Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Monograph: Vitamin B12

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.



Date: 2007-11-08

NHPID Name

Vitamin B12 (O'Neil et al. 2012)

Proper Name(s)

Vitamin B12 ( Sweetman 2007 , IOM 2003 , O'Neil et al. 2001 )

Common Name(s)

Source Material


The slash (/) indicates that the terms are synonyms. Either term may be selected by the applicant

Route 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(s) or Purpose(s)

Statement(s) to the effect of:

General
A factor in the maintenance of good health  (IOM 2006, IOM 1998)

Specific

Dose-specific
For products providing daily doses of Vitamin B12 at or above the Recommended Dietary Allowance (RDA):
Helps to prevent vitamin B12 deficiency  (IOM 2006, Shils et al. 2006, Groff and Gropper 2000, IOM 1998)

Dose(s)

Children and adolescents 1 - 13 years:

Dose(s): 0.09 - 1000 Micrograms per day

Adults and adolescents 14 and over:

Dose(s): 0.14 - 1000 Micrograms per day

  • Adults includes pregnant and breastfeeding women.
  • The maximum daily doses are supported by the following references: HC 2006 and FSA 2003.
  • The minimum daily doses are based on approximately 5% of the highest AI (IOM 2006). See Appendix 1 for definitions and Table 2 in Appendix 2 for AI values.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
No statement is required

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database 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 NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

References cited

  • Chalmers RA, Bain MD, Costello I. Oral cobalamin therapy. Lancet 2000;355(9198):148.
  • EC 2000: European Commission. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake level of Vitamin B12. Brussels (BE): European Commission, SCF/CS/NUT/UPPLEV/42 Final 28 November 2000. [Accessed 2007-09-26]. Available from: http://ec.europa.eu/food/fs/sc/scf/out80_en.html.
  • FSA 2003: Food Standards Agency. Expert Group on Vitamins and Minerals. Risk Assessment: Vitamin B12. London (UK): Food Standards Agency, Expert Group on Vitamins and Minerals 2003. [Accessed 2007-06-04] Available at: www.food.gov.uk/multimedia/pdfs/evm_b12.pdf
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • HC 2006: Health Canada. NHPD Expert Advisory Committee Issue Analysis Summary: What is an appropriate maximum daily dose for vitamin B12? Ottawa (ON): Natural Health Products Directorate, Health Canada; 2006.
  • IOM 1998: Institute of Medicine. Panel on Folate, other B Vitamins, and Choline and Subcommittee on Upper Reference Levels of Nutrients, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline. Washington (DC): National Academies Press; 1998.
  • IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press; 2003.
  • IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc.; 2001.
  • Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • Van Der Kuy PH, Merkus FW, Lohman JJ, Ter Berg JW, Hooymans PM. Hydroxocobalamin, a nitric oxide scavenger, in the prophylaxis of migraine: an open, pilot study. Cephalalgia 2002;22(7):513-519.
  • Yamagata S, Goto Y, Mita M, Kikuchi J, Yamauchi Y. Treatment of diabetic neuropathy with the oral administration of hydroxocobalamin. Vitamins 1966;34(3):349-356.
  • Zeitlin HC, Sheppard K, Baum JD, Bolton FG, Hall CA. Homozygous transcobalamin II deficiency maintained on oral hydroxocobalamin. Blood 1985;66(5):1022-1027.

Appendix 1: Definitions

Recommended Dietary Allowances (RDA):

The average daily dietary nutrient intake level sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group (IOM 2006).

Appendix 2: RDA Values

The RDA values for vitamin B12 are provided below. For the purpose of this monograph, these values are intended to:

  • provide targets for setting appropriate supplement dosage levels;
  • provide the minimum dose for the use of the dose specific use or purpose: "Helps to prevent vitamin B12 deficiency";
  • facilitate the optional labelling of % RDA values.
Table 1: Recommended Dietary Allowance for vitamin B12 based on life stage group (IOM 2006)
Life stage group Vitamin B12 (μg/day)
Children 1-3 y 0.9
4-8 y 1.2
Adolescents 9-13 y 1.8
14-18 y 2.4
Adults ≥ 19 y 2.4
Pregnancy 14-50 y 2.6
Breastfeeding 14-50 y 2.8