In July 1997, the National Institutes of Health announced that its National Toxicology Program (NTP) was reviewing data that could delist saccharin from the federal government’s Report on Carcinogens.

This review was prompted by the Calorie Control Council’s request to have saccharin delisted from the report. According to the Council, saccharin’s presence on the list is wrong, misleading to consumers, and not based on current science. Extensive evidence compiled over the past 20 years, as well as safe use for over a century, has demonstrated saccharin’s safety. In addition, leading health groups have reviewed the scientific research on saccharin and supported its safety. Among these groups are the American Cancer Society, American Medical Association, American Institute for Cancer Research, American Dietetic Association and American Diabetes Association.

In the 1997 announcement, NTP noted that saccharin was never listed as a “known” carcinogen, and that recent human studies have shown no link between saccharin and bladder cancer. In fact, saccharin’s listing in the first place was based primarily on controversial high-dose rat experiments, in which the animals were fed the human equivalent of hundreds of cans of diet soft drinks per day for a lifetime.

According to saccharin researcher Dr. Samuel Cohen, Professor and Chairman of the Department of Pathology and Microbiology at the University of Nebraska Medical Center, who has performed such mechanistic studies, the feeding of high doses of a sodium salt, including sodium ascorbate (vitamin C) and sodium saccharin, to male rats alters the rat urine and leads to the formation of a precipitate which, in turn, may lead to the formation of rat bladder tumors. These sodium salts produce tumors only when administered at high doses and only in rats. Therefore, the mechanism by which the rats develop cancer is not present in humans.

“The lack of effect in mice, and more importantly in monkeys, combined with the strong epidemiological evidence from humans and our understanding of mechanism, strongly support the conclusion that exposure to saccharin does not pose a carcinogenic risk to humans,” Dr. Cohen stated in a recent paper.

Two working groups of the International Agency for Research on Cancer (IARC) have recently agreed that the bladder tumors observed in male rats fed high doses of sodium saccharin are not relevant to man. IARC, too, considered mechanistic data in its evaluation of saccharin. IARC also downgraded its overall rating on saccharin from “possibly carcinogenic to humans” in 1987 to “not classifiable as to its carcinogenicity to humans” in 1998. IARC made its decision based on their findings that “there is strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans.”

First discovered in 1879, saccharin has been used as a non-caloric sweetener in foods and beverages for more than 100 years. American consumers and the doctors, dentists and dietitians who counsel them have widely supported its benefits.

Challenges to saccharin’s safety began in 1977 when the Food and Drug Administration proposed a ban on the sweetener, shortly after the results of a Canadian rat study were released. Soon after, Congress, scientists and the American public launched into action. Congress received thousands of letters opposing the ban and supporting saccharin’s availability, prompting Congress to pass a moratorium on the ban to allow time for more research. That moratorium has since been extended seven times, as saccharin’s continued popularity and mounting scientific evidence of saccharin’s safety have prompted Congress each time to support its continued availability. In 1991, FDA formally withdrew its 1977 proposal to ban the use of saccharin.

In May 2000, the NTP released the 9th edition of its Report on Carcinogens and announced that saccharin had been delisted. The final decision was based on the recommendation of NTP Director Dr. Kenneth Olden, and endorsed by U.S. Secretary of Health and Human Services Donna Shalala. The NTP report was submitted to Congress.

In 1977, Congress passed a moratorium preventing an FDA-proposed saccharin ban. The moratorium has been extended seven times based on the scientific evidence, the counsel of qualified professionals, and the support of consumers. At a 1985 Senate hearing, then-FDA Commissioner Frank Young supported an extension of the moratorium, noting that FDA has less concern about saccharin than in 1977. The Commissioner added that “the actual risk, if any, of saccharin to humans still appears to be slight.”

And, on December 21, 2000, President Clinton signed a bill that will remove the warning label that had been required on saccharin-sweetened products since 1977. Government, scientists and industry are now all in agreement on saccharin’s safety.

[ More about health group statements regarding artificial sweetener Saccharin. ]