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Drugs and Health Products

Monograph: Niacinamide

For products containing Nicotinic acid, please refer to the Niacin monograph.

Date: 2009-12-23

NHPID Name

Niacinamide (USP 2008a)

Proper Name(s)

3-Pyridinecarboxamide ( USP 2009 )

Common Name(s)

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

Dose(s)

Children 1 - 3 years:

Dose(s): 0.6 - 10 Milligrams per day

Children 4 - 8 years:

Dose(s): 0.6 - 15 Milligrams per day

Adolescents 9 - 13 years:

Dose(s): 0.6 - 20 Milligrams per day

Adolescents 14 - 18 years:

Dose(s): 1 - 30 Milligrams per day

Adults:

Dose(s): 1 - 500 Milligrams per day

  • Adults includes pregnant and breastfeeding women.
  • For products providing a daily dose of Niacinamide above 35 mg/day, at least one of the Specific and/or the Dose-specific Use(s) or Purpose(s) indicated above is required.
  • The daily minimum doses are based on approximately 5% of the highest RDA (IOM 2006). See Appendix 1 for definitions and Table 3 in Appendix 2 for RDA values.
  • The maximum daily doses for children and adolescents are based on the UL which applies to total nicotinic acid and/or niacinamide intake from food and supplements (IOM 2006). Maximum dose for adults supported by the following references: HC 2007, FSA 2003, Mills et al. 2003 and EC 2002.

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

  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • EC 2002: European Commission. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake level of Nicotinic Acid and Nicotinamide (Niacin). Brussels (BE): European Commission, SCF/CS/NUT/UPPLEV/39 Final 6 May 2002. [Accessed 2007-05-18]. Available from: http://ec.europa.eu/food/fs/sc/scf/out80j_en.pdf.
  • FSA 2003: Food Standards Agency. Expert Group on Vitamins and Minerals: Safe Upper Levels for Vitamins and Minerals. London (UK): Food Standards Agency, Expert Group on Vitamins and Minerals May 2003. [Accessed 2007-03-21]. Available from: http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdf
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • HC 2007: Health Canada. NHPD Expert Advisory Committee Issue Analysis Summary: What is an appropriate maximum daily dose for niacin? Ottawa (ON): Natural Health Products Directorate, Health Canada; 2007.
  • 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.
  • Mills E, Prousky J, Raskin G, Gagnier J, Rachlis B, Montori V, Juurlink D. The safety of over-the-counter niacin. A randomized placebo-controlled trial. BMC Clinical Pharmacology 2003;3:4.
  • NLM 2009: United States National Library of Medicine. ChemIDplus advanced [online]. Chemical name. RN: 000-00-0. Bethesda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2009 May 19]. Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?CHEM
  • 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.
  • 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).

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 and UL Values

The RDA values for niacinamide 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 niacin deficiency";
  • facilitate the optional labelling of % RDA values.

Table 1: Recommended Dietary Allowance values for niacinamide based on life stage group (IOM 2006)
Life stage group Niacinamide (mg/day)
Children 1-3 y 6
4-8 y 8
Adolescent males 9-13 y 12
14-18 y 16
Adult males ≥ 19 y 16
Adolescent females 9-13 y 12
14-18 y 14
Adult females ≥ 19 y 14
Pregnancy 14-50 y 18
Breastfeeding 14-50 y 17

Table 2: Tolerable Upper Intake Level for niacinamide for adults 19 years and older (IOM 2006)
Life stage group Niacinamide (mg/day)

Footnotes

Footnote 1

Includes pregnant and breastfeeding women.

Return to table 2 footnote 1 referrer

Adults Table 2 Footnote 1 35