Scientist Disputes FDA’s Ban on Red Dye No. 3, Says Risk Is Overstated

Tags: FDA, Red Dye No. 3, food safety, cancer risk, food additives, consumer advocacy

FDA Cites 1987 Study to Justify Ban

The U.S. Food and Drug Administration (FDA) has banned Red Dye No. 3 in food and ingested drugs, citing a 1987 rat study as evidence of potential carcinogenic effects. However, the lead scientist behind the study, Joseph Borzelleca, argues that the FDA misinterpreted his findings.

Borzelleca, a toxicologist and professor emeritus at Virginia Commonwealth University, insists his research did not conclude that Red 3 causes cancer in humans. “If I thought there was a problem, I would have stated it in the paper,” he said, emphasizing that he has no concerns about his own family consuming products containing the dye.

FDA’s Longstanding Concerns Over Red 3

The FDA banned Red 3 in cosmetics in 1990 after reviewing Borzelleca’s study and determining that the dye caused cancer in male lab rats. In 1992, the agency sought to remove it from food and drugs but lacked the resources to enforce the ban at the time.

More than three decades later, the FDA acted on renewed pressure from consumer advocacy groups. The ban was finalized just before President Joe Biden left office, weeks ahead of Robert F. Kennedy Jr.’s confirmation as Secretary of Health and Human Services under the Trump administration.

Consumer Advocates Applaud the Ban

Consumer advocacy organizations, including the Center for Science in the Public Interest (CSPI), welcomed the FDA’s decision. CSPI scientist Thomas Galligan pointed to the Delaney Clause, a federal regulation that prohibits any ingredient found to cause cancer in animals from being used in food, stating, “No amount of cancer risk is acceptable in foods.”

Industry and Scientific Debate Over Safety

The International Association of Color Manufacturers (IACM) maintains that Red 3 is safe in the small amounts typically consumed by humans. The dye, first approved in 1907, is found in thousands of products, including cereals, candy, and beverages.

The FDA itself has acknowledged that Red 3 does not cause cancer in humans in the same way it does in lab rats. However, newly appointed FDA commissioner Marty Makary has raised concerns over food additives’ potential risks, particularly to children.

Global Bans and Industry Alternatives

California recently became the first U.S. state to ban Red 3 in food, effective 2027, citing potential links to hyperactivity in children. The European Union, Australia, and Japan have already prohibited the dye in food products.

Many food manufacturers have started phasing out Red 3, replacing it with natural alternatives like beet juice, carmine (from insects), and pigments from red cabbage or purple sweet potatoes.

Borzelleca remains skeptical of the ban, arguing that his study was misrepresented. “Our study did not find this was a carcinogen,” he said, expressing surprise that Red 3 is being removed from the market after decades of widespread use.