FDA proposes revoking authorization of "Orange B" coloring due to abandonment of use

Washington, DC — On September 17, 2025, the Food and Drug Administration (FDA) announced its intention to revoke the authorization of the food coloring Orange B, used as a food additive, determining that its use has been abandoned by the industry and that the regulations authorizing it have become obsolete.

Table of contents

1. What is Orange B and why is it being revoked?

2. Key dates and public participation

3. Impacts and motivations

4. What can companies do?

FDA proposes revoking authorization of "Orange B" coloring due to abandonment of use

What is Orange B and why is it being revoked?

Orange B is a petroleum-derived colorant that was previously approved for use in foods under the current food additive regulations. However, according to the FDA, the industry has virtually stopped using it, leading the agency to conclude that maintaining its approval no longer makes sense from a regulatory perspective.

The proposed revocation is part of a broader strategy to eliminate synthetic, petroleum-derived dyes from the U.S. food supply. In that context, the FDA has also added six other widely used dyes (including FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3 ) to its list of chemicals under review .

Key dates and public participation

The FDA has opened a 30-day public comment period, which runs until October 16, 2025. After reviewing the comments received, the agency will determine whether to formally revoke Orange B.

Interested parties may submit comments through the Federal eRulemaking Portal , citing docket FDA-2025-C-3543 , or by submitting written comments to the FDA's Dockets Management staff.

Impacts and motivations

• By revoking Orange B, the FDA is aligning itself with a regulatory trend to restrict or eliminate the use of petroleum-based synthetic colors, especially in products with direct exposure to the consumer public.

• The argument for revocation is not based on new toxicological findings, but rather on the fact that the use of this colorant has been virtually abandoned in commercial practice, making its authorization considered "unnecessary and outdated."

• The measure also sends a strong signal to the food industry: for manufacturers that still use synthetic colorings derived from petroleum, increasing regulatory pressure is anticipated toward cleaner or more natural alternatives.

What can companies do?

• Review current formulations to identify if they use Orange B (although few likely do today).

• Anticipate the future regulatory framework that could extend to other colorants under review.

• Prepare and submit comments if the company has relevant experience or data, especially during the public comment period.

• Explore safe and accepted colorant alternatives to avoid risks of regulatory discontinuity.

Contact our team of experts in international cosmetics regulation.