# Zinc Gluconate

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> Markdown URL: https://additivefacts.com/additives/zinc-gluconate.md

**Safety rating:** SAFE
**CAS number:** 4468-02-4
**Category:** nutrient
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Zinc gluconate is an organic zinc salt used as a nutrient supplement in fortified foods and beverages. It provides bioavailable zinc to help address nutritional deficiencies in the diet.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | approved |
| Canada | approved |
| Australia | approved |
| Japan | approved |
| South Korea | approved |
| Brazil | approved |
| China | approved |
| India | approved |

## Detailed analysis

## What is Zinc Gluconate?

Zinc gluconate is a mineral supplement compound formed from zinc and gluconic acid. It appears as a white to off-white powder and is highly soluble in water, making it suitable for liquid food applications. The compound has a CAS number of 4468-02-4 and functions as a source of elemental zinc in nutritional products.

## Common Uses

Zinc gluconate is primarily used in food fortification programs and dietary supplement products. It is commonly added to:

- Breakfast cereals and grain-based products
- Nutritional beverages and drinks
- Protein bars and fortified snacks
- Infant formulas and pediatric nutritional products
- Dietary supplements in tablet and powder forms

The gluconate form is chosen because it exhibits good bioavailability, meaning the body can absorb and utilize the zinc effectively compared to other zinc salts.

## Safety Assessment

Zinc gluconate has a documented safety profile with no reported adverse events in FDA records and zero product recalls associated with this ingredient. The compound is recognized as a safe source of supplemental zinc when used at appropriate levels.

Zinc is an essential micronutrient critical for immune function, protein synthesis, wound healing, and DNA synthesis. The Recommended Dietary Allowance (RDA) for zinc varies by age and gender, ranging from 2-11 mg per day for different populations. Zinc gluconate provides a bioavailable form that allows the body to meet these nutritional requirements.

Excessive zinc intake can potentially cause adverse effects including nausea, copper deficiency with long-term overuse, and interactions with certain medications. However, these concerns relate to excessive supplementation rather than normal dietary fortification levels.

## Regulatory Status

Zinc gluconate does not carry FDA GRAS (Generally Recognized as Safe) status, which means it has not undergone the formal GRAS notification process. However, this does not indicate a safety concern. Rather, it reflects that zinc fortification is regulated under different FDA frameworks, including food fortification standards and dietary supplement regulations under the Dietary Supplement Health and Education Act (DSHEA).

The ingredient is permitted for use in foods and supplements under FDA regulations as a nutrient supplement. It appears on the FDA's List of Affirmed as GRAS (21 CFR 184) under broader zinc compound allowances for nutrition fortification.

International regulatory bodies including the European Food Safety Authority (EFSA) recognize zinc gluconate as an acceptable nutrient source for food fortification within established guidelines.

## Key Studies

Scientific literature supports zinc gluconate's bioavailability. Research demonstrates that the gluconate form provides effective zinc absorption compared to inorganic zinc sources. Studies on zinc fortification programs show that gluconate-fortified foods contribute meaningfully to dietary zinc intake in populations at risk of deficiency.

The safety of zinc supplementation at fortification levels has been extensively studied, with established Tolerable Upper Intake Levels (UL) of 40 mg per day for adults. Fortification levels in foods and typical supplement doses remain well below these limits.

No specific toxicological studies have identified safety concerns unique to the gluconate form itself, and the ingredient's safety profile is consistent with other approved zinc supplements used in food fortification.

## Brands using Zinc Gluconate

- KSF Acquisition Corporation (5 products)
- Wal-Mart Stores, Inc. (4 products)
- Kinderfarms LLC (3 products)
- Silk (3 products)
- Abbott Laboratories Inc (2 products)
- Designer Protein LLC (2 products)
- Hydrant, Inc (2 products)
- Orgain, Inc. (2 products)
- Abbott Nutrition (1 product)
- Bubly (1 product)
- CVS Pharmacy, Inc. (1 product)
- Classic Edition Fragrances (1 product)
- Gummy Vites (1 product)
- Ketologic, LLC (1 product)
- Muse Nutrition LLC (1 product)
- Plum Organics (1 product)
- Polar Tech Industries Inc. (1 product)
- Walgreens Co. (1 product)
- plum organics (1 product)
- vitaminwater (1 product)

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Zinc Gluconate — Safety, regulation, and evidence." https://additivefacts.com/additives/zinc-gluconate. Accessed 2026-05-20.