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

Colin Berry, David Brusick, Samuel Monroe Cohen, Jerry F. Hardisty, V. Lee Grotz, Gary M. Williams

Research output: Contribution to journalReview article

10 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1247-1261
Number of pages15
JournalNutrition and cancer
Volume68
Issue number8
DOIs
StatePublished - Nov 16 2016

Fingerprint

trichlorosucrose
Sweetening Agents
Animal Models
Pharmacokinetics
Eating
Databases

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Oncology
  • Nutrition and Dietetics
  • Cancer Research

Cite this

Sucralose Non-Carcinogenicity : A Review of the Scientific and Regulatory Rationale. / Berry, Colin; Brusick, David; Cohen, Samuel Monroe; Hardisty, Jerry F.; Grotz, V. Lee; Williams, Gary M.

In: Nutrition and cancer, Vol. 68, No. 8, 16.11.2016, p. 1247-1261.

Research output: Contribution to journalReview article

Berry, Colin ; Brusick, David ; Cohen, Samuel Monroe ; Hardisty, Jerry F. ; Grotz, V. Lee ; Williams, Gary M. / Sucralose Non-Carcinogenicity : A Review of the Scientific and Regulatory Rationale. In: Nutrition and cancer. 2016 ; Vol. 68, No. 8. pp. 1247-1261.
@article{6d0fad188aad4f78908ee8f4610c2316,
title = "Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale",
abstract = "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.",
author = "Colin Berry and David Brusick and Cohen, {Samuel Monroe} and Hardisty, {Jerry F.} and Grotz, {V. Lee} and Williams, {Gary M.}",
year = "2016",
month = "11",
day = "16",
doi = "10.1080/01635581.2016.1224366",
language = "English (US)",
volume = "68",
pages = "1247--1261",
journal = "Nutrition and Cancer",
issn = "0163-5581",
publisher = "Routledge",
number = "8",

}

TY - JOUR

T1 - Sucralose Non-Carcinogenicity

T2 - A Review of the Scientific and Regulatory Rationale

AU - Berry, Colin

AU - Brusick, David

AU - Cohen, Samuel Monroe

AU - Hardisty, Jerry F.

AU - Grotz, V. Lee

AU - Williams, Gary M.

PY - 2016/11/16

Y1 - 2016/11/16

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84994121600&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84994121600&partnerID=8YFLogxK

U2 - 10.1080/01635581.2016.1224366

DO - 10.1080/01635581.2016.1224366

M3 - Review article

C2 - 27652616

AN - SCOPUS:84994121600

VL - 68

SP - 1247

EP - 1261

JO - Nutrition and Cancer

JF - Nutrition and Cancer

SN - 0163-5581

IS - 8

ER -