FDA Revokes Orange B Authorization, Proposes Citrus Red No. 2 Ban in Push to Eliminate Petroleum-Based Food Dyes
核心洞察
The FDA issued a final order revoking Orange B (搜索) as a food color additive, concluding industry has abandoned its use and no public comments changed this assessment.
The agency also proposed revoking Citrus Red No. 2 (搜索), authorized since 1959 for coloring mature orange skins, with a 30-day public comment period ending August 24, 2026.
These actions are part of a broader FDA-HHS initiative to phase out petroleum-based synthetic dyes from the U.S. food supply, targeting six additional colors for removal by end of 2027.
The U.S. Food and Drug Administration has taken two significant regulatory actions targeting petroleum-based color additives in food, continuing a broader federal initiative to modernize the nation's food supply. On July 22, 2026, the agency issued a final order revoking the authorized use of Orange B (搜索) and simultaneously proposed revoking the authorization for Citrus Red No. 2 (搜索), both on the grounds that industry has abandoned their use.
"The FDA is committed to maintaining a science-based, modern regulatory framework that reflects current manufacturing practices and marketplace realities," said Acting FDA Commissioner Kyle Diamantas, J.D. "By working to remove outdated and unnecessary authorizations under President Trump's regulatory reform agenda, we are ensuring our regulations remain effective, transparent, and aligned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."
Orange B Authorization Formally Revoked
The FDA's final order on Orange B (搜索) follows an evaluation of public comments submitted during the proposal phase. The agency concluded that it received no information that changed its assessment that the authorized use of Orange B has been abandoned by industry. With the final order now in effect, Orange B can no longer be used as a color additive in food products marketed in the United States.
Citrus Red No. 2 Faces Proposed Revocation
Citrus Red No. 2 (搜索) has held authorization since 1959, with its use strictly limited to coloring the skins of mature oranges. The FDA has now tentatively concluded that this use, too, has been abandoned by industry, prompting the proposed revocation. The proposal is now subject to a 30-day public comment period, with all comments due by August 24, 2026. Stakeholders may submit comments electronically through the Federal eRulemaking Portal to docket FDA-2026-N-6304 or by mail to the Dockets Management Staff in Rockville, Maryland. After reviewing the public comments, the FDA will determine whether to finalize the proposed revocation.
Broader Initiative to Phase Out Petroleum-Based Dyes
These actions form part of a wider FDA and U.S. Department of Health and Human Services (搜索) initiative announced in 2025 to phase out petroleum-based synthetic dyes from the U.S. food supply. The program is targeting six other certified colors — FD&C Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2 — with the FDA working alongside food manufacturers, retailers, and trade associations on their removal by the end of 2027.
"The Trump Administration is taking decisive action to strengthen the safety of America's food supply," said 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."
The FDA continues to track voluntary industry commitments through its Tracking Food Industry Pledges to Remove Petroleum-Based Food Dyes webpage, which summarizes pledges from manufacturers, retailers, and trade associations as companies transition to alternative color sources.
Implications for the Nutraceutical and Supplement Industry
For stakeholders in the supplement and nutraceutical industry, the regulatory direction carries implications beyond the two colors directly affected. Formulators developing products for the U.S. market may increasingly need to assess color systems, sourcing, and formulation performance as demand grows for alternatives to synthetic petroleum-derived colors.
The FDA has been taking parallel steps to expand the range of alternatives available to manufacturers. In February 2026, the agency announced enforcement discretion for certain voluntary "no artificial colours" claims where products do not contain petroleum-based colors, alongside expanded use of spirulina extract and approval of beetroot red as a new color option. These developments add further momentum to a shift that could create both opportunities and formulation challenges for suppliers of natural and naturally derived color solutions across the food, beverage, and nutraceutical sectors.
