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FDA Proposes Revocation of Authorization for Orange B in Food

The U.S. Food and Drug Administration has taken another step in the national initiative to phase out petroleum-based food dyes by proposing to revoke the regulation authorizing the use of the petroleum-based food dye, Orange B, as a color additive in food because the FDA tentatively concluded that its use has been abandoned by industry and that the color additive regulation is outdated and unnecessary.

Today’s action accompanies other recent steps, including posting a tracker of voluntary industry commitments to remove petroleum-based food dyes in products sold in schools by the start of the 2026 school year and more broadly by 2027. The FDA also recently included the six remaining petroleum-based dyes frequently used in the food supply—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2 – on its list of select chemicals under FDA review. The FDA continues to work proactively with the industry to advance efforts to facilitate the removal of these petroleum-based food dyes from the food supply.

The FDA is accepting public comment for 30 days. All comments must be submitted by Oct. 16, 2025. After reviewing public comments, the agency will determine whether to finalize this action.

Electronic Submissions

Comments can be submitted via the Federal eRulemaking Portal to docket FDA-2025-C-3543.

Follow the instructions for submitting comments.

Written Submissions

Written comments may be mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Please ensure that all comments include Docket No. FDA-2025-C-3543. Confidential submissions should be appropriately marked.

Source: US Food and Drug Administration

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