The US regulatory authority, the Food and Drug Administration (FDA), has decreed a prohibition on red dye No. 3 for food and oral medicines. This outcome comes three decades post the discovery that this color additive instigated carcinogenic conditions in lab rats. Over the years, an array of advocates had persistently urged the FDA to debar this additive.
The year 2022 saw these advocates file an appeal, requesting the FDA to delist this harmful red dye from ‘generally recognized as safe’ color additives. Jim Jones, who helms the FDA’s food regulation department expressed in a congressional hearing last December that an impending verdict would likely emerge within weeks.
Environmental Working Group’s president Ken Cook celebrated the FDA’s decision as an unprecedented triumph for public health and safety. In an issued statement, he emphasized that the ban underlines the need to prioritize American health, particularly that of susceptible children, over the vertical interests of the food sector.
Peter Lurie, president of the Center for Science in the Public Interest, another participant in the petitioning process, highlighted the extraordinary delay in enforcing the ban. He underscored the astonishing lag considering the agency acknowledged the underlying science decades ago, leading to the removal of red dye No. 3 from cosmetic and topical drugs.
Robert F. Kennedy Jr., who had been selected for the secretary of Health and Human Services role by Donald Trump, has previously criticized the FDA’s delayed reaction to potentially detrimental additives. This sentiment echoes among public health professionals who have expressed confusion over the stubborn inertia of the agency.
The timing of the FDA prohibition notably precedes Trump’s tenure, facilitating the fulfillment of his and Kennedy’s campaign proposition to tighten the reins on food additives. The use of these additives by companies is explained by the improved appearance, texture, and longevity that they confer to consumables.
The petitioners had earlier cited the Delaney Clause of the Food, Drug and Cosmetic Act, which disallows FDA approval of an additive proven to cause cancer in humans or animals. The FDA ultimately concurred that red dye No. 3 fits this criteria, even though Jones further clarified that its mode of inducing cancer in male rats is not translate to humans.
The Food, Drug and Cosmetic Act’s Delaney Clause stands firm; it strictly forbids the FDA from endorsing a food or color additive identified as a carcinogen for humans or animals,’ said Jones. The enacted ban allows the food industry until January 2027, and pharmaceutical manufacturers till January 2028 to sever their usage of red dye No. 3.
Various industry trade bodies have indicated an absence of resistance against the ruling. National Confectioners Association, in a public statement, reiterated their commitment to abide by the FDA’s regulations and safety standards, emphasizing that food safety remains a top priority for U.S. confectionery companies.
Sarah Gallo, an executive at the industry trade organization Consumer Brands Association, lauded the FDA’s decision to repeal the authorized utilization of red dye No. 3. She viewed it as a testament to the FDA’s commitment towards making risk assessments and scientific adjudications in ensuring product safety in the market.
This industry response is rather exceptional, considering the long-standing industry lobbying largely attributed to the delay in prohibiting the dye’s usage in most foods. Peter Lurie from CSPI highlighted this point, further referencing the maraschino cherry industry’s deliberate opposition to the ban, claiming it would impact consumer preferences.
Ban on red dye No.3 was enacted in Europe much earlier back in 1994, with an exemption given for maraschino cherries. The dye is also found in Pez Candy, Brach’s Candy Corn, certain meat products, various juices, and more – spanning across more than 3000 products, as indicated by the Environmental Working Group database.
An early study from the ’80s revealed that 15 out of 70 male rats developed thyroid tumors after being administered red dye No. 3, equivalent to 4% of their lifetime diet. Although benign for the most part, these cases led to a partial ban by the agency in 1990 on use with ice creams, baked goods, and cosmetics.
California took unilateral action in recent years, eliminating red dye along with three other additives due to studies suggesting these synthetic dyes could heighten hyperactivity in children. This move sparked a wave of activism urging states to adopt their own legislations on additives, in turn increasing pressure on the FDA.
Last fall, the FDA put forward a comprehensive plan for proactive safety evaluations of chemical food additives. However, a requested $19 million funding for the program was denied by Congress. Jones warns that, despite high intention and priority, progress could be hampered in face of current budget constraints.