title: United States pharmacopeia safety evaluation of spirulina.
abstract: The Dietary Supplements Information Expert Committee (DSI-EC) of the United States Pharmacopeial Convention (USP) reviews the safety of dietary supplements and dietary supplement ingredients for the purpose of determining whether they should be admitted as quality monographs into the United States Pharmacopeia and National Formulary (USP-NF). The United States Food and Drug Administration (FDA) has enforcement authority to pursue a misbranding action in those instances where a dietary supplement product indicates that it conforms to USP standards but fails to so conform. Recently DSI-EC undertook a safety evaluation of spirulina, a widely used dietary ingredient. DSI-EC reviewed information from human clinical trials, animal studies, and regulatory and pharmacopeial sources and analyzed 31 adverse event reports regarding spirulina to assess potential health concerns. At the conclusion of this review, DSI-EC assigned a Class A safety rating for Spirulina maxima and S. platensis, thereby permitting the admission of quality monographs for these dietary supplement ingredients in USP-NF. DSI-EC continually monitors reports concerning the safety of dietary supplements and dietary supplement ingredients for which USP dietary supplement monographs are developed. The DSI-EC may revisit the safety classification of spirulina as new information on this dietary ingredient becomes available.
authors.affiliation: United States Pharmacopeia Dietary Supplements Information Expert Committee Members, Rockville, MD 20852-1790, USA.
authors.forename: Robin J
authors.initials: RJ
authors.lastname: Marles
authors.forename: Marilyn L
authors.initials: ML
authors.lastname: Barrett
authors.forename: Joanne
authors.initials: J
authors.lastname: Barnes
authors.forename: Mary L
authors.initials: ML
authors.lastname: Chavez
authors.forename: Paula
authors.initials: P
authors.lastname: Gardiner
authors.forename: Richard
authors.initials: R
authors.lastname: Ko
authors.forename: Gail B
authors.initials: GB
authors.lastname: Mahady
authors.forename: Tieraona
authors.initials: T
authors.lastname: Low Dog
authors.forename: Nandakumara D
authors.initials: ND
authors.lastname: Sarma
authors.forename: Gabriel I
authors.initials: GI
authors.lastname: Giancaspro
authors.forename: Maged
authors.initials: M
authors.lastname: Sharaf
authors.forename: James
authors.initials: J
authors.lastname: Griffiths
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic; D019587:Dietary Supplements / Q000009:adverse effects*; D004341:Drug Evaluation / Q000379:methods*; D004347:Drug Interactions; D017408:Guidelines as Topic; D006801:Humans; D019216:Metals, Heavy / Q000032:analysis / Q000633:toxicity; D052998:Microcystins / Q000032:analysis / Q000633:toxicity; D053545:Spirulina / Q000737:chemistry*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D019216:Metals, Heavy; D052998:Microcystins