FDA bans on red dye No. 3 after long-standing delays in food safety

The Food and Drug Administration announced a ban on red dye No. 3 in food products, marking the end of a decades-long delay in removing the artificial color additive despite evidence of its cancer-causing properties in animals.

The decision comes 25 years after FDA scientists determined that rats fed large amounts of the dye developed malignant thyroid tumors at higher rates than those not exposed to the additive. Food manufacturers will have two years to reformulate their products, while pharmaceutical companies have three years to remove the dye from medicines.

The ban extends restrictions already in place since 1990, when the FDA prohibited the use of red dye No. 3 in cosmetics and topical drugs based on the same animal studies. That partial ban was implemented under the Delaney clause, a federal law requiring the FDA to prohibit any color additive shown to cause cancer in animals or humans.

Jim Jones, FDA deputy commissioner for human foods, told Congress last month that despite the ban, the agency does not consider the dye a risk to human health. "We do not believe there is a risk to humans," Jones said, explaining that the biological mechanism causing cancer in rats does not occur in people.

The dye, also known as erythrosine, has been present in U.S. food products since its approval in 1907. It currently appears in various processed foods, including Del Monte fruit cocktail, Nesquik strawberry milk, beef jerky, fruit rolls, candy and ice cream.

Jensen N. Jose, regulatory counsel for food chemical safety at the Center for Science in the Public Interest, which led efforts to ban the dye, emphasized that the FDA's assessment of risk was irrelevant under the law. "Regardless of the truth behind their argument, it does not matter," Jose said. "Once it is established that it causes cancer, FDA must prohibit the chemical by law."

Diana Winters, deputy director of the Resnick Center for Food Law and Policy at UCLA Law, said the situation demonstrates why many experts believe the law needs updating. "A lot of people think we need to reform this," Winters said. "It does lead to some absurd results."

The Delaney clause emerged during a period of heightened concern about cancer-causing substances in the post-World War II era. Rep. James Delaney, a New York Democrat whose wife was undergoing cancer treatment, championed the zero-tolerance provision for cancer-causing substances, though the law did not address other potential health risks.

Studies of red dye No. 3 in the 1970s and 1980s showed male rats consuming the highest concentrations developed significantly more thyroid tumors, both malignant and benign, compared to rats not fed the dye. Female rats showed elevated rates of benign tumors at certain doses.

The World Health Organization and Food and Agriculture Organization of the United Nations conducted extensive reviews finding "no concerns" about cancer risk, fertility problems or developmental issues in humans consuming realistic amounts of the dye.

FDA Commissioner Robert Califf addressed the challenges of implementing the Delaney clause at a Senate Health, Education, Labor and Pensions committee hearing last month. "When we ban something, it will go to court," Califf said. "And if we do not have the scientific evidence that will stand up in court, we will lose in court."

Emily Broad Leib, director of the Center for Health Law and Policy Innovation at Harvard Law School, noted that removing additives from the food supply involves complex regulatory procedures. "The Delaney clause probably works a lot better at the outset if you are trying to add a new substance to food," Leib said. "Once things are in food, it takes a really long time to remove it."

Some experts argue the law's narrow focus on cancer risk overlooks other potential health concerns. "There are a lot of things in foods naturally that cause cancer, and the Delaney clause does not cover that," said Alyson Mitchell, a food scientist at UC Davis. "It also does not speak to anything regarding other illnesses, whether it is kidney dysfunction or ADHD or mental health issues or endocrine imbalances."

The General Accounting Office, now known as the U.S. Government Accountability Office, recommended updating the Delaney clause in 1981 to reflect current scientific knowledge and apply "equally to cancer-causing and non-cancer-causing substances."

California has already banned red dye No. 3 and six other dyes in foods served or sold in schools. Scientists examining the dyes for California's Office of Environmental Health Hazard Assessment found behavioral impacts more concerning than cancer risk, according to Asa Bradman, an exposure assessment and epidemiology expert at UC Merced who co-authored the state's report.

The FDA has studied behavioral effects of color additives but has not found "a clear and causal link," according to an FDA spokesperson. While some children with ADHD appear sensitive to food dyes, possibly due to genetic variants affecting histamine processing, the agency does not consider the dyes "neurotoxic."

Mitchell, who contributed to the California report, said red dye No. 3 poses less concern now as manufacturers have been phasing it out for over a decade. She expressed more worry about red dye No. 40, which remains widely used in processed foods marketed to children and has been linked to hyperactivity.

"I am grateful for the Delaney clause because I do think it has been very helpful in trying to protect our food," Mitchell said. "But it does not go far enough. So much of this needs to be revisited."

The FDA's decision illustrates similar challenges with other food additives. In 2018, the agency revoked authorization for myrcene, a flavoring additive, after studies showed it caused cancer in rats and mice at high doses. However, the FDA noted that typical human consumption was 813,000 times lower than doses causing cancer in animals, and natural myrcene occurs in foods like mangoes and citrus juices at levels 16,500 times higher than the synthetic version.

Food industry scientists argued in a 2020 paper published in Regulatory Toxicology and Pharmacology that such decisions driven by the Delaney clause undermine public trust in regulatory agencies and promote irrational fear of chemicals in the food supply.

The FDA spokesperson said the agency would act on convincing evidence of safety concerns for any artificial dye, whether covered by the Delaney clause or not. For now, manufacturers must begin reformulating products containing red dye No. 3 while continuing to navigate the complex landscape of food additive regulation under aging legal frameworks.

Also Read:

1. That "Healthy" Glass of Wine? It Could Be Raising Your Cancer Risk
2. FDA bans red dye No. 3 from food, drinks and ingested drugs in the US