Spirulina - Spirulina platensis

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

• Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 31, 2018

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information

Proper name(s)	Common name(s)	Source information
		Source material(s)	Part(s)
Arthrospira platensis	Spirulina	Arthrospira platensis	Whole

References: Proper name: Guiry and Guiry 2014; Common name: Mazokopakis et al. 2013, CNF 2010; Source information: Yu et al. 2012, CNF 2010, Dillon et al. 1995.

Route of administration

Oral

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms by age group:

Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

All Products

• Source of/Provides antioxidants (Yu et al. 2012; Kalafati et al. 2010).
• Helps reduce symptoms of allergic rhinitis such as nasal discharge, sneezing, nasal congestion and itching (Cingi et al. 2008; Mao et al. 2005).

Uses based on constituent potency at or above the minimum doses indicated in the dose section below

• Source of beta-carotene, a provitamin A, for the maintenance of good health (CNF 2010; IOM 2006; Shils et al. 2006).
• Source of beta-carotene, a provitamin A, to help maintain eyesight, skin, membranes and immune function (CNF 2010; IOM 2006; Shils et al. 2006).
• Source of beta-carotene, a provitamin A, to help in the development and maintenance of night vision (CNF 2010; IOM 2006; Shils et al. 2006).
• Source of beta-carotene, a provitamin A, to help in the development and maintenance of bones and teeth (CNF 2010; IOM 2006; Shils et al. 2006).
• Source of iron for the maintenance of good health (CNF 2010; IOM 2006).
• Source of iron which helps to form red blood cells and helps in their proper function (CNF 2010; IOM 2006; Shils et al. 2006).
• Source of protein for the maintenance of good health (CNF 2010; IOM 2005).
• Source of protein which helps build and repair body tissues (CFIA 2012).
• Source of (an) essential amino acid(s) for the maintenance of good health (CNF 2010; IOM 2005).
• Source of (an) (essential) amino acid(s) involved in muscle protein synthesis (CNF2010; IOM 2005).

Note
The recommended use or purpose , "Source of vitamin B12" is not acceptable as most vitamin B12 from this source is not bioactive (Michaelson 2009; Watanabe F. 2007, Watanabe et al. 1999).

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Methods of preparation: Dry, powder, Non-Standardized and Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Allergic rhinitis/Antioxidant

Table 2. Daily doses of spirulina for allergic rhinitis. Note that for the antioxidant claim no minimum dose of spirulina has been established; however, the maximum dose of spirulina applies.

Subpopulation(s)
		Minimum dose of Spirulina (g/day) 1	Maximum dose of Spirulina (g/day) 2,3
Children
	2-4 years	0.3	1
	5-9 years	0.5	2
	10-11 years	1	4
Adolescents
	12-14 years	1	4
	15-17 years	2	8
Adults	18 years and older	2	8

¹ Children and adolescent minimum doses calculated as a fraction of the adult dose; Adult minimum doses supported by the following references: Cingi et al. 2008; Mao et al. 2005.
² Children and adolescent maximum doses calculated as a fraction of the adult dose and supported by the following references: Dia et al. 2009; Simpore et al. 2006; Samuels et al. 2002.
³Adult maximum dose supported by the following references: Marles et al. 2011; CNF 2010; Cingi et al. 2008; Lee et al. 2008; Park et al. 2008; Baicus and Baicus 2007.

Claims based on the constituent protein

Table 3. Daily doses of algal protein (no minimum spirulina dose required).

Subpopulation(s)
		Minimum dose of Algal protein (g/day) 1	Maximum dose of Algal protein and Spirulina (g/day) 2,3
Children
	2-4 years	0.6	1
	5-9 years	0.9	2
	10-11 years	1.5	4
Adolescents
	12-14 years	1.5	4
	15-17 years	2.6	8
Adults	18 years and older	2.6	8

¹ Children, adolescent and adult minimum doses of protein supported by the following references: IOM 2006; IOM 2005.
² Children and adolescent maximum doses of spirulina calculated as a fraction of the adult dose and supported by the following references: Dia et al. 2009; Simpore et al. 2006; Samuels et al. 2002.
³Adult maximum dose supported by the following references: Marles et al. 2011; CNF 2010; Cingi et al. 2008; Lee et al. 2008; Park et al. 2008; Baicus and Baicus 2007.

Claims based on the constituents Beta-carotene or Iron

Table 4. Daily doses of beta-carotene and iron (no minimum spirulina dose required).

