Title: Alternative Sweeteners

Alitame 37
Figure 5 Metabolism of alitame.
bution of 1.4 calories per gram is clearly insignificant at the use levels in the
diet.
IX. SAFETY
Alitame has been evaluated in the extensive series of studies designed to establish
its safety as a sweetener in the human diet. A list of the major studies completed
is shown in Table 4. On the basis of substantial safety factors determined in these
studies, it is concluded that alitame is safe for its intended use as a component
of the diet of man.
The appropriateness of the animal studies is supported by the fact that the
major metabolites of the compound are common to laboratory animals and man.
The cumulative data amassed during the safety evaluation demonstrate that this
sweetener has an extremely low order of toxicity that supports its estimated mean
chronic daily human dietary intake of 0.34 mg/kg body weight, assuming that
alitame is the sole sweetener in all food categories requested in the Food Additive
Petition. In all the studies the no-effect level (NOEL) was consistently greater
than 100 mg/kg, or 300 times the mean chronic human exposure.
The primary effect of alitame in animals treated with levels greater than
the NOEL (100 mg/kg) for periods ranging from 5 days to 2 years was the dose-