Artificial Sweeteners and Cancer Risk (Fact Sheet)

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The Food Additives Amendment to the Food, Drug, and Cosmetic Act requires the FDA to approve food additives, including artificial sweeteners.
The Food Additives Amendment to the Food, Drug, and Cosmetic Act requires the FDA to approve food additives, including artificial sweeteners.

What are artificial sweeteners and how are they regulated in the United States?

Artificial sweeteners, also called sugar substitutes, are substances that are used instead of sucrose (table sugar) to sweeten foods and beverages. Because artificial sweeteners are many times sweeter than table sugar, much smaller amounts (200 to 20,000 times less) are needed to create the same level of sweetness.

Artificial sweeteners are regulated by the U.S. Food and Drug Administration (FDA). The FDA, like the National Cancer Institute (NCI), is an agency of the Department of Health and Human Services. The FDA regulates food, drugs, medical devices, cosmetics, biologics, tobacco products, and radiation-emitting products. The Food Additives Amendment to the Food, Drug, and Cosmetic Act, which was passed by Congress in 1958, requires the FDA to approve food additives, including artificial sweeteners, before they can be made available for sale in the United States. However, this legislation does not apply to products that are “generally recognized as safe.” Such products do not require FDA approval before being marketed.

Is there an association between artificial sweeteners and cancer?

Questions about artificial sweeteners and cancer arose when early studies showed that cyclamate in combination with saccharin caused bladder cancer in laboratory animals. However, results from subsequent carcinogenicity studies (studies that examine whether a substance can cause cancer) of these sweeteners have not provided clear evidence of an association with cancer in humans. Similarly, studies of other FDA-approved sweeteners have not demonstrated clear evidence of an association with cancer in humans.

What have studies shown about a possible association between specific artificial sweeteners and cancer?

Saccharin

Studies in laboratory rats during the early 1970s linked saccharin with the development of bladder cancer, especially in male rats. However, mechanistic studies (studies that examine how a substance works in the body) have shown that these results apply only to rats. Human epidemiology studies (studies of patterns, causes, and control of diseases in groups of people) have shown no consistent evidence that saccharin is associated with bladder cancer incidence.

Because the bladder tumors seen in rats are due to a mechanism not relevant to humans and because there is no clear evidence that saccharin causes cancer in humans, saccharin was delisted in 2000 from the U.S. National Toxicology Program's Report on Carcinogens, where it had been listed since 1981 as a substance reasonably anticipated to be a human carcinogen (a substance known to cause cancer). More information about the delisting of saccharin is available in the Report on Carcinogens, Fourteenth Edition

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