The Curious Case of Red Dye No. 3: A Decades-Long Debate

A Controversial Ban Rooted in a Single Study

In a move that surprised many, the FDA announced a ban on Red Dye No. 3 in food and ingested drugs in January. The agency's justification? A single, industry-funded rat study from 1987. Ironically, the toxicologist who led the study, Joseph Borzelleca, maintains that his research showed no carcinogenic risk to humans.

"If I thought there was a problem, I would have stated it in the paper," Borzelleca, now a professor emeritus, told KFF Health News. "I have no problem with my family – my kids and grandkids – consuming Red 3."

The FDA's Conflicting Stance

Despite Borzelleca's conclusions, the FDA's interpretation of the same data led to a ban on Red 3 in cosmetics in 1990, and a desire to ban it in food and drugs in 1992. This desire, however, remained dormant for over 30 years, only resurfacing under the Biden administration shortly before Robert F. Kennedy Jr.'s confirmation as head of the Department of Health and Human Services.

Even while enacting the ban, the FDA itself admitted a lack of evidence suggesting Red 3 is dangerous to people. This seeming contradiction further fuels the debate around the dye's safety.

A Long and Winding Road to Regulation

Red 3, approved for food use in the U.S. back in 1907, has become a ubiquitous ingredient in countless products. The International Association of Color Manufacturers (IACM) insists on its safety at the low levels consumed by humans, pointing to studies supporting this claim.

However, consumer advocacy groups, including the Center for Science in the Public Interest, championed the ban, citing the Delaney Clause, which prohibits any cancer-causing ingredient in animals from being used in food.

"At the end of the day, this is an unnecessary additive," argues Thomas Galligan, a scientist at the Center for Science in the Public Interest. "It’s a marketing tool...But federal law is clear: No amount of cancer risk is acceptable in foods.”

A Global Perspective and Future Implications

California took the lead in 2023, banning Red 3 in food starting in 2027 based on concerns about hyperactivity in children. This mirrors similar bans in the European Union, Australia, and Japan. The EU even requires warnings on food labels about potential hyperactivity links to other allowed dyes.

Some manufacturers, anticipating the ban, have already begun reformulating products, using alternatives like beet juice, carmine, and plant-based pigments. But questions remain about the scientific basis for the FDA's decision and the long-term implications for the food industry.

The Scientist Behind the Study

Borzelleca, whose research sparked this entire saga, expressed surprise at the FDA's decision, particularly given the lack of clear evidence of carcinogenicity in his study.

"I am surprised all this time has gone by and it’s been safe for human use, and now it’s being pulled from the market due to concerns not supported by the data," Borzelleca stated. "Our study did not find this was a carcinogen.”

His long and distinguished career, spanning decades of research on food additives and other potentially harmful substances, adds another layer of complexity to the Red Dye No. 3 debate.