Our Verdict: RATING UNKNOWN

(+/-)-dihydromintlactone

CAS92015-65-1

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

(+/-)-dihydromintlactone — food additive

(+/-)-dihydromintlactone is a synthetic flavoring compound used to impart mint and cooling sensations in food and beverage products. It functions as a flavoring agent or adjuvant to enhance taste profiles in various consumer 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
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 (+/-)-dihydromintlactone?

(+/-)-dihydromintlactone, identified by CAS Number 92015-65-1, is a synthetic organic compound belonging to the lactone family of flavor chemicals. It is the racemic mixture (equal parts of both enantiomers) of dihydromintlactone, a compound that chemically mimics cooling and mint-like sensory properties found in natural sources. The compound is manufactured through synthetic processes in specialized flavor production facilities.

Common Uses

This flavoring agent is utilized primarily in the food and beverage industry to create mint and cooling flavor profiles. Common applications include:

- Chewing gums and mints

- Confectionery products

- Beverages (both alcoholic and non-alcoholic)

- Dental care products with food-grade applications

- Flavor blends for processed foods

- Mouth fresheners and breath products

The cooling sensation it provides makes it particularly valuable in products designed to deliver a refreshing or menthol-like experience without using natural mint extracts, allowing manufacturers greater control over flavor consistency and cost.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with (+/-)-dihydromintlactone, and no food recalls have been initiated involving this ingredient. The absence of adverse event reports indicates no known safety concerns have been formally documented through FDA surveillance systems.

However, it is important to note that this compound has not been designated as Generally Recognized As Safe (GRAS) by the FDA. GRAS status represents a specific regulatory determination based on extensive safety data and expert consensus. The absence of GRAS status does not indicate the ingredient is unsafe; rather, it reflects that the formal GRAS petition process has not been completed or that the ingredient may be used in food under other regulatory frameworks.

The European Food Safety Authority (EFSA) maintains separate evaluations of food additives used in European Union member states. Manufacturers using this ingredient must comply with regulations in each jurisdiction where products are sold.

Regulatory Status

In the United States, (+/-)-dihydromintlactone is not listed as a GRAS ingredient by the FDA. This means any use in food products may require either:

1. A Food Additive Petition (FAP) submitted to the FDA with safety data

2. Use under the Generally Recognized As Safe exemption if adequate safety data exists and expert consensus is documented

3. Compliance with applicable regulations in jurisdictions where it is permitted

Manufacturers should verify current regulatory status in their specific markets before use. Regulations vary significantly between countries, with some nations permitting synthetic flavor compounds more readily than others.

Key Studies

Direct published safety studies specifically focused on (+/-)-dihydromintlactone are limited in publicly available scientific literature. Most safety evaluations for synthetic flavor compounds of this type follow standard toxicological assessment protocols established by regulatory bodies and the International Organization of the Flavor Industry (IOFI).

Safety assessments for lactone-based flavorings typically evaluate:

- Acute toxicity data

- Subchronic and chronic toxicity studies

- Genotoxicity potential

- Reproductive and developmental toxicity

- Metabolism and kinetics data

The lack of reported adverse events in FDA surveillance data suggests that products containing this ingredient have not raised safety flags in consumer populations. However, comprehensive published safety data would strengthen the regulatory foundation for this ingredient.

Manufacturers considering use of this flavoring agent should consult with regulatory specialists and review applicable safety dossiers prepared during product development.

Frequently Asked Questions

What is (+/-)-dihydromintlactone?

(+/-)-dihydromintlactone is a synthetic flavoring compound used to impart mint and cooling sensations in food and beverage products. It functions as a flavoring agent or adjuvant to enhance taste profiles in various consumer foods.

Is (+/-)-dihydromintlactone safe?

(+/-)-dihydromintlactone 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 (+/-)-dihydromintlactone banned in any country?

(+/-)-dihydromintlactone 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.