More than 30 years after researchers found ties to cancer in animals, the US Food and Drug Administration announced Wednesday that it has banned the use of red dye No. 3 in food, drinks, and swallowed medications.
Red dye No. 3, a petroleum-based synthetic colorant chemically called erythrosine, is used to give meals and drinks a vivid cherry-red hue.
The action responds to a petition filed in November 2022 by a number of advocacy groups and individuals, including the Environmental Working Group and the Center for Science in the Public Interest, which pointed to connections to cancer. The federal agency’s decision is also in line with California’s, which outlawed the additive in October 2023.
The FDA has given manufacturers who use red No. 3 in food and swallowed medications until January 19, 2028, and January 15, 2027, respectively, to reformulate their products. The rules also apply to foods that are imported into the United States.
According to Dr. Jerold Mande, an adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, via email, “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.”
In a news statement, Ken Cook, cofounder and president of the Environmental Working Group, called the ruling a “monumental victory” for consumer health and safety. “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.”
At least dozens of candies, foods, and beverages include red dye No. 3, yet some of the most well-known brands have either never used the addition or have already quit. For instance, the candy manufacturer Ferrara, which makes Brach’s candies, started to phase out the use of the ingredient in early 2023, and today less than 10% of its products use it, according to an email from a Ferrara representative.
According to a spokeswoman, Just Born, the company that makes PEEPS, stopped using red dye No. 3 in its manufacturing after Easter 2024.
Instead, some businesses use red dye No. 40, which has been regarded as a healthier substitute because it hasn’t been as widely linked to animal cancer.
But in September, California also outlawed red No. 40 from foods and beverages served in public schools because of worries about its potential to cause behavioral and attention issues in kids. According to some sources, the dye contains benzene, a known carcinogen, and another study suggested a possible connection to mice’s immune system tumor growth being accelerated.
‘The regulatory paradox’ of dye red No. 3
Despite the FDA’s Federal Food, Drug, and Cosmetic Act’s Delaney Clause, red dye No. 3 has been allowed for use in food. The FDA claims that the clause, among other things, “prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested.”
Under the Delaney Clause, the FDA had prohibited the use of red dye No. 3 in cosmetics and topical medications in 1990 after studies revealed that the additive was carcinogenic to rats at high concentrations in laboratory experiments. The FDA did not revoke the license for red dye No. 3 in those investigations since the mechanism by which the dye causes cancer in rats does not occur in people.
Since the chemical was first approved in 1969 based on animal experiments rather than human ones, the FDA has reevaluated its safety several times, the agency claims.
According to the FDA’s congressional update published on Wednesday, “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 there don’t seem to be any research linking the dye to cancer in humans. “The available scientific data does not support claims that FD&C Red No. 3 in food and ingested medications puts people at risk.”
However, Dr. Jennifer Pomeranz, an associate professor of public health policy and management at New York University’s School of Global Public Health, stated that “it doesn’t matter, because the FDA mandate under the Delaney Clause shows that if it shows cancer in animals or humans, they’re supposed to keep it from the food supply.”
According to the FDA, the decision to withdraw the approval for the use of red dye No. 3 is a legal one.
Red No. 3’s safety has been called into question by a few additional studies, including one published in 2012 that linked the additive to animal cancer. In the same year, scientists came to the conclusion that artificial food coloring “may contribute significantly to some cases, and in some cases may additively push a youngster over the diagnostic threshold, but they are not a main cause of (attention deficit hyperactivity disorder).”
The California Office of Environmental Health Hazard Assessment study from 2021 then discovered that red dye No. 3 can put kids at risk for behavioral problems like inattention. The study also came to the conclusion that children’s brain health might not be protected by the government standards for safe food dye consumption at the time. According to the Environmental Working Group, the present regulatory thresholds, which were established by the FDA decades ago, did not take new studies into account.
