BLUEBERRY

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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

June 3, 2019

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)	Preparation
Vaccinium angustifolium	Blueberry Late sweet blueberry Lowbush blueberry Low sweet blueberry Sweethurts Upland lowbush blueberry	Vaccinium angustifolium	Fruit	Fresh Dried
Vaccinium corymbosum	American blueberry Blueberry Highbush blueberry Swamp blueberry	Vaccinium corymbosum
Vaccinium pallidum	Blueberry Hillside lowbush blueberry	Vaccinium pallidum

References: Proper names: USDA 2019a,b,c; Common names: USDA 2019a,b,c; Source materials: USDA 2019a,b,c.

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/Provides antioxidants (Serafini et al. 2009; Kolosova et al. 2004).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

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

• Not to exceed 20 grams of dried fruit, per day (CNF 2015; McAnulty et al. 2004).
• Not to exceed 150 grams of fresh fruit, per day (CNF 2015; McAnulty et al. 2004).

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

Extracts providing up to 40 % Anthocyanins and not to exceed 195 milligrams Anthocyanins, per day and a Quantity crude equivalent of 20 grams of dried fruit or 150 grams of fresh fruit, per day (CNF 2015; McAnulty et al. 2004; Prior et al. 1998).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Products providing 5 grams or more of dried fruit, per day; Products providing 37.5 grams or more of fresh fruit, per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood thinners (ASHP 2005; Franco et al. 2004; IOM 2001; Hansten et al. 1997).

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

• ASHP 2005: American Society of Health-System Pharmacists. Amercan Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins;2005.
• CNF 2015: Canadian Nutrient File (CNF). 2015 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Accessed 2019 May 14]. Available from: https://food-nutrition.canada.ca/cnf-fce/index-eng.jsp
• Franco V, Polanczyk CA, Clausell N, Rohde LE. Role of dietary vitamin K intake in chronic oral anticoagulation: prospective evidence from observational and randomized protocols. The American Journal of Medicine 2004;166(10):651-6.
• Hansten PD, Horn JR, editors. Drug Interactions Analysis and Management. Vancouver (WA): Applied Therapeutics Inc.; 1997.
• IOM 2001: Institute of Medicine. Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academies Press; 2001.
• McAnulty SR, McAnulty LS, Nieman DC, Dumke CL, Morrow JD, Utter AC, Henson DA, Proulx WR, George GL. Consumption of blueberry polyphenols reduces exercise induced oxidative stress compared to vitamin C. Nutrition Research 2004;24:209-221.
• Kolosova, NG, Lebedev PA, Dikalova AE. Comparison of antioxidants in the ability to prevent cataract in prematurely aging OXYS rats. Bulletin of experimental biology and medicine 2004;3:249-251.
• Prior RL, Cao, G, Martin A, Sofic , McEwen J, O'Brien C, Lischner N, Ehlenfeldt M, Kalt W, Krewer G, Mainland CM. Antioxidant Capacity As Influenced by Total Phenolic and Anthocyanin Content, Maturity, and Variety of Vaccinium Species. Journal of Agricultural and Food Chemistry 1998;46(7):2686-2693.
• Serafini M, Testa MF, Villano D, Pecorari M, van Wieren K, Azzini E, Brambilla A, Maiani G. Antioxidant activity of blueberry fruit is impaired by association with milk. Free Radical Biology & Medicine 2009;46:769-774.
• USDA 2019a: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Vaccinium corymbosum (L). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• USDA 2019b: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Vaccinium pallidum Aiton. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• USDA 2019c: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Vaccinium angustifolium Aiton. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx

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.
• Heinonen I, Meyer A, Frankel E. Antioxidant Activity of Berry Phenolics on Human Low- Density Lipoprotein and Liposome Oxidation. Journal of Agricultural and Food Chemistry 1998;46(10):4107-4112
• Martindale 2010: Sweetman SC (ed), Martindale: The Complete Drug Reference. [Internet] London (GB): Pharmaceutical Press; Copyright 1933-2010. [Accessed 2013 August 06].Available from: http://www.medicinescomplete.com
• Merck 2012: The Merck Index Version 14.1 [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2010; Accessed 2011 June 16]. Available from: http://www.medicinescomplete.com/mc/merck/current/monographs.htm
• 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.