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Drugs and Health Products

Flaxseed oil

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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.


  • Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicants' discretion.
  • The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.
  • Vitamin E is an optional medicinal ingredient in flaxseed oil products. However, no use or purpose statements may be associated with vitamin E. See Appendix 2 for vitamin E proper name, common name, source material, and dose information.


July 18, 2017

Proper name(s)

Linum usitatissimum L. (Linaceae) (USDA 2004)

Common name(s)

  • Flaxseed oil (Hoffman 2003)
  • Linseed oil (Ph. Eur. 2008; Sweetman 2007)
  • Flax oil (Hendler and Rorvik 2001)

Source material(s)

Seed (Sweetman 2007)

Route(s) of administration:


Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

Statement(s) to the effect of:

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


Table 1: Dose information of Linum usitatissimum L. oil presented as dose per day, based on uses or purposes and subpopulations.
Use(s) or Purpose(s) Subpopulations Table 1 Footnote1 Table 1 Footnote2 Table 1 Footnote3 Oil g/day Oil ml/day
Min. Max. Min. Max.
Source of essential fatty acids, omega-3 fatty acids, and/or ALA Children 2-4 y 0.045.330.175.67
Children and adolescents 5-9 y 0.0680.258.50
Adolescents 10-14 y 0.12160.517
Adults, and adolescents ≥ 15 y 0.2332134
Source of omega-6 fatty acids and/or LA Children 2-4 y 1.285.331.335.67
Children and adolescents 5-9 y 1.93828.50
Adolescents 10-14 y 3.8516417
Adults, and adolescents ≥ 15 y 7.7032834

Table 1 Footnotes

Table 1 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Flaxseed oil in children and adolescents is supported by Bove 2001.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

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

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

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

Return to Table 1 footnote3 referrer

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)

See Appendix 1 for examples of dosages according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s):

No statement required.


No statement required.

Known adverse reaction(s):

No statement required.

Storage condition(s)

Statement(s) to the effect of:

For all products, except those encapsulated: Refrigerate after opening (Nykter et al. 2006; Lukaszewicz et al. 2004).

Non-medicinal ingredients

  • Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
  • For products providing vitamin E at doses lower than the minima specified in Table 2 of Appendix 2, vitamin E must be declared as a non-medicinal ingredient.


  • 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).
  • The medicinal ingredient may comply with the specifications outlined in the Linseed or Linseed Oil, Virgin, monographs published in the European Pharmacopoeia, or the Linseed or Virgin Linseed Oil monographs published in the British Pharmacopoeia.

References cited

  • BHP 1996: The British Herbal Pharmacopoeia. Exeter (GB): British Herbal Medicine Association.
  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
  • Boon H. 2000. Flax in: Herbs: Everyday Reference for Health Professionals. Chandler F, editor. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
  • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. Toronto (ON): McGraw-Hill.
  • BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008. Volume 1. London (GB): The Stationary Office.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • CGC 2008: Canadian Grain Commission. Flaxseed quality in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2010 January 20]. Available from :
  • CGC 2005: Canadian Grain Commission. The Quality of Flaxseed in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2006 July 20]. Available from :
  • Cunnane SC, Ganguli S, Menard C, Liede AC, Hamadeh MJ, Chen ZY, Wolever TM, Jenkins DJ. 1993. High alpha-linolenic acid flaxseed (Linum usitatissimum): some nutritional properties in humans. British Journal of Nutrition 69(2):443-53.
  • Daun JK, Barthet VJ, Chornick TL, Diguid S. 2003. Structure, composition, and variety development of flaxseed. In: Thompson LU, Connane SC, editors. Flaxseed in Human Nutrition. 2nd edition. Champaign (IL): AOCS Press.
  • EMEA 2006. European Medicines Agency. Community Herbal Monograph on Linum usitatissimum L., Semen. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2008 July 23]. Available from :
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web siteFormulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products. 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
  • 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.
  • Gennaro AR, editor. 2000. Remington: The Science and Practice of Pharmacy. 20th edition. Baltimore (MD): Lippincott Williams & Wilkins.
  • HC 2008: Health Canada. The Canadian Nutrient File [online]. Ottawa (ON): Health Canada. [Accessed 2009 July 22]. Available from:
  • 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 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.
  • 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.
  • JC 2008: Justice Canada. Food and Drug Regulations (C.01.021) [online]. Ottawa (ON): Justice Canada. [Accessed 2009 June 24] Available from :
  • Jenkins DJA, Kendall CWC, Vidgen E, Agarwal S, Rao AV, Rodenberg RS, Diamandis EP, Novokmet R, Mehling CC, Perera T, Griffin LC, Cunnane SC. 1999. Health aspects of partially defatted flaxseed, including effects on serum lipids, oxidative measures, and ex vivo androgen and progestin activity: A controlled crossover trial. The American Journal of Clinical Nutrition 69(3):395-402.
  • 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.
  • Kinniry P, Amrani Y, Vachani A, Solomides CC, Arguiri E, Workman A, Carter J, Christofidou-Solomidou M. 2006. Dietary flaxseed supplementation ameliorates inflammation and oxidative tissue damage in experimental models of acute lung injury in mice. The Journal of Nutrition 136(6):1545-1551.
  • Lucas EA, Wild RD, Hammond LJ, Khalil DA, Juma S, Daggy BP, Stoecker BJ, Arjmandi BH. 2002. Flaxseed improves lipid profile without altering biomarkers of bone metabolism in postmenopausal women. Journal of Clinical Endocrinology and Metabolism 87(4):1527-1532.
  • 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):225-231
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • 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.
  • Nordström DC, Honkanen VE, Nasu Y, Antila E, Friman C, Konttinen YT. 1995. Alpha-linolenic acid in the treatment of rheumatoid arthritis. A double-blind, placebo-controlled and randomized study: flaxseed vs. sanflower seed. Rheumatology International 14(6):231-234.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2009. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals [Online]. Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 2010-01-26]. Available at:
  • Patade A, Devareddy L, Lucas EA, Korlagunta K, Daggy BP, Arjmandi BH. 2008. Flaxseed reduces total and LDL cholesterol concentrations in Native American postmenopausal women. Journal of Women’s Health 17(3):355-366.
  • 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).
  • Prasad K. 2005. Hypocholesterolemic and antiatherosclerotic effect of flax lignan complex isolated from flaxseed. Atherosclerosis 179(2):269-275
  • Prasad K. 1997. Dietary flax seed in prevention of hypercholesterolemic atherosclerosis. Atherosclerosis 132(1):69-76.
  • Pray WS. 2006. Non-Prescription Product Therapeutics. 2nd edition. New York (NY): Lippincott Williams & Wilkins.
  • Rajesha J, Murthy KNC, Kumar MK, Madhusudhan B, Ravishankar GA. 2006. Antioxidant potentials of flaxseed by in vivo model. Journal of Agricultural and Food Chemistry 54(11):3794-3799.
  • Repchinsky 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association.
  • Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers.
  • 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 2004: 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 2008 June 17]. Available from:

