Sucralose, which is sold under the brand name Splenda, was approved by the U.S. Food and Drug Administration in 1998. It's accepted as safe by the U.S. Food and Drug Administration, the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives, and the Canadian, Australian and European regulating bodies. When it was accepted, the FDA determined that sucralose did not cause any carcinogenic, neurological or reproductive problems based on more than 100 studies done over 20 years. A few newer studies have raised concerns, however.
Sucralose may be a trigger for migraines, according to a study published in the August, 2006 issue of ''Headache: Journal of Head and Face Pain.'' Physicians should keep the potential causal relationship between sucralose and migraines in mind when they are taking the health history of people who suffer migraines, recommends lead study author Rajendrakumar M. Patel of the Mercer University School of Medicine in Macon, Georgia.
A study by Y.F. Sasaki published in the 2002 ''Journal of Mutation Research'' concluded that high doses of sucralose led to DNA damage in the gastrointestinal organs of mice. The dose given was 2,000 mg per kg of body weight. According to tripatlas.com, the acceptable intake for sucralose is 9 mg per kg of body weight each day. Based on his study results, Sasaki recommended more extensive study of sucralose and 38 other food additives.
Some concern has been raised regarding the effect of sucralose on the thymus, reports TripAtlas.com. The thymus is a small organ in the upper chest that helps a person's body make white blood cells during childhood. A report from Australia's National Industrial Chemicals Notification and Assessment Scheme cites two studies on rats that were given the substance at extremely high doses. These studies found a decrease in mean thymus weight. The report also noted, however, that sucralose would not be classified as hazardous under NOHSC's criteria for classifying a hazardous substance. The amount of sucralose given to the rats was 3,000 mg per kg of body weight daily for some 28 days. That would translate to 240 g sucralose, or more than 20,000 individual packets of Splenda per day, for 28 days for a 176-pound person, translates TripAtlas.com.