Postmarketing surveillance of consumption and of anecdotal reports of
adverse health effects has been recognized by a number of regulatory a
uthorities as a potentially useful method to provide further assurance
of the safety of new food additives. Surveillance of consumption is u
sed to estimate more reliably actual consumption levels relative to th
e acceptable daily intake of a food additive. Surveillance of anecdota
l reports of adverse health effects is used to determine the presence
of infrequent idiosyncratic responses that may not be predictable from
premarket evaluations. The high-intensity sweetener, aspartame, is a
food additive that has been the subject of extensive evaluation during
the postmarketing period and is thus used as an example to discuss po
stmarketing surveillance. (C) 1994 Academic Press, Inc.