FLAXSEED OIL

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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

September 25, 2018

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 material(s)
Proper name(s)	Common name(s)	Proper name(s)	Part(s)
Linum usitatissimum	Flax Oil Flaxseed Oil Linseed Oil	Linum usitatissimum	Seed

References: Proper name: USDA 2018; Common names: Ph. Eur. 2008, Sweetman 2007, Hoffman 2003, Hendler and Rorvik 2001; Source material: Sweetman 2007.

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 Form(s)by Age Group

Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Source of essential fatty acids (alpha-linolenic acid (ALA) and linoleic acid (LA)) for the maintenance of good health (IOM 2006).
Source of omega-3 fatty acids for the maintenance of good health (IOM 2006).
Source of alpha-linolenic acid (ALA) for the maintenance of good health (IOM 2006).
Source of omega-6 fatty acids for the maintenance of good health (IOM 2006).
Source of linoleic acid (LA) for the maintenance of good health (IOM 2006).

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Methods of preparation: Non-standardized fixed oil

Table 2.Dose information for Linseed oil presented as dose per day, based on uses or purposes and subpopulations.
Uses or Purposes	Subpopulation(s)^1,2,3		Oil g/day		Oil ml/day
Uses or Purposes	Subpopulation(s)^1,2,3		Min.	Max.	Min.	Max.
Source of essential fatty acids, omega-3 fatty acids, and/or ALA	Children	2-4 years	0.04	5.33	0.17	5.67
		5-9 years	0.06	8	0.25	8.50
		10-11 years	0.12	16	0.5	17
	Adolescents	12-14 years	0.12	16	0.5	17
	Adolescents	15-17 years	0.23	32	1	34
	Adults	18 years and older	0.23	32	1	34
Source of omega-6 fatty acids and/or LA	Children	2-4 years	1.28	5.33	1.33	5.67
		5-9 years	1.93	8	2	8.50
		10-11 years	3.85	16	4	17
	Adolescents	12-14 years	3.85	16	4	17
	Adolescents	15-17 years	7.70	32	8	34
	Adults	18 years and older	7.70	32	8	34

¹Children and adolescent doses were calculated as a proportion of the adult dose (JC 2018). The use of Flaxseed oil in children and adolescents is supported by Bove 2001.

²Adult dose supported by the following references: IOM 2006; Schwab et al. 2006; Nordström et al. 1995; Kelley et al. 1993; Fischer et al. 1984.

³Includes pregnant and breastfeeding women (Mills et al. 2006).

Method of preparation: Standardized fixed oil

If potencies are declared, the only acceptable potencies are as follows:

35-65 % ALA (CGC 2008; HC 2008; Ph. Eur. 2008; Hoffmann 2003)
11-24 % LA (HC 2008; Ph. Eur. 2008; Hoffmann 2003)

The following potency is considered as additional information and can be included on the label:

11-35% oleic acid (Ph. Eur. 2008)

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

All products, except those encapsulated

Refrigerate after opening (Nykter et al. 2006; Lukaszewicz et al. 2003).

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.
For products indicating one or more of the optional potencies listed in the dose section, an assay must be performed in order to confirm the potency(ies).

References Cited

Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. 2^nd edition. Toronto (ON): McGraw-Hill.

CGC 2008: Canadian Grain Commission. Flaxseed quality in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2018 July 11]. Available from: https://www.grainscanada.gc.ca/flax-lin/harvest-recolte/2012/hqf12-qrl12-eng.pdf

EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population.[Accessed 2018 June 1]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf

Fischer VS, Honigmann G, Hora C, Schimke E, Beitz J, Hanefeld M, Leonhardt W, Haller H, Förster W, Schliack V. 1984. Results of linseed oil and olive therapy in hyperlipoproteinemia patients. Deutsche Zaitschrift für Verdauungs - und Stoffwechselkrankheiten 44(5):245-251.

Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.

HC 2008: Health Canada. The Canadian Nutrient File [online]. Ottawa (ON): Health Canada.[Accessed 2018 July 11]. Available from:https://food-nutrition.canada.ca/cnf-fce/index-eng.jsp

Hendler S, Rorvik D, editors. 2001. PDR for Nutritional Supplements. Montvale (NJ): Thompson PDR.

Hoffmann D. 2003. Medical Herbalism. Rochester (VT): Healing Arts Press.

IOM 2003: Institute of Medicine. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Washington (DC): National Academies Press.

IOM 2006: Institute of Medicine. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Washington (DC): National Academies Press.

JC 2018: Justice Canada. Food and Drug Regulations (C.01.021) [online]. Ottawa (ON): Justice Canada. [Accessed 2018 July 11] Available from:http://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-110.html#h-156

Kelley DS, Nelson GJ, Love JE, Branch LB, Taylor PC, Schmidt PC, Mackey BE, Iacono JM. 1993. Dietary alpha-linolenic acid alters tissue fatty acid composition, but not blood lipids, lipoproteins or coagulation status in humans. Lipids 28(6):533-537.

Lukaszewicz M, Szopa Jan, Krasowska A. 2003. Susceptibility of lipids from different flax cultivars to peroxidation and its lowering by added antioxidants. Food Chemistry 88(2004):225231

McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce. 2^nd edition. Silver Spring (MD): American Herbal Products Association.

Mills E, Duguoa J, Perri D, Koren G. 2006. Herbal Medicines in Pregnancy and Lactation. An Evidence-Based Approach. New York (NY): Taylor and Francis.

Nordström DC, Honkanen VE, Nasu Y, Antila E, Friman C, Konttinen YT. 1995. Alphalinolenic acid in the treatment of rheumatoid arthritis. A double-blind, placebo-controlled and randomized study: flaxseed vs. safflower seed. Rheumatology International 14(6):231-234.

Nykter M, Kymäläinen H-R, Gates F, Sjöberg A-M. 2006. Quality characteristics of edible linseed oil. Agricultural and Food Science 15(4):402-413.

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2018. The Merck Index: An

Encyclopedia of Chemicals, Drugs, and Biologicals [Online]. Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 2018 July 11]. Available at:http://www.medicinescomplete.com/mc/merck/current/09495.htm

Ph. Eur. 2008: European Pharmacopoeia Commission. 2007. European Pharmacopoeia. 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

Schwab US, Callaway JC, Erkkilä AT, Gynther J, Uusitupa MI, Järvinen T. 2006. Effects of hempseed and flaxseed oils on the profile of serum lipids, serum total and lipoprotein lipid concentrations and haemostatic factors. European Journal of Nutrition 45(8):470-477.

Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference. 35th edition. London (GB): Pharmaceutical Press.

USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Linum usitatissimum. Beltsville (MD): National Germplasm Resources Laboratory.[Accessed 2018 July 11]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References Reviewed

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