FDA Bans Red 3 Dye from Food and Medicines—What You Should Know About This Color

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For many years, dyes have been used in food, drinks, and even medicines to imitate the colors of fruits like strawberries, cherries, oranges, blueberries, and others.

While natural dyes from plants and insects were used in the past, artificial dyes have become popular since the late 1800s.

Today, many processed foods—like candies, sodas, and snacks you usually eat—have artificial colors to look more appealing.

If you look at them, bright red gummy bears and sports drinks do really catch our attention, right?

However, artificial colors aren’t just in food; they’re also found in makeup, giving lipsticks, eyeshadows, and blush their different red shades. You can even spot these colors in many toys for kids.

chocolate cupcake with white icing and strawberry on top

However, did you know that some artificial colors might not be safe for our health?

Yes. You read that right.

The U.S. Food and Drug Administration has banned Red No. 3 dye in foods, drinks, and medicines. Food companies have until January 2027 to take the dye out of their products, and drug makers have until January 2028 to do the same.

So, what is Red Dye No. 3?

Red No. 3, or erythrosine, is a petroleum-based color additive that gives foods and drinks a bright cherry-red color.

Red No. 3 was first approved for food consumption by the FDA in 1907. It’s widely used in candy, cereals, cakes, frostings, carbonated drinks, and many other products in the US that give foods a vibrant cherry-red color.

It was banned from cosmetics in the U.S. in 1990 because studies showed it could cause cancer in lab rats at high doses.

However, Red No. 3 was still allowed at that time in food products but has certain restrictions because its safety is considered differently when used in food than cosmetics.

Why Did the FDA Ban it Now?

The FDA banned Red No. 3 dye in 2022 after a petition from several advocacy groups, including the Center for Science in the Public Interest. They argue that this dye is connected to cancer and behavior issues in children.

This decision also supports California’s ban on the dye, which took place in October 2023. It now aligns with countries like the European Union and Japan that have already banned the dye.

The FDA’s action is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which stops using any food or color additive that can cause cancer in people or animals.

While research shows that high amounts of Red No. 3 can cause cancer in male rats, there is no proof that it poses the same risk for humans.

The FDA looked at 35 years of research showing the harmful effects of Red No. 3. Although a direct link to cancer in humans hasn’t been confirmed, studies on animals indicate it could be dangerous.

According to studies, Red No. 3 can affect thyroid hormone functions and may lead to thyroid tumors. It also has harmful effects on the brain, which could increase the risk of conditions like Alzheimer’s disease.

Concerns about Red No. 3 date back to the 1980s when studies connected it to thyroid tumors in rats, resulting in a ban on its use in cosmetics in the U.S. in 1990.

FDA Regulations on Color Additives

But will companies not have the chance to use it at all?

According to the FD&C Act, color additives must be approved by the FDA to make sure they are safe. While Red No. 3 has been banned, the FDA claims it doesn’t pose a serious threat to humans.

The cancer-related effects noticed in rats don’t occur in people, and the levels that people typically encounter are much lower.