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Drugs and Health Products

Monograph: Borage Oil

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: (i) 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. (ii) 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: 2009-06-19

NHPID Name

Borago Officinalis Seed Oil (USDA 2008)

Proper Name(s)

Borago officinalis L. (Boraginaceae) ( USDA 2008 )

Common Name(s)

Borage oil ( Sweetman 2007 )

Source Material

Seed ( Sweetman 2007 , Hoffmann 2003 )

Route 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:

Dose(s)

Adults:

Preparation: Oil fixed

Dose(s): 3.7 - 5 Grams per day
Preparation: Oil fixed standardised

Dose(s): 3.7 - 5 Grams per day

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
No statement is required

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

  • Must be chosen from the current 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 specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • 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).
  • The medicinal ingredient may comply with the specifications outlined in the Refined Borage Oil Monograph published in the British Pharmacopoeia or the Refined Borage (Starflower) Oil Monograph published in the European Pharmacopoeia

References cited

  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • IOM 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; 2002.
  • IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press; 2003.
  • IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc.; 2001.
  • 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. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • 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 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • 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. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • 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):101-3.
  • Stone KJ, Willis AL Hart M, Kirtland SJ, Kernoff PBA, McNicol GP. 1979. The metabolism of dihomo-gamma-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 names, common names and source materials
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 alpha-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-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