FDA Proposes Formal Ban on Orange B Food Dye, Unused in U.S. for Decades

FDA Orange B Ban: Formal Proposal Targets Food Dye Unused in U.S. for Decades | The Lifesciences Magazine

Key Points:

  • FDA Orange B Ban – FDA moved to formally ban Orange B dye, which has been unused since the 1970s.
  • No Impact – Ban won’t affect today’s food supply.
  • Dye Scrutiny – Part of wider FDA review of synthetic dyes.

Regulatory housekeeping targets synthetic dye not used in the food supply for nearly five decades. Federal health officials are proposing the FDA Orange B ban, a step to formally prohibit a synthetic food dye once approved for sausage casings and frankfurters but not used in the U.S. since the late 1970s. The Food and Drug Administration (FDA) announced Wednesday that it intends to repeal the outdated authorization, calling the regulation “unnecessary.”

No certified batches of Orange B have been produced or requested for nearly half a century. Officials said the step is a regulatory cleanup measure, designed to remove a color additive that industry long ago abandoned.

FDA emphasizes limited impact

“The color additive regulation is outdated and unnecessary,” the FDA said in a statement. The agency confirmed that the FDA Orange B ban will have no effect on today’s food supply, since the dye has not been used in decades.

The proposal, if finalized after a public comment period, will take effect within 45 days. It follows the FDA’s January ban on Red No. 3, a dye still widely used in candies, baked goods, and medicines, until concerns about cancer risks prompted action.

Industry trends and consumer concerns

While the FDA Orange B ban is mostly symbolic, it comes amid a broader reassessment of synthetic food dyes. Major manufacturers have been pressured in recent years to reduce or remove petroleum-based color additives from cereals, snacks, and beverages, reflecting growing consumer preference for natural alternatives.

Some consumer advocates argue that the FDA should go further, citing studies that suggest certain dyes may contribute to hyperactivity, attention issues, and other behavioral problems in children. “It says they are currently willing to take mandatory steps only where it has no impact,” said Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest.

Scientific review continues

The FDA maintains that most approved dyes are safe when consumed as intended, noting that “the totality of scientific evidence shows that most children have no adverse effects when consuming foods containing color additives.”

Still, the agency has placed six widely used synthetic dyes, Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2, under review. Another dye, Citrus Red No. 2, remains legal but is rarely used, limited mainly to the skins of some citrus fruits.

Broader food safety oversight

Experts say the FDA Orange B ban reflects the FDA’s ongoing effort to modernize regulations and align them with current industry practices and public health standards. By removing obsolete approvals, federal officials aim to keep the regulatory framework relevant while continuing to examine the potential risks of additives still found in the marketplace.

Although Orange B itself has not been present in the food supply for decades, its formal removal underscores the continued scrutiny of synthetic additives and the industry’s gradual shift toward cleaner labels and natural alternatives.

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