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Multi-Vitamin/Mineral Supplements

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October 22, 2007

1.0 Proper name(s), Common name(s) and Source material(s)
2.0 Route(s) of administration
3.0 Dosage form(s)
4.0 Use(s) or Purpose(s)
- 4.1 General use or purpose statement(s)
  - 4.1.1 Medicinal ingredients for which only general use or purpose statement(s) are permitted
- 4.2 Specific use or purpose statements(s)
5.0 Dose(s)
6.0 Duration of use
7.0 Risk information
8.0 Non-medicinal ingredients
9.0 Specifications
10.0 References
11.0 Appendices

Multi-Vitamin/Mineral Supplement Monograph

This monograph is intended for multi-vitamin, multi-mineral or multi-vitamin/mineral supplements that contain any two or more of the medicinal ingredients listed in Tables 1, 2 or 3. This monograph is not intended for combinations of only the following medicinal ingredients: boron, choline, inositol, L-methionine, lutein, lycopene, nickel, silicon, tin and vanadium.
For products containing a single vitamin or mineral as their sole medicinal ingredient, please refer to the appropriate single ingredient monograph.
Products that are manufactured, sold or represented for use as a food or beverage are excluded.
Sodium is not permitted as a medicinal ingredient on this monograph due to health concerns associated with chronic supplemental use, namely hypertension, which remains the most common and most important risk factor for cardiovascular disease. However, the use of sodium as a counter-ion in medicinal or non-medicinal ingredients (e.g. sodium salts of minerals) is acceptable where warranted.
Chlorine, fluorine and sulfur are not permitted as medicinal ingredients on this monograph.

1.0 Proper name(s), Common name(s) and Source material(s)

1.1 Vitamin proper name(s), common name(s) and source material(s)

Table 1: Vitamin proper name(s), common name(s) and source material(s)
Proper name(s)¹	Common name(s)²	Source material(s)³
Biotin	Biotin	Biocytin Biotin
Folate	Folacin; Folate; Folic acid; Vitamin B₉	Folacin/Folate/Folic acid
Niacin; Nicotinic acid	Niacin; Nicotinic acid; Vitamin B₃	Nicotinic acid
Niacinamide; Nicotinamide	Niacinamide; Nicotinamide; Vitamin B₃	Niacinamide/Nicotinamide Niacinamide ascorbate/Nicotinamide ascorbate
Pantothenic acid	Pantothenic acid; Vitamin B₅	Calcium-d-pantothenate Calcium-dl-pantothenate Pantethine d-Panthenol/Dexpanthenol dl-Panthenol d-Pantothenic acid dl-Pantothenic acid
Riboflavin	Riboflavin; Vitamin B₂	Riboflavin Riboflavin-5-phosphate (sodium salt)
Thiamine	Thiamine; Vitamin B₁	Thiamine/Thiamine monochloride Thiamine diphosphate Thiamine hydrochloride Thiamine mononitrate Thiamine monophosphate
Vitamin A	Retinol; Vitamin A	Beta-carotene/All-trans beta-carotene Vitamin A/All-trans retinol Vitamin A acetate/All-trans retinyl acetate Vitamin A palmitate/All-trans retinyl palmitate
Vitamin B₆	Pyridoxine; Vitamin B₆	Pyridoxal Pyridoxal hydrochloride Pyridoxal-5-phosphate (calcium salt) Pyridoxamine Pyridoxamine-5-phosphate Pyridoxine Pyridoxine hydrochloride Pyridoxine-5-phosphate
Vitamin B₁₂	Cyanocobalamin; Vitamin B₁₂	Cyanocobalamin/Vitamin B₁₂ Hydroxocobalamin Methylcobalamin
Vitamin C	Ascorbic acid; Vitamin C	Ascorbic acid/Vitamin C Ascorbyl palmitate Calcium ascorbate Magnesium ascorbate Niacinamide ascorbate/Nicotinamide ascorbate Potassium ascorbate Sodium ascorbate
Vitamin D	Vitamin D; Vitamin D₂; Vitamin D₃	Vitamin D₂/Ergocalciferol Vitamin D₃/Cholecalciferol
Vitamin E	Alpha (α)-tocopherol; Vitamin E	All racemic (all rac)-α-tocopherol/dl-α-Tocopherol All rac-α-tocopheryl acetate/dl-α-Tocopheryl acetate All rac-α-tocopheryl succinate/dl-α-Tocopheryl acid succinate/dl-α-Tocopheryl succinate RRR-α-Tocopherol/d-α-Tocopherol RRR-α-Tocopheryl acetate/d-α-Tocopheryl acetate RRR-α-Tocopheryl succinate/ d-α-Tocopheryl acid succinate/d-α-Tocopheryl succinate
Vitamin K₁; Vitamin K₂	Vitamin K₁; Vitamin K₂	Vitamin K₁/Phylloquinone/Phytomenadione/ Phytonadione Vitamin K₂/Menaquinones/Menatetrenone

^1,2 At least one of the following references was consulted per name: NIH 2007; Sweetman 2007; USP 30; IOM 2003; O'Neil et al. 2001.
³ At least one of the following references was consulted per source material: HC 2007a; NIH 2007; Sweetman 2007; USP 30; IOM 2003; Van Der Kuy et al. 2002; O'Neil et al. 2001; Chalmers et al. 2000; EC 2000; Zeitlin et al. 1985; Yamagata et al. 1966.
Additional note: The slash (/) indicates that the terms are synonyms. Either term may be selected by the applicant.

