Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Multi-Vitamin/Mineral Supplements (Under consultation)

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Date

February 9, 2016

Table Of Contents


Multi-Vitamin/Mineral Supplements Monograph

  • This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) forms and labels for Natural Health Product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

  • The medicinal ingredients boron, inositol, nickel, PABA, tin and vanadium are complementary ingredients that must be combined with at least one other medicinal ingredient listed in Tables 1, 2 and/or 3. No claim can be supported based on these medicinal ingredients. The product claim must be supported by another medicinal ingredient from 1, 2 and/or 3.

  • 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 included as medicinal ingredients on this monograph.

  • The PLA form and label must declare all active components (i.e. vitamin and mineral) of a source ingredient as medicinal ingredients and provide their quantity per dosage unit if the total daily dose of that vitamin or mineral exceeds the monograph's minimum dosage value. For example, if calcium ascorbate is cited as a source ingredient for calcium and also provides vitamin C (ascorbic acid) at medicinal levels (i.e. ≥ 6 mg/day for adults), then the PLA form and label must include vitamin C as a medicinal ingredient and its quantity per dosage unit. See Appendix I for additional information.

Note:
  • Text in parentheses is additional optional information which can be included on the PLA form and label at the applicant's discretion.
  • The solidus (/) indicates that the terms or the statements are synonymous. Either term or statement may be selected by the applicant.

1.0 Proper names, Common names and Source ingredients/materials

1.1 Vitamin proper names, common names and source ingredients/materials

Table 1. Vitamin proper names, common names and source material ingredients/materials
Proper name(s)1 Common name(s)2 Source ingredient(s)/material(s)3, 4

Table 1 Footnotes

Table 1 Footnote 1 and 2

At least one of the following references was consulted per name: Merck 2015; NIH 2015a; Sweetman 2015; USP 38; FCC 9; IOM 2006.

Return to Table 1 footnote1 referrer Return to Table 1 footnote2 referrer

Table 1 Footnote 3

At least one of the following references was consulted per source ingredient/material: Merck 2015; NIH 2015a; FAO 2012; Sweetman 2015; EFSA 2009a; USP 38; FCC 9; FSANZ 2008; IOM 2006; Van Der Kuy et al. 2002; Chalmers et al. 2000; EC 2000; Zeitlin et al. 1985.

Return to Table 1 footnote3 referrer

Table 1 Footnote 4

For source ingredients providing two active components (e.g. calcium ascorbate which provides calcium and ascorbic acid), see Appendix I for additional information about acceptable doses.

Return to Table 1 footnote4 referrer

Table 1 Footnote 5

Folic acid: Folic acid is only acceptable as a common name if the source ingredient is folic acid. All other source ingredients should be associated with folate as the common name.

Return to Table 1 footnote5 referrer

Biotin Biotin Biocytin

Biotin
Folate5 Folate

Folic acid5

Vitamin B9
Folic acid5

L-5-Methyltetrahydrofolate

L-5-Methyltetrahydrofolate, calcium salt

L-5-Methyltetrahydrofolic acid, glucosamine salt

Niacin

Niacin

Vitamin B3

Niacinamide

Nicotinic acid

Inositol hexanicotinate

Niacinamide Niacinamide

Nicotinamide

Vitamin B3
Niacinamide

Niacinamide ascorbate
Pantothenic acid D-Pantothenic acid

Pantothenic acid

Vitamin B5
Calcium D-pantothenate

Calcium DL-pantothenate

Dexpanthenol

DL-Panthenol

DL-Pantothenic acid

D-Pantethine

D-Pantothenic acid
Riboflavin Riboflavin

Vitamin B2
Riboflavin

Riboflavin 5-phosphate

Riboflavin 5-phosphate sodium
Thiamine Thiamine

Vitamin B1
Benfotiamine

Thiamine

Thiamine diphosphate

Thiamine hydrochloride

Thiamine mononitrate

Thiamine monophosphate
Vitamin A Vitamin A All-trans retinol

Vitamin A acetate

Vitamin A palmitate

Vitamin A propionate
Vitamin B6 Vitamin B6 Pyridoxal

Pyridoxal 5'-phosphate

Pyridoxal 5'-phosphate, calcium salt

Pyridoxal hydrochloride

Pyridoxamine

Pyridoxamine 5'-phosphate

Pyridoxine

Pyridoxine 5'-phosphate

Pyridoxine hydrochloride
Vitamin B12 Vitamin B12 Cobamamide

Cyanocobalamin

Hydroxocobalamin

Methylcobalamin
Vitamin C Vitamin C Ascorbic acid

Ascorbyl palmitate

Calcium ascorbate

Calcium ascorbate, dihydrate

Magnesium ascorbate

Manganese (II) ascorbate

Niacinamide ascorbate

Potassium ascorbate

Sodium ascorbate

Zinc ascorbate
Vitamin D Vitamin D

Vitamin D2
Ergocalciferol
Vitamin D

Vitamin D3
Cholecalciferol
Vitamin E Vitamin E d-alpha Tocopherol

d-alpha Tocopheryl acetate

d-alpha Tocopheryl acid succinate

dl-alpha Tocopherol

dl-alpha Tocopheryl acetate

dl-alpha Tocopheryl acid succinate
Vitamin K1 Vitamin K1 Vitamin K1
Vitamin K2 Vitamin K2 Vitamin K2

1.2 Mineral proper names, common names and source ingredients/materials

Table 2. Mineral proper names, common names and source ingredients/materials
Proper name(s)1 Common name(s)2 Source ingredient(s)/material(s)3, 4

Table 2 Footnotes

Table 2 Footnote 1 and 2

At least one of the following references was consulted per name: Merck 2015; NIH 2015a; Sweetman 2015; USP 38; FCC 9.

Return to Table 2 footnote1 referrer Return to Table 2 footnote2 referrer

Table 2 Footnote 3

At least one of the following references was consulted per source ingredient/material: Albion 2015; BP 2015; Merck 2015; NIH 2015a,b; Sweetman 2015; USP 38; Jain et al. 2012; FCC 9; EFSA 2010a; Summers et al. 2010; EC 2009; EFSA 2009b,c,d,e,f,g,h,i,j; EFSA 2008a,b,c,d,e,f; Nowak et al. 2008; Richards 2008; EFSA 2007; Guiry and Guiry 2007; TGA 2007; EFSA 2006; Walsdorf and Alexandrides 2005; Albion 2004a,b; ANZFA 2004; Gruenwald et al. 2004; Albion 2003a,b; Allen 2002; ANZFA 2002; Ball et al. 2002; Van Der Kuy et al. 2002; Anderson et al. 2001; Hendler and Rorvik 2001; Albion 2000; Chalmers et al. 2000; EC 2002; EC 2000; Tsuboi et al. 2000; Ishitani et al. 1999; Patrick 1999; IPCS 1998; Albion 1997a,b; Grant et al. 1997; Albion 1996a,b; Murray 1996; Fujita et al. 1996; Albion 1995; Henderson 1994; Albion 1993a,b,c,d,e; Evans and Pouchnik 1993; Albion 1992; Zeitlin et al. 1985.

Return to Table 2 footnote3 referrer

Table 2 Footnote 3

For source ingredients providing two active components (e.g. calcium ascorbate which provides calcium and ascorbic acid), see Appendix I for additional information about acceptable doses.

Return to Table 2 footnote4 referrer

Table 2 Footnote 3

Bone meal: 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 2013).

Return to Table 2 footnote5 referrer

Table 2 Footnote 3

Silicon from Equisetum arvense: Data (or certification) must be submitted to the Natural and Non-Prescription Health Products Directorate (NNHPD) upon request to show that thiaminase has been inactivated.

