MULTI-VITAMIN/MINERAL SUPPLEMENTS MONOGRAPH

Date

April 24, 2026

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
  • 4.1 GENERAL USE OR PURPOSE STATEMENTS
  • 4.2 SPECIFIC USE OR PURPOSE STATEMENTS
    • 4.2.1 Specific use or purpose statements for vitamins
    • 4.2.2 Specific use or purpose statements for minerals
    • 4.2.3 Specific use or purpose statements for other medicinal ingredients
• 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
  • 7.1 CAUTIONS AND WARNINGS
  • 7.2 CONTRAINDICATIONS
  • 7.3 KNOWN ADVERSE REACTIONS
• 8.0 NON-MEDICINAL INGREDIENTS
• 9.0 STORAGE CONDITIONS
• 10.0 SPECIFICATIONS
• 11.0 EXAMPLE OF PRODUCT FACTS
• 12.0 REFERENCES
• 13.0 APPENDICES
  • APPENDIX I
  • APPENDIX II
  • APPENDIX III
  • APPENDIX IV
  • APPENDIX V
  • APPENDIX VI
  • APPENDIX VII
  • APPENDIX VIII
  • APPENDIX IX
• 14.0 VERSION HISTORY

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.

Notes

• Text in parentheses is additional optional information which can be included on the label at the applicant's discretion except in cases where a plural form of the statement does not apply (e.g., Source of electrolyte(s), when only one electrolyte is included in the product).
• The solidus (/) indicates that either term and/or statement may be selected on the label.
• 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.
• Sodium and ingredients where sodium is a substantial component are not included as medicinal ingredients on this monograph, due to health concerns associated with chronic supplemental use of sodium, 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.
• The web-based 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 web-based PLA form and label must include vitamin C as a medicinal ingredient and its quantity per dosage unit. See Appendix I for additional information.

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).
• For medicinal ingredients from Tables 1.1 to 1.4, both the synthetic and non-synthetic forms are supported by this monograph. However, if non-synthetic, the medicinal ingredient must be isolated and purified from a source material listed in its NHPID entry.
• All medicinal ingredients isolated from source materials must be of an acceptable purity. This monograph does not support extracts. Consult the NNHPD Quality of Natural Health Products Guide for more information on purity standards.

1.1 Vitamin proper names, common names and source information

^1,2 At least one of the following references was consulted per name: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024; IOM 2006.
3 At least one of the following references was consulted per source information: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024; FAO 2012; 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: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024.
³ At least one of the following references was consulted per source information: FCC 2026; NHPID 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024; NIH 2015; 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; Gruenwald et al. 2004; Allen 2002; Ball et al. 2002; EC 2002; Van Der Kuy et al. 2002; Anderson et al. 2001; Hendler and Rorvik 2001; Chalmers et al. 2000; EC 2000; Tsuboi et al. 2000; Ishitani et al. 1999; Patrick 1999; IPCS 1998; Grant et al. 1997; Fujita et al. 1996; Murray 1996; Henderson 1994; Evans and Pouchnik 1993; Zeitlin et al. 1985.
⁴ 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 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 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.
⁸ 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.
⁹ 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: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RCS 2025; USP-NF 2024.
³ At least one of the following references was consulted per source information: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024; FAO 2018; EFSA 2009e; EFSA 2008d; EFSA 2007.
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.

1.4 Complementary medicinal ingredients proper names, common names and source information

Note: 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.

^1,2 At least one of the following references was consulted per name: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024.
³ At least one of the following references was consulted per source information: FCC 2026; NIH 2026; Brayfield and Cadart 2025; RSC 2025; USP-NF 2024; EFSA 2009a,e; EFSA 2008d,g; EFSA 2007; 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; EMA/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; EMA/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’.
• Refer to Appendix IX, for multi-vitamin/mineral supplements claims acceptable at Class II and III for products recommended for occasional use only.