1.2 Mineral proper name(s), common name(s) and source material(s)

Table 2: Mineral proper name(s), common name(s) and source material(s)
Proper name(s)¹	Common name(s)²	Source material(s)³
Boron	Boron	Boracic acid/Orthoboric acid Borax/Disodium tetraborate/Sodium biborate/Sodium borate/Sodium pyroborate/Sodium tetraborate Boron aspartate Boron citrate Boron glycinate Boron hydrolyzed animal protein (HAP) chelate Boron hydrolyzed vegetable protein (HVP) chelate Calcium borate/Calcium pyroborate/Calcium tetraborate Calcium borogluconate/Calcium diborogluconate Calcium fructoborate Magnesium borate
Calcium	Calcium	Bone meal⁴ Calcium acetate Calcium ascorbate Calcium bisglycinate Calcium carbonate Calcium chloride Calcium chloride dihydrate Calcium chloride hexahydrate Calcium citrate Calcium citrate malate Calcium citrate tetrahydrate Calcium fumarate Calcium glubionate Calcium glubionate monohydrate Calcium gluceptate Calcium gluconate Calcium gluconate monohydrate Calcium glutarate Calcium glycerophosphate Calcium HAP chelate Calcium HVP chelate Calcium hydroxide Calcium lactate Calcium lactate gluconate Calcium lactate pentahydrate Calcium lactate trihydrate Calcium lactobionate dihydrate Calcium levulinate Calcium levulinate dihydrate Calcium malate Calcium oxide Calcium phosphate dibasic Calcium phosphate monobasic Calcium phosphate tribasic Calcium pidolate Calcium pyrophosphate Calcium silicate Calcium sodium lactate Calcium succinate Calcium sulfate Calcium sulfate dihydrate Coral Dolomite Oyster shell
Chromium	Chromium	Chromium (III) bisglycinate/Chromic bisglycinate Chromium (III) chloride/Chromic chloride Chromium (III) chloride hexahydrate/Chromic chloride hexahydrate Chromium (III) citrate/Chromic citrate Chromium (III) dinicotinate/Chromic dinicotinate Chromium (III)-enriched yeast/Chromic-enriched yeast Chromium (III) fumarate/Chromic fumarate Chromium (III) glutarate/Chromic glutarate Chromium (III) HAP chelate/Chromic HAP chelate Chromium (III) HVP chelate/Chromic HVP chelate Chromium (III) malate/Chromic malate Chromium (III) nicotinate/Chromic nicotinate Chromium (III) pidolate/Chromic pidolate Chromium (III) polynicotinate/Chromic polynicotinate Chromium (III) potassium sulfate dodecahydrate/Chromic potassium sulfate dodecahydrate Chromium (III) succinate/Chromic succinate Chromium (III) sulfate/Chromic sulfate
Cobalt	Cobalt	Cyanocobalamin/Vitamin B₁₂ Hydroxocobalamin Methylcobalamin
Copper	Copper	Calcium copper edetate Copper (II) acetate/Cupric acetate Copper (II) bisglycinate/Cupric bisglycinate Copper (II) carbonate/Cupric carbonate Copper (II) chloride/Cupric chloride Copper (II) chloride dihydrate/Cupric chloride dihydrate Copper (II) citrate/Cupric citrate Copper (II) fumarate/Cupric fumarate Copper (II) gluconate/Cupric gluconate Copper (II) glutarate/Cupric glutarate Copper (II) HAP chelate/Cupric HAP chelate Copper (II) HVP chelate/Cupric HVP chelate Copper (II) malate/Cupric malate Copper (II) succinate/Cupric succinate Copper (II) sulfate/Cupric sulfate Copper (II) sulfate pentahydrate/Cupric sulfate pentahydrate
Iodine	Iodine	Bladderwrack (dried thallus of Fucus vesiculosus L., Fucus serratus L. (Fucaceae) or Ascophyllum nodosum L. Le Jolis (Fucaceae)) Kelp (species from the order Laminariales) Potassium iodate Potassium iodide Sodium iodide
Iron	Iron	Ferritin Ferrocholinate Iron, carbonyl (not pentacarbonyl) Iron, electrolytic Iron HAP chelate Iron HVP chelate Iron, reduced Iron (II) ascorbate/Ferrous ascorbate Iron (II) aspartate/Ferrous aspartate Iron (II) aspartate tetrahydrate/Ferrous aspartate tetrahydrate Iron (II) bisglycinate/Ferrous bisglycinate Iron (II) carbonate/Ferrous carbonate Iron (II) chloride/Ferrous chloride Iron (II) chloride tetrahydrate/Ferrous chloride tetrahydrate Iron (II) citrate/Ferrous citrate Iron (II) fumarate/Ferrous fumarate Iron (II) gluceptate/Ferrous gluceptate Iron (II) gluconate/Ferrous gluconate Iron (II) gluconate dihydrate/Ferrous gluconate dihydrate Iron (II) glutarate/Ferrous glutarate Iron (II) glycine sulfate/Ferrous glycine sulfate Iron (II) lactate/Ferrous lactate Iron (II) lactate trihydrate/Ferrous lactate trihydrate Iron (II) malate/Ferrous malate Iron (II) oxalate/Ferrous oxalate Iron (II) oxalate dihydrate/Ferrous oxalate dihydrate Iron (II) succinate/Ferrous succinate Iron (II) sulfate/Ferrous sulfate Iron (II) sulfate dried (monohydrate)/Ferrous sulfate dried (monohydrate) Iron (II) sulfate heptahydrate/Ferrous sulfate heptahydrate Iron (II) tartrate/Ferrous tartrate Iron (III) ammonium citrate/Ferric ammonium citrate Iron (III) citrate/Ferric citrate Iron (III) glycerophosphate/Ferric glycerophosphate Iron (III) phosphate/Ferric phosphate Iron (III) pyrophosphate/Ferric pyrophosphate
Magnesium	Magnesium	Magnesium acetate Magnesium acetate tetrahydrate Magnesium ascorbate Magnesium aspartate Magnesium bisglycinate Magnesium carbonate Magnesium chloride Magnesium chloride hexahydrate Magnesium citrate Magnesium fumarate Magnesium gluceptate Magnesium gluconate Magnesium gluconate dihydrate Magnesium glutarate Magnesium glycerophosphate Magnesium HAP chelate Magnesium HVP chelate Magnesium hydroxide Magnesium lactate Magnesium malate Magnesium oxide Magnesium phosphate dibasic trihydrate/Magnesium hydrogen phosphate trihydrate/Dimagnesium phosphate trihydrate Magnesium phosphate tribasic tetra-, penta-, or octahydrate/Trimagnesium phosphate tetra-, penta-, or octahydrate Magnesium pidolate Magnesium succinate Magnesium sulfate Magnesium sulfate heptahydrate
Manganese	Manganese	Manganese (II) bisglycinate/Manganous bisglycinate Manganese (II) chloride/Manganous chloride Manganese (II) chloride tetrahydrate/Manganous chloride tetrahydrate Manganese (II) citrate/Manganous citrate Manganese (II) gluconate/Manganous gluconate Manganese (II) glycerophosphate/Manganous glycerophosphate Manganese (II) HAP chelate/Manganous HAP chelate Manganese (II) HVP chelate/Manganous HVP chelate Manganese (II) sulfate/Manganous sulfate Manganese (II) sulfate monohydrate/Manganous sulfate monohydrate Manganese (II) sulfate tetrahydrate/Manganous sulfate tetrahydrate Manganese (IV) dioxide
Molybdenum	Molybdenum	Ammonium molybdate (VI) Ammonium molybdate (VI) tetrahydrate Molybdenum bisglycinate Molybdenum citrate Molybdenum fumarate Molybdenum glutarate Molybdenum HAP chelate Molybdenum HVP chelate Molybdenum malate Molybdenum succinate Sodium molybdate (VI) Sodium molybdate (VI) dihydrate
Nickel	Nickel	Nickel (II) sulfate Nickel (II) sulfate heptahydrate Nickel (II) sulfate hexahydrate
Phosphorus	Phosphorus	Bone meal⁴ Calcium glycerophosphate Calcium phosphate dibasic Calcium phosphate monobasic Calcium phosphate tribasic Potassium phosphate dibasic Potassium phosphate monobasic Sodium phosphate dibasic Sodium phosphate dibasic dihydrate Sodium phosphate dibasic dodecahydrate Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic Sodium phosphate monobasic dihydrate Sodium phosphate monobasic monohydrate
Selenium	Selenium	Monohydrated selenium dioxide Selenium citrate Selenium HAP chelate Selenium HVP chelate Selenium yeast Selenocysteine Selenomethionine Sodium selenate Sodium selenite
Silicon	Silicon	Horsetail (Equisetum arvense L.) aerial parts⁵ Silicic acid Silicon dioxide Silicon HAP chelate Silicon HVP chelate Sodium metasilicate
Tin⁶	Tin	Tin (II) chloride/Stannous chloride
Vanadium	Vanadium	Sodium metavanadate Vanadium citrate Vanadium HAP chelate Vanadium HVP chelate Vanadyl sulfate (IV)
Zinc	Zinc	Zinc acetate Zinc acetate dihydrate Zinc bisglycinate Zinc chloride Zinc citrate Zinc fumarate Zinc gluconate Zinc glutarate Zinc glycerate Zinc HAP chelate Zinc HVP chelate Zinc malate Zinc monomethionine Zinc oxide Zinc phosphate Zinc succinate Zinc sulfate Zinc sulfate heptahydrate

