U.S. FOOD COLOR ADDITIVE UPDATE
The U.S. Food and Drug Administration (FDA) revoked the authorization for Orange B, effective September 8, 2026, and has proposed revoking the authorization for Citrus Red No. 2. The two actions have different regulatory status: Orange B's listing has been revoked, while the Citrus Red No. 2 proposal remains pending.
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What the Two FDA Actions Cover
On July 22, 2026, the FDA announced a final order revoking the color additive listing for Orange B and a proposal to revoke the listing for Citrus Red No. 2. Both actions were published in the Federal Register on July 23, 2026, but they do not have the same legal status.
The final Orange B order applies to its authorized use on frankfurter and sausage casings or surfaces. The revocation became effective on September 8, 2026.
For Citrus Red No. 2, the FDA has proposed revoking its authorization for use on the skins of mature oranges. The agency's proposal is based on its tentative conclusion that the use has been abandoned. The public comment period closed on August 24, 2026; as of October 28, 2026, the action remained a proposal, pending a final FDA decision. See the Citrus Red No. 2 proposed order.
The Wider Transition Away from Petroleum-Based Colors
The Orange B revocation is part of a broader U.S. shift away from petroleum-based synthetic food dyes. In April 2025, the U.S. Department of Health and Human Services and the FDA announced an initiative to work with industry on phasing out the remaining petroleum-based FD&C colors. The FDA's current industry transition target is the end of 2027 for the six remaining certified colors.
This target reflects an industry transition initiative. It should not be read as a single blanket revocation order or as a uniform legal effective date for all six colors. Companies should continue to track individual FDA actions, applicable product requirements and transition arrangements. The FDA's tracker of industry pledges provides current information on the initiative.
A separate FDA action revoked the authorization for Red No. 3. For foods and dietary supplements, the compliance deadline is January 15, 2027. This deadline is specific to Red No. 3 and should not be conflated with the broader transition target.
Natural Color Developments and Pending Petitions
As companies evaluate alternatives, the FDA has also taken steps on color additives from natural sources. Actions in 2025 included authorizations involving Galdieria extract blue, calcium phosphate and expanded uses of butterfly pea flower extract, followed by an authorization for gardenia blue.
In February 2026, the FDA issued final orders for beetroot red and an expanded use of spirulina extract. The agency later delayed the effective dates while it evaluates objections. Companies should therefore distinguish the issuance of an order from its effective date and confirm the current status before relying on a new use.
As of October 28, 2026, FDA's petition tracker listed three relevant petitions as under review: an expansion and specification change for gardenia (genipin) blue; safflower extract; and amendments concerning the use of acetone as a solvent in carrot oil manufacture, including specifications and alternate names. The carrot oil petition concerns specific amendments and should not be described as a general approval of acetone-extracted carrot oil as a color additive. Check the FDA color additive petition tracker for status updates.
Natural origin does not remove the need for regulatory review: color additives from natural sources still require FDA premarket approval for their intended use.
"No Artificial Colors" Claims Remain Subject to Limits
In February 2026, the FDA said it intends to exercise enforcement discretion for certain voluntary "no artificial colors" claims on human foods that contain none of the color additives listed in 21 CFR Part 74. The policy does not extend to foods containing certified FD&C colors, and other applicable labeling requirements continue to apply.
Companies should review both the ingredient statement and the wording and context of any voluntary color claim. The FDA's letter on "no artificial colors" claims describes the scope of the enforcement discretion.
What Food Companies Should Review
Food manufacturers, importers and brand owners selling in the U.S. can use the latest actions to review color use across their portfolios. Priority checks include:
Ingredient and product scope: identify products using Orange B or other affected color additives, and confirm the specific authorized use and product category.
Regulatory status and timing: distinguish final revocations and effective dates from proposals, petition reviews and voluntary transition targets.
Reformulation and supply: assess candidate replacement colors for permitted uses, specifications, technical performance and supply continuity.
Label review: check ingredient declarations and voluntary claims against the color additives actually used and the current FDA guidance.
For context on the FDA's broader color transition, see REACH24H's earlier coverage of FDA actions on food colors and the phase-out of synthetic dyes. For ingredient, formulation and label questions, REACH24H provides U.S. food regulatory compliance support.
How REACH24H Can Help
REACH24H can support companies assessing U.S. food regulatory requirements through:
Ingredient and formula regulatory review.
U.S. food label review.
Regulatory consulting and update monitoring.
Review Your U.S. Food Color Compliance
If your products use food color additives or make color-related claims in the U.S., REACH24H can help review ingredient, formulation and labeling questions against applicable requirements.
Recommended Reading
FDA's 2025 Approvals of Food Colors and the Shift Away from Synthetic Dyes
Food Color Additive Approval Pathways in China, the U.S. and the EU
