The U.S. Food and Drug Administration (FDA) continues its close review of federal regulations governing color additives used in food, drugs and cosmetics. On February 5, 2026, FDA announced a significant policy shift regarding voluntary food labeling claims related to artificial colors, issuing a Letter to the Food Industrystating that it will exercise enforcement discretion under Section 403(a)(1) of the Food, Drug and Cosmetic Act (FD&C) with respect to certain "no artificial colors" labeling claims.
Under this new policy, FDA does not intend to take enforcement action against food companies that use "no artificial colors" claims, as long as the products do not contain any FD&C-certified (petroleum-based) color additives. This represents a departure from prior practice, which generally only permitted these claims where a product contained no added color of any kind, whether derived from natural sources or synthetic.
Background & Rationale
FDA's action here is part of the Agency's broader effort to facilitate the transition of the U.S. food supply away from synthetic, petroleum-based color additives, and move instead toward alternatives derived from natural sources. FDA has indicated that the current regulatory definition of "artificial color," which does not distinguish between naturally derived and synthetic colors, may impede industry efforts to adopt naturally sourced alternatives. "We acknowledge that calling colors derived from natural sources 'artificial' might be confusing for consumers and a hindrance for companies to explore alternative food coloring options," FDA commissioner Marty Makary said in a statement. "We're taking away that hindrance and making it easier for companies to use these colors in the foods our families eat every day."
FDA's announcement reflects ongoing regulatory trends toward reducing synthetic additives in food products. In April 2025, the Department of Health and Human Services (HHS) and FDA announced a series of measures intended to phase out all petroleum-based synthetic dyes from the nation's food supply, with deadlines for some certified colors quickly approaching in 2026. The agency also recently approved natural color additives for food, including beetroot red and expanded use of spirulina extract, further expanding the palette of alternatives available to manufacturers. Notably, some consumer groups have raised concerns that the new policy could be misunderstood by food shoppers, as products labeled with "no artificial colors" might still include added natural colorants that change the product's appearance.
Which Claims are Covered:
Per the Letter, FDA's enforcement discretion will apply to voluntary labeling claims such as:
- "Made without artificial food colors/colorings"
- "No artificial color/colors/coloring"
- "No added artificial color/colors/coloring"
Such claims will be acceptable under FDA's new policy where the product does not contain color additives listed in 21 C.F.R. Part 74 – i.e., FD&C Blues Nos. 1 and 2, Green No. 3, Orange B, Citrus Red No. 2, Red Nos. 3 and 40 and Yellow Nos. 3 and 6.
Practical Implications
This new policy gives manufacturers increased flexibility to make "no artificial colors" claims on product labels even when colorants have been added to the product, so long as synthetic petroleum-based colors have been replaced with FDA-approved natural alternatives. This enforcement discretion does not change the underlying law, however – though FDA has signaled that it will not enforce Section 403(a)(1) for labeling claims covered by the guidance under certain conditions, Section 403(a)(1) still prohibits labeling that is false or misleading.
Nor does FDA's exercise of discretion at the federal level preempt more stringent state consumer protection laws. California and West Virginia, for example, have recently passed laws banning food items containing some of the synthetic color additives listed in 21 C.F.R. Part 74. Those laws, which go into effect in 2027 and 2028, will also prohibit public schools from offering or making available foods containing synthetic color additives. This focus at the state level may also generate enforcement actions by attorneys general or private litigants under state statutes if they view "no artificial colors" claims as misleading.
Next Steps for Industry
Buchanan's FDA & Biotechnology Section is closely following the rapidly evolving color additive regulatory landscape. In light of FDA's recent guidance, industry participants can take various steps to stay informed and ensure continued compliance:
- Review and assess existing product portfolios to identify opportunities to update labeling where synthetic colors have already been removed;
- Assess labeling and marketing strategies to ensure compliance with the new discretionary policy and avoid potential misinterpretation by consumers or enforcement authorities;
- Pay close attention to the patchwork landscape of state-specific requirements and restrictions on color additives; and
- Monitor related regulatory developments, including federal and state actions regarding food labeling and color additives.
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