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The sweetener is sucralose, and the byproduct is sucralose-6-acetate (S6A). A 2023 laboratory study found DNA-damage-related signals from S6A in screening assays and changes in a human intestinal-cell model. It did not show that people who consume sucralose sustain DNA damage or develop disease. Regulators’ assessments also differ by use and jurisdiction: the FDA permits sucralose in U.S. foods under specified conditions, while EFSA’s 2026 review retained its acceptable daily intake for assessed uses but identified an unresolved question about prolonged high-temperature processing in a proposed bakery use.
What did the scientists find?
In a paper published online May 29, 2023, in the Journal of Toxicology and Environmental Health, Part B, Schiffman, Scholl, Furey, and Nagle tested sucralose-6-acetate as well as sucralose. The authors describe S6A as an intermediate and impurity in sucralose manufacture. Their abstract reports that commercial sucralose samples they examined contained S6A at levels up to 0.67%; that finding does not establish the amount in every product or batch. Read the study record on PubMed.
The researchers used a MultiFlow genotoxicity screening assay and a micronucleus test. They reported results indicating that S6A was genotoxic, with a clastogenic mechanism—a pattern consistent with chromosome or DNA-strand breakage. In a human intestinal epithelial model, S6A increased expression of genes associated with inflammation, oxidative stress, and cancer. Both S6A and sucralose impaired barrier integrity in that model.
These are findings from laboratory assays and a cell model, not a clinical study of people eating sucralose. A signal in an experimental system identifies a possible hazard under the tested conditions; it does not, by itself, measure ordinary dietary exposure or prove harm to consumers.
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Does sucralose damage DNA in people?
The study does not establish that it does. Its DNA-damage-related findings concern S6A in laboratory tests. The intestinal-cell experiment also found changes in gene expression and barrier integrity, but it was not evidence that consumers experience those effects after eating sucralose. The cited sources do not establish clinical harm from ordinary sucralose consumption or that humans produce S6A after consuming it.
The authors also reported S6A in rodent fecal samples at levels up to 10% relative to sucralose and interpreted this as suggesting acetylation in the intestines. That animal observation is not proof of S6A production in humans. Likewise, the paper’s estimate that S6A in a single daily sucralose-sweetened drink might exceed the genotoxicity threshold of toxicological concern—0.15 micrograms per person per day—is the authors’ estimate, not a measured amount in a typical drink or an independently established estimate of human risk.
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What do U.S. and European regulators say?
United States: FDA
The FDA lists sucralose as an approved food additive in the United States under specified conditions of use. It describes uses in products including baked goods, beverages, chewing gum, gelatins, and frozen dairy desserts, and says authorized high-intensity sweeteners are safe for the general population under certain conditions of use. Consumers can identify sucralose by name in an ingredient list. See the FDA’s information on high-intensity sweeteners.
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In a re-evaluation published February 16, 2026, EFSA retained sucralose’s acceptable daily intake (ADI) at 15 mg per kilogram of body weight per day. EFSA said the highest estimated dietary exposure in the EU was below the ADI in all population groups, indicating no safety concern for the uses and exposure data it assessed. This conclusion is about that reviewed scope; it is not a finding that every possible exposure scenario has been tested. Read EFSA’s plain-language summary.
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The specific high-temperature uncertainty
EFSA did not confirm the safety of a proposed extension of sucralose use in fine bakery wares. It cited uncertainty about potential chlorine transfer to organic molecules under prolonged high-temperature conditions. EFSA said the uncertainty also applies to homemade foods when sucralose is heated, such as by baking or frying. This is a concern tied to the proposed use and processing conditions, not a blanket warning about all sucralose uses or proof that baking with it causes harm.
Is S6A in a particular sweetener brand?
The 2023 paper reports S6A in the commercial samples its authors examined, but it does not establish that every brand or lot contains it. The Splenda manufacturer disputes the paper’s implications and says its products do not contain S6A, its testing does not detect it, and there is no scientific evidence that humans produce S6A after consuming sucralose. Those are the company’s claims; they do not independently verify the purity of all brands or batches.
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Ingredient lists can show whether a food contains sucralose, but the cited evidence does not provide shoppers a way to verify S6A in a particular product lot. The study’s sample finding and the manufacturer’s response should not be treated as universal proof about every product.
How to interpret the evidence
- Compound: The strongest DNA-damage-related signal in the paper concerns S6A; the study also tested sucralose and reported barrier effects for both compounds in an intestinal-cell model.
- Setting: The genotoxicity results came from screening assays, and the intestinal findings came from a laboratory model—not human health outcomes.
- Exposure: Experimental results and the authors’ drink estimate are not direct measurements of what a person absorbs from a typical serving.
- Regulatory scope: FDA’s U.S. approval applies under specified conditions. EFSA’s 2026 conclusion concerns assessed EU uses and exposure, with a separate uncertainty for prolonged high-temperature processing in a proposed bakery extension.
The evidence therefore supports a precise conclusion: S6A raised laboratory concerns in the 2023 study, but the study did not demonstrate DNA damage or disease in people who consume sucralose. Regulatory assessments address different jurisdictions and defined conditions of use, rather than resolving every question about every product, dose, or cooking scenario.
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