Cordle F, Miller S A
Public Health Rep. 1984 Jul-Aug;99(4):365-9.
The increasing use of nonnutritive sweeteners and the widely publicized 1969 ban on cyclamate led to additional investigations in rodents of the carcinogenic potential of saccharin. Preliminary results of a long-term feeding study indicated formation of bladder tumors in rodents, and collective experimental evidence has demonstrated that high doses of the synthetic sweetener saccharin can cause bladder cancer in rodents. Based on the results of that and other rodent studies indicating an increased risk of bladder cancer associated with saccharin, the Commissioner of the Food and Drug Administration announced the agency's intention to propose a ban on saccharin. This intention was made known in April 1977 under the Delaney Clause of the Food, Drug, and Cosmetic Act. The clause essentially states that no additive shall be deemed safe if it is found to induce cancer in man or animals, or if it is found, after tests appropriate for the evaluation of the safety of food additives, to induce cancer in man or animals. Also in 1977, a group of epidemiologists began to assess the available epidemiologic information to determine the potential human risk. This report describes the assessment of several human epidemiologic studies available then and the results of more recent epidemiologic studies.
非营养性甜味剂的使用日益增加，以及1969年对环己基氨基磺酸钠的广泛宣传禁令，引发了对糖精致癌潜力在啮齿动物身上的更多研究。一项长期喂养研究的初步结果表明啮齿动物会形成膀胱肿瘤，并且汇总的实验证据已证明高剂量的合成甜味剂糖精可导致啮齿动物患膀胱癌。基于该研究及其他表明糖精与膀胱癌风险增加相关的啮齿动物研究结果，食品药品监督管理局局长宣布该机构打算提议禁止使用糖精。这一意向于1977年4月根据《食品、药品和化妆品法案》的德莱尼条款公布。该条款本质上规定，如果发现某种添加剂会在人或动物身上诱发癌症，或者在经过适用于评估食品添加剂安全性的测试后发现它会在人或动物身上诱发癌症，则该添加剂不应被视为安全。同样在1977年，一组流行病学家开始评估现有的流行病学信息，以确定对人类的潜在风险。本报告描述了当时对几项人类流行病学研究的评估以及近期流行病学研究的结果。
