Red dye no. 3: FDA bans ingredient from food

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The US Food and Drug Administration has banned the use of red dye no. 3 in food, drinks and ingested drugs, more than 30 years after researchers 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 used to give food and drink a bright cherry-red color.

The move acts on a petition from November 2022 submitted by several 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 medicine, have until 15 January 2027 and 18 January 2028 respectively to reformulate their products according to the FDA. Food imported into the United States must also comply.

“Today’s action by the FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by the FDA to do its job despite the many barriers the food industry puts in its way,” said Dr. Jerold Mande, adjunct professor of nutrition at Harvard University TH Chan School of Public Health, via email.

The decision marks a “monumental victory” for consumer health and safety,” said Ken Cook, co-founder and president of the Environmental Working Group, in a news release. “We would not 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 candies, foods and beverages, but some of the most popular brands have either never used the additive or have already stopped using it. Fewer than 10% of products made by the Ferrara candy company, which makes Brach’s candies, for example, contain the additive as the company began phasing out its use in early 2023, a Ferrara spokesman said by email.

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

Some companies use red dye no. 40, which has been considered a healthier alternative since it has not been as extensively linked to cancer in animals.

However, California also banned red no. 40 from food 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.

Red dye no. 3 has been permitted for use in food despite the Delaney clause of the FDA’s Federal Food, Drug and Cosmetic Act. The clause “prohibits, in part, the FDA from approving an ingestible color additive 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 to rats in laboratory tests. The mechanism of the dye causing cancer in rats does not occur in humans, so these studies did not raise safety concerns, and therefore, according to the agency, the FDA did not revoke approval for red dye no. 3 in food.

The FDA has re-evaluated the ingredient’s safety several times since its initial approval – based on tests done on animals, not humans – in 1969, according to the agency.

There do not appear to be any studies establishing correlations between red dye no. 3 and cancer in humans, and “relevant exposure levels to FD&C Red No. 3 in humans are typically much lower than those causing the effects shown in male rats,” the FDA said in its constitutive update published Wednesday. “Claims that the use of ​​FD&C Red No. 3 in food and in ingested medicines put people at risk, is not supported by the available scientific information.”

But “it doesn’t matter because the FDA mandate under the Delaney clause says if it shows cancer in animals or humans, they have to keep it out of 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, i.a a report from 2012 who found a link between the additive and cancer in animals. the same year, researchers concluded artificial food dyes “are not a major cause of (attention deficit hyperactivity disorder), but they can contribute significantly to some cases and in some cases can additively push a youth over the diagnostic threshold.”

So in 2021, the California Office of Environmental Health Hazard Assessment investigation found red dye no. 3 can make children vulnerable to behavioral problems such as attention deficit disorder. The report also concluded that federal safe intake levels for food dyes at the time may not protect children’s brain health. The study noted that the current legal levels, set decades ago by the FDA, did not consider new research, according to Environmental working group.

The FDA’s decision “ends the regulatory paradox of Red 3,” said Dr. Thomas Galligan, senior scientist for food additives and dietary 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 food decades after it was found to cause cancer when eaten by animals.”

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

“There is no rational reason within the FDA’s mission that they did not ban red dye #3 from foods in the 1990s,” and why the agency is taking “so long to ban ingredients with known health hazards” is unclear, Pomeranz said via email -mail.

At least 10 other states — besides California — has introduced legislation seeks to ban red no. 3 from food, according to the Center for Science in the Public Interest.

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

“This is because food companies have lost sight of their primary mission of providing food we want to thrive and are focusing solely on their profits instead,” Mande added. “Unfortunately, the US government is not funding the research needed to determine the exact health risks posed by Red Dye #3. The industry is working 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 American 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 called for more transparency, more funding, and more staffing resources for the FDA to continue to fulfill its mission, and it’s time to put politics aside and work together to fund the FDA at levels that do possible to continue his work.”

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

FDA have already demanded manufacturers to indicate 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 colors are mostly found in ultra-processed foods and drinks you couldn’t make at home, Pomeranz said, so avoiding these products is another way you can eliminate red dye No. 3 from your diet. The Center for Science in the Public Interest recommends that parents also avoid all numbered dyes, such as yellow no. 5 and red no. 40.

You can find out how much ultra-processed food you eat by taking this quiz.

Before medications that are not topical, look for dyes in the “inactive ingredients” section of the drug label or package insert, or look for dye-free versions of some medications, Consumer Reports suggests. But always talk to your doctor before changing medications.