Title: Alternative Sweeteners

144 Stargel et al.
for general use of neotame was submitted to FDA in December, 1998 (11). Dossiers
for the registration of neotame are being submitted to various regulatory
agencies worldwide.
VIII. CONCLUSION
Neotame is a new, noncaloric, high-intensity sweetener and flavor enhancer. Neotame
is structurally related to and chemically derived from aspartame but is 30
to 60 times sweeter. Neotame is 7000 to 13,000 times sweeter than sucrose.
Neotame should not require special labeling for phenylketonuria and does not
degrade to a diketopiperazine. Neotame can favorably modify and enhance flavor
and taste at or below sweetening levels. The small amounts of neotame required
for sweetening will reduce the cost of delivering and handling sweeteners.
On a sweetness equivalency basis versus existing sweetener alternatives,
neotame offers the potential to deliver improved cost structure because of its high
sweetness potency and low levels of use.
Consumer exposure to neotame in foods is estimated to be 0.05 mg/kg/day
at the 90th percentile level of consumption. Clinical studies have demonstrated
neotame to be safe and well tolerated in amounts up to 40 times the projected
90th percentile of use. In addition, neotame does not alter glycemic control in
subjects with non-insulin-dependent diabetes mellitus. Margins of safety for neotame
in the various species used for safety testing are tens of thousands fold
greater than estimated human exposure levels. Thus, the very large safety margins
in animals and the demonstrated safety in humans at multiples many times 90th
percentile consumption levels establish the safety of neotame for its intended use
as a sweetener and flavor enhancer. The technical and functional qualities of
neotame make this new high-intensity sweetener and flavor enhancer desirable
in a wide variety of food and beverage preparations.
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