Subpopulation(s)		Beta-carotene 1		Iron 1		Maximum dose of Spirulina (g/day)2,3
		Min (mcg/day)	Max (mcg/day)	Min (mg/day)	Max (mg/day)
Children
	2-3 years	180	3600	0.6	40	1
	4 years	180	5400	0.6	40	1
	5-8 years	180	5400	0.6	40	2
	9 years	180	10200	0.6	40	2
	10-11 years	180	10200	0.6	40	4
Adolescents
	12-13 years	180	10200	0.6	40	4
	14 years	390	16800	1.4	45	4
	15-17 years	390	16800	1.4	45	8
Adults
	18 years	390	16800	1.4	45	8
	19 years and older	390	18000	1.4	45	8

¹ Children, adolescent and adult minimum and maximum doses of beta-carotene and iron supported by the NNHPD Multi-Vitamin/Mineral Supplements Monograph
²Children and adolescent maximum doses of spirulina calculated as a fraction of the adult dose and supported by the following references: Dia et al. 2009; Simpore et al. 2006; Samuels et al. 2002.
³Adult maximum dose of spirulina supported by the following references: Marles et al. 2011; CNF 2010; Cingi et al. 2008; Lee et al. 2008; Park et al. 2008; Baicus and Baicus 2007.

Notes

• For a use or purpose based on a particular constituent (e.g., beta-carotene, iron, or protein), the name and the amount of the constituent must be provided in the potency section of the Product Licence Application form.
• The minimum and maximum daily doses of the constituents must be within the range of doses listed on the NNHPD Multi-Vitamin/Mineral Supplements Monograph or the NNHPD Workout Supplement Monograph. Note that the maximum dose of protein is limited by the maximum dose of spirulina.
• If ingredients such as vitamins and minerals are added to the product they should be listed as separate medicinal ingredients on the Product Licence Application form and label. In this case, it would be considered a Class II or III application

Directions for use

Products providing 0.6 mg or more iron per day for children and adolescents 2-13 years old, or 1.4 mg or more iron per day for adults

Take a few hours before or after taking other medications or natural health products (Sweetman 2007).

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s)

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Allergic rhinitis

Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

• Baicus C, Baicus A. Spirulina did not ameliorate idiopathic chronic fatigue in four N-of-1 randomized controlled trials. Phytotherapy Research 2007;21(6):570-573.
• CFIA 2012 : Canadian Food Inspection Agency. Guide to Food Labelling and Advertising, Ottawa (ON): Canadian Food Inspection Agency and Health Canada. [Internet]. [Date modified 2013 November 4; Accessed 2018 June 1]. Available from: http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/healthclaims/eng/1392834838383/1392834887794?chap=8#s16c8
• Cingi C, Conk-Dalay M, Cakli H, Bal C. The effects of spirulina on allergic rhinitis. European Archives of Oto-Rhino-Laryngology 2008;265(10):1219-1223.
• CNF 2010: Canadian Nutrient File, Food and Nutrition, Health Canada. [Accessed2018 June 1] Available from: https://food-nutrition.canada.ca/cnf-fce/index-eng.jsp
• Dia AT, Camara MD, Ndiaye P, Faye A, Wone I, Gueye BC, Seck I, Diongue M. Contribution of supplementation by spiruline to the performance of school children in an introductory course in Dakar (Senegal). Sante Publique 2009;21(3):297-302.
• Dillon JC, Phuc AP, Dubacq JP. Nutritional value of the alga Spirulina. World Review of Nutrition and Dietetics 1995;77:32-46.
• EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. [Accessed 2018 June 1]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf
• Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
• Guiry MD, Guiry GM. 2014. AlgaeBase. World-wide electronic publication, National University of Ireland, Galway. Algaebase taxon LSID: urn:lsid:algaebase.org:taxname:47342. [Accessed 2018 June 1]. Available from: http://www.algaebase.org
• IOM 2005: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board, Institute of Medicine. Washington (DC): National Academy Press; 2005.
• IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
• Kalafati M, Jamurtas AZ, Nikolaidis MG, Paschalis V, Theodorou AA, Sakellariou GK, Koutedakis Y, Kouretas D. Ergogenic and antioxidant effects of spirulina supplementation in humans. Medicine and Science in Sports and Exercise 2010;42(1):142-151.
• Lee EH, Park JE, Choi YJ, Huh KB, Kim WY. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients. Nutrition Research and Practice 2008;2(4):295-300.
• Mao TK, Van de Water J, Gershwin ME. Effects of a Spirulina-based dietary supplement on cytokine production from allergic rhinitis patients. Journal of Medicinal Food 2005;8(1):27-30.
• 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. United States pharmacopeia safety evaluation of spirulina. Critical Reviews in Food Science and Nutrition 2011;51(7):593-604.
• Mazokopakis EE, Starakis IK, Papadomanolaki MG, Mavroeidi NG and Ganotakis ES. The hypolipidaemic effects of spirulina (Arthrospira platensis) supplementation in a Cretan population: a prospective study. Society of Chemical Industry 2013;94(3):432-437.
• Park HJ, Lee YJ, Ryu HK, Kim MH, Chung HW, Kim WY. A randomized double-blind, placebo-controlled study to establish the effects of spirulina in elderly Koreans. Annals of Nutrition and Metabolism 2008;52(4):322-328.
• Samuels R, Mani UV, Iyer UM, Nayak US.Hypocholesterolemic effect of spirulina in patients with hyperlipidemic nephrotic syndrome. Journal of Medicinal Food 2002;5(2):91-96.
• Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease. 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
• Simpore J, Kabore F, Zongo F, Dansou D, Bere A, Pignatelli S, Biondi DM, Ruberto G, Musumeci S. Nutrition rehabilitation of undernourished children utilizing Spiruline and Misola. Nutrition Journal 2006;5(3):1-7.
• Sweetman SC, editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
• Yu B, Wang J, Suter PM, Russell RM, Grusak MA, Wang Y, Wang Z, Yin S, Tang G. Spirulina is an effective dietary source of zeaxanthin to humans. British Journal of Nutrition 2012;108(4):611-619.

