Our Verdict: SAFE

Ferric Ammonium Citrate, Brown

CAS1332-98-5

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Ferric Ammonium Citrate, Brown — food additive

Ferric Ammonium Citrate, Brown is an iron compound used as a nutrient supplement in food products to fortify foods with bioavailable iron. It provides an essential mineral necessary for oxygen transport and metabolic function in the human body.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Ferric Ammonium Citrate, Brown?

Ferric Ammonium Citrate, Brown (CAS Number: 1332-98-5) is an iron-containing compound formed from ferric iron, ammonia, and citric acid. The brown variant refers to its specific color and chemical composition. This additive belongs to the nutrient supplement category and is used primarily to increase the iron content of food products. Iron is an essential micronutrient critical for hemoglobin formation, oxygen transport, and numerous enzymatic processes in human metabolism.

Common Uses

Ferric Ammonium Citrate, Brown is utilized in food fortification programs to address iron deficiency, a significant public health concern worldwide. Common applications include:

- Fortified grain products and cereals

- Nutritional beverages and supplements

- Infant and pediatric nutrition products

- Enriched flour and baked goods

- Dietary supplement formulations

The citrate form enhances bioavailability, meaning the iron is more readily absorbed by the human body compared to some alternative iron sources. This makes it particularly valuable in populations at risk for iron deficiency anemia, including children, pregnant women, and individuals with increased iron requirements.

Safety Assessment

Ferric Ammonium Citrate, Brown has not received GRAS (Generally Recognized as Safe) status from the FDA, though this designation does not indicate a safety concern. Rather, it reflects the regulatory pathway and approval status of this specific compound. According to FDA records, there have been zero reported adverse events associated with this additive and zero recalls linked to its use, indicating a strong safety record in commercial applications.

Iron supplementation through food fortification has been extensively studied and is recognized internationally as a safe and effective public health intervention. The safety of iron compounds in food depends on appropriate dosing levels, which are carefully controlled in fortified products to prevent excessive intake while ensuring nutritional benefit.

General iron supplementation safety considerations include the risk of iron overload in individuals with hemochromatosis or other iron metabolism disorders. However, fortified foods contain regulated iron levels designed for the general population and are not typically harmful to individuals with normal iron metabolism. As with all nutrients, excessive supplementation beyond recommended dietary allowances can pose risks, but this is a concern for supplement overuse rather than properly fortified foods.

Regulatory Status

While Ferric Ammonium Citrate, Brown lacks FDA GRAS status, it operates within the regulatory framework for food additives and nutrient supplements. Various iron compounds are approved for food fortification purposes under different regulatory jurisdictions. The European Food Safety Authority (EFSA) and other international regulatory bodies have established safety assessments for iron compounds used in food fortification.

The specific regulatory status may vary by country and region. Some jurisdictions permit its use in specific food categories at defined levels, while approval requirements and maximum use levels are established based on nutritional needs and safety data.

Key Studies

Numerous peer-reviewed studies have demonstrated the effectiveness of iron fortification programs in reducing anemia prevalence. Research supports the bioavailability of citrate-based iron compounds and their efficacy in improving iron status when incorporated into staple foods. International organizations including the World Health Organization (WHO) and UNICEF have promoted iron fortification as a cost-effective strategy for addressing iron deficiency at the population level.

Long-term safety monitoring of fortified foods has not identified significant adverse health effects in populations consuming fortified products as intended. Studies on iron bioavailability show that citrate complexes enhance absorption compared to some other iron sources, improving nutritional effectiveness while maintaining safety margins.

Frequently Asked Questions

What is Ferric Ammonium Citrate, Brown?

Ferric Ammonium Citrate, Brown is an iron compound used as a nutrient supplement in food products to fortify foods with bioavailable iron. It provides an essential mineral necessary for oxygen transport and metabolic function in the human body.

Is Ferric Ammonium Citrate, Brown safe?

Ferric Ammonium Citrate, Brown is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Ferric Ammonium Citrate, Brown banned in any country?

Ferric Ammonium Citrate, Brown is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.