Out of the blue: What the FDA delay means for spirulina extract

Food colors are facing heightened scrutiny in the US, particularly around safety and labeling.

Understanding how they’re regulated has become increasingly important for manufacturers – but is often misunderstood.

In the US, the food and beverage industry uses many naturally derived colors that are made from edible raw materials and processed using physical methods and water.

Based on the concept of coloring food with food, they are created from fruits, vegetables, and plants that are regularly consumed as foodstuffs and where safety is established by historical data.

Most of these colors are approved for use in all foods generally, provided they are added only at levels necessary to achieve their intended visual effect and that overall dietary exposure remains appropriate.

Spirulina extract is made in much the same way as these colors. Spirulina is an edible ingredient that can be processed with physical methods and water to produce natural blue colors.

Spirulina-based colors have been used for decades in a vast array of countries around the world. Spirulina extract has also been used for many years in the US in products including beverages, confectionery, and dairy.

Despite this, the US FDA recently announced it has delayed the effective date of a final order related to spirulina extract’s expanded use as a color in foods generally.¹

Why the delay? It’s not for the reasons you might expect – and it therefore offers a useful case study for understanding how food colors are evaluated and regulated in the US.

Spirulina extract in a global regulatory context

Spirulina extract is neither a novel ingredient nor a newly introduced food color. It is derived from Arthrospira platensis, a type of microalgae that has been consumed for centuries and is now in widespread global use across a range of food and beverage applications, including functional foods.

In the EU, spirulina‑based colors produced through physical processing are classified as “coloring foods” and treated as food ingredients.

In the US, however, FDA oversight distinguishes between two broad categories of color additives:

• Certified color additives, such as FD&C colors, which require batch‑to‑batch certification and are primarily petroleum-derived.
• Color additives exempt from certification, a category that includes a range of color sources and manufacturing approaches. These exempt colors may include: colors derived from edible fruits, vegetables, and plants that are processed using physical methods and water to concentrate naturally occurring pigments; and colors that are produced through more selective extraction processes, where pigments are isolated from source materials that are not necessarily consumed as foods in their original form.

Spirulina extract is currently approved for use as a color additive in many categories under FDA regulations – but with certain exceptions. For example, while it may be used in the frosting or decorations on a baked good, there is no explicit approval for its use in the batter or dough. These distinctions reflect how FDA permissions for spirulina extract have expanded incrementally over time.

Table 1. Timeline of FDA regulatory actions related to spirulina extract and expanded conditions of use.

GNT therefore petitioned the FDA to expand its use across all foods generally – aiming to eliminate uncertainty over categories where approval had yet to be officially confirmed.

Safety review is the foundation of the petition process

The US classification framework first considers why something is being added to a product. If spirulina extract is added for reasons other than color – such as in a functional spirulina smoothie – it falls under food ingredient requirements. Color additive regulations do not apply.

Where spirulina extract is added solely to create a blue visual effect, it is regulated as an exempt‑from‑certification color additive. When assessing a color additive, the FDA review process specifically assesses safety data presented by the petitioner. The agency must consider whether there is a reasonable certainty of no harm under the intended conditions of use before determining where or how a color may be permitted.

It applies this framework both to new color approvals and to requests that expand permitted uses for already approved colors.

Depending on the color additive and proposed scope, the review can be extensive. It may include dietary exposure assessments across different population groups and, for new ingredients, toxicological studies. The scope and duration of review reflect the complexity of the data and the breadth of proposed use.

Spirulina extract has been evaluated within this same structure since its first FDA approval in 2013. As proposed uses have evolved, FDA’s review has considered whether current safety data and exposure estimates support the specific food categories being requested.

In February, FDA approved spirulina extract for use in foods generally. While that approval has now been delayed, this reflects only procedural requirements and does not change FDA’s safety determination.

When colors are permitted across foods generally

For manufacturers, the breadth of permitted use can determine whether a color is commercially viable across product portfolios. This is why the FDA designation of use in “foods generally” matters in practice.

