"Today's action by the FDA is long overdue, but it represents a small step in the right direction and hopefully signals a renewed commitment from the agency to fulfill its responsibilities despite the numerous obstacles the food industry places in its path," said Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, in an email.
Ken Cook, cofounder and president of the Environmental Working Group, called the decision a "monumental victory" for consumer health and safety in a news release. "We wouldn’t be celebrating this historic decision today without the relentless leadership of public health advocates like Michael Jacobson and others who have fought for decades on behalf of consumers."
Red dye No. 3 is found in numerous candy, food, and beverage products, although some of the most popular brands have either stopped using it or never used it in the first place. For instance, fewer than 10% of products from candy company Ferrara, known for Brach’s candies, contain the dye, as the company began phasing it out in early 2023, a Ferrara spokesperson confirmed via email.
According to a spokesperson, Just Born, the company behind PEEPS, ceased using red dye No. 3 after Easter 2024.
In its place, many companies now use red dye No. 40, which is considered a healthier alternative, as it has not been as closely linked to cancer in animals.
However, red dye No. 40 also faces scrutiny. In September, California banned it in foods and drinks sold in public schools over concerns about its potential links to behavioral and attention problems in children. One study found a possible connection to accelerated immune-system tumor growth in mice, and other sources have raised concerns about its content of benzene, a known carcinogen.
The Regulatory Paradox of Red Dye No. 3
Red dye No. 3 has been allowed in food products despite the Delaney Clause in the FDA’s Federal Food, Drug, and Cosmetic Act. This clause prohibits the approval of any color additive that is found to cause cancer in animals or humans when ingested.
In 1990, the FDA banned the use of red dye No. 3 in cosmetics and topical drugs under the Delaney Clause, after studies revealed that high doses of the dye caused cancer in lab rats. However, since the cancer-causing mechanism observed in rats does not occur in humans, the FDA did not revoke its approval for red dye No. 3 in food, as the studies did not raise concerns about human safety.
Since its initial approval in 1969, the FDA has reassessed the safety of red dye No. 3 several times, based on animal studies rather than human trials.
While no studies have conclusively linked red dye No. 3 to cancer in humans, the FDA maintains that "relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats," and that there is no scientific evidence supporting claims that the dye poses a risk to human health when used in food and drugs.
However, Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University, argues that the issue remains unresolved because the Delaney Clause requires the FDA to remove any substance that causes cancer in animals or humans from the food supply, regardless of the exposure levels or the relevance of animal studies to human health.
The FDA’s decision to revoke red dye No. 3’s authorization is based on legal considerations, the agency said.
Additional studies have raised further concerns. A 2012 report found a link between red dye No. 3 and cancer in animals, while other research has suggested that artificial food colorings, including red dye No. 3, could contribute to attention deficit hyperactivity disorder (ADHD) in some children, although they are not considered a primary cause.
In 2021, a study by the California Office of Environmental Health Hazard Assessment found that red dye No. 3 could contribute to behavioral issues in children, such as decreased attention. The report also raised concerns that the federal standards for safe intake of food dyes, which had been established decades earlier by the FDA, may not be sufficient to protect children's brain health. The study pointed out that these legal limits did not take into account recent scientific findings, according to the Environmental Working Group.
“The FDA’s decision finally ends the regulatory paradox of Red 3,” said Dr. Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest in Washington, DC. However, he added, the agency still has a long way to go in reforming the flawed system that allowed Red 3 to remain in food products long after it was shown to cause cancer in animals.
This ban also brings the U.S. food landscape closer to that of the European Union, which banned red dye No. 3 in 1994, with a few exceptions for maraschino cherry products, noted Dr. Jennifer Pomeranz. “Europe follows the precautionary principle when it comes to these matters.”
“There is no rational reason, within the FDA’s mission, for not banning red dye No. 3 from food in the 1990s,” Pomeranz said in an email. “It’s unclear why the FDA takes so long to remove ingredients with known health risks.”
At least 10 other states, in addition to California, have introduced legislation to ban red dye No. 3 from food products, according to the Center for Science in the Public Interest.
“Americans are suffering because of our food system,” said Dr. Jerold Mande. Despite being one of the wealthiest nations, the U.S. ranks 49th out of 204 countries in terms of life expectancy.
“This is because food companies have lost sight of their primary mission—providing food that helps us thrive—and are instead focusing solely on profits,” Mande continued. “Unfortunately, the U.S. government doesn’t fund the research needed to understand the exact health risks of Red Dye No. 3, and the industry works with Congress to block that essential research.”
How to Avoid Dyes in Your Diet
The FDA already requires manufacturers to list red dye No. 3 on food labels, so if you’re trying to avoid products with the dye before the ban takes effect, simply check the ingredient list. Red dye No. 3 may also appear as “Red 3” or “FD&C Red #3” on labels.
Artificial food colorings are most commonly found in ultraprocessed foods and beverages that you wouldn’t typically make at home, according to Dr. Jennifer Pomeranz. To avoid red dye No. 3, consider steering clear of these types of products. The Center for Science in the Public Interest also recommends that parents avoid all artificial dyes, including yellow No. 5 and red No. 40.
You can assess how much ultraprocessed food you’re consuming by taking this quiz.
For non-topical medications, check the “inactive ingredients” section on the drug label or packaging for any dyes. Alternatively, search for dye-free versions of certain medications, as suggested by Consumer Reports. However, it’s important to consult your doctor before making any changes to your medications.
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