Our Verdict: AVOID

Calamus Extract--prohibited

CAS84775-39-3

Significant regulatory concerns

This additive is banned, restricted, or under active review in one or more major jurisdictions. The data below explains what we know.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Calamus Extract--prohibited — food additive

Calamus extract is a flavoring substance derived from the rhizome of Acorus calamus (sweet flag plant). It has been prohibited in food use by the FDA due to safety concerns, despite limited adverse event reports in the agency's database.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

Banned in 8 jurisdictions
United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
BannedUK FSA
Canada
BannedHealth Canada
Australia
BannedFSANZ
Japan
BannedMHLW
South Korea
BannedMFDS
Brazil
BannedANVISA
China
BannedNHC / GB 2760
India
BannedFSSAI
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 Calamus Extract?

Calamus extract is derived from Acorus calamus, commonly known as sweet flag or calamus root. The extract is obtained from the underground rhizomes of this plant, which has been used historically in traditional medicine and food flavoring across various cultures. The extract contains volatile oils and other chemical compounds that produce a distinctive aromatic and slightly bitter taste profile.

Common Uses

Historically, calamus extract was used as a flavoring agent in beverages, bitters, and traditional medicinal preparations. It was also employed in some food products for its aromatic properties. However, due to regulatory restrictions implemented in the 1960s, its use in food products intended for human consumption has been prohibited in most countries, including the United States. The extract is no longer permitted in foods marketed to consumers.

Safety Assessment

The FDA prohibition of calamus extract was based on toxicological studies conducted in the 1960s that raised safety concerns. Research identified the presence of beta-asarone, a component found in certain varieties of calamus, as a potential concern. Animal studies suggested potential toxicity at high doses. Interestingly, the FDA's adverse events database contains zero reported incidents and zero recalls associated with calamus extract, though this likely reflects its removal from the market rather than safety confirmation.

It is important to note that calamus plants exist in two main chemotypes: those rich in beta-asarone and those essentially free of this compound. The toxicological profiles of these varieties differ significantly. The prohibition appears to have been a precautionary measure based on available evidence at that time.

Regulatory Status

The FDA prohibited calamus extract for use in human food in 1968. The extract is classified as not Generally Recognized As Safe (GRAS) for food use. This prohibition has remained in effect and represents one of the more complete restrictions on a flavoring substance in the United States.

The European Food Safety Authority (EFSA) has also restricted calamus extract and products derived from Acorus calamus in food applications due to the potential presence of beta-asarone. Similar restrictions exist in Canada and other regulatory jurisdictions.

While prohibition for food use is in place, calamus is still permitted in some countries for use in dietary supplements and traditional herbal preparations, where different regulatory frameworks apply.

Key Studies

The primary scientific basis for the FDA's prohibition came from toxicological research conducted in the 1960s examining the effects of calamus extract and beta-asarone in laboratory animals. These studies documented potential adverse effects at elevated dose levels, though human exposure data was limited. Subsequent research has further characterized beta-asarone's toxicological properties, supporting the cautious regulatory approach.

More recent scientific literature continues to examine calamus species and their chemical composition, contributing to ongoing understanding of why the chemotype matters significantly for safety assessment. However, the evidence base remains primarily historical, as continued research on calamus for food use has been minimal following the regulatory prohibition.

Frequently Asked Questions

What is Calamus Extract--prohibited?

Calamus extract is a flavoring substance derived from the rhizome of Acorus calamus (sweet flag plant). It has been prohibited in food use by the FDA due to safety concerns, despite limited adverse event reports in the agency's database.

Is Calamus Extract--prohibited safe?

Calamus Extract--prohibited is currently rated "avoid" 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 Calamus Extract--prohibited banned in any country?

Calamus Extract--prohibited 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.