MULTI-VITAMIN/MINERAL SUPPLEMENTS MONOGRAPH
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(PDF Version - 604 KB)Date
March 31, 2023
Table of Contents
- 1.0 Proper names, common names and source information
- 1.1 Vitamin proper names, common names and source information
- 1.2 Mineral proper names, common names and source information
- 1.3 Other medicinal ingredient proper names, common names and source information
- 1.4 Complementary medicinal ingredients proper names, common names and source information
- 2.0 Route of administration
- 3.0 Dosage forms
- 4.0 Uses or purposes
- 5.0 Doses
- 5.1 Subpopulations
- 5.2 Background on dose
- 5.3 Dose information for vitamins
- 5.4 Dose information for minerals
- 5.5 Dose information for other medicinal ingredients
- 5.6 Dose information for complementary medicinal ingredients
- 5.7 Directions for use
- 6.0 Durations of use
- 7.0 Risk information
- 8.0 Storage conditions
- 9.0 Non-medicinal ingredients
- 10.0 Specifications
- 11.0 References
- 12.0 Appendices
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.
- This monograph includes specific information for each vitamin and mineral as well as combination rules and may be used to support single ingredient or multi-ingredient products containing any medicinal ingredient from Tables 1, 2 and/or 3.
- 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(s) must be supported by at least one medicinal ingredient from Tables 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 listed 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.
- The dose information for vitamins and minerals outlined in this monograph is the quantity of the medicinal ingredient as opposed to the source material and/or source ingredient, i.e., the amount of the vitamin itself and elemental mineral, respectively. For products containing calcium, iron, magnesium and/or zinc as medicinal ingredient(s), please refer to Appendix VIII for additional guidance on labelling in order to avoid misinterpretation which may lead to serious health consequences.
- 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 and/or statements are synonymous. Either term or statement may be selected by the applicant.
1.0 Proper names, Common names and Source information
Notes
- The terms chromic, cupric, ferrous, ferric and manganous are not available on the web-based PLA form and will not be added; however, these synonyms may be used on the marketed label for chromium (III), copper (II), iron (II), iron (III) and manganese (II) respectively.
- Any hydrated form of a source ingredient listed in Tables 1, 2 and 3 would be acceptable on the marketed label as long as it is included in the Natural Health Products Ingredients Database (NHPID).
1.1 Vitamin proper names, common names and source information
1,2 At least one of the following references was consulted per name: NIH 2015a; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013; IOM 2006.
3 At least one of the following references was consulted per source information: NIH 2015a; FAO 2012; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013; EFSA 2009a; FSANZ 2008; IOM 2006; Van Der Kuy et al. 2002; Chalmers et al. 2000; EC 2000; Zeitlin et al. 1985.
1.2 Mineral proper names, common names and source information
1, 2 At least one of the following references was consulted per name: NIH 2015a; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013.
3 At least one of the following references was consulted per source information: Albion 2015; BP 2015; NIH 2015a,b; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013; Jain et al. 2012; 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; EC 2002; Van Der Kuy et al. 2002; Anderson et al. 2001; Hendler and Rorvik 2001; Albion 2000; Chalmers et al. 2000; EC 2000; Tsuboi et al. 2000; Ishitani et al. 1999; Patrick 1999; IPCS 1998; Albion 1997a,b; Grant et al. 1997; Albion 1996a,b; Fujita et al. 1996; Murray 1996; Albion 1995; Henderson 1994; Albion 1993a,b,c,d,e; Evans and Pouchnik 1993; Albion 1992; Zeitlin et al. 1985.
4 Bone meal: When bone meal is used as a source ingredient for calcium or phosphorus, it must be sourced from a non-human animal that is not susceptible to transmissible spongiform encephalopathy diseases, including bovine spongiform encephalopathy (HC 2013).
5 Chromium picolinate: If chromium picolinate is indicated as a source ingredient of chromium, additional restrictions apply (refer to Tables 12, 13 and 14).
6 If iodine is sourced from Fucus vesiculosus, Fucus serratus, Ascophyllum nodosum, Laminaria digitata or Laminaria japonica, it should be isolated and purified. This monograph does not support algal extracts.
7 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. If silicon is sourced from Equisetum arvense herb top, it should be isolated and purified. This monograph does not support Equisetum arvense extracts.
8 Zinc picolinate: If zinc picolinate is indicated as a source ingredient of zinc, the product must be for Adults only and the maximum daily dose is restricted to 25 mg (refer to Table 9). In addition, additional restrictions apply (refer to Tables 12 and 14).
1.3 Other medicinal ingredient proper names, common names and source information
1,2 At least one of the following references was consulted per name: NIH 2015a; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013.
3 At least one of the following references was consulted per source information: NIH 2015a; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013; EFSA 2009e; EFSA 2008d; EFSA 2007; FAO 2006.
4 If lutein is sourced from Tagetes erecta herb flowering oleoresin, it should be isolated and purified. This monograph does not support Tagetes erecta extracts.
5 If lycopene is sourced from Solanum lycopersicum fruit flesh, it should be isolated and purified. This monograph does not support Solanum lycopersicum extracts.
6 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.
1.4 Complementary medicinal ingredients proper names, common names and source information
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 medicinal ingredients. The product claim(s) must be supported by at least a medicinal ingredient from Tables 1, 2 and/or 3.
| Proper name(s)1 | Common name(s)2 | Source information3 | ||
|---|---|---|---|---|
| Source ingredient(s) | Source material(s) | Part(s) | ||
| Boron | Boron |
|
N/A | N/A |
| myo-Inositol | Inositol |
|
N/A | N/A |
| Nickel | Nickel |
|
N/A | N/A |
|
|
para-Aminobenzoic acid | N/A | N/A |
| N/A | Saccharomyces cerevisiae4 | Whole | ||
| Tin | Tin | Stannous chloride | N/A | N/A |
| Vanadium | Vanadium |
|
N/A | N/A |
1,2 At least one of the following references was consulted per name: NIH 2015a; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013.
