FDA Bans Red Dye No. 3 From Food Due to Cancer Risk

A Bright Pink Dye Finally Gets a Red Light

If you grew up with neon-pink frosted cupcakes, cherry candies, or those pastel marshmallow treats that mysteriously appear every spring, there’s a good chance you’ve eaten Red Dye No. 3. Also known as FD&C Red No. 3 or erythrosine, this synthetic color has been painting American snacks hot pink for decades.

As of January 2025, the U.S. Food and Drug Administration (FDA) has officially revoked the authorization for using Red Dye No. 3 in foods, dietary supplements, and ingested drugs, citing evidence that the dye causes cancer in male lab rats at high doses under specific testing conditions. The decision comes under the “Delaney Clause” of the Federal Food, Drug, and Cosmetic Act, which says that if an additive has been shown to cause cancer in humans or animals, it cannot be considered safe as a matter of law.

The twist: the FDA actually banned Red 3 from cosmetics and topical drugs back in 1990, but let it hang around in food for more than 30 years. Now, after years of pressure from health advocates and new scrutiny of synthetic food dyes, that loophole is finally closing.

What Exactly Is Red Dye No. 3?

Red Dye No. 3 is a petroleum-derived, synthetic food colorant that gives products a bright, bubblegum-pink or cherry-red hue. Chemically, it’s a type of xanthene dye that contains iodine atoms, which are part of the concern around how it may affect thyroid function in animals.

You might have seen it on labels as:

• FD&C Red No. 3
• Red 3
• Erythrosine

Before the ban, Red 3 showed up in:

• Candies (including some seasonal marshmallow treats and fruit-flavored candies)
• Frostings and cake decorations
• Gelatin desserts and some puddings
• Breakfast pastries and snack cakes
• Some strawberry or cherry-flavored nutritional drinks, shakes, and supplements

It wasn’t in all red foodsother dyes like Red 40 often carried that jobbut Red 3 had a unique fluorescent, almost “toy pink” tone that food manufacturers loved.

Why Is the FDA Banning Red 3 Now?

The new ban didn’t appear out of nowhere. It’s the result of a long, messy relationship between regulators, industry, and public health advocates.

Back in the 1980s, animal studies found that high doses of Red 3 caused thyroid tumors in male rats. That led the FDA to ban it from cosmetics and topical drugs in 1990, but the agency didn’t pull it from food at the time.

Fast forward to 2022: the Center for Science in the Public Interest (CSPI), along with other organizations, filed a color additive petition asking the FDA to revoke Red 3’s approval in foods, dietary supplements, and medications. They pointed out that:

• The FDA had already acknowledged that Red 3 caused cancer in animals.
• The Delaney Clause doesn’t allow “wiggle room” once carcinogenicity in animals is established.
• Red 3 was widely used in products heavily marketed to children.

In January 2025, the FDA agreed. The agency said that although more recent science suggests the rat tumors may be of “limited relevance” to humans, the Delaney Clause doesn’t let them ignore positive cancer findings in animals. In legal terms, once you have credible animal data showing a color additive causes cancer, you can’t keep it on the menu.

What Does the Science Actually Say About Cancer Risk?

The cancer concern around Red 3 comes mostly from two long-term rat feeding studies. When rats were given very high doses of the dye in their diet for long periods, male rats developed thyroid tumors. That led to the conclusion that Red 3 “induces cancer” in animals under those conditions.

A few important nuances:

• Dose matters. The rats were exposed to amounts much higher than a typical person would get from normal food consumption. That doesn’t mean the risk is zero at lower dosesit just means we don’t have definitive proof either way.
• Mechanism matters. The FDA has said that Red 3 appears to cause thyroid tumors in male rats through a hormonal mechanism related to thyroid-stimulating hormone (TSH) and iodine metabolism.
• Humans aren’t rats. Studies in other animal species and humans haven’t clearly shown the same effect, which is why some industry groups argued the dye should stay.

However, under the Delaney Clause, the FDA doesn’t get to say, “Well, it’s probably fine for humans.” Once an additive is shown to cause cancer in animals in credible studies, it’s legally considered unsafe as an ingested color additive. That’s what ultimately pushed the agency to act.

Beyond Cancer: Concerns About Kids’ Behavior and Food Dyes

While the Red 3 ban is legally tied to cancer in animals, synthetic food dyes in general have been under scrutiny for potential effects on children’s behavior.

The American Academy of Pediatrics (AAP) and other researchers have noted that artificial colors may worsen attention and hyperactivity symptoms in some children, especially those with ADHD or attention-related vulnerabilities.

