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Orange B

Orange B was first approved by the FDA for use as a certified food dye in 1966. However, in 1978, the FDA proposed removing it from the list of approved food additives due to concerns over potential carcinogenic contaminants, particularly the presence of 2-naphthylamine. Around the same time, its sole U.S. manufacturer, the William J. Stange Company, ceased production. Despite its non-use in food products since the late 20th century, the FDA did not formally revoke its approval. On April 22, 2025, the FDA announced plans to phase out synthetic food dyes by the end of 2026. This decision, led by FDA Commissioner Martin Makary, was driven by growing concerns over the potential health risks…

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Articles of Interest

Orange B Food Dye: Is it Safe or Should You Avoid It?

The United States FDA has restricted its use to the casings of hot dogs and sausages, and it is no longer manufactured in the United States, significantly reducing dietary exposure.

What to Know About the 2 Banned Food Dyes

It’s unlikely that you’d ingest either of the two synthetic food dyes—Citrus Red No. 2 and Orange B—that the U.S. Food and Drug Administration announced on April 22 it will ban in the coming months. You’d only be at risk of the two dyes if you were to eat the peel of Florida oranges, which are often injected with Citrus Red No. 2 to make them more visually appealing to consumers, or if Orange B were currently produced—which it hasn’t been for decades. The FDA approved Orange B in 1966, with a limitation that it not exceed 150 parts per million in finished food. It was a colorant limited to hot dog and sausage casings and wasn’t permitted in cosmetics or medications. Studies showed Orange B, an azo dye, was damaging to the spleens, livers, and kidneys in rats. The Center for Science in the Public Interest (CSPI) asked the FDA to officially ban it in its 2010 food dye report—more than 35 years after the single producer stopped making it due to carcinogenic concerns.

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In a study of pregnant rats given Orange B daily throughout pregnancy in their drinking water, when intake was 0.4% of the diet the offspring had higher rates of tissue malformations. Other studies in rats and rabbits have not found effects on fetal development.