RED WINE 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)
Vitis vinifera	Red Wine Extract Red Wine Polyphenol Extract	Vitis vinifera	Fruit

References: Proper name: USDA 2018; Common names: Leifert and Abeywardena 2008; Source material: Nigdikar et al. 1998, Brouillard et al. 1997.

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 (Meskin et al. 2002; Cuevas et al. 2000).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Standardized or Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 1 gram of red wine extract, per day (Chopra et al. 2000; Cuevas et al. 2000; Nigdikar et al. 1998).

Potency (Optional): Not to exceed 95% polyphenols (Botden et al. 2012; Chopra et al. 2000).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (Meskin et al. 2002).

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

• Botden I, Draijer R, Westerhof B, Rutten J, Langendonk J, Sijbrands E, Danbser A, Zock P, Meiracker A. Red wine polyphenols do not lower peripheral or central blood pressure in high normal blood pressure and hypertension. American Journal of Hypertension 2012; 25 (6): 718-723.
• Brouillard R, George F, Fougerousse A. Polyphenols produced during red wine ageing. Biofactors 1997;6:403-410.
• Chopra M, Fitzsimons PE, Strain JJ, Thurnham DI, Howard AN. Nonalcoholic Red Wine Extract and Quercetin Inhibit LDL Oxidation without Affecting Plasma Antioxidant Vitamin and Carotenoid Concentrations. Clinical Chemistry 2000;46(8):1162-1170.
• Cuevas AM, Guasch V, Castillo O, Irribarra V, Mizon C, San Martin A, Strobel P, Perez D, Germain AM, Leighton F. A High-Fat Induces and Red Wine Counteracts Endothelial Dysfunction in Human Volunteers. Lipids 2000;35(2):143-148.
• Leifert, W.R. Abeywardena, M.Y. Grape seed and red wine polyphenol extracts inhibit cellular cholesterol uptake, cell proliferation, and 5-lipoxygenase activity. Nutrition Research 2008;28: 842-850.
• Meskin MS, Bidlack WR, Davies AJ, Omaye ST. Phytochemicals in nutrition and health. CRC Press LLC. Boca Raton, Florida;2002:46-60.
• Nigdikar SV, Williams NR, Griffin BA, Howard AN. Red Wine Polyphenols and LDL Oxidation. American Journal of Clinical Nutrition 1998;68:258-265.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 June 18]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References reviewed

• Blumenthal M. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in cooperation with Integrative Medicine Communications;1998.
• Bove M. An Encyclopedia of Natural Healing for Children and Infants. 2^nd edition. New York (NY): McGraw-Hill Publishing, Incorporated;2001.
• Brinker F. Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications;2001.
• Merck 2012:  The Merck Index Version 14.1. Whitehouse Station (NJ): Merck & Co., Inc. Copyright © 2006, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. [Published 2006; Updated 2012; Accessed 2013 August 12].
• Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine. Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier;2006.
• Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists: With reference to Commission E Monographs of the Federal Department of Health in Germany. Includes 100 Commission E monographs and 15 ESCOP Monographs. Stuttgart (DE): Medpharm Scientific Publishers;1997.
• Sweetman SC, editor. Martindale:  The Complete Drug Reference. London (GB): Pharmaceutical Press; 2011. [Arnica: Last modified 2010 November 27; Accessed 2011 February 1]