3 At least one of the following references was consulted per source information: NIH 2015a; Sweetman 2015; USP 38 2015; FCC 9 2014; O'Neil 2013; EFSA 2009a,e; EFSA 2008d,g; EFSA 2007; O'Neil et al 2006, EFSA 2004.
4 If PABA is sourced from Saccharomyces cerevisiae whole, it should be isolated and purified. This monograph does not support Saccharomyces cerevisiae extracts.
2.0 Route of administration
Oral
3.0 Dosage forms
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms by age group:
Infants 0-12 months, Children 1-2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/ liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.
4.0 Uses or Purposes
- It is mandatory for all natural health products to indicate at least one use or purpose statement.
- The use or purpose statements can be combined on the product label as appropriate (e.g. Helps to form red blood cells; Helps in energy metabolism/(and) tissue formation = Helps to form red blood cells and in energy metabolism and tissue formation).
- In addition, claims such as 'Helps in energy metabolism/(and) tissue formation' could be listed on the label as 'Helps in energy metabolism' or 'Helps in tissue formation' or 'Helps in energy metabolism and tissue formation'.
4.1 General use or purpose statements
Products containing any vitamin and/or mineral from Tables 1 and/or 2 and/or beta-carotene and potassium from Table 3 (not acceptable for other medicinal ingredients from Table 3 or medicinal ingredients listed in Table 4).
- 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.
- Maintains/supports good health.
- Contributes to maintaining general health.
- For maintaining general health.
- A factor in the maintenance of good health.
- A factor in normal growth and development
Products containing at least one vitamin or mineral from Tables 1 and/or 2 (all vitamins and minerals in the product must be at minimum therapeutic dose as listed in Tables 8 and 9)
- Vitamin supplement.
- Mineral supplement.
- Vitamin and mineral supplement.
Products containing at least two vitamins and/or minerals from Tables 1 and/or 2 (all vitamins and minerals in the product must be at minimum therapeutic dose as listed in Tables 8 and 9)
- Multi-vitamin supplement
- Multi-mineral supplement
- Multi-vitamin and multi-mineral supplement.
4.2 Specific use or purpose statements
Notes
- Refer to Appendix II for guidelines on using the specific uses or purposes outlined in this section.
- Since several medicinal ingredients are associated with a source of antioxidant or electrolyte claim, there is an option to use these statements in plural. The singular should be used when the product only contains one medicinal ingredient associated with these claims; the plural form should be used when more than one medicinal ingredient with such properties are included in the product formulation at therapeutic dose.
4.2.1 Specific use or purpose statements for vitamins
1 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.
2 For deficiency claims: 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.
3 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'.
4 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.
5 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.
4.2.2 Specific use or purpose statements for minerals
1 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.
2 For deficiency claims: 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.
3 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'.
4 Iron: A specific use or purpose statement must be made for products providing > 35 mg iron per day.
5 Magnesium: A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.
6 Magnesium deficiency claim: As the RDA for magnesium for children 1-3 years, children 4-8 years and adolescents 14-18 years exceeds the maximum dose, this claim is not permitted for these subpopulations.
7 Zinc: A specific use or purpose statement must be made for products providing > 40 mg zinc per day.
4.2.3 Specific use or purpose statements for other medicinal ingredients
1At 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; Wickett et al. 2007; IOM 2006; Miranda et al. 2006; Shao and Hathcock 2006; Shils et al. 2006; Zeisel 2006; Barel et al. 2005; 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.
2 beta-Carotene: Vitamin A deficiency claim: See Appendix V for guidance on the appropriate use of this claim.
3 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.
5.0 Doses
5.1 Subpopulations
Adults 19 and older is the only acceptable subpopulation for the source ingredients HAP or HVP as well as for the following medicinal ingredients:
- Boron
- Chromium
- Lutein
- Lycopene
- Manganese
- Molybdenum
- Nickel
- PABA
- Potassium
- Selenium
- Silicon
- Tin
- Vanadium
- Zinc sourced from zinc picolinate
5.2 Background on dose
Notes
- 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 B12, vitamin D and vitamin E.
- Dose information for adults includes pregnant and breastfeeding women. However, products containing PABA, vanadium, chromium sourced from chromium picolinate and/or zinc sourced from zinc picolinate require a mandatory risk statement for these subpopulations. See Section 7.0 for additional details.
5.3 Dose information for vitamins
1 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.
2 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.
3 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.
4 Vitamin B12 + Cobalt: As vitamin B12 is the source ingredient for cobalt, the maximum dose for vitamin B12 and cobalt combined must not exceed 1000 μg vitamin B12 per day. Refer to Appendix VI for conversion from vitamin B12 to cobalt.
5 Vitamin E: A combination of dl-alpha-tocopherol (synthetic form) and d-alpha-tocopherol (natural form) must not exceed the maximum daily dose of 1000 mg of alpha-tocopherol from all sources (IOM 2006) with a maximum of 1500 IU/day of d-alpha-tocopherol and 1100 IU/day of dl-alpha-tocopherol.
1 IU = 0.67 mg for d-alpha-tocopherol
1 IU = 0.90 mg for dl-alpha-tocopherol which is equivalent to 0.45 mg of the biologically active alpha-tocopherol equivalent.
The total amount of vitamin E should be used to determine if additional risk statements are required (refer to Table 13).