Return to Table 2 footnote6 referrer

Calcium Calcium Bone meal5

Calcium acetate

Calcium ascorbate

Calcium aspartate

Calcium bisglycinate

Calcium carbonate

Calcium chloride

Calcium chloride, dihydrate

Calcium chloride, hexahydrate

Calcium citrate

Calcium citrate malate

Calcium citrate, tetrahydrate

Calcium diglutamate

Calcium fumarate

Calcium glubionate

Calcium glubionate, monohydrate

Calcium gluceptate

Calcium gluconate

Calcium gluconate, monohydrate

Calcium glutarate

Calcium glycerophosphate

Calcium hydrolyzed animal protein (HAP) chelate

Calcium hydrolyzed vegetable protein (HVP) chelate

Calcium hydroxide

Calcium hypophosphite

Calcium lactate

Calcium lactate gluconate

Calcium lactate gluconate

Calcium lactate, pentahydrate

Calcium lactate, trihydrate

Calcium lactobionate, dihydrate

Calcium levulinate

Calcium levulinate, dihydrate

Calcium malate

Calcium orotate

Calcium oxide

Calcium phosphate, dibasic

Calcium phosphate, dibasic, dihydrate

Calcium phosphate, monobasic

Calcium phosphate, tribasic

Calcium pidolate

Calcium pyrophosphate

Calcium pyruvate

Calcium silicate

Calcium sodium lactate

Calcium succinate

Calcium sulfate

Calcium sulfate, dihydrate

Calcium sulfate, hemihydrate

Calcium threonate

Coral

Dolomite

Oyster
Chromium Chromium Chromium (III) bisglycinate

Chromium (III) chloride

Chromium (III) chloride, hexahydrate

Chromium (III) citrate

Chromium (III) dinicotinate

Chromium (III) dinicocysteinate

Chromium (III)-enriched yeast

Chromium (III) fumarate

Chromium (III) glutarate

Chromium (III) hydrolyzed animal protein (HAP) chelate

Chromium (III) hydrolyzed vegetable protein (HVP) chelate

Chromium (III) lactate, trihydrate

Chromium (III) malate

Chromium (III) nicotinate

Chromium (III) nicotinate glycinate

Chromium (III) nitrate

Chromium (III) pidolate

Chromium (III) potassium sulfate, dodecahydrate

Chromium (III) succinate

Chromium (III) sulfate
Cobalt Cobalt Hydroxocobalamin

Methylcobalamin

Vitamin B12
Copper Copper Calcium copper edetate

Copper (II) acetate

Copper (II) aspartate

Copper (II) bisglycinate

Copper (II) carbonate

Copper (II) chloride

Copper (II) chloride, dihydrate

Copper (II) citrate

Copper (II) fumarate

Copper (II) gluconate

Copper (II) glutarate

Copper (II) hydrolyzed animal protein (HAP) chelate

Copper (II) hydrolyzed vegetable protein (HVP) chelate

Copper (II) malate

Copper (II) sebacate

Copper (II) succinate

Copper (II) sulfate

Copper (II) sulfate, monohydrate

Copper (II) sulfate, pentahydrate
Iodine Iodine Isolated and purified from the thallus of Fucus vesiculosus, Fucus serratus or Ascophyllum nodosum

Isolated and purified from the thallus of Laminaria digitata or Laminaria japonica

Potassium iodate

Potassium iodide

Sodium iodide
Iron Iron Dried iron (II) sulfate

Ferritin

Ferrocholinate

Iron, Carbonyl

Iron, Electrolytic

Iron, Reduced

Iron hydrolyzed animal protein (HAP) chelate

Iron hydrolyzed vegetable protein (HVP) chelate

Iron (II) ascorbate

Iron (II) aspartate

Iron (II) aspartate

Iron (II) bisglycinate

Iron (II) carbonate

Iron (II) carbonate mass

Iron (II) chloride

Iron (II) chloride, tetrahydrate

Iron (II) citrate

Iron (II) citrate, decahydrate

Iron (II) citrate, monohydrate

Iron (II) fumarate

Iron (II) gluceptate

Iron (II) gluconate

Iron (II) gluconate, dihydrate

Iron (II) glutarate

Iron (II) glycine sulfate

Iron (II) lactate

Iron (II) lactate, trihydrate

Iron (II) malate

Iron (II) oxalate

Iron (II) oxalate, dihydrate

Iron (II) phosphate

Iron (II) pidolate

Iron (II) succinate

Iron (II) sulphate

Iron (II) sulphate, heptahydrate

Iron (II) tartrate

Iron (II) taurate

Iron (III) ammonium citrate

Iron (III) citrate

Iron (III) glycerophosphate

Iron (III) glycinate

Iron (III) phosphate

Iron (III) pyrophosphate

Polysaccharide-iron complex
Magnesium Magnesium Magnesium acetate

Magnesium acetate, tetrahydrate

Magnesium ascorbate

Magnesium aspartate

Magnesium aspartate, dihydrate

Magnesium aspartate hydrochloride, trihydrate

Magnesium aspartate, tetrahydrate

Magnesium bisglycinate

Magnesium carbonate

Magnesium chloride

Magnesium chloride, hexahydrate

Magnesium citrate

Magnesium citrate, tribasic

Magnesium fumarate

Magnesium gluceptate

Magnesium gluconate

Magnesium gluconate, dihydrate

Magnesium glutarate

Magnesium glycerophosphate

Magnesium glycinate

Magnesium hydrolyzed animal protein (HAP) chelate

Magnesium hydrolyzed vegetable protein (HVP) chelate

Magnesium hydroxide

Magnesium lactate

Magnesium lysinate

Magnesium malate

Magnesium orotate

Magnesium oxide

Magnesium phosphate, dibasic

Magnesium phosphate, dibasic, trihydrate

Magnesium phosphate, monobasic

Magnesium phosphate, tribasic

Magnesium phosphate, tribasic, octahydrate

Magnesium phosphate, tribasic, pentahydrate

Magnesium phosphate, tribasic, tetrahydrate

Magnesium pidolate

Magnesium succinate

Magnesium sulfate

Magnesium sulfate, heptahydrate

Magnesium sulfate, monohydrate

Magnesium sulfate, trihydrate

Magnesium taurate
Manganese Manganese Manganese (II) ascorbate

Manganese (II) aspartate

Manganese (II) bisglycinate

Manganese (II) carbonate

Manganese (II) chloride

Manganese (II) chloride, tetrahydrate

Manganese (II) citrate

Manganese (II) gluconate

Manganese (II) gluconate, dihydrate

Manganese (II) glycerophosphate

Manganese (II) hydrolyzed animal protein (HAP) chelate

Manganese (II) hydrolyzed vegetable protein (HVP) chelate

Manganese (II) pidolate

Manganese (II) sulfate

Manganese (II) sulfate, monohydrate

Manganese (II) sulfate, tetrahydrate

Manganese (IV) dioxide
Molybdenum Molybdenum Ammonium molybdate (VI)

Ammonium molybdate (VI), tetrahydrate

Molybdenum (VI) aspartate

Molybdenum (VI) bisglycinate

Molybdenum (VI) citrate

Molybdenum (VI) fumarate

Molybdenum (VI) glutarate

Molybdenum (VI) hydrolyzed animal protein (HAP) chelate

Molybdenum (VI) hydrolyzed vegetable protein (HVP) chelate

Molybdenum (VI) malate

Molybdenum (VI) succinate

Potassium molybdate (VI)

Sodium molybdate (VI)

Sodium molybdate (VI), dihydrate
Phosphorus Phosphorus Ammonium phosphate, dibasic

Ammonium phosphate, monobasic

Bone meal5

Calcium glycerophosphate

Calcium phosphate, dibasic

Calcium phosphate, dibasic, dihydrate

Calcium phosphate, monobasic

Calcium phosphate, monobasic, monohydrate

Calcium phosphate, tribasic

Durapatite

Magnesium phosphate, dibasic, mixed hydrates

Magnesium phosphate, dibasic, trihydrate

Magnesium phosphate, tribasic

Potassium phosphate, dibasic

Potassium phosphate, monobasic

Potassium phosphate, tribasic

Sodium glycerophosphate

Sodium phosphate, dibasic

Sodium phosphate, dibasic, dihydrate

Sodium phosphate, dibasic, monohydrate

Sodium phosphate, dibasic, dodecahydrate

Sodium phosphate, dibasic, heptahydrate

Sodium phosphate, monobasic

Sodium phosphate, monobasic, dihydrate

Sodium phosphate, monobasic, monohydrate

Sodium phosphate, tribasic

Trisodium phosphate, dodecahydrate
Selenium Selenium Selenious acid

Selenium aspartate

Selenium citrate

Selenium dioxide, monohydrate

Selenium fumarate

Selenium glycinate

Selenium hydrolyzed animal protein (HAP) chelate

Selenium hydrolyzed vegetable protein (HVP) chelate

Selenium malate

Selenium succinate

Selenium-enriched yeast

Selenocysteine

Selenomethionine

Sodium hydrogen selenite

Sodium selenate

Sodium selenite
Silicon Silicon Calcium silicate

Choline-stabilised orthosilicic acid

Isolated and purified from Equisetum arvense6 - aerial parts

Orthosilicic acid

Silicic acid

Silicon dioxide

Silicon hydrolyzed animal protein (HAP) chelate

Silicon hydrolyzed vegetable protein (HVP) chelate

Sodium metasilicate
Zinc Zinc Zinc acetate

Zinc acetate, dihydrate

Zinc arginate

Zinc ascorbate

Zinc aspartate

Zinc bisglycinate

Zinc carbonate

Zinc chloride

Zinc citrate

Zinc citrate, dihydrate

Zinc citrate, trihydrate

Zinc fumarate

Zinc gluconate

Zinc gluconate glycine

Zinc glutarate

Zinc glycerate

Zinc histidinate

Zinc hydrolyzed animal protein (HAP) chelate

Zinc hydrolyzed vegetable protein (HVP) chelate

Zinc lactate

Zinc lysinate

Zinc malate

Zinc methionine

Zinc monomethionine

Zinc oxide

Zinc phosphate

Zinc pidolate

Zinc succinate

Zinc sulfate

Zinc sulfate, heptahydrate

Zinc sulfate, monohydrate

1.3 Other medicinal ingredient proper names, common names and source ingredients/materials

Table 3. Other medicinal ingredient proper names, common names and source ingredients/materials
Proper name(s)1 Common name(s)2 Source ingredient(s)/material(s)3, 4

Table 3 Footnotes

Table 3 Footnote 1 and 2

At least one of the following references was consulted per name: Merck 2015; NIH 2015a; Sweetman 2015; USP 38; FCC 9.