^1,2 At least one of the following references was consulted per name: NIH 2007; Sweetman 2007; USP 30; IOM 2003; O'Neil et al. 2001.
³ At least one of the following references was consulted per source material: Guiry and Guiry 2007; HC 2007a; NIH 2007; Sweetman 2007; USP 30; Albion 2004a; Albion 2004b; Commonwealth of Australia 2004; Gruenwald et al. 2004; Albion 2003a; Albion 2003b; IOM 2003, Allen 2002; Commonwealth of Australia 2002; Van Der Kuy et al. 2002; Anderson et al. 2001; Firoz and Graber 2001; Hendler and Rorvik 2001; O'Neil et al. 2001; Albion 2000; Chalmers et al. 2000; EC 2000; Patrick 1999; Albion 1997a; Albion 1997b; Grant et al. 1997; Albion 1996a; Albion 1996b; Murray 1996; Albion 1995; Albion 1993a; Albion 1993b; Albion 1993c; Albion 1993d; Albion 1993e; Evans and Pouchnik 1993; Albion 1992; Zeitlin et al. 1985; Abbott and Hollenberg 1976; Yamagata et al. 1966.
⁴ When bone meal is used as a source material for calcium or phosphorus, it must be sourced from a non-human animal that is not susceptible to Transmissible Spongiform Encephalopathy (TSE) diseases, including Bovine Spongiform Encephalopathy (BSE) (HC 2006).
⁵ Data (or certification) must be submitted to show that thiaminase has been inactivated.
⁶ There is no evidence to support tin as a factor in the maintenance of good health (FSA 2003; FSA 2002).

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

1.3 Other medicinal ingredient proper name(s), common name(s) and source material(s)

Table 3: Other medicinal ingredient proper name(s), common name(s) and source material(s)
Proper name(s)¹	Common name(s)²	Source material(s)³
All-trans beta-carotene; Beta-carotene	All-trans beta-carotene; Beta-carotene	Beta-carotene/All-trans beta-carotene
Choline	Choline	Choline⁴ Choline bitartrate⁴ Choline chloride⁴ Choline dihydrogen citrate⁴ Choline orotate⁴
Inositol	Inositol	Inositol⁴ Inositol dihydrate⁴ Inositol monophosphate⁴
L-Methionine; Methionine	L-Methionine; Methionine	DL-Methionine⁴ L-Methionine⁴
Lutein	Lutein	Lutein isolated from marigold flower (oleoresin of Tagetes erecta L. (Asteraceae))⁴
Lycopene	Lycopene	Lycopene⁴ Lycopene extracted from tomato (pulp of ripe fruit of Lycopersicon esculentum Mill. (Solanaceae))⁴
Potassium	Potassium	Potassium acetate Potassium aspartate Potassium bicarbonate Potassium carbonate Potassium chloride Potassium citrate Potassium citrate monohydrate Potassium gluconate Potassium glycerophosphate Potassium glycerophosphate trihydrate Potassium sulfate

^1,2 At least one of the following references was consulted per name: NIH 2007; Sweetman 2007; USP 30; IOM 2003; O'Neil et al. 2001.
³ At least one of the following references was consulted per source material: HC 2007a; NIH 2007; Sweetman 2007; USP 30; IOM 2003; O'Neil et al. 2001.
⁴ Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs) or cited in an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
Additional note: The slash (/) indicates that the terms are synonyms. Either term may be selected by the applicant.

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2.0 Route(s) of administration

Oral

3.0 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, gums or beverages.

4.0 Use(s) or Purpose(s)

Refer to Appendix I for guidelines on using the use(s) or purpose(s) outlined in this section.

4.1 General use or purpose statement(s)

The following use or purpose statement(s) can be used in reference to any combination of vitamins or minerals, as appropriate.

Statement(s) to the effect of:

Vitamin supplement, mineral supplement, vitamin/mineral supplement, multi-vitamin, multi-mineral or multi-vitamin/mineral
A factor in the maintenance of good health.

4.1.1 Medicinal ingredients for which only general use or purpose statement(s) are permitted

Table 4: Medicinal ingredients for which only general use or purpose statement(s) are permitted
Medicinal Ingredient	Reference(s)
Boron	IOM 2006; IOM 2001
Choline¹	IOM 2006; IOM 1998
Inositol¹	FDA 1975
L-Methionine¹	IOM 2006; IOM 2005a
Lutein	Shao and Hathcock 2006; Alves-Rodrigues and Shao 2004
Lycopene	Shao and Hathcock 2006
Nickel	IOM 2006; IOM 2001
Potassium	IOM 2006; IOM 2005b; Burgess et al. 1999
Silicon	IOM 2006; IOM 2001
Tin²	FSA 2003; FSA 2002
Vanadium	IOM 2006; IOM 2001

¹ The term "lipotropic factor" is not permitted to describe choline, inositol or L-methionine. This term may mislead consumers to perceive the product as fat-burning or for the purpose of weight loss.
² There is no evidence to support tin as a factor in the maintenance of good health (FSA 2003; FSA 2002).

4.2 Specific use or purpose statement(s)

Statements(s) to the effect of:

4.2.1 Specific use or purpose statement(s) for vitamins

Table 5: Specific use or purpose statement(s) for vitamins
Vitamin	Specific use(s) or purpose(s)¹
Biotin	Helps the body to metabolize carbohydrates, fats and proteins. Helps to prevent biotin deficiency^*.
Folate	For products providing at least 400 μg per day: Helps to reduce the risk of neural tube defects when taken daily prior to becoming pregnant and during early pregnancy. Helps the body to metabolize proteins. Helps to form red blood cells. Helps to prevent folate deficiency.^*
Niacin and Niacinamide²	Helps the body to metabolize carbohydrates, fats and proteins. Helps normal growth and development. Helps to prevent niacin deficiency.^*
Pantothenic acid	Helps the body to metabolize carbohydrates, fats and proteins. Helps in tissue formation. Helps to prevent pantothenic acid deficiency.^*
Riboflavin	Helps the body to metabolize carbohydrates, fats and proteins. Helps in tissue formation. Helps to prevent riboflavin deficiency.^*
Thiamine	Helps the body to metabolize carbohydrates, fats and proteins. Helps normal growth. Helps to prevent thiamine deficiency.^*
Vitamin A	Helps to maintain eyesight, skin, membranes and immune function. Helps in the development and maintenance of night vision. Helps in the development and maintenance of bones and teeth. Helps to prevent vitamin A deficiency.^*
Vitamin B₆	Helps the body to metabolize carbohydrates, fats and proteins. Helps in tissue formation. Helps to prevent vitamin B₆ deficiency.^*
Vitamin B₁₂	Helps the body to metabolize carbohydrates, fats and proteins. Helps to form red blood cells. Helps to prevent vitamin B₁₂ deficiency.^*
Vitamin C	Helps the body to metabolize fats and proteins. Helps in the development and maintenance of bones, cartilage, teeth and gums. Helps in connective tissue formation. Helps in wound healing. An antioxidant for the maintenance of good health. Helps to prevent vitamin C deficiency.^*
Vitamin D	Helps in the development and maintenance of bones and teeth. Helps in the absorption and use of calcium and phosphorus. For products providing calcium as a medicinal ingredient, if the following statement is used it must be verbatim: "Calcium intake, when combined with sufficient vitamin D, a healthy diet, and regular exercise, may reduce the risk of developing osteoporosis." Helps to prevent vitamin D deficiency.^*
Vitamin E	An antioxidant for the maintenance of good health. Helps to prevent vitamin E deficiency.^*
Vitamin K₁ and K₂	Helps in the maintenance of bones. Helps to prevent vitamin K deficiency.^*

¹ At least two of the following references were consulted per use or purpose statement: IOM 2006; Shils et al. 2006; MacKay and Miller 2003; IOM 2001; Groff and Gropper 2000; IOM 2000; NIH 2000; IOM 1998; IOM 1997.
² A specific use or purpose statement must be made for products providing > 35 mg niacin or niacinamide per day
^* This use or purpose statement is acceptable only if the vitamin is present at dosages at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI). See Appendix II for RDA and AI definitions and Appendix III for detailed values according to life stage group. Note that most vitamin deficiencies are rare in North America.

