saccharin molecule
Saccharin

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Introduction
In 1958, Congress passed the Delaney Clause of the Food, Drug, and Cosmetic Act. The Clause prohibited the use of all food additives found to be carcinogenic to humans or animals, and makes the U.S. Food and Drug Administration responsible for its implementation. In the late 1970’s, a Canadian study by Arnold, D. L., et al, indicated the formation of bladder tumors in rats exposed to high doses of saccharin. Later, the FDA responded by proposing a ban on saccharin in 1977 - under the Delaney Clause. Due to public outcry following the ban proposal, Congress used its authority over the FDA to place a moratorium on the ban for two years until further research could be conducted. The moratorium has remained in place to date, while the controversy over the research results has continued.

Background
The groundwork for the ban on saccharin was established in 1938 when Congress passed the Food, Drug and Cosmetic Act. The Act tightened the existing food standards and reinforced the roles and responsibilities of the FDA. In 1958, laws addressing food additives were introduced to give the FDA additional control over new chemicals entering the food supply. The Delaney Clause, a provision of the law that prohibited the use of any food additive shown to cause cancer in animals and humans, would come into play twenty years later in an FDA attempt to ban saccharin.

The primary reason that saccharin remained on the market during the first 70 years of its use was its labeling as a “generally recognized as safe” (GRAS) status among the regulatory agencies. It was not until the 1969 ban on cyclamates, a non-nutritive sweetener often mixed with saccharin, that the FDA made a push to further investigate saccharin for possible carcinogenicity. At this same time, the FDA started a program to review all GRAS substances employing the most current science and technology.

In 1972, toxicological studies indicated possible bladder cancer caused by saccharin. The data suggested the tumors might be a result of the impurities versus the saccharin itself. In response, the FDA removed saccharin from the GRAS status and issued an interim food additive regulation limiting the use of saccharin in foods while waiting for additional study results. The National Academy of Sciences (NAS) reviewed the study data in 1974 and agreed with the previous study conclusions. The interim regulations continued until 1977 when additional rat studies were completed by Canadian research teams. Based on the claim that saccharin itself was causing bladder tumors in rats, the FDA proposed the ban on saccharin as a food additive via the Delaney Clause.

Public outcry and voiced concerns from the diabetic community pushed Congress to place a moratorium on the ban for two years to allow for additional research. In lieu of the moratorium, labeling requirements were established to warn individuals of the possible risk of cancer associated with the use of saccharin based on laboratory animal studies.

To date numerous studies have been conducted in an effort to determine if saccharin and its salt compounds are truly human carcinogens. Much debate has challenged the original rat studies, claiming that the toxicological effects of saccharin exposure in rats differ from that in humans. Based on recent studies supporting these claims, the FDA formally withdrew its 1977 proposal to ban the use of saccharin. Also, the International Agency for Research on Cancer (IARC) downgraded its rating of saccharin from Group 2B, “possibly carcinogenic to humans” to Group 3, “not classifiable as to the carcinogenicity to humans”. Additionally, the National Toxicology Program (NTP) removed saccharin from its Report on Carcinogens.

Recent Developments
In 2000, President Clinton signed a bill to remove the warning label from products containing saccharin. To this day a salt derivative of saccharin, sodium saccharin, remains on the list of carcinogens and still requires warning labels.

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Page last updated: 2/22/05