References reviewed

  • Arjmandi BH, Khan DA, Juma S, Drum ML, Venkatesh S, Sohn E, Wei L, Derman R. 1998. Whole flaxseed consumption lowers serum LDL-cholesterol and lipoprotein(a) concentrations in postmenopausal women. Nutritional Research; 18(7):1203-1214.
  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association. 
  • Birch DG, Birch EE, Hoffman DR, Uauy RD. 1992. Retinal development in very-low-birth-weight infants fed diets differing in omega-3 fatty acids. Investigative Ophthalmology and Visual Science 33(8):2365-2376.
  • Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. 2008. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. Journal of the American College of Nutrition 27 (1):65-74.
  • Brinker 2008. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2008 July 23]. Available from:
  • Chevallier A.1996. The Encyclopedia of Medicinal Plants. London (GB): Dorling Kindersley Limited.
  • Finnegan YE, Howarth D, Minihane AM, Kew S, Miller GJ, Calder PC, Williams CM. 2003. Plant and marine derived (n-3) polyunsaturated fatty acids do not affect blood coagulation and fibrinolytic factors in moderately hyperlipidemic humans. Journal of Nutrition 133(7):2210-2213.
  • Freese R, Mutanen M. 1997. Alpha-linolenic acid and marine long-chain n-3 fatty acids differ only slightly in their effects on hemostatic factors in healthy subjects. American Journal of Clinical Nutrition 66(3):591-598
  • Hallund J, Ravn-Haren G, Bugel S, Tholstrup T, Tetens I. 2006. A lignan complex isolated from flaxseed does not affect plasma lipid concentrations or antioxidant capacity in healthy postmenopausal women. The Journal of Nutrition 136(1):112-116.
  • HC 2005: Health Canada. Addition of Vitamins and Minerals to Foods, 2005. Health Canada's Proposed Policy and Implementation Plans [online]. Ottawa (ON): Health Canada. [Accessed 2008 June 16]. Available from:
  • Jenkins DJ, Kendall CW, Vuksan V, Augustin LS, Mehling C, Parker T, Vidgen E, Lee B, Faulkner D, Seyler H, Josse R, Leiter LA, Connelly PW, Fulgoni V 3rd. 1999b. Effect of wheat bran on serum lipids: influence of particle size and wheat protein. Journal of the American College of Nutrition 18(2):159-65. 
  • Jenkins DJA, Wolever TMS, Leeds AR, Gassull MA, Haisman P, Dilawari J, Goff DV, Metz GL, Alberti KG. 1978. Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. British Medical Journal 1(6124):1392-1398.
  • Lemay A, Dodin S, Kadri N, Jacques H, Forest J-C. 2002. Flaxseed dietary supplement versus hormone replacement therapy in hypercholesterolemic menopausal women. The American Colege of Obstetricians and Gynecologists 100(3):495-504.
  • Li D, Sinclair A, Wilson A, Nakkote S, Kelly F, Abedin L, Mann N, Turner A. 1999. Effect of dietary alpha-linolenic acid on thrombotic risk factors in vegetarian men. American Journal of Clinical Nutrition 69(5):872-882.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2001. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th edition. Whitehouse Station (NJ): Merck & Co., Inc.
  • Pagana CD, Pagana TJ. 2002. Mosby's Manual of Diagnostic and Laboratory Tests. 2nd edition. St. Louis (MO): Mosby, Inc.
  • Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. 2007. Effects of a flaxseed-derived lignan supplement in Type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS ONE 11:1-7.
  • Sanders TA, Lewis F, Slaughter S, Griffin BA, Griffin M, Davies I, Millward DJ, Cooper JA, Miller GJ. 2006. Effect of varying the ratio of n-6 to n-3 fatty acids by increasing the dietary intake of alpha-linolenic acid, eicosapentaenoic and docosahexaenoic acid or both on fibrinogen and clotting factors VII and XII in persons aged 45-70 y: the OPTILIP Study. American Journal of Clinical Nutrition 84(3):513-522.
  • Simmer K, Schulzke SM, Patole S. 2008. Longchain polyunsaturated fatty acid supplementation in preterm infants. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000375. Update of: Cochrane Database Syst Rev. 2004;(1):CD000375.
  • Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. 2008. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholestrolaemic subjects. British Journal of Nutrition 99(6):1301-1309.

