Title: Alternative Sweeteners

Neotame 139
cific taste requirements by blending. Sweetener blends offer taste advantages such
as lower off-flavors and more sucrose-like temporal profiles (quicker onset and
shorter sweet linger) than individual sweeteners. In the same way, blends of neotame
with other sweeteners will provide opportunities for food manufacturers to
formulate better tasting products. The flavor enhancement quality of neotame,
which masks bitter flavors even at subsweetening levels, makes neotame in admixture
blends a desirable choice with other sweeteners that possess potentially
undesirable or more complex taste profiles.
V. SAFETY
A. Projected Consumption/Exposure
The mean consumption of neotame for all users is estimated to be 0.02 mg/kg
body weight/day. Consumption for 90th percentile users of neotame is estimated
to be 0.05 mg/kg body weight/day. These anticipated consumption levels of neotame
provide extremely wide margins of safety when evaluated in light of results
from animal safety studies. Anticipated levels of neotame consumption are based
on known 14-day estimates of aspartame consumption (7–9), a conservative
sweetening intensity ratio for neotame of 31 times that of aspartame, and the
potential for neotame to replace 50% of current market share for aspartame.
B. Safety Evaluation of Neotame
Neotame has been subjected to extensive investigations in toxicological studies
to establish the safety of its use in foods (10, 11). Numerous studies, including
subchronic, chronic, and special studies, have been done in rats, mice, dogs, and
rabbits. In addition, long-term feeding studies were done in rodents to evaluate
carcinogenic potential; teratogenicity studies were done in rats and rabbits to
determine the potential for effects on the fetus; a two-generation study was done
in rats to determine the potential for reproductive effects. Studies including bacterial
and mammalian systems evaluated mutagenic potential of both neotame and
its major metabolite. Chronic and carcinogenicity studies in the rat included in
utero exposure to neotame, ensuring that animals were dosed throughout the duration
of the studies from conception to study termination. Safety studies were done
according to the general principles in current U.S. FDA guidelines (12) and other
international guidelines.
Neotame was generally administered in the diet, because this route of exposure
is the most relevant to human consumption. Diets were formulated and concentrations
adjusted regularly to provide dosages in mg/kg/day rather than dosing
at fixed percentages of neotame in the diet. Safety studies were performed with
those strains for which the most complete databases were available; for example,