Return to Table 3 footnote1 referrer Return to Table 3 footnote2 referrer

Table 3 Footnote 3

At least one of the following references was consulted per source ingredient/material: Merck 2015; NIH 2015a; Sweetman 2015; USP 38; FCC 9; EFSA 2009e; EFSA 2008d; EFSA 2007; FAO 2006.

Return to Table 3 footnote3 referrer

Table 3 Footnote 3

For source ingredients providing two active components (e.g. calcium ascorbate which provides calcium and ascorbic acid), see Appendix I for additional information about acceptable doses.

Return to Table 3 footnote4 referrer

Table 3 Footnote 3

Potassium: At least 100 mg of potassium per day is required to support the uses or purposes listed in Section 4.2.3. Only general uses or purposes are permitted at daily doses below 100 mg of potassium.

Return to Table 3 footnote5 referrer

All-trans-beta-carotene

Beta-carotene
All-trans-beta-carotene

Beta-carotene
Beta-carotene
Choline

2-Hydroxy-N,N,N-trimethylethanaminium
Choline Choline

Choline bitartrate

Choline chloride

Choline citrate

Choline dihydrogen citrate

Choline orotate

Lecithin

Phosphatidylcholine
Lutein

(3R,3R,6R)-beta,epsilon-Carotene-3,3-diol
Lutein Lutein(USP)

Isolated and purified from Tagetes erecta - Herb flowering oleoresin
Lycopene

All-trans-lycopene
Lycopene Lycopene

Isolated and purified from Solanum lycopersicum - fruit flesh
L-Methionine L-Methionine

Methionine
Calcium sodium caseinate

DL-Methionine

Hydrolyzed collagen

N-Acetyl-L-methionine

L-Methionine
Potassium5 Potassium Potassium acetate

Potassium ascorbate

Potassium aspartate

Potassium bicarbonate

Potassium carbonate

Potassium chloride

Potassium citrate

Potassium citrate, monohydrate

Potassium gluconate

Potassium glycerophosphate

Potassium glycerophosphate, trihydrate

Potassium lactate

Potassium malate

Potassium phosphate, dibasic

Potassium phosphate, monobasic

Potassium phosphate, tribasic

Potassium pidolate

Potassium sulfate

Potassium tartrate

Potassium tartrate, hemihydrate

1.4 Complementary medicinal ingredients proper names, common names and source ingredients/materials.

The medicinal ingredients boron, inositol, nickel, PABA, tin, and vanadium are complementary ingredients that must be combined with at least one medicinal ingredient listed in Tables 1, 2 and/or 3. No claim can be supported based on these ingredients. The product claim must be supported by another medicinal ingredient from Tables 1, 2 and/or 3.

Table 4. Complementary medicinal ingredients proper names, common names and source ingredients/materials.
Proper name(s)1 Common name(s)2 Source ingredient(s)/material(s)3, 4

Table 4 Footnotes

Table 4 Footnote 1 and 2

At least one of the following references was consulted per name: Merck 2015; NIH 2015a; Sweetman 2015; USP 38; FCC 9.

Return to Table 4 footnote1 referrer Return to Table 4 footnote2 referrer

Table 4 Footnote 3

At least one of the following references was consulted per source ingredient/material: Merck 2015; NIH 2015a; Sweetman 2015; USP 38; FCC 9; EFSA 2009a,e; EFSA 2008d,g; EFSA 2007; O'Neil et al 2006, EFSA 2004.

Return to Table 4 footnote3 referrer

Table 4 Footnote 3

For source ingredients providing two active components (e.g. calcium ascorbate which provides calcium and ascorbic acid), see Appendix I for additional information about acceptable doses.

Return to Table 4 footnote4 referrer

Boron Boron Borax

Boric acid

Boron aspartate

Boron citrate

Boron glycinate

Boron hydrolyzed animal protein (HAP) chelate

Boron hydrolyzed vegetable protein (HVP) chelate

Calcium borate

Calcium borogluconate

Calcium fructoborate

Magnesium borate

Sodium borate
Inositol Inositol Inositol

Inositol dihydrate

Inositol hexanicotinate

Inositol monophosphate
Nickel Nickel Nickel (II) sulfate

Nickel (II) sulfate, heptahydrate

Nickel (II) sulfate, hexahydrate
para-Aminobenzoic acid PABA

para-Aminobenzoic acid
para-Aminobenzoic acid

Saccharomyces cerevisiae - whole
Tin Tin Stannous chloride
Vanadium Vanadium Sodium metavanadate

Vanadium citrate

Vanadium fumarate

Vanadium glutarate

Vanadium hydrolyzed animal protein (HAP) chelate

Vanadium hydrolyzed vegetable protein (HVP) chelate

Vanadium malate

Vanadium succinate

Vanadyl sulfate

Vanadyl sulfate, dihydrate

2.0 Route of administration

Oral

3.0 Dosage form

  • 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.

4.0 Uses or Purposes

4.1 General use or purpose statements

The following use or purpose statements can be used in reference to any vitamin and/or mineral and/or other ingredient from Tables 1, 2 and/or 3.

They are not acceptable for medicinal ingredients listed in Table 4.

Statement(s) to the effect of:

For all products

  • Source of vitamin(s)/mineral(s)/vitamin(s) and mineral(s), a factor/factors in the maintenance of good health.
  • Source of vitamin(s)/mineral(s)/vitamin(s) and mineral(s), a factor/factors in normal growth and development.
  • Source of vitamin(s)/mineral(s)/vitamin(s) and mineral(s) to support biological functions which play a key role in the maintenance of good health.

For products containing at least one vitamin or mineral (all vitamins and minerals in the product must be at minimum dose):

  • Vitamin supplement or mineral supplement or vitamin and mineral supplement.

For products containing at least two vitamins and/or minerals (all vitamins and minerals in the product must be at minimum dose):

  • Multi-vitamin supplement or multi-mineral supplement or multi-vitamin and multi-mineral supplement.

4.2 Specific use or purpose statements

Note:
Refer to Appendix II for guidelines on using the specific uses or purposes outlined in this section.

Statements(s) to the effect of:

4.2.1 Specific use or purpose statements for vitamins
Table 5. Specific uses or purposes statements for vitamins
Vitamin Specific uses or purposes1

Table 5 Footnotes

t5fn1

At least two of the following references were consulted per use or purpose statement: CFIA 2015; EC 2015; IOM 2011; NIH 2011; HC 2009a,b; de Benoist 2008; IOM 2006; Shils et al. 2006; Bjørke Monsen and Ueland 2003; MacKay and Miller 2003; IOM 2001; Groff and Gropper 2000; IOM 2000; NIH 2000; IOM 1998; IOM 1997; Colombo et al. 1990.

Return to Table 5 footnote1 referrer

t5fn2

For each deficiency claim: This use or purpose statement is only acceptable if the vitamin is present at dosages at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI). See Appendix III for RDA and AI definitions and Appendix IV for detailed values according to life stage group. Note that most vitamin deficiencies are rare in North America.

Return to Table 5 footnote2 referrer

t5fn3

These vitamins are cofactors in specific biochemical reactions (e.g. inter-conversion of amino acids). This claim is not intended to convey that taking these vitamins helps to boost metabolism, upregulate a bodily system and/or directly convert food to energy. Inferring such claims would be misleading and is not permitted. In order to avoid any misinterpretation of this claim, the terms 'carbohydrates, fats, proteins, etc.' must not be used to further specify the term 'nutrients'.

Return to Table 5 footnote3 referrer

t5fn4

Folate: If a product is marketed specifically as a prenatal supplement (for pregnant women), it must have at least 400 µg of folate per day. Health Canada (HC 2009a,b) recommends that all women who could become pregnant take a daily multivitamin/mineral supplement containing 400 µg of folic acid per day. At a minimum, women who are planning to become pregnant should start taking this supplement 3 months before the pregnancy. Pregnant women should take a multivitamin/mineral supplement containing 400-800 µg of folic acid per day to help meet the folate requirements of the pregnancy.

Return to Table 5 footnote4 referrer

t5fn5

Niacin/niacinamide: A specific use or purpose statement must be made for products providing > 35 mg niacin, niacinamide or a combination of the two, per day.

Return to Table 5 footnote5 referrer

Biotin

Helps to maintain healthy hair, nail, mucous membranes and/or skin.

Helps to maintain cognitive functions.

Helps to prevent biotin deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Folate4

Helps to form red blood cells.

Helps to support normal early fetal development.

Helps to support normal early development of the fetal brain and spinal cord.

Helps to prevent folate deficiency.2

For products providing at least 400 µg folate per day:
Helps to reduce the risk of neural tube defects when taken daily at least three months prior to becoming pregnant and during early pregnancy.

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Niacin/ Niacinamide5

Helps normal growth and development.

Helps in energy metabolism and tissue formation.

Helps to prevent vitamin B3 deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Pantothenic acid

Helps in energy metabolism and in tissue formation.

Helps to prevent pantothenic acid deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Riboflavin

Helps in energy metabolism and in tissue formation.

Helps to maintain healthy mucous membranes.

Helps to maintain normal red blood cells.

Helps to maintain normal metabolism of iron.

