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Drugs and Health Products

FLAXSEED - LINUM USITATISSIMUM

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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) Part(s) Preparation(s)

Linum usitatissimum

  • Flax
  • Flaxseed
  • Linseed

Linum usitatissimum

Seed

Dried

References: Proper name: USDA 2018; Common name: Sweetman 2007, McGuffin et al. 2000; Source material: Blumenthal et al. 2000.

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)

  • Source of essential fatty acids 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).
  • (Used in Herbal Medicine as a) bulk-forming laxative (Blumenthal et al. 2000; BHP 1996).
  • (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 (Kinniry et al. 2006; Rajesha et al. 2006; Prasad 2005; Prasad 1997).

The following combined use(s) or purpose(s) is/are also acceptable:

  • (Used in Herbal Medicine as a) bulk-forming laxative to promote bowel movements and to provide gentle relief of constipation and/or irregularity (EMEA 2006; Pray 2006; ESCOP 2003; Gennaro 2000; McGuffin et al. 1997).

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Method of preparation: Powder (unextracted)

Table 2. Dose information of dried Flaxseed presented as dose per day and single dose, based on uses or purposes, subpopulations.
Uses or Purposes Subpopulations1,2,3
Dried seed (g)/day
Dried seed (g)/single dose
Min. Max. Max. single dose
Source of essential fatty acids, omega-3 fatty acids, and/or ALA

Children

6-11 years

0.18

15

7.5

Adolescents

12-17 years

0.36

45

22.5

Adults

18 years and older

0.36

45

22.5

Source of omega-6 fatty acids and/or LA

Children

6-11 years

7

15

7.5

Adolescents

12-17 years

14

45

22.5

Adults

18 years and older

14

45

22.5

Provides antioxidants

Children

6-11 years

>0

15

7.5

Adolescents

12-17 years

>0

45

22.5

Adults

18 years and older

>0

45

22.5

Reduces blood lipid levels

Adults

18 years and older

30

45

22.5

Table 2 Footnotes

Table 2 Footnote 1

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; Bove 2001; Boon 2000; Schilcher 1997.

Return to Table 2 footnote1 referrer

Table 2 Footnote 2

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.

Return to Table 2 footnote2 referrer

Table 2 Footnote 3

Includes pregnant and breastfeeding women (Mills et al. 2006; ESCOP 2003).

Return to Table 2 footnote3 referrer

Methods of preparation: Dry, Powder (unextracted)

Table 3. Dose information of dried Flaxseed presented as dose per day and single dose, based on uses or purposes, subpopulations.
Uses or Purposes Subpopulations1,2,3
Dried seed (g)/day
Dried seed (g)/single dose
Min. Max. Max. single dose
Laxative

Children

6-11 years

4.5

15

7.5

Adolescents

12-17 years

10

45

22.5

Adults

18 years and older

10

45

22.5

Table 3 Footnotes

Table 3 Footnote 1

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; Bove 2001; Boon 2000; Schilcher 1997.

Return to Table 3 footnote1 referrer

Table 3 Footnote 2

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.

Return to Table 3 footnote2 referrer

Table 3 Footnote 3

Includes pregnant and breastfeeding women (Mills et al. 2006; ESCOP 2003).

Return to Table 3 footnote3 referrer

Note

All products

ALA and/or LA (optional potency): 20-30 % ALA (CGC 2008; HC 2008; Cunnane 1993) and/or 5-7 % LA (HC 2008)

Direction(s) for use

Products providing 5 g or more of flaxseed per day

  • For each dose, drink (or mix with) at least 150 ml of liquid (EMEA 2006; ESCOP 2003).
  • Take 2 hours before or after taking other medications (Sweetman 2007; EMEA 2006).

Laxative products

  • Optional: Take during the day (not immediately prior to bedtime) (EMEA 2006).
  • Effects observed 12-24 hours after first dose, and may take 2-3 days (EMEA 2006; ESCOP 2003).

Optional (for products with a dosage range)

Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Products providing 5 g or more of flaxseed 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 (EMEA 2006).
  • 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 (EMEA 2006).
  • 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) (Brinker 2010; EMEA 2006; ESCOP 2003).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have diabetes or difficulty swallowing (EMEA 2006; ESCOP 2003).

Laxative

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 (Pray 2006; Repchinsky 2002).

Contraindication(s)

So statement required.

Known adverse reaction(s)

All products

Stop use is hypersensitivity/allergy occurs (EMEA 2006; León et al. 2003).

Products providing 5 g or more of flaxseed per day

May cause temporary gas and bloating (EMEA 2006).

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

  • 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.

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.
  • Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • CGC 2008: Canadian Grain Commission. Flaxseed quality in Canada [online]. Winnipeg (MB): Canadian Grain Commission. [Accessed 2018 July 10]. Available from: https://www.grainscanada.gc.ca/flax-lin/harvest-recolte/2012/hqf12-qrl12-eng.pdf
  • 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.
  • 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 2018 July 10]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2010/01/WC500059157.pdf
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
  • 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 2018 July 10]. Available from: https://food-nutrition.canada.ca/cnf-fce/index-eng.jsp
  • IOM 2006: 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.
  • 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.
  • Kinniry P, Amrani Y, Vachani A, Solomides CC, Arguiri E, Workman A, Carter J, ChristofidouSolomidou 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):225231
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 2018 July 10]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References Reviewed

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  • 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 SelfCare, 13th edition. Washington (DC): American Pharmaceutical Association.
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  • 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
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