Our Verdict: SAFE

Wintergreen, Extract (gaultheria Procumbens L.)

CAS90045-28-6

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

Wintergreen, Extract (gaultheria Procumbens L.) — food additive

Wintergreen extract is a flavoring agent derived from Gaultheria procumbens L., a plant native to North America. It is used in food products to impart a characteristic minty, cooling flavor and is commonly found in candies, beverages, and confections.

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 Wintergreen Extract?

Wintergeen extract (CAS Number: 90045-28-6) is a flavoring ingredient derived from Gaultheria procumbens L., commonly known as eastern teaberry or checkerberry. The plant is native to eastern North America and has been traditionally used for centuries in herbal preparations. The extract is obtained through various extraction methods from the leaves and berries of the plant and contains volatile compounds that produce the distinctive peppermint-like, cooling flavor associated with wintergreen.

Common Uses

Wintergeen extract is primarily used as a flavoring agent in the food industry. Common applications include:

- Chewing gums and mints

- Hard candies and lozenges

- Beverages and syrups

- Baked goods and confections

- Oral care products (toothpastes and mouthwashes)

The extract is valued for its intense, refreshing flavor profile that requires only small quantities to achieve the desired taste effect in finished products.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with wintergreen extract as a food additive, and no recalls have been issued. This safety profile reflects decades of use in food products without documented harm at typical consumption levels.

It is important to note that wintergreen extract contains methyl salicylate as a primary active compound. While the extract itself is used in flavoring applications at very low concentrations, methyl salicylate is structurally related to aspirin and has known pharmacological properties. However, the quantities used in food flavoring are substantially below levels associated with systemic effects.

The safety of wintergreen extract in food applications should be distinguished from concentrated wintergreen oil, which carries different safety considerations and is not approved for internal food use. Extract products used in food flavoring represent dilute formulations with a different safety profile than pure essential oils.

Regulatory Status

Wintergeen extract does not currently have FDA GRAS (Generally Recognized As Safe) status. This designation does not indicate that the ingredient is unsafe; rather, it means that a formal GRAS petition has not been submitted to or approved by the FDA, or that insufficient data was submitted to meet GRAS criteria.

Despite lacking GRAS status, wintergreen extract may be used in food products under FDA regulations for color additives and food additives, provided it complies with applicable food safety requirements and ingredient declarations. The absence of GRAS status requires manufacturers to maintain detailed safety documentation and comply with food additive regulations.

International regulatory bodies in the European Union and other regions have varying positions on wintergreen extract, with some permitting its use under specific conditions and maximum concentration limits.

Key Studies

Limited peer-reviewed research specifically addresses wintergreen extract safety in food applications. Available scientific literature focuses primarily on:

- The chemical composition of Gaultheria procumbens extracts and identification of volatile compounds

- Traditional uses and historical safety data from herbal preparations

- Toxicological studies on methyl salicylate at various concentrations

The lack of documented adverse events at current usage levels, combined with long historical use in food flavoring, suggests an acceptable safety margin for typical dietary exposure. However, comprehensive modern safety studies specifically evaluating wintergreen extract in food applications would strengthen the evidence base.

Research on related Gaultheria species and their traditional uses in North American and Asian cuisines provides additional context for the ingredient's historical safety profile, though direct applicability to modern food additive use requires careful interpretation.

Frequently Asked Questions

What is Wintergreen, Extract (gaultheria Procumbens L.)?

Wintergreen extract is a flavoring agent derived from Gaultheria procumbens L., a plant native to North America. It is used in food products to impart a characteristic minty, cooling flavor and is commonly found in candies, beverages, and confections.

Is Wintergreen, Extract (gaultheria Procumbens L.) safe?

Wintergreen, Extract (gaultheria Procumbens L.) 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 Wintergreen, Extract (gaultheria Procumbens L.) banned in any country?

Wintergreen, Extract (gaultheria Procumbens L.) 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.