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.
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 [1], 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 [1], 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.
Links:
[1] http://www.sciencedirect.com