ALFALFA - MEDICAGO SATIVA

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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 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 on the label.

Date

November 29, 2024

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)
Medicago sativa	Alfalfa Lucerne	Medicago sativa	Herb top Leaf	Dry

References: Proper name: USDA 2024; Common names: BHP 1996; Meyer 1993; Source information: Boon and Smith 2004; BHP 1996.

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)

• Source of antioxidants/Provides antioxidants (Raeeszadeh et al. 2022; Orak et al. 2021).
• Source of antioxidants/Provides antioxidants that help fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals (Raeeszadeh et al. 2022; Orak et al. 2021).
• (Traditionally) used in Herbal Medicine as a nutritive tonic (BHP 1996; Meyer 1993).

Notes

For multiple-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., Alfalfa is traditionally used in Herbal Medicine as a nutritive tonic).
• 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)

Antioxidant

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

Up to 30 grams of herb top/leaf, per day (BHP 1996; Mills 1985).

Nutritive tonic

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

9 - 30 grams of dried herb top/leaf, per day (BHP 1996; Mills 1985).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Products providing more than 900 mg of Alfalfa dried herb top/leaf, per day

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking blood thinners, birth control medication or hormone therapy (Brinker 2010; Barnes et al. 2007; Boon and Smith 2004).

Contraindication(s)

All products

Do not use if you are pregnant or breastfeeding (Brinker 2010; Barnes et al. 2007; Boon and Smith 2004).

Products providing more than 900 mg of Alfalfa dried herb top/leaf, per day

Do not use if you have a history of systemic lupus erythematosus (Brinker 2010; Barnes et al. 2007; Boon and Smith 2004).

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

• Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): Pharmaceutical Press; 2007.
• BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medical Association; 1996.
• Boon H, Smith MJ. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc; 2004.
• Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• Meyer JE. The Herbalist. Glenwood (IL): Meyerbooks; 1993.
• Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
• Orak HH, Karamac M, Orak A, Tenikecier HS, Amarowicz R. Antioxidant Activity and Total Phenolic Contents of Different Alfalfa (Medicago sativa L.) Varieties Grown in Turkey. Yuzuncu Yil University: Journal of Agricultural Sciences 2021;31(4):995-1000.
• Raeeszadeh M, Beheshtipour J, Jamali R, Akbari A. The Antioxidant Properties of Alfalfa (Medicago sativa L.) and Its Biochemical, Antioxidant, Anti-Inflammatory, and Pathological Effects on Nicotine-Induced Oxidative Stress in the Rat Liver. Oxidative Medicine and Cellular Longevity 2022. Article ID 2691577 | https://doi.org/10.1155/2022/2691577
• USDA 2023: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2024 February 29]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch

References Reviewed

• Bartram T. Bartram's Encyclopedia of Herbal Medicine: The Definitive Guide to the Herbal Treatments of Diseases. New York (NY): Marlowe & Company; 1995.
• Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1919 original].
• Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. Second Edition. Boca Raton (FL): Taylor and Francis Group; 2013.
• Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
• Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.
• Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.