Dr. Jerold Mande
The FDA’s decision stems from a 2022 petition by organizations such as the Center for Science in the Public Interest (CSPI) and the Environmental Working Group. Dr. Jerold Mande, a Harvard University adjunct professor of nutrition, described the ban as “long overdue” and “a small step in the right direction.” The move also follows California’s 2023 prohibition of the dye, signaling a broader push for stricter food safety regulations.
Red dye No. 3 was already banned in cosmetics and topical drugs in 1990 under the FDA’s Federal Food, Drug, and Cosmetic Act’s Delaney Clause. The clause mandates that additives linked to cancer in humans or animals be prohibited. However, the FDA had allowed its continued use in foods and ingested drugs, citing the lack of direct evidence connecting the dye to human cancer. This decision, according to Dr. Jennifer Pomeranz of NYU’s School of Global Public Health, highlights a troubling “regulatory paradox.”
The additive has been shown to cause cancer in male rats at high doses, leading to its ban in non-food applications. Yet, as FDA Deputy Commissioner Jim Jones noted, the mechanism by which the dye induces cancer in rats does not occur in humans.
The agency’s recent reevaluation underscores this distinction, emphasizing that human exposure levels are significantly lower than those used in animal studies. Despite this, critics argue that any association with cancer, regardless of the species, should have prompted a swifter ban.
Ken Cook, cofounder and president of the Environmental Working Group, hailed the FDA’s decision as a “monumental victory” for consumer safety, crediting public health champions like Michael Jacobson for their decades-long efforts. However, he cautioned that this should only be the beginning of broader regulatory reforms.
The United States has lagged behind other major economies in addressing Red 3. The European Union imposed a ban on its use in 1994, followed by similar restrictions in Japan, China, the UK, Australia, and New Zealand.
“They don’t add any nutritional value, they don’t preserve the food — they’re just there to make food look pretty,” Thomas Galligan, a scientist told reporters.
Manufacturers have been given a phased timeline to comply with the new regulations; food producers must reformulate products by January 2027, and drug makers by January 2028.
Some companies, including Ferrara (makers of Brach’s candies) and Just Born (makers of PEEPS), have already removed red dye No. 3 from their products. Others are turning to alternatives like red dye No. 40, beet juice, and pigments from natural sources such as radishes and purple sweet potatoes.
Advocates hope this decision will push the FDA toward adopting the “precautionary principle” seen in Europe, where regulators prioritize consumer safety even in the absence of conclusive evidence.
Consumers concerned about exposure to red dye No. 3 are advised to check ingredient labels, where it is listed as “FD&C Red No. 3” or “red 3.” The National Confectioners Association emphasized that food safety remains a priority for the industry, calling for greater transparency and increased funding for the FDA.
Dr. Peter Lurie, director of CSPI, summarized the sentiment of many: “This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy.” However, he added, “The fight doesn’t stop here.”
