About
What it is and where it shows up.
Magnesium gluconate is the magnesium salt of gluconic acid, used as a source of dietary magnesium in food fortification and nutritional supplements. It is valued for its relatively high bioavailability and mild gastrointestinal tolerability compared to other magnesium salts.
Safety summary
The regulatory and scientific consensus.
Magnesium gluconate is well tolerated at normal dietary and supplemental doses, with no significant genotoxic or carcinogenic concern identified by major regulatory bodies. High-dose supplemental intake can cause osmotic diarrhoea, and individuals with renal failure face risk of hypermagnesemia because the kidney is the primary route of magnesium excretion. No specific ADI has been established; the EU tolerable upper level for supplemental magnesium from readily dissociable salts (inclusive of gluconate) is 250 mg elemental magnesium per day.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Permitted as a nutritive substance (magnesium source) under Australia New Zealand Food Standards Code Standard 1.1.1 and Schedule 17; conditions of use tied to good manufacturing practice.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Permitted as a magnesium source in food supplements under Directive 2002/46/EC and Regulation (EC) No 1333/2008 (E346). The 250 mg/day figure is the EU tolerable upper level for supplemental magnesium from readily dissociable salts, applicable to magnesium gluconate. Excluded from food supplements for infants and young children.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Magnesium gluconate is permitted as a nutrient supplement/fortification ingredient under FSSAI regulations for food supplements and fortified foods; specific quantum limits follow label declaration requirements.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed in FDA's Substances Added to Food inventory; magnesium gluconate is recognised as a nutrient/dietary supplement ingredient. Multiple related magnesium salts hold explicit GRAS status under 21 CFR Part 184; use is subject to current good manufacturing practice (cGMP) limits.source |
Who should approach with care
Whose guidance would steer them away.
Kidney Disease — The kidney is the primary route of magnesium excretion; renal failure causes increased magnesium retention and is the most significant cause of hypermagnesemia, which can progress to cardiac arrest at high serum levels, as noted in NIH/StatPearls guidance.
Infants — The EU explicitly excludes magnesium gluconate-containing food supplements from use in infants and young children under Directive 2002/46/EC and EFSA guidance, due to the lack of safety data in this age group.
Pregnancy — EFSA's 250 mg/day supplemental magnesium upper level explicitly excludes pregnant women from the novel magnesium source authorisation, and high supplemental magnesium intake in pregnancy warrants medical supervision.
Lactation — Similar to pregnancy, EFSA guidance excludes lactating women from the maximum supplemental intake authorisation for readily dissociable magnesium salts; supplemental use should be supervised by a healthcare provider.
Heart Disease — Excess magnesium at high serum concentrations (above 15 mg/dL) can cause cardiac arrest; individuals with pre-existing heart conditions should seek medical advice before using supplemental magnesium gluconate.
Research citations
The sources behind this verdict.
- 1FDA. Magnesium Gluconate – Substances Added to Food (formerly EAFUS). hfpappexternal.fda.gov
- 2FAO/WHO (JECFA). Magnesium Gluconate – JECFA Food Additives Detail. fao.org
- 3FDA. Petition for a Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure. fda.gov
- 4EFSA. Safety of magnesium l-threonate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC, 2024. efsa.europa.eu
- 5PubMed. Magnesium – StatPearls (NIH/NCBI Bookshelf), 2023. ncbi.nlm.nih.gov
Independently researched5 citations