Our Verdict: SAFE

Ferrous Citrate

CAS23383-11-1

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

Ferrous Citrate — food additive

Ferrous citrate is an iron compound used as a nutrient supplement in food and beverages to fortify products with bioavailable iron. It serves as an alternative iron source for addressing dietary iron deficiency in fortified foods.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Ferrous Citrate?

Ferrous citrate (CAS Number: 23383-11-1) is a chemical compound consisting of iron in the ferrous (Fe2+) state complexed with citric acid. This combination creates a soluble iron salt that can be readily absorbed by the human body. The citrate component acts as a chelating agent, improving the bioavailability of iron compared to some other iron compounds used in food fortification.

Common Uses

Ferrous citrate is used primarily as a nutrient supplement in fortified food and beverage products. Common applications include breakfast cereals, grain products, nutritional beverages, and other processed foods designed to increase dietary iron intake. The compound is chosen for fortification applications because of its relative stability and bioavailability in food matrices. The citrate form helps prevent oxidation and maintains iron solubility across varying pH conditions in different food products.

Safety Assessment

Ferrous citrate has not been designated as Generally Recognized as Safe (GRAS) by the FDA under its current CAS number, though iron compounds as a category are well-established nutrients with extensive safety data. The FDA has recorded zero adverse events and zero recalls associated with ferrous citrate, indicating no documented safety incidents in the U.S. food supply.

Iron as a nutrient is essential for human health, functioning primarily in oxygen transport and energy metabolism. However, like all nutrients, iron has established tolerable upper intake levels. The National Academies of Sciences, Engineering, and Medicine sets the tolerable upper intake level for iron at 40-45 mg per day for adults to avoid gastrointestinal distress and iron accumulation concerns. Products containing ferrous citrate are formulated to remain well within these safety parameters for typical consumption patterns.

The citrate chelation of iron does not introduce additional safety concerns. Citric acid and citrate salts are commonly used food additives with established safety records. The combination maintains the safety profile of both iron and citrate as separate ingredients.

Regulatory Status

Ferrous citrate is not approved as a direct food additive under FDA regulations in the United States, though iron compounds generally appear on the FDA's list of affirmed GRAS substances for nutrient supplementation. Its specific regulatory status reflects the FDA's classification framework rather than safety concerns. In other regulatory jurisdictions, ferrous compounds are commonly permitted for food fortification.

Manufacturers using ferrous citrate as a nutrient supplement must comply with applicable labeling regulations, including accurate declaration on ingredient lists and nutrition facts panels. The compound must be used in accordance with good manufacturing practices and at levels that do not exceed established nutrient intake recommendations.

Key Studies

Iron bioavailability studies have demonstrated that ferrous compounds, particularly those in citrate form, are among the most bioavailable iron sources for food fortification. Research published in nutritional science literature confirms that citrate complexation improves iron absorption compared to ferric forms and some other iron salts. These findings support the selection of ferrous citrate as a fortification ingredient in products designed to address iron deficiency.

The long safety history of iron fortification in foods, combined with zero documented adverse events and recalls for ferrous citrate specifically, provides substantial reassurance regarding its safety when used as directed in food fortification applications.

Frequently Asked Questions

What is Ferrous Citrate?

Ferrous citrate is an iron compound used as a nutrient supplement in food and beverages to fortify products with bioavailable iron. It serves as an alternative iron source for addressing dietary iron deficiency in fortified foods.

Is Ferrous Citrate safe?

Ferrous Citrate 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 Ferrous Citrate banned in any country?

Ferrous Citrate 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.