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The U.S. Food and Drug Administration (FDA) announced several coordinated updates on February 5, 2026, that collectively signal a major shift in the agency's oversight of "no artificial colors" claims on foods intended for human consumption. These changes include the adoption of a new enforcement discretion policy and expanded use approvals for two non-petroleum-based color additive petitions. In its announcement, FDA stated it was taking these steps to support a move away from use of "artificial petroleum-based colors to alternatives derived from natural sources."
FDA Will Not Take Action Against Food Products Bearing Certain "No Artificial Colors" Claims When They Do Not Contain Certified Colors
In its "Letter to the Food Industry," FDA noted that the current definition of "artificial color" does not differentiate between colors from "natural sources" and other colors. The letter announced that it will exercise enforcement discretion under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when manufacturers use specific voluntary labeling claims on foods that do not contain any FD&C Act certified colors listed in 21 CFR Part 74. The allowable claims for non-certified approved food colors include:
- "Made without artificial food colors/colorings"
- "No artificial color/colors/coloring"
- "No added artificial color/colors/coloring"
The enforcement discretion applies only to foods that lack certified colors. Products containing any FD&C Act certified color additives are not eligible for these claims under the policy and remain subject to enforcement. This is different from FDA's current regulation, which only allows manufacturers to make these types of claims when a food product does not contain any color ingredient regardless of whether it was derived from natural sources. The updated enforcement policy may incentivize manufacturers to rely more heavily on noncertified color ingredients to qualify for "made without artificial food colors/coloring" claims.
Importantly, FDA's letter makes clear that any colors derived from natural sources must still be pre-approved by FDA under FDA's color additive petition process as required under Section 721 of the FD&C Act (21 U.S.C. 379e). See also 21 CFR Part 71.
Limitations of the Enforcement Discretion
The announcement does not address whether FDA will revisit the regulatory definitions of "artificial color"1 or "color additive,"2 both of which continue to classify all added colors, even those from natural sources, as artificial. As a result, manufacturers should understand that state consumer protection challenges to "no artificial color" claims may still arise in situations where color additives are used, even if those color additives are derived from natural sources.
FDA Approves Expanded Uses for Spirulina Extract and Beetroot Red
In addition to announcing its new labeling enforcement policy, FDA approved two new color additive petitions. Spirulina extract is now authorized for broader use in food, with exceptions for infant formula, certain USDA‑regulated foods, and foods subject to a standard of identity (unless the standard allows such use). The approval also tightens specifications for heavy metals, including the addition of a cadmium limit.
Beetroot red has likewise been approved for general use in foods, subject to the same category‑specific limitations. FDA issued a reminder to manufacturers emphasizing their ongoing responsibility to ensure the safety of all color additives used in foods.
Key Considerations for Manufacturers
- Companies may now make certain "no artificial colors" claims when their products contain approved colors that are not required to be "certified colors" under 21 CFR Part 74 without concern of FDA enforcement action. However, without a change to the regulatory definition of "artificial color," potential private or state litigation exposure persists despite FDA's non‑enforcement posture.
- Manufacturers making "no artificial colors" claims consistent with FDA's new enforcement policy should review ingredient sourcing carefully to confirm natural sources.
- Companies intending to use the voluntary "no artificial colors" claim should maintain dossiers that will support the use of the claim.
Wiley's Food & Drug practice will continue to monitor developments as FDA refines its approach to color additive oversight and labeling policies. For more information, please contact one of the authors of this alert.
Footnotes
1 21 C.F.R. 101.22(a)(4).
2 21 C.F.R. 70.3(f).
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