4.2.2 Specific use or purpose statement(s) for minerals

Table 6: Specific use or purpose statement(s) for minerals
Mineral	Specific use(s) or purpose(s)¹
Calcium	Helps in the development and maintenance of bones and teeth (optional: "especially in childhood, adolescence and young adulthood"). If the following statement is used, it must be verbatim: "Calcium intake, when combined with sufficient vitamin D, a healthy diet, and regular exercise, may reduce the risk of developing osteoporosis." Helps to prevent calcium deficiency.^*
Chromium	Provides support for healthy glucose metabolism. Helps the body to metabolize carbohydrates and fats. Helps to prevent chromium deficiency.^*
Cobalt	A structural component of vitamin B₁₂ that helps the body metabolize carbohydrates, fats and proteins. A structural component of vitamin B₁₂ that helps form red blood cells. A structural component of vitamin B₁₂ that helps prevent vitamin B₁₂ deficiency.^*
Copper	Helps to produce and repair connective tissue. Helps to form red blood cells. Helps to prevent copper deficiency.^*
Iodine	Helps in the function of the thyroid gland. Helps to prevent iodine deficiency.^*
Iron²	Helps to form red blood cells and helps in their proper function. If one of the following statements is used, it must be verbatim: "Helps to prevent iron deficiency." ^* "Helps to prevent iron deficiency anaemia." ^*
Magnesium³	Helps the body to metabolize carbohydrates, fats and proteins. Helps in the development and maintenance of bones and teeth. Helps in tissue formation. Helps to maintain proper muscle function. Helps to prevent magnesium deficiency.^*
Manganese	Helps the body to metabolize carbohydrates, fats and proteins. Helps in the development and maintenance of bones. Helps to prevent manganese deficiency.^*
Molybdenum	Helps the body to metabolize proteins. Helps to prevent molybdenum deficiency.^*
Phosphorus	Helps in the development and maintenance of bones and teeth. Helps the body to metabolize carbohydrates, fats and proteins. Helps to prevent phosphorus deficiency.^*
Selenium	An antioxidant for the maintenance of good health. Helps to prevent selenium deficiency.^*
Zinc⁴	Helps in connective tissue formation. Helps to maintain healthy skin. Helps the body to metabolize carbohydrates, fats and proteins. Helps to maintain immune function. Helps to prevent zinc deficiency.^*

¹ At least two of the following references were consulted per use or purpose statement: IOM 2006; Shils et al. 2006; Meisel et al. 2005; Schwartz et al. 2005; IOM 2001; Groff and Gropper 2000; IOM 2000; NIH 2000; IOM 1997; Klimis-Tavantis 1994.
² A specific use or purpose statement must be made for products providing > 35 mg iron per day.
³ A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.
⁴ A specific use or purpose statement must be made for products providing > 40 mg zinc per day.
^*This use or purpose statement is acceptable only if the mineral is present at dosages at or above the RDA or AI. See Appendix II for RDA and AI definitions and Appendix III for detailed values according to life stage group. Note that most mineral deficiencies are rare in North America.

4.2.3 Specific use or purpose statement(s) for other medicinal ingredients

Table 7: Specific use or purpose statement(s) for other medicinal ingredients
Medicinal ingredient	Specific use(s) or purpose(s)¹
Beta-carotene	Source of vitamin A for the maintenance of good health. Provitamin A for the maintenance of good health. Source of vitamin A to help maintain eyesight, skin, membranes and immune function. Provitamin A to help maintain eyesight, skin, membranes and immune function. Source of vitamin A to help in the development and maintenance of night vision. Provitamin A to help in the development and maintenance of night vision. Source of vitamin A to help in the development and maintenance of bones and teeth. Provitamin A to help in the development and maintenance of bones and teeth. Helps to prevent vitamin A deficiency.^*

¹ At least two of the following references were consulted per use or purpose statement: IOM 2006; Shils et al. 2006; IOM 2001; Groff and Gropper 2000.
^* This use or purpose statement is only acceptable if beta-carotene is present at dosages at or above the RDA or AI for vitamin A. See Appendix II for RDA and AI definitions and Appendix III for detailed values according to life stage group. Note that most vitamin deficiencies are rare in North America.

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5.0 Dose(s)

5.1 Background on dose

The daily dose of each medicinal ingredient must be at or above the minimum dosage value and at or below the maximum dosage value. Refer to Appendix II for definitions and derivations of dosage values.
Vitamin E is expressed as milligrams (mg) of RRR-α-tocopherol (AT) and vitamin A as micrograms (μg) of retinol activity equivalents (RAE).
Refer to Appendix IV for conversion factors (pantothenic acid, vitamin A, beta-carotene, vitamin D, and vitamin E).

5.2 Dose information for vitamins

Table 8: Dose information for vitamins presented as dose per day
Life Stage Group		Biotin (μg /day)		Folate¹ (μg /day)		Niacin or Niacinamide² (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	1.0	500	15	300	0.6	10
Children	4-8 y	1.0	500	15	400	0.6	15
Adolescents	9-13 y	1.0	500	15	600	0.6	20
Adolescents	14-18 y	1.8	500	30	800	1.0	30
Adults	≥ 19 y	1.8	500	30	1,000	1.0	500

Table 8a: Dose information for vitamins presented as dose per day
Life Stage Group		Pantothenic acid (mg/day)		Riboflavin (mg/day)		Thiamine (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	0.2	500	0.04	100	0.04	100
Children	4-8 y	0.2	500	0.04	100	0.04	100
Adolescents	9-13 y	0.2	500	0.04	100	0.04	100
Adolescents	14-18 y	0.4	500	0.08	100	0.07	100
Adults	≥ 19 y	0.4	500	0.08	100	0.07	100

Table 8b: Dose information for vitamins presented as dose per day
Life Stage Group		Vitamin A³ (µg RAE/day)		Vitamin B₆ (mg/day)		Vitamin B₁₂⁴ (µg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	30	600	-	-	-	-
Children	1-3 y	30	600	0.05	30	0.09	1,000
Children	4-8 y	30	900	0.05	40	0.09	1,000
Adolescents	9-13 y	30	1,700	0.05	60	0.09	1,000
Adolescents	14-18 y	65	2,800	0.10	80	0.14	1,000
Adults	≥ 19 y	65	3,000	0.10	100	0.14	1,000

Table 8c: Dose information for vitamins presented as dose per day
Life Stage Group		Vitamin C (mg/day)		Vitamin D (µg/day)		Vitamin E (mg AT/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	0.2	25	-	-
Children	1-3 y	2.2	400	0.2	25	0.6	179
Children	4-8 y	2.2	650	0.2	25	0.6	179
Adolescents	9-13 y	2.2	1,200	0.2	25	0.6	179
Adolescents	14-18 y	6.0	1,800	0.8	25	1.0	179
Adults	≥ 19 y	6.0	2,000	0.8	25	1.0	179

Table 8d: Dose information for vitamins presented as dose per day
Life Stage Group		Vitamin K₁ and K₂ (µg/day)
Life Stage Group		Minimum	Maximum
Infants	0-12 mo	-	-
Children	1-3 y	3	30
Children	4-8 y	3	55
Adolescents	9-13 y	3	60
Adolescents	14-18 y	6	75
Adults	≥ 19 y	6	120

¹ Products providing folate at doses > 200 µg per day must supplement with vitamin B₁₂ at the RDA dosage (HC 2005a). See Appendix II for the RDA definition and Appendix III for a detailed list of RDA values.
² A specific use or purpose statement must be made for products providing > 35 mg niacin or niacinamide per day.
³ 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. (The UL for vitamin A is equivalent to the maximum daily dose outlined in Table 8.)
⁴ The maximum dose for cobalt and vitamin B₁₂ combined must not exceed 1000 µg vitamin B₁₂ per day.

