Postmarketing surveillance in the food industry: The aspartame case study

The Federal Food, Drug, and Cosmetic Act of 1938 gave the US Food and Drug Administration (FDA) its regulatory authority over foods and food additives. Twenty years later, this act was amended to require that the FDA be provided with proof of reasonable certainty that any substance added to food was safe for its proposed uses (1). Often such proof requires extensive toxicologic testing (2,3). Regulatory agencies require prospective demonstration that the additive is safe for its proposed use and that its probable consumption will be less than the acceptable daily intake (ADI). Another useful tool in further ensuring the safety of a food additive is monitoring it following approval, or postmarketing surveillance. With widespread use of an additive, postmarketing surveillance of consumption levels can determine whether actual consumption exceeds the ADI established from safety studies. Furthermore, postmarketing surveillance of anecdotal reports of health effects may identify issues for further evaluation that had not been identified in earlier animal and human studies.