Foods / Tuesday, 09-Sep-2025

Viewpoint: Every study shows that Red Dye 3 is safe for humans. So why is the U.S. — but not Canada — banning it?

Viewpoint: Every study shows that Red Dye 3 is safe for humans. So why is the U.S. — but not Canada — banning it?

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Credit: ABC
Credit: ABC

The U.S. Food and Drug Administration’s (FDA) … announcement that the red dye known as erythrosine, FD&C Red No. 3 or Red 3 – previously authorized for use as a colour additive in food and ingested drugs – will be banned in the U.S. will go down in history as the very definition of a red herring.

While Health Canada says the dye does not pose a health risk to the general population in Canada, the ban means food manufacturers in the U.S. have until January 2027 to remove the dye from their products. Drug manufacturers have until January 2028 to remove the dye from ingested drugs.

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When the FDA was asked to evaluate the safety of Red 3, chronic feeding studies conducted prior to 1976 revealed no evidence of neoplastic responses. Unsatisfied with this data, [the] FDA subsequently conducted additional longer-term studies – the first of which was a chronic feeding study where mice were randomly assigned to one of five treatment groups (120 mice per group) that received Red 3 in dietary concentrations of 0 percent, 0 percent, 0.3 percent, 1.0 percent, and 3.0 percent for 24 months. This study also found no adverse effects.

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