDA. Critics of the agency, including Robert F. Kennedy Jr., have urged for a crackdown on the use of certain food additives, arguing that the current regulatory environment leaves room for hazardous ingredients to be included in food products.