4.1 General use or purpose statements

Products containing any vitamin from Table 1 and/or beta-carotene from Table 3 at a therapeutic dose

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

Products containing any mineral from Table 2 at a therapeutic dose

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

Products containing any vitamin and mineral from Tables 1 and 2 and/or beta-carotene from Table 3 at a therapeutic dose

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

Products containing any vitamin and/or mineral from Tables 1 and/or 2 and/or beta-carotene from Table 3 at a therapeutic dose

• 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.
• Uses or purposes associated with pregnancy are not acceptable for products containing medicinal ingredients associated with a caution or contraindication regarding this subpopulation (i.e., chromium sourced from chromium picolinate, zinc sourced from zinc picolinate, nicotinamide mononucleotide, PABA and/or vanadium).

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 2025; 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; NIH 2001; Groff and Gropper 2000; IOM 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 the subpopulations. 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 Folic acid versus L-5-methyltetrahydrofolate: As mentioned in the HC's guide for healthy pregnancy, only folic acid has been proven to reduce the risk of neural tube defects in clinical trials. Also, individuals who are deficient in vitamin B12 may be less responsive to 5-methyltetrahydrofolate, but do respond to folic acid.
⁶ 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 2025; 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; NIH 2001; Groff and Gropper 2000; IOM 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 subpopulations. Note that most mineral deficiencies are rare in North America.
³These 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’.
⁴Iron: A specific use or purpose statement must be made for products providing > 35 mg iron per day.
⁵Magnesium: A specific use or purpose statement must be made for products providing > 350 mg magnesium per day.
⁶Magnesium 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.
⁷Zinc: 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

¹ At least two of the following references were consulted per use or purpose statement: CNF 2024; Abdellatif et al. 2021; Blanco-Vaca et al. 2021; Covarrubias et al. 2021; Picciotto et al. 2016; 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.
²beta-Carotene: Vitamin A deficiency claim: See Appendix V for guidance on the appropriate use of this claim.
³The 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.
⁴ NMN is a vitamin B₃ derivative and therefore uses associated with vitamin B₃ are acceptable.
⁵ 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’.

5.0 Doses

5.1 Subpopulations

Adults 19 years and older is the only acceptable subpopulation for the source ingredients HAP or HVP as well as for the following medicinal ingredients:

• Boron
• Chromium
• Manganese
• Molybdenum
• Nickel
• PABA
• Selenium
• Silicon
• Tin
• Vanadium
• Zinc sourced from zinc picolinate

Adults 18 years and older is the only acceptable subpopulation for the following medicinal ingredients:

• Lutein
• Lycopene
• Nicotinamide mononucleotide
• Potassium

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.
• For deficiency claims, the medicinal ingredient must be 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 subpopulations.
• 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.
• 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, vitamin E and folate.
• Dose information for adults includes pregnant and breastfeeding women, except for products containing chromium sourced from chromium picolinate, zinc sourced from zinc picolinate, nicotinamide mononucleotide, PABA and/or vanadium which require a mandatory risk statement for these subpopulations. See Section 7.0 for additional details.

5.3 Dose information for vitamins

¹ Folate:

• The units for folate are in micrograms of folic acid, not in micrograms dietary folate equivalents (DFE). Refer to Appendix VI, 7, for the conversion factors.
• 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.

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

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.
² 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. Refer to Appendix VI for conversion from cobalt to vitamin B_12.
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 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.
⁶ Zinc: A specific use or purpose statement must be made for products providing > 40 mg zinc per day.
⁷ 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 VIIVII 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

¹beta-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.
²At least two of the following references were consulted: Huang 2022; Okabe et al. 2022; Liao et al. 2021; 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.

5.6 Dose information for complementary medicinal ingredients

¹The 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 niacin sourced from nicotinic acid, per day

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

Products providing 10 mg or more of niacin sourced from nicotinic acid, per day

• Take with food (Brayfield and Cadart 2025; IOM 2011).

