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This finding in animals suggested that cyclamate may increase the risk of bladder cancer in humans; for this reason, the U.S. Food and Drug Administration (FDA) banned the use of cyclamate in 1969. However, results of animal studies conducted in more recent years have failed to demonstrate that cyclamate is a carcinogen (a substance that is known to cause cancer). Nevertheless, other issues must be resolved before cyclamate can be approved for commercial use in restricted amounts. These issues include determining whether cyclamate is a co-carcinogen (a substance that enhances the effect of a cancer-causing substance) and ascertaining the potential risk for specific groups within the population, such as those who would consume large amounts of cyclamate.
Other animal studies, including one conducted in Canada several years ago, have linked saccharin, another artificial sweetener, with the development of bladder cancer. The FDA consequently proposed a ban on saccharin in April 1977. However, the Saccharin Study and Labeling Act, passed by Congress in November 1977, placed an 18-month moratorium on any action against saccharin by FDA and required that all food containing saccharin bear the following warning label: "Use of this product may be hazardous to your health. This product contains saccharin, which has been determined to cause cancer in laboratory animals." The moratorium has been extended to May 1997.
During 1978 and 1979, the National Cancer Institute (NCI) and FDA conducted a population-based study on the possible role of saccharin in causing bladder cancer in humans. In general, people in the study who used an artificial sweetener had no greater risk of bladder cancer than people in the population as a whole. However, when only the data for heavy users were examined, there was some suggestive evidence of an increased risk, particularly in persons who consumed both diet drinks and sugar substitutes and who used at least one of these two forms heavily. In the study, which included a large number of elderly people, heavy use was defined as six or more servings of sugar substitute or two or more 8-ounce servings of diet drink daily.
The results of the NCI-FDA study, together with findings of additional research with laboratory animals, suggest that consumption of saccharin is not a strong risk factor for bladder cancer in humans. More recent animal studies also suggest that saccharin is unlikely to be a risk factor for cancer in humans.
Aspartame, a third type of artificial sweetener, was approved in 1981
by the FDA after tests showed that it did not cause cancer in
laboratory animals, although not all the laboratory experiments
agreed. At present, aspartame is a common artificial sweetener and is
distributed under the trade name of Nutrasweet or Equal. Interest in
aspartame was renewed by a 1996 publication which suggests that an
increase in the number of persons with brain tumors
between 1975 and 1992 may be associated with the introduction and use
of this sweetener in the United States. However, a recent analysis of
NCI statistics on cancer incidence in the United States does not
support an association between the use of aspartame and an increased
incidence of brain tumors. These data show that the overall incidence
of brain and central nervous system cancers began to rise in 1973, 8
years before the approval of aspartame, and continued to rise until
1985. Increases in overall brain cancer incidence have occurred
primarily in the 70 and older age group, a group that has not been
exposed to the highest doses of aspartame since its 1981 introduction.
Since 1985, the incidence of these cancers has stabilized, and, in the
last 2 years for which data are available (1991 to 1993), the
incidence has, in fact, decreased slightly. Thus, at this time, there
is no clear link, based on animal or human studies, between the use of
aspartame and the development of brain tumors.
Department of Health, Education, and Welfare: FDA and NCI Announce Plans to Conduct a Nationwide Study on the Possible Role of Saccharin in Causing Bladder Cancer in Humans, January 25, 1978 (press release). Olney, John: Increasing brain tumor rates: Is there a link to Aspartame? Journal of Neuropathology and Experimental Neurology, 55:
11151123, 1996.
Thorgeirsson, UP, et al: Tumor incidence in a chemical carcinogenesis study of nonhuman primates. Regul Toxicol Pharmacol, 19(2):130151, 1994.
This fact sheet was reviewed on 4/9/1997
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