ABSTRACT
Aspartame, the methyl ester of L-aspartyl-L-phenylalanine, and its principal decomposition product, 3-carboxymethyl-6-benzyl-2,5-diketopiperazme (DKP) have been extensively studied for their toxicological potential for the past 15 years. The development of a data base for product safety assessment typically starts in three scientific areas: metabolism, pharmacology, and toxicology. The metabolism of aspartame and its diketopiperazine have been extensively studied in mice, rats, rabbits, dogs, monkeys, and man. Chronic short-term toxicity studies, thirty nine to ninety days in duration, were carried out in mice and rats with aspartame and with aspartame’s DKP and in dogs with aspartame. The data from preclinical studies, cannot by themselves assure that a food additive is completely safe for all segments of the consuming population. When integrated with the clinical data and with projected consumption data, there is reasonable certainty that aspartame will cause no harm to the public who consume it.