Dr. Thomas Galligan, lead scientist for food additives and supplements at the Center for Science in the Public Interest in Washington, DC, stated that the FDA’s ruling “ends the regulatory paradox of Red 3.” However, the organization “still has a long way to go to fix the flawed system that allowed Red 3 to be in foods for decades after it was proven to cause cancer in animals.”
With the exception of certain maraschino cherry items, the restriction also brings the food scene a little closer to that of the European Union, which outlawed the dye in 1994, according to Pomeranz. “In these matters, Europe adopts the precautionary principle.”
“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.
According to the Center for Science in the Public Interest, legislation to prohibit red No. 3 from foods has been introduced in at least ten other states in addition to California.
“Our food is making Americans sick,” Mande claimed. Even though it is one of the richest countries, the United States ranks 49th out of 204 in terms of life expectancy.
“This is because food companies have lost sight of their primary mission, which is to provide food that will sustain us, and are instead solely focused on their profits,” Mande continued. Regretfully, the research required to identify the precise health concerns associated with Red Dye #3 is not funded by the U.S. government. Congress and industry collaborate to prevent funding for necessary research.
Food safety is the top priority for US confectionery producers, according to a statement from the National Confectioners Association.
“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.”
In order to provide consumers with safe and accessible options, food and beverage companies will continue to adhere to all food safety regulations and the most recent scientific findings, said Sarah Gallo, senior vice president of product policy and federal affairs at the Consumer Brands Association, in an email statement.
Avoiding dyes in your diet
Check ingredient lists before purchasing if you’re worried about avoiding products that contain red dye No. 3 until the ban is put into effect, as the FDA has already mandated that manufacturers identify the dye as an ingredient on food labels. “red 3” and “FD&C Red #3” are other names for red dye No. 3.
You can also cut red dye No. 3 out of your diet by eliminating ultraprocessed foods and beverages, which are the main source of artificial food colorings, according to Pomeranz. Additionally, the Center for Science in the Public Interest advises parents to stay away from all dyes with numbers, including red No. 40 and yellow No. 5.
Consumer Reports advises searching for dye-free versions of some prescriptions or looking for dyes in the “inactive ingredients” part of the drug labeling or package insert for non-topical treatments. However, you should always see your physician before changing drugs.
FAQs
What has Red Dye 3 in it?
Red Dye 3 is commonly found in:
Candies: Gummy bears, lollipops, and jellybeans.
Baked Goods: Cakes, cookies, and frostings.
Snacks: Fruit snacks and cereal bars.
Beverages: Flavored drinks and certain sodas.
Cosmetics: Lipsticks and blushes.
What foods have Red Dye 3?
Examples of foods containing Red Dye 3 include:
Maraschino cherries (used as toppings).
Candy canes and seasonal treats.
Gelatin desserts like Jell-O.
Processed snack foods with bright red coloring.
Always check ingredient labels for “Erythrosine” or “FD&C Red No. 3.”
Is Red 40 banned in the USA?
No, Red Dye 40 is not banned in the USA. It is approved by the U.S. Food and Drug Administration (FDA) for use in food, beverages, and cosmetics. However, it is restricted in some other countries due to potential health concerns.
Foods That Contain Red Dye 3
Desserts: Ice creams, puddings, and whipped toppings.
Drinks: Powdered drink mixes and some fruit juices.
Confectionery: Candies and gummies, particularly those with a cherry or strawberry flavor.
Medications: Coated pills and syrups.
Difference between Red 3 vs. Red 40
Composition:
Red Dye 3 (Erythrosine): Derived from coal tar, used mainly in candies and baked goods.
Red Dye 40 (Allura Red AC): A petroleum-based dye used more broadly in foods and drinks.
Health Concerns:
Red 3 has been linked to thyroid tumors in animal studies and is limited in some applications.
Red 40 is under scrutiny for potential behavioral effects in children but is generally considered safe at regulated levels.
Usage:
Red 3 is less common than Red 40 due to its limited approval in certain products.
Red 40 is a widely used dye in the U.S. and globally.
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