FDA Delays Effective Date for Spirulina Extract Color Additive Expansion in Human Foods

The FDA is delaying the effective date of a February 6, 2026, final order that would have expanded the permitted use of spirulina (Arthrospira platensis) extract as a color additive in most human foods at levels consistent with good manufacturing practice (GMP). The expansion excluded infant formula, certain USDA-regulated foods, and foods governed by standards of identity under section 401 of the FD&C Act unless those standards explicitly allow added color. The original final order also tightened heavy metal safety specifications, lowering allowable limits for lead, arsenic, and mercury, and introduced a new specification for cadmium. The delay is legally mandated following the timely filing of objections and a request for a formal hearing, a process established under FDA administrative law. The FDA emphasizes that this delay does not signal any reversal of its scientific conclusion that spirulina extract is safe under its intended conditions of use. The agency also clarifies that filing objections does not automatically mean those objections are valid, nor does it guarantee a formal hearing will be granted.

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