Helps to prevent riboflavin deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Thiamine

Helps in energy production.

Helps normal growth.

Helps to prevent thiamine deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

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 build strong bones and teeth.

Helps to maintain normal metabolism of iron.

Helps to maintain healthy skin and/or mucous membranes.

Helps to prevent vitamin A deficiency.2

Vitamin B6

Helps in energy metabolism and in tissue formation.

Helps to form red blood cells.

Helps to prevent vitamin B6 deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Vitamin B12

Helps to form red blood cells.

Helps in the normal function of the immune system.

Helps in energy metabolism in the body.

Helps to prevent vitamin B12 deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Vitamin C

Helps in the development and maintenance of bones, cartilage, teeth and/or gums.

Helps in connective tissue formation.

Helps in wound healing.

Source of/An antioxidant for the maintenance of good health.

Source of/An antioxidant that decreases the adverse effects of free radicals on normal physiological functions.

Source of/An antioxidant that helps to reduce free radicals and lipid oxidation in body tissues.

Source of/An antioxidant that helps (to): a) fight / b) protect (cells) against / c) reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals.

Helps in collagen formation to maintain healthy bones, cartilage, teeth and/or gums.

Helps to maintain immune function.

Helps to prevent vitamin C deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Vitamin D

Helps in the development and maintenance of bones and teeth.

Helps in the absorption and use of calcium and phosphorus

Calcium intake, when combined with sufficient Vitamin D, a healthy diet and regular exercise may reduce the risk of developing osteoporosis.

Helps to build strong bones and teeth.

Helps to maintain immune function.

Helps in the process of normal cell division.

Helps to prevent vitamin D deficiency.2

Vitamin E

Source of/An antioxidant for the maintenance of good health.

Source of/An antioxidant that protects the fat in body tissues from oxidation.

Source of/An antioxidant that helps (to): a) fight / b) protect (cells) against / c) reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals.

Helps to prevent vitamin E deficiency.2

Vitamin K1 and K2

Helps in the maintenance of bones.

Helps to prevent vitamin K deficiency.2
4.2.2 Specific use or purpose statements for minerals
Table 6. Specific uses or purposes statements for minerals
Mineral Specific uses or purposes1

Table 6 Footnotes

t6fn1

At least two of the following references were consulted per use or purpose statement: CFIA 2015; EC 2015; IOM 2011; FDA 2008; Tang et al 2007; IOM 2006; Jackson et al 2006; NAMS 2006; Shils et al. 2006; Meisel et al. 2005; Schwartz et al. 2005; Brown and Josse 2002; IOM 2001; Groff and Gropper 2000; IOM 2000; NIH 2000; IOM 1997; Klimis-Tavantis 1994.

Return to Table 6 footnote1 referrer

t6fn2

For each deficiency claim: this use or purpose statement is only acceptable if the mineral is present at dosages at or above the RDA or AI. See Appendix III for RDA and AI definitions and Appendix IV for detailed values according to life stage group. Note that most mineral deficiencies are rare in North America.

Return to Table 6 footnote2 referrer

t6fn3

These minerals are involved as cofactors in specific biochemical reactions (e.g. inter-conversion of amino acids). This claim is not intended to convey that taking these minerals helps to boost metabolism, upregulate a bodily system and/or directly convert food to energy. Inferring such claims would be misleading and is not permitted. In order to avoid any misinterpretation of this claim, the terms 'carbohydrates, fats, proteins, etc.' must not be used to further specify 'nutrients'.

Return to Table 6 footnote3 referrer

t6fn4

Iron: A specific use or purpose statement must be made for products providing > 35 mg iron per day.

Return to Table 6 footnote4 referrer

t6fn5

Magnesium: A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.

Return to Table 6 footnote5 referrer

t6fn6

Magnesium deficiency claim: As the RDA for magnesium for adolescents 14-18 years exceeds the maximum dose, this claim is not permitted for this subpopulation.

Return to Table 6 footnote6 referrer

t6fn7

Zinc: A specific use or purpose statement must be made for products providing > 40 mg zinc per day.

Return to Table 6 footnote7 referrer

Calcium

Helps in the development and maintenance of bones and teeth (especially in childhood, adolescence and young adulthood).

Adequate calcium (and vitamin D) (throughout life) as part of a healthy diet, (along with physical activity) may reduce the risk of developing osteoporosis (in peri- and postmenopausal women) (in later life).

Adequate calcium (and vitamin D) (throughout life) as part of a healthy diet, (along with physical activity) may help prevent bone loss/osteoporosis (in peri- and postmenopausal women) (in later life).

Source of/An electrolyte for the maintenance of good health.

Helps to maintain normal muscle function.

Helps in the process of normal regulation of cell division and specialisation.

Helps to prevent calcium deficiency.2

Chromium

Provides support for healthy glucose metabolism.

Helps to maintain normal blood glucose levels.

Helps to prevent chromium deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Cobalt

Cobalt is a structural component of vitamin B12 that helps form red blood cells.

Cobalt is a structural component of vitamin B12 that helps prevent vitamin B12 deficiency.2

If the following statement is used, it must be verbatim:
Cobalt is a structural component of vitamin B12 that helps to maintain the body's ability to metabolize nutrients.3

Copper

Helps to produce and repair connective tissue

Helps to form red blood cells.

Helps to maintain normal iron transport in the body.

Helps to prevent copper deficiency.2

Iodine

Helps in the function of the thyroid gland.

Helps to maintain normal production of thyroid hormones.

Helps to prevent iodine deficiency.2

Iron4

Helps to form red blood cells and helps in their proper function.

Helps to reduce tiredness and fatigue caused by iron deficiency anemia.

For products providing 16-20 mg iron, per day:
Helps pregnant women meet (the) (Health Canada's) recommended intake for iron, when taken in conjunction with a healthy diet.

If one of the following statements is used, it must be verbatim:
  • Helps to prevent iron deficiency. 2
  • Helps to prevent iron deficiency anaemia. 2
  • Helps to prevent iron deficiency anemia and associated tiredness and fatigue. 2

Magnesium5

Helps in the development and maintenance of bones and teeth.

Helps in tissue formation.

Helps to maintain proper muscle function.

Helps to maintain proper muscle function, including the heart muscle.

Source of/An electrolyte for the maintenance of good health.

Helps in energy metabolism, tissue formation and bone development.

Helps to maintain normal electrolyte balance.

Helps to prevent magnesium deficiency. 2, 6

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Manganese

Helps in the development and maintenance of bones.

Helps to prevent manganese deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Molybdenum

Helps to prevent molybdenum deficiency. 2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Phosphorus

Helps in the development and maintenance of bones and teeth.

Source of/An electrolyte for the maintenance of good health.

Helps to prevent phosphorus deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3

Selenium

Source of/An antioxidant for the maintenance of good health.

Source of/An antioxidant that helps protect against oxidative stress.

Source of/An antioxidant that helps (to): a) fight / b) protect (cells) against / c) reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals.

Helps to maintain normal function of the thyroid gland.

Helps to prevent selenium deficiency.2

Zinc7

Helps in connective tissue formation.

Helps to maintain healthy skin.

Helps to maintain immune function.

Helps in energy metabolism and tissue formation.

Helps to maintain normal DNA synthesis.

Helps to maintain normal acid-base metabolism.

Helps to maintain healthy bones, hair, nail and/or skin.

Helps to prevent zinc deficiency.2

If the following statement is used, it must be verbatim:
Helps to maintain the body's ability to metabolize nutrients.3
4.2.3 Specific use or purpose statements for other medicinal ingredients
Table 7. Specific uses or purposes statements for other medicinal ingredients
Medicinal ingredient Specific uses or purposes1

Table 7 Footnotes

t7fn1

At least two of the following references were consulted per use or purpose statement: CNF 2015; EC 2015; Erdman et al. 2009; Christen et al. 2008; Fletcher et al. 2008; Johnson et al. 2008; Kristal et al. 2008; Moeller et al. 2008; Schwarz et al. 2008; Silaste et al. 2007; IOM 2006; Shao and Hathcock 2006; Miranda et al. 2006; Shils et al. 2006; Zeisel 2006; IOM 2005a,b; Mohanty et al. 2005; Porrini et al. 2005; Alves-Rodrigues and Shao 2004; Richer et al. 2004; Blakely et al. 2003; Olmedilla et al. 2003; Giovannucci et al. 2002; IOM 2002; Kucuk et al. 2002; Dwyer et al. 2001; IOM 2001; Kucuk et al. 2001; Matos et al. 2001; Groff and Gropper 2000; Brown et al 1999; Gann et al. 1999; IOM 1998; Seyoum and Persaud 1991; Benevenga 1984.

Return to Table 7 footnote1 referrer

t7fn2

Vitamin A deficiency claim: See Appendix V (Determining dosage requirements for the claim "Helps to prevent vitamin A deficiency") for guidance on the appropriate use of this claim.

Return to Table 7 footnote2 referrer

t7fn3

The term "lipotropic factor" is not permitted to describe choline, methionine or inositol. This term may mislead consumers to perceive that the product is intended for the purpose of weight loss.

Return to Table 7 footnote3 referrer

Beta-carotene

Provitamin A for the maintenance of good health.

