Beta-Carotene

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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

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Date: November 21, 2007

Proper name(s): All-trans beta-carotene, beta-carotene (Sweetman 2007; IOM 2003)

Common name(s): All-trans beta-carotene, beta-carotene (Sweetman 2007; IOM 2003

Source material(s): All-trans beta-carotene/beta-carotene (Sweetman 2007; IOM 2003)

Note: The slash indicates that the terms are synonyms. Either term may be selected by the applicant.

Route(s) of administration: Oral

Dosage form(s): Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewable tablets, caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons, or tablespoons are acceptable. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s): Statement(s) to the effect of:

General:

• Source of vitamin A for the maintenance of good health (IOM 2006).
• Provitamin A (IOM 2006) for the maintenance of good health.

Specific:

• Source of vitamin A to help maintain eyesight, skin, membranes and immune function (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
• Provitamin A (IOM 2006) to help maintain eyesight, skin membranes and immune function (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
• Source of vitamin A to help in the development and maintenance of night vision (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
• Provitamin A (IOM 2006) to help in the development and maintenance of night vision (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
• Source of vitamin A to help in the development and maintenance of bones (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
• Provitamin A (IOM 2006) to help in the development and maintenance of bones (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).
• Source of vitamin A to help in the development and maintenance of teeth (Shils et al. 2006).
• Provitamin A (IOM 2006) to help in the development and maintenance of teeth (Shils et al. 2006).

Dose specific: For products providing daily doses of beta-carotene at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) for vitamin A (adjusted for the life stage group), the following use or purpose is acceptable:
Helps to prevent vitamin A deficiency (IOM 2006; Shils et al. 2006; Groff and Gropper 2000).

See Appendix 1 for definitions and Table 2 in Appendix 2 for AI and RDA values.

Dose(s):

Beta-carotene must be expressed in both:

• micrograms (μg) or milligrams (mg) of beta-carotene and
• micrograms (μg) or milligrams (mg) of retinol activity equivalents (RAE)

Table 1: Dose information for beta-carotene presented as μg beta-carotene per day and μg RAE per day.

Life stage group		μg beta-carotene/day (μg RAE/day)
		Minimum1	Maximum2,3
Infants	0-12 mo	60 (30)	1,200 (600)
Children	1-3 y	60 (30)	1,200 (600)
	4-8 y	60 (30)	1,800 (900)
Adolescents	9-13 y	60 (30)	3,400 (1,700)
	14-18 y	130 (65)	5,600 (2,800)
Adults4	≥ 19 y	130 (65)	6,000 (3,000)

¹ Based on approximately 5% of the highest AI or RDA for vitamin A (IOM 2006). See Appendix 1 for definitions and Table 2 in Appendix 2 for RDA and AI values.
² Based on the UL for vitamin A, which applies to total vitamin A intake from food and supplements (IOM 2006).
³ As per the NHPD Multi-vitamin/mineral Supplement Monograph, the maximum daily dose for beta-carotene in combination with other vitamin A source materials must not exceed the Tolerable Upper Intake Level (UL) for vitamin A. See the Multi-vitamin/mineral Supplement Monograph for more information.
⁴ Includes pregnant and breastfeeding women.

Conversion Factors:

1 IU beta-carotene = 0.15 μg RAE
1 μg beta-carotene = 0.50 μg RAE

See Appendix 3 for examples on how to use the conversion factors appropriately.

Duration of use: No statement required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s): No statement required.

Contraindication(s): No statement required.

Known adverse reaction(s): No statement required.

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications: Must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

References:

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

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 Academy Press; 2006.

IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5^th edition. Washington (DC): National Academies Press; 2003

Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease. 10^th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.

Sweetman SC, editor. Martindale: The Complete Drug Reference, 35^th edition. London (UK): Pharmaceutical Press; 2007.

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 Allowance (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 asterisk) 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 2: Recommended Dietary Allowance and Adequate Intake* values for vitamin A based on life stage group (IOM 2006)

Life stage group		Vitamin A (µg 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	1,200
	19-50 y	1,300

Appendix 3: Conversion factors

Examples using the beta-carotene conversion factors:

a) Converting beta-carotene activity into quantity of RAE (µg)

Convert 500 IU of beta-carotene activity into μg RAE:
= 500 IU beta-carotene x 0.15 μg RAE/IU beta-carotene
= 75 μg RAE

b) Converting beta-carotene quantity into quantity of RAE (µg)

Convert 2000 μg of beta-carotene into μg RAE:
= 2000 μg beta-carotene x 0.5 μg RAE/μg beta-carotene
= 1000 μg RAE