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Drugs and Health Products

Multiple Ingredient fixed Oil Products - Oral

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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 of multiple ingredient oil products that contain any two or more of the medicinal ingredients listed in Table 1. The monograph is not intended to be a comprehensive review of the medicinal ingredients.
  • Essential/volatile oil preparations (e.g. those prepared by distillation) are not within the scope of this monograph.
  • Hydrogenated oils and partially hydrogenated oils are not within the scope of this monograph.
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 or statements are synonymous. Either term or statement may be selected by the applicant.

Date

January 7, 2015

Proper name(s), Common name(s), and Source material(s)

Table 1 Proper and common names and source materials of medicinal ingredients
Proper nameTable 1 footnote 1 Common nameTable 1 Footnote2           Source material

Table 1 footnotes

Table 1 footnote 1

Proper name(s) and common name(s): Natural Health Products Ingredient Database (NHPID)

Return to table 1 footnote 1,2 referrer

Borago officinalis Borage oil Seed (Martindale 2012; Hoffmann 2003)
Brassica napus
  • Canola oil
  • Rapeseed oil
Seed (FCC 2014)
Brassica juncea
Brassica rapa
Camelina sativa False flax oil Seed (Dubois et al. 2007)
Cannabis sativa Hemp seed oil Seed (Callaway et al. 2005)
Carthamus tinctorius Safflower oil Seed (USP 37)
Cocos nucifera Coconut oil Seed endosperm (FCC 2014)
Cod liver oil Cod liver oil As per NNHPD Cod liver oil monograph
Cucurbita pepo var. pepo Pumpkin seed oil Seed (Dubois et al. 2007)
Fish oil Fish oil As per NNHPD Fish oil monograph
Helianthus annuus
  • Sunflower seed oil
  • Sunflower oil
Seed (FCC 2014)
Hippophae rhamnoides Sea buckthorn seed oil Seed (Yang et al. 1999)
Krill oil Krill oil As per NNHPD Krill oil monograph
Linum usitatissimum
  • Flax oil
  • Flaxseed oil
  • Linseed oil
As per NNHPD Flaxseed oil monograph
Oenothera biennis Evening primrose oil As per NNHPD Evening Primrose oil monograph
Olea europaea Olive oil Fruit (NF 32)
Prunus dulcis var. dulcis
  • Almond oil
  • Sweet almond oil
Kernel (NF 32)
Ribes nigrum Blackcurrant seed oil Seed (Linnamaa et al. 2010)
Salvia hispanica Chia seed oil Seed (Dubois et al. 2007)
Schizochytrium spp Schizochytrium Oil Schizochytrium spp. (Yurko-Mauro et al. 2010)
Seal oil Seal oil As per NNHPD Seal oil monograph
Squid oil Squid oil Todarodes pacificus - whole (ITIS 2014)
Docidicus gigas - whole (ITIS 2014)
Illex argentinus - whole (ITIS 2014)
Illex illecebrosus - whole (ITIS 2014)
Triticum aestivum
  • Wheatgerm oil
  • Wheat germ oil
Germ (Ph.Eur 2013)
Vitis vinifera Grape seed oil Seed (Dubois et al. 2007)

Route(s) of administration

Oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

Table 2: Recommended Use(s) or Purpose(s) based on Fatty Acid Content
Required Fatty Acid ConstituentsTable 2 Footnote 1 Minimum Daily DoseTable 2 Footnote 2(mg per day) Recommended Use(s) or Purpose(s)

Table 2 footnotes

Table 2 footnote 1

For products making claims from this table, the potencies must be indicated for the relevant fatty acid constituents. Refer to Appendix I for guidance on potency constituents and their percentages.

