FLAXSEED - LINUM USITATISSIMUM

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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

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)

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

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

Laxative products

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

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 if 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

References Cited

References Reviewed