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Regulatory Controversy

Cyclamate's regulatory problems began in 1969, when a small number of rats fed very large amounts of Sucaryl for two years (virtually their entire lives) developed bladder cancer. This led the FDA to ban use of cyclamate—but not of saccharin, the mixture's other ingredient—the following year. The issue was far from settled, however. In 1973, Abbott Laboratories filed what the FDA calls a Food Additive Petition—that is, a request to allow use of cyclamate in foods. (A fine legal point is that this was the first such request for cyclamate. The law requiring FDA permission for use of food additives was not passed until 1958, so cyclamate and other additives used before that time were exempt.) This request was accompanied by a number of additional studies supporting the compound's safety. The FDA considered and debated this petition for seven years before finally rejecting it in 1980.

In 1982, Abbott Laboratories filed another Food Additive Petition, this time joined by an industry group called the Calorie Control Council. As of 1995, the FDA still has not acted. With the passage of so many years, however, the issue has become almost purely one of principle: Since the patent on cyclamate has expired, few believe Abbott Laboratories would manufacture and market the sweetener if allowed to do so. Possibly, though, another company might choose to offer it.

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