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Perception, Planning, and Scoping, Problem Formulation, and Hazard Identification
Published in Ted W. Simon, Environmental Risk Assessment, 2019
For example, high doses of the artificial sweetener saccharin have been shown to be carcinogenic in rats, evidenced by a dose-related increase in urinary bladder tumors. High doses of the sweetener aspartame produced an increase in brain tumors in rats.42 As a society, shouldn’t we be concerned about these two carcinogenic chemicals that are used ubiquitously as sweeteners and consumed every day by millions of people? Why are these substances approved for human consumption? Shouldn’t they be banned? Such a ban would certainly be in the spirit of the Delaney Clause.
Foodborne Illness
Published in Gary S. Moore, Kathleen A. Bell, Living with the Earth, 2018
Gary S. Moore, Kathleen A. Bell
Saccharin is a low-calorie sweetener that was approved by the FDA but still remains highly scrutinized. In laboratory animals, saccharin promotes bladder cancer after exposure to a bladder carcinogen. In 1977, the FDA proposed a ban on saccharin as a food additive. However, the ban was postponed by Congress pending additional studies to support the results. Saccharin was not removed under the Delaney Clause because various studies have reported conflicting results. A considerably high amount of saccharin is needed to produce the observed effects. It has been speculated that sodium, not saccharin, may be responsible for the bladder cancer.18
Chemistry, food and the modern diet: what’s in food besides food?
Published in Richard J. Sundberg, The Chemical Century, 2017
For many years, it was the only available noncaloric sweetener, although used alone, it can have a bitter after-taste. Its use was especially high during WWII when sugar was rationed. When regulation of food additives was mandated in 1958, saccharin was approved as “generally recognized as safe” on the basis of its extensive previous use. The 1958 law, however, also stated that any substance found to “induce cancer in man or animal” should not be deemed “safe” (Delaney Amendment). In the 1970s, several studies showed that high doses of saccharin can cause bladder cancer in rats. The FDA announced its intention to ban saccharin, but Congress intervened with a series of moratoria. Further study showed that the mechanism of induction of cancer was not specific to saccharin but also applied to other sodium salts, including table salt, and was due to precipitation of calcium phosphate crystals that causes irritation and cell proliferation. There is not a comparable mechanism for tumor induction in humans. Finally, in 2000, FDA removed saccharin from the list of suspected carcinogens and Congress mandated the removal of the warning label.
Principles of risk decision-making
Published in Journal of Toxicology and Environmental Health, Part B, 2022
Daniel Krewski, Patrick Saunders-Hastings, Patricia Larkin, Margit Westphal, Michael G. Tyshenko, William Leiss, Maurice Dusseault, Michael Jerrett, Doug Coyle
Artificial sweeteners have been used to reduce the caloric content of food for over a century. When saccharin was found to produce malignant urinary bladder tumors in a series of two-generation studies involving Sprague-Dawley rats fed up to 7.5% saccharin in their diets, the U.S. Food & Drug Administration (FDA) quickly moved to ban the use of saccharin as a direct food additive in 1977. The ban was subsequently superseded by a series of moratoriums imposed by the U.S. Congress, which has permitted the limited use of saccharin through to the present. This action was consistent with the 1958 Delaney Amendment to the U.S. Food, Drug & Cosmetic Act, which bans the use of carcinogenic food additives such as certain artificial sweeteners or food colors. This amendment overrides the principle of balancing benefits and risks, on the grounds that no organoleptic benefits of direct food additives might offset a cancer risk (FDA: United States Food and Drug Administration 2014). In this case, banning a food additive that does not occur naturally in the food supply achieved the ideal goal of zero risk (P6).