5.3 Dose information for minerals

Table 9: Dose information for minerals presented as dose per day
Life Stage Group		Boron (µg/day)		Calcium (mg/day)		Chromium (µg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	-	-	65	1,500	-	-
Children	4-8 y	-	-	65	1,500	-	-
Adolescents	9-13 y	-	-	65	1,500	-	-
Adolescents	14-18 y	-	-	65	1,500	-	-
Adults	≥ 19 y	0	700	65	1,500	2.2	500

Table 9a: Dose information for minerals presented as dose per day
Life Stage Group		Cobalt¹ (µg/day)		Copper (µg/day)		Iodine (µg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	0.004	44	35	700	6	133
Children	4-8 y	0.004	44	35	2,500	6	200
Adolescents	9-13 y	0.004	44	35	4,000	6	400
Adolescents	14-18 y	0.006	44	65	6,500	14	800
Adults	≥ 19 y	0.006	44	65	8,000	14	800

Table 9b: Dose information for minerals presented as dose per day
Life Stage Group		Iron² (mg/day)		Magnesium³ (mg/day)		Manganese (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	0.6	40	-	-	-	-
Children	1-3 y	0.6	40	12	65	-	-
Children	4-8 y	0.6	40	12	110	-	-
Adolescents	9-13 y	0.6	40	12	350	-	-
Adolescents	14-18 y	1.4	45	20	350	-	-
Adults	≥ 19 y	1.4	45	20	500	0.13	9

Table 9c: Dose information for minerals presented as dose per day
Life Stage Group		Molybdenum (µg/day)		Nickel (µg/day)		Phosphorus (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	-	-	-	-	62	2,000
Children	4-8 y	-	-	-	-	62	2,000
Adolescents	9-13 y	-	-	-	-	62	2,000
Adolescents	14-18 y	-	-	-	-	62	2,000
Adults	≥ 19 y	2.5	2,000	0	350	62	2,000

Table 9d: Dose information for minerals presented as dose per day
Life Stage Group		Selenium (µg/day)		Silicon (mg/day)		Tin (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	-	-	-	-	-	-
Children	4-8 y	-	-	-	-	-	-
Adolescents	9-13 y	-	-	-	-	-	-
Adolescents	14-18 y	-	-	-	-	-	-
Adults	≥ 19 y	3.5	400	0	84	0	2

Table 9e: Dose information for minerals presented as dose per day
Life Stage Group		Vanadium (µg/day)		Zinc⁴ ⁵ (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	0.2	2
Children	1-3 y	-	-	0.4	7
Children	4-8 y	-	-	0.4	12
Adolescents	9-13 y	-	-	0.4	23
Adolescents	14-18 y	-	-	0.7	34
Adults	≥ 19 y	0	182	0.7	50

¹ The maximum dose for cobalt and vitamin B₁₂ combined must not exceed 1000 µg of vitamin B₁₂ per day.
² A specific use or purpose statement must be made for products providing > 35 mg iron per day.
³ A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.
⁴ A specific use or purpose statement must be made for products providing > 40 mg zinc per day.
⁵ Products providing zinc without copper or with copper at doses less than those specified below must be labelled with the risk statement set out in 7.3.

Table 9f: Dose information for minerals presented as dose per day
Life Stage Group	Zinc (doses exceeding UL - average Intake) (mg/day)	Required Copper (Zn:Cu 25:1) (µg/day)
Infants 0-12 mo	≤ 2	0
Children 1-3 y	5-7	280-700
Children 4-8 y	8-12	480-2,500
Children 9-13 y	16-23	920-4,000
Adolescents 14-18 y	25-34	1,360-6,500
Adults ≥19 y	31-50	2,000-8,000

5.4 Dose information for other medicinal ingredients

Table 10: Dose information for other medicinal ingredients presented as dose per day
Life Stage Group		Beta-carotene¹ ² (µg/day)		Choline (mg/day)		Inositol (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	60	1,200	-	-	-	-
Children	1-3 y	60	1,200	0	1,000	0	650
Children	4-8 y	60	1,800	0	1,000	0	650
Adolescents	9-13 y	60	3,400	0	1,000	0	650
Adolescents	14-18 y	130	5,600	0	1,000	0	650
Adults	≥ 19 y	130	6,000	0	1,000	0	650

Table 10a: Dose information for other medicinal ingredients presented as dose per day
Life Stage Group		L-Methionine (mg/day)		Lutein (mg/day)		Lycopene (mg/day)
Life Stage Group		Minimum	Maximum	Minimum	Maximum	Minimum	Maximum
Infants	0-12 mo	-	-	-	-	-	-
Children	1-3 y	0	1,000	-	-	-	-
Children	4-8 y	0	1,000	-	-	-	-
Adolescents	9-13 y	0	1,000	-	-	-	-
Adolescents	14-18 y	0	1,000	-	-	-	-
Adults	≥ 19 y	0	1,000	0	10	0	5

Table 10b: Dose information for other medicinal ingredients presented as dose per day
Life Stage Group		Potassium (mg/day)
Life Stage Group		Minimum	Maximum
Infants	0-12 mo	-	-
Children	1-3 y	-	-
Children	4-8 y	-	-
Adolescents	9-13 y	-	-
Adolescents	14-18 y	-	-
Adults	≥ 19 y	0	100

¹ Beta-carotene must be expressed in both micrograms (µg) or milligrams (mg) of beta-carotene and micrograms (µg) or milligrams (mg) of RAE. For conversion factors for beta-carotene to RAE, see Appendix IV.
² 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. (The UL for vitamin A is equivalent to the maximum daily dose outlined in Table 8.)

5.5 Directions for use

Statement(s) to the effect of:

For products containing calcium, iron or zinc, the following statement is required:

Take a few hours before or after taking other medications (Sweetman 2007; ASHP 2005).

For products containing nicotinic acid at doses ≥ 10 mg per day or containing iron or zinc, the following statement is required:

Take with food (Sweetman 2007).

In all other cases, optional statement(s), as appropriate:

Take with food, or
Take on an empty stomach.

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6.0 Duration of use

No statement required.

7.0 Risk information

Statement(s) to the effect of:

7.1 Caution(s) and warning(s)

Table 11: Caution(s) and warning(s) for all medicinal ingredients with associated daily doses
Medicinal ingredient	Daily dose	Caution(s) and warning(s)
Iron	Where the package contains more than the equivalent of 250 mg of elemental iron	Keep out of reach of children. There is enough drug in this package to seriously harm a child. Note: this must be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour (As per Section 97 of the Natural Health Products Regulations, citing Sections C.01.029 and C.01.031 of the Food and Drug Regulations(HC 2007b)).
Manganese	> 5 mg	Consult a health care practitioner prior to use if you have a liver disorder (IOM 2006; IOM 2001; Krieger et al. 1995).
Selenium	≥ 200 μg	Consult a health care practitioner prior to use if you have a history of non-melanoma skin cancer (Duffield-Lillico et al. 2003).
Vanadium	All doses	Consult a health care practitioner prior to use if you are pregnant or breastfeeding (IOM 2006; IOM 2001).
Vitamin K₁ and K₂	All doses	Consult a health care practitioner prior to use if you are taking blood thinners (ASHP 2005; Franco et al. 2004; IOM 2001; Hansten et al. 1997).

