Sucralose - Health, Safety, and Regulation

Health, Safety, and Regulation

Sucralose has been accepted by several national and international food safety regulatory bodies, including the FDA, Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives, the European Union's Scientific Committee on Food, Health Protection Branch of Health and Welfare Canