FDA Finally Bans Carcinogenic Red 3 Dye — Better Late than Never

That maraschino cherry in your Manhattan may be your last — the FDA has finally banned the use of Red 3, a known carcinogen, in foods, beverages, and ingested drugs¹. 

This announcement comes more than 30 years after scientists first discovered the links between this common food dye and cancer in animals. The discovery led to it being banned across the board in the European Union, but, confusingly, only in topical medications in the U.S.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said CSPI President Dr. Peter G. Lurie².

What Is Red 3?

Added colors have long been used to render foods more appealing, from the annatto that makes winter butter look richer to the beet juice that gives Pennsylvania Dutch pickled eggs a pretty purple hue. But synthetic food dyes are another story. Invented in the 19^th century, these artificial colorings soon became popular — and then quickly raised suspicion around their safety³.

Red 3 dye, also known by its chemical name erythrosine, is one of the oldest approved food colorings in the U.S. Derived from petroleum, this synthetic dye is used to give hundreds of products a bright, cherry-red color. You’ll find Red 3 in sprinkles, icings, strawberry milk, candy, processed meats, and seasoning mixes, not to mention non-topical medications like cough syrups and acetaminophen.

The FDA Ban on Red Dye No. 3

Red 3 dye was first linked to thyroid cancer in rats in a 1988 study in the Japanese Journal of Cancer Research⁴. These findings were later confirmed by a 2012 research review in the International Journal of Occupational Environmental Health⁵. 

As a result of this animal research, Red 3 has been (mostly) banned in the European Union since 1994⁶. But while the FDA enacted a partial ban on the dye in 1990, eradicating it from topical drugs and cosmetics, it remained legal in food until January 16, 2025⁷. 

This red dye ban is a long time coming, according to Dr. Joseph Mercola, Board Certified Family Medicine Osteopathic Physician (DO) and author of Your Guide to Cellular Health. “Animal studies decades ago showed that high doses could trigger thyroid tumors, so there’s always been a concern,” he said. “While everyday exposure might be lower than lab doses, the cumulative effect still matters. And since this dye is synthetic—not something found in nature—we’ve had safer natural color options all along. It makes little sense that we banned it in cosmetics 35 years ago but kept it in foods.”

So why did it take us over 30 years longer than our European friends to ban this carcinogenic (and entirely aesthetic!) additive?

A Dangerous Loophole

The initial partial ban on Red 3 hinged on the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act. Enacted in 1960, the clause prohibited any color additives linked to cancer in animals or humans. But while the FDA reports reevaluating the ingredient’s safety multiple times since it was approved in the 1960s, Red 3 remained approved for use in food and non-topical drugs. This, the FDA stated, came down to a lack of “resources required to remove this authorization.”⁸ But it also was due to a loophole. 

The way that Red 3 caused cancer in the lab rats in the 1988 study was linked to a rat-specific hormonal mechanism that cannot occur in humans. As a result, the FDA maintained that humans were in the clear. But for many experts, this interpretation runs counter to the very spirit of the clause.

“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,” Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health, told CNN. “There is not a rational reason within FDA’s mission that they did not ban red dye #3 from food in the 1990s.” There is, however, an irrational reason: industry pressure. 

How the Industry Silenced Red Dye Cancer Prevention

“Industry works with Congress to block funding for the needed research,” Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, told CNN⁹. The Washington Post reported back in 1989 that the maraschino cherry industry, which, according to the Center for Science in the Public Interest, is the biggest consumer of red No. 3.⁷, was particularly vocal in opposing a ban, arguing that “consumers will never consume them unless they have this bright red element.”¹⁰ It’s not for nothing that the EU still has an exception for maraschino cherries in its ban.

One additional factor Mande cited is the lack of U.S. government funding of the exact sort of studies that would potentially prove more conclusively the “exact health risks” posed by the dye. In other words, if the government had funded the relevant research, we might have already had the scientific evidence to prove Red 3 is carcinogenic to humans.

New Research and New Mobilization

If the FDA was finally forced to take action on Red 3, it was in part thanks to a 2022 petition submitted by over 20 consumer advocacy groups and individuals, including the Center for Science in the Public Interest and the Environmental Working Group¹¹.  The petition demanded the FDA review whether the Delaney Clause applied. Roughly three years later, the FDA complied by revoking the use of the dye and effectively banning it in the U.S.

Other Worries Linked to Red 3

The ban on Red 3 comes not a moment too soon. After all, in the 30 years since the carcinogenic effects of Red 3 came to light, other studies have spotlighted additional health risks. Most notably, we’ve seen concerning effects of the chemical on children — often the very targets of the brightly-colored sweets that use the dye most.

In 2021, a California Office of Environmental Health Hazard Assessment research review appraised the body of data linking synthetic dyes, including Red 3, to behavioral issues like ADHD in children¹². As a result, the state of California passed a ban on the additive in October 2023, effective in 2027¹³. At least 10 other states followed suit and introduced similar legislation. 

The FDA’s decision ultimately “ends the regulatory paradox of Red 3,” Dr. Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest in Washington, DC told CNN⁹. But, he adds, 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.”

What Happens Next?

Just because Red 3 has been banned doesn’t mean it’s going to disappear from grocery stores immediately. Food manufacturers have until January 15, 2027 to eradicate the additive from their recipes; drug manufacturers have another year and three days to do the same. The same rules and regulations will apply for imported foods produced outside of the U.S. 

