On February 5, 2026, the U.S. Food and Drug Administration announced a shift in how it will approach voluntary “no artificial colors” claims on food labels. The agency also granted two petitions expanding the availability of alternative colour additives derived from natural sources.
For manufacturers operating in the United States, this development introduces both strategic labelling opportunities and renewed compliance obligations under the colour additive framework.
This article examines the regulatory update, what “enforcement discretion” means in practice, and how brands should assess formulation and claim strategy moving forward.
FDA to Exercise Enforcement Discretion on “No Artificial Colors” Claims
Historically, companies could generally only claim “no artificial colors” if their products contained no added colours whatsoever, whether synthetic or derived from natural sources. This created a commercial limitation for brands that had replaced petroleum-based synthetic colours with naturally derived alternatives but still used added colouring.
The FDA has now issued a letter to industry stating its intent to exercise enforcement discretion with respect to voluntary “no artificial colors” claims where products do not contain petroleum-based synthetic colours.
As a result, the following applies:
- Products formulated without petroleum-based synthetic colours may now bear “no artificial colors” claims
- The presence of colours derived from natural sources will not automatically preclude such claims
- The change is grounded in FDA’s view that describing naturally derived colours as “artificial” may confuse consumers
It is important to emphasize that this is an exercise of enforcement discretion, not a formal amendment to the Federal Food, Drug, and Cosmetic Act or its implementing regulations. Manufacturers should therefore ensure that claims remain truthful and not misleading under section 403(a) of the Act.
New and Expanded Natural Colour Additive Approvals
In addition to the labelling policy shift, the FDA granted two colour additive petitions that expand the range of authorized alternatives to petroleum-based dyes.
Beetroot Red Approved as New Colour Option
The FDA approved beetroot red as a new colour option derived from a natural source. This provides manufacturers with an additional plant-based alternative suitable for various food applications.
As with all colour additives, use remains subject to the conditions specified in the applicable colour additive regulation, including purity specifications and permitted food categories.
Expanded Use of Spirulina Extract
The FDA also approved the expanded use of spirulina extract, an existing colour additive derived from a natural source. The expansion increases formulation flexibility for manufacturers seeking alternatives to synthetic blue dyes.
According to the agency, these actions bring the total number of new food colour options approved under the current administration to six.
Broader Policy Context: Phase Out of Petroleum-Based Colours
This announcement builds on earlier initiatives by the U.S. Department of Health and Human Services and the FDA to encourage voluntary phase out of petroleum-based synthetic colours.
In April 2025, HHS and the FDA announced measures aimed at working with industry to remove petroleum-based colours from the U.S. food supply. The agency is publicly tracking industry commitments through its “Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes” initiative.
The February 2026 update signals continued regulatory momentum in that direction.
Regulatory Considerations for Food Manufacturers
While this policy shift offers marketing flexibility, manufacturers should approach implementation carefully.
1. Enforcement Discretion Is Not a Regulatory Update
The FDA’s position is articulated through a letter expressing enforcement intent. This communication does not amend the statutory or regulatory definitions of “artificial colouring” or “colour additive” under the Federal Food, Drug, and Cosmetic Act or its implementing regulations. The underlying legal framework therefore remains unchanged, and the agency’s enforcement posture may be refined over time.
Accordingly, companies should avoid interpreting this update as an automatic authorization to modify labels without appropriate review. A formal assessment of formulation records, ingredient specifications, colour additive authorizations, and existing claim substantiation documentation should be conducted prior to implementing labelling revisions to ensure that claims remain truthful, not misleading, and fully defensible under applicable U.S. law.
2. Colour Additive Safety and Purity Remain Mandatory
The FDA has reiterated that manufacturers are responsible for ensuring colour additive safety.
Compliance with Identity and Purity Specifications
Manufacturers must ensure that each colour additive used in formulation meets the identity and purity criteria established in the applicable FDA regulation. This includes confirming compositional parameters, contaminant limits, and manufacturing specifications to ensure the ingredient conforms to its authorized standard.
Adherence to Permitted Uses and Maximum Levels
Colour additives may only be used in the specific food categories and at the maximum levels authorized by the regulations. Companies must verify that the intended application, concentration, and functional purpose of the pcolour additive fall within the scope of its approved conditions of use.
Supplier Qualification and Documentation
Comprehensive supplier qualification procedures are essential to demonstrate ongoing compliance. This includes reviewing technical specifications, certificates of analysis, manufacturing process controls, and maintaining documented evidence that the supplier consistently meets regulatory requirements.
Appropriate Quality Control Testing
Manufacturers should implement quality control testing protocols to confirm that incoming and finished product batches comply with regulatory specifications. Routine analytical verification supports product consistency, safety, and defensibility in the event of regulatory scrutiny.
The agency’s communication highlights available resources to assist manufacturers in maintaining high safety and purity standards.
3. Claim Substantiation and Consumer Perception
Although the FDA acknowledges that classifying naturally derived colours as “artificial” may be confusing, companies must still ensure that claims are not misleading in context.
For example, brands should assess:
- Whether ingredient statements accurately reflect colour additive identity
- Whether front of pack messaging aligns with consumer expectations
- Whether marketing materials remain consistent with regulatory positioning
Strategic Implications for Brands
From a commercial standpoint, the update lowers a practical barrier for companies seeking to transition away from petroleum-based dyes while maintaining competitive “clean label” positioning.
However, companies should undertake a structured regulatory review before implementing label changes:
- Conduct a formulation audit to confirm the absence of petroleum-based synthetic colours
- Verify colour additive authorizations and conditions of use
- Update label proofs and marketing materials accordingly
- Maintain internal documentation supporting claim eligibility
For multi-jurisdictional brands, harmonization considerations are critical. Other markets may define “artificial” differently and claims acceptable under FDA enforcement discretion may not align with regulatory expectations in Canada, the European Union, or other jurisdictions.
Final Remarks
As the FDA continues to encourage the transition away from petroleum-based synthetic colours, this latest policy shift signals both regulatory flexibility and heightened responsibility. The ability to use “no artificial colors” claims where petroleum-based dyes are absent creates meaningful commercial opportunity, but it does not diminish manufacturers’ obligations under the colour additive framework or the prohibition against misleading labelling. Companies that proactively align formulation strategy, colour additive authorization, and claim substantiation will be best positioned to leverage this change while maintaining regulatory defensibility in an evolving U.S. compliance environment.
Regulatory Consulting for U.S. Food Compliance
SNI supports food manufacturers transitioning away from petroleum-based synthetic colours by conducting formulation audits, verifying colour additive authorizations and purity requirements, and assessing eligibility for “no artificial colors” claims under current FDA enforcement policy. Our Regulatory Affairs team reviews labels and marketing materials for compliance with the Federal Food, Drug, and Cosmetic Act, identifies enforcement risks, and provides strategic guidance on reformulation and substantiation to ensure regulatory defensibility while preserving commercial objectives.
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