Splenda (pronounced /ˈsplɛndə/) is the commercial name and registered trade mark of a sucralose-based artificial sweetener derived from sugar, owned by the British company Tate & Lyle. Sucralose was discovered by Tate & Lyle and researchers at Queen Elizabeth College, University of London, in 1976. Tate & Lyle subsequently developed sucralose-based Splenda products in partnership with Johnson & Johnson subsidiary McNeil Nutritionals LLC.
Since its approval by the United States government in 1998 and introduction there in 1999, sucralose has overtaken Equal in the $1.5 billion artificial sweetener market, holding a 62% market share. According to market research firm IRI Splenda sold $212 million in 2006 in the U.S. while Equal sold $48.7 million.
In April 2009 the International Trade Commission closed a patent infringement case that will permit Chinese manufacturers to produce copycat versions of Splenda products which will be sold under different brand names.
Splenda is available in granular and tablet form.
Sucralose has no caloric content, and Splenda products have a lower caloric content than sugar. The actual caloric content of a single-serving (1-gram packet) of Splenda is 3.36 calories, 31% of the calories of a single-serving (2.8-gram packet) of granulated sugar (10.8 calories.) In the United States it is legally, labelled "zero calories"; U.S.FDA regulations allow this "if the food contains less than 5 calories per reference amount customarily consumed and per labeled serving". Further, Splenda contains a relatively small amount of sucralose, little of which is metabolized; virtually all of Splenda's caloric content derives from the dextrose or highly fluffed maltodextrin "bulking agents" that give Splenda its volume. Like other carbohydrates, dextrose and maltodextrin have 3.75 calories per gram.
Splenda usually contains 95% dextrose and maltodextrin which the body readily metabolizes, combined with a small amount of mostly indigestible sucralose. Sucralose is made by replacing three select hydrogen-oxygen groups on sucrose (table sugar) molecules with three chlorine atoms. The tightly bound chlorine atoms create a molecular structure that is remarkably stable. Sucralose itself is recognized as safe to ingest as a diabetic sugar substitute, but some Splenda products may contain sugars or other carbohydrates that should be evaluated individually. Research as of 2003 suggested that the amount of sucralose that can be consumed on a daily basis over a person's lifetime without any adverse effects is 15 mg/kg/day, or about 1 g for a 70 kg (150 lb) person. This was revised downward in 2008 to 9 mg/kg/day, or about 0.6 g.
A repeated dose study of sucralose in human subjects concluded that "there is no indication that adverse effects on human health would occur from frequent or long-term exposure to sucralose at the maximum anticipated levels of intake". Conversely, a Duke University study conducted on rats shows that at sucralose consumption levels of 1.1 mg/kg (below the FDA 'safe' level) to 11 mg/kg, throughout a 12-week administration of Splenda exerted numerous adverse effects, including reduction in beneficial fecal microflora, increased fecal pH, and enhanced expression levels of P-gp, CYP3A4, and CYP2D1, which are known to limit the bioavailability of nutrients and orally administered drugs. These effects have not been observed in humans, and the relevance of this animal study to human health is unknown. The study has been the subject of some controversy, with experts disagreeing over the validity of its conclusions. The other ingredients in Splenda, dextrose and maltodextrin, are listed as generally recognized as safe because of their long history of safe consumption.