Our Verdict: RATING UNKNOWN

Desoxycholic Acid

CAS83-44-3

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Desoxycholic Acid — food additive

Desoxycholic acid (deoxycholic acid) is a naturally occurring bile acid that functions as an emulsifier in food products. It is not currently approved by the FDA as a food additive, though it has no recorded adverse events or recalls in the food safety database.

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 Desoxycholic Acid?

Desoxycholic acid, also known as deoxycholic acid (DCA), is a secondary bile acid naturally produced in the human body during the breakdown of primary bile acids by intestinal bacteria. It is a steroid acid with the chemical formula C24H40O4 and CAS number 83-44-3. In its pure form, it is a white to off-white crystalline powder. While desoxycholic acid occurs naturally in bile, synthetic versions can be produced for various applications.

Common Uses

Desoxycholic acid is classified as an emulsifier or emulsifier salt, meaning it helps blend immiscible substances like oil and water in food formulations. Its structure allows it to reduce surface tension between liquids and promote the formation of stable emulsions. This property makes it theoretically useful in processed foods, baked goods, sauces, and other products requiring uniform texture and consistency. However, its actual use in food products remains limited due to regulatory restrictions.

Safety Assessment

Desoxycholic acid presents an interesting safety profile. The FDA has not approved it as a Generally Recognized as Safe (GRAS) food additive, meaning it lacks formal authorization for food use in the United States. However, the FDA database records zero adverse events and zero recalls associated with this substance in food applications, suggesting either minimal food use or no documented safety incidents.

As a naturally occurring compound in human bile, desoxycholic acid is familiar to the human body at physiological concentrations. When produced endogenously, it plays a role in lipid absorption and intestinal health. However, the safety of intentionally added desoxycholic acid at food-relevant concentrations has not been comprehensively established through standard toxicology studies submitted to regulatory agencies.

It is worth noting that desoxycholic acid has received FDA approval for non-food medical uses, specifically for subcutaneous fat reduction (marketed under brand names like Kybella), indicating the FDA has determined it can be used safely under controlled conditions in other applications.

Regulatory Status

In the United States, desoxycholic acid is not approved as a food additive by the FDA. It does not appear on the Generally Recognized as Safe (GRAS) list for food use. This means manufacturers cannot legally add it to food products intended for sale in the U.S. market without FDA approval.

European regulatory status is similarly restrictive, with desoxycholic acid not approved as a food additive under EFSA (European Food Safety Authority) regulations. Most other regulatory jurisdictions worldwide have not approved its use in food applications.

Despite lacking food additive approval, desoxycholic acid remains available for pharmaceutical and research purposes, where its use is regulated separately.

Key Studies

Limited published research exists specifically examining desoxycholic acid as a food emulsifier. Most scientific literature focuses on its biological roles in bile and lipid metabolism rather than its functional properties in food systems.

Studies on bile acids generally demonstrate they are well-tolerated at physiological levels and have recognized roles in digestion and metabolic health. However, these investigations do not directly address the safety or efficacy of added desoxycholic acid in food products at concentrations typical for emulsifiers.

The lack of GRAS approval suggests that comprehensive food safety studies meeting FDA standards have not been completed and submitted for this application, or that such studies did not meet approval criteria.

Frequently Asked Questions

What is Desoxycholic Acid?

Desoxycholic acid (deoxycholic acid) is a naturally occurring bile acid that functions as an emulsifier in food products. It is not currently approved by the FDA as a food additive, though it has no recorded adverse events or recalls in the food safety database.

Is Desoxycholic Acid safe?

Desoxycholic Acid is currently rated "unknown" 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 Desoxycholic Acid banned in any country?

Desoxycholic Acid 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.