Provitamin A to help maintain eyesight, skin, membranes and immune function.

Provitamin A to help in the development and maintenance of night vision.

Provitamin A to help in the development and maintenance of bones and teeth.

Helps to prevent vitamin A deficiency.2

Choline3

Helps to support liver function.

L-Methionine3

Helps to support liver function.

Source of/An essential amino acid for the maintenance of good health.

Source of/An essential amino acid involved in protein synthesis.
Lutein Source of/An antioxidant for the maintenance of good health/eye health.

Source of/An antioxidant that helps (to): a) fight / b) protect (cells) against / c) reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals.

For products providing at least 6 mg per day:
  • Helps to maintain/support eyesight in certain conditions (associated with sunlight damage) such as cataracts and age-related macular degeneration.
  • Helps to reduce the risk of developing cataracts.
  • Helps to improve macular pigment optical density.
Lycopene Source of/An antioxidant.

Source of/An antioxidant that helps (to): a) fight / b) protect (cells) against / c) reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals.

For products providing at least 6.5 mg per day:
  • Helps to support prostate health.
Potassium For products providing at least 100 mg per day:
  • Source of/An electrolyte for the maintenance of good health.
  • Helps to prevent potassium deficiency due to low dietary intake.
Silicon Helps to maintain healthy hair, nails and/or skin.

5.0 Doses

5.1 Subpopulations

An adult subpopulation only is indicated for HAP or HVP as a source ingredient as well as for the following medicinal ingredients:

  • Boron
  • Chromium
  • Lutein
  • Lycopene
  • Manganese
  • Molybdenum
  • Nickel
  • PABA
  • Potassium
  • Selenium
  • Silicon
  • Tin
  • Vanadium

5.2 Background on dose

  • The daily dose of each vitamin and/or mineral, listed in Tables 8, 9 and 10, must meet the minimum dosage value if a general or specific claim is being attributed to them. In addition, the minimum daily dose must be met for all vitamins and minerals in a product making a (multi-)vitamin and/or mineral supplement claim in the brand name or as part of the recommended uses or purposes.
  • The daily dose of each medicinal ingredient must not exceed the maximum dosage value. Refer to Appendix III for definitions and derivations of dosage values.
  • Refer to Appendix VI for conversion factors for pantothenic acid, vitamin A, beta-carotene, vitamin D and vitamin E.
  • Dose information for adults includes pregnant and breastfeeding women. However, products containing PABA and/or vanadium require a mandatory risk statement for these subpopulations. See Section 6.0 Risk information.

5.3 Dose information for vitamins

Table 8. Daily doses for vitamins (Min = minimum; Max = maximum)
Life Stage Group Biotin
(μg /day)
Folate1
(μg /day)
Niacin/niacinamide2
(mg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y 1.0 500 15 300 0.6 10
4-8 y 1.0 500 15 400 0.6 15
Adolescents 9-13 y 1.0 500 15 600 0.6 20
14-18 y 1.8 500 30 800 1.0 30
Adults ≥ 19 y 1.8 500 30 1,000 1.0 500

Life Stage Group Pantothenic acid
(mg /day)
Riboflavin
(mg /day)
Thiamine
(mg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y 0.2 500 0.04 100 0.04 100
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
14-18 y 0.4 500 0.08 100 0.07 100
Adults ≥ 19 y 0.4 500 0.08 100 0.07 100

Life Stage Group Vitamin A3
(µg RAE/day)
Min All-trans retinol - Max All-trans retinyl acetate - Max All-trans retinyl palmitate - Max
Infants 0-12 mo 30 600 600 600
Children 1-3 y 30 600 600 600
4-8 y 30 900 900 900
Adolescents 9-13 y 30 1,700 1,700 1,700
14-18 y 65 2,800 2,800 2,800
Adults ≥ 19 y 65 3,003 3,000 3,022

Life Stage Group Vitamin B6
(mg /day)
Vitamin B124
(µg /day)
Vitamin C
(mg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y 0.05 30 0.09 1,000 2.2 400
4-8 y 0.05 40 0.09 1,000 2.2 650
Adolescents 9-13 y 0.05 60 0.09 1,000 2.2 1,200
14-18 y 0.10 80 0.14 1,000 6.0 1,800
Adults ≥ 19 y 0.10 100 0.14 1,000 6.0 2,000

Life Stage Group Vitamin D
(µg /day)
Vitamin E5
(mg ATday)
Min Max Min dl-alpha-Tocopherol - Max d-alpha-Tocopherol - Max
Infants 0-12 mo 0.5 25 - - -
Children 1-3 y 0.8 25 0.6 100 200
4-8 y 0.8 25 0.6 150 300
Adolescents 9-13 y 0.8 25 0.6 300 600
14-18 y 1.0 25 1.0 400 800
Adults ≥ 19 y 1.0 25 1.0 500 1,000

Life Stage Group Vitamin K1 or K2
(µg /day)
Min Max

Table 8 Footnotes

t8fn1

Return to Table 8 footnote1 referrer

Folate and vitamin B12:

  • As folate supplementation can mask a vitamin B12 deficiency, products providing folate at doses ≥400 µg per day are required to supplement with vitamin B12 at the RDA dosage. Refer to Appendix III for the RDA definition and Appendix IV for a detailed list of RDA values.
  • For products providing folate at doses between 200 - 399 µg per day, products are required to add a risk statement. Refer to Section 6.0 Risk information.
  • If a product is marketed specifically as a prenatal supplement (for pregnant women), it must have at least 400 µg of folate per day. Health Canada (HC 2009a,b) recommends that all women who could become pregnant take a daily multivitamin/mineral supplement containing 400 µg of folic acid per day. At a minimum, women who are planning to become pregnant should start taking this supplement 3 months before the pregnancy. Pregnant women should take a multivitamin/mineral supplement containing 400-800 µg of folic acid per day to help meet the folate requirements of the pregnancy.
t8fn2

Niacin/Niacinamide: A specific use or purpose statement must be made for products providing > 35 mg niacin, niacinamide, or a combination of the two per day.

Return to Table 8 footnote2 referrer

t8fn3

Vitamin A: There is a potential risk of hypervitaminosis A resulting from the use of products which combine high doses of vitamin A and beta-carotene. See Appendix V ("Mitigating the Risk of Hypervitaminosis A") for information on how to determine acceptable daily doses of each of these medicinal ingredients when used in combination.

Return to Table 8 footnote3 referrer

t8fn4

Cobalt + Vitamin B12: As vitamin B12 is the source ingredient for cobalt, the maximum dose for cobalt and vitamin B12 combined must not exceed 1000 µg vitamin B12 per day.

Return to Table 8 footnote4 referrer

t8fn5

Vitamin E: A combination of dl-alpha-tocopherol and d-alpha-tocopherol must not exceed the maximum daily dose established for dl-alpha-tocopherol (i.e. 500 mg AT/day).

Return to Table 8 footnote5 referrer

Infants 0-12 mo - -
Children 1-3 y 3 30
4-8 y 3 55
Adolescents 9-13 y 3 60
14-18 y 6 75
Adults ≥ 19 y 6 120

5.4 Dose information for minerals

Table 9. Daily doses for minerals (Min = minimum; Max = maximum)
Life Stage Group Calcium
(mg /day)
Chromium
(μg /day)
Cobalt1
(μg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y 65 1,500 - - 0.004 44
4-8 y 65 1,500 - - 0.004 44
Adolescents 9-13 y 65 1,500 - - 0.004 44
14-18 y 65 1,500 - - 0.006 44
Adults ≥ 19 y 65 1,500 2.2 500 0.006 44

Life Stage Group Copper
(μg /day)
Iodine
(μg /day)
Iron2
(mg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - 0.6 40
Children 1-3 y 35 700 6 133 0.6 40
4-8 y 35 2,500 6 200 0.6 40
Adolescents 9-13 y 35 4,000 6 400 0.6 40
14-18 y 65 6,500 14 800 1.4 45
Adults ≥ 19 y 65 8,000 14 800 1.4 45

Life Stage Group Magnesium3
(mg /day)
Manganese
(mg /day)
Molybdenum
(μg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y 12 65 - - - -
4-8 y 12 110 - - - -
Adolescents 9-13 y 12 350 - - - -
14-18 y 20 350 - - - -
Adults ≥ 19 y 20 500 0.13 9 2.5 2,000

Life Stage Group Phosphorus
(mg /day)
Selenium
(μg /day)
Silicon
(mg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y 62 2,000 - - - -
4-8 y 62 2,000 - - - -
Adolescents 9-13 y 62 2,000 - - - -
14-18 y 62 2,000 - - - -
Adults ≥ 19 y 62 2,000 3.5 200 >0 84

Life Stage Group Zinc4 5
(mg /day)
Min Max

Table 9 Footnotes

t9fn1

Cobalt + Vitamin B12: As vitamin B12 is the source ingredient for cobalt, the maximum dose for cobalt and vitamin B12 combined must not exceed 1000 µg of vitamin B12 per day.

Return to Table 9 footnote1 referrer

t9fn2

Iron: A specific use or purpose statement must be made for products providing > 35 mg iron per day.

Return to Table 9 footnote2 referrer

t9fn3

Magnesium: A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.

