Flaxseed Oil: Uses, Forms & Precautions

What is it used for?

All products

Source of essential fatty acids (alpha-linolenic acid (ALA) and linoleic acid (LA)) for the maintenance of good health [Source note 2].
Source of omega-3 fatty acids for the maintenance of good health [Source note 3].
Source of alpha-linolenic acid (ALA) for the maintenance of good health [Source note 4].
Source of omega-6 fatty acids for the maintenance of good health [Source note 5].
Source of linoleic acid (LA) for the maintenance of good health [Source note 6].

Note: The above uses can be combined on the product label (e.g., Source of omega-3 and omega-6 fatty acids for the maintenance of good health).

What this guide covers

The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.

Who does this guide cover?

As specified below.

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references 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; EMA/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; EMA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The

Quantities

Method 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	Subpopulations¹,²	Subpopulations¹,²	Oil g/day / Min.	Oil g/day / Max.	Oil ml/day / Min.	Oil ml/day / 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
Source of essential fatty acids, omega-3 fatty acids, and/or ALA	Children	5-9 years	0.06	8	0.25	8.50
Source of essential fatty acids, omega-3 fatty acids, and/or ALA	Children	10-11 years	0.12	16	0.5	17
Source of essential fatty acids, omega-3 fatty acids, and/or ALA	Adolescents	12-14 years	0.12	16	0.5	17
Source of essential fatty acids, omega-3 fatty acids, and/or ALA	Adolescents	15-17 years	0.23	32	1	34
Source of essential fatty acids, omega-3 fatty acids, and/or ALA	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
Source of omega-6 fatty acids and/or LA	Children	5-9 years	1.93	8	2	8.50
Source of omega-6 fatty acids and/or LA	Children	10-11 years	3.85	16	4	17
Source of omega-6 fatty acids and/or LA	Adolescents	12-14 years	3.85	16	4	17
Source of omega-6 fatty acids and/or LA	Adolescents	15-17 years	7.70	32	8	34
Source of omega-6 fatty acids and/or LA	Adults	18 years and older	7.70	32	8	34

¹Children and adolescent doses were calculated as a proportion of the adult dose [Source note 7]. 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.

Method of preparation: Standardized fixed oil

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

35-65 % ALA [Source note 8]
11-24 % LA [Source note 9]

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

11-35% oleic acid [Source note 10]
XX% total omega-3 fatty acids
XX% total omega-6 fatty acids