Sucralose: Safety & Research

February 27, 2019

By Rosanne Rust, MS, RDN, LDN

February 27, 2019 — Sucralose has been approved for use in our food supply since 1998 and its safety has been validated by several health organizations including the FDA, European Food Safety Authority, the National Cancer Institute, and Health Canada. Over 80 countries have approved sucralose for human consumption. Sucralose is six hundred times as sweet as table sugar (sucrose), and mimics the sweetness of sucrose, without the calories or glycemic effect.

Sucralose is also heat-stable, which makes it a versatile low-calorie sweetener with applications in baked goods and recipes. Often food manufacturers meet the demands for low calorie foods by combining different low- or no-calorie sweeteners to improve the taste and stability of these products.

While sucralose is derived from sucrose, it does not impact blood sugar levels because it’s not metabolized or recognized by the body as a carbohydrate. This makes it appealing to those with diabetes, as they can enjoy foods or beverages sweetened with sucralose without the added glycemic effect. However, given that some food products use sucralose as only a partial replacement for the sugar content, the total calories and carbohydrate contained still needs to be accounted for in the total glycemic affect when planning meals and snacks for someone with diabetes. The incorporation of sucralose into food and beverages to replace part of the caloric sweeteners offers appealing products that taste good. These products can be helpful for weight management, as they are lower in sugar and calories.

There have been over 100 studies demonstrating the safety of sucralose, however some continue to bring its safety into question, linking it to GI issues, headaches, cancer, or weight gain. These allegations are contrary to a large body of scientific evidence.

Gut Health

A study suggesting that Splenda® affects the gut microbiome has been disputed as well. The study, “The Artificial Sweetener Splenda Promotes Gut Proteobacteria, Dysbiosis, and Myeloperoxidase Reactivity in Crohn’s Disease–Like Ileitis” was published the March 2018 issue of Inflammatory Bowel Diseases. The mice were “predisposed to a Crohn’s disease-like condition”, and when given a solution containing sucralose in their drinking water, their gut inflammation worsened. This is a correlational affect, and the “worsening” of their gut seemed to be due to an increase in Proteobacteria in their stool or their predisposed bowel disease.  Since many studies involving sweeteners and the microbiome are poorly designed it makes it difficult to link the source of any changes in the microbiome to low calorie sweetener use. We still need more microbiome studies that are designed to accurately assess and link the source of any changes in the microbiome. What we know about how diet impacts the microbiome is limited, although there’s good research about fiber’s impact. Any health implications of these changes are still unclear, and further human research in this area is still needed.


There is no evidence that nonnutritive sweeteners cause cancer in humans. A 2017 study conducted by the Ramazzini Institute (Soffritti et al) continues to occasionally surface in popular media, even though its conclusions have been sharply disputed.  The study’s poor methodology and lack of a dose-response relationship, does not imply any cause and effect. Global regulators do not rely on single studies, but rather the body of evidence, when determining safety of ingredients. The Soffritti study tested quantities from 500 to 16000 ppm (parts per million) which translates to 100 to 3200 times the established Acceptable Daily Intake (ADI).

Some studies question the potential for sucralose to form chlorinated byproducts under high temperatures, while others have shown its heat stable. Other studies suggest a need for further research in this area.

Other Concerns

A recent study questioned whether sucralose may accumulate in the adipose (fat) tissue of mice. The study, “Intestinal Metabolism and Bioaccumulation of Sucralose in Adipose Tissue in the Rat” conducted by Bornemann et al, was published last summer in the Journal of Toxicology and Environmental Health.

The study also tested high doses of sucralose in ten rats. The rats were given daily doses of 36.5mg sucralose per animal for the 5 male rats, and 25mg/day per animal for the 5 female rats. These doses would be equivalent to a 150 pound human consuming 800 teaspoons of sugar every day (a can of regular soda has about 9 teaspoons). In addition, this study did not include a control group, nor was it designed to test for bioaccumulation.


The studies and testing that have supported the safety of sucralose far outweigh the studies correlating sucralose to metabolic issues or otherwise. This sweetener has been used safely in food and beverages for over two decades without ill effect. Since sucralose is not absorbed by the body, it stands to reason that there is no metabolic impact.

Ingredients are tested by regulatory bodies to determine the Acceptable Daily Intake (ADI). The ADI is one hundredth of the highest amount a human could consume every day of their life with no ill effects. The ADI for sucralose is 5 milligrams per kilogram of body weight (mg/kg) per day. This would be 340 milligrams (which is more than 28 packets of Splenda or nine cans of diet soda) per day of sucralose for a 150 pound person (which is 100 times less than what was tested to be safe). So you see, the ADI is quite conservative.

Yes, animal studies are important to establishing toxicity levels, but they are not valuable when translated to typical human consumption of a substance, food or beverage. The high levels of sucralose used in the Bornemann, et al. and Soffritti, et al. studies for instance, do not represent typical human intakes at all. For example, the Ramizzini study noted adverse effects at doses starting at 240 mg/kg, an unrealistic consumer dose. When evaluating new research or topics covered in the news about low or no calorie sweeteners, keep in mind the type of study, the dose-response relationship, and match that up with the larger body of evidence.




Rosanne Rust MS, RDN, LDN is a registered, licensed dietitian-nutritionist with over 25 years experience. Rosanne is a paid contributor to Allulose.org. As a Nutrition Communications Consultant  she delivers clear messages helping you understand the science of nutrition so you can enjoy eating for better health. Rosanne is the co-author of several books, including DASH Diet For Dummies® and the The Glycemic Index Cookbook For Dummies®. A wife, and mother of 3 boys, she practices what she preaches, enjoying regular exercise, good food and festive entertaining. Follow her on Twitter @RustNutrition.

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