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Seldom has that intrusion generated the outrage caused last month when the FDA announced that it planned to ban noncaloric saccharin as a food additive (TIME, March 21). Last week the FDA decided to hedge a little. Newly appointed Commissioner Donald Kennedy announced that the agency will go ahead with the ban, probably by midsummer -but will allow saccharin to be sold, like aspirin, as an over-the-counter drug, at least until the end of the year...
...saccharin, some Canadian rats developed bladder cancer when they were fed the sweetener in amounts that would be equivalent, in a human, to 800 cans of diet soda a day throughout his life. The Delaney clause, however, makes no mention of dosage levels. By considering saccharin a drug, the FDA allowed itself to apply less rigid standards: the agency may weigh hazard against benefit in deciding which drugs can be sold. Yet, drugs must be proved "effective," so manufacturers will have until the end of 1977 to demonstrate that saccharin can actually help to control obesity. If they cannot, saccharin...
...latest ruling may add a further touch of cynicism to attacks against the FDA: If saccharin is unsafe in food, what makes it acceptable in a drugstore? Certainly, the ruling has helped to make some of the criticism more pointed...
Complains Allen Fox, an aide to Senator Edward Kennedy's subcommittee on health resources and scientific research: "There is no accountability in decision making. The FDA must be reorganized internally." Dr. Sidney Wolfe, director of the Ralph Nader-affiliated Public Citizen's Health Research Group in Washington, says of the agency's initial decision to ban saccharin altogether: "The FDA wrote up its intention in one hour and 20 minutes. The furor could have been avoided if they thought of public reaction. They blew...
Morale at the FDA is frequently bad these days, and senior positions can be hard to fill. Example: Commissioner Kennedy, a biologist, took over last month, a full three months after the resignation of his predecessor, Dr. Alexander Schmidt. In addition, Schmidt had given five months' notice of his intent to leave. Acknowledges Kennedy, who has developed a crash-course understanding of the FDA's problems: "I am learning that the agency does little that is not controversial...