MARSHMALLOW - ALTHAEA OFFICINALIS - LEAF

Date

November 29, 2024

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

References: Proper name: USDA 2024; Gardner and McGuffin 2013; Common names: USDA 2024; Gardner and McGuffin 2013, Wiersema and León 1999; Source information: Blumenthal et al. 2000; BHP 1996, 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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

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 (Bradley 2006; Mills and Bone 2005; Wichtl 2004; Hoffman 2003; Blumenthal et al. 2000; 1998; BHP 1996; Grieve 1971).
• (Traditionally) used in Herbal Medicine (as a demulcent) to relieve mild inflammation of the gastro-intestinal mucosa (e.g., gastritis) (Bradley 2006; Mills and Bone 2005; Wichtl 2004; Bone 2003; Hoffman 2003; Blumenthal et al. 2000; 1998; BHP 1996; Grieve 1971).

Notes

• The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g., Traditionally used in Herbal Medicine to relieve the irritation of the oral and pharyngeal mucosa and associated dry cough and mild inflammation of the gastro-intestinal mucosa).
• For multi-ingredient products:
  • To prevent the product from being represented as a "traditional medicine", any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Marshmallow is traditionally used in Herbal Medicine to relieve mild inflammation of the gastro-intestinal mucosa).
  • When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Dry, Powdered, Infusion, cold water

2 - 15 grams dried leaf, per day; Not to exceed 5 grams per single dose (EMA 2016; Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000; BHP 1996).

Note: Dried/powdered leaf 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) (EMA 2016; Bradley 2006; Blumenthal et al. 2000).

Direction(s) for use

All products

Take a few hours before or after taking other medications or health products (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000; BHP 1996).

Dried/powdered leaf

Add dried/powdered leaf to 150 milliliters of cold water and let steep for 30 minutes. Stir frequently. Strain and warm (if desired) before drinking (Bradley 2006; Blumenthal 2000).

Duration(s) of use

No statement is required.

Risk information

Caution(s) and warning(s)

• Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
• Ask a health care practitioner/health care provider/health care professional/doctor/physician before 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

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

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.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

References cited

• BHP 1996: British Herbal Medicine Association's Scientific Committee. British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1996.
• 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.
• Bradley PR, editor. 2006: 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.
• EMA: European Medicines Agency 2016. European Union Herbal monograph on Althaea officinalis L., Radix. London (GB): Committee on Herbal Medicinal Products (HMPC); 12 July 2016. [Consulté le 14 mars 2024]. Disponible à : https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-althaea-officinalis-l-radix_en.pdf
• Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. 2^nd Edition. Boca Raton (FL): Taylor and Francis Group; 2013.
• 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. 2^nd 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 2024: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2024 March 9]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
• 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. 3^rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.

References reviewed

• Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. 3^rd 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.
• Brinker F. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.
• 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. Cincinnati (OH): WH Cook; 1869. Reprint version by Medical Herbalism: Journal for the Clinical Practitioner [Accessed 2024 March 9]. 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.
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• Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
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• Mills S, Bone K. Principles and Practice of Phytotherapy, Modern Herbal Medicine. Edinburg: Churchill Livingston; 2000.
• 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 20^th edition; 1918. Abridged; botanicals only. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2024 March 9]. Available from: http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf
• Weiss RF, Fintelmann V. Herbal Medicine. 2^nd 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. Geneva (CH): World Health Organization; 2011. [Accessed 2024 March 9]. Available from: https://www.inchem.org/documents/jecfa/jecmono/v63je01.pdf
• WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva: World Health Organization; 2002.
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• Wren RC, Evans FJ. Potter's New Encyclopedia of Botanical Drugs and Preparations. Essex (GB); Potter's (Herbal Supplies) Limited; 1985 (Reprint of 1907).

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