Regul Toxicol Pharmacol. 1994 Aug;20(1 Pt 1):105-18.

Postmarketing surveillance of food additives.

Butchko HH, Tschanz C, Kotsonis FN.

Preclinical and Clinical Research, NutraSweet Company, Deerfield, Illinois 60015.

Postmarketing surveillance of consumption and of anecdotal reports of adverse health effects has been recognized by a number of regulatory authorities as a potentially useful method to provide further assurance of the safety of new food additives. Surveillance of consumption is used to estimate more reliably actual consumption levels relative to the acceptable daily intake of a food additive. Surveillance of anecdotal 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 sweetner, 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 postmarketing surveillance.