LECITHIN

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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 1, 2019

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

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

Proper name(s)	Common name(s)	Source ingredient(s)	Source material(s)
		Common name(s)	Proper name(s)	Part(s)
1,2-Diacylglycero-3-phosphocholine 1,2-diacyl-sn-glycero-3-phosphocholine Lecithin	Lecithin	Soya oil	Glycine max	Seed
		N/A	Brassica napus Helianthus annuus
		N/A	Salmo salar	Egg

References: Proper names: HC 2015, NIH 2009; Common name: HC 2015, NIH 2009; Source information: HC 2015, NIH 2009, USP 32 2009.

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

Use(s) or Purpose(s)

Helps to support liver function (IOM 2006; Shils et al. 2006; IOM 1998).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

1 - 6 grams of Lecithin, per day (IOM 2006; HC 2005; Blumenthal et al. 2000; IOM 1998; Canty and Zeisel 1994; WHO 1974).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

No statement required.

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

• No statement required.
• The finished product specifications must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.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 may must comply with the specifications requirements outlined in the NHPID.United Stated (USP) pharmacopoeial monograph listed below:

References Cited

• Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
• Canty DJ, Zeisel SH. 1994. Lecithin and choline in human health and disease. Nutrition Reviews. 52(10):327-339.
• HC 2015: Health Canada. Canadian Nutrient File [online]. Ottawa (ON): Health Canada. [Accessed 2019 May 13]. Available from: https://food-nutrition.canada.ca/cnf-fce/index-eng.jsp
• HC 2005: Health Canada. 2005. Addition of Vitamins and Minerals to Foods: Health Canada's Proposed Policy Recommendations [online]. Ottawa (ON): Health Canada. [Accessed 2019 May 13]. Available from: http://publications.gc.ca/collections/Collection/H58-1-2-1999E.pdf
• IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. 2006. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press.
• IOM 1998: Institute of Medicine. Panel on Folate, other B Vitamins, and Choline and Subcommittee on Upper Reference Levels of Nutrients, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. 1998. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline. Washington (DC): National Academy Press.
• NIH 2009: National Institutes of Health. ChemIDplus advanced [online]. Soy Lecithin. Bethseda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2019 May 13]. Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp
• Shils ME, Olson JA, Shike M, Ross AC, editors. 2006. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams and Wilkins.
• USP 32: United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

References Reviewed

• WHO 1974: World Health Organization. Joint FAO/WHO Expert Committee on Food Additives. 1974. Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers and thickening agents: Lecithin. WHO Food Additives Series No. 5 [online]. Geneva (CH): World Health Organization. [Accessed 2009 June 10]. Available at: http://www.inchem.org/documents/jecfa/jecmono/v05je42.htm