FDA bans red dye No. 3 from food and drinks in the U.S.

This handout image shows red food products. (U.S. Food and Drug Administration)

The U.S. Food and Drug Administration has banned the use of red dye No. 3 in food and ingested drugs, more than 30 years after scientists discovered links to cancer in animals, the agency announced Wednesday.

A synthetic color additive made from petroleum and chemically known as erythrosine, red dye No. 3 is used to give foods and beverages a bright cherry-red color.

The move acts on a November 2022 petition submitted by multiple advocacy organizations and individuals, including the Center for Science in the Public Interest and the Environmental Working Group, which cited links to cancer. The decision by the federal agency also follows in the footsteps of California, whose government banned the additive in October 2023.

Manufacturers using red No. 3 in food and ingested drugs have until January 15, 2027, and January 18, 2028, respectively, to reformulate their products, according to the FDA. Foods imported to the United States also must comply with the requirements.

“Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way,” said Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, via email.

The decision marks a “monumental victory” for consumer health and safety,” said Ken Cook, cofounder and president of the Environmental Working Group, in a news release. “We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson and others who took up this fight decades ago on behalf of consumers.”

Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either never used, or have already stopped using, the additive. Fewer than 10 per cent of products made by the candy company Ferrara, which produces Brach’s candies, for example, contain the additive, as the company began phasing out the use of it in early 2023, a Ferrara spokesperson said via email.

Just Born, the company behind PEEPS, stopped using red dye No. 3 in its production after Easter of 2024, according to a spokesperson.

Some companies instead utilize red dye No. 40, which has been considered a healthier alternative as it hasn’t been as extensively associated with cancer in animals.

However, California also banned red No. 40 from foods and drinks sold in public schools in September due to concerns over links to behavioral and attention difficulties among children. One study found a potential link to accelerated immune-system tumor growth in mice, and other sources say the dye contains benzene, a known carcinogen.

‘The regulatory paradox’ of dye red No. 3

Red dye No. 3 has been permissible for use in food despite the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act. The clause, in part, “prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested,” according to the agency.

The FDA already banned the use of red dye No. 3 in cosmetics and topical drugs in 1990 under the Delaney Clause after research found the additive to be carcinogenic at high doses for rats in lab tests. The mechanism for the dye causing cancer in rats doesn’t occur in humans, so those studies didn’t raise safety concerns, and therefore the FDA didn’t revoke the authorization for red dye No. 3 in food, according to the agency.

The FDA has reevaluated the ingredient’s safety multiple times since its initial approval — based on trials conducted in animals, not humans — in 1969, according to the agency.

There don’t appear to be any studies establishing links between red dye No. 3 and cancer in humans, and “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,” the FDA said in its constituent update posted Wednesday. “Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”

But “it doesn’t matter, because the FDA mandate under the Delaney Clause says that if it shows cancer in animals or humans, they’re supposed to keep it from the food supply,” said Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health.

The FDA’s decision to revoke the authorization for the use of red dye No. 3 is a matter of law, the agency said.

A few other studies have cast further doubt on the safety of red No. 3, including a 2012 report that found a link between the additive and cancer in animals. That same year, researchers concluded artificial food colorings “are not a main cause of (attention deficit hyperactivity disorder), but they may contribute significantly to some cases, and in some cases may additively push a youngster over the diagnostic threshold.”

Then in 2021, the California Office of Environmental Health Hazard Assessment study found red dye No. 3 can make children vulnerable to behavioral issues, such as decreased attention. The report also concluded that federal levels for safe intake of food dyes at that time may not protect children’s brain health. The study noted that the current legal levels, set decades ago by the FDA, didn’t consider new research, according to the Environmental Working Group.

The FDA’s decision “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. But the agency “has a long way to go to reform the broken system that allowed Red 3 to remain in foods decades after it was shown to cause cancer when eaten by animals.”

The ban also moves the food landscape slightly closer to that of the European Union, which banned the dye in 1994, with the exception of some maraschino cherry products, Pomeranz said. “Europe takes the precautionary principle when it comes to these things.”

“There is not a rational reason within FDA’s mission that they did not ban red dye #3 from food in the 1990s,” and why the agency takes “so long to ban ingredients with known health harms” is unclear, Pomeranz said via email.

At least 10 other states — besides California — have introduced legislation seeking to ban red No. 3 from foods, according to the Center for Science in the Public Interest.

“Americans are sick because of our food,” Mande said. Though the United States is one of the wealthiest nations, in terms of overall life expectancy, the nation ranks as 49th out of 204 countries.

“This is because food companies have lost sight of their primary mission, providing food we will thrive on, and focusing entirely on their profits instead,” Mande added. “Unfortunately, the U.S. government doesn’t fund the research needed to determine the exact health risks posed by Red Dye #3. Industry works with Congress to block funding for the needed research.”

The National Confectioners Association said in a statement that food safety is the number one priority for US confectionery companies.

“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework,” the association said via email. “For years, our industry has been calling for more transparency, more funding, and more staff resources for the FDA to continue fulfilling its mission, and it’s time to put politics aside and work together to fund the FDA at levels that will allow it to continue its work.”

Food and beverage companies will continue to follow the latest science and comply with all food safety regulations to ensure safe and available choices for consumers, Sarah Gallo, senior vice president of product policy and federal affairs at the Consumer Brands Association, said in a statement via email.

Avoiding dyes in your diet

The FDA has already required manufacturers to list red dye No. 3 as an ingredient on food labels — so if you’re concerned about avoiding products containing the dye until the ban is implemented, check ingredient lists before buying. Red dye No. 3 is also listed as “red 3” and “FD&C Red #3.”

Artificial food colorings are mostly found in ultraprocessed foods and beverages you couldn’t make at home, Pomeranz said, so avoiding those products is another way you can eliminate red dye No. 3 from your diet. The Center for Science in the Public Interest recommends parents avoid all numbered dyes, such as yellow No. 5 and red No. 40, as well.

You can find out how much ultraprocessed food you may be eating by taking this quiz.

For medications that aren’t topical, look for dyes in the “inactive ingredients” section of the drug labeling or package insert, or search for dye-free versions of some drugs, Consumer Reports suggests. But always talk with your doctor before switching medications.

CTVnews.ca has reached out to Health Canada to see if it plans to put a similar ban in place.