Return to table 2 footnote 1 referrer

Table 2 footnote 2

At least one of the following references was used to support the minimum dose and recommended uses or purposes: NNHPD 2014; EFSA 2010a; EFSA 2010b; EFSA 2009; Simopolous 2007; IOM 2006; IOM 2002; Simopolous 1999;

Return to table 2 footnote 2 referrer

LA(Linoleic acid) 850
  • Source of linoleic acid (LA) for the maintenance of good health
  • Source of omega-6 fatty acid for the maintenance of good health
  • Source of an essential fatty acid for the maintenance of good health
ALA (Alpha-linolenic acid) 80
  • Source of alpha-linolenic acid (ALA) for the maintenance of good health
  • Source of omega-3 fatty acid for the maintenance of good health
  • Source of an essential fatty acid for the maintenance of good health
LA + ALA 850 LA + 80 ALA Source of essential fatty acids for the maintenance of good health
EPA + DHA + DPA
(Eicosapentaenoic acid + Docosahexaenoic acid + Docosapentaenoic acid (n-3))
100 EPA+DHA+DPA Source of omega-3 fatty acids for the maintenance of good health
EPA 100 Source of eicosapentaenoic acid (EPA) for the maintenance of good health
DHA 100 Source of docosahexaenoic acid (DHA) for the maintenance of good health
250
  • Helps support/maintain eye health/function
  • Helps support/maintain visual health/function
  • Helps support/maintain normal brain function
DPA 100 Source of docosapentaenoic acid (DPA) for the maintenance of good health
EPA+DHA 250 EPA+DHA Helps support/maintain (normal) heart/ cardiovascular health/function
2000 EPA+DHA Helps to support/maintain normal serum/blood triglyceride/triacylglycerol levels
GLA (Gamma-linoleic acid) 100 Source of gamma-linoleic acid
OA (Oleic acid) 100 Source of oleic acid
Products containing Coconut oil, Olive oil and/or Wheat germ oil

Provides/source of antioxidants (Marina et al. 2009; Alessandri et al. 2006; Fito et al. 2005; Visioli et al. 2005; Marrugat et al. 2004;Weinbrenner et al. 2004).

Products containing Schizochytrium Oil, Borage oil, Cod liver oil, Fish oil, Krill oil, Evening Primrose oil, Seal oil and/or Cognitive Functions products

Claims permitted as per the other NNHPD monographs for these ingredients. Individual monograph respective doses and potencies apply.

Dose(s)

Subpopulation

All Products

Adults (≥ 18 years)

Products containing Fish oil, Flaxseed oil, Seal oil and/or Cod liver oil

As per their respective NNHPD monographs.

Preparations

Oil fixed; Oil fixed standardized

Maximum Daily Doses of Medicinal Ingredients
Medicinal ingredient Maximum Daily Dose (g per day)
Borago officinalis/Borage oil As per NNHPD Borage Oil monograph
Brassica napus/B. juncea/B. rapa/Canola oil 15.0 (NNHPD 2014)
Camelina sativa/False flax Oil 15.0 (NNHPD 2014)
Cannabis sativa/Hemp seed oil 15.0 (NNHPD 2014)
Carthamum tinctorius/Safflower seed oil 15.0 (NNHPD 2014)
Cocos nucifera/Coconut oil 15.0 (NNHPD 2014)
Cod liver oil As per NNHPD Cod Liver Oil monograph
Cucurbita pepo var. pepo/Pumpkin seed oil 15.0 (NNHPD 2014)
Fish oil As per NNHPD Fish Oil monograph
Helianthus annuus/Sunflower seed oil 15.0 (NNHPD 2014)
Hippophae rhamnoides/Sea buckthorn seed oil 5.0 (Yang et al. 1999)
Krill oil As per NNHPD Krill Oil monograph
Linum usitatissimum/Flaxseed oil As per NNHPD Flaxseed Oil monograph
Oenothera biennis/Evening primrose oil As per NNHPD Evening Primrose Oil monograph
Olea europaea/Olive oil 15.0 (NNHPD 2014)
Prunus dulcis var. dulcis/Almond oil 15.0 (NNHPD 2014)
Ribes nigrum/Blackcurrant seed oil 10.5 (Leventhal et al. 1994)
Salvia hispanica/Chia seed oil 4.5 (NNHPD 2014)
Schizochytrium spp./Schizochytrium Oil A quantity of oil providing no more than 2000 mg DHA/day (Quinn et al. 2010)
Seal oil As per NNHPD Seal Oil monograph
Squid oil 5.0 (NNHPD 2014)
Triticum aestivum/Wheatgerm oil 15.0 (NNHPD 2014)
Vitis vinifera/Grape seed oil 15.0 (NNHPD 2014)
Direction(s) for use

