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Statement on Washington University/Pepino Study

June 2, 2013

People who use Splenda® Brand Sweetener (sucralose) should not be misled by the recent study from Washington University on sucralose and its potential to affect the body’s sugar levels. This small study in morbidly obese people does not reflect the extensive body of science that shows sucralose is safe and can be used by everyone, including people with diabetes. Splenda® has been available for more than 20 years and has been used by millions of people around the world, and rigorous research has shown that it does not raise people’s sugar or insulin levels. The American Diabetes Association and the Academy of Nutrition and Dietetics both support the role of sucralose as a useful tool in managing weight and diabetes. People can continue to use Splenda® safely and we urge anyone with questions about using Splenda® to speak with their health care professional. Here is more important information about the study:

 

  • The study was of short duration (two separate test days, one week apart) and involved people who did not have diabetes.
  • The study looked at how the participants responded to a sugar-sweetened drink consumed immediately after drinking water or water containing sucralose. It is normal for blood sugar levels to rise after consuming a sugar-sweetened drink, whether or not sucralose was consumed beforehand.
  • The researchers did not point out that even the highest sugar level observed in the participants is considered to be normal, based on normal ranges set by health care professionals. This means no clinical significance can or should be drawn from the differences observed between the two people who drank unsweetened water, compared to those who drank water with sucralose.
  • Moreover, researchers did not control for conditions that could have affected the participants’ response to the sugar test drinks — such as diet or exercise — in the days before each of the two testing days. Changes in exercise can particularly affect insulin responses.
  • The study involved people who were morbidly overweight (avg BMI = 41), which could affect the way their bodies respond to consuming sugar. It’s common for people with extreme obesity to have a different response to sugar than people of normal weight.
  • Importantly, more than 120 studies over a 20-year period have demonstrated that sucralose is a safe sweetener that can be used by everyone, including children, women who are pregnant or nursing, and people with diabetes. These studies included clinical trials in people with Type 1 and Type 2 diabetes and in people without diabetes, where sucralose was consumed in high doses for months. The total evidence shows that sucralose has no negative effects on blood sugar levels, insulin, or hemoglobin A1c (a measure of long-term blood glucose control).

Learn more about how Splenda® Brand Sweetener is suitable for people with diabetes.

Sucralose and the Environment

Sucralose, the sweetening ingredient in Splenda® Sweetener Products, has been rigorously tested to meet U.S. and international regulations necessary for approving a food ingredient for use in the general population. Over 120 studies have been conducted to demonstrate that sucralose can be used safely by all populations, including children, women who are pregnant or nursing, and people with diabetes. Additionally, studies have been done to study the potential for environmental impact and the results showed that sucralose is safe in the environment and does not bioaccumulate in animals or plants.

Specifically, the U.S. Food and Drug Administration (FDA) reviewed numerous studies conducted to investigate the potential for environmental impact, before approving sucralose for marketing in the U.S. In the FDA’s initial approval of sucralose as a food additive, the FDA stated:

“The agency has carefully considered the potential environmental effects of this action. FDA had concluded that the action [approval of sucralose] will not have a significant impact on the human environment, and that an environmental impact statement is not required.” (Federal Register, Vol. 63, No. 64, Friday, April 3, 1998, Rules and Regulations, page 16431).

Additionally, as part of the regulatory approval process for sucralose, a comprehensive range of scientific studies on sucralose was conducted to investigate the potential impact on plant and aquatic life. The data was submitted to regulatory agencies around the world, including Canada, the European Union, Japan, and Australia. All environmental studies on sucralose were conducted to internationally agreed protocols validated for regulatory purposes. Specific studies clearly demonstrate that sucralose has no adverse effect on fish, invertebrates (e.g., water flea), algae or higher plants. These studies showed no effects at concentrations of sucralose that were many times greater than would be found in the environment. Every regulatory authority who reviewed the environmental data on sucralose arrived at the same conclusion: Sucralose has no adverse effect on the environment.