Review · Nutrition and cancer · 2016

Sucralose and cancer: what the studies show

What it found

Across animal studies, lab tests and short human trials, sucralose did not show cancer-causing activity.

The authors say it is noncarcinogenic even at doses far above normal daily intake.

What they found

Studies in people

Human tolerance trial

In a 13-week randomized, double-blind, placebo-controlled study, healthy adults took up to 500 mg of sucralose daily. Blood, urine and heart readings stayed stable, and no abnormalities were attributed to sucralose.

Human cancer studies

Two large human studies looked at cancer rates in people consuming nonnutritive sweeteners, but they were focused on aspartame and were conducted when sucralose exposure would have been minimal. They do not add evidence that sucralose might be carcinogenic.

Animal and lab studies

Long-term animal studies

In 104-week studies in rats and mice, sucralose in the diet did not affect survival, behavior or tumor numbers. A 52-week dog study also found no tissue changes linked to sucralose.

Studies in people and animals

Gene damage tests

A range of lab and animal tests found that sucralose does not cause gene mutations or chromosome damage. A few early or isolated positive results were questioned because of very high concentrations, false positives or cell lines not representative of normal human tissue.

How the body handles it

About 85% of sucralose taken in is not absorbed and leaves the body unchanged in feces. The small amount absorbed is not broken down into reactive compounds, and it is excreted in urine without building up in the body.

Other findings

Chemical structure

Sucralose is a chlorinated form of sucrose. Its structure shows no features that would suggest cancer-causing or gene-damaging activity, and it is expected to be very stable.

What the authors conclude

“In summary, review of the evidence retrieved, including key studies recommended by international regulatory bodies and toxicology experts, confirm that sucralose is noncarcinogenic and safe to ingest.”
Berry C, Brusick D, Cohen SM, Hardisty JF, Grotz VL, Williams GM, 2016

Also in their conclusions

  • They conclude that sucralose is noncarcinogenic and safe to ingest.
  • They state that sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.
  • They note that regulatory authorities worldwide have found sucralose to be noncarcinogenic based on a range of studies.

How it was done

Health and regulatory authorities are repeatedly asked whether nonnutritive sweeteners can cause cancer. The authors wanted to bring together the studies that led regulators to conclude sucralose is noncarcinogenic, for health professionals and others who answer nutrition questions.

They searched electronic databases for studies on sucralose, cancer, metabolism and safety, and also considered studies submitted as part of the Sucralose Food Additive Petition. The review covered lab tests, animal studies and human trials, including a 13-week randomized, double-blind, placebo-controlled study in healthy adults who took increasing daily amounts of sucralose (125 mg, then 250 mg, then 500 mg).

What it can’t tell you

  • The human cancer studies were not designed to test sucralose specifically, and people in them would have had little to no exposure to sucralose.
  • Animal and lab results cannot by themselves show what happens in people, though the authors say the metabolic profile is similar among rodents, dogs and humans.
  • The review relies on studies submitted to regulators and published literature; it cannot rule out effects that those studies did not measure.

The paper

Title
Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale
Type
ReviewThe authors read earlier studies and describe what they found. It isn’t a new study.
Evidence
Studies in people · animals · lab
Summarised from
Full text
Cite
Berry C, Brusick D, Cohen SM, Hardisty JF, Grotz VL, Williams GM (2016). Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale. Nutrition and cancer. doi:10.1080/01635581.2016.1224366Free full textPubMed 27652616DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error