Products providing calcium, iron or zinc

• Take with food (Brayfield and Cadart 2025; IOM 2011; ASHP 2005).
• Take a few hours before or after taking other medications or health products (Brayfield and Cadart 2025; 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)*

• 400 mcg of folate per day is adequate for most women (to reduce the risk of neural tube defects). Ask 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.

*Note: It is recommended that products provide 400 micrograms (mcg) of folate per dosage unit. This allows consumers to meet the recommended daily dose of 400 mg of folate without exceeding it, if a higher dose is unnecessary.

Combination rule

When the medicinal ingredients Niacin and/or Niacinamide and/or Nicotinamide mononucleotide are combined, the total quantity per day must not exceed the maximum quantity listed in Table 8 for Niacin/Niacinamide (i.e., 500 mg/day).

6.0 Durations of use

7.0 Risk information

7.1 Cautions and warnings

¹ Zinc: Statement required if the product does not meet the minimum copper requirements outlined in Appendix VII, Table 24.

7.2 Contraindications

7.3 Known adverse reactions

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 Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

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 EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

12.0 References

• Abdellatif M, Sedej S, Kromer G. NAD+ Metabolism in Cardiac Health, Aging, and Disease. Circulation 2021;144(22):1795-1817.
• Allen LH. Advantages and limitations of iron amino acid chelates as iron fortificants. Nutrition Reviews 2002;60(7 Pt 2):S18-S21.
• Alves-Rodrigues A, Shao A. The science behind lutein. Toxicology Letters 2004;150(1):57-83.
• Anderson RA, Cheng N, Bryden NA, Polansky MM, Cheng N, Chi J, Feug J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes. Diabetes 1997;46(11):1786-1791.
• Anderson RA, Roussel AM, Zouari N, Mahjoub S, Matheau JM, Kerkeni A. Potential antioxidant effects of zinc and chromium supplementation in people with type 2 diabetes mellitus. Journal of the American College of Nutrition 2001;20(3):212-218.
• Anton SD, Morrison CD, Cefalu WT, Martin CK, Coulon S, Geiselman P, Hongmei H, White CL, Williamson DA. 2008. Diabetes Technology & Therapeutics 10:405-412.
• ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins.
• ATBC (Alpha-tocopherol, beta-carotene cancer prevention) study group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. The New England Journal of Medicine 1994;330(15):1029-1035.
• Bairati I, Meyer F, Gélinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Têtu B, Harel F, Mâsse B, et al. A randomized trial of antioxidant vitamins to prevent second primary cancers in head and neck cancer patients. The Journal of National Cancer Institute 2005;97(7):481-488.
• Bairati I, Meyer F, Jobin E, Gélinas M, Fortin A, Nabid A, Brochet F, Têtu B. Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients. International Journal of Cancer 2006;119(9):2221-2224.
• Ball P, Woodward D, Beard T. Shoobridge A, Ferrier M. Calcium diglutamate improves taste characteristics of lower-salt soup. European Journal of Clinical Nutrition 2002;56(6):519-523.
• Bardhan PK, Feger A, Kogon M, Muller J, Gillessen D, Beglinger C, Gyr N. Urinary choloyl-PABA excretion in diagnosing small intestinal bacterial overgrowth: evaluation of a new non-invasive method. Digestive Diseases and Sciences 2000;45(3):474-479.
• Barel A, Calomme M, Timchenko A, De Paepe K, Demeester N, Rogiers V, Clarys P, Vanden Berghe D. Effect of oral intake of choline-stabilized orthosilicic acid on skin, nails and hair in women with photodamaged skin. Arch Dermatol Res. 2005 Oct;297(4):147-53. Epub 2005 Oct 26.
• Benevenga NJ. Evidence for alternative pathways of methionine catabolism. Advances in Nutritional Research 1984;6:1-18.
• Bjørke Monsen AL, Ueland PM. Homocysteine and methylmalonic acid in diagnosis and risk assessment from infancy to adolescence. American Journal of Clinical Nutrition 2003;78(1):7-21.
• Blanco-Vaca F, Rotllan N, Canyelles M, Mauricio D, Escolà-Gil JC, Julve J. NAD+-Increasing Strategies to Improve Cardiometabolic Health? Frontiers in Endocrinology 2021;12.
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• 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 2026 March 5]. 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 2026 March 5]. 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 2026 March 5]. 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 2026 March 5]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.947
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• 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 2026 March 5]. Available from: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.1136
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13.0 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.

