Title: Alternative Sweeteners

50 Butchko et al.
verse health effects thought to be related to foods, food and color additives, and
vitamin/mineral supplements (70, 71). Through this system, spontaneous reports
of food-associated adverse health events received from consumers, physicians,
and industry are documented, investigated, and evaluated.
On the basis of reviews of anecdotal complaints for aspartame, the FDA
concluded that there is no ‘‘reasonable evidence of possible public health harm’’
and ‘‘no consistent or unique patterns of symptoms reported with respect to aspartame
that can be causally linked to its use’’ (70, 71). In a recent evaluation, they
further concluded that there was a gradual decrease in the number of reports
regarding aspartame received over time and that the reports remained comparable
to previous ones in terms of demographics, severity, strength of association, and
symptoms (72).
In considering the anecdotal reports, it is important to keep in mind that,
because about 100 million people consume aspartame in the United States alone,
it is not unlikely that a consumer may experience a medical event or ailment
near the same time aspartame is consumed. The error of inclinations to associate
causality with coincidence is perhaps best stated by one scientist who indicated,
‘‘As aspartame is estimated to be consumed by about half the U.S. population,
one need not be an epidemiologist to grasp the problem of establishing a causeand-effect
relationship. Half the headaches in America would be expected to
occur in aspartame users, as would half the seizures and half the purchases of
Chevrolets.’’ (73).
E. Research to Investigate Issues Raised in the
Postmarketing Period
To expand the knowledge base about aspartame and further address the anecdotal
reports and other scientific issues raised during the postmarketing period, a number
of studies, including ‘‘focused’’ studies in humans as suggested by the CDC,
were done. For example, the results of a long-term clinical study with high doses
of aspartame (75 mg/kg/day for 24 weeks, or about 25 to 30 times current consumption
levels at the 90th percentile) provided additional confirmatory evidence
of aspartame’s safety (60). Even after these enormous daily doses of aspartame,
there were no changes in clinical or biochemical parameters or increased adverse
experiences compared with a placebo. Clinical studies to evaluate whether aspartame
causes headache, seizures, or allergic-type reactions were done (74–87).
In some of these studies, individuals identified through the company’s medical
postmarketing surveillance system, who were convinced that aspartame caused
their symptoms, were studied (77, 83–85). In addition, studies were done to evaluate
whether aspartame had any effect on brain neurotransmitter concentrations
or neurotransmission or on indicators of brain function, such as memory, learning,