Not every child is sensitive, and the effect size appears modest overall, but it’s enough that:

• Some families try dye-free diets for kids with ADHD.
• Certain European countries require warning labels on foods with specific dyes.
• California has passed laws limiting some synthetic food colors in school meals.

Red 3 isn’t the only color under the microscope, but its cancer-related history made it the first to lose its U.S. food authorization in this wave of concern.

What Foods and Drinks Are Affected?

If your mental picture of Red 3 is just candy, you’re not wrong, but the dye’s reach is broader than the candy aisle.

Products that historically used Red 3 include:

• Seasonal marshmallow candies and jelly beans
• Candies marketed to children (including some fruit-flavored or “cherry” items)
• Frosted snack cakes, cupcakes, and packaged pastries
• Breakfast cereals with pink or red pieces
• “Strawberry” or “cherry” nutritional drinks and shakes
• Some dietary supplements, especially chewables and gummies
• Certain oral medications, particularly chewables and liquids

It’s important to note that many major brands have already started phasing out Red 3 and other synthetic dyes, either in response to consumer demand, state-level laws, or the expectation that federal rules were coming.

Key Dates and What the Ban Actually Does

The FDA’s order revoking the color additive listing for Red 3 is effective in 2025, but manufacturers get a transition period to reformulate. According to federal notices and news reports:

• Now – early 2025: Ban is announced; Red 3 can no longer be legally listed as an approved color additive for food and ingested drugs going forward.
• By January 15, 2027: Foods and dietary supplements containing Red 3 must be off the market or reformulated.
• By January 2028: Ingested drugs must also comply, giving pharmaceutical companies extra time to reformulate.

After those dates, any new products containing Red 3 would be considered adulterated under federal law, meaning they could be subject to enforcement actions.

How This Fits with State Laws and Global Trends

The Red 3 story doesn’t live in a vacuum. It’s part of a larger shift in how countries treat synthetic food dyes.

In the U.S., California passed a landmark law in 2023 that bans Red 3 and several other additives from foods sold in the state, starting in 2027. The law covers candies, baked goods, and other products marketed nationwide but sold within California borders.

Internationally, many countries in Europe and elsewhere have already moved away from certain synthetic dyes, requiring warning labels or restricting their use. Some large food manufacturers reformulated products for European markets years ago while keeping the dyed versions in the U.S. Now, with the FDA action, the U.S. is playing catch-up.

What Consumers Can Do Right Now

You don’t have to panic and throw out your entire pantry, but this is a good moment to become a more label-savvy shopperespecially if you have kids at home.

1. Learn to Spot Red 3 on Labels

On ingredient lists, Red 3 typically appears as:

• FD&C Red No. 3
• Red 3
• Erythrosine

If you see it and would rather avoid it, you can choose alternative productsoften from the exact same brand.

2. Watch Out for “Kiddie” Foods

Kids’ products are overachievers in the artificial color department. Bright cereals, gummy snacks, neon drinks, and holiday candies tend to rely heavily on food dyes. If you’re trying to cut back on synthetic colors, start there.

3. Try Products with Natural Colors

More manufacturers now use color from beets, carrots, paprika, spirulina, and other plant sources. The shades may be a little softerless “highlighter pink,” more “real fruit”but your health probably doesn’t care if your cupcake glows in the dark.

4. Talk With Your Child’s Pediatrician

If you suspect your child may be sensitive to food dyes (for example, if behavioral symptoms seem to flare with certain snacks), talk to their pediatrician or a registered dietitian before making big diet changes. They can help you evaluate whether a dye-restricted diet makes sense and how to keep it nutritionally balanced.

How Food Companies Are Responding

For food and candy manufacturers, the Red 3 ban is inconvenient, but not impossible. Many companies already reformulated products for the European market years ago. Others started earlier transitions when California passed its Food Safety Act.

Industry groups have pushed back on some aspects of the ban, arguing that international risk assessment bodies have not found strong evidence of harm to humans and that reforms come with costs. But most major brands have also publicly committed to staying in compliance with FDA rules and are working on dye-free or naturally-colored versions of popular products.

In practice, that means we’ll likely see:

• Subtle changes in product appearance (slightly different pinks and reds)
• New “no artificial colors” claims on packaging
• Quiet reformulations that happen without any marketing fanfare at all

Does This Mean All Food Dyes Are Going Away?

Not overnight. Red 3 is currently the main star of the show because it carries that clear animal cancer signal plus a long regulatory history. Other artificial dyes (like Red 40, Yellow 5, Yellow 6, and various blues) remain legal, though they continue to be studied for potential behavioral and other effects, especially in children.