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
PM_Ca = 40,1 g/mol
M_Ca= ?

Ascorbic acid = Aa
PM_Aa = 176,1 g/mol
M_Aa = 2 g

[M_Ca]/[PM_Ca x n] = [M_Aa]/[PM_Aa x n]

[M_Ca]/[40,1 g/mol x 1] = [2 g]/[176,1 g/mol x 2]

M_Ca = [g x 40.1 g/mol x 1]/[176,1 g/mol x 2]

M_Ca = [80,2 g²/mol]/[352,2 g/mol]

M_Ca = 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

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 value:

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

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?)?
   2. What is the average dietary intake?
   3. What doses have previously been marketed in Canada?
   4. What do other regulatory agencies and expert groups recommend as their maximum daily dose?
   5. What doses have been used in clinical trials and have demonstrated evidence for safety and efficacy?
   The only vitamins which were excluded from the method outlined above were:
   • Vitamin D (due to its previous listing on the Prescription Drug List at 1,000 IU or 25 µg/day and the separate single ingredient monograph for high dose vitamin D);
   • Vitamin K₁ and K₂ [adult dose was set as per the listing on the Prescription Drug List at 120 µg/day (HC 2021) and children's doses were set at the AI level (IOM 2006)].
2. 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 Regulation respecting the terms and conditions for the sale of medications in Quebec and as previously also applied by the National Association of Pharmacy Regulatory Authorities.

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 subpopulation [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 2026a)].
  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 subpopulations 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 19 years and older" 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.

¹The 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.

¹Calculated 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":

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 19 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).

¹ These values are based on the RDA and AI values for vitamin A based on the subpopulation (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:

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 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

Conversion factors

1. Pantothenic acid (USP-NF 2024):

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 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.

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

3. beta-Carotene:

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-NF 2024)

4. Vitamin B₁₂:

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.

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 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

7. Folate (NIH 2022; US FDA 2019; HC 2006b; IOM 1998):

Folic acid in Natural Health Products is to be represented in mcg of folic acid. Factors for converting mcg of dietary folate equivalents (DFE) to mcg for supplemental folate have not been formally established by Health Canada but conversion factors established by other regulatory agencies can be used if DFE is listed as additional information on the label.

Following conversion factors established by the US Food and Nutrition Board and also included in the Codex nutrient reference values can be used for conversion between food folate and folic acid (supplemental form):

• 1 DFE = 1 µg food folate.
• 1 DFE = 0.6 µg folic acid from fortified food or from a supplement consumed with food (factor of 1.7).
• 1 DFE = 0.5 µg folic acid from a supplement taken on an empty stomach (factor of 2).

Note: The bioavailability of L-5-Methyltetrahydrofolate (5-methyl-THF) in supplements is the same as or greater than that of folic acid. However, conversion factors between mcg and mcg DFE for 5-methyl-THF have not been formally established. The US FDA allows manufacturers to use either a conversion factor of 1.7 to be comparable to folic acid, or their own established conversion factors not to exceed 1.7 (NIH 2022).

Appendix VII

Zinc and copper interaction

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 the subpopulation 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.

Examples using Table 24:

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 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.


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 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:

* 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:

* For minerals, the medicinal ingredient quantity represents the amount of the element per tablet.

Appendix IX

14.0 Version History