FDA Revokes Orange B, Proposes Citrus Red No. 2 Ban; Allows 'No Artificial Colors' Claim

The FDA has finalized the revocation of Orange B and proposed revoking Citrus Red No. 2, while exercising enforcement discretion to permit ‘no artificial colors’ claims on foods that avoid petroleum‑based dyes. The actions are part of a broader initiative to phase out synthetic dyes and fast‑track natural alternatives.

The U.S. Food and Drug Administration has issued a final order revoking the authorized use of Orange B as a color additive in food and proposed revoking Citrus Red No. 2, while separately announcing it will exercise enforcement discretion to allow ‘no artificial colors’ claims on products that do not contain petroleum-based color additives.

The final revocation of Orange B follows an evaluation of public comments that did not alter the agency’s conclusion that the color’s use has been abandoned by industry. For Citrus Red No. 2—authorized since 1959 for coloring the skins of mature oranges—the FDA has tentatively concluded that its use has likewise been abandoned. The proposed revocation is open for a 30‑day public comment period, with submissions due by August 24, 2026, under docket FDA‑2026‑N‑6304.

The actions are part of a broader initiative launched in April 2025, when the Department of Health and Human Services and FDA announced measures to phase out petroleum‑based food dyes. The agency is partnering with the National Institutes of Health on research into the health and developmental impacts of food additives on children. Under this effort, the FDA plans to eliminate six additional synthetic dyes—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—by the end of 2026. The FDA is also asking food companies to remove FD&C Red No. 3 ahead of the previously required 2027–2028 deadline.

On February 5, 2026, the FDA sent letters to food manufacturers advising that it will exercise enforcement discretion regarding Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act. Under this new policy, companies can claim “no artificial colors” when products do not contain petroleum‑based colors. Previously, such claims were generally permitted only when a product contained no added color whatsoever. The administration is establishing a national standard and timeline for the industry’s transition from petrochemical‑based dyes to natural alternatives.

To support the shift, the FDA is fast‑tracking the review and approval of new natural color additives, including beetroot red and expanded use of spirulina extract for blues and greens. Spirulina extract, derived from Arthrospira platensis, is already approved for use in many food categories—including candy and chewing gum (2013), confections and frozen desserts (2014), dietary supplement coatings (2015), hard‑boiled eggs (2017), and non‑alcoholic beverages, condiments, and dairy alternatives (2022). However, a petition to expand its use across all foods generally has faced delay: the FDA recently postponed the effective date of a final order that would have broadened its permitted applications.

While brands are already advertising plant‑based dyes—using phrases like “sourced from plants”—the FDA emphasizes that substitute color additives must meet all safety and purity standards, including limits on heavy metals and other contaminants. The agency has issued guidance resources to assist manufacturers. Separately, the FDA continues to track voluntary industry commitments to remove petroleum‑based food dyes through a public webpage summarizing pledges from manufacturers, retailers, and trade associations.

Despite the FDA’s enforcement discretion, consumer‑filed lawsuits over misleading labeling remain a risk. In the last five years, more than 20 lawsuits have been filed alleging that claims about artificial colors are false or misleading. The FDA’s position does not preempt state laws that define all added colors as artificial, and the agency’s enforcement discretion does not bar private class actions.

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References

  1. FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food · fda.gov
  2. How FDA food color regulations affect spirulina extract - FoodNavigator-USA.com · foodnavigator-usa.com
  3. 'No Artificial Colors' Claims Get More Colorful As FDA Announces Shift Away from Petroleum ... · morganlewis.com