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Drugs and Health Products

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 (PLA) 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) Preparation(s)
Althaea officinalis
  • Marshmallow
  • White-mallow
  • Althaea officinalis Leaf Dried

    References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000, Wiersema and León 1999; Source information: Blumenthal et al. 2000, 1998, BHP 1983, Grieve 1971.

    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 for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

    Use(s) or Purpose(s)

    • (Traditionally) used in Herbal Medicine (as a demulcent) to relieve the irritation of the oral and pharyngeal mucosa and associated dry cough (BHC 2006; Mills and Bone 2005; Wichtl 2004; Hoffman 2003; Blumenthal et al. 2000; 1998; BHP 1983; Grieve 1971).
    • (Traditionally) used in Herbal Medicine (as a demulcent) to relieve mild inflammation of the gastro-intestinal mucosa (e.g. gastritis) (BHC 2006; Mills and Bone 2005; Wichtl 2004; Bone 2003; Hoffman 2003; Blumenthal et al. 2000; 1998; BHP 1983; Grieve 1971).

    Note
    Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

    Dose(s)

    Subpopulation(s)

    Adults 18 years and older

    Quantity(ies)

    Methods of preparation: Dry, Infusion, cold water

    2-15 grams dried leaf, per day; Not to exceed 5 grams per single dose (Mills and Bone 2005)

    Note: Dried leaves should be prepared as a cold infusion (see direction for use).


    Method of preparation: Fluid extract

    2-15 milliliters of dried leaf fluid extract, per day; Not to exceed 5 milliliters per single dose (1:1, in 25% ethanol) (BHC 2006; Blumenthal et al. 2000)


    Method of preparation: Powder

    5 grams powdered dried leaf, per day (BHC 2006; Blumenthal et al. 2000, 1998; BHP 1983)

    Direction(s) for use

    All products

    Take a few hours before or after taking other medications or natural health products (BHC 2006; Mills and Bone 2005; Blumenthal et al. 2000; BHP 1983).

    Dried leaf

    Add dried leaves to 150 ml cold water and let steep for 30 minutes. Stir frequently. Strain and warm (if desired) before drinking (Blumenthal 2000; BHC 1996).

    Duration(s) of use

    No statement is required.

    Risk information

    Caution(s) and warning(s)

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

    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

    • 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.
    • Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. St. Louis (MI): Churchill Livingstone; 2003.
    • 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 2018: 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 2018 June 5]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
    • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
    • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.

    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 edition. 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.
    • 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 January 9].  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 January 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 HarperCollins 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.
    • 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/complianconform-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, The 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.
    • Williamson EM. Potter’s Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited; 2003.
    • Wren RC, Evans FJ. Potter’s New Encyclopedia of Botanical Drugs and Preparations. Essex (GB); Potter’s (Herbal Supplies) Limited; 1985 (Reprint of 1907).