The Food and Drug Administration (FDA) has officially banned Red No. 3, a synthetic petroleum-based dye used to create a bright red color in foods, beverages, and dietary supplements. The decision comes after decades of evidence linking the dye to cancer in laboratory animals.
The dye, commonly found in products like candy, cereals, fruit cocktail cherries, and strawberry-flavored drinks, was first approved for food use in 1907. However, studies in the 1980s revealed that male rats exposed to high levels of the additive developed tumors, prompting renewed calls for its removal. The FDA had already banned Red No. 3 from cosmetics in 1990.
Dr. Peter Lurie, president of the Center for Science in the Public Interest (CSPI), celebrated the ban as a significant step forward, stating, “It removes an unnecessary hazard from the American food supply, even though it should have occurred more than three decades ago.”
The ban gives food manufacturers until January 15, 2027, to reformulate their products. Producers of dietary supplements and other ingested drugs will have an additional year to comply.
Red No. 3 is already banned or heavily restricted in regions such as Australia, Japan, and the European Union. Some U.S. manufacturers have voluntarily removed the dye in anticipation of stricter regulations.
While the FDA’s move is a victory for consumer safety advocates, the agency noted that it could not authorize the continued use of a color additive if it has been shown to cause cancer in humans or animals. Deputy Director Jim Jones emphasized that the decision aligns with the FDA’s mandate to protect public health.
This ban highlights growing concerns over artificial dyes’ health impacts, including potential behavioral effects in children, although the FDA has previously found insufficient evidence to link synthetic dyes to hyperactivity.
The FDA’s action underscores the importance of science-based regulation and marks a long-awaited shift toward safer food standards in the U.S.