5.4 Dose information for minerals
Table 9. Daily doses for minerals (Min = minimum; Max = maximum)
| Life Stage Group | Calcium1 (mg/day) | Chromium (µg/day) | Cobalt2 (µg/day) | |||||
|---|---|---|---|---|---|---|---|---|
| Min | Max | Min | Max | Min | Max | |||
| Infants | 0-12 months | - | - | - | - | - | - | |
| Children | 1-3 years | 65 | 1,500 | - | - | 0.004 | 44 | |
| 4-8 years | 65 | 1,500 | - | - | 0.004 | 44 | ||
| Adolescents | 9-13 years | 65 | 1,500 | - | - | 0.004 | 44 | |
| 14-18 years | 65 | 1,500 | - | - | 0.006 | 44 | ||
| Adults | 19 years and older | 65 | 1,500 | 2.2 | 500 | 0.006 | 44 | |
| Life Stage Group | Copper (µg/day) | Iodine (µg/day) | Iron1,3 (mg/day) | |||||
| Min | Max | Min | Max | Min | Max | |||
| Infants | 0-12 months | - | - | - | - | 0.6 | 40 | |
| Children | 1-3 years | 35 | 700 | 6 | 133 | 0.6 | 40 | |
| 4-8 years | 35 | 2,500 | 6 | 200 | 0.6 | 40 | ||
| Adolescents | 9-13 years | 35 | 4,000 | 6 | 400 | 0.6 | 40 | |
| 14-18 years | 65 | 6,500 | 14 | 800 | 1.4 | 45 | ||
| Adults | 19 years and older | 65 | 8,000 | 14 | 800 | 1.4 | 45 | |
| Life Stage Group | Magnesium1,4 (mg/day) | Manganese (mg/day) | Molybdenum (µg/day) | |||||
| Min | Max | Min | Max | Min | Max | |||
| Infants | 0-12 months | - | - | - | - | - | - | |
| Children | 1-3 years | 12 | 65 | - | - | - | - | |
| 4-8 years | 12 | 110 | - | - | - | - | ||
| Adolescents | 9-13 years | 12 | 350 | - | - | - | - | |
| 14-18 years | 20 | 350 | - | - | - | - | ||
| Adults | 19 years and older | 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 months | - | - | - | - | - | - | |
| Children | 1-3 years | 62 | 2,000 | - | - | - | - | |
| 4-8 years | 62 | 2,000 | - | - | - | - | ||
| Adolescents | 9-13 years | 62 | 2,000 | - | - | - | - | |
| 14-18 years | 62 | 2,000 | - | - | - | - | ||
| Adults | 19 years and older | 62 | 2,000 | 3.5 | 200 | >0 | 84 | |
| Life Stage Group | Zinc (from non-picolinate sources)1,5,6 (mg/day) | Zinc (from zinc picolinate)1,5,6 (mg/day) | ||||||
| Min | Max | Min | Max | |||||
| Infants | 0-12 months | 0.2 | 4 | - | - | |||
| Children | 1-3 years | 0.4 | 7 | - | - | |||
| 4-8 years | 0.4 | 12 | - | - | ||||
| Adolescents | 9-13 years | 0.4 | 23 | - | - | |||
| 14-18 years | 0.7 | 34 | - | - | ||||
| Adults | 19 years and older | 0.7 | 50 | 0.7 | 25 | |||
1 Refer to Appendix VIII for additional wording on the label to clarify that the quantity of the medicinal ingredient is the amount of elemental mineral in order to avoid misinterpretation that may lead to serious health consequences.
2Cobalt + 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. Refer to Appendix VI for conversion from cobalt to vitamin B12.
3 Iron: A specific use or purpose statement must be made for products providing > 35 mg iron per day.
4 Magnesium: A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.
5 Zinc: A specific use or purpose statement must be made for products providing > 40 mg zinc per day.
6 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 is necessary.
5.5 Dose information for other medicinal ingredients
| Life Stage Group | beta-Carotene1 (µg/day) | Choline2 (mg/day) | L-Methionine2 (mg/day) | ||||
|---|---|---|---|---|---|---|---|
| Min | Max | Min | Max | Min | Max | ||
| Infants | 0-12 months | 180 | 3,600 | - | - | - | - |
| Children | 1-3 years | 180 | 3,600 | 19 | 1,000 | 40 | 1,000 |
| 4-8 years | 180 | 5,400 | 19 | 1,000 | 40 | 1,000 | |
| Adolescents | 9-13 years | 180 | 10,200 | 19 | 1,000 | 40 | 1,000 |
| 14-18 years | 390 | 16,800 | 27 | 1,000 | 66.5 | 1,000 | |
| Adults | 19 years and older | 390 | 18,000 | 27 | 1,000 | 66.5 | 1,000 |
| Life Stage Group | Lutein2 (mg/day) | Lycopene2 (mg/day) | Potassium3 (mg/day) | ||||
| Min | Max | Min | Max | Min | Max | ||
| Infants | 0-12 months | - | - | - | - | - | - |
| Children | 1-3 years | - | - | - | - | - | - |
| 4-8 years | - | - | - | - | - | - | |
| Adolescents | 9-13 years | - | - | - | - | - | - |
| 14-18 years | - | - | - | - | - | - | |
| Adults | 19 years and older | >0 | 20 | >0 | 30 | >0 | 200 |
1 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 for information on how to determine acceptable daily doses of each of these medicinal ingredients when used in combination.
2 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.
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.
5.6 Dose information for complementary medicinal ingredients
| Life Stage Group | Boron (µg/day) | Inositol (mg/day) | Nickel (µg/day) | ||||
|---|---|---|---|---|---|---|---|
| Min | Max | Min | Max | Min | Max | ||
| Infants | 0-12 months | - | - | - | - | - | - |
| Children | 1-3 years | - | - | >0 | 650 | - | - |
| 4-8 years | - | - | >0 | 650 | - | - | |
| Adolescents | 9-13 years | - | - | >0 | 650 | - | - |
| 14-18 years | - | - | >0 | 650 | - | - | |
| Adults | 19 years and older | >0 | 700 | >0 | 650 | >0 | 350 |
| Life Stage Group | PABA1 (mg/day) | Tin (mg/day) | Vanadium (µg/day) | ||||
| Min | Max | Min | Max | Min | Max | ||
| Infants | 0-12 months | - | - | - | - | - | - |
| Children | 1-3 years | - | - | - | - | - | - |
| 4-8 years | - | - | - | - | - | - | |
| Adolescents | 9-13 years | - | - | - | - | - | - |
| 14-18 years | - | - | - | - | - | - | |
| Adults | 19 years and older | >0 | 1,200 | >0 | 2 | >0 | 182 |
1 The following references were consulted: Weidner et al. 2005, Bardhan et al. 2000, Tisdale et al. 1995, Clegg et al. 1994.
