More Than a Century of Use
The granddaddy of all sugar substitutes is saccharin. Discovered in 1879, it was used during both world wars to sweeten foods, helping to compensate for sugar shortages and rationing. It is 300 times sweeter than sugar.
An early attempt to ban saccharin came in 1911 when a board of federal scientists called the artificial sweetener "an adulterant" that should not be used in foods. This same board later decided to limit saccharin just to products "intended for invalids," a restriction that was lifted after World War I began.
In 1958, Congress passed the Food Additives Amendment to the Food, Drug, and Cosmetic Act, which required premarket approval from FDA for food additives developed after 1958. This requirement did not apply to ingredients "generally recognized as safe," or GRAS. Saccharin was considered GRAS, so it remained on the market.
FDA began reviewing hundreds of GRAS substances—including saccharin—in the early 1970s to ensure that the latest scientific information continued to back up their safety. Studies in 1972 and 1973 of rats fed saccharin raised concerns about the sweetener’s role in causing bladder cancer, but data analysis later suggested that impurities, not saccharin, may have caused the tumors.
Then in 1977, a Canadian study that looked specifically at the role of impurities—and of other suspected tumor causes, such as parasites in test animals—showed convincingly that saccharin itself was causing bladder cancer in rats. That same year, FDA proposed to ban saccharin for all uses except as an over-the-counter drug in the form of a tabletop sweetener. At the time, saccharin was the only available alternative to sugar.
The FDA proposal prompted a public outcry, fueled in part by media reports that the test rats were fed the equivalent of as many as 800 diet sodas a day. Congress responded by passing the Saccharin Study and Labeling Act, which placed a two-year moratorium on any ban of the sweetener while additional safety studies were conducted. The law also required that any foods containing saccharin must carry a label that reads "Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals." Congress has extended the moratorium several times, most recently renewing it until 2002.
Saccharin has remained on the market and continues to have a fairly large appeal as a tabletop sweetener, particularly in restaurants, where it is available in single-serving packets under trade names such as Sweet ‘n Low. Because it has a good shelf life, saccharin is used widely in fountain sodas, and its stability at high temperatures makes it an option for sweetening baked goods, unlike aspartame, which degrades when heated. Saccharin also is favored economically because it can be made inexpensively.
But given saccharin’s continuing tentative status, should consumers use it? "We know for certain that it causes cancer in animals," says Andrew Laumbach, Ph.D., consumer safety officer in FDA’s Office of Premarket Approval. He acknowledges, however, that animal studies do not always predict the behavior of a substance in the human body.
The National Cancer Institute states in its "Cancer Facts" documents that "epidemiological studies do not provide clear evidence" of a link to human cancer. Regina Ziegler, Ph.D., an NCI epidemiologist, says, "Typical intakes of saccharin at normal levels for adults show no evidence of a public health problem."
The government’s National Toxicology Program has kept saccharin on its roster of "anticipated carcinogens," though it periodically considers "de-listing" the sweetener based on available safety evidence.
In the late 1970s FDA and NCI conducted a population-based study of saccharin’s role in causing bladder cancer in humans and found that "in general," people who used the sweetener had no greater risk of bladder cancer than the population at large. However, the study found "suggestive evidence" that heavy saccharin users—defined as those using six or more servings of the sweetener a day—may have an increased risk. Laumbach says that for consumers who use saccharin, the key to a lower risk may be moderation, as is the case with many foods that can cause problems when eaten in excess. Other health groups, including the American Medical Association, the American Cancer Society, and the American Dietetic Association, agree that saccharin use is acceptable.
