ABSTRACT

The Food Additives Amendment enacted in 1958 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 intensity of the debate over the wisdom of the Delaney clause dramatized the need for an artificial sweetener for dieters and diabetics for whom obesity is a health problem. Blood methanol determinations for thirty three subjects of all age categories were negative. Pre-test and post-test physical examinations, including blood pressure measurements, revealed no significant changes. It is reasonable to expect that a potent sweetener with little caloric value would find particular use among weight-conscious individuals. Random assignment to treatments resulted in tightly clustered groups that were virtually identical for average height, weight, and caloric intake.