Safety assessment of kola nut extract as a food ingredient.

Kola nut extract is used in the food industry as a flavoring ingredient. Kola nut extract is derived from the seeds of primarily two tropical Cola species (Cola nitida (Vent.) Schott et Endl. or Cola acuminata (Beauv.) Schott et Endl.) of the Family, Sterculiaceae. Present day consumption of kola nut extract is 0.69 mg/kg/day. Caffeine and theobromine are two important constituents of kola nuts. Although limited biological data are available for kola nut extract specifically, the published data of the major constituents of kola nuts suggest the pharmacological/toxicological properties of kola nut extract, parallel to those of a roughly equivalent dose of caffeine. Frank developmental/reproductive effects have not been reported and changes in offspring cannot be extrapolated to humans. A NOEL/NOAEL cannot be defined for repeated oral exposure to kola nut extract from available data. Notwithstanding the foregoing, U.S. consumers have a history of safe consumption of cola-type beverages containing kola nut extract that dates at least to the late 19th Century, with a significant global history of exposure to the intact kola nuts that date centuries longer.