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Nutr Cancer. 2016 Nov-Dec;68(8):1247-1261. Epub 2016 Sep 21.

Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale.

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a Emeritus Professor of Pathology, Queen Mary University of London , London , UK.
b Consulting Toxicologist , Richmond , Virginia , USA.
c Department of Pathology and Microbiology , Havlik-Wall Professor of Oncology, University of Nebraska Medical Center , Omaha , Nebraska , USA.
d Experimental Pathology Laboratories, Inc. , Durham , North Carolina , USA.
e Director and R&D Fellow, Medical Affairs, Johnson & Johnson Consumer Inc. , Fort Washington , PA , USA.
f Department of Pathology , New York Medical College , Valhalla , New York , USA.


Regulatory authorities worldwide have found the nonnutritive sweetener, sucralose, to be noncarcinogenic, based on a range of studies. A review of these and other studies found through a comprehensive search of electronic databases, using appropriate key terms, was conducted and results of that review are reported here. An overview of the types of studies relied upon by regulatory agencies to assess carcinogenicity potential is also provided as context. Physiochemical and pharmacokinetic/toxicokinetic studies confirm stability under conditions of use and reveal no metabolites of carcinogenic potential. In vitro and in vivo assays reveal no confirmed genotoxic activity. Long-term carcinogenicity studies in animal models provide no evidence of carcinogenic potential for sucralose. In studies in healthy adults, sucralose was well-tolerated and without evidence of toxicity or other changes that might suggest a potential for carcinogenic effects. In summary, sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.

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