No statement required.

Combination rules and restrictions
All medicinal ingredients included in this monograph may be combined with the following restrictions:
  • The combined maximum daily dose of oils in a product must not exceed 15.0 g per day (NNHPD 2014).
  • Maximum daily doses for individual medicinal ingredient as per Table 2 apply.
  • The combined maximum daily dose of EPA+DHA+DPA in a single product must not exceed 5.0 g per day (EFSA 2012).
  • Maximum daily doses of EPA+DHA+DPA for Schizochytrium Oil apply.
  • Maximum daily doses of EPA+DHA+DPA for Krill oil, Fish Oil, and Seal Oil apply as per individual NNHPD respective monographs.
  • Maximum daily doses of EPA+DHA, Vitamin A and Vitamin D for Cod liver oil apply as per the NNHPD Cod liver oil monograph.

Duration(s) of Use

No statement required.

Risk Information

Statement(s) to the effect of

Caution(s) and warnings(s)

Products containing Hemp seed oil, Sea buckthorn seed oil, Krill oil, Blackcurrant seed oil and/or Squid oil

If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindication(s)

No statements required.

Known adverse reaction(s)

Products containing Krill oil and/or Squid oil

Hypersensitivity/allergy has been known to occur (with shellfish); if this occurs, discontinue use (Martindale 2012).

Non-medicinal ingredients

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

Storage conditions

All products:

Store in airtight container, protected from light (Ph.Eur. 2012; USP 35).

Products containing Schizochytrium oil, False flax oil, Hemp seed oil, Cod liver oil, Fish oil, Sea buckthorn seed oil, Krill oil, Flaxseed oil, Black current seed oil, Chia seed oil, Seal oil and Squid Oil except those encapsulated

Refrigerate after opening (Wille and Gonus 1989).

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide. Cod liver oil, Fish oil, Krill oil, Seal oil and Squid oil are considered marine oils and therefore Section 3.3.8 Contaminants in marine oils of the NNHPD Quality of Natural Health Products Guide applies to products containing these ingredients.
  • Section 3.3.11 Oxidative stability in oils of the NNHPD Quality of Natural Health Products Guide applies to all products containing any medicinal ingredient on this monograph.
  • The medicinal ingredients must comply with the requirements outlined in the NHPID. In addition, the medicinal ingredient may comply with the specifications published in the American (USP), British (BP) and/or European (Ph.Eur.) Pharmacopoeias.
  • Products containing Hemp seed oil must contain no greater than 10 ppm of delta-9-tetrahydro-cannabinol (THC), and their production must be in compliance with the Industrial Hemp Regulations (GC 2014).
  • For all products indicating one or more of the potencies listed in the dose section, an assay must be performed in order to confirm the potency(ies).
  • For the following ingredients please see the respective NNHPD monographs for additional quality requirements: Borage oil, Cod liver oil, Fish oil, Krill Oil, Flaxseed oil, Evening Primrose Oil, Seal oil.

