FDA Finalizes Order for Orange B Revocation, Proposes to Remove Citrus Red No. 2

On July 22, 2026, U.S. Food and Drug Administration (FDA) announced two actions on petroleum-based color additives with food uses: a final order revoking the authorization of Orange B and a proposed order to revoke the authorization of Citrus Red No. 2.¹ Both actions rest on the same basic finding — that the additives are no longer being certified for commercial use — and both are framed as part of the agency's broader effort to phase out petroleum-based dyes from the food supply.

“The Trump Administration is taking decisive action to strengthen the safety of America’s food supply,” stated Secretary of Health and Human Services Robert F. Kennedy, Jr. “By working to eliminate outdated authorizations for petroleum-based color additives that are no longer used, we are modernizing our food safety regulations and helping to Make America Healthy Again.”

These actions trace back to an April 22, 2025, announcement from the Department of Health and Human Services (HHS) and FDA outlining a six-part plan to phase out petroleum-based dyes, which included a commitment to begin revoking Citrus Red No. 2 and Orange B and to remove remaining synthetic dyes, such as Yellow No. 5 and Red No. 40, by the end of 2026.²

“The FDA is committed to maintaining a science-based, modern regulatory framework that reflects current manufacturing practices and marketplace realities,” stated Acting FDA Commissioner Kyle Diamantas, J.D. “By working to remove outdated and unnecessary authorizations under President Trump’s regulatory reform agenda, we are ensuring our regulations remain effective, transparent, and aligned with the agency’s public health mission.”

Both the final order and proposal are scheduled to be published on July 23, 2026.

Why Is FDA Revoking Orange B, and What Does the Final Order Do?

As explained in the final order, Orange B was authorized under 21 CFR 74.250 for coloring the casings or surfaces of frankfurters and sausages, subject to certification.³ FDA's records show the additive was last batch certified in 1978, and the agency has not received a certification request since, leading the agency to conclude that Orange B's authorized use has been abandoned and that the listing is outdated and unnecessary.

The agency proposed this revocation in September 2025 and received 16 public comments; all but one supported revocation, and none provided evidence that Orange B remains in use. In responding to comments, FDA also clarified that color additives, including Orange B, are not eligible for "generally recognized as safe" (GRAS) status, since no GRAS provision applies to color additives.

This is a final order, not a proposal. It takes effect 45 days after publication in the Federal Register unless timely objections and a hearing request are filed within 30 days of publication. Once effective, any remaining certified batches of Orange B will be treated as uncertified, and using it in food afterward would render that food adulterated.

What Is Being Proposed for Citrus Red No. 2, and How Does It Differ?

According to the proposal, Citrus Red No. 2 has been authorized since 1963 for coloring the skins of mature oranges not intended for processing, limited to 2.0 parts per million by weight of the whole fruit.⁴ FDA's records indicate the additive was last batch certified in 2020, with no certification requests since. On that basis, FDA has tentatively concluded — not finally determined — that this use has also been abandoned and that the regulation is outdated.

Unlike the Orange B action, this is only a proposal. FDA proposes that any resulting final order take effect 90 days after publication, followed by a one-year period during which the agency would not enforce the rule against existing product, to allow depletion of certified inventory. FDA is specifically requesting comment on whether to provide that compliance period and how long it should last.

What Should Manufacturers Do Now?

FDA is accepting comments on the Citrus Red No. 2 proposal for 30 days, with a deadline of August 24, 2026, submitted to docket FDA-2026-N-6304 via the Federal eRulemaking Portal or by mail to the Dockets Management Staff. After reviewing comments, the agency will decide whether to finalize the revocation.

Because certification records show no recent commercial use of either additive, the direct formulation impact appears limited. Manufacturers with legacy authorizations, specifications, or labeling referencing either substance may want to review those materials and determine whether comment on the Citrus Red No. 2 proposal, including on the proposed compliance period, is warranted before the deadline.

The agency also maintains a webpage tracking voluntary industry pledges to remove petroleum-based food dyes, summarizing commitments from manufacturers, retailers, and trade associations as companies shift to alternative colorants.

References

1. FDA takes further steps to remove outdated authorizations for color additives in food [press release]. Silver Spring, MD: U.S. Food and Drug Administration; July 22, 2026. Accessed July 22, 2026. https://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-remove-outdated-authorizations-color-additives-food
2. McEvoy E. FDA and HHS announce plans to phase out petroleum-based synthetic food dyes. Nutritional Outlook. April 23, 2025. Accessed July 22, 2026. https://www.nutritionaloutlook.com/view/fda-and-hhs-announce-plans-to-phase-out-petroleum-based-synthetic-food-dyes
3. Revocation of the color additive listing for use of Orange B on casings or surfaces of frankfurters and sausages. Fed Regist. To be published July 23, 2026. Docket No. FDA-2025-C-3543. Accessed July 22, 2026. https://public-inspection.federalregister.gov/2026-14910.pdf
4. Proposal to revoke the color additive listing for use of Citrus Red No. 2 on the skins of mature oranges. Fed Regist. To be published July 23, 2026. Docket No. FDA-2026-N-6304. Accessed July 22, 2026. https://public-inspection.federalregister.gov/2026-14909.pdf