5.7 Directions for use
Products providing 500 mg of nicotinic acid, per day
- Do not exceed the recommended dose except on the advice of a physician.
Products providing 10 mg or more of nicotinic acid, per day
- Take with food (IOM 2011; Sweetman 2015).
Products providing calcium, iron or zinc
- Take with food, a few hours before or after taking other medications or natural health products (Sweetman 2015; IOM 2011; ASHP 2005).
In all other cases, optional statement(s), as appropriate
- Take with food, or
- Take on an empty stomach.
Products providing 400 mcg or more of folate, per day (e.g. as a prenatal supplement) (optional statement)
- 400 mcg of folate per day is adequate for most women (to reduce the risk of neural tube defects). Consult a health care practitioner/health care provider/health care professional/doctor/physician to determine if you would benefit from additional folate before taking this product.
6.0 Durations of use
| Medicinal ingredient | Daily dose | Contraindication(s) |
|---|---|---|
| Chromium sourced from chromium picolinate | All doses | Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 6 months (Anton et al. 2008; Campbell et al. 2002; Campbell et al. 1999; Cefalu et al. 1999; Kato et al. 1998; Anderson et al. 1997; Pasman et al. 1997; Lee et al. 1994). |
| Zinc sourced from zinc picolinate | All doses | Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 3 months (Sakai et al. 2002) |
7.0 Risk information
7.1 Cautions and warnings
| Medicinal ingredient | Daily dose | Caution(s) and warning(s) |
|---|---|---|
| beta-Carotene | > 6,000 μg | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are a tobacco smoker (Touvier et al. 2005; Omenn et al. 1996; ATBC 1994). |
| Chromium sourced from chromium picolinate | ≥ 200 μg | Consult a health care practitioner/health care provider/health care professional/doctor/physician if you have a kidney disorder and/or diabetes (Wani et al. 2006; Cupp et al. 2003; Bunner and McGinnis 1998; Cerulli et al. 1998; McCarty et al. 1997; Wasser et al. 1997). |
| 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 | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a liver disorder (IOM 2006; IOM 2001; Krieger et al. 1995). |
| PABA | All doses | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding or if you are taking sulfonamides (Maren 1976). |
| Selenium | > 70 μg | Consult a health care practitioner/health care provider/health care professional/doctor/physician 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/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (IOM 2006; IOM 2001). |
| Vitamin E | ≥ 180 mg AT | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have cancer (Meyer et al. 2008; Bairati et al. 2006; Bairati et al. 2005). |
| ≥ 268 mg AT | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have cardiovascular disease or diabetes (Ward et al. 2007; Winterbone et al. 2007; Lonn et al. 2005). | |
| ≥ 360 mg AT | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood thinners (CPS 2012; IOM 2006; Booth et al. 2004; Corrigan and Marcus 1974). | |
| Vitamin K1 and/or K2 | All doses | Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking blood thinners (ASHP 2005; Franco et al. 2004; IOM 2001; Hansten et al. 1997). |
7.2 Contraindications
| Medicinal ingredient | Daily dose | Contraindication(s) |
|---|---|---|
| Chromium sourced from chromium picolinate | All doses | Do not use this product if you are pregnant or breastfeeding (EFSA 2009k; IOM 2001). |
| Potassium | ≥ 100 mg | Do not use this product with other potassium-containing supplements or with potassium-containing salt-substitutes (Sweetman 2015). |
| Zinc sourced from zinc picolinate | All doses | Do not use this product if you are pregnant or breastfeeding (EFSA 2009k; IOM 2001). |
7.3 Known adverse reactions
| Medicinal ingredient | Daily dose | Known adverse reaction(s) | |
|---|---|---|---|
| Iron | > 35 mg | Some people may experience constipation, diarrhoea and/or vomiting (IOM 2006; IOM 2001). | |
| All doses | Stop use if hypersensitivity occurs (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 | Stop use if hypersensitivity occurs (Maren 1976). | |
| Zinc1 | Infants 0-12 months | ≤ 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 years | 5-7 mg | ||
| Children 4-8 years | 8-12 mg | ||
| Adolescents 9-13 years | 16-23 mg | ||
| Adolescents 14-18 years | 25-34 mg | ||
| Adults 19 years and older | 31-50 mg | ||
1 Zinc: Statement required if the product does not meet the minimum copper requirements outlined in Appendix VII, Table 24.
8.0 Storage conditions
Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).
9.0 Non-medicinal ingredients
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
10.0 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.
