Why the FDA is banning Red No. 3, a common red food dye

A particular food coloring (FD&C Red No. 3) was recently re-evaluated by the U.S. Food & Drug Administration (FDA), which has revoked authorization of the dye’s use in foods, drinks and drugs sold in the United States.

Let’s explore how this ban came to be and what it means.

What is Red No. 3?

FD&C stands for Federal Food, Drug, and Cosmetic Act, which classifies color additives in foods, drinks, cosmetics, medications and devices. Red No. 3 is also known as erythrosine, or E127 in Europe, and it’s a chemical compound used to color food, ink and other products.

It isn’t the same as Red No. 40, also known as allura red AC or E129.

Why is the FDA banning Red No. 3?

The Center for Science in the Public Interest and 23 other organizations, along with some additional scientists, petitioned the FDA in 2022 to review whether Red No. 3 should be banned based on the Delaney Clause, which says the FDA can’t authorize a food additive or color additive if it’s been found to cause cancer in humans or animals.

Right now, there’s no evidence that Red No. 3 causes cancer in humans. However, Red No. 3 has been identified as a carcinogen in rats. In studies that found that the dye caused cancer in rats, the exposure levels were also much higher than are likely to be found in humans.

Is Red No. 3 harmful for humans?

There’s little evidence to support that there’s direct harm to humans from eating red dye, unless you’re allergic to it. Some studies have linked red dye to behavioral issues in children, but they haven’t shown sufficient cause to support a federal ban on the dyes’ use.

What products will this affect?

Many foods contain Red No. 3, particularly ones that have cherry red in their flavor colors, such as “birthday cake” or “rainbow” flavors. These include candy, chocolate, gum, mints, cookies, muffins, frosting, frozen desserts, some flavored drinks (including milks and nutrition shakes), maraschino cherries and some packaged fruit cups.

Some other foods that you might not expect to include artificial coloring, such as imitation bacon bits, sausages or season packets, can include Red No. 3. Some flavored medications, such as cough syrups, include this dye, too.

When does this ban take place?

This change doesn’t take place until Jan. 15, 2027, for food, and Jan. 18, 2028, for drugs.

The bottom line

As we gather more evidence about negative health effects of artificial food additives in more highly processed food, it makes sense to reduce or eliminate those ingredients when possible. Look for food brands or online markets that advertise “no dyes” on their products.

If you’re looking to color baked goods or icings at home, there are natural sources of the color red, such as beet juice, pomegranate juice or pureed cherries. They provide a viable alternative, producing visually attractive food without additional risk.