Manufacturers and importers will likely need all the time they can get — according to a database compiled by the Environmental Working Group, Red 3 is present in more than 2,000 foods¹⁴. These red dye 3 foods include many seasonal candies like conversation hearts and candy corn, as well as PEZ, some Ringpops, Betty Crocker Red Decorating Icing, TruMoo Strawberry Whole Milk, Kroger Extra Cherry canned fruit cocktail, and Ensure Original Strawberry Nutrition Shake.

How to Spot Red 3 In Your Food Products

Luckily, it’s relatively easy to avoid Red 3, seeing as the FDA requires manufacturers to list its presence on food labels. Look not just for Red 3, but also Red Dye 3, Red Dye No. 3, or FD&C Red #3, or erythrosine. When it comes to non-topical medications like cough syrup or red-colored acetaminophen, be sure to check the “inactive ingredients” section of the packaging.

It’s easy to feel that the U.S. has fallen woefully behind on safety standards. But it may be heartening to know that many companies had already begun phasing out this chemical independently prior to the FDA ban. 

Ferrara, which produces Brach’s candies, has been reducing its use of the chemical since early 2023 — only 10 percent of the company’s products still use Red Dye 3 today⁹. Just Born, the company behind PEEPS, stopped using Red 3 after last Easter¹⁵. But other companies are all talk: General Mills vowed to remove all artificial colors from its Trix and Lucky Charms cereals by the end of 2016, and Kellogg’s promised to eradicate them entirely by 2019. Both companies still use synthetic dyes.

Where’s the Next Red Dye Coming From?

As is often the case, rather than eradicating synthetic dyes entirely, this ban is prompting many food companies to simply switch to a different Red. While moving away from Red Dye 3 is a win, it won’t necessarily represent progress if we simply shift to another potentially harmful synthetic dye. 

Red No. 40 is currently the most-used food dye in the U.S. and has been touted as a healthier option. So is red dye 40 bad for you? Well, studies show it may not be the saving grace we hoped for.

Can Red 40 Cause Cancer?

In 2023, research published in Toxicology Reports found that Red 40 caused DNA damage and colonic inflammation in mice¹⁶, and benzene, an ingredient in Red 40, has been identified by the International Agency for Research on Cancer as “carcinogenic to humans¹⁷.”

In addition to its potential cancer risks, research published in 2012 linked the dye to similar behavioral problems in children as Red 3⁵, leading the State of California to ban the dye from foods and drinks sold in public schools this past September¹⁸. It’s also for this reason that, while it has yet to ban the dye altogether, the EU requires foods containing red No. 40 to carry a health warning referencing its “adverse effect on activity and attention in children.”

What Other Dyes Should We Be Wary Of?

Red dyes aren’t the only problematic synthetic additives on the market. Yellow 5 (tartrazine) has been linked to mood problems in children and is the second-most widely used food dye in the U.S., according to the Center for Science in the Public Interest¹⁹. It’s commonly found in products with a tell-tale neon yellow shade, like Gatorade and Mountain Dew. Yellow 6 is the third most widely used dye — it’s found in Skittles and may be carcinogenic⁵. Both yellow dyes are already banned in the EU. And other dyes like Blue 1, Blue 2, and Green 3 have been examined for their potential health risks²⁰.

Luckily, there are companies paving a new way forward in the space, taking advantage of natural food colorings from beetroot, spirulina, carmine, paprika, and turmeric. Choosing natural dyes is the safest way to ensure our food system is healthier — while still making space for a vibrant range of colors. “Rather than waiting ages for final proof, choosing fewer artificial additives is the safer bet,” suggests Mercola.

Sources:

1. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs?utm_medium=email&utm_source=govdelivery
2. https://www.cspinet.org/press-release/fda-moves-eliminate-carcinogenic-red-3-foods
3. https://www.fda.gov/industry/color-additives/color-additives-history
4. https://pubmed.ncbi.nlm.nih.gov/2836348/
5. https://pubmed.ncbi.nlm.nih.gov/23026007/
6. https://www.cspinet.org/cspi-news/red-3-why-hasnt-fda-banned-carcinogenic-food-dye
7. https://www.cspinet.org/cspi-news/red-3-fda-finally-bans-cancer-causing-food-dye
8. https://www.fda.gov/industry/color-additives/fdc-red-no-3
9. https://www.cnn.com/2025/01/15/health/red-dye-no-3-ban-fda-wellness/index.html
10. https://www.washingtonpost.com/archive/politics/1989/07/18/dyeing-to-keep-the-cherry-red/59c82b6b-c37c-466c-adb6-f4ce3636d0e7/
11. https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FAP-CAP&id=CAP_3C0323
12. https://oehha.ca.gov/risk-assessment/report/health-effects-assessment-potential-neurobehavioral-effects-synthetic-food-dyes-children
13. https://www.cnn.com/2023/10/09/health/california-governor-bans-red-dye-no-3-wellness/index.html
14. https://www.ewg.org/news-insights/news-release/2025/01/biden-fda-moves-ban-toxic-red-dye-no-3-food
15. https://advocacy.consumerreports.org/press_release/consumer-reports-applauds-peeps-candy-maker-for-decision-to-stop-using-red-dye-3-in-advance-of-californias-ban-of-the-dye/
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC10502305/
17. https://www.cancer.org/cancer/risk-prevention/chemicals/benzene.html
18. https://www.cnn.com/2024/08/30/health/california-food-dye-ban-schools-wellness/index.html
19. https://pmc.ncbi.nlm.nih.gov/articles/PMC9052604/
20. https://www.cspinet.org/cspi-news/synthetic-food-dyes-rainbow-risks

Tags: carcinogen FDA ban red 3 dye red 40 red dye synthetic dyes