Appendix 1: Examples of dosages

  • 230 mg (∼1 ml), per day (provides approximately 5% of the IOM's AI for alpha-linolenic acid) (IOM 2006)
  • 7.7 g (∼8 ml), per day (provides approximately 5% of the IOM's AI for linoleic acid) (IOM 2006)
  • 28 g (∼30 ml), per day (Schwab et al 2006)
  • 30 g (∼32 ml), per day (Nordström 1995; Fischer 1984)
  • 32 g (∼34 ml), per day (Kelley 1993)

Appendix 2: Vitamin E

Proper name(s), common name(s), and source material(s):

Table 1: Vitamin E proper name(s), common name(s) and source material(s)
Proper name(s) Common name(s) Source material(s)

Vitamin E (O'Neil et al. 2009;
Sweetman 2007; IOM 2003)

Alpha (α)-tocopherol (O'Neil et al. 2009; Sweetman 2007);

Vitamin E (O'Neil et al. 2009; Sweetman 2007; IOM 2003)

All racemic (all rac)-α-tocopherol/ dl-α-tocopherol (Sweetman 2007; IOM 2003)

All rac-α-tocopheryl acetate/ dl-α-tocopheryl acetate (Sweetman 2007; IOM 2003)

All rac-α-tocopheryl succinate/ dl-α-tocopheryl acid succinate/ dl-α-tocopheryl succinate (Sweetman 2007)

RRR-α-tocopherol/ d-α-tocopherol (O'Neil et al. 2009; Sweetman 2007; IOM 2003)

RRR-α-tocopheryl acetate/ d-α-tocopheryl acetate (Sweetman 2007; IOM 2003)

RRR-α-tocopheryl succinate/ d-α-tocopheryl acid succinate/ d-α-tocopheryl succinate (Sweetman 2007; IOM 2003)


The quantity of vitamin E must always be provided in terms of α-tocopherol (AT) (i.e. mg RRR-α-tocopherol), irrespective of the source material used.

IUs may be provided as optional additional information on the Product Licence Application form in the "potency" field and on product labels.

Table 2: Dose information for vitamin E presented as dose per day (IOM 2006)
Subpopulation Vitamin E (mg AT/day)
Minimum Maximum
Children1-8 y2.2179
Adolescents 9-13 y 4.5179
14-18 y 4.5179
Adults≥ 19 y4.5179

Conversion factors:

Table 3: Conversion of vitamin E source material quantity into vitamin E quantity in terms of alpha-(α)-tocopherol (AT) and vitamin E activity in terms of International Units (IU) (IOM 2006)
Source material
(1 mg)
Vitamin E quantity
(mg AT)
Vitamin E activity




RRR-α-Tocopheryl acetate



RRR-α-Tocopheryl succinate



All rac-α-tocopherol



All rac-α-tocopheryl acetate



All rac-α-tocopheryl succinate



Table 4: Conversion of vitamin E source material activity into vitamin E quantity in terms of alpha-(α)-tocopherol (AT) (IOM 2006)
Source material
(1 IU)
Vitamin E quantity
(mg AT)



RRR-α-Tocopheryl acetate


RRR-α-Tocopheryl succinate


All rac-α-tocopherol


All rac-α-tocopheryl acetate


All rac-α-tocopheryl succinate


Examples using the vitamin E conversion factors:

a) Converting vitamin E activity into quantity of AT (mg)

Convert 400 IU of RRR-α-tocopheryl succinate activity into mg AT:

= 400 IU x 0.67 mg AT/IU

= 268 mg AT

b) Converting vitamin E source material quantity into quantity of AT (mg)

Convert 200 mg of all rac-α-tocopheryl acetate into mg AT:

= 200 mg x 0.45 mg AT/mg

= 90 mg AT