The U.S. Food and Drug Administration (FDA) has announced two actions targeting outdated authorizations for color additives in food: a final order revoking the use of Orange B, and a proposal to revoke the use of Citrus Red No. 2. The announcement, issued July 22, 2026, builds on an effort the FDA has had underway since early 2025 to remove color additive authorizations that no longer reflect current industry practices. The Citrus Red No. 2 proposal remains open for public comment through August 24, 2026.
For companies manufacturing or importing products that rely on color additives in food formulations, these actions raise immediate questions about compliance timelines, reformulation requirements, and labeling obligations. Although neither Orange B nor Citrus Red No. 2 is reported to be in significant current commercial use, the formal actions change the regulatory status of these substances and signal the FDA’s continued attention to legacy color additive approvals.
Which Color Additives Are Affected
The FDA’s announcement addresses two specific color additives. The first is Orange B, historically authorized for use on the casings or surfaces of frankfurters. It is now subject to a final order revoking its authorization. The FDA reached this decision after reviewing public comments on its earlier proposal and found no information that changed its conclusion that use of Orange B has been abandoned by industry.
The second color additive is Citrus Red No. 2, authorized since 1959 for coloring the skins of mature oranges, is subject to a proposed revocation rather than a final one. The FDA has tentatively concluded that its use has also been abandoned by industry, but the proposal remains open for public comment.
Comments are due by August 24, 2026, and can be submitted through the Federal eRulemaking Portal under docket FDA-2026-N-6304, or by mail to the FDA’s Dockets Management Staff. The agency will review submitted comments before deciding whether to finalize the revocation.
In both cases, the FDA’s determination rests on abandonment by industry rather than on new safety findings specific to either substance.
Regulatory Context and the Broader FDA Strategy
This action does not exist in isolation. It follows a pattern of intensified FDA activity around food chemical safety that has continued since early 2025, when the agency began accelerating its review of legacy authorizations. The July 2026 actions on Orange B and Citrus Red No. 2 fit squarely within this ongoing strategy.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that color additives used in food be specifically listed and authorized by the FDA. Unlike other food ingredients that may qualify for Generally Recognized as Safe (GRAS) status, color additives must receive explicit pre-market approval. This distinction matters. Revocation of an authorization has a clear and immediate legal effect, and any product containing a revoked color additive would be considered adulterated under federal law once the revocation takes effect.
Several legislative proposals introduced in Congress during 2024 and 2025 called for mandatory re-evaluation of legacy food additive approvals. The FDA’s proactive revocations appear designed to show that the agency can address these concerns using its existing authority.
Compliance Timelines and Transition Periods
The FDA typically provides a compliance transition period following formal revocation of a color additive authorization. During this window, manufacturers are expected to reformulate affected products and update labeling accordingly. Specific transition periods can vary depending on the substance and the scope of its use in the marketplace.
Companies should monitor the Federal Register for the final rules associated with each revocation, since those documents specify the effective dates and any applicable compliance deadlines. In previous revocations of this type, the FDA has generally allowed transition periods ranging from several months to two years. The length depends on the complexity of reformulation required and the volume of affected products already in commerce.
What This Means for Your Business
Even if your formulations do not include Orange B or Citrus Red No. 2, you should treat this as an ongoing FDA program rather than a one-time cleanup, and expect further authorizations to face review.
Three steps are worth taking now. First, audit current formulations against the additives named in this action. Second, confirm with suppliers that they are aware of the changes and can certify compliance. Third, begin evaluating alternative colorants that remain authorized and meet performance requirements.
Companies selling into both the U.S. and Canada should also note that Health Canada maintains its own permitted colours list under the Food and Drug Regulations. An FDA revocation does not automatically change a colorant’s status in Canada, but it may signal a Health Canada review is coming, so track both jurisdictions independently.
Frequently Asked Questions
Will products already on store shelves need to be recalled if they contain a revoked color additive?
For Orange B, now subject to a final order, the answer depends on the effective date and transition terms set out in that order. In past revocations of this kind, the FDA has generally allowed products manufactured before the effective date to be sold through during a transition period, though manufacturers should not assume this will apply uniformly. Citrus Red No. 2 remains a proposed revocation, so no compliance timeline applies to it yet. The FDA will address transition details only if it finalizes that action.
Does this FDA action affect color additives used in dietary supplements or cosmetics?
The current announcement specifically addresses color additives authorized for use in food. Color additives used in dietary supplements and cosmetics are regulated under separate provisions of the Federal Food, Drug, and Cosmetic Act, and their authorizations are listed in different sections of the CFR. However, some colorants are authorized across multiple product categories, so a revocation in food could foreshadow similar reviews in supplements or cosmetics. Companies with products spanning multiple categories should assess their exposure across all relevant regulatory listings.
How will the FDA determine which color additives to review next in this ongoing initiative?
The agency has indicated that its review prioritizes substances where the original safety data is most outdated or where new evidence raises questions about safety at current exposure levels. The FDA is also reportedly considering public petitions and congressional recommendations when setting its review agenda. Companies that want to track upcoming actions should monitor the FDA’s Unified Agenda and any advance notices of proposed rulemaking published in the Federal Register related to color additive authorizations.
Key Takeaways
- The FDA issued a final order revoking authorization for Orange B and proposed revoking authorization for Citrus Red No. 2, both petroleum-based color additives.
- Once the Orange B revocation takes effect, any product containing it will be considered adulterated under federal law. The Citrus Red No. 2 proposal remains open for public comment through August 24, 2026.
- Compliance transition periods are specified in the final rules published in the Federal Register, and companies should monitor those documents closely.
- Cross-border manufacturers selling into both the U.S. and Canada should track regulatory developments in both jurisdictions independently.
- This initiative reflects a broader FDA strategy to modernize food additive oversight, and companies using synthetic colorants should prepare for ongoing scrutiny.
Next Steps for Your Ingredient Compliance
Whether Orange B, Citrus Red No. 2, or another legacy color additive shows up in your formulations, now is the time to confirm where you stand. Reformulation, supplier verification, and labeling updates all take lead time, and companies that start early avoid scrambling once a final rule sets a compliance deadline.
Our ingredients and GRAS compliance team works with food and beverage companies to review formulations against current FDA and Health Canada requirements and to manage the notification or reformulation process when an authorization changes. Contact us to get your formulations reviewed before the next round of revocations lands.