Return to Table 9 footnote3 referrer

t9fn4

Zinc: A specific use or purpose statement must be made for products providing > 40 mg zinc per day.

Return to Table 9 footnote4 referrer

t9fn5

Zinc: As zinc supplementation can cause a copper deficiency, manufacturers of products providing high doses of zinc are encouraged to supplement with sufficient quantities of copper. Refer to Appendix VII to determine how much copper is sufficient to mitigate this risk and for information on how to determine if a risk statement might be necessary.

Return to Table 9 footnote5 referrer

Infants 0-12 mo 0.2 2
Children 1-3 y 0.4 7
4-8 y 0.4 12
Adolescents 9-13 y 0.4 23
14-18 y 0.7 34
Adults ≥ 19 y 0.7 50

5.5 Dose information for other medicinal ingredients

Table 10. Daily doses for other medicinal ingredients (Min = minimum; Max = maximum)
Life Stage Group Beta-carotene1
(μg /day)
Choline2
(mg /day)
L-Methionine2
(mg/day)
Min Max Min Max Min Max
Infants 0-12 mo 180 3,600 - - - -
Children 1-3 y 180 3,600 19 1,000 40 1,000
4-8 y 180 5,400 19 1,000 40 1,000
Adolescents 9-13 y 180 10,200 19 1,000 40 1,000
14-18 y 390 16,800 27 1,000 91 1,000
Adults ≥ 19 y 390 18,000 27 1,000 91 1,000

Life Stage Group Lutein2
(mg /day)
Lycopene2
(mg /day)
Potassium3
(mg/day)
Min Max Min Max Min Max

Table 10 Footnotes

t10fn1

Beta-carotene: There is a potential risk of hypervitaminosis A resulting from the use of products which combine high doses of vitamin A and beta-carotene. See Appendix V ("Mitigating the Risk of Hypervitaminosis A") for information on how to determine acceptable daily doses of each of these medicinal ingredients when used in combination.

Return to Table 10 footnote1 referrer

t10fn2

At least two of the following references were consulted: Christen et al. 2008; Fletcher et al. 2008; Johnson et al. 2008; Kristal et al. 2008; Moeller et al. 2008; Silaste et al. 2007; IOM 2006; Shao and Hathcock 2006; Shils et al. 2006; Porrini et al. 2005; WHO 2005; Alves-Rodrigues and Shao 2004; Richer et al. 2004; Olmedilla et al. 2003; Giovannucci et al. 2002; IOM 2002; Kucuk et al. 2002; Brown et al. 1999; Gann et al. 1999; IOM 1998; Giovannucci et al. 1995.

Return to Table 10 footnote2 referrer

t10fn3

Potassium: At least 100 mg of potassium per day is required to support the uses or purposes listed in Section 4.2.3. Only general uses or purposes are permitted at daily doses below 100 mg of potassium.

Return to Table 10 footnote3 referrer

Infants 0-12 mo - - - - - -
Children 1-3 y - - - - - -
4-8 y - - - - - -
Adolescents 9-13 y - - - - - -
14-18 y - - - - - -
Adults ≥ 19 y >0 20 >0 30 >0 200

5.6 Dose information for complementary medicinal ingredients

Table 11. Daily doses for complementary medicinal ingredients (Min = minimum; Max = maximum)
Life Stage Group Boron
(μg /day)
Inositol
(mg /day)
Nickel
(μg/day)
Min Max Min Max Min Max
Infants 0-12 mo - - - - - -
Children 1-3 y - - 0 650 - -
4-8 y - - 0 650 - -
Adolescents 9-13 y - - 0 650 - -
14-18 y - - 0 650 - -
Adults ≥ 19 y >0 700 >0 650 >0 350

Life Stage Group PABA1
(mg /day)
Tin
(mg /day)
Vanadium
(μg/day)
Min Max Min Max Min Max

Table 11 Footnotes

t11fn1

The following references were consulted: Weidner et al. 2005, Bardhan et al. 2000, Tisdale et al. 1995, Clegg et al. 1994.

Return to Table 11 footnote1 referrer

Infants 0-12 mo - - - - - -
Children 1-3 y - - - - - -
4-8 y - - - - - -
Adolescents 9-13 y - - - - - -
14-18 y - - - - - -
Adults ≥ 19 y >0 1,200 >0 2 >0 182

5.7 Directions for use

Statement(s) to the effect of:

For products providing nicotinic acid at doses of 500 mg per day:

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

For products containing calcium, iron or zinc:

  • Take a few hours before or after taking other medications or natural health products (Sweetman 2015; ASHP 2005).

For products providing nicotinic acid at doses ≥ 10 mg per day or containing calcium, iron or zinc:

  • Take with food (IOM 2011; Sweetman 2015).

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

  • Take with food, or
  • Take on an empty stomach.

6.0 Risk information

Statement(s) to the effect of:

6.1 Cautions and warnings

Table 12. Cautions and warnings for all medicinal ingredients with associated daily doses
Medicinal ingredient Daily dose Caution(s) and warning(s)
Beta-carotene > 6,000 µg If you are a tobacco smoker, consult a health care practitioner prior to use (Touvier et al. 2005; Omenn et al. 1996; ATBC 1994).
Iron Where the package contains more than the equivalent of 250 mg of elemental iron Keep out of reach of children. There is enough iron 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 (JC 2011, 2008)].
Manganese > 5 mg If you have a liver disorder, consult a health care practitioner prior to use (IOM 2006; IOM 2001; Krieger et al. 1995).
PABA All doses
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use (Maren 1976).
  • If you are taking sulfonamides, consult a health care practitioner prior to use (Maren 1976).
Selenium 200 µg If you have a history of non-melanoma skin cancer, consult a health care practitioner prior to use (Duffield-Lillico et al. 2003).
Vanadium All doses If you are pregnant or breastfeeding, consult a health care practitioner prior to use (IOM 2006; IOM 2001).
Vitamin E ≥ 180 mg AT If you have cancer, consult a health care practitioner prior to use (Meyer et al. 2008; Bairati et al. 2006; Bairati et al. 2005).
≥ 268 mg AT If you have cardiovascular disease or diabetes, consult a health care practitioner prior to use (Ward et al. 2007; Winterbone et al. 2007; Lonn et al. 2005).
≥ 360 mg AT If you are taking blood thinners, consult a health care practitioner prior to use (CPS 2012; IOM 2006; Booth et al. 2004; Corrigan and Marcus 1974).
Vitamin K1 and/or K2 All doses If you are taking blood thinners, consult a health care practitioner prior to use (ASHP 2005; Franco et al. 2004; IOM 2001; Hansten et al. 1997).

6.2 Contraindications

Table 13. Contraindications for all medicinal ingredients with associated daily doses
Medicinal ingredient Daily dose Contraindication(s)

Potassium

≥ 100 mg

Do not use with other potassium-containing supplements or with potassium-containing salt-substitutes (Sweetman 2015).

6.3 Known adverse reactions

Table 14. Known adverse reactions for all medicinal ingredients with associated daily doses
Medicinal ingredient Daily dose Known adverse reaction(s)

Table 14 Footnotes

Table 14 Footnote 1

Folate: Statement required if the product does not include Vitamin B12 at the RDA dosage. See Appendix III for the
RDA definition and Appendix IV for detailed values according to life stage group. Products containing a quantity of
folate equal or superior to 400 µg must include Vitamin B12 at the RDA dosage.

Return to Table 14 footnote1 referrer

Table 14 Footnote 2

Zinc: Statement required if the product does not meet the minimum copper requirements outlined in Appendix VII, Table 23.

Return to Table 14 footnote2 referrer

Calcium

Adults > 50 y

≥ 1000 mg

Kidney stone formation has been known to occur. Consult a health care practitioner to determine appropriate supplementation levels (IOM 2011; Jackson et al. 2006).

Folate1

200-399 µg

Folate supplementation can mask a vitamin B12 deficiency (IOM 2006; IOM 1998). If you are unsure whether you are taking enough vitamin B12, consult a health care practitioner prior to use.

Iron

> 35 mg

Some people may experience constipation, diarrhoea and/or vomiting (IOM 2006; IOM 2001).

All doses

Hypersensitivity has been known to occur; in which case, discontinue use (de Barrio et al. 2008)

Magnesium

> 350 mg

Some people may experience diarrhoea (IOM 2006; IOM 1997).

Nicotinic acid

≥ 10 mg

People sensitive to nicotinic acid may experience flushing of the skin that is generally mild and transient (IOM 2006; IOM 1998).
PABA

All doses

Hypersensitivity has been known to occur; in which case, discontinue use (Maren 1976).

Zinc2

Infants 0-12 mo

≤ 2 mg

Zinc supplementation can cause a copper deficiency (IOM 2006; IOM 2001). If you are unsure whether you are taking enough copper, consult a health care practitioner prior to use.

Children 1-3 y

5-7 mg

Children 4-8 y

8-12 mg

Children 9-13

16-23 mg

Adolescents 14-18

25-34 mg

Adults ≥ 19

31-50 mg

7.0 Storage Conditions

Statement(s) to the effect of:

Store in airtight container, protected from light.