The FDA’s move on Red 3 sends a strong message: if a color additive cannot clear the safety barespecially under long-standing laws like the Delaney Clauseit’s not going to stay in the food supply forever. It also signals that what happens in state legislatures and advocacy petitions can eventually reshape national policy.

Real-Life Experiences with the Red 3 Ban

Policy decisions can feel abstract until they show up in your cart. The Red 3 ban is already changing the daily routines of parents, people with food sensitivities, and even the occasional candy superfan.

A Parent in the Cereal Aisle

Picture a parent who has spent years doing label gymnastics in the grocery store. They’ve read about synthetic dyes and ADHD, they’ve tried eliminating certain snack foods, and they’ve had at least one dramatic “sugar-and-dye-fueled” meltdown in public that will live in family lore forever.

For them, the Red 3 ban feels like one less battle. Instead of combing through every pink cereal loop or gummy bear for FD&C Red No. 3, they’re seeing more boxes with “no artificial colors” splashed on the front. When they flip the package over, they’re likelier to see beet juice or fruit and vegetable extracts instead of a long list of numbered dyes.

It doesn’t mean every behavior challenge magically disappears, but there’s a sense of relief: one known carcinogenic dye is officially out of the rotation, and they didn’t have to personally email every candy company to make it happen.

A Food-Allergy and Sensitivity Household

In another household, synthetic dyes have never been about cancer riskthey’ve been about unpredictable reactions. One child gets hives after certain bright red candies. Another has mystery stomachaches that seem to track with colorful snacks. The family’s solution has been to stick mostly to whole foods, but birthdays, holidays, and classroom parties remain minefields.

When news of the Red 3 ban hits, the parents feel cautiously optimistic. They start seeing fewer ultra-bright pink treats at school events and more naturally-colored alternatives. The ingredient lists on gummies and chewables become shorter and less intimidating. While they still keep an eye on labels, the mental load lightens a bit. The system is finally making changes they’ve been patching together on their own for years.

The Candy Fan’s Perspective

Then there’s the unapologetic candy loverthe person who has strong opinions about the “right” shade of pink in a nostalgic marshmallow treat. At first, they’re skeptical. Will reformulation ruin the texture? Will the candy look “washed out”? Will their childhood favorite ever taste the same?

As companies roll out new versions of classic products, they’re surprised: some look a little different, but the taste is still familiar. A few brands even use the change as a marketing point, highlighting “no artificial colors” without messing with the beloved flavor too much. Over time, the fan stops thinking about the dye at allexcept when they see old photos and are reminded just how neon everything used to be.

Health Professionals on the Front Lines

Pediatricians, dietitians, and family doctors have been fielding questions about food dyes for years: “Could this be affecting my child’s behavior?”, “Should we go dye-free?”, “Is that pink drink really bad for them?” Until now, the answer has often been a cautious “We don’t have proof of serious harm in most kids, but if you want to avoid dyes, here’s how.”

With the Red 3 ban, their conversations shift slightly. They can now say, “This particular dye was removed because it caused cancer in lab animals, and legally it couldn’t stay approved. Companies are phasing it out, so you’ll see fewer products with FD&C Red No. 3 over the next couple of years.” It’s still not a reason to panic, but it is a concrete step toward a simpler, less controversial ingredient list in everyday foods.

A Bigger Cultural Shift

Perhaps the most interesting part of the Red 3 story is what it says about our relationship with food. For decades, we accepted extremely bright, almost fluorescent colors as normaleven desirablein kids’ foods. Now, consumers, states, and federal regulators are collectively asking a new question: “Do we really need this?”

As natural colors become more common and companies reformulate to avoid dyes like Red 3, the visual “look” of food may change. Snacks might be a little less neon, but they’ll still be fun, familiar, and appealing. The ban doesn’t mean the end of pink cupcakes or strawberry shakesit just means the color behind that pink will be a little more compatible with what we know about long-term health.

In that sense, the FDA’s decision is about more than one dye. It’s a signal that dazzling color isn’t worth even a theoretical cancer risk, especially when safer alternatives are on the tableand in the mixing bowl.

Conclusion

The FDA’s ban on Red Dye No. 3 from food, dietary supplements, and ingested drugs closes a long-standing gap between what the science, the law, and common sense have been saying for decades. While the actual human risk from everyday consumption is still debated, the legal standard under the Delaney Clause is clear: if a color additive causes cancer in animals, it doesn’t belong in our food supply.

For consumers, the ban is both a reassurance and a reminder. It’s reassuring because a known carcinogenic dye is finally being phased out. It’s a reminder because it highlights how important it is to read labels, stay informed, and push for transparency in the food system. As manufacturers reformulate and new products hit the shelves, we’ll continue to seeand tastethe long-term impact of this decision.