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U.S. Department of Health and Human Services

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This Week In FDA History - April 4, 1977

Donald Kennedy, Ph.D. April 4, 1977:
Donald Kennedy, Ph.D., becomes Commissioner of Food and Drugs. In one of the more controversial issues of Dr. Kennedy's tenure, the FDA dealt with the public fallout over a ban of the artificial sweetener saccharin proposed in April 1977. Later that year the proposed ban was stayed by the U.S. Congress.

 

FDA in 2006

 

Saccharin remains on the market today. The basis for the proposed ban was a study that documented an increase in cancer in rats being fed saccharin. The "Delaney clause" of the Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act states that no substance can be deemed safe if it causes cancer in humans or animals. In suspending the proposed saccharin ban, Congress ordered that products containing the popular sweetener must carry a warning about its potential to cause cancer. The FDA formally lifted its proposal to ban the sweetener in 1991 based on new studies, and the requirement for a label warning was eliminated by the Saccharin Notice Repeal Act in 1996.