Evening Primrose Oil

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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

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Note: Vitamin E is an optional medicinal ingredient in evening primrose 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: July 16, 2008

Proper name(s): Oenothera biennis L. (Onagraceae) (USDA 2005)

Common name(s): Evening primrose (McGuffin et al. 2000), evening primrose oil (Sweetman 2007)

Source material(s): Seed oil (Sweetman 2007; WHO 2002)

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 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; IOM 2006) for the maintenance of good health
• Source of omega-6 fatty acids (EP 2008; IOM 2006; Mills and Bone 2005; WHO 2002) for the maintenance of good health
• Source of linoleic acid (EP 2008; IOM 2006; Mills and Bone 2005; WHO 2002) for the maintenance of good health

Dose(s): 1,300-6,000 mg, per day (Sweetman 2007; IOM 2006; Keen 1993)

Optional potencies:

• 7-14% gamma-linolenic/gamolenic acid (GLA) (EP 2008; Mills and Bone 2005; WHO 2002);
• 65-85% linoleic acid (EP 2008; Mills and Bone 2005; WHO 2002)

Duration of use: No statement required.

Risk information:

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 List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
• 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 Evening Primrose Oil Monograph published in the British Pharmacopoeia or the Evening Primrose Oil, Refined Monograph published in the European Pharmacopoeia.
• 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:

EP 2008: European Pharmacopoeia, 6th edition, Volume 2. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. 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. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press.

Keen H, Payan J, Allawi J, Walker J, Jamal GA, Weir AI, Henderson LM, Bissessar EA, Watkins PJ, Sampson M, Gale EA, Scarpello J, Boddie HG, Hardy KJ, Thomas PK, Misra P, Halonen JP. 1993. Treatment of diabetic neuropathy with gamma-linolenic acid. The gamma-Linolenic Acid Multicenter Trial Group. Diabetes Care 16(1):8-15.

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

Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.

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USDA 2005: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Oenothera biennis L. Beltsville (MD): National Germplasm Resources Laboratory. Available from:
http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl [Accessed 16 July 2008].

WHO 2002: World Health Organization (WHO) Monographs on Selected Medicinal Plants, Volume 2. Geneva (CHE): World Health Organization.

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