11.0 References
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EFSA 2010a: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Scientific Opinion on the use of ferric sodium EDTA as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses. The EFSA Journal 2010;8(1):1414. [Accessed 2018 July 24]. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/1414.pdf
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EFSA 2009a: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Inositol hexanicotinate (inositol hexaniacinate) as a source of niacin (vitamin B3) added for nutritional purposes in food supplements. The EFSA Journal 2009;949:1-20 [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.949
EFSA 2009b: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Calcium ascorbate, magnesium ascorbate and zinc ascorbate added for nutritional purposes in food supplements. The EFSA Journal 2009;994:1-22. [Accessed 2018 July 24]. Available from: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/994.pdf
EFSA 2009c: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Inability to assess the safety of chromium-enriched yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source, based on the supporting dossiers. The EFSA Journal 2009;1083:1-8. [Accessed 2018 July 24]. Available from: http://focalpointbg.com/images/stories/efsa/contents/pdfdocs/ans_ej1083_Chromiumenrichedyeast_st_en.pdf
EFSA 2009d: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Manganese ascorbate, manganese aspartate, manganese bisglycinate and manganese pidolate as sources of manganese added for nutritional purposes to food supplements. The EFSA Journal 2009;1114:1-23. [Accessed 2018 July 24]. Available from: http://focalpointbg.com/images/stories/efsa/contents/pdfdocs/ans_ej1114_Manganesesources_op_en.pdf
EFSA 2009e. European Food Safety Authority (EFSA) SCIENTIFIC OPINION Calcium acetate, calcium pyruvate, calcium succinate, magnesium pyruvate magnesium succinate and potassium malate added for nutritional purposes to food supplements. The EFSA Journal 2009;1088:1-25. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.1088
EFSA 2009f. European Food Safety Authority (EFSA) SCIENTIFIC OPINION Chromium (III) lactate trihydrate as a source of chromium added for nutritional purposes to food supplements. The EFSA Journal 2009;1112:1-20. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.1112
EFSA 2009g. European Food Safety Authority (EFSA) SCIENTIFIC OPINION Chromium nitrate as a source of chromium added for nutritional purposes to food supplements. The EFSA Journal 2009;1111:1-19. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.1111
EFSA 2009h: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Iron (II) taurate, magnesium taurate and magnesium acetyl taurate as sources of iron or magnesium added for nutritional purposes in food supplements. The EFSA Journal 2009;947:1- 30. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.947
EFSA 2009i: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Ferrous phosphate added for nutritional purposes to food supplements. The EFSA Journal 2009;951:1-13. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.951
EFSA 2009j. European Food Safety Authority (EFSA) SCIENTIFIC OPINION Potassium molybdate as a source of molybdenum added for nutritional purposes to food supplements. The EFSA Journal 2009;1136:1-21. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.1136
EFSA 2009k: European Food Safety Authority. 2009. The EFSA Journal: Scientific Opinion Chromium picolinate, zinc picolinate and zinc picolinate dehydrate added for nutritional purposes in food supplements. The EFSA Journal 2009; 1113:1-41. [Accessed 2018 July 24]. Available from: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1113/epdf
EFSA 2008a: European Food Safety Authority (EFSA). SCIENTIFIC OPINION Calcium Sulphate for Use as a Source of Calcium in Food Supplements. The EFSA Journal 2008;814:1-9. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2008.814
EFSA 2008b: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Mixture of chromium di- and tri-nicotinate as a source of chromium added for nutritional purposes in food supplements and in foods for particular nutritional uses. The EFSA Journal 2008;887:1-24. [Accessed 2018 July 24]. Available from: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/887.pdf
EFSA 2008c: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Selenium-enriched yeast as source for selenium added for nutritional purposes in foods for particular nutritional uses and foods (including food supplements) for the general population. The EFSA Journal 2008;766:1-42. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2008.766
EFSA 2008d: European Food Safety Authority (EFSA). SCIENTIFIC OPINION Magnesium aspartate, potassium aspartate, magnesium potassium aspartate, calcium aspartate, zinc aspartate, and copper aspartate as sources for magnesium, potassium, calcium, zinc, and copper added for nutritional purposes to food supplements. The EFSA Journal 2008;883:1-23. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2008.883
EFSA 2008e: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Magnesium L-lysinate, calcium L- lysinate, zinc L- lysinate as sources for magnesium, calcium and zinc added for nutritional purposes in food supplements. The EFSA Journal 2008;761:1-11. [Accessed 2018 July 24]. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/761.pdf
EFSA 2008f: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Calcium L-methionate, magnesium L-methionate and zinc mono-L-methionine sulphate added for nutritional purposes to food supplements. The EFSA Journal 2008;924:1-26. [Accessed 2018 July 24]. Available from: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/924.pdf
EFSA 2008g: European Food Safety Authority (EFSA) SCIENTIFIC OPINION Vanadium citrate, bismaltolato oxo vanadium and bisglycinato oxo vanadium added for nutritional purposes to foods for particular nutritional uses and foods (including food supplements) intended for the general population and vanadyl sulphate, vanadium pentoxide and ammonium monovanadate added for nutritional purposes to food supplements. The EFSA Journal 2008;634:1-15. [Accessed 2018 July 24]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2008.634
EFSA 2007: European Food Safety Authority (EFSA) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to Calcium, iron, magnesium, potassium and zinc L-pidolate as sources for calcium, iron, magnesium, potassium and zinc added for nutritional purposes to food supplements and to foods intended for particular nutritional uses. The EFSA Journal 2007:495-503:1-10. [Accessed 2018 July 24]. Available from: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/495.pdf
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12.0 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 PLA 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 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.
| Life Stage Group | Maximum dosage value of calcium from calcium ascorbate (mg Ca/day) (mg/day calcium ascorbate) | |
|---|---|---|
| Infants | 0-12 months | - |
| Children | 1-3 years | 46 (443) |
| 4-8 years | 74 (720) | |
| Adolescents | 9-13 years | 137 (1,330) |
| 14-18 years | 205 (1,995) | |
| Adults | 19 years and older | 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
Calcium = Ca
PMCa = 40,1 g/mol
MCa= ?
Ascorbic acid = Aa
PMAa = 176,1 g/mol
MAa = 2 g
[MCa]/[PMCa x n] = [MAa]/[PMAa x n]
[MCa]/[40,1 g/mol x 1] = [2 g]/[176,1 g/mol x 2]
MCa = [g x 40.1 g/mol x 1]/[176,1 g/mol x 2]
MCa = [80,2 g2/mol]/[352,2 g/mol]
MCa = 0,228 g ou 228 mg
Appendix II
Guidelines for use or purpose statements
It is mandatory for all natural health products to indicate 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
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:
These values were established by the Food and Nutrition Board of the Institute of Medicine in collaboration with Health Canada (IOM 2006).
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:
- 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?)?
- What is the average dietary intake?
- What doses have previously been marketed in Canada?
- What do other regulatory agencies and expert groups recommend as their maximum daily dose?
- 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)].
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 Regulations, Sections D.01.004 and D.02.002 (JC 2011)].
- 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, 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.
- For the prevention of deficiency claims, the daily dose of the medicinal ingredient must meet the highest AI or RDA amount for the given subpopulation.
