Sweet taste is a natural preference in humans (Beidler, 1982, Lawless, 1985). In the U.S., the average adult consumes over 300 calories per day in added sugars (USDA, 2001, USDA, 2003). Excess calorie consumption is a significant concern, due to its correlation with obesity. Although the causes of obesity are multifactorial (Grundy, 1998, Kaila and Raman, 2008), non-nutritive sweeteners represent one way for consumers to decrease calorie intake by reducing calorie intake from sugar. Research shows that non-nutritive sweeteners can be used to achieve overall caloric reduction and help manage body weight (Rolls, 1991, Blackburn et al., 1997, de la Hunty et al., 2006, Rodearmel et al., 2007).

Sucralose, a substituted disaccharide (Merck, 2006), is a non-nutritive sweetener that is synthesized by selective chlorination of sucrose at three of the primary hydroxyl groups, involving inversion of configuration at carbon-4, from the gluco- to the galacto-analogue. As a non-nutritive sweetener, sucralose has qualities of specific interest to food and beverage manufacturers, as well as to consumers. Sensory studies show that sucralose does not have the bitter aftertaste attributed to some other non-nutritive sweeteners (Wiet and Beyts, 1992, Horne et al., 2002, Kuhn et al., 2004). Sucralose is also highly stable at elevated temperatures that are often used in food, beverage and drug manufacturing processes, so that product sweetness levels can be maintained following cooking, baking and/or pasteurization. Sucralose also has excellent stability in low-pH products, so that sweetness degradation is not a determining factor in the shelf-life of such products. Although sucralose has become a popular sweetener, estimated daily intakes are low. This is because, like other non-nutritive sweeteners, sucralose is intensely sweet. By weight, sucralose is about 600 times sweeter than sucrose (Wiet and Beyts, 1992, Grice and Goldsmith, 2000).

McNeil Nutritionals, LLC (McNeil), a Johnson & Johnson company, markets retail SPLENDA^® Sweetener Products, which contain the non-nutritive sweetener, sucralose, and common food ingredients that add volume and texture. For example, by dry weight, Granulated SPLENDA^® No Calorie Sweetener is approximately 1% sucralose and 99% maltodextrin.

Maltodextrin is a starch-based carbohydrate that is completely digested and non-toxic. The safety of maltodextrin for human consumption has been affirmed by the United States Food and Drug Administration (FDA). Maltodextrin is affirmed as Generally Recognized as Safe (GRAS) for general use in foods by the FDA under Title 21 of the Code of Federal Regulations, Part 184, Section 1444 (21 CFR §184.1444).

Similarly, sucralose has been found safe by public health authorities worldwide, on the basis of critical reviews of extensive safety research (JECFA, 1989, JECFA, 1991, Canada Gazette, 1991, US FDA, 1998a, US FDA, 1999, JMHW, 1999, SCF, 2000, EU, 2004, FSANZ, 2008 [formerly ANFSC, approved 1993]).

While there is a wide body of evidence supporting the safety of sucralose and other common food ingredients like maltodextrin, which enable consumer use of non-nutritive sweeteners, a recent study reported that a sucralose-mixture product containing maltodextrin (Granulated SPLENDA^® No Calorie Sweetener), causes adverse effects in male rats consisting of alterations in body weight, gut microflora and changes in gut enzyme and protein activity (Abou-Donia et al., 2008). The authors indicate that the reported effects are related to the consumption of sucralose. At the request of McNeil, a panel of internationally recognized experts thoroughly reviewed the study design, results and conclusions. The panel found that the study had serious design flaws and did not represent evidence of any adverse health effect of either sucralose or the retail sucralose-mixture product tested (Brusick et al., submitted for publication). Given the broad use of sucralose and its clinical utility in calorie and carbohydrate management, it is important to convey such results, as well as a general understanding of the safety of sucralose to members of both the lay public and the scientific, including healthcare professional, community. The current paper briefly reviews the safety of sucralose and considers the safety of sucralose-mixture products, like Granulated SPLENDA^® No Calorie Sweetener.