Title: Alternative Sweeteners

Sucralose 191
fructose, and/or insulin secretion in healthy animals, and it was therefore predicted
that no effect in these parameters would be seen in healthy human volunteers
or individuals with diabetes. A clinical trial that used 1000 mg/day for 3
months in healthy volunteers demonstrated no adverse effect on glucose homeostasis.
Subsequent studies with individuals having type 1 or type 2 diabetes have
shown no abnormalities in glucose control. The most important of these studies
was a 3 month, five-center study, in which 136 patients were carefully evaluated
and monitored following a protocol developed with regulatory authorities. After
dosing with 667 mg/day for 3 months to individuals with type 2 diabetes, no
adverse effect on glucose homeostasis was detected, particularly in parameters
that monitored the long-term blood glucose levels.
B. Regulatory Status
Before the submission of the sucralose database to regulatory agencies, an independent
panel of 16 internationally recognized scientific experts was asked to
review the sucralose toxicological database and projected human intake data.
They were to provide a detailed review on the adequacy of the toxicological data
and evaluate the safety of sucralose for human consumption. The panel included
experts in toxicology, oncogenicity, clinical toxicology, genetic toxicology, metabolism,
biochemistry, reproductive toxicology, physiology, nutrition, hematology,
pediatrics, risk assessment, neurotoxicology, and immunology. The expert
panel on sucralose concluded that on the basis of the evaluation of the data presented
to them and regulatory agencies and on the discussions and deliberations
of the entire panel ‘‘sucralose is safe for its intended purpose of use’’ (7).
Regulatory agencies around the world have concluded that sucralose is safe.
At present, more than 40 countries and international bodies have endorsed the
safety of sucralose, including. South Africa, Japan, China, Saudi Arabia, Russia,
Australia, New Zealand, Brazil, Argentina, Mexico, Canada, and the United
States. In June 1990, the Joint FAO/WHO Expert Committee on Food Additives
(JECFA), assigned a permanent Acceptable Daily Intake (ADI) for sucralose of
15 mg/kg body weight/day. Because the Expected Daily Intake (EDI) for sucralose
at the 90th percentile as determined by the U.S. Food and Drug Administration
(FDA) is 1.6 mg/kg/day (8), the assignment of an ADI value greater than
2.0 mg/kg/day allows virtually unrestricted use of sucralose as a sweetener. The
approval granted sucralose by the U.S. FDA in April 1998 was the broadest initial
approval ever granted a new food additive. Subsequently, in August 1999, the
FDA approved sucralose as a general-purpose sweetener.
C. Cariogenicity
Sprague-Dawley rats infected with Streptococcus mutans were provided with sucrose
or sucralose along with a diet that contained no additional sucrose. After