For example, for vitamin A, if the subpopulation is "Adults" and if the product is not contraindicated for
pregnant or breastfeeding women, the RDA value to be met would be 1,300 μg RAE/day.
| Life Stage Group | Vitamin A (μg RAE/day) | |
|---|---|---|
| Adult males | 19-30 years | 900 |
| 31-50 years | 900 | |
| 51-70 years | 900 | |
| More than 70 years | 900 | |
| Adult females | 19-30 years | 700 |
| 31-50 years | 700 | |
| 51-70 years | 700 | |
| More than 70 years | 700 | |
| Pregnancy | 14-18 years | 750 |
| 19-50 years | 770 | |
| Breastfeeding | 14-18 years | 1,200 |
| 19-50 years | 1,300 | |
| Life Stage Group | Biotin (μg/day) | Folate (μg/day) | Niacin/ niacinamide (mg/day) | Panto-thenic acid (mg/day) | Riboflavin (mg/day) | |
|---|---|---|---|---|---|---|
| Infants | 0-6 months | - | - | - | - | - |
| 7-12 months | - | - | - | - | - | |
| Children | 1-3 years | 8* | 150 | 6 | 2* | 0.5 |
| 4-8 years | 12* | 200 | 8 | 3* | 0.6 | |
| Adolescent males | 9-13 years | 20* | 300 | 12 | 4* | 0.9 |
| 14-18 years | 25* | 400 | 16 | 5* | 1.3 | |
| Adult males | 19-30 years | 30* | 400 | 16 | 5* | 1.3 |
| 31-50 years | 30* | 400 | 16 | 5* | 1.3 | |
| 51-70 years | 30* | 400 | 16 | 5* | 1.3 | |
| More than 70 years | 30* | 400 | 16 | 5* | 1.3 | |
| Adolescent females | 9-13 years | 20* | 300 | 12 | 4* | 0.9 |
| 14-18 years | 25* | 400 | 14 | 5* | 1.0 | |
| Adult females | 19-30 years | 30* | 400 | 14 | 5* | 1.1 |
| 31-50 years | 30* | 400 | 14 | 5* | 1.1 | |
| 51-70 years | 30* | 400 | 14 | 5* | 1.1 | |
| More than 70 years | 30* | 400 | 14 | 5* | 1.1 | |
| Pregnancy | 14-18 years | 30* | 600 | 18 | 6* | 1.4 |
| 19-50 years | 30* | 600 | 18 | 6* | 1.4 | |
| Breastfeeding | 14-18 years | 35* | 500 | 17 | 7* | 1.6 |
| 19-50 years | 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 months | - | 400* | - | - | - |
| 7-12 months | - | 500* | - | - | - | |
| Children | 1-3 years | 0.5 | 300 | 0.5 | 0.9 | 15 |
| 4-8 years | 0.6 | 400 | 0.6 | 1.2 | 25 | |
| Adolescent males | 9-13 years | 0.9 | 600 | 1.0 | 1.8 | 45 |
| 14-18 years | 1.2 | 900 | 1.3 | 2.4 | 75 | |
| Adult males | 19-30 years | 1.2 | 900 | 1.3 | 2.4 | 90 |
| 31-50 years | 1.2 | 900 | 1.3 | 2.4 | 90 | |
| 51-70 years | 1.2 | 900 | 1.7 | 2.4 | 90 | |
| More than 70 years | 1.2 | 900 | 1.7 | 2.4 | 90 | |
| Adolescent females | 9-13 years | 0.9 | 600 | 1.0 | 1.8 | 45 |
| 14-18 years | 1.0 | 700 | 1.2 | 2.4 | 65 | |
| Adult females | 19-30 years | 1.1 | 700 | 1.3 | 2.4 | 75 |
| 31-50 years | 1.1 | 700 | 1.3 | 2.4 | 75 | |
| 51-70 years | 1.1 | 700 | 1.5 | 2.4 | 75 | |
| More than 70 years | 1.1 | 700 | 1.5 | 2.4 | 75 | |
| Pregnancy | 14-18 years | 1.4 | 750 | 1.9 | 2.6 | 80 |
| 19-50 years | 1.4 | 770 | 1.9 | 2.6 | 85 | |
| Breastfeeding | 14-18 years | 1.4 | 1,200 | 2.0 | 2.8 | 115 |
| 19-50 years | 1.4 | 1,300 | 2.0 | 2.8 | 120 | |
| Life Stage Group | Vitamin D (μg/day) | Vitamin E (mg AT/day) | Vitamin K1 (μg/day) | |||
| Infants | 0-6 months | 10* | - | - | ||
| 7-12 months | 10* | - | - | |||
| Children | 1-3 years | 15 | 6 | 30* | ||
| 4-8 years | 15 | 7 | 55* | |||
| Adolescent males | 9-13 years | 15 | 11 | 60* | ||
| 14-18 years | 15 | 15 | 75* | |||
| Adult males | 19-30 years | 15 | 15 | 120* | ||
| 31-50 years | 15 | 15 | 120* | |||
| 51-70 years | 15 | 15 | 120* | |||
| More than 70 years | 20 | 15 | 120* | |||
| Adolescent females | 9-13 years | 15 | 11 | 60* | ||
| 14-18 years | 15 | 15 | 75* | |||
| Adult females | 19-30 years | 15 | 15 | 90* | ||
| 31-50 years | 15 | 15 | 90* | |||
| 51-70 years | 15 | 15 | 90* | |||
| More than 70 years | 20 | 15 | 90* | |||
| Pregnancy | 14-18 years | 15 | 15 | 75* | ||
| 19-50 years | 15 | 15 | 90* | |||
| Breastfeeding | 14-18 years | 15 | 19 | 75* | ||
| 19-50 years | 15 | 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); however this AI applies to vitamin K1, vitamin K2 and total vitamin K1 + K2.