Examples of food‑based, plant‑derived colors with established use include fruit juice, vegetable juice, and annatto extract, which are permitted for use as colorants in foods generally, subject to Good Manufacturing Practice and standard exclusions.

The intent of GNT’s petition to expand the permitted uses of spirulina extract follows this same regulatory logic. As interest in spirulina‑based colors has expanded across more food applications, broader permissions can help align regulatory treatment with how comparable food‑based colors are already regulated, while maintaining established safeguards.

How spirulina extract is made: Transparency through processing

Processing methods increasingly shape how ingredients are understood and evaluated. It is therefore important to clarify exactly what spirulina extract is. GNT began developing blue color solutions from spirulina in the 1990s, using water and physical processing methods to concentrate naturally occurring pigments.

Spirulina contains a vibrant blue pigment known as phycocyanin. Spirulina extract is made through water-based extraction, separation, and filtration, without the use of chemical solvents or modification. This allows for the production of a stable blue color for food applications.

Similar processes are used to produce fruit and vegetable juice concentrates, where the natural pigments are made into food colors using steps such as chopping, separating, filtering, and concentrating.

Quality, testing, and safety assurance

One of the most common concerns manufacturers raise about natural colors is variability. This can include differences in color hue and strength, variability in performance under processing conditions, and the presence of naturally occurring contaminants that must be appropriately managed.

Unlike certified FD&C colors, color additives that are exempt from certification do not undergo FDA batch-by-batch review. However, this does not mean they are unregulated or less safe. Natural colors remain subject to FDA food safety requirements, including preventive controls regulations, and manufacturers have an obligation to identify hazards specific to their raw materials, processes, and supply chains to implement effective controls.

In practice, consistency and safety are achieved through the application of robust quality and food safety systems that extend beyond regulatory requirements alone. Defined specifications, validated processes, and disciplined quality management play a central role in delivering reliable performance from natural color ingredients.

At GNT, the production of spirulina extract is built around this preventive, risk-based approach. Its facilities operate in compliance with FSSC 22000 certification requirements, which emphasize hazard analysis, process control, and continuous improvement. GNT carefully qualify suppliers and apply multiple control steps designed to address risks commonly associated with natural raw materials.

These controls include several filtration steps to eliminate potential pathogens, routine testing for naturally occurring contaminants such as heavy metals, and systematic lot-to-lot verification to confirm color strength and hue remain within defined parameters. Together, these measures support the consistent delivery of safe, high-quality spirulina extract for food and beverage manufacturers.

Formulation expertise is vital

Successful use of natural colors extends beyond ingredient quality to formulation expertise and ongoing application research.

Factors such as pH, heat, processing conditions, and the food matrix all influence how spirulina extract behaves in finished products.

For this reason, manufacturers benefit from working with suppliers who combine regulatory and food safety expertise with deep application knowledge, helping translate well-designed manufacturing controls into consistent performance across diverse formulations.

Why clarity – and trust – matter more than ever

As demand for natural colors continues to grow, clarity around regulatory frameworks, labeling, and performance expectations has become increasingly important.

For manufacturers navigating this transition, support increasingly means addressing these challenges holistically, from regulatory engagement and application research to high standards for quality, safety, and resilient supply chains.

Through decades of experience with plant‑based colors, GNT’s approach is grounded in close collaboration, scientific expertise, safety, and a commitment to transparency and sustainability.

These principles are the foundation of the EXBERRY® color portfolio and of GNT’s role in helping manufacturers meet growing consumer demand for natural colors with confidence.

References

1. Federal Register. Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date. 2026.
2. Federal Register. Listing of Color Additives Exempt From Certification; Spirulina Extract. 2013.
3. Federal Register. Listing of Color Additives Exempt From Certification; Spirulina Extract. 2014.
4. Federal Register. Listing of Color Additives Exempt From Certification; Spirulina Extract. 2015.
5. Federal Register. Listing of Color Additives Exempt From Certification; Spirulina Extract. 2017.
6. Federal Register. Federal Listing of Color Additives Exempt From Certification; Spirulina Extract. 2022.