What does the FDA say about spirulina?: A Guide to Safety and Regulation

October 15, 2025 •

3 min read

According to the U.S. Food and Drug Administration (FDA), dietary supplements are regulated differently from foods and drugs, meaning the FDA does not approve them for safety and effectiveness before they are marketed. This distinction is vital for understanding what the FDA says about spirulina, which is categorized under different regulatory frameworks depending on its intended use.

Quick Summary

The FDA considers spirulina Generally Recognized As Safe (GRAS) as a food ingredient but regulates it strictly as a color additive for specific uses. While manufacturers bear responsibility for supplement safety, consumers face potential contamination risks from poorly sourced products.

Key Points

Dual FDA Regulation: Spirulina is treated differently by the FDA depending on its use, either as a dietary supplement or a food color additive.
GRAS Status for Supplements: As a supplement, spirulina is Generally Recognized As Safe (GRAS), but manufacturers are responsible for ensuring product safety and accurate labeling, not the FDA.
Approval for Color Additive: Spirulina extract used for coloring requires specific FDA approval for its use in foods like candies, beverages, and coatings for tablets.
Contamination Risk: Poorly sourced spirulina can be contaminated with toxins (microcystins) and heavy metals, posing significant health risks, especially in unregulated supplement products.
Importance of Third-Party Testing: Consumers should choose reputable brands and look for third-party certifications (e.g., USP, NSF) to verify the purity and safety of spirulina supplements.
Contraindications and Drug Interactions: Certain groups, such as those with autoimmune diseases or on blood thinners, should avoid spirulina due to potential adverse effects.
Post-Market Enforcement: The FDA primarily regulates dietary supplements after they are on the market, taking action against unsafe products rather than pre-approving them.

The FDA's Dual Regulatory Stance on Spirulina

The FDA's perspective on spirulina is not singular but depends on its application. The agency has designated spirulina as Generally Recognized As Safe (GRAS) for specific uses as a food ingredient, particularly in certain contexts. However, the use of spirulina extract as a color additive is subject to pre-market approval and strict regulation. Understanding this dual approach is key for consumers seeking to incorporate spirulina into their diets.

Spirulina as a Dietary Supplement: The GRAS Designation

When sold as a dietary supplement, spirulina falls under the Dietary Supplement Health and Education Act (DSHEA). DSHEA does not require FDA pre-market approval for safety or effectiveness; manufacturers are responsible for ensuring their supplements are safe and properly labeled. The FDA has acknowledged the GRAS status of spirulina-based ingredients for use in various foods, based on expert consensus regarding safety under intended use conditions. This is distinct from FDA approval for medical purposes.

Spirulina as a Color Additive: Specific Approvals

Unlike supplements, spirulina extract used for coloring is regulated as a color additive and requires explicit FDA approval. This approval process, involving a safety evaluation, has led to spirulina extract being approved for use in a range of foods and drugs, including confections, chewing gum, ice cream, yogurts, beverages, and coatings for tablets. Manufacturers must meet specific standards for identity, composition, and safety, including limits on heavy metals and toxins.

Critical Safety Considerations: Contamination Risks

Contamination is a major safety concern for spirulina, particularly when harvested from unregulated environments. Potential contaminants include:

Microcystins: Toxins from cyanobacteria that can cause liver damage.
Heavy Metals: Absorption of lead, mercury, and arsenic from the growth environment.
Bacteria: Contamination from microbes in open-pond systems.

To minimize these risks, consumers should look for products certified by independent third parties like USP, ConsumerLab, or NSF International, which test for contaminants and verify ingredient content.

FDA Regulation: Supplements vs. Color Additives


Feature	Dietary Supplement (e.g., Powder)	Color Additive (e.g., Spirulina Extract)
Regulatory Framework	DSHEA of 1994, regulated as a food.	Color Additive Regulations, strict pre-market approval.
Premarket Approval	No FDA review or approval required before marketing.	FDA approval required for specific uses and foods.
Burden of Safety	Manufacturer is responsible for product safety.	FDA conducts a safety evaluation based on data.
Manufacturing Standards	Must adhere to Good Manufacturing Practices (GMPs).	Must conform to specific purity and composition standards.
Labeling	Must include a disclaimer: “This statement has not been evaluated by the FDA...”.	Specific labeling requirements for the additive.

Conclusion: Informed Choices for a Safe Diet

Understanding the FDA's different approaches to spirulina—as a GRAS dietary supplement with manufacturer-led safety and as a strictly regulated color additive—is crucial for consumers. The primary risk lies in consuming contaminated supplements. By choosing third-party tested products and consulting healthcare professionals, individuals can safely benefit from high-quality spirulina while mitigating risks associated with potential contamination and the lack of pre-market FDA approval for supplements.

Who Should Exercise Caution?

Certain individuals should avoid spirulina or consult a healthcare provider, including pregnant or breastfeeding women due to insufficient research, individuals with autoimmune diseases as it can stimulate the immune system, those with Phenylketonuria (PKU) due to phenylalanine content, and those on blood-thinning medications due to potential anticoagulant effects. Consulting a healthcare professional is recommended for personalized advice.

Frequently Asked Questions

No, the FDA does not 'approve' dietary supplements, which is how spirulina is typically sold to consumers. However, the FDA has acknowledged spirulina's Generally Recognized As Safe (GRAS) status for certain uses in food. Spirulina extract used as a color additive is approved for specific applications after a safety review.

The FDA's main concern is the potential for contamination, particularly with toxins like microcystins and heavy metals. This risk is higher with spirulina harvested from natural, uncontrolled bodies of water.

To ensure safety, purchase spirulina from reputable brands that provide proof of third-party testing and certification from organizations like U.S. Pharmacopeia (USP) or NSF International.

The FDA has approved spirulina extract for coloring various foods and beverages, including candy, chewing gum, ice cream, yogurts, and some alcoholic and non-alcoholic drinks.

For spirulina, GRAS status means that experts generally agree it is safe under its intended conditions of use in food. This is different from FDA drug approval, and manufacturers still hold the responsibility for proving safety.

Yes, certain individuals should avoid spirulina or consult a doctor first. This includes pregnant or breastfeeding women, people with autoimmune conditions like lupus, and those with Phenylketonuria (PKU).

Yes, the FDA regulates supplement labeling, including requiring a disclaimer that the product has not been evaluated by the FDA and is not intended to treat, cure, or prevent any disease.