The International Agency for Research on Cancer (IARC) has recently concluded that isoeugenol, a naturally occurring substance commonly found in numerous foods, is possibly carcinogenic to humans. IARC does not perform risk assessments; its findings are based on hazard information alone. However, even the hazard-based conclusion of possibly carcinogenic to humans is wholly inconsistent with the determinations of all other regulatory and scientific bodies. Isoeugenol is considered safe for use as a flavoring by the U.S. FDA, the Joint WHO/FAO Expert Committee on Food Additives (JECFA), the FEMA Expert Panel, the Japan Ministry of Health, and many others.
All other food safety evaluators, including the FEMA Expert Panel and the European Food Safety Authority, that have reviewed the carcinogenicity data have concluded that the marginal evidence of carcinogenicity from high-dose studies in rodents is rodent-specific and not relevant to the safety assessment of isoeugenol as a flavoring.
Further, IARC has contradicted their previous findings of “not classifiable” for carcinogenicity data sets similar to the results for isoeugenol. The IARC has historically served an important role in global public health, but increasingly the IARC’s classifications are not based on state-of-the-art evaluations of the mechanisms of carcinogenicity.
The Flavor and Extract Manufacturers Association of the United States (FEMA) is composed of flavor manufacturers, flavor users, flavor ingredient suppliers, and others with an interest in the U.S. flavor industry. Founded in 1909, it is the national association of the U.S. flavor industry. FEMA is committed to assuring a substantial supply of safe flavoring substances. More information about FEMA is available at www.femaflavor.org.