8.0 Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

9.0 Specifications

  • The finished product specifications must be established in accordance with the requirements
    described in the Natural and Non-prescription Health Products Directorate (NNHPD)
    Quality of Natural Health Products Guide.
  • The medicinal ingredient(s) must comply with the requirements outlined in the NHPID.
  • The medicinal ingredient(s) may comply with the specifications outlined in the following standards listed in Schedule B of the Food and Drugs Act:

     European Pharmacopoeia (Ph.Eur.)
     Pharmacopée française (Ph.F.)
     Pharmacopoeia Internationalis (Ph.I.)
     The British Pharmacopoeia (B.P.)
     The Canadian Formulary (C.F.)
     The National Formulary (N.F.)
     The Pharmaceutical Codex: Principles and Practices of Pharmaceuticals
     The United States Pharmacopeia (USP)

10.0 References

11.0 Appendices

Appendix I

Source ingredients with two active components

A source ingredient may provide more than one active component in this monograph. For example, calcium ascorbate provides both calcium and ascorbic acid (vitamin C). The form and label must declare all active components of a source ingredient as medicinal ingredients and provide their quantity per dosage unit if the total daily dose of that active component (i.e. vitamin or mineral) exceeds the monograph's minimum dosage value.

For certain source ingredients that provide more than one active component, when one of the components is used within its acceptable dosage range it could result in the other component exceeding its acceptable dosage range.

For example, a product formulated to provide the maximum dosage value of calcium for adults (i.e. 1500 mg) from the source ingredient calcium ascorbate would provide 13.2 g of vitamin C. This exceeds vitamin C's adult maximum dosage value of 2000 mg; and therefore, such a product would not be supported for safety. Based on the calculation described below, the maximum dosage value of calcium from the source ingredient calcium ascorbate would be 228 mg as this dose provides 2000 mg of vitamin C.

The following table outlines dose restriction information for calcium ascorbate. It provides the maximum dosage values for calcium and its corresponding source ingredient. Below this table is a sample calculation which demonstrates how these values were derived.

Table 15. Dose restrictions for calcium from the source ingredient calcium ascorbate
Life Stage Group Maximum dosage value of calcium from calcium ascorbate
(mg Ca/day) (mg/day calcium ascorbate)
Infants 0-12 mo
Children 1-3 y 46 (443)
4-8 y 74 (720)
Adolescents 9-13 y 137 (1,330)
14-18 y 205 (1,995)
Adults ≥19 y 228 (2,216)

Sample Calculation

Question: What is the maximum quantity of calcium (maximum dosage value for adults ≥19 y) from the source ingredient calcium ascorbate that can be used in a formulation?

Solution: In order to make this determination, the quantity of calcium from calcium ascorbate that provides the maximum dosage value for adults ≥19 y of ascorbic acid (vitamin C) must be calculated.

Source ingredient: calcium ascorbate (calcium di-ascorbate): Ca(C6H7O6)2
There are 2 molecules of ascorbate (C6H7O6) for every one of calcium (Ca)

Molecular weight = MW
Maximum dosage value (for adults,≥19 y) = M
Number of molecules = N

Sample Calculation

Appendix II

Guidelines for use or purpose statements

It is mandatory for all Natural Health Products to cite at least one use or purpose statement.

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 statements).

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.

Appendix III

Definitions and dosage value 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 a RDA cannot be determined (IOM 2006).
Maximum dosage value:
The highest medicinal ingredient quantity which a product can supply in a daily dose to support its safe use.
Minimum dosage value:
The lowest medicinal ingredient quantity which a product can supply in a daily dose to support recommended claims.
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 values:

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.

  1. 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?)?
    1. What is the average dietary intake?
    2. What doses have previously been marketed in Canada?
    3. What do other regulatory agencies and expert groups recommend as their maximum daily dose?
    4. 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 the Prescription Drug List at 1,000 IU or 25 µg/day (HC 2015)];
    • Vitamin K1 and K2 [adult dose was set as per the listing on the Prescription Drug List at 120 µg/day (HC 2015) and children's doses were set at the AI level (IOM 2006)].
  1. Maximum dosage values for minerals with unestablished physiological functions (i.e. 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 and potassium, 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 (applying the following conversion factor: 6 µg beta-carotene = 1 µg RAE) (HC 1990; FAO/WHO 1967). For potassium, the maximum dosage value was set as per Schedule II of the National Association of Pharmacy Regulatory Authorities (NAPRA 1999).

Minimum dosage value:

For medicinal ingredients which did not have an RDA or AI, the minimum dose was set at >0. For the remaining medicinal ingredients (with the exception of potassium), 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 vitamin and mineral minimum dose requirements of the Food and Drug Regulation, Sections D.01.004 and D.02.002 (JC 2011)].
    1. The highest value derived for children (1-13 years) was applied to all children within this age category;
    2. The highest value derived for adolescents (≥ 14 years) and adults (including pregnant and breastfeeding women) was applied;
    3. The highest value derived for infants (0-12 months) was applied (if applicable).

For potassium, the AI was inappropriate for setting a minimum dosage value; therefore, the minimum was set at >0.

Appendix IV

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

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 or purpose statement: "Helps to prevent (appropriate vitamin or mineral) deficiency"; and
  • 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, a RDA or AI value has not been established.
Table 16. Recommended Dietary Allowance (RDA) and Adequate Intake* (AI) for vitamins (IOM 2011; IOM 2006)
Life Stage Group Biotin
(μg /day)
Folate
(μg /day)
Niacin/niacinamide
(mg/day)
Pantothenic acid
(mg/day)
Riboflavin
(mg/day)
Infants 0-6 mo - - - - -
7-12 mo - - - - -
Children 1-3 y 8* 150 6 2* 0.5
4-8 y 12* 200 8 3* 0.6
Adolescent Males 9-13 y 20* 300 12 4* 0.9
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
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
19-50 y 30* 600 18 6* 1.4
Breastfeeding 14-18 y 35* 500 17 7* 1.6
19-50 y 35* 500 17 7* 1.6

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* - - -
7-12 mo - 500* - - -
Children 1-3 y 0.5 300 0.5 0.9 15
4-8 y 0.6 400 0.6 1.2 25
Adolescent Males 9-13 y 0.9 600 1.0 1.8 45
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
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
19-50 y 1.4 770 1.9 2.6 85
Breastfeeding 14-18 y 1.4 1,200 2.0 2.8 115
19-50 y 1.4 1,300 2.0 2.8 120

Life Stage Group Vitamin D
(μg /day)
Vitamin E
(mg AT/day)
Vitamin K11
(μg /day)

Table 16 Footnotes

t16fn1

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).

Return to Table 16 footnote1 referrer

Infants 0-6 mo 10* - -
7-12 mo 10* - -
Children 1-3 y 15 6 30*
4-8 y 15 7 55*
Adolescent Males 9-13 y 15 11 60*
14-18 y 15 15 75*
Adult Males 19-30 y 15 15 120*
31-50 y 15 15 120*
51-70 y 15 15 120*
> 70 y 20 15 120*
Adolescent Females 9-13 y 15 11 60*
14-18 y 15 15 75*
Adult Females 19-30 y 15 15 90*
31-50 y 15 15 90*
51-70 y 15 15 90*
> 70 y 20 15 90*
Pregnancy 14-18 y 15 15 75*
19-50 y 15 15 90*
Breastfeeding 14-18 y 15 19 75*
19-50 y 15 19 90*
Table 17. Recommended Dietary Allowance (RDA) and Adequate Intake* (AI) for minerals (IOM 2011; IOM 2006)
Life Stage Group Boron
(mg/day)
Calcium
(mg/day)
Chromium
(μg /day)
Cobalt1
(μg /day)
Copper
(μg /day)
Infants 0-6 mo - 200* - - -
7-12mo - 260* - - -
Children 1-3 y - 700 - 0.04 340
4-8 y - 1,000 - 0.05 440
Adolescent Males 9-13 y - 1,300 - 0.08 700
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 - 1,000 30* 0.10 900
> 70 y - 1,200 30* 0.10 900
Adolescent Females 9-13 y - 1,300 - 0.08 700
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
19-50 y - 1,000 30* 0.11 1,000
Breastfeeding 14-18 y - 1,300 - 0.12 1,300
19-50 y - 1,000 45* 0.12 1,300

Life Stage Group Iodine
(μg /day)
Iron
(mg/day)
Magnesium
(mg/day)
Manganese
(mg/day)
Molybdenum
(μg /day)
Infants 0-6 mo - 0.27* - - -
7-12 mo - 11 - - -
Children 1-3 y 90 7 80 - -
4-8 y 90 10 130 - -
Adolescent Males 9-13 y 120 8 240 - -
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 - -
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 - -
19-50 y 220 27 355 2.0* 50
Breastfeeding 14-18 y 290 10 360 - -
19-50 y 290 9 315 2.6* 50

Life Stage Group Nickel
(mg/day)
Phosphorus
(mg/day)
Selenium
(μg /day)
Silicon
(mg/day)
Tin
(mg/day)
Infants 0-6 mo - - - - -
7-12 mo - - - - -
Children 1-3 y - 460 - - -
4-8 y - 500 - - -
Adolescent Males 9-13 y - 1,250 - - -
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 - - -
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 - - -
19-50 y - 700 60 - -
Breastfeeding 14-18 y - 1,250 - - -
19-50 y - 700 70 - -