References cited

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Appendix I

Table 1 Fatty acid composition for medicinal ingredients (%)Appendix Table 1 Footnote 1>Appendix Table 1 Footnote 2
Medicinal ingredient Linoleic acid 18:2 (n-6) (LA) Alpha-linolenic acid 18:3(n-3) (ALA) Eicosa-penta- enoic acid 20:5(n-3) (EPA) Docosa-hexa-enoic acid 22:6(n-3) (DHA) Docosa-penta-enoic acid 22:5(n-3) (DPA) Gamma-linolenic acid 18:3(n-6) (GLA) Oleic acid 18:1(n-9) (OA)

Appendix table 1 Footnotes

Table 1 Footnote 1

All acceptable potency constituents are listed for each of the respective MIs along with their typical amounts (shown as a percentage). The percentage range for an indicated constituent is provided as guidance only and may differ based on the natural variation of the source material used and/or method of preparation.

Return to Appendix Table 1 footnote 1 referrer

Appendix table 1 Footnote 2

At least one of the following references was used to support potency ranges: FCC 2014; USP 37; Quinn et al. 2010; Arafiles et al. 2011; BP 2014; Ph.Eur. 2013; Schirmer and Phinney 2007; Hoffman 2003; Takwale et al. 2003; van Gool et al. 2003; Ziboh et al. 2004; Mills and Bone 2005; WHO 2002; HC 2009; Cunnane et al. 1993; NF 32; Mansour et al. 2014; Hrastar et al. 2009; Kirkhus et al. 2013; Leizer et al. 2000; Bagci et al. 2002; Dubois et al. 2007; Laureles et al. 2002; Murkovic et al. 1996; Kirbaslar et al. 2012; Stevenson et al. 2007; Beveridge et al. 1999; Yang et al. 2001; Fatima et al. 2012; Kazantis et al. 2003; Soler et al. 1988; Ziboh and Fletcher, 1992; Ruiz del Castillo et al. 2002; Ixtaina et al. 2011; Segura-Campos et al. 2014; Ayerza, 2009; Grahl-Nielsel and Miaavtten, 1991; Gregersen et al. 2010; Bjorkkjaer et al. 2009; Mann et al. 2010; AU TGA 2013; Sabir et al. 2011; Lutterodt et al. 2011; Crews et al. 2006; Beveridge et al. 2005.

Return to Appendix Table 1 footnote 2 referrer

Schizochytrium Oil -- -- Up to 3.9 22-55 -- -- --
Borage seed oil 23-37 0.2-10 -- -- -- 18-27 12-22
Canola seed oil 16-40 6-14 -- -- -- -- 50-67
Camelina seed oil 15-25 29-40 -- -- -- -- 11-36
Hemp seed oil 49-70 12-25 -- -- -- 1-6 8-16
Safflower seed oil 7-84 Up to 1.5 -- -- -- -- 7-84
Coconut oil 1-4 Up to 0.2 -- -- -- -- 1-10
Cod liver oil 0.5-3 Up to 2 7-16 6-18 -- -- 12-21
Pumpkin seed oil 42-71 -- -- -- -- -- 17-47
Fish oil -- -- Minimum 4 Minimum 9 -- -- --
Sunflower seed oil 20-75 Up to 0.5 -- -- -- -- 14-65
Sea buckthorn seed oil 29-44 20-39 -- -- -- -- 12-27
Krill oil 1.4-3 0.5-3.5 14-22.1 7.5-13.2 Up to 0.7 -- 7-14.5
Flaxseed oil 11-24 35-65 -- -- -- -- 11-35
Evening primrose oil 65-85 Up to 0.5 -- -- -- 7-14 5-12
Olive oil 3.5-20 Up to 1.2 -- -- -- -- 56-85
Almond oil 10-30 Up to 0.4 -- -- -- -- 59-86
Black currant seed oil 30-49 11-34 -- -- -- 11-23 11-15
Chia seed oil 16-23 52-69 -- -- -- -- 6-11
Seal oil Up to 1.5 Up to 2.1 3-8 7-13 3-5 -- 14-29
Squid oil -- -- Minimum 5 Minimum 18 -- -- --
Wheatgerm oil 52-59 3-10 -- -- -- -- 12-23
Grape seed oil 53-76 Up to 1.8 -- -- -- -- 12-32