FDA proposes ban on Orange B dye not used for decades

The U.S. Food and Drug Administration on Wednesday proposed removing Orange B, a synthetic food color no longer used in the United States, from the nation’s food supply. The agency said it would seek to repeal the regulation that allowed the dye, which was approved in 1966 to color sausage casings and frankfurters. No batches have been certified or requested for use since 1978, the FDA said, and the color additive regulation is outdated and unnecessary.

The move comes as part of a broader FDA effort to reexamine artificial color additives. It follows the agency’s January decision to ban Red No. 3 because of potential cancer risk; Red No. 3 has been used far more widely in candies, snack foods and medicines. The Orange B proposal also comes amid a separate push by the Trump administration to press top food manufacturers to voluntarily remove artificial dyes from cereals, yogurt, sodas and other products.

After a brief public comment period, the change would take effect within 45 days of final approval. The proposal is not part of any broad overhaul of all food color additives but a targeted removal of one older additive that regulators say has been abandoned by industry.

On health, the FDA notes that studies on food dyes show mixed results about behavioral effects in children, but the agency maintains that the dyes approved for use are safe. The agency said the totality of scientific evidence shows that most children do not experience adverse effects from consuming foods containing color additives.

In a broader regulatory context, the FDA has included six widely used dyes — Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1 and Blue No. 2 — on a list of chemicals under review. Citrus Red No. 2 is also approved but is rarely used and has been found in small amounts in the skins of some citrus products. The agency stressed that Orange B’s proposed removal does not imply immediate changes to all color additives already allowed in commerce.

Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have pledged to remove petroleum-based dyes from U.S. foods, citing concerns about children’s health, even as regulators emphasize that approved dyes are safe within current exposure levels. The new proposal reflects a continuing effort to reduce the prevalence of synthetic colorants in the U.S. food supply, while maintaining a focus on scientific evidence and consumer safety.