Highlights in the history of saccharin toxicology

Abstract

Saccharin has successfully survived a half century of scrutiny of its safety. Experience during almost 60 years of common use in foods, as well as several rat feeding studies including that conducted by the FDA, established its GRAS status under the 1958 Food Additives Amendment. Many chronic one-generation and three (unvalidated) two-generation rat studies subsequently conducted by regulatory and independent agencies in the USA and elsewhere have been interpreted by expert committees, especially those of the National Academy of Sciences/National Research Council, as supportive of saccharin's non-carcinogenicity under possible conditions of use. Not convinced of saccharin's safety, because of the (inconsistent) evidence of bladder tumours in saccharin-treated F 1 male rats, the FDA proposed a ban on its use as a food additive. This ban has been temporarily postponed by Congressional moratoria, while better designed and executed studies into the mode of action of this unmetabolized non-genotoxic substance are in progress.