FDA Bans Artificial Coloring Red Dye No. 3 From U.S. Foods and Drinks -

The U.S. Food and Drug Administration (FDA) has banned the food dye known as Red 3 in U.S. foods, drinks, candy, and medications — more than three decades after studies showed the additive causes cancer in rats.

The FDA announced on Wednesday that manufacturers have until January 2027 to remove the coloring from their products. Drugmakers will have until January 2028 to comply.

“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals,” said Jim Jones, the FDA’s deputy director for human foods, in a statement to NBC News. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”

“This is the right decision and matches recommendations from other countries to protect against toxicity and future health harms. Overall, it is one small step amidst a larger need to make our food supply safer for the most vulnerable, such as young children,” says Sheela Sathyanarayana, MD, a professor of pediatrics at the University of Washington and an investigator with the Seattle Children’s Research Institute.

What Is Red Dye No. 3 and How Does It Impact Our Health?

FD&C Red No. 3, also called Red 3 and erythrosine, is a synthetic food coloring made from petroleum that is used to give foods and drinks a bright red cherry color.

For many years Red 3 was also used in cosmetics, but the FDA forbade its use in 1990 after research established the link to cancer.

Scientists believe Red 3 causes a hormonal reaction specific to male rats that results in cancer. But later animal studies didn’t find any cancer link, and there’s no evidence showing that Red No. 3 causes cancer in humans.

There is also evidence that consumption of synthetic food dyes, including Red No. 3, can result in hyperactivity and other behavioral problems in some children.

What Foods Contain Red Dye No. 3?

Some food companies have already phased out their use of Red 3, and California banned Red 3 and three other food dyes in October of 2023. But many products with the potentially harmful additive remain on grocery store shelves. These include:

Seasonal candies: Valentine treats like “conversation hearts,” cherry cordials, and other candies including PEZ, Fruit by the Foot, Hot Tamales, Dubble Bubble gum, candy corn, and ring pops may include Red 3.
Maraschino cherries: Some companies have made the switch to Red 40, but the cherry industry is the largest user of Red 3–dyed products in the United States and Europe.
Fruit cocktails: Some common brands of canned or packaged fruit medleys use cherries dyed with Red 3.

The dyes can also be found in some strawberry-flavored milks, sodas, vegetarian meats, ice creams, and desserts.

Why the FDA Finally Banned Red Dye No. 3

The FDA decision acts on a November 2022 petition submitted by the Center for Science in the Public Interest (a not-for-profit food and health watchdog) and 23 other organizations, based on the decades-old findings on cancer.

The authorization for use was revoked because of the Delaney Clause, which prohibits FDA authorization of a food additive or color additive if it has been “found to induce cancer in humans or animals.”

Red Dye No. 3 Ban Is a Good Thing for Consumers

The ban is a long overdue decision from the FDA, says Kate Donelan, RD, a registered dietitian with Stanford Health Care in California.

“It’s certainly positive to eliminate unnecessary risks, especially as there are safer, natural coloring agents like beet juice or paprika extract that can have the same impact as Red Dye 3 without the potential for harm,” she says.

Regulation makes it easier for people to avoid potentially risky additives, says Dr. Sathyanarayana.

“Often, consumers are left with the burden of deciding what food products to buy, without significant knowledge of health harms. This creates confusion and anxiety for those who are trying to make positive decisions for household meals, but are left with endless choices,” she says.

FDA Move Reflects Growing Public Concern About Food Additives

“People are waking up to the much more lenient food policies here in the United States compared with the EU, where stricter regulations have been the norm for years,” says Donelan. “We need to expand this critical eye to other artificial additives with questionable safety profiles, such as Red Dye 40 or Yellow 5,” she says.

Sathyanarayana agrees. “This is one positive step, but there is so much more to do to make our food supply safer and healthier. The FDA needs to reevaluate the safety of many additives that have long been thought to be safe based on outdated data or limited data. It also needs to start regulating environmental contaminants from food processing and packaging that can be harmful to human health,” she says.

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