US EPA

1248757 

Journal Article 

Review 

United States pharmacopeia safety evaluation of spirulina 

Marles, RJ; Barrett, ML; Barnes, J; Chavez, ML; Gardiner, P; Ko, R; Mahady, GB; Low Dog, T; Sarma, ND; Giancaspro, GI; Sharaf, M; Griffiths, J 

2011 

Yes 

Critical Reviews in Food Science and Nutrition
ISSN: 1040-8398
EISSN: 1549-7852 

TAYLOR & FRANCIS INC 

PHILADELPHIA 

51 

7 

593-604 

English 

21793723 

10.1080/10408391003721719 

WOS:000293839700002 

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. 

Arthrospira; Blue-green algae; Cyanobacteria; Dietary supplements; Spirulina; Usp; Arthrospira; Blue green algae; Cyanobacteria; Dietary supplements; Spirulina; Usp; Algae; Measurement theory; Nutrition; Vitamins; Food additives; Animalia; Arthrospira; Chlorophyta; Cyanobacteria; Spirulina; Spirulina maxima; Spirulina platensis; heavy metal; microcystin; chemistry; clinical trial (topic); diet supplementation; drug interaction; drug screening; drug surveillance program; food and drug administration; human; methodology; practice guideline; review; Spirulina; United States; Adverse Drug Reaction Reporting Systems; Clinical Trials as Topic; Dietary Supplements; Drug Evaluation; Drug Interactions; Guidelines as Topic; Humans; Metals, Heavy; Microcystins; Spirulina; United States; United States Food and Drug Administration