Our Verdict: RATING UNKNOWN

Dimethylethanolamine

CAS108-01-0

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

Dimethylethanolamine — food additive

Dimethylethanolamine (DMAE) is a small organic compound with the chemical formula C4H11NO. While its specific function in food applications remains unclear, it has been studied in various industrial and pharmaceutical contexts.

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 Dimethylethanolamine?

Dimethylethanolamine (DMAE), also known as N,N-dimethylethanolamine, is an organic compound with CAS Number 108-01-0. It belongs to a class of chemicals called tertiary amines and has a molecular formula of C4H11NO. The compound consists of a two-carbon backbone with a hydroxyl group (-OH) and a dimethylamino group (-N(CH3)2). DMAE is a colorless to slightly yellow liquid at room temperature with a characteristic amine odor.

Common Uses

Dimethylethanolamine is primarily used in industrial applications rather than as a conventional food additive. It serves as a precursor or intermediate chemical in the manufacture of various products, including cosmetics, pharmaceuticals, and industrial chemicals. The specific application of DMAE in food products is not well-documented in publicly available scientific literature, and its function in food, if any, remains unknown. It may be encountered as a trace component or byproduct in certain manufacturing processes, but intentional food use appears limited or non-existent.

Safety Assessment

The safety profile of dimethylethanolamine in food applications cannot be thoroughly evaluated due to the lack of documented food use. The FDA has not classified DMAE as Generally Recognized as Safe (GRAS) for food applications, which means it has not undergone the rigorous safety review required for intentional food additives. However, the absence of documented adverse events or recalls associated with DMAE in the FDA database suggests no known public health incidents have occurred.

Toxicological studies conducted on DMAE in non-food contexts have examined its effects through various exposure routes. As with many industrial chemicals, the relevant safety considerations depend heavily on the concentration, route of exposure, and duration of contact. Most available toxicological data comes from occupational exposure studies and industrial safety assessments rather than dietary exposure studies.

The lack of GRAS status does not necessarily indicate the substance is unsafe; rather, it indicates that safety for food use has not been formally established through FDA review. Without specific food safety studies, including absorption, metabolism, and potential effects at food-relevant doses, a complete safety assessment for dietary exposure cannot be completed.

Regulatory Status

In the United States, dimethylethanolamine is not approved as a food additive by the FDA. It does not appear on the FDA's GRAS list or the approved food additives list. This means any intentional use in food would be prohibited unless a food additive petition were submitted and approved.

The chemical is registered and regulated as an industrial chemical under the Toxic Substances Control Act (TSCA). It may be subject to workplace safety regulations such as OSHA standards when used in occupational settings. International regulatory agencies, including the European Food Safety Authority (EFSA), have not published specific food safety assessments for DMAE as a food additive.

Key Studies

Published scientific literature on dimethylethanolamine is limited, with most research focusing on industrial applications and occupational health rather than dietary safety. Available toxicological data comes primarily from occupational exposure studies and product safety data sheets. Without peer-reviewed studies specifically examining DMAE's safety in food at realistic consumption levels, drawing conclusions about its dietary safety profile is not possible.

The absence of documented food use, combined with lack of FDA approval and limited safety data in a food context, suggests DMAE is not currently employed as an intentional food additive in commercial food production.

Frequently Asked Questions

What is Dimethylethanolamine?

Dimethylethanolamine (DMAE) is a small organic compound with the chemical formula C4H11NO. While its specific function in food applications remains unclear, it has been studied in various industrial and pharmaceutical contexts.

Is Dimethylethanolamine safe?

Dimethylethanolamine 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 Dimethylethanolamine banned in any country?

Dimethylethanolamine 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.