| Life Stage Group | Boron (mg/day) | Calcium (mg/day) | Chromium (μg/day) | Cobalt1 (μg/day) | Copper (μg/day) | |
|---|---|---|---|---|---|---|
| Infants | 0-6 months | - | 200* | - | - | - |
| 7-12 months | - | 260* | - | - | - | |
| Children | 1-3 years | - | 700 | - | 0.04 | 340 |
| 4-8 years | - | 1000 | - | 0.05 | 440 | |
| Adolescent males | 9-13 years | - | 1,300 | - | 0.08 | 700 |
| 14-18 years | - | 1,300 | - | 0.10 | 890 | |
| Adult males | 19-30 years | - | 1,000 | 35* | 0.10 | 900 |
| 31-50 years | - | 1,000 | 35* | 0.10 | 900 | |
| 51-70 years | - | 1,000 | 30* | 0.10 | 900 | |
| More than 70 years | - | 1,200 | 30* | 0.10 | 900 | |
| Adolescent females | 9-13 years | - | 1,300 | - | 0.08 | 700 |
| 14-18 years | - | 1,300 | - | 0.10 | 890 | |
| Adult females | 19-30 years | - | 1,000 | 25* | 0.10 | 900 |
| 31-50 years | - | 1,000 | 25* | 0.10 | 900 | |
| 51-70 years | - | 1,200 | 20* | 0.10 | 900 | |
| More than 70 years | - | 1,200 | 20* | 0.10 | 900 | |
| Pregnancy | 14-18 years | - | 1,300 | - | 0.11 | 1,000 |
| 19-50 years | - | 1,000 | 30* | 0.11 | 1,000 | |
| Breastfeeding | 14-18 years | - | 1,300 | - | 0.12 | 1,300 |
| 19-50 years | - | 1,000 | 45* | 0.12 | 1,300 | |
| Life Stage Group | Iodine (μg/day) | Iron (mg/day) | Magnesium (mg/day) | Manganese (mg/day) | Molyb-denum (μg/day) | |
| Infants | 0-6 months | - | 0.27* | - | - | - |
| 7-12 months | - | 11 | - | - | - | |
| Children | 1-3 years | 90 | 7 | 80 | - | - |
| 4-8 years | 90 | 10 | 130 | - | - | |
| Adolescent males | 9-13 years | 120 | 8 | 240 | - | - |
| 14-18 years | 150 | 11 | 410 | - | - | |
| Adult males | 19-30 years | 150 | 8 | 400 | 2.3* | 45 |
| 31-50 years | 150 | 8 | 420 | 2.3* | 45 | |
| 51-70 years | 150 | 8 | 420 | 2.3* | 45 | |
| More than 70 years | 150 | 8 | 420 | 2.3* | 45 | |
| Adolescent females | 9-13 years | 120 | 8 | 240 | - | - |
| 14-18 years | 150 | 15 | 360 | - | - | |
| Adult females | 19-30 years | 150 | 18 | 310 | 1.8* | 45 |
| 31-50 years | 150 | 18 | 320 | 1.8* | 45 | |
| 51-70 years | 150 | 8 | 320 | 1.8* | 45 | |
| More than 70 years | 150 | 8 | 320 | 1.8* | 45 | |
| Pregnancy | 14-18 years | 220 | 27 | 400 | - | - |
| 19-50 years | 220 | 27 | 355 | 2.0* | 50 | |
| Breastfeeding | 14-18 years | 290 | 10 | 360 | - | - |
| 19-50 years | 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 months | - | - | - | - | - |
| 7-12 months | - | - | - | - | - | |
| Children | 1-3 years | - | 460 | - | - | - |
| 4-8 years | - | 500 | - | - | - | |
| Adolescent males | 9-13 years | - | 1,250 | - | - | - |
| 14-18 years | - | 1,250 | - | - | - | |
| Adult males | 19-30 years | - | 700 | 55 | - | - |
| 31-50 years | - | 700 | 55 | - | - | |
| 51-70 years | - | 700 | 55 | - | - | |
| More than 70 years | - | 700 | 55 | - | - | |
| Adolescent females | 9-13 years | - | 1,250 | - | - | - |
| 14-18 years | - | 1,250 | - | - | - | |
| Adult females | 19-30 years | - | 700 | 55 | - | - |
| 31-50 years | - | 700 | 55 | - | - | |
| 51-70 years | - | 700 | 55 | - | - | |
| More than 70 years | - | 700 | 55 | - | - | |
| Pregnancy | 14-18 years | - | 1,250 | - | - | - |
| 19-50 years | - | 700 | 60 | - | - | |
| Breastfeeding | 14-18 years | - | 1,250 | - | - | - |
| 19-50 years | - | 700 | 70 | - | - | |
| Life Stage Group | Vanadium (mg/day) | Zinc (mg/day) | ||||
| Infants | 0-6 months | - | 2* | |||
| 7-12 months | - | 3 | ||||
| Children | 1-3 years | - | 3 | |||
| 4-8 years | - | 5 | ||||
| Adolescent males | 9-13 years | - | 8 | |||
| 14-18 years | - | 11 | ||||
| Adult males | 19-30 years | - | 11 | |||
| 31-50 years | - | 11 | ||||
| 51-70 years | - | 11 | ||||
| More than 70 years | - | 11 | ||||
| Adolescent females | 9-13 years | - | 8 | |||
| 14-18 years | - | 9 | ||||
| Adult females | 19-30 years | - | 8 | |||
| 31-50 years | - | 8 | ||||
| 51-70 years | - | 8 | ||||
| More than 70 years | - | 8 | ||||
| Pregnancy | 14-18 years | - | 12 | |||
| 19-50 years | - | 11 | ||||
| Breastfeeding | 14-18 years | - | 13 | |||
| 19-50 years | - | 12 | ||||
1 Calculated from the vitamin B12 RDA (IOM 2006).
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 list beta-carotene as a source ingredient for 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":
- The product could provide vitamin A on its own: See Appendix IV to determine vitamin A minimum dosage requirements;
- The product could provide beta-carotene on its own: See Table 19 below for minimum dosage requirements; or
- 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).
