GRAPE SEED EXTRACT

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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

August 28, 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)
Grape seed extract	Grape seed extract	Vitis vinifera	Seed

References: Sano et al. 2007; Common name: Sano et al. 2007; Source material: USDA 2018, Sano et al. 2007, Henriet 1993.

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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• Source of/Provides antioxidants (Sano et al. 2007; Natella et al. 2002; Bagchi et al. 2000; Bagchi et al. 1998).
• Helps to relieve symptoms related to non-complicated chronic venous insufficiency (CVI), such as sensation of swelling, heaviness and tingling of the legs (Henriet 1993; Henriet 1988; Thébaut et al. 1985; Delacroix et al. 1981; Sarrat 1981).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidant

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 475 milligrams of grape seed extract, per day; standardized to 70-85% oligomeric proanthocyanidins (OPC) (Sano et al. 2007; Natella et al. 2002).

Relief of symptoms related to non-complicated CVI

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

150 - 475 milligrams of grape seed extract, per day; standardized to 80-85% oligomeric proanthocyanidins (OPC) (Sano et al. 2007; Henriet 1993; Henriet 1988; Thébaut et al. 1985; Delacroix 1981; Sarrat 1981)

Direction(s) for use

No statement required.

Duration of Use

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 3 months (Sano et al. 2007).

Relief of symptoms related to non-complicated CVI

Use for at least 1 month to see beneficial effects (Thébaut et al. 1985; Delacroix 1981; Sarrat 1981).

Risk Information

Caution(s) and Warning(s)

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Relief of symptoms related to non-complicated CVI

Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen.

Contraindication(s)

No statement required.

Known Adverse Reaction(s)

No statement required.

Storage Condition(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.

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

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• Bagchi D, Garg A, Krohn L, Bagchi M, Bagchi DJ, Balmoori J, Stohs SJ. 1998. Protective effects of grape seed proanthocyanidins and selected antioxidants against TPA-induced hepatic and brain lipid peroxidation and DNA fragmentation, and peritoneal macrophage activation in mice. General Pharmacology 30(5):771-776.
• Delacroix P. 1981. [Double-blind study of Endotelon in chronic venous insufficiency.] Étude en double aveugle de l’endotelon dans l’insuffisance veineuse chronique. La Revue de Médecine 22(27-28):1793-1802 (in French).
• Henriet JP. 1993. [Veno-lymphatic insufficiency. 4 729 patients undergoing hormonal and procyanidol oligomer therapy.] Insuffisance veino-lymphatique 4 729 patientes sous thérapeutique hormonale et oligomères procyanidoliques. Phlébologie 46(2):313-325 (in French).
• Henriet JP. 1988. [EndotelonR in the functional disorders caused by peripheral vascular insufficiency.] EndotelonR dans les manifestations fonctionnelles de l’insuffisance veineuse périphérique: Étude EIVE. Actualité Médicales Internationales-Angiologie 5(74):167-170 (in French).
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• Sarrat L. 1981. [Therapeutic relief of functional problems of the lower legs by Endotelon, a microangrioprotector.] Abord Thérapeutique des troubles fonctionnels des membres inférieurs par un microangrioprotecteur l’Endotelon. Bordeaux Médical 14:685-688 (in French).
• Thébaut J-F, Thébaut P, Vin F. 1985. [Study of Endotelon in the functional manifestations of peripheral venous insufficiency. Results of a double-blind study of 92 patients.] Étude de l’Endotelon dans les manifestations fonctionelles de l’insuffisance veineuse périphérique. Résultats d’une étude en double aveugle portant sur 92 patients. Gazette Médicale 92(1):96-100 (in French).
• USDA 2018: United States Department of Agriculture, Agricultural Research Service,National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2018 July 3]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

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