Life Stage Group Vanadium
(mg/day)
Zinc
(mg/day)

Table 17 Footnotes

t17fn1

Calculated from the vitamin B12 RDA (IOM 2006)

Return to Table 17 footnote1 referrer

Infants 0-6 mo - 2*
7-12 mo - 3
Children 1-3 y - 3
4-8 y - 5
Adolescent Males 9-13 y - 8
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
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
19-50 y - 11
Breastfeeding 14-18 y - 13
19-50 y - 12

Appendix V

Guidance for Products Containing Beta-Carotene

Background:

Although all of the claims for beta-carotene are associated with its vitamin A activity, it is not acceptable to cite beta-carotene as a source of vitamin A. This is because the rate of conversion of beta-carotene to vitamin A in the human body depends on numerous factors (e.g. vitamin A status, dietary factors such as vegetable consumption and fat intake, genetic factors, etc.). In other words, the consumption of supplemental beta-carotene does not always result in a consistent rate of conversion to vitamin A. Nevertheless, products providing beta-carotene do contribute to vitamin A requirements; therefore, all of the health claims associated with beta-carotene are linked to its vitamin A activity. Furthermore, there is a potential risk of hypervitaminosis A associated with the consumption of combinations including both beta-carotene and vitamin A.

Determining dosage requirements for the claim "Helps to prevent vitamin A deficiency":

In order to make any prevention of deficiency health claims, a nutrient must be included in a product at a dose at or above its Recommended Dietary Allowance (RDA) or Adequate Intake (AI). There are three potential scenarios in which a product would qualify for the claim: "Helps to prevent vitamin A deficiency":

  1. The product could provide vitamin A on its own: See Appendix IV to determine vitamin A minimum dosage requirements;
  2. The product could provide beta-carotene on its own: See Table 18 below for minimum dosage requirements; or
  3. The product could provide both beta-carotene and vitamin A: See Appendix IV to determine vitamin A minimum dosage requirements and apply the conversion factor of 6 µg of beta-carotene = 1 µg all-trans retinol (HC 1990; FAO/WHO 1967).
Table 18. Daily dose in microgram (µg) of beta-carotene
Life Stage Group Minimum dosage value of beta-carotene1 (µg/day)

Table 18 Footnotes

t18fn1

These values are based on the RDAand AI values for vitamin A based on life stage group (IOM 2006) and were derived from the conversion factor of 6 µg of beta-carotene = 1 µg all-trans retinol; hence, a ratio of 6:1 beta-carotene:vitamin A, on a weight to weight basis (HC 1990; FAO/WHO 1967).

Return to Table 18 footnote1 referrer

Infants 0-6 mo 2,400*
7-12 mo 3,000*
Children 1-3 y 1,800
4-8 y 2,400
Adolescent males 9-13 y 3,600
14-18 mo 5,400
Adult males ≥ 19 y 5,400
Adolescent females 9-13 y 3,600
14-18 y 4,200
Adult females ≥ 19 y 4,200
Pregnancy 14-18 y 4,500
19-50 y 4,620
Breastfeeding 14-18 y 7,200
19-50 y 7,800

Example:

As per Appendix IV, the minimum dose for the vitamin A deficiency claim for adults (excluding breastfeeding women) is 900 µg per day. This is based on the highest RDA for all adult subpopulations (i.e. 900 µg for adult males). There are three potential ways this dose can be achieved:

  1. Vitamin A alone (900 µg RAE (from vitamin A) per day);
  2. Beta-carotene alone (5400 µg beta-carotene per day); or
  3. Combinations of vitamin A plus beta-carotene (e.g. 500 µg RAE (from vitamin A) + 2400 µg beta carotene = 900 µg RAE per day).

Note: The depiction of beta-carotene in RAE is to demonstrate the efficacy of the combination of vitamin A and beta-carotene only and must not appear on the PLA form or label.

Mitigating the Risk of Hypervitaminosis A:

In products containing both vitamin A and beta-carotene, the risk of hypervitaminosis A is to be mitigated by ensuring that the combined doses of these two medicinal ingredients is not excessively high. Therefore, the combined dose of vitamin A plus beta-carotene must not exceed the maximum dosage value for vitamin A, measured in µg RAE (See Table 8). The conversion factor of 6 µg beta-carotene = 1 µg RAE (HC 1990; FAO/WHO 1967) can be applied for the specific purpose of ensuring safety of the combined dose. The example below illustrates how the 6:1 conversion factor can be used to determine the safety of combinations including beta-carotene and vitamin A:

Example:

The maximum dosage value of vitamin A for adults is 3000 µg RAEper day. If a product contained 2800 µg vitamin A (i.e. all-trans retinol, vitamin A acetate, vitamin A palmitate), then it could contain no more than 1200 µg beta-carotene. See calculation below:

2800 µg vitamin A + 1200 µg beta-carotene (200 µg RAE) = 3000 µg RAE.

Note: The value of 3000 µg RAE is to demonstrate the safety of the combination of vitamin A and beta-carotene only and must not appear on the PLA form or label.

Appendix VI

Conversion factors

1. Pantothenic Acid (USP 38):
Table 19: Conversion of pantothenic acid source ingredient quantity into pantothenic acid quantity
Source ingredient
(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 0.53
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 PLA form in the potency field and on product labels.

Table 20: Conversion of vitamin A source ingredient quantity into vitamin A quantity in terms of retinol activity equivalents (RAE) and vitamin A activity in terms of International Units (IU)
Source ingredient
(1 μg)
Vitamin A quantity
(μg RAE)
Vitamin A activity
(IU)
All-trans retinol 1.00 3.33
All-trans retinyl acetate 0.87 2.91
All-trans retinyl palmitate 0.55 1.82

Examples using the vitamin A conversation factors:

Converting vitamin A activity into quanitity of RAE (µg)

Converting 500IU 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

or

= 3000 IU x 0.87 µg RAE/2.91 IU vitamin A

= 897 µg RAE

3. Beta-carotene:

1 IU beta-carotene = 0.6 µg beta-carotene(USP 38)

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 alpha-tocopherol (AT) (i.e. mg 2R-alpha-tocopherol), irrespective of the source ingredient used.

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

Table 21. 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 ingredient
(1 mg)
Vitamin E quantity
(mg AT)
Vitamin E activity
(IU)
d-alpha-tocopherol 1.00 1.49
d-alpha-tocopheryl acetate 0.91 1.36
d-alpha-tocopheryl succinate 0.81 1.21
dl-alpha-tocopherol 0.50 1.10
dl-alpha-tocopheryl acetate 0.46 1.00
dl-alpha-tocopheryl succinate 0.41 0.89
Table 22. Conversion of vitamin E source ingredient activity (IU) into vitamin E quantity in terms of alpha-tocopherol (mg AT)
Source ingredient
(1 IU)
Vitamin E quantity
(mg AT)
d-alpha-tocopherol 0.67
d-alpha-tocopheryl acetate 0.67
d-alpha-tocopheryl succinate 0.67
dl-alpha-tocopherol 0.45
dl-alpha-tocopheryl acetate 0.46
dl-alpha-tocopheryl succinate 0.46

Examples using the vitamin E conversion factors:

  1. Converting vitamin E activity into quantity of AT (mg)

    Convert 400 IU of d-alpha-tocopheryl succinate activity into mg AT:
    = 400 IU x 0.67 mg AT/IU
    = 268 mg AT

  2. 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

Appendix VII

Zinc and Copper Relationship

Zinc supplements can cause a copper deficiency. In order to mitigate this risk, applicants are encouraged to supplement high dose zinc products with copper. Table 23 below outlines how much copper is sufficient to mitigate this risk based on both life stage group and zinc daily dosage. Products which do not fulfill the zinc and copper quantity guidelines require an additional risk statement. See Section 6.0 Risk Information.

Table 23. Daily dosage of copper required to mitigate the risk of copper deficiency in products containing high doses of zinc
Life Stage Group Daily dosage range of zinc which requires added copper or a risk statement
(mg/day)
Daily dosage range of copper required to avoid a risk statement
(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

Examples using Table 23:

  1. Question: Product A is targeted to adults only. The product provides a daily dose of zinc of 30 mg but does not contain copper. Is a risk statement necessary on this product?

    Answer: No. According to Table 23, for an adult subpopulation, there is no need for copper supplementation at a dose of 30 mg zinc per day. Therefore, no risk statement is required.


  2. Question: Product B is targeted to adults and adolescents ≥ 12 years. The product provides zinc and copper at daily dosages of 20 mg and 500 µg, respectively. Is a risk statement necessary on this product?

    Answer: Yes. According to Table 23, for an adult subpopulation, there is no need for copper supplementation at a daily dose of 20 mg zinc. However, for adolescents ≥ 12 years, products providing daily doses of zinc between 16-23 mg need at least 920 µg copper per day. As the product in this example provides 500 µg of copper per daily dose, the following risk statement is required: "Zinc supplementation can cause a copper deficiency. If you are unsure whether you are taking enough copper, consult a health care practitioner prior to use"