Additional caution(s) and warning(s)

When HAP or HVP chelate is used as a source material, the products should be indicated for an adult subpopulation only.

Products containing one or more of the following medicinal ingredients should be indicated only for an adult subpopulation:

Boron
Chromium
Lutein
Lycopene
Manganese
Molybdenum
Nickel
Potassium
Selenium
Silicon
Tin¹
Vanadium

¹ There is no evidence to support tin as a factor in the maintenance of good health (FSA 2003; FSA 2002).

7.2 Contraindication(s)

For products providing niacin at doses of 500 mg per day, the following statement is required.

Do not exceed the recommended dose except on the advice of a physician.

7.3 Known adverse reaction(s)

Table 12: Known adverse reaction(s) for all medicinal ingredients with associated daily doses
Medicinal ingredient	Daily dose (mg/day)		Known adverse reaction(s)
Iron	> 35		Some people may experience constipation, diarrhoea and/or vomiting (IOM 2006; IOM 2001).
Magnesium	> 350		Some people may experience diarrhoea (IOM 2006; IOM 1997).
Nicotinic acid	≥ 10		People sensitive to nicotinic acid may experience flushing of the skin that is generally mild and transient (IOM 2006; IOM 1998).
Zinc	Infants 0-12 mo	≤ 2	Statement not required if the product meets the minimum copper requirements outlined on Table 9, footnote 5, otherwise: Zinc supplementation can cause a copper deficiency (IOM 2006; IOM 2001).
	Children 1-3 y	5-7
	Children 4-8 y	8-12
	Children 9-13 y	16-23
	Adolescents 14-18 y	25-34
	Adults > 19 years	31-50

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8.0 Non-medicinal ingredients

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

9.0 Specifications

Products must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

10.0 References

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11.0 Appendices

Appendix I

Guidelines for use or purpose statements

It is mandatory for all natural health products to cite at least one use or purpose statement.

General use or purpose statements:

Permissible use or purpose statements for products containing one or more minerals and one or more vitamins:
- Vitamin/mineral supplement
- Multi-vitamin/mineral supplement
- A factor in the maintenance of good health.
Permissible use or purpose statements for products containing two or more minerals:
- Mineral supplement
- Multi-mineral supplement
- A factor in the maintenance of good health.
Permissible use or purpose statements for products containing two or more vitamins:
- Vitamin supplement
- Multi-vitamin supplement
- A factor in the maintenance of good health.

Specific use or purpose statements:
Ingredient specific use or purpose statements can be used for any or all of the medicinal ingredients contained in a multi-ingredient product as applicable (see Section 4.2 - Specific use or purpose statement(s)).

A specific use or purpose statement must be made for products providing magnesium (> 350 mg per day), niacin (> 35 mg per day), iron (> 35 mg per day), or zinc (> 40 mg per day).

Inclusion of medicinal ingredient names in a specific use or purpose statement is optional, for example, the specific use or purpose statement can be applied to the whole product. However, if medicinal ingredient names are specified in a use or purpose statement, the statement must be valid for all medicinal ingredients specified. See below for examples on the correct and incorrect use of specific ingredient use or purpose statements:

Correct use:
"Biotin and pantothenic acid to help the body metabolize carbohydrates, fats and proteins."
This is correct because both medicinal ingredients contribute to that use or purpose.

Incorrect use:
"Biotin and folate to help the body metabolize carbohydrates, fats and proteins."
This is incorrect because biotin has that purpose but folate does not.

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Appendix II

Dosage value definitions and derivations

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).

Maximum dosage value:The highest medicinal ingredient quantity which a product can supply in a daily dose.

Minimum dosage value: The lowest medicinal ingredient quantity which a product can supply in a daily dose.

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).

2) Derivations:

AI, RDA and UL values:

These values were established by the Food and Nutrition Board of the Institute of Medicine in collaboration with Health Canada (IOM 2006).

Maximum dosage value:

The method used to set maximum dosage values varied for each medicinal ingredient depending on numerous factors. The method used to derive maximum dosage levels for vitamins and minerals with established physiological functions was different from the method used for those with unestablished physiological functions.

Maximum dosage values for vitamins and minerals with established physiological functions were developed based on the following criteria:
1. Is there an established UL?
  - If there is an established UL, does it apply to supplements only or to food and supplements?
  - If there is an established UL, how was it derived (i.e., what was the critical adverse reaction on which it was based? was it serious or non-serious? if non-serious, could it be mitigated?)?
2. What is the average dietary intake?
3. What doses have previously been marketed in Canada?
4. What do other regulatory agencies and expert groups recommend as their maximum daily dose?
5. What doses have been used in clinical trials and have demonstrated evidence for safety and efficacy?
  
  The only vitamins which were excluded from the method outlined above were:
  - - Vitamin D (due to its listing on Schedule F of the Food and Drug Regulations at 25 µg/ day (HC 2007b))
  - Vitamin E (due to the potential health risks of high dose vitamin E in certain subpopulations)
  - Vitamin K₁ and K₂ (adult dose was set in Canada Gazette II (HC 2005b) and children's doses were set at the AI level (IOM 2006)).
Maximum dosage values for minerals with unestablished physiological functions (boron, nickel, silicon, tin and vanadium) were calculated from the No Observed Adverse Effect Level (NOAEL) divided by an uncertainty factor (UF). The UF chosen was based on the following: 10 for extrapolation of animal data to humans, 10 for intra-species variation, and 10 for chronic use in humans. If applicable, (i.e., NOAEL was based on animal data) the final value was multiplied by an average adult body weight of 70 kg.

With the exception of beta-carotene, the maximum dosage value for non-vitamin and non-mineral ingredients was set based on doses demonstrated to be safe in clinical trials. For beta-carotene the maximum dosage value was set as per the vitamin A UL.

Minimum dosage value:

For medicinal ingredients which did not have an RDA or AI, the minimum dose was set at zero. For the remaining medicinal ingredients (with the exception of potassium and choline), the minimum was set using the following method:

5% of the RDA and/or AI was calculated for each life stage group (This method was modelled after the Food and Drug Regulation vitamin and mineral minimum dose requirements as per Sections D.01.004 and D.02.002 (HC 2007b)).

The highest value derived for children (1-13 years) was applied to all children within this age category;
the highest value derived for adolescents (> 14 years) and adults (including pregnant and breastfeeding women) was applied;
The highest value derived for infants (0-12 months) was applied (if applicable).

For potassium and choline, the AIs were inappropriate for setting minimum dosage values and therefore, the minimums were set at zero.

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Appendix III

Recommended Dietary Allowance (RDA) and Adequate Intake (AI) values

The AI (as indicated by an asterisk) and RDA values 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 statement: "Helps to prevent (appropriate vitamin or mineral) deficiency";
facilitate the optional labelling of % RDA and AI values.

Notes:

RDA and AI values have not been provided for those Life Stage Groups where the vitamin or mineral dosage is outside the scope of this Monograph.
For certain minerals, an RDA or AI value has not been established.

