Cyclamate, discovered in 1937, is a non-caloric sweetener approximately 30 times as sweet as sucrose. Like other low-calorie sweeteners, cyclamate is of benefit to those seeking to control weight, manage diabetes, or help prevent tooth decay. Cyclamates, whether in the form of sodium cyclamate or calcium cyclamate, are stable and soluble. Cyclamate is used as a tabletop sweetener, in diet beverages, and in other low-calorie foods. In addition, cyclamate is useful as a flavor enhancer. Cyclamate's heat stability, high order of sweetness and other technological advantages also make it a good flavoring agent for many pharmaceutical preparations and toiletries. 

Benefits

When cyclamate is combined with other low-calorie sweeteners, a synergistic effect results--that is the two sweeteners in combination taste sweeter than what normally would be expected from the sum of the individual sweeteners. Additionally, the aftertaste sometimes associated with the use of a single sweetener can be masked by combining sweetening agents. For example, the mixture of 10 parts cyclamate to one part saccharin is a combination which was widely used in foods and beverages during the 1960s. Cyclamate can serve as an excellent complement to other low-calorie sweeteners which are available and, particularly because of its unique synergistic sweetening properties, makes possible a wider variety of good-tasting low-calorie products. Cyclamate is stable in heat and cold and has good shelf life. Its solubility in liquids enables use in beverages.

Safety

The scientific evidence overwhelmingly supports the safety of cyclamate and assists in determining safe levels of human consumption. Specifically:

  • Two dozen studies demonstrate that even after ingestion of high doses of cyclamate throughout the lives of laboratory animals, cyclamate does not cause cancer;
  • More than 70 studies, comprising an unusually comprehensive group of mutagenicity tests and incorporating at least ten different testing methodologies, demonstrate that cyclamate is not mutagenic;
  • Numerous studies of human populations have found no excess cancer risk -- this despite the fact that subjects consumed cyclamate, as well as saccharin, for a number of years.

The distinguished scientists of the World Health Organization, Food and Agriculture Organization's Joint Expert Committee on Food Additives (JECFA) have, over the past 10 years, consistently determined human cyclamate use is safe. In 1982, JECFA increased the Acceptable Daily Intake level for cyclamate use almost threefold, following a review of recent scientific evidence. The establishment of an acceptable daily intake of cyclamate further assures safety at human consumption levels.

Regulatory Status

The conclusion that cyclamate can be safely consumed has been reached by an increasing number of governments throughout the world. More than 50 countries around the world, having assessed the wealth of scientific evidence, have concluded that cyclamate can be used safely and have made it available for various uses. This includes Europe, where the European Community has placed cyclamate on its approved sweeteners list.

Despite that support, and the overwhelming scientific evidence indicating cyclamate's safety, cyclamate remains restricted in some countries. The controversy regarding cyclamate is based principally upon one experiment in which bladder tumors were found in some rats fed extremely large doses of cyclamate and other substances. As a result, the United States banned cyclamate in 1970 and some countries restricted its use. The rat study has been criticized by a number of scientists, including the study director himself. Since 1970, new scientific evidence has become available and several countries have reconsidered the use of cyclamate. For example, in Canada, the Minister of Health and Welfare reinstated certain uses of cyclamate after concluding in 1978 that "new and more sophisticated testing procedures have led to a general agreement that cyclamates are not carcinogenic."

A petition for cyclamate reapproval is currently under review by the U.S. Food and Drug Administration (FDA). The petition seeks reapproval primarily in light of three sets of facts: 1) scientists from the American Statistical Association and the Society of Toxicology have called upon FDA to reassess the statistical and scientific principles relied upon in its 1980 decision not to reapprove cyclamate; 2) new scientific evidence, including some 75 new studies, demonstrates the safety of cyclamate for human use and assists in determining safe consumption levels; and 3) JECFA has determined human cyclamate use is safe in its 1978, 1980 and 1982 reports, and has found sufficient data to establish a safe human consumption level.

In 1984, FDA's Cancer Assessment Committee (CAC) reviewed the scientific evidence and reached the following conclusion: "[T]he collective weight of the many experiments . . . indicates that cyclamate is not carcinogenic." In June 1985, the National Academy of Sciences (NAS) reaffirmed the CAC's conclusion, noting "the totality of the evidence from studies in animals does not indicate that cyclamate or its major metabolite cyclohexylamine is carcinogenic by itself." Before cyclamate is returned to the marketplace, FDA has noted it will conduct an extensive review of the NAS report and resolve other questions which relate primarily to the acceptable daily intake for cyclamate.

Summary

Substantial scientific evidence supports cyclamate's safe use by the millions of consumers who seek to control their intake of carbohydrate-based sweeteners and calories. A favorable decision on the current petition for reapproval would provide for a greater variety of low-calorie foods and beverages to help meet consumer demand. No low-calorie sweetener is perfect for all uses. However, with several low-calorie sweeteners available, each can be used in the applications for which it is best suited. Also, when used in combination (as would most often be the case with cyclamate), the strengths of one sweetener can compensate for the limitations of another, providing for increased stability, improved taste, lower production costs and more product choices for the consumer.

More information is available at www.cyclamate.org.

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