Health experts have long voiced concern about artificial food dyes, and one in particular. Red dye 3 has been linked to several possible health issues but has remained on the market for decades. As the FDA finally bans red dye 3, it’s an interesting look at the ingredient approval process in the US. 

What Is Red Dye 3?

Red dye three, also known as erythrosine, is a synthetic food dye used in dozens of popular food and beverage products. Like most food dyes and colors (FD&C), it is partially derived from petroleum and used in other industries, including cosmetics and pharmaceuticals. It has been used commercially since its discovery in 1876, and it was initially used to dye wool and silk. 

It was officially legalized in the US in 1906 and gained FDA approval for use in food, cosmetics, and related products in 1969. Since then, a growing 

Red Dye 3 Health Risks

Research on red dye 3 raised concerns around the same time it was approved. There is considerable evidence that red dye 3 disrupts thyroid hormone regulation, may contribute to tumor growth on the thyroid, and increases oxidative stress that can lead to tissue damage. 

It’s important to note that all of these health concerns were found in rodent students, and there is no strong evidence linking red dye 3 and cancer in humans. Still, concerns were strong enough that the US banned red dye 3 in cosmetics in 1990, and the EU restricted its use to processed cherries in 1994. 

These concerns led California to ban red dye 3 in 2023, reignited interest in the ingredient, and contributed to renewed debate on a national ban. 

Read more: DDT’s Lasting Impact

The FDA Finally Bans Red Dye 3

A full thirty-five years since initial evidence of thyroid cancer in rodents, the FDA issued a ban on red dye 3 in January 2025. The ban aligns with the 1958 Delaney Clause, which was included in that year’s Food, Drug and Cosmetic Act. 

The ban means manufacturers must reformulate food and beverage products and ingested drugs. The ban won’t be completely enforced until 2027 (or 2028 for drugs), though there are some minor exceptions included in the legislation. Many manufacturers have anticipated the ban and, in response to popular opinion, shifted away from the ingredient and many other artificial colors, including Mars in 2016 and General Mills in 2024. 

The FDA has approved nine FD&C dyes, most of which are still allowed in consumer goods. Red dye 40, yellow dye 5, and others also have question marks, and it remains to be seen whether the FDA will take further action on these additives, especially in a shorter interval than over three decades. 

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