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Drugs and Health Products

Blueberry

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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

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • 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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

February 7, 2014

Proper name(s)

  • Vaccinium corymbosum L. (USDA 2010a)
  • Vaccinium angustifolium Aiton (USDA 2011)
  • Vaccinium pallidum Aiton (USDA 2010b)

Common name(s)

Blueberry (USDA 2010a,b, 2011)

Source material(s)

Fruit (USDA 2010a,b,2011)

Route(s) of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use or Purpose

Statement to the effect of:

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

Dose(s)

Statement(s) to the effect of:

Subpopulation(s)

Adult (≥ 18 years)

Quantity(ies)

Dry, Non-Standardized extracts & Standardized extracts :

  • Up to 20 g Quantity Crude Equivalent (QCE), per day (CNF 2010; McAnulty et al. 2004)
  • Up to 150 g fresh fruit, per day (CNF 2010; McAnulty et al. 2004).

Note
When submitting by ePLA , choose fresh for original material field and indicate approximate value of fresh:dry ratio (e.g.7:1).

Duration of use

No statement required.

Risk information

Statement(s) to the effect of:

Caution(s)/Warning(s)

Products providing ≥ 5 g QCE per day; Products providing ≥ 37.5 g fresh fruit per day

If you are taking blood thinners, consult a health care practitioner prior to use (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 NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

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 2010: Canadian Nutrient File (CNF). 2010 Next link will take you to another Web site Canadian Nutrient File. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012 April 26; Accessed 2013 August 06].
  • 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.
  • 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 2010a: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network Next link will take you to another Web site GRIN Taxonomy for Plants(GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Vaccinium corymbosum L.. Last updated 2010 January 14; Accessed 2013 July 12].
  • USDA 2010b: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network Next link will take you to another Web site GRIN Taxonomy for Plants(GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Vaccinium pallidum Aiton. Last updated 2010 January 14; Accessed 2013 July 12].
  • USDA 2011: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network Next link will take you to another Web site GRIN Taxonomy for Plants(GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Vaccinium angustifolium Aiton. Last updated 2011 September 27; Accessed 2013 July 12].

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. 2nd edition. New York (NY): McGraw-Hill Publishing, Incorporated;2001.
  • Brinker F. Herb Contraindications and Drug Interactions, 3rd 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. Next link will take you to another Web site MedicinesComplete London (GB): Pharmaceutical Press; Copyright 1933-2010. [Accessed 2013 August 06].
  • Merck 2012: The Merck Index Version 14.1 Next link will take you to another Web site MedicinesComplete - Merck. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2010; Accessed 2011 June 16].
  • 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.