,The U.S. Food and Drug Administration (FDA) regulates all color additives used in foods, drugs, cosmetics, and certain medical devices to ensure safety and proper labeling. On September 17, 2025, the FDA proposed revoking authorization for Orange B, a petroleum-based food dye, due to its discontinued use. In April and May 2025, the FDA announced measures to phase out petroleum-based synthetic dyes and approved new color additive petitions from natural sources. Color additives include dyes, pigments, and substances that impart color either directly or through chemical reactions. They are classified as straight colors, lakes, or mixtures, each with specific manufacturing and certification requirements. FDA approval is required before use, with certain synthetic colors subject to batch certification. The agency monitors reports of adverse reactions, particularly in children, and takes enforcement actions if color additives are misused or unsafe. Consumers and industry can report complaints through the FDA.
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