In a historic move, the US Food and Drug Administration (FDA) announced a ban on the use of red dye No. 3 in food, beverages, and ingestible drugs. This decision comes more than 30 years after scientists identified links to cancer in animals exposed to the synthetic color additive. Red dye No. 3, a chemical known as erythrosine, has been used to color a variety of consumer products, including candy, food, and beverages, giving them a bright cherry-red hue. The ban follows a November 2022 petition from advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, citing the harmful effects of the additive.
A long-delayed victory for public health
The ban is part of the FDAās effort to address mounting concerns about the safety of artificial food dyes, especially those with cancerous properties. Although red dye No. 3 has been approved for use in food since 1969, its carcinogenic effects on animals were first observed in the 1980s, yet it remained in products for decades. Notably, red dye No. 3 was banned from cosmetics and topical drugs in 1990 due to similar concerns. However, its continued use in foods and drugs had been a source of controversy, with experts calling for greater regulation of additives.
Dr. Jerold Mande, an adjunct professor at Harvard Universityās T.H. Chan School of Public Health, called the decision ālong overdueā but a positive step forward. He emphasized the barriers the food industry has historically placed in the way of such decisions. This ban is seen as a monumental victory by public health advocates, including Ken Cook, cofounder of the Environmental Working Group, who hailed the decision as a result of years of tireless advocacy.
The FDA has given manufacturers of food products containing red dye No. 3 until January 2027, and those using the dye in drugs until January 2028, to reformulate their products. This shift will affect both domestic and imported goods. While many popular brands have already reduced or eliminated the use of red dye No. 3, such as Ferrara (makers of Brachās candies), the ban will further reduce exposure. Some companies have already switched to alternatives like red dye No. 40, which is not as closely linked to cancer in animal studies, though it has its own set of concerns.
The regulatory paradox and global implications
The FDAās decision to revoke red dye No. 3’s approval comes after years of ongoing studies and scientific review. Despite earlier studies indicating the dyeās potential carcinogenic effects in animals, the FDA maintained its approval for food use, arguing that the exposure levels for humans were lower than those that caused harm in rats. However, the Delaney Clause of the Federal Food, Drug, and Cosmetic Act prohibits any substance that causes cancer in animals from being approved for food use. Critics argue that this paradox has allowed the FDA to continue approving harmful additives despite clear evidence of their potential dangers.
This ban also brings the United States closer to European standards, where red dye No. 3 has been banned in food products since 1994, though exceptions exist for certain products like maraschino cherries. The decision signals a shift towards a more cautious regulatory approach, akin to the precautionary principle followed in Europe. At the same time, the FDAās history of delayed action on harmful food ingredients raises concerns about its effectiveness in protecting public health, with many calling for greater transparency and funding for the agency.
The ban also aligns with the growing trend of states like California, which enacted its own ban on red dye No. 3 in 2023. In addition, at least 10 other states have introduced legislation aimed at restricting or banning the use of this additive. Public health experts like Dr. Jennifer Pomeranz and Dr. Thomas Galligan have long criticized the FDA for its slow response to scientific evidence, urging stronger regulatory measures to protect consumers.
As the ban moves forward, consumers can take steps to avoid red dye No. 3 by checking ingredient lists on food and medication labels. Many ultra processed foods and beverages contain artificial dyes, so limiting these products is another way to reduce exposure. For medications, consumers should review the inactive ingredients section or opt for dye-free alternatives. While the ban is a significant step forward in protecting public health, it also highlights the need for continued vigilance and reform in the food industryās approach to additives.