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McNeil Nutritionals, LLC
Statement on Sucralose and the Center for Science in the Public Interest (CSPI)
Recently, the Center for Science in the Public Interest (CSPI) made comments about the safety of sucralose. Their comments were based on pending data from an Italian research lab. That data has not been published and, to our knowledge, has not been peer reviewed, which is a critical step in validating research. Previous studies from this lab have been questioned by international food safety authorities, partly because the researchers did not follow accepted standards for assessing safety.1
In contrast, more than 110 studies conducted over 20 years have proven the safety of sucralose, the sweetening ingredient in SPLENDA® Sweeteners. Worldwide authorities, including the U.S. Food and Drug Administration, the European Food Safety Authority, Health Canada, and the World Health Organization, have reviewed these studies and confirm that results show no link between sucralose and any form of cancer. The National Cancer Institute (NCI) and the American Cancer Society (ACS) are among numerous health organizations that support this conclusion1.
SPLENDA® Sweeteners have been enjoyed safely by millions of people around the world and are an excellent tool for people looking to reduce added sugar in their diet. The American Diabetes Association and the Academy of Nutrition and Dietetics both support that sucralose can be a useful tool in managing weight and diabetes. People can continue to use SPLENDA® safely and we urge anyone with questions about using SPLENDA® Sweeteners to speak with a healthcare professional
1 U.S. Food and Drug Administration, European Food Safety Authority.
2 http://www.cancer.gov/cancertopics/factsheet/Risk/artificial-sweeteners
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.
Regulatory Toxicology and Pharmacology journal publishes new sucralose papers (October 2009)
The scientific journal, Regulatory Toxicology and Pharmacology, has published two articles affirming the safety of sucralose. Sucralose is the sweetening ingredient in SPLENDA® Sweetener Products and is used by millions of people worldwide to reduce their use of sugar as part of a healthier lifestyle. Both papers on sucralose appeared in the October 2009 issue of the journal (Volume 55, Issue 1).
In the paper, "Expert Panel Report on a Study of SPLENDA in Male Rats," internationally recognized experts in nutrition, weight management, toxicology, food safety, medical and public health and other relevant areas, assessed the design, results and conclusions from a small study in male rats given a retail SPLENDA® product. The study was funded by the Sugar Association and the study investigators had raised certain questions about possible adverse effects. The Expert Panel found that the study was deficient in several critical areas, had serious design flaws, and did not represent evidence of any adverse health effects of either sucralose or SPLENDA® No Calorie Sweetener. They noted that the safety data surrounding sucralose has "been rigorously evaluated by experts around the world" and that the available evidence demonstrates that Splenda and sucralose are safe. (For more information, go to: www.sciencedirect.com, Browse by Title, Regulatory Toxicology and Pharmacology, Vol. 55, Issue 1)
A second paper, "An Overview of the Safety of Sucralose," provides a comprehensive review of some 110 studies conducted on sucralose, including a detailed discussion of the fate of sucralose in the body and key findings with regard to sucralose safety. The article also describes the extensive reviews conducted by food safety and public health authorities from around the world, and reports that these "trained safety and health protection authorities have concluded from [the scientific] database [on sucralose], that sucralose is a safe food ingredient that can be safely consumed for a lifetime." The paper also notes that these expert independent evaluations resulted in "no limitations for use by any population subtypes," and, for example, is "safe for use by children and people with diabetes." (For more information, go to: www.sciencedirect.com, Browse by Title, Regulatory Toxicology and Pharmacology, Vol. 55, Issue 1)
"SPLENDA® Brand Sweetener is one of the most vigorously studied food ingredients, and we're pleased that leading exerts in the fields of nutrition and public health continue to verify its excellent safety profile," says Roberto Moran, M.D., Senior Director, Clinical Medical Affairs, McNeil Nutritionals, LLC. "SPLENDA® Sweetener Products are valuable tools for people who want to decrease the amount of calories and carbohydrates from sugar to help them manage their health and wellness."
McNeil Nutritionals, LLC, is a global marketer of innovative nutritional products. The company's mission is to give people the ability to actively manage their own health. McNeil Nutritionals, LLC, markets SPLENDA® Sweetener Products, new SUN CRYSTALS® All-Natural Sweetener with Stevia, VIACTIV® Dietary Supplements, LACTAID® Milk and Dietary Supplements, and BENECOL® Products. McNeil Nutritionals, LLC, is headquartered in Fort Washington, PA.