Our Verdict: SAFE

Potassium Fumarate

CAS7704-72-5

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

Potassium Fumarate — food additive

Potassium fumarate is a potassium salt of fumaric acid used as a nutrient supplement in food products. It provides an additional source of potassium, an essential mineral important for various physiological functions, and is utilized in select food applications.

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 Potassium Fumarate?

Potassium fumarate (CAS Number: 7704-72-5) is an organic compound composed of potassium and fumaric acid. Fumaric acid is a naturally occurring organic acid found in small quantities in foods like mushrooms, lichen, and plants. When combined with potassium, it forms a salt that can serve as a source of both fumarate and potassium in food products.

Common Uses

Potassium fumarate is primarily used as a nutrient supplement in food applications where additional potassium intake is desired. It may be incorporated into fortified foods, dietary supplements, and functional food products. The compound serves dual purposes: providing supplemental potassium, which is essential for heart health, muscle function, and electrolyte balance, while also contributing fumaric acid, which plays a role in cellular energy production through the citric acid cycle.

Specific food applications may include beverages, nutritional supplements, and fortified grain products, though usage remains relatively limited compared to other potassium and nutrient supplement ingredients.

Safety Assessment

Potassium fumarate has generated no reported adverse events in FDA databases and has not been subject to any FDA recalls. The compound's constituent parts—potassium and fumaric acid—are both recognized as safe when used appropriately in food.

Fumaric acid has a long history of use in foods and has been designated as Generally Recognized as Safe (GRAS) by the FDA for specific applications. Potassium itself is an essential nutrient required for human health. However, it should be noted that potassium fumarate specifically has not received a formal FDA GRAS determination, which means it operates under different regulatory oversight than GRAS-affirmed ingredients.

The absence of documented adverse events and recalls suggests a favorable safety profile in current use. Individual tolerance may vary, particularly for consumers with certain health conditions affecting potassium metabolism, such as kidney disease or those taking specific medications that affect potassium levels.

Regulatory Status

Potassium fumarate is not formally recognized as GRAS by the FDA, distinguishing it from some other food additives and supplements. Despite this, it may be used in food under FDA regulatory frameworks for food additives or dietary supplement ingredients, depending on its intended application and dosage.

The regulatory status varies internationally. Different countries maintain separate assessments of food additive safety and approval, so availability and use permissions may differ based on regional regulations.

Manufacturers using potassium fumarate must ensure compliance with applicable food safety regulations, labeling requirements, and ingredient restrictions in their respective markets.

Key Studies

Limited published research specifically addresses potassium fumarate as a food ingredient. However, extensive research supports the safety and biological role of both component parts: potassium's essential functions in human physiology are well-documented, and fumaric acid's metabolism through normal cellular pathways is well-established.

The safety profile relies on the demonstrated safety of fumaric acid in food applications and potassium's recognized status as an essential nutrient. Most safety concerns related to potassium supplementation involve excessive intake, particularly in vulnerable populations, rather than concerns specific to potassium fumarate as a delivery form.

Future research examining long-term dietary exposure to potassium fumarate in fortified foods could provide additional safety data, though current evidence does not indicate cause for concern at typical usage levels.

Frequently Asked Questions

What is Potassium Fumarate?

Potassium fumarate is a potassium salt of fumaric acid used as a nutrient supplement in food products. It provides an additional source of potassium, an essential mineral important for various physiological functions, and is utilized in select food applications.

Is Potassium Fumarate safe?

Potassium Fumarate 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 Potassium Fumarate banned in any country?

Potassium Fumarate 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.