FDA issues health warning for a popular candy sold in the U.S.
12-04-2025

FDA issues health warning for a popular candy sold in the U.S.

Bright pink and purple marshmallow chicks look playful in an Easter basket, but some still contain a color additive called Red Dye No. 3. Regulators classify it as a carcinogen, a substance that can cause cancer in living tissues.

Consumer advocates have tied that dye to far more than one holiday sweet. An analysis of the Environmental Working Group food database suggested that more than 2,900 foods and drinks on U.S. shelves have contained Red 3, many advertised heavily to children.

Red 3 in the spotlight

Much of the scientific debate centers on a long term rat feeding experiment that followed animals for up to 30 months. 

That work was led by toxicologist Joseph Borzelleca at the Medical College of Virginia (VCU), whose research examined how food additives affect organs such as the thyroid gland in a lifetime toxicity study

At the highest tested dose in that experiment, male rats showed enlarged thyroid glands and more microscopic tissue changes than unexposed animals, while lower dose groups did not. 

Those results flagged the thyroid as a possible target organ for the dye, even though the study authors focused on overall toxicity rather than making a clear cancer call.

Years later, public health groups described the findings bluntly when they wrote to regulators about Red 3.

“The FDA found in 1990 that long-term feeding studies of FD&C Red No. 3 in rats showed that treated animals developed adenomas and carcinomas of the thyroid and ‘provided convincing evidence that FD&C Red No. 3 is an animal carcinogen,’ the petition states,” their letter argued.

Law treats Red No. 3 Dye as unsafe

A key phrase in this debate is the Delaney Clause. This federal rule bars the Food and Drug Administration, known as FDA, from listing any food or color additive that has been found to cause cancer in humans or animals.

In 2022, Consumer Reports, the Center for Science in the Public Interest (CSPI), and more than 20 other groups petitioned FDA to delist Red 3 from food, dietary supplements, and ingested drugs. 

They pointed to the rat thyroid findings, the cosmetic ban from 1990, and estimates showing that young children take in more of the dye per pound of body weight than adults, based on analyses of national diet surveys.

In January 2025, FDA announced that it would revoke authorization for Red No. 3 in food and ingested drugs, acting under the Delaney Clause rather than new evidence of human harm. 

Food makers have until January 15, 2027 to remove the dye from foods, and drug manufacturers must follow by January 18, 2028.

In that announcement, agency scientists noted that studies in other animals and in people generally do not show thyroid hormone changes or tumors at typical dietary exposure levels for Red 3. 

Even so, they emphasized that the law still forces them to treat the additive as unsafe once tumors appear in any well conducted animal study, so banning it becomes a legal requirement rather than a risk calculation.

Food dyes and kids’ behavior

Scientists also worry about possible neurobehavioral effects. These are changes in brain function that affect behavior, attention, or learning, and a 2021 review from California’s health agency found that synthetic food dyes are linked to these problems in some children.

That assessment noted that acceptable daily intake levels, regulators’ estimates of how much people can safely consume each day, were based on older toxicity tests that did not even measure behavior. 

For some dyes, the doses linked to behavioral changes in newer work actually fell below those traditional intake limits, raising questions about whether current standards protect the most sensitive children.

A systematic review examined 27 clinical trials where children received controlled doses of dye mixtures or placebo. This type of study pools evidence from many earlier experiments, and in this case most trials used blinded, crossover designs so each child served as their own control.

Sixteen of those 25 challenge trials reported some evidence of worse behavior with dyes, and in 13 the association reached statistical significance, supporting the idea that a subset of children reacts strongly. 

These findings suggest that synthetic dyes, including Red 3, may amplify attention or impulse control difficulties in a slice of the child population, even at doses regulators once considered acceptable.

What this means for candy lovers

Consumer Reports has pointed out that Purple and Pink Peeps marshmallow chicks and bunnies, along with certain Hot Tamales and fruit punch or wildberry flavored Peeps, have used Red Dye No. 3 in recent seasons. 

Parents scanning Easter displays might not realize that these colorful items sit at the center of the current safety debate.

“Parents should know that the purple and pink colored Peeps they may be putting in their kids’ Easter basket are made with an ingredient that is a known carcinogen,” Consumer Reports senior staff scientist Michael Hansen said. 

Red Dye No. 3 has been banned by the FDA from use in cosmetics since 1990, but inexplicably is still allowed in food. The company behind Peeps has defended its products by stressing regulatory compliance. 

“We manufacture all our candies in compliance with FDA regulations, sourcing our ingredients and packaging exclusively from reputable suppliers who adhere to high quality and safety standards,” Just Born Quality Confections said in a statement.

Because the Red 3 ban takes effect gradually, candies made before the cutoff will not suddenly vanish, and reformulated recipes may appear on shelves alongside older batches.

That slow shift means families who want to avoid the dye cannot simply rely on brand names, but instead need to check each specific package for changes.

Lessons from Red 3

One straightforward step is to look for the words Red 3 or erythrosine on the ingredient list and put that package back if you are trying to cut exposure. 

U.S. rules require that certified color additives appear by name, so the label itself provides the quickest guide.

Many candy makers already use colors from fruits, vegetables, or spices instead of synthetic dyes, and some offer dye free versions of classic sweets

Choosing those options, or plainer treats that rely less on intense color, trims away uncertain additives without making holidays any less fun.

Taken together, the cancer signal in male rats, the legal standard that treats any such signal as unacceptable in food, and the behavioral concerns in children all point in the same direction. 

For a product as simple as a marshmallow chick, switching away from Red Dye No. 3 trades a vivid pink hue for a little more peace of mind about what goes into a child’s candy.

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