Borage Oil

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Archived Monograph - May 2008

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications 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 Product Licence Application and product labels at the applicants' 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.
• Vitamin E is an optional medicinal ingredient in borage oil products. However, no use or purpose statements may be associated with vitamin E. See Appendix 1 for vitamin E proper name, common name, source material, and dose information.

Date: June 19, 2009

Proper name(s): Borago officinalis L. (Boraginaceae) (USDA 2000)

Common name(s): Borage (McGuffin et al. 2000); Borage oil (Sweetman 2007)

Source material(s): Seed oil (Sweetman 2007; Hoffmann 2003)

Route(s) of administration: Oral

Dosage form(s):Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewables (eg. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons, are acceptable. 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:

• Source of essential fatty acids (Sweetman 2007; Hoffmann 2003) for the maintenance of good health
• Source of omega-6 fatty acids (Ziboh 2004; van Gool 2003; IOM 2002) for the maintenance of good health.
• Source of linoleic acid (LA) (Ziboh 2004; van Gool 2003; IOM 2002) for the maintenance of good health

Dose(s):

• 3.7-5.0 g borage seed oil, per day (Schirmer and Phinney 2007; Takwale et al. 2003; IOM 2002)
  Optional potencies:
• 23-37 % linoleic acid (LA) (Ziboh 2004; van Gool 2003);
• 18-27% gamma-linolenic/gamolenic acid (GLA) (Schirmer and Phinney 2007; Hoffmann 2003; Takwale et al. 2003; van Gool 2003);
• 0.2-10% alpha-linolenic acid (ALA) (Ziboh 2004; Hoffmann 2003; van Gool 2003)

Duration of use: No statement required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s): No statement required.

Contraindication(s): No statement required.

Known adverse reaction(s): No statement required.

Non-medicinal ingredients:

• Must be chosen from the current NHPD Natural Health Products Ingredients Database and must meet the limitations outlined in the database.
• For products providing vitamin E at doses lower than the minima specified in Table 2 of Appendix 1, vitamin E must be declared as a non-medicinal ingredient.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs. The medicinal ingredient may comply with the specifications outlined in the Refined Borage Oil monograph published in the British Pharmacopoeia (BP 2008) or the Refined Borage (Starflower) Oil Monograph published in the European Pharmacopoeia (Ph. Eur. 2008).
• For products indicating one or more of the optional potencies listed in the dose section, an assay must be performed in order to confirm the potency(ies).

References cited:

BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (UK): The Stationary Office.

Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.

IOM 2006: Institute of Medicine. 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.

IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. 2003. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press.

IOM 2002: Institute of Medicine. 2002. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board, Institute of Medicine. Washington (DC): National Academy Press.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.

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.

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).

Schirmer MA, Phinney SD. 2007. Gamma-linolenate reduces weight regain in formerly obese humans. The Journal of Nutrition 137(6):1430-1435.

Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press.

Takwale A, Tan E, Agarwal S, Barclay G, Ahmed I, Hotchkiss K, Thompson JR, Chapman T, Berth-Jones J. 2003. Efficacy and tolerability of borage oil in adults and children with atopic eczema: randomised, double blind, placebo controlled, parallel group trial. British Medical Journal 327(7428):1385.

USDA 2000: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online]. 2000. Borago officinalis L. Beltsville (MD): National Germplasm Resources Laboratory. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl [Accessed 30 May 2008].

van Gool CJ, Thijs C, Henquet CJ, van Houwelingen AC, Dagnelie PC, Schrander J, Menheere PP, van den brandt PA. 2003. Gamma-linolenic acid supplementation for prophylaxis of atopic dermatitis--a randomized controlled trial in infants at high familial risk. American Journal of Clinical Nutrition 77(4):943-951.

Ziboh VA, Naguwa S, Vang K, Wineinger J, Morrissey BM, Watnik M, Gershwin ME. 2004. Suppression of leukotriene B4 generation by ex-vivo neutrophils isolated from asthma patients on dietary supplementation with gammalinolenic acid-containing borage oil: possible implication in asthma. Clinical and Developmental Immunology 11(1):13-21.

References reviewed:

Brinker F. 2008. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. [online]. Sandy (OR): Eclectic Medical Publications. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html [Accessed 30 May 2008].

Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.

