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Drugs and Health Products

Monograph: Flaxseed

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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. It is a referenced document to be used as a labelling standard. Note: 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 are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2018-08-28

NHPID Name

Linum usitatissimum (USDA 2008)

Proper Name(s)

Linum usitatissimum ( USDA 2004 )

Common Name(s)

Source Material

Seed ( Blumenthal et al. 2000 )

Route Of Administration

Oral

Dosage Form(s)

Use(s) or Purpose(s)

Statement(s) to the effect of:

  • (Used in Herbal Medicine as a) bulk-forming laxative to promote bowel movements and to provide gentle relief of constipation and/or irregularity.
  • Source of essential fatty acids for the maintenance of good health.
  • Source of omega-3 fatty acids for the maintenance of good health.
  • Source of alpha-linolenic acid (ALA) for the maintenance of good health.
  • Source of omega-6 fatty acids for the maintenance of good health.
  • Source of linoleic acid (LA) for the maintenance of good health.
  • (Used in Herbal Medicine as a) bulk-forming laxative.
  • (Used in Herbal Medicine to) promote(s) bowel movement by increasing bulk volume and water content.  (Pray 2006, ESCOP 2003, Gennaro 2000, McGuffin et al. 1997)
  • (Used in Herbal Medicine to) provide(s) gentle relief of constipation and/or irregularity.  (EMEA 2006, Pray 2006, ESCOP 2003, Gennaro 2000)
  • (Used in Herbal Medicine to) help(s) reduce blood lipid levels in adults.  (Patade et al. 2008, Lucas et al. 2002, Jenkins et al. 1999, Cunnane et al. 1993)
  • Source of/Provides antioxidants.  (Rajesha et al. 2006, Prasad 2005)

Dose(s)

Adults:

Dose(s): 1 Day per day

Directions For Use:
  • Effects observed 12-24 hours after first dose, and may take 2-3 days.
  • For products providing doses that are ≥ 5 g per day, the following statement is required:
    For each dose, drink (or mix with) at least 150 ml of liquid. (EMEA 2006, ESCOP 2003)
  • Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
  • For products providing doses that are ≥ 5 g per day, the following statement is required:
    Take 2 hours before or after taking other medications. (Sweetman 2007)
  • null;promote(s) bowel movement;constipation and/or irregularity:
    Take during the day (not immediately prior to bedtime). (EMEA 2006, ESCOP 2003)


  • Adult dose supported by the following references: Patade et al. 2008; EMEA 2006; IOM 2006; ESCOP 2003; Lucas et al. 2002; Jenkins et al. 1999; Cunnane et al. 1993.
  • Children and adolescent doses were calculated as a proportion of the adult dose (ESCOP 2003; Boon 2000). The use of Flaxseed in children and adolescents is supported by the following references: ESCOP 2003; Boon 2000; Bove 2001; Schilcher 1997
  • If potencies are declared, the only acceptable potencies are: (I)20-30 % ALA (CGC 2008; HC 2008; Cunnane 1993); (ii) 5-7 % LA (HC 2008)
  • Includes pregnant and breastfeeding women (Mills et al. 2006; ESCOP 2003).
  • See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.
  • The following directions of use is optional: (for laxative products which provide a dosage range): Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
  • The following directions of use is optional: ( For products with dose greater or equal to 5 g/day) Take during the day (, not immediately prior to bedtime) (EMEA 2006).

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen or if laxative effect does not occur within seven days.
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are experiencing a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or have failed to defaecate following the use of a laxative product.
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have diabetes or difficulty swallowing.
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have symptoms such as abdominal pain, nausea, vomiting or fever (as these could be signs of other serious conditions).
  • Doses greater than or equal to 5 Grams per day:
    Consult a health care practitioner/health care provider/health care professional/doctor/physician immediately if you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product.  (BHP 1996)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
  • Stop use if hypersensitivity/allergy occurs.
  • Doses greater than or equal to 5 Grams per day:
    May cause temporary gas and/or bloating.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Storage Conditions