Table 13: Recommended Dietary Allowance and Adequate Intake* values for vitamins (IOM 2006)
Life Stage Group		Biotin (μg /day)	Folate (μg /day)	Niacin (mg/day)	Panto-thenic acid (mg/day)	Riboflavin (mg/day)
Infants	0-6 mo	-	-	-	-	-
Infants	7-12 mo	-	-	-	-	-
Children	1-3 y	8*	150	6	2*	0.5
Children	4-8 y	12*	200	8	3*	0.6
Adolescent Males	9-13 y	20*	300	12	4*	0.9
Adolescent Males	14-18 y	25*	400	16	5*	1.3
Adult Males	19-30 y	30*	400	16	5*	1.3
	31-50 y	30*	400	16	5*	1.3
	51-70 y	30*	400	16	5*	1.3
	> 70 y	30*	400	16	5*	1.3
Adolescent Females	9-13 y	20*	300	12	4*	0.9
Adolescent Females	14-18 y	25*	400	14	5*	1.0
Adult Females	19-30 y	30*	400	14	5*	1.1
	31-50 y	30*	400	14	5*	1.1
	51-70 y	30*	400	14	5*	1.1
	> 70 y	30*	400	14	5*	1.1
Pregnancy	14-18 y	30*	600	18	6*	1.4
Pregnancy	19-50 y	30*	600	18	6*	1.4
Breastfeeding	14-18 y	35*	500	17	7*	1.6
Breastfeeding	19-50 y	35*	500	17	7*	1.6

Table 13a: Recommended Dietary Allowance and Adequate Intake* values for vitamins (IOM 2006)
Life Stage Group		Thiamine (mg/day)	Vitamin A (μg RAE/day)	Vitamin B₆ (mg/day)	Vitamin B₁₂ (μg /day)	Vitamin C (mg/day)
Infants	0-6 mo	-	400*	-	-	-
Infants	7-12 mo	-	500*	-	-	-
Children	1-3 y	0.5	300	0.5	0.9	15
Children	4-8 y	0.6	400	0.6	1.2	25
Adolescent Males	9-13 y	0.9	600	1.0	1.8	45
Adolescent Males	14-18 y	1.2	900	1.3	2.4	75
Adult Males	19-30 y	1.2	900	1.3	2.4	90
	31-50 y	1.2	900	1.3	2.4	90
	51-70 y	1.2	900	1.7	2.4	90
	> 70 y	1.2	900	1.7	2.4	90
Adolescent Females	9-13 y	0.9	600	1.0	1.8	45
Adolescent Females	14-18 y	1.0	700	1.2	2.4	65
Adult Females	19-30 y	1.1	700	1.3	2.4	75
	31-50 y	1.1	700	1.3	2.4	75
	51-70 y	1.1	700	1.5	2.4	75
	> 70 y	1.1	700	1.5	2.4	75
Pregnancy	14-18 y	1.4	750	1.9	2.6	80
Pregnancy	19-50 y	1.4	770	1.9	2.6	85
Breastfeeding	14-18 y	1.4	1,200	2.0	2.8	115
Breastfeeding	19-50 y	1.4	1,300	2.0	2.8	120

Table 13b: Recommended Dietary Allowance and Adequate Intake* values for vitamins (IOM 2006)
Life Stage Group		Vitamin D (μg /day)	Vitamin E (mg AT/day)	Vitamin K₁¹ (μg /day)
Infants	0-6 mo	5*	-	-
Infants	7-12 mo	5*	-	-
Children	1-3 y	5*	6	30*
Children	4-8 y	5*	7	55*
Adolescent Males	9-13 y	5*	11	60*
Adolescent Males	14-18 y	5*	15	75*
Adult Males	19-30 y	5*	15	120*
	31-50 y	5*	15	120*
	51-70 y	10*	15	120*
	> 70 y	15*	15	120*
Adolescent Females	9-13 y	5*	11	60*
Adolescent Females	14-18 y	5*	15	75*
Adult Females	19-30 y	5*	15	90*
	31-50 y	5*	15	90*
	51-70 y	10*	15	90*
	> 70 y	15*	15	90*
Pregnancy	14-18 y	5*	15	75*
Pregnancy	19-50 y	5*	15	90*
Breastfeeding	14-18 y	5*	19	75*
Breastfeeding	19-50 y	5*	19	90*

¹ The AI for vitamin K is based on median dietary intakes. Vitamin K1 is the predominant form of vitamin K in the diet (IOM 2006; IOM 2001).

Table 14: Recommended Dietary Allowance and Adequate Intake* values for minerals (IOM 2006)
Life Stage Group		Boron (mg/day)	Calcium (mg/day)	Chromium (μg /day)	Cobalt¹ (μg /day)	Copper (μg /day)
Infants	0-6 mo	-	-	-	-	-
Infants	7-12mo	-	-	-	-	-
Children	1-3 y	-	500*	-	0.04	340
Children	4-8 y	-	800*	-	0.05	440
Adolescent Males	9-13 y	-	1,300*	-	0.08	700
Adolescent Males	14-18 y	-	1,300*	-	0.10	890
Adult Males	19-30 y	-	1,000*	35*	0.10	900
	31-50 y	-	1,000*	35*	0.10	900
	51-70 y	-	1,200*	30*	0.10	900
	> 70 y	-	1,200*	30*	0.10	900
Adolescent Females	9-13 y	-	1,300*	-	0.08	700
Adolescent Females	14-18 y	-	1,300*	-	0.10	890
Adult Females	19-30 y	-	1,000*	25*	0.10	900
	31-50 y	-	1,000*	25*	0.10	900
	51-70 y	-	1,200*	20*	0.10	900
	> 70 y	-	1,200*	20*	0.10	900
Pregnancy	14-18 y	-	1,300*	-	0.11	1,000
Pregnancy	19-50 y	-	1,000*	30*	0.11	1,000
Breastfeeding	14-18 y	-	1,300*	-	0.12	1,300
Breastfeeding	19-50 y	-	1,000*	45*	0.12	1,300

Table 14a: Recommended Dietary Allowance and Adequate Intake* values for minerals (IOM 2006)
Life Stage Group		Iodine (μg /day)	Iron (mg/day)	Magnesium (mg/day)	Manganese (mg/day)	Molyb-denum (μg /day)
Infants	0-6 mo	-	0.27*	-	-	-
Infants	7-12 mo	-	11	-	-	-
Children	1-3 y	90	7	80	-	-
Children	4-8 y	90	10	130	-	-
Adolescent Males	9-13 y	120	8	240	-	-
Adolescent Males	14-18 y	150	11	410	-	-
Adult Males	19-30 y	150	8	400	2.3*	45
	31-50 y	150	8	420	2.3*	45
	51-70 y	150	8	420	2.3*	45
	> 70 y	150	8	420	2.3*	45
Adolescent Females	9-13 y	120	8	240	-	-
Adolescent Females	14-18 y	150	15	360	-	-
Adult Females	19-30 y	150	18	310	1.8*	45
	31-50 y	150	18	320	1.8*	45
	51-70 y	150	8	320	1.8*	45
	> 70 y	150	8	320	1.8*	45
Pregnancy	14-18 y	220	27	400	-	-
Pregnancy	19-50 y	220	27	355	2.0*	50
Breastfeeding	14-18 y	290	10	360	-	-
Breastfeeding	19-50 y	290	9	315	2.6*	50

