# Iron Citrate

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**Safety rating:** SAFE
**CAS number:** 2338-05-8
**Category:** nutrient
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Iron Citrate is an iron compound used as a nutrient supplement in food and beverages to enhance iron content. It provides a bioavailable form of iron for fortification purposes, helping address iron deficiency in populations.

## 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 Iron Citrate?

Iron Citrate (CAS Number: 2338-05-8) is a chemical compound formed from iron and citric acid. It functions as a source of elemental iron and is used in the food industry as a nutrient supplement. The citrate form of iron is valued in food applications because citric acid acts as a chelating agent, potentially improving the bioavailability and absorption of iron in the human digestive system compared to some other iron forms.

## Common Uses

Iron Citrate is primarily used in food fortification applications, including:

- Breakfast cereals and grain-based products
- Flour and baked goods
- Nutritional supplements and fortified beverages
- Infant formulas and pediatric nutritional products
- Vitamin and mineral supplement tablets

The compound is selected for these applications because it can effectively increase the iron content of foods while maintaining stability during storage and processing. Food manufacturers use iron fortification to help address iron deficiency, a significant public health concern globally, particularly in developing countries and among vulnerable populations including women and children.

## Safety Assessment

Iron Citrate has no reported adverse events associated with its use as a food additive according to FDA records. Additionally, there are no FDA recalls linked to this ingredient. The safety profile of iron citrate is generally considered favorable for its intended use as a nutrient fortification agent.

Like all iron supplements, iron citrate should be used at appropriate levels in food products. The safety of any nutrient depends on total dietary intake and individual health status. Excessive iron intake can pose health risks, which is why iron fortification levels are carefully regulated and designed to supplement, not replace, dietary sources of iron.

The citrate form itself has a well-established safety history in food applications, as citric acid and its salts are widely used in the food industry as preservatives and pH regulators.

## Regulatory Status

Iron Citrate is not designated as Generally Recognized as Safe (GRAS) by the FDA. However, this designation does not indicate a safety concern. Rather, it reflects that the ingredient may be approved for specific uses under FDA food additive regulations without GRAS status. Iron compounds for food fortification are regulated under 21 CFR Part 182 and related FDA regulations governing nutrient fortification.

The ingredient is permitted for use in food fortification in various countries, including within the European Union framework for food additives. Regulatory acceptance is based on established safety data and the recognized need for iron fortification in public health.

## Key Studies

Research on iron citrate and similar iron chelate compounds demonstrates the citrate form's role in enhancing iron bioavailability. Studies on iron citrate absorption indicate that the citrate chelate improves iron uptake compared to non-chelated forms, making it an effective choice for food fortification programs.

Published literature supports the safety of iron citrate at levels used in food fortification. Research examining iron fortification programs demonstrates positive public health outcomes in reducing iron deficiency prevalence, with no safety concerns attributable to the citrate form specifically.

The European Food Safety Authority and similar regulatory bodies have reviewed iron compounds used in food fortification and established acceptable usage levels based on bioavailability data and safety margins.

## 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. "Iron Citrate — Safety, regulation, and evidence." https://additivefacts.com/additives/iron-citrate. Accessed 2026-05-20.