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Drugs and Health Products

Monograph: Vitamin B6

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Date: 2007-11-08

NHPID Name

Vitamin B6 (USNLM 2007)

Proper Name(s)

Vitamin B6 ( Sweetman 2007 , IOM 2003 , O'Neil et al. 2001 )

Common Name(s)

Vitamin B6 ( Sweetman 2007 , IOM 2003 , O'Neil et al. 2001 )

Source Material


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 B6 at or above the Recommended Dietary Allowance (RDA):
Helps to prevent vitamin B6 deficiency  (IOM 2006, Shils et al. 2006, Groff and Gropper 2000, IOM 1998)

Dose(s)

Children 1 - 3 years:

Dose(s): 0.05 - 30 Milligrams per day

Children 4 - 8 years:

Dose(s): 0.05 - 40 Milligrams per day

Adolescents 9 - 13 years:

Dose(s): 0.05 - 60 Milligrams per day

Adolescents 14 - 18 years:

Dose(s): 0.1 - 80 Milligrams per day

Adults:

Dose(s): 0.1 - 100 Milligrams per day

  • Adults includes pregnant and breastfeeding women.
  • The maximum daily doses are based on the Tolerable Upper Intake Level (UL), which applies to total vitamin B6 intake from food and supplements (IOM 2006).
  • 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

  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • 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.

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).

Tolerable Upper Intake Level (UL): The highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects may increase (IOM 2006).

Appendix 2: RDA Values

The RDA values for vitamin B6 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 B6 deficiency";
  • facilitate the optional labelling of % RDA values.
Table 1: Recommended Dietary Allowance values for vitamin B6 based on life stage group (IOM 2006)
Life stage group Vitamin B6 (mg/day)
Children 1-3 y 0.5
4-8 y 0.6
Adolescent males 9-13 y 1.0
14-18 y 1.3
Adult males 19-30 y 1.3
31-50 y 1.3
51-70 1.7
≥ 70 y 1.7
Adolescent females 9-13 y 1.0
14-18 y 1.2
Adult females 19-30 y 1.3
31-50 y 1.3
51-70 y 1.5
≥ 70 y 1.5
Pregnancy 14-50 y 1.9
Breastfeeding 14-50 y 2.0