Table 14b: Recommended Dietary Allowance and Adequate Intake* values for minerals (IOM 2006)
Life Stage Group		Nickel (mg/day)	Phosphorus (mg/day)	Selenium (μg /day)	Silicon (mg/day)	Tin (mg/day)
Infants	0-6 mo	-	-	-	-	-
Infants	7-12 mo	-	-	-	-	-
Children	1-3 y	-	460	-	-	-
Children	4-8 y	-	500	-	-	-
Adolescent Males	9-13 y	-	1,250	-	-	-
Adolescent Males	14-18 y	-	1,250	-	-	-
Adult Males	19-30 y	-	700	55	-	-
	31-50 y	-	700	55	-	-
	51-70 y	-	700	55	-	-
	> 70 y	-	700	55	-	-
Adolescent Females	9-13 y	-	1,250	-	-	-
Adolescent Females	14-18 y	-	1,250	-	-	-
Adult Females	19-30 y	-	700	55	-	-
	31-50 y	-	700	55	-	-
	51-70 y	-	700	55	-	-
	> 70 y	-	700	55	-	-
Pregnancy	14-18 y	-	1,250	-	-	-
Pregnancy	19-50 y	-	700	60	-	-
Breastfeeding	14-18 y	-	1,250	-	-	-
Breastfeeding	19-50 y	-	700	70	-	-

Table 14c: Recommended Dietary Allowance and Adequate Intake* values for minerals (IOM 2006)
Life Stage Group		Vanadium (mg/day)	Zinc (mg/day)
Infants	0-6 mo	-	2*
Infants	7-12 mo	-	3
Children	1-3 y	-	3
Children	4-8 y	-	5
Adolescent Males	9-13 y	-	8
Adolescent Males	14-18 y	-	11
Adult Males	19-30 y	-	11
	31-50 y	-	11
	51-70 y	-	11
	> 70 y	-	11
Adolescent Females	9-13 y	-	8
Adolescent Females	14-18 y	-	9
Adult Females	19-30 y	-	8
	31-50 y	-	8
	51-70 y	-	8
	> 70 y	-	8
Pregnancy	14-18 y	-	12
Pregnancy	19-50 y	-	11
Breastfeeding	14-18 y	-	13
Breastfeeding	19-50 y	-	12

¹ Calculated from the vitamin B₁₂ RDA (IOM 2006)

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Appendix IV

Conversion factors

1. Pantothenic Acid (USP 30):

Table 15: Conversion of pantothenic acid source material quantity into pantothenic acid quantity
Source material (1 mg )	Pantothenic acid quantity (mg )
d- Pantothenic acid	1.00
d- Panthenol	1.07
Calcium-d-pantothenate	0.92
dl- Pantothenic acid	0.50
dl- Panthenol	0.54
Calcium-dl-pantothenate	0.46

2. Vitamin A (IOM 2006):

The quantity of vitamin A must always be provided in terms of retinol activity equivalents (RAE) (i.e. μg 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.

1 IU Vitamin A = 2 IU beta-carotene

Table 16: Conversion of vitamin A source material quantity into vitamin A quantity in terms of retinol activity equivalents (RAE) and vitamin A activity in terms of International Units (IU)
Source material (1 μg)	Vitamin A quantity (μg RAE)	Vitamin A activity (IU)
All-trans beta-carotene	0.50	1.67
All-trans retinol	1.00	3.33
All-trans retinyl acetate	0.87	2.94
All-trans retinyl palmitate	0.55	1.82

Examples using the vitamin A conversion factors:

Converting vitamin A activity into quantity of RAE (µg)

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

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

or

= 3000 IU x 0.87 μg RAE/2.94 IU vitamin A
= 900 μg RAE
Converting vitamin A source material quantity into quantity of RAE (µg)

Convert 2000 µg of all-trans retinyl palmitate into µg RAE:
= 2000 µg x 0.55 µg RAE/µg all-trans retinyl palmitate
= 1100 µg RAE
Converting beta-carotene activity into quantity of RAE (µg)

Convert 500 IU of beta-carotene activity into µg RAE:
= 500 IU beta-carotene x 1 IU vitamin A/2 IU beta-carotene x 1 µg RAE/3.33 IU vitamin A
= 75 µg RAE

or

= 500 IU beta-carotene x 1 IU vitamin A/2 IU beta-carotene x 0.5 µg RAE/1.67 IU vitamin A
= 75 µg RAE

or

see beta-carotene conversion factors below.

3. Beta-carotene (IOM 2006):

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

Examples using the beta-carotene conversion factors:

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
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

4. Vitamin D:

1 IU of vitamin D = 0.025 μg cholecalciferol (IOM 2006)
= 0.025 μg ergocalciferol

5. Vitamin E (IOM 2006):

The quantity of vitamin E must always be provided in terms of α-tocopherol (AT) (i.e. mg RRR-α-tocopherol), irrespective of the source material used.

IUs may be provided as optional additional information on the PLA form in the "potency" field and on product labels.

Table 17: Conversion of vitamin E source material quantity into vitamin E quantity in terms of alpha-(a)-tocopherol (AT) and vitamin E activity in terms of International Units (IU)
Source material (1 mg )	Vitamin E quantity (mg AT)	Vitamin E activity (IU)
RRR -α-Tocopherol	1.00	1.49
RRR -α-Tocopheryl acetate	0.91	1.36
RRR -α-Tocopheryl succinate	0.81	1.21
All rac-α-tocopherol	0.50	1.10
All rac-α-tocopheryl acetate	0.46	1.00
All rac-α-tocopheryl succinate	0.41	0.89

Table 18: Conversion of vitamin E source material activity into vitamin E quantity in terms of alpha-(a)-tocopherol (AT)
Source material (1 IU)	Vitamin E quantity (mg AT)
RRR -α-Tocopherol	0.67
RRR -α-Tocopheryl acetate	0.67
RRR -α-Tocopheryl succinate	0.67
All rac-α-tocopherol	0.45
All rac-α-tocopheryl acetate	0.45
All rac-α-tocopheryl succinate	0.45

Examples using the vitamin E conversion factors:

Converting vitamin E activity into quantity of AT (mg)

Convert 400 IU of RRR-α-tocopheryl succinate activity into mg AT:
= 400 IU x 0.67 mg AT/IU
= 268 mg AT
Converting vitamin E source material quantity into quantity of AT (mg)

Convert 200 mg of all rac-α-tocopheryl acetate into mg AT:
= 200 mg x 0.46 mg AT/mg
= 92 mg AT

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Multi-Vitamin/Mineral Supplements

Table Of Contents

Multi-Vitamin/Mineral Supplement Monograph

1.0 Proper name(s), Common name(s) and Source material(s)

1.1 Vitamin proper name(s), common name(s) and source material(s)

1.2 Mineral proper name(s), common name(s) and source material(s)

1.3 Other medicinal ingredient proper name(s), common name(s) and source material(s)

2.0 Route(s) of administration

3.0 Dosage form(s)

4.0 Use(s) or Purpose(s)

4.1 General use or purpose statement(s)

4.1.1 Medicinal ingredients for which only general use or purpose statement(s) are permitted

4.2 Specific use or purpose statement(s)

4.2.1 Specific use or purpose statement(s) for vitamins

4.2.2 Specific use or purpose statement(s) for minerals

4.2.3 Specific use or purpose statement(s) for other medicinal ingredients

5.0 Dose(s)

5.1 Background on dose

5.2 Dose information for vitamins

5.3 Dose information for minerals

5.4 Dose information for other medicinal ingredients

5.5 Directions for use

6.0 Duration of use

7.0 Risk information

7.1 Caution(s) and warning(s)

Additional caution(s) and warning(s)

7.2 Contraindication(s)

7.3 Known adverse reaction(s)

8.0 Non-medicinal ingredients

9.0 Specifications

10.0 References

11.0 Appendices

Appendix I

Guidelines for use or purpose statements

Appendix II

Dosage value definitions and derivations

1) Definitions:

2) Derivations:

Appendix III

Appendix IV

Conversion factors

1. Pantothenic Acid (USP 30):

2. Vitamin A (IOM 2006):

3. Beta-carotene (IOM 2006):

4. Vitamin D:

5. Vitamin E (IOM 2006):