Illustration by Hazel Zavala
Your candy heart might lovingly read “Be Mine,” but it’s probably best if you “Beware.” Certain brands of the popular Valentine’s Day conversation hearts, such as those manufactured by Brach’s and Spangler, contain FD&C Red No. 3, also known as Red Dye No. 3, a synthetic colorant that’s now in the spotlight due to legislative action targeting ongoing concerns about its safety.
More than three decades ago, the Food and Drug Administration (FDA) banned the use of Red 3 in cosmetics, like lipsticks and blushes, because studies had found that high doses of the dye caused thyroid cancer in rats. But the ingredient has remained approved for use in food and medicines, and appears on thousands of product labels—mostly candies and beverages.
Public pressure has been mounting for months, urging the FDA to eliminate the dye, which has been on the market since 1907. In October last year, California became the first US state to ban Red 3 in food products starting in 2027. And a slew of other states, including New York, Illinois, and Washington, have introduced bills to ban Red 3. (Red 3 has been prohibited for almost all food uses in the European Union since the early ’90s. It’s also banned in Japan, China, the UK, Australia, and New Zealand.)
In lieu of federal action, the patchwork of statewide laws could, in theory, see the dye largely removed from American retail shelves. California alone has serious buying power: If the state were a country, it would have the world’s fifth-largest economy. “I can’t imagine that companies are going to be selling a California-specific candy and then another version to the rest of the states,” says Thomas Galligan, PhD, the principal scientist for food additives and supplements at the Center for Science in the Public Interest (CSPI), a food and health watchdog that petitioned the FDA back in 2022 to prohibit the colorant in foods and drugs.
Here’s what you need to know about Red Dye No. 3.
What is Red Dye 3?
Also known as Erythrosine, Red Dye No. 3 “is a coal tar dye, meaning that it’s a synthetic colorant made from petroleum,” says Homer Swei, PhD, the senior vice president of Healthy Living and Consumer Safety Science at the Environmental Working Group, a nonprofit research organization focused on public health and consumer safety. Since the early 1900s, the dye has skyrocketed in popularity in the food and drug industries due to its bright red hue, making it a go-to choice for adding colors to drinks, confectioneries, and more.
Though Red 3, like most artificial colorants, has no functional purpose, our brains are hardwired to prefer red foods. The dye “is added to food to make it look good so that consumers like you and I want to spend our money,” says Galligan. “It’s a marketing tool for companies.”
Which foods contain Red Dye 3?
According to the Environmental Working Group’s database, which is designed to provide users with information about the potential health impacts of various consumer goods, more than 3,200 products currently sold in the US contain Red 3.
The dye is most commonly used to color cookies, cupcakes, and candies—but you’ll also find it in drinks, snacks, and medicines. Think strawberry-flavored Nesquik, Wise onion rings, Morningstar Farms’ vegetarian bacon, and certain brands of fruit cups containing cherries.
Why is Red Dye 3 banned in cosmetics but not in foods?
When it comes to colorants, the FDA keeps two different lists. There’s one for colors allowed in food, supplements, and ingested drugs (like pills and liquid medicine), and another for cosmetics and applied drugs (like prescription topicals). That essentially means the FDA makes decisions about them separately—and what’s decided for one list doesn’t necessarily apply to the other. Red Dye No. 3 got tangled up in the web. “It’s a classic case of bureaucracy getting in its own way,” Galligan says, citing the FDA’s complex legal history for approving additives.
When the colorant was first approved for use in food in 1907, there was little research on its effects. But in 1960, the Color Additives Amendment was passed by Congress and required the FDA to determine whether dyes were “suitable and safe” for a given use. At the time, the FDA placed Red Dye No. 3 on a provisional list for all uses—including those two separate food and cosmetics categories—with tentative approval pending further evaluation.
In 1969, responding to a 1968 color industry petition—from the Certified Color Industry Committee (now called the International Association of Color Manufacturers), which represents both color makers and the companies that use them—the FDA permanently approved the dye for use in food, based on the limited research available at the time. Meanwhile, Red Dye No. 3 remained only provisionally allowed in cosmetics.
Fast-forward past a few more legal hoops to 1990: Citing a study that found the consumption of Red 3 caused thyroid cancer in male rats, the FDA outright banned the dye in cosmetics and applied drugs. At the time, the agency estimated that it might cause cancer in fewer than 1 in 100,000 people. Despite what it insinuated was relatively small risk, it vowed to do the same with food.
Only, it never did. The FDA stance is “baffling,” says Galligan. While there’s no unequivocal proof that Red 3 causes cancer in humans, given the gravity of the illness, “the baseline assumption is that animal research is relevant to humans until proven otherwise.” According to a 1958 federal law, called the Delaney Clause in honor of its author, the FDA cannot approve food additives which are known “to induce cancer when ingested by man or animal.”
On its website, the FDA cites animal studies as the core reason for banning Red 3 in cosmetics but not foods: “The way that Red No. 3 causes cancer in animals, specifically rats, does not occur in humans so these animal results have limited relevance to humans. Because these studies did not raise safety concerns, the FDA did not take action to revoke the authorization of Red No. 3 in food.”
But a November 2023 statement from James Jones, the FDA’s deputy commissioner for human foods, notes that Red 3 is under review due to a rule that “prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested,” and states that a decision on whether Red 3 is appropriate for use in food is “forthcoming.”
What are the risks of eating Red Dye 3?
“Most concerning are the long-term health effects,” Swei says, referring to studies revealing a direct link between high doses of the additive and thyroid cancer in rats. “The FDA itself has concluded that Red 3 causes cancer in animals.”
More recently, behavioral issues have also become a concern associated with eating Red 3. Rigorous research that informed the California ban, including double-blind studies that control for variations in children’s diets, has found an association between various artificial color additives and hyperactivity. Even tiny doses of some colors triggered increased inattentiveness and restlessness in some children, compared to dye-free diets.
Kids are perhaps most at risk to the potential behavioral and health effects of Red 3, because they’re bodies are smaller and “they tend to consume more processed foods that may contain artificial dyes,” says Daniel Ganjian, MD, FAAP, a pediatrician at Providence Saint John’s Health Center in Santa Monica, CA. (The FDA estimates that children aged two to five ingest twice the amount of Red 3 per kilogram of body weight compared with the overall US population.)
The color industry has largely refuted the science. Responding to research that later informed California’s ban, the International Association of Color Manufacturers said in a 2021 statement that the conclusions “are based on insufficient scientific evidence.”
Should you be worried about other dyes?
Certain studies of children’s exposure to colorants such as Red No. 40, Yellow No. 5, and Yellow No. 6 have also shown associations with neurobehavioral impacts. But Red No. 3 is under particularly strong scrutiny right now because there’s more evidence for its potential harm and the FDA itself has already determined it carcinogenic in animals.
How can you avoid Red Dye 3?
The FDA mandates that food and medicine manufacturers declare Red Dye No. 3. On food packaging, you’ll find it on the ingredient label as “Red 3,” “FD&C Red No. 3,” or “Erythrosine.” You might also see “Red 3 Lake,” which is a derivative. On medicine packaging, you’ll find the dye listed under the “inactive ingredients” section. If you’re still not sure, the Environmental Working Group’s Healthy Living app lets you scan barcodes with your phone, revealing any concerning ingredients.
Originally Appeared on Bon Appétit
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