FDA Internal Memoranda for Color Additive Petitions – Spirulina Extract

What You Get: Four FDA internal review memoranda released under an FDA FOIA request, covering FDA's scientific review of spirulina extract (phycocyanins) as a color additive across two color additive petitions — CAP 2C0293 (Mars Inc./Keller & Heckman) and CAP 2C0297 (GNT USA/Hogan Lovells).

Documents Included:
• Chemistry Exposure Memo (May 31, 2012) — FDA's independent eaters-only exposure estimate for phycocyanins from proposed use of spirulina blue in candy and chewing gum (CAP 2C0293)
• Toxicology Review Memo (Oct 2, 2012) — Safety review of Arthrospira platensis; establishes NOEL at highest dose tested, concludes adequate margin of safety (CAP 2C0293)
• OCAC Chemistry Review Memos (Dec 2012 – May 2013) — Office of Cosmetics and Colors review of identity, specifications, manufacturing process, stability, and proposed uses for both petitions; includes recommended chemical specifications (lead, arsenic, mercury, microcystin toxin)
• Final Toxicology Review Memo (Nov 1, 2013) — Comprehensive safety evaluation for CAP 2C0297 with full appendices of 100+ animal and human studies; concludes no safety concerns at estimated cumulative dietary intakes

Key Topics Covered: Phycocyanin identity and composition, NHANES-based dietary exposure modeling, NOEL/CEDI comparison, cumulative exposure from all spirulina-based GRAS ingredients, chemical specifications, manufacturing process review, GRAS notices GRN 127/394/417/424, international regulatory status

Petition Numbers: CAP 2C0293, CAP 2C0297
FOIA Request: 2024-9497
Pages: ~75
Format: PDF (partially redacted under FOIA exemption b(4) — trade secrets/CCI)

Note: Additional responsive records for the underlying Colorcon, McCormick, and GNT petitions are publicly available on regulations.gov (dockets FDA-2014-C-1552, FDA-2016-C-2570, and FDA-2020-C-1309) and are not included here.

Original Request: Copies of the internal FDA memoranda reviewing FDA's approval of color additive petitions relating to the color additive "spirulina extract." The federal registry entries for each of these petition approvals are listed at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives&id=SpirulinaExtract
Tags: Food, Color Additive, 2024