FDA’s rules for blue phycocyanin-rich extracts depend on how the material is used and which source it comes from. A 2026 order would expand spirulina extract’s permitted use as a food color, but FDA delayed that order’s effective date indefinitely. As of October 4, 2026, the delay remains in place.
What did FDA’s 2026 spirulina extract order change?
On February 6, 2026, FDA issued a final order amending 21 CFR § 73.530. It would allow spirulina (Arthrospira platensis) extract to color human foods generally at levels consistent with good manufacturing practice (GMP), subject to exceptions. The order excludes infant formula; certain products regulated by USDA under federal meat, poultry, and egg inspection laws; and foods with standards of identity unless the standard permits the added color.
The order also called for lower specifications for lead, arsenic, and mercury, and a new cadmium specification. These changes were part of the order whose effective date was delayed.
Is the expansion currently in effect?
No. FDA announced that, effective March 20, 2026, it was delaying the order’s effective date indefinitely while it evaluates timely objections and hearing requests. The delay notice was published on March 24. FDA said the procedural delay did not change its safety determination for the intended use. Until FDA takes further action, manufacturers should consult the currently effective version of 21 CFR § 73.530 for the permitted color-additive uses; the broader 2026 use should not be treated as effective.
What was already approved before the expansion?
Before the delayed 2026 amendment, 21 CFR § 73.530 permitted specified color uses at GMP levels, including confections, frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (except extruded cereals), alcoholic beverages below 20% ABV, nonalcoholic beverages, unheated seasoning mixes, salad dressings, condiments and sauces, dips, dietary supplement tablet and capsule coatings, and seasonal coloring of hard-boiled egg shells. Food identity-standard restrictions applied unless the standard allowed the added color.
The 2026 order would also lower the existing maximum limits for lead (from 2 to 0.2 mg/kg), arsenic (from 2 to 0.3 mg/kg), and mercury (from 1 to 0.1 mg/kg), and add a cadmium limit of 0.3 mg/kg. Because the amendment’s effective date remains delayed, the current eCFR text notes the delay and continues to show the existing specifications.
How does the 2025 Galdieria extract blue approval differ?
Galdieria extract blue is a separate, phycocyanin-rich extract derived from the red microalga Galdieria sulphuraria. FDA listed it under 21 CFR § 73.167 for specified categories, including nonalcoholic beverages, certain juices and dairy-based products, cereal coatings, candies, frozen desserts, and selected other foods. FDA issued the final order on May 12, 2025, and confirmed its effective date on August 21, 2025. This approval is source-specific and use-specific; it is not a general approval for spirulina extract.
What did the 2024 petition propose?
GNT USA filed its color-additive petition on July 18, 2024. FDA announced the filing on August 5, 2024. The petition proposed expanding spirulina extract’s use as a color additive in foods generally, subject to GMP and regulatory exceptions. It formed the basis for the 2026 order.
How is the 2012 GRAS notice different?
GRN 424 concerned a C-phycocyanin-enriched water extract of Arthrospira intended as a food ingredient, up to 250 mg per serving, excluding infant formula and foods under USDA jurisdiction. FDA responded that it had no questions about the notifier’s GRAS conclusion and noted that some uses may require a color-additive listing. A GRAS notice for an ingredient is a separate regulatory pathway; it should not be read as blanket authorization to use the substance as a food color.
What should food businesses take away?
“Phycocyanin,” “spirulina extract,” and “Galdieria extract blue” are related terms, but they do not describe interchangeable regulatory approvals. The permitted use depends on the identity and source of the extract, whether it is used as an ingredient or to impart color, the food category, and the applicable FDA listing. Check the current regulation and FDA notices before making formulation, labeling, or compliance decisions.
This article summarizes public FDA materials for general information and is not legal or regulatory advice.