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Monograph: Marshmallow - Althaea Officinalis - Leaf

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

Date: 2013-05-21

NHPID Name

Althaea officinalis (USDA 2008)

Proper Name(s)

Althaea officinalis L. (Malvaceae) ( USDA 2013 , McGuffin et al. 2000 )

Common Name(s)

Source Material

Leaf ( Blumenthal et al. 2000 , Blumenthal et al. 1998 , BHP 1983 , Grieve 1971 )

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Preparation: Cold Infusion

Dose(s): 2 - 15 Grams per day, dried leaf
Directions For Use:

Preparation: Fluid extract

Dose(s): 2 - 15 Millilitres per day, (1:1, in 25% ethanol)
Directions For Use:

Preparation: Powdered

Dose(s): 5 Grams per day, cut or ground leaf
Directions For Use:

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Marshmallow monographs published in the British Pharmacopoeia (BP) and European Pharmacopoeia (Ph. Eur.)

References cited

  • BHC 2006: Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drugs—Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • BHP 1983: British Herbal Medicine Association's Scientific Committee. British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1983.
  • Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in Cooperation with Integrative Medicine Communications; 1998.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications; 2000.
  • Boullard B. Plantes Médicinales du Monde: Réalités et Croyances. Paris (FR): Éditions ESTEM; 2001.
  • Grieve M. A Modern Herbal, Volume 2. New York (NY): Dover Publications; 1971.
  • Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • USDA 2013: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Online Database]. National Germplasm Resources Laboratory, Beltsville (MD). [Althaea officinalis L. Last updated: 23-Aug-1994; Accessed 2013 May 10]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
  • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1998.

References reviewed

  • Althaea officinalis L. [References 2011] from the Integrated Taxonomic Information System (ITIS) [Internet]. Accessed 2012 August 13]. Available from: http://www.itis.gov
  • Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. 3rd ed. London (GB): Pharmaceutical Press; 2007.
  • Bartram T. Bartram's Encyclopedia of Herbal Medicine: The definitive guide to the herbal treatment of diseases. London (GB): Robinson Publishing Ltd; 1998.
  • Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. St. Louis (MI): Churchill Livingstone; 2003.
  • Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs - Companion Volume 1 of the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
  • Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drugs—Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • Brinker 2010: Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 3rd edition, including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 April 18]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brinker F. Herb Contraindications and Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 19]. Available from: http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
  • Chandler F, editor. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association; 2000.
  • Cook WMH. The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet] Cincinnati (OH): WH Cook; 1869. Reprint version by Medical Herbalism: Journal for the Clinical Practitioner [Accessed 2012 Jan 5]. Available from: http://www.henriettesherbal.com/eclectic/cook/index.html
  • derMarderosian A, Beutler JA, editors. The Review of Natural Products. [Mallow: Date of issue January 2007]. St Louis (MO): Facts and Comparisons, Wolters Kluwer Health; Printed in 2008 and Updated July 2012.
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1998 [Reprint of 1919 original].
  • EMEA/HMPC/98717/2009 Community Herbal Monograph on Althaea officinalis L., Radix. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC); 14 May 2009. [Accessed 2012 January 4] Available from: http://www.ema.europa.eu/
  • ESCOP 2003: E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products. Second edition. Completely revised and Expanded. Exeter (GB): ESCOP, the European Scientific Cooperative on Phytotheraphy in collaboration with Georg ThiemeVerlag and Thieme; 2003.
  • Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Hoffman D. Complete Illustrated Guide to The Holistic Herbal: A safe and practical guide to making and using herbal remedies. London (GB): Element, an imprint of Harper Collins Publishers; 2002.
  • Lust J. The Herb Book: The Complete and Authoritative Guide to More than 500 Herbs. New York (NY): Benedict Lust Publications; 2005.
  • Mashmallow (Althaea officinalis L.) Copyright 2012 [Internet]. [Accessed 2012 April 18]. Available from: http://www.naturalstandard.com.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
  • Mills S, Bone K. Principles and Practice of Phytotherapy, Modern Herbal Medicine. Edinburg: Churchill Livingston; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Natural Health Products Compliance and Enforcement Policy. Ottawa (ON): Health Products and Food Branch. [Date Modified 2010-08-27; Accessed 2012 January 11]. Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/info-prod/prodnatur/complian-conform-pol-eng.pdf
  • Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A guide for health-care professionals. London (GB): The Pharmaceutical Press; 1996.
  • Remington JP, Woods HC, editors. The Dispensatory of the United States of America [Internet] 20th edition; 1918. Abridged; botanicals only. Scanned by Michael Moore, director, Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 19]. Available from: http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf
  • Weiss RF, Fintelmann V. Herbal Medicine. Second edition, revised and expanded. New York (NY): Thieme; 2000.
  • WHO Food Additives Series: 63; FAO JECFA Monographs 8. Safety evaluation of certain contaminants in food. [Internet]. Geneva (CH): World Health Organization; 2011. [Accessed 2012 April 19]. Available from http://www.inchem.org/documents/jecfa/jecmono/v63je01.pdf
  • WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva (CH): World Health Organization; 2002.
  • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1998.
  • Wren RC, Evans FJ. Potter's New Encyclopedia of Botanical Drugs and Preparations. Essex (GB); Potter's (Herbal Supplies) Limited; 1985 (Reprint of 1907).