References reviewed

• Annapurna VV, Deosthale YG, Bamji MS. Spirulina as a source of vitamin A. Plant Foods for Human Nutrition 1991;41(2):125-134.
• Bogatov NV. Selenium deficiency and its dietary correction in patients with irritable bowel syndrome and chronic catarrhal colitis. Voprosy Pitaniia 2007;76(3):35-39.
• Brinker F. 2010.  Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30].
• Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
• Chen T, Zheng W, Wong YS, Yang F, Bai Y. Accumulation of selenium in mixotrophic culture of Spirulina platensis on glucose. Bioresource Technology 2006;97(18):2260-2265.
• Ciferri O. Spirulina, the Edible Microorganism. Microbiological Reviews 1983;47(4):551-578.
• Ciferri O, Tiboni O. The biochemistry and industrial potential of Spirulina. Annual Review of Microbiology 1985;39:503-526.
• Colla LM, Bertolin TE, Costa JA. Fatty acids profile of Spirulina platensis grown under different temperatures and nitrogen concentrations. Zeitschrift für Naturforschung C 2004;59(1-2):55-59.
• Deng R, Chow TJ. Hypolipidemic, antioxidant, and anti-inflammatory activities of microalgae Spirulina. Cardiovascular Therapy 2010;28(4):e33-45.
• Eun-Kyung K, Gang-Guk C, Hee-Sik K, Chi-Young A, Hee-Mock O. Increasing gamma-linolenic acid content in Spirulina platensis using fatty acid supplement and light-dark illumination. Journal of applied phycology 2011:1-8.
• Facciola S. Cornucopia II. A source book of edible plants. Vista (CA): Kampong Publications; 1998.
• Katz M, Levine AA, Kol-Degani H, Kav-Venaki L. A compound herbal preparation (CHP) in the treatment of children with ADHD: a randomized controlled trial. Journal of Attention Disorders 2010;14(3):281-291.
• Lee EH, Park JE, Choi YJ, Huh KB, Kim WY. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients. Nutrition Research and Practice 2008;2(4):295-300.
• Mazokopakis EE, Karefilakis CM, Tsartsalis AN, Milkas AN, Ganotakis ES. Acute rhabdomyolysis caused by spirulina (Arthrospira platensis). Phytomedicine. 2008;15(6-7):525-527.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
• Puyfoulhoux G, Rouanet JM, Besançon P, Baroux B, Baccou JC, Caporiccio B. Iron availability from iron-fortified spirulina by an in vitro digestion/Caco-2 cell culture model. Journal of Agricultural and Food Chemistry 2001;49(3):1625-1629.
• Ronda SR, Lele SS. Culture conditions stimulating high γ linoleic acid accumulation by Spirulina platensis. Brazilian Journal of Microbiology 2008;39(4):693-697.
• Samuels R, Mani UV, Iyer UM, Nayak US.Hypocholesterolemic effect of spirulina in patients with hyperlipidemic nephrotic syndrome. Journal of Medicinal Food 2002;5(2):91-96.
• Vicat JP, Mbaigane JCD, Bellion Y. Contents of macromineral and trace elements in spirulina (Arthrospira platensis) from France, Chad, Togo, Niger, Mali, Burkina-Faso and Central African Republic. Comptes Rendus Biologies 2014;337(1):44-52.
• Yamani E, Kaba-Mebri J, Mouala C, Gresenquet G, Rey JL. Use of spirulina supplement for nutritional management of HIV-infected patients: study in Bangui, Central African Republic. Medecine Tropicale: Revue du Corps de Santé Colonial 2009;69(1):66-70.