| Life Stage Group | Minimum dose of beta-carotene1 (μg/day) | |
|---|---|---|
| Infants | 0-6 months | 2,400* |
| 7-12 months | 3,000* | |
| Children | 1-3 years | 1,800 |
| 4-8 years | 2,400 | |
| Adolescent males | 9-13 years | 3,600 |
| 14-18 years | 5,400 | |
| Adult males | 19 years and older | 5,400 |
| Adolescent females | 9-13 years | 3,600 |
| 14-18 years | 4,200 | |
| Adult females | 19 years and older | 4,200 |
| Pregnancy | 14-18 years | 4,500 |
| 19-50 years | 4,620 | |
| Breastfeeding | 14-18 years | 7,200 |
| 19-50 years | 7,800 | |
1 These values are based on the RDA and 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).
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:
- Vitamin A alone (900 µg RAE (from vitamin A) per day);
- beta-Carotene alone (5400 µg beta-carotene per day); or
- 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 RAE per 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
1. Pantothenic acid (USP 38):| Source ingredient (1 mg) | Pantothenic acid quantity (mg) |
|---|---|
| Calcium D-pantothenate | 0.92 |
| Calcium DL-pantothenate | 0.46 |
| Dexpanthenol | 1.07 |
| DL-Panthenol | 0.53 |
| DL-Pantothenic acid | 0.50 |
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 ingredient used.
International Units (IU) may be provided as optional additional information on the PLA form in the "additional quantity per dosage unit" field and on product labels.
| 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 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
or
= 3000 IU x 0.87 μg RAE/2.91 IU vitamin A
= 897 μg RAE
The quantity of beta-carotene must always be provided in weight amount (i.e. μg).
IUs may be provided as optional additional information on the PLA form in the "additional quantity per dosage unit" field and on product labels.
1 IU beta-carotene = 0.6 μg beta-carotene (USP 38)
1.5 μg of vitamin B12 = 0.06 μg of cobalt
5. Vitamin D:
The quantity of vitamin D must always be provided in weight amount (i.e. μg).
IUs may be provided as optional additional information on the PLA form in the "additional quantity per dosage unit" field and on product labels.
1 IU of vitamin D = 0.025 μg cholecalciferol (IOM 2006)
= 0.025 μg ergocalciferol
6. 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 "additional quantity per dosage unit" field and on product labels.
| 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 | 0.45 | 1.00 |
| dl-alpha-Tocopheryl succinate | 0.40 | 0.89 |
| 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 | 0.45 |
| dl-alpha-Tocopheryl succinate | 0.45 |
Examples using the vitamin E conversion factors:
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 ATConverting vitamin E source ingredient quantity into quantity of AT (mg)
Convert 200 mg of dl-alpha-tocopheryl acetate into mg AT:
= 200 mg x 0.45 mg AT/mg
= 90 mg AT
Appendix VII
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 24 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 below require an additional risk statement. See Section 7.0 Risk Information.
| 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 months | ≤ 2 | 0 |
| Children 1-3 years | 5-7 | 280-700 |
| Children 4-8 years | 8-12 | 480-2,500 |
| Adolescents 9-13 years | 16-23 | 920-4,000 |
| Adolescents 14-18 years | 25-34 | 1,360-6,500 |
| Adults 19 years and older | 31-50 | 2,000-8,000 |
Examples using Table 24:
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 24, 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.
- 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 24, 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".
Appendix VIII
Guidance on labelling for specific mineral supplements: calcium, iron, magnesium and zinc
Health care professionals and consumers have reported confusion in distinguishing between the quantity of the element (i.e., the medicinal ingredient) and the quantity of the salt (i.e., the source information) of the above four mineral supplements when reading the product label, which has led to medication errors in Canada including dosing errors. In the case of these minerals, dosing errors may lead to serious health consequences (ISMP 2021a, b, c). Health care professionals may recommend or prescribe to consumers calcium, iron, magnesium or zinc by either the elemental quantity or the salt quantity. The medicinal ingredient quantity listed on the label should be clearly associated with the elemental mineral.
a) Single ingredient mineral supplements
The quantity of the element must be clearly associated with the element name, so that it is not confused with the quantity of the salt. In addition, the quantity of the element and the salt may both appear on the label. Anhydrous salts should be clearly identified in order to account for their element-to-salt ratio. Note that the label generated by the web-based PLA form has not been adjusted to represent single ingredient products as recommended above; however, the information on the marketed label should be represented as clearly as possible based on this guideline.
Examples
Each tablet contains:
Calcium.....500 mg (calcium carbonate 1250 mg)
Each tablet contains:
Calcium.....500 mg
derived from calcium carbonate 1250 mg
Each tablet contains:
Iron..........60 mg (from anhydrous Iron (II) sulfate 190 mg)
In cases where a mineral supplement is derived from mixed source ingredients or complexes of the same element, the quantity of the salt(s) does not need to be identified. However, the addition of a note clarifying that the quantity of the mineral represents the amount of the element is recommended.
As per the label generated from the web-based PLA form:
|
Medicinal ingredient
(Source information) |
Medicinal ingredient Quantity per 1 tablet* |
|
Calcium ..................................................................................... (Calcium carbonate, Calcium citrate, Calcium fumarate) |
500 mg |
* For minerals, the medicinal ingredient quantity represents the amount of the element per tablet.
b) Multi-ingredient mineral supplements
The quantity of the element(s) must be clearly associated with the element name, so that it is not confused with the quantity of the salt(s). The quantity of the salt(s) does not need to be identified. However, the addition of a note clarifying that the quantity of the mineral represents the amount of the element would be recommended.
As per the label generated from the web-based PLA form:
|
Medicinal ingredient
(Source information) |
Medicinal ingredient Quantity per 1 tablet* |
|
Calcium ..................................................................................... (Calcium carbonate) |
500 mg |
|
Iron .......................................................................................... (Iron (II) sulfate) |
30 mg |
* For minerals, the medicinal ingredient quantity represents the amount of the element per tablet.