The Food Additives Amendment enacted in 1958 (Public Law 85-929) requires that manufacturers demonstrate the safety of a new food additive. The amendment includes the extremely important but controversial Delaney clause, which states that any food additive in any concentration found to cause cancer in animals or humans will be prohibited for food and beverage use. The intent of the Delaney clause is to protect the consuming public. However, the problems it raises in data interpretation, protocol evaluation, and extrapolation of the data to conditions of use in man have polarized scientists, legislative bodies, and the consuming public into proponents and opponents of the measure. These controversies were brought into particular focus in the case of artificial sweeteners when the cyclamates were banned (1) under the Delaney provision in 1969 and when the Food and Drug Administration (FDA) proposed to ban saccharin in 1977 (2). The proposed ban on the use of saccharin came at a time when it was the only general-use artificial sweetener approved in the United States. The majority of the 100,000 comments the FDA received concerning this issue were opposed to the ban. The public outcry was so intense that the U.S. Congress passed the Saccharin Study and Labeling Act (Public Law 95-203), which imposed an 18month moratorium on the proposed ban to consider its impact. This latter law also required warning labels and notices for foods containing saccharin stating that saccharin has been shown to cause cancer in laboratory animals (3).