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FDA Proposes Repeal of Orange B Food Dye Authorization

The move trims an obsolete approval, signaling ongoing scrutiny of widely used synthetic colorants.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Overview

  • The dye, approved in 1966 for sausage casings, has had no certified batches or requests since 1978, according to the FDA.
  • The rule change will undergo a brief public comment period and could take effect within about 45 days.
  • Consumer advocates describe the step as largely symbolic because Orange B has not been used in the food supply for decades.
  • The action follows January’s federal ban on Red No. 3, which the FDA targeted over cancer concerns from animal studies.
  • Six widely used dyes are under FDA review as health leaders push reductions in petroleum-based colorants and the agency says most children show no adverse effects from approved additives.