EVENING PRIMROSE OIL

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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. It is not intended to be a comprehensive review of the medicinal ingredient.

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 and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

September 25, 2018

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

Table 1. Proper name(s), Common name(s), Source material(s)

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)
Oenothera biennis	Evening Primrose Oil Oenothera Biennis (Evening Primrose) Oil Primrose oil	Oenothera biennis	Seed

References: Proper name: USDA 2018; Common names: Sweetman 2007, McGuffin et al. 2000; Source material: Sweetman 2007, WHO 2002.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• Source of essential fatty acids for the maintenance of good health (Sweetman 2007; IOM 2006).
• Source of omega-6 fatty acids for the maintenance of good health (EP 2008; IOM 2006; Mills and Bone 2005; WHO 2002).
• Source of linoleic acid for the maintenance of good health (EP 2008; IOM 2006; Mills and Bone 2005; WHO 2002).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Method of preparation: Non-standardized fixed oil

1.3-6 grams of evening primrose oil, per day (EP 2008; Sweetman 2007; IOM 2006; Mills and Bone 2005; WHO 2002; Keen et al. 1993).

Method of preparation: Standardized fixed oil

1.3-6 grams of evening primrose oil, per day (EP 2008; Sweetman 2007; IOM 2006; Mills and Bone 2005; WHO 2002; Keen et al. 1993) standardized to:

• 7-14% gamma-linolenic/gamolenic acid (GLA), and/or
• 65-85% linoleic acid (LA).

Direction(s) for use

No statement required.

Duration(s) 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 Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

• EP 2008: European Pharmacopoeia, 6^th edition, Volume 2. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
• IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5^th edition. Washington (DC): National Academies Press.
• 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.
• 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, 2^nd 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.
• O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2001. Merck Index: An Encyclopedia of Chemicals, Drugs, & Biologicals, 13^th edition. Whitehouse Station (NJ): Merck & Co., Inc.
• Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35^th edition. London (UK): Pharmaceutical Press.
• USDA 2018: 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. [Accessed 2018 July 11]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• WHO 2002: World Health Organization (WHO) Monographs on Selected Medicinal Plants, Volume 2. Geneva (CHE): World Health Organization.

References Reviewed

• Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3^rd edition. London (UK): The Pharmaceutical Press.
• Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13^th edition. Washington (DC): American Pharmaceutical Association.
• BP 2008: British Pharmacopoeia, Volume 1. London (UK): British Pharmacopoeia Commission. The Stationary Office.
• Brinker F. 2001. Herb Contraindication and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications.
• Guivernau N, Meza N, Barja P, Roman O. 1994. Clinical and experimental study on the longterm effect of dietary gamma-linolenic acid on plasma lipids, platelet aggregation, thromboxane formation, and prostacyclin production. Prostaglandins, Leukotrienes, and Essential Fatty Acids 51(5):311-316.
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• IOM 2002: Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington (DC): National Academy Press.
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