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Drugs and Health Products

Monograph: Zinc (from Zinc picolinate)

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) For Zinc sourced from non-picolinate sources, please refer to the monograph entitled `Zinc (from non-picolinate sources)'

Date: 2009-12-11


Zinc (O'Neil et al. 2012)

Proper Name(s)

Zinc ( O'Neil et al. 2009 , Sweetman 2007 )

Common Name(s)

Zinc ( O'Neil et al. 2009 , Sweetman 2007 )

Source Material

Zinc picolinate (EFSA 2009)

Route Of Administration


Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

A factor in the maintenance of good health  (IOM 2006, IOM 2001)


For products providing daily doses of Zinc at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI):
Helps to prevent Zinc deficiency  (IOM 2006, Shils et al. 2006, IOM 2001, Groff and Gropper 2000)



Dose(s): 0.7 - 25 Milligrams per day
Directions For Use:

  • Adults includes pregnant and breastfeeding women, except for use of zinc picolinate (EFSA 2009; IOM 2001).
  • When zinc picolinate is used as a source of elemental zinc, the product should be indicated for an adult subpopulation only
  • Zinc deficiency is rare in North America (IOM 2006; Shils et al. 2006; IOM 2001)

Duration of use

Consult a health care practitioner for use beyond 3 months  (Sakai et al. 2002)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
No statement is required

Do not use if you are pregnant or breastfeeding  (EFSA 2009, IOM 2001)

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

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


  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

References cited

  • Albion 1992: Zinc - the multifaceted trace mineral. Albion Research Notes 1992;1(3) [Accessed 2007-05-18]. Available from:
  • Albion 2000: Implications of the "other half" of a mineral compound. Albion Research Notes 2000;9(3) [Accessed 2007-05-18]. Available from:
  • Albion 2004: Zinc: A mineral of complex biological activity. Albion Research Notes 2004;13(1) [Accessed 2007-05-18]. Available from:
  • ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Davis CD, Milne DB, Nielsen FH. Changes in dietary zinc and copper affect zinc-status indicators of postmenopausal women, notably extracellular superoxide dismutase and amyloid precursor proteins. American Journal of Clinical Nutrition 2000;71(3):781-788.
  • EFSA 2009a: 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 1113:1-41. Adopted 2009 June 4.
  • EFSA 2009b: European Food Safety Authority. 2009. Scientific Document: Calcium ascorbate, magnesium ascorbate and zinc ascorbate added for nutritional purposes in food supplements. Adopted 2009 February 24. [Accessed 2009 December 4]. Available from:
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • EVM 2003: Expert Group on Vitamins and Minerals of the Food Standards Agency (FSA). Part 3: Trace Elements- Chromium and Zinc. In Safe Upper Levels for Vitamins and Minerals; Report of the Expert Group on Vitamins and Minerals. London, England. 1-31, 171-179, 253-262.
  • Fischer PWF, Giroux A, L'Abbe MR. Effect of zinc supplementation on copper status in adult man. American Journal of Clinical Nutrition 1984;40(4):743-746.
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • HC 2007: Health Canada. NHPD Expert Advisory Committee Issue Analysis Summary: What is an acceptable maximum daily dose for oral zinc supplements? Ottawa (ON): Natural Health Products Directorate, Health Canada; 2007.
  • HC 2008: Health Canada. 2008. Drug Product Database [online]. Ottawa (ON): Health Canada. [Accessed 2009 April 17]. Available from:
  • IOM 2001: Institute of Medicine. Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academy Press; 2001.
  • IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press; 2003.
  • IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
  • Milne DB, Davis CD, Neilsen FH. Zinc alters indices of copper function and status in postmenopausal women. Nutrition 2001;17(9):701-708.
  • Murray MT. Encyclopedia of Nutritional Supplements: The Essential Guide for Improving Your Health Naturally. Rocklin (CA): Prima Health; 1996.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2009. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. Whitehouse Station (NJ): Merck & Co., Inc.
  • Sakai F, Yoshida S, Endo S, Tomita H. 2002. Double-blind, Placebo-controlled Trial of Zinc Picolinate for Taste Disorders. Informa healthcare 122:129-133.
  • SCF 2003: Scientific Committee on Food, 2003. Opinion of the Scientific Committee on Food on the tolerable upper intake level of zinc (expressed on 5 March 2003). European Commission, Health and Consumer Protection Directorate-General, Directorate C - Scientific Opinions, C2 - Management of scientific committees; scientific co-operation and networks. [Accessed 2009 December 4]. Available from:
  • Schwartz JR, Marsh RG, Draelos ZD. Zinc and skin health: overview of physiology and pharmacology. Dermatologic Surgery 2005;31(7 Part 2):837-847.
  • Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.
  • Yadrick MK, Kenney MA, Winterfeldt EA. Iron, copper, and zinc status: response to supplementation with zinc or zinc and iron in adult females. American Journal of Clinical Nutrition 1989;49(1):145-150.