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

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.
  • Brouillet L, Hay SG, Goulet I, Marie-Victorin. Flore laurentienne, 3e édition. Boucherville (QC): Éditions Gaëtan Morin; 2002.
  • Bruneton J. Pharmacognosie, Phytochimie, Plantes Médicinales, 3rd edition. Paris (FR): Technique & Documentation; 1999.
  • CGC 2005: Canadian Grain Commission. The Quality of Flaxseed in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2006 July 20]. Available from: http://www.grainscanada.gc.ca/flax-lin/trend-tendance/qfc-qlc-eng.htm
  • CGC 2008: Canadian Grain Commission. Flaxseed quality in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2010 January 20]. Available from: http://www.grainscanada.gc.ca/flax-lin/trend-tendance/qfc-qlc-eng.htm
  • 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: http://www.emea.europa.eu/pdfs/human/hmpc/lini_semen/34084905en.pdf
  • 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.
  • 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: http://205.193.93.51/cnfonline/newSearch.do?applanguage=en_CA
  • Hendler S, Rorvik D, editors. 2001. PDR for Nutritional Supplements. Montvale (NJ): Thompson PDR.
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. 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 2008: Justice Canada. Food and Drug Regulations (C.01.021) [online]. Ottawa (ON): Justice Canada. [Accessed 2009 June 24] Available from: http://laws.justice.gc.ca/en/showdoc/cr/C.R.C.-c.870/bo-ga:l_C-gb:s_C_01_001/20090622/enanchorbo-ga:l_C-gb:s_C_01_001
  • 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.
  • León F, Rodríguez M, Cuevas M. 2003. Anaphylaxis to Linum. Allergologia et immunopathologia 31(1):47-49.
  • 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, 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, 2nd edition. Silver Spring (MD): American Herbal Products Association.
  • 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. 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. 2009. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals [Online]. Whitehouse Station (NJ): Merck & Co., Inc. [Accessed 2010-01-26]. Available at: http://www.medicinescomplete.com/mc/merck/current/09495.htm
  • 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. 1997. Dietary flax seed in prevention of hypercholesterolemic atherosclerosis. Atherosclerosis 132(1):69-76.
  • Prasad K. 2005. Hypocholesterolemic and antiatherosclerotic effect of flax lignan complex isolated from flaxseed. Atherosclerosis 179(2):269-275
  • 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: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, Anton R, éditeurs. Plantes thérapeutiques : Tradition, pratique officinale, sciences et thérapeutique, 2e édition. Paris (F) : Lavoisier; 2003

References reviewed

  • Alonso L, Marcos ML, Blanco JG, Navarro JA, Juste S, del Mar Garcés M, Pérez R, Carretero PJ. 1996. Anaphylaxis caused by linseed (flaxseed) intake. The Journal of Allergy and Clinical Immunology 98(2):469-470.
  • 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: http://www.eclecticherb.com/emp/updatesHCDI.html
  • CGC 2005: Canadian Grain Commission. The Quality of Flaxseed in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2006 July 20]. Available from: http://www.grainscanada.gc.ca/flax-lin/trend-tendance/qfc-qlc-eng.htm
  • 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: http://www.hc-sc.gc.ca/fn-an/nutrition/vitamin/fortification_final_doc_1-eng.php
  • 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.
  • Lezaun A, Fraj J, Colás C, Duce F, Domínguez MA, Cuevas M, Eiras P. 1998. Anaphylaxis from linseed. Allergy 53(1):105-106.
  • 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 appropriate dosage preparations, frequencies of use and directions for use

  • 30 g (flaxseed powder), per day (Patade et al. 2008)
  • 10-15 g flaxseed, 2-3 times per day (EMEA 2006)
  • 350 mg flaxseed, per day (provides approximately 5% of the Institute of Medicine's (IOM's) Adequate Intake (AI) for alpha-linolenic acid) (IOM 2006)
  • 14 g flaxseed, per day (provides at least 5% of the IOM's AI for linoleic acid) (IOM 2006)
  • 5 g flaxseed, 3 times per day (ESCOP 2003)
  • 40 g ground flaxseed, per day (Lucas et al. 2002)
  • 5-10 g flaxseed, 1-3 times per day (Boon 2000)
  • 50 g ground flaxseed, per day (Jenkins et al. 1999; Cunnane et al. 1993)