Our Verdict: SAFE

Isopulegol

CAS89-79-2

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

Isopulegol — food additive

Isopulegol (CAS 89-79-2) is a naturally occurring terpene alcohol used as a flavoring agent in food products. It is derived from peppermint and other mint plants and imparts minty, cooling sensations to beverages, confections, and other food items.

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
Not EvaluatedHealth 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 Isopulegol?

Isopulegol is a colorless to pale yellow liquid monoterpene alcohol with the molecular formula C10H18O. It occurs naturally in essential oils of mint plants, particularly peppermint (Mentha piperita) and spearmint (Mentha spicata), where it contributes to the characteristic cooling and minty flavor profile. The compound can be extracted from natural sources or synthesized through chemical processes. It is chemically related to menthol and pulegone, other common mint-derived flavor compounds.

Common Uses

Isopulegol is primarily used as a flavoring agent in the food and beverage industry. Common applications include:

- Chewing gums and mints

- Breath fresheners

- Beverages (soft drinks, flavored waters, teas)

- Confectionery products

- Oral care products (mouthwashes, toothpastes)

- Baked goods and desserts

The compound is valued for its ability to provide a cooling, refreshing taste sensation similar to menthol. Its flavor intensity and sensory profile make it useful at relatively low concentrations in finished products.

Safety Assessment

Isopulegol has been used in food applications with no reported adverse events documented in FDA records. The compound has not been the subject of any FDA recalls related to food safety. As a naturally occurring component of mint essential oils that have a long history of culinary use, isopulegol is generally recognized as presenting minimal food safety risk at typical use levels.

The acute toxicity profile of isopulegol is low in standard animal testing models. Like other mint-derived compounds, it undergoes hepatic metabolism and is not known to accumulate in body tissues. Contact with skin or mucous membranes at high concentrations may cause irritation, but this is not relevant to food consumption at normal use levels.

Toxicological studies on related compounds (menthol, pulegone) provide supporting evidence for the safety of isopulegol in food applications. The compound's chemical stability in food matrices and resistance to significant degradation under normal storage conditions support its suitability as a flavoring agent.

Regulatory Status

Isopulegol has not been formally designated as Generally Recognized As Safe (GRAS) by the FDA. However, this does not indicate a safety concern; rather, it reflects that formal GRAS affirmation has not been pursued through the regulatory process. The substance is permitted as a flavoring agent in the United States under 21 CFR 182.60 (natural flavoring substances) or as part of approved mint-derived flavor complexes.

In the European Union, isopulegol is listed in the EFSA flavoring database as a substance that has been evaluated and is permitted for use as a flavoring in food. It appears on flavor industry "acceptable" lists maintained by the International Organization for Standardization (ISO) and flavor industry associations.

The compound is approved for use in flavoring applications in Canada, Japan, and other jurisdictions that recognize it as a natural flavoring substance derived from mint sources.

Key Studies

Scientific literature on isopulegol remains limited compared to more widely studied mint compounds like menthol. Available pharmacokinetic studies demonstrate rapid absorption and metabolism of isopulegol, with elimination primarily through urinary and fecal routes. Metabolism studies indicate conversion to glucuronide and sulfate conjugates.

Toxicological evaluations of isopulegol and structurally related monoterpenes have not identified specific health concerns relevant to food use. The compound's LD50 values in animal models are consistent with low acute toxicity. Irritation studies note potential for local irritation at undiluted concentrations, but such exposure does not occur through normal food consumption.

Flavor perception studies document isopulegol's sensory properties and its contribution to cooling sensations, supporting its functional application as a flavoring agent. The threshold detection level in humans is well below typical use concentrations in food products.

Frequently Asked Questions

What is Isopulegol?

Isopulegol (CAS 89-79-2) is a naturally occurring terpene alcohol used as a flavoring agent in food products. It is derived from peppermint and other mint plants and imparts minty, cooling sensations to beverages, confections, and other food items.

Is Isopulegol safe?

Isopulegol 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 Isopulegol banned in any country?

Isopulegol 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.