References reviewed

  • Bailey MM, Boohaker JG, Jernigan PL, Townsend MB, Sturdivant J, Rasco JF, Vincent JB, Hood RD. 2008. Effects of Pre- and Postnatal Exposure to Chromium Picolinate or Picolinic Acid on Neurological Development in CD-1 Mice. Biological Trace Element Research 124:70-82.
  • Bailey MM, Boohaker JG, Sawyer RD, Behling JE, Rasco JF, Jernigan JJ, Hood RD, Vincent JB. 2006. Exposure of pregnant mice to chromium picolinate results in skeletal defects in their offspring. Birth Defects Research. Part B. Developmental and Reproductive Toxicology 77(3):244-249.
  • Barrie SA, Wright JV, Pizzorno JE, Kutter E, and Barron PC. 1987. Comparative absorption of zinc picolinate, zinc citrate and zinc gluconate in humans. Agents and Actions 21: 223-228
  • Berner TO, Murphy MM, Slesinki R. 2004. Determining the safety of chromium tripicolinate. The ENVIRON Health Sciences Institute, Arlington. Food and Chemical Toxicology 42:1029-1042.
  • Beskid M, Jachimowicz J, Taraszewska A, Kukulska D. 1995. Histological and ultrastructural changes in the rat brain following systemic administration of picolinic acid. Experimental and Toxicologic Pathology 47(1):25-30.
  • Bosco MC, Rapisarda A, Massazza S, Melillo G, Young H, Varesio L. 2000. The tryptophan catabolite picolinic acid selectively induces the chemokines macrophage inflammatory protein-1alpha and -1beta in macrophages. The Journal of Immunology 164(6):3283-3291.
  • COM 2004: Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment. Statement on the Mutagenicity of Trivalent Chromium and Chromium Picolinate. December 2004. Department of Health. United Kingdom. [Accessed 2009 December 4]. Available from:
  • Fernandez-Pol JA. 1978. Morphological changes induced by picolinic acid in cultured mammalian cells. Experimental and Molecular Pathology 29(3):348-357.
  • Goda K, Kishimoto R, Shimizu S, Hamane Y, Ueda M. 1996. Quinolinic acid and active oxygens: possible contribution of active oxygens during cell death in the brain. Advances in Experimental Medicine and Biology 398:247-254.
  • Goodwin FK, Sack RL. 1974. Behavioral effects of new dopamine-beta-hydroxylase inhibitor (fusaric acid) in man. Journal of Psychiatric Research 11:211-217.
  • Guidi R, Rao M. 2004. In vitro Mammalian Chromosome Aberration Test. Bioreliance Report no AA85MC.331.BTL
  • HC 1996: Health Canada. Drugs Directorate Labelling Standard: Mineral Supplements. Ottawa (ON): Health Canada.
  • HC 2007: Health Canada. Monograph- Multi-vitamin/mineral Supplement. [Accessed 2009 December 4]. Available from:
  • HC 2009: Health Canada. Licensed Natural Health Products Database. [Accessed 2009 December 4]. Available from:
  • Kirkil G, Muz MH, Seckin D, Sahin K, Kucuk O. 2008. Antioxidant effect of zinc picolinate in patients with chronic obstructive pulmonary disease. Respiratory Medicine 102: 840-844
  • Manygoats KR, Yazzie M, Stearns DM. 2002.Ultrastructural damage in chromium picolinate-treated cells: a TEM study. Journal of Biological Inorganic Chemistry 7(7-8):791-798.
  • Mehler AH. 1956. Formation of picolinic and quinolinic acids following enzymatic oxidation of 3-hydroxyanthranilic acid. The Journal of Biological Chemistry 218(1):241-254.
  • Melillo G, Bosco MC, Musso T, Varesio L. 1996. Immunobiology of picolinic acid. Advances in Experimental Medicine and Biology 398:135-141.
  • Reading SA, Wecker L. 1996. Chromium picolinate. The Journal of the Florida Medical Association 83(1):29-31.
  • Rhodes MC, Hébert CD, Herbert RA, Morinello EJ, Roycroft JH, Travlos GS, Abdo KM. 2005. Absence of toxic effects in F344/N rats and B6C3F1 mice following subchronic administration of chronic administration of chromium picolinate monohydrate. Food and Chemical Toxicology 43:21-29.
  • Roth P, Kirchgessner M. 1985. Utilization of Zinc from Picolinic or Citric Acid Complexes in Relation to Dietary Protein Source in Rats. Journal of Nutrition 115:1641-1649.
  • San RH, Clarke JJ. 2004. In vitro Mammalian Cell Gene Mutation (CHO/HGPRT) Test with 48-hour exposure. Bioreliance Report no AA85MC.782048.BTL
  • San RH, Clarke JJ. 2004a. In vitro Mammalian Cell Gene Mutation (CHO/HGPRT) Test with an Independent Repeat Assay. Bioreliance Report no AA85MC.782001.BTL.
  • SCF/EFSA 2006: Scientific Committee on Food/ European Food Safety Authority. 2006. Tolerable Upper Intake Levels for Vitamins and Minerals by the Scientific Panel on Dietetic products, Nutrition and Allergies (NDA) and Scientific Committee on Food (SCF). Edited by EFSA, Parma, February 2006.
  • Speetjens JK, Collins RA, Vincent JB, Woski SA. 1999. The nutritional supplement chromium(III) tris(picolinate) cleaves DNA. Chemical Research in Toxicology 12(6):483-487.
  • Speetjens JK, Parand A, Crowder MW, Vincent JB, Woski SA. 1999. Low-molecular-weight chromium-binding substance and biomimetic [Cr3O(O2CCH2CH3)6(H2O)3]+ do not cleave DNA under physiologically-relevant conditions. Polyhedron 18(20):2617-2624.
  • Stearns DM, Belbruno JJ, Wetterhahn KE. 1995. A prediction of chromium(III) accumulation in humans from chromium dietary supplements. The FASEB Journal 9(15):1650-1657.
  • Stearns DM, Silveira SM, Wolf KK, Luke AM. 2002. Chromium(III) tris(picolinate) is mutagenic at the hypoxanthine (guanine) phosphoribosyltransferase locus in Chinese hamster ovary cells. Mutation Research 513(1-2):135-142.
  • Stout MD, Nyska A, Collins BJ, Witt KL, Kissling GE, Malarkey DE, Hooth MJ. 2009. Chronic toxicity and carcinogenicity studies of chromium picolinate monohydrate administered in feed to F344/N rats and B6C351 mice for 2 years. National Toxicology Program. Food and Chemical Toxicology 47: 729-733.
  • Sugden KD, Geer RD, Rogers SJ. 1992. Oxygen radical-mediated DNA damage by redox-active Cr(III) complexes. Biochemistry 31(46):11626-11631.
  • TGA 2003: Therapeutic Goods Administration. 2003. CMEC Meeting 41 Complementary Medicines Evaluation Committee: Extracted ratified minutes forty-first meeting. Symonston (AU): Commonwealth Department of Health and Ageing, Therapeutic Goods Administration. [Accessed 2009 December 4]. Available from:
  • Whittaker P, San RHC, Clarke JJ, Seifried HE, Dunkel VC. 2005. Mutagenicity of chromium picolinate and its components in Salmonella typhimurium and L5178Y mouse lymphoma cells. Food and Chemical Toxicology 43(11):1619-1625.
  • WHO 1996: World Health Organization. 1996. Trace elements in human nutrition and health (A report of a re-evaluation of the role of trace elements in human health and nutrition). Geneva (CH): World Health Organization

