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Drugs and Health Products

Monograph: Folate

Date: 2009-06-24

NHPID Name

Folate (NHPD 2007a)

Proper Name(s)

Folate ( O'Neil et al. 2006 )

Common Name(s)

Source Material

Folate (Sweetman 2007, O'Neil et al. 2006, IOM 2003)
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(s)

Children and adolescents 1 - 13 years:

Dose(s): 15 - 199 Micrograms per day

Adults and adolescents 14 and over:

Dose(s): 30 - 199 Micrograms per day

  • Adults includes pregnant and breastfeeding women.
  • For products with more than 199 micrograms/day of Folate, please refer to the NHPD multi-vitamin/ mineral supplement monograph.
  • 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).
  • The medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs: 'Folic Acid' of the British Pharmacopoeia, 'Folic Acid' of the European Pharmacopoeia, and 'Folic Acid' and 'Folic Acid Tablets' of the US Pharmacopoeia.

References cited

  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • 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. 2006. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. Whitehouse Station (NJ): Merck & Co., Inc.
  • 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.
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

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 folate are provided below. For the purposes of this monograph, these values are intended to:

facilitate the optional labelling of % RDA values.

Table 1: RDA values based on life stage group for folate dose per day (IOM 2006)
Life stage group Folate (g/day)
Children 1-3 y 150
4-8 y 200
Adolescent males 9-13 y 300
14-18 y 400
Adult males 19-30 y 400
31-50 y 400
51-70 y 400
>70 y 400
Adolescent females 9-13 y 300
14-18 y 400
Adult females 19-30 y 400
31-50 y 400
51-70 y 400
>70 y 400
Pregnancy 14-18 y 600
19-50 y 600
Breastfeeding 14-18 y 500
19-50 y 500