Kernoff PBA, Willis AL, Stone KJ, Davies JA, McNicol GP. 1977. Antithrombotic potential of dihomo-gamma-linolenic acid in man. British Medical Journal 2(6100):1441-1444.

Laidlaw M, Holub BJ. 2003. Effects of supplementation with fish oil-derived n-3 fatty acids and gamma-linolenic acid on circulating plasma lipids and fatty acid profiles in women. American Journal of Clinical Nutrition 77(1):37-42.

Puri BK. 2007. The safety of evening primrose oil in epilepsy. Prostaglandins Leukotrienes and Essential Fatty Acids 77(2):101-103.

Stone KJ, Willis AL Hart M, Kirtland SJ, Kernoff PBA, McNicol GP. 1979. The metabolism of dihomo-γ-linolenic acid in man. Lipids 14(2):174-180.

Appendix 1: Vitamin E

Proper name(s), common name(s), and source material(s):

Table 1: Vitamin E proper name(s), common name(s) and source material(s)

Proper name(s)	Common name(s)	Source material(s)
Vitamin E (Sweetman 2007; IOM 2003; O’Neil et al. 2001)	Alpha-Tocopherol/α-Tocopherol (Sweetman 2007; O’Neil et al. 2001); Vitamin E (Sweetman 2007; IOM 2003; O’Neil et al. 2001)	All racemic-α-Tocopherol/all rac-α-Tocopherol/ dl-α-Tocopherol (Sweetman 2007; IOM 2003) All racemic α-Tocopheryl acetate/all-rac-α-Tocopheryl acetate/ dl-α-Tocopheryl acetate (Sweetman 2007; IOM 2003) All racemic-α-Tocopheryl succinate/all rac-α-Tocopheryl succinate/ dl-α-Tocopheryl acid succinate/ dl-α-Tocopheryl succinate (Sweetman 2007) RRR-α-Tocopherol/ d-α-Tocopherol (Sweetman 2007; IOM 2003; O’Neil et al. 2001) RRR-α-Tocopheryl acetate/ d-α-Tocopheryl acetate (Sweetman 2007; IOM 2003) RRR-α-Tocopheryl succinate/ d-α-Tocopheryl acid succinate/ d-α-Tocopheryl succinate (Sweetman 2007; IOM 2003)

Quantity:

The quantity of vitamin E must always be provided in terms of α-Tocopherol (AT) (i.e. mg RRR-α-Tocopherol), irrespective of the source material used.

IUs may be provided as optional additional information on the PLA form in the "potency" field and on product labels.

Table 2: Dose information for vitamin E presented as dose per day (IOM 2006)

Subpopulation		Vitamin E (mg AT/day)
		Minimum	Maximum
Adults	≥ 19 y	4.5	179

Conversion factors:

Table 3: Conversion of vitamin E source material quantity into vitamin E quantity in terms of
α-Tocopherol (AT) and vitamin E activity in terms of International Unit (IU) (IOM 2006)

Source material (1 mg)	Vitamin E quantity (mg AT)	Vitamin E activity
RRR-α-Tocopherol	1.00	1.49
RRR-α-Tocopheryl acetate	0.91	1.36
RRR-α-Tocopheryl succinate	0.81	1.21
All rac-α-tocopherol	0.50	1.10
All rac-α-tocopheryl acetate	0.46	1.00
All rac-α-tocopheryl succinate	0.41	0.89

Table 4: Conversion of vitamin E source material activity into vitamin E quantity in terms of alpha-(α)-tocopherol (AT) (IOM 2006)

Source material (1 IU)	Vitamin E quantity (mg AT)
RRR-α-Tocopherol	0.67
RRR-α-Tocopheryl acetate	0.67
RRR-α-Tocopheryl succinate	0.67
All rac-α-tocopherol	0.45
All rac-α-tocopheryl acetate	0.45
All rac-α-tocopheryl succinate	0.45

Examples using the vitamin E conversion factors:

1. Converting vitamin E activity into quantity of AT (mg)
   
   Convert 400 IU of RRR-α-tocopheryl succinate activity into mg AT:
   = 400 IU x 0.67 mg AT/IU
   = 268 mg AT
2. Converting vitamin E source material quantity into quantity of AT (mg)
   
   Convert 200 mg of all rac-α-tocopheryl acetate into mg AT:
   = 200 mg x 0.46 mg AT/mg
   = 92 mg AT