Appendix 1: Definitions

Adequate Intake (AI): The recommended average daily intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people that are assumed to be adequate. An AI is used when an RDA cannot be determined (IOM 2006).

Recommended Dietary Allowances (RDA): The average daily dietary nutrient intake level sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group (IOM 2006).

Tolerable Upper Intake Level (UL): The highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects may increase (IOM 2006).

Appendix 2: RDA, AI and UL Values

The AI (as indicated by an asterix) and RDA values for zinc are provided below. For the purpose of this monograph, these values are intended to:

  • provide targets for setting appropriate supplement dosage levels;
  • provide the minimum dose for the use of the dose-specific use or purpose: "Helps to prevent zinc deficiency";
  • facilitate the optional labelling of % RDA and AI values.
Table 1: Recommended Dietary Allowance and Adequate Intake values for zinc based on life stage group (IOM 2006)
Life stage group Zinc (mg/day)
Infants 0-6 mo 2*
7-12 mo 3
Children 1-3 y 3
4-8 y 5
Adolescent males 9-13 y 8
14-18 y 11
Adult males ≥ 19 y 11
Adolescent females 9-13 y 8
14-18 y 9
Adult females ≥ 19 y 8
Pregnancy 14-18 y 12
19-50 y 11
Breastfeeding 14-18 y 13
19-50 y 12

The RDA values for copper are provided below. These values are intended to provide guidance on the minimum quantity of copper required for zinc products, as zinc supplementation is known to cause copper deficiency.

Table 2: Recommended Dietary Allowance values for copper based on life stage group (IOM 2006)
Life stage group Copper (µg/day)


Footnote 1

An AI for infants exists but has not been included since copper supplementation is not appropriate in infants.

Return to table 2 footnote 1 referrer

Infants Table 2 Footnote 1 0-6 mo -
7-12 mo -
Children 1-3 y 340
4-8 y 440
Adolescent males 9-13 y 700
14-18 y 890
Adult males ≥ 19 y 900
Adolescent females 9-13 y 700
14-18 y 890
Adult females ≥ 19 y 900
Pregnancy 14-50 y 1000
Breastfeeding 14-50 y 1300


Table 3: Tolerable Upper Intake Level for zinc for adults 19 years and older (IOM 2006)
Life stage group Zinc (mg/day)


Footnote 1

Includes pregnant and breastfeeding women.

Return to table 3 footnote 1 referrer

Adults Table 3 Footnote 1 40


Note: Products containing zinc picolinate as source of elemental zinc are for adults only and are not for pregnant and breastfeeding women.