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Drugs and Health Products

Monograph: Vitamin A

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2010-03-01


Vitamin A (BPC 2008a)

Proper Name(s)

Vitamin A ( O'Neil 2009 , Sweetman 2007 , IOM 2003 )

Common Name(s)

Source Material

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

Route Of Administration


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:

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


For products providing daily doses of Vitamin A at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI):
Helps to prevent Vitamin A deficiency  (IOM 2006, Shils et al. 2006, Groff and Gropper 2000)


Children 0 - 3 years:

Dose(s): 30 - 600 Micrograms Retinol activity equivalents per day

Children 4 - 8 years:

Dose(s): 30 - 900 Micrograms Retinol activity equivalents per day

Adolescents 9 - 13 years:

Dose(s): 30 - 1700 Micrograms Retinol activity equivalents per day

Adolescents 14 - 18 years:

Dose(s): 65 - 2800 Micrograms Retinol activity equivalents per day


Dose(s): 65 - 3000 Micrograms Retinol activity equivalents per day

  • Adults includes pregnant and breastfeeding women.
  • Conversion Factors: (i) All-trans retinol (1 microgram) = 1.00 Vitamin A (microgram RAE) = 3.33 Vitamin A activity (IU); (ii) All-trans retinyl acetate (1 microgram) = 0.87 Vitamin A (microgram RAE) = 2.94 Vitamin A activity (IU); (iii) All-trans retinyl palmitate (1 microgram) = 0.55 Vitamin A (microgram RAE) = 1.82 Vitamin A activity (IU). See Appendix 3 for examples on how to use the conversion factors appropriately.
  • The daily minimum doses are based on approximately 5% of the highest RDA or AI for vitamin A(IOM 2006). See Appendix 1 for definitions and Table 3 in Appendix 2 for RDA values and AI values
  • The maximum daily doses are based on the Tolerable Upper Intake Level (UL) which applies to total vitamin A intake from food and supplements (IOM 2006).
  • The quantity of vitamin A must always be provided in terms of retinol activity equivalents (RAE) (i.e. micrograms of all-trans retinol), irrespective of the source material used. International Units (IU) may be provided as optional additional information on the Product Licence Application (PLA) form in the "potency" field and on product labels.
  • Vitamin A must be expressed as micrograms or milligrams of retinol activity equivalents (RAE).

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

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

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.


  • 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 Vitamin A and Vitamin A Capsules monographs published in the U.S. Pharmacopeia (USP 32), and the Vitamin A monographs published in the European Pharmacopoeia (Ph. Eur. 2007) and the British Pharmacopoeia (BP 2008).

References cited

  • BP 2008: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009, Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • 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, Heckelman PE, Koch CB, Roman KJ, editors. 2009. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals [en ligne]. Whitehouse Station (NJ): Merck & Co., Inc. Electronic version [Accessed February 4, 2010]. Available from :
  • 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.
  • Ph. Eur. 2007: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • 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 Pharmacopeia. 2009. Official Monographs: Vitamin A, Vitamin A capsules. The United States Pharmacopeia USP 32 / The National Formulary NF 27. Rockville (MD): The United States Pharmacopeial Convention.

References reviewed

  • Expert Group on Vitamins and Minerals. 2003. Safe Upper Levels for Vitamins and Minerals. United Kingdom Food Standards Agency. [online]. [Accessed 2010 January 27]. Available from:
  • 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. 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academy Press.
  • JC 2009: Department of Justice Canada. Food and Drug Regulations. [online]. Schedule F, Part I. Ottawa (ON): Department of Justice Canada. [Accessed 2010 March 3]. Available from:
  • van Lieshout M, de Pee S. 2005. Vitamin A equivalency estimates: understanding apparent differences. American Journal of Clinical Nutrition 81(4):943-945.
  • WHO/FAO 2004: World Health Organization / Food and Agricultural Organization of the United Nations. 2004. Vitamin and mineral requirements in human nutrition, 2nd edition. [online].

Appendix 1: Definitions

Adequate Intake (AI): The recommended average daily intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people that are assumed to be adequate. An AI is used when an RDA cannot be determined (IOM 2006).

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 AI Values

The AI (as indicated by an asterix) and RDA values for vitamin A 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 A deficiency";
  • facilitate the optional labelling of % RDA and AI values.

Table 1: Recommended Dietary Allowance and Adequate Intake values for vitamin A based on life stage group (IOM 2006)
Life stage group Vitamin A (g RAE/day)
Infants 0-6 mo 400*
7-12 mo 500*
Children 1-3 y 300
4-8 y 400
Adolescent males 9-13 y 600
14-18 y 900
Adult males ≥ 19 y 900
Adolescent females 9-13 y 600
14-18 y 700
Adult females ≥ 19 y 700
Pregnancy 14-18 y 750
19-50 y 770
Breastfeeding 14-18 y 1200
19-50 y 1300

Appendix 3: Conversion Factors

Examples using the vitamin A conversion factors:

  a)  Converting vitamin A activity into quantity of RAE (g) 

Convert 500 IU of vitamin A activity from all-trans retinol into g RAE:
= 500 IU x 1 g RAE / 3.33 IU vitamin A
= 150 g RAE

Convert 3000 IU of vitamin A activity from all-trans retinyl acetate into g RAE:
= 3000 IU x 1 g RAE / 3.33 IU vitamin A
= 900 g RAE
= 3000 IU x 0.87 g RAE / 2.94 IU vitamin A
= 900 g RAE

b) Converting vitamin A source material quantity into quantity of RAE (g)
Convert 2000 g of all-trans retinyl palmitate into g RAE:
= 2000 g x 0.55 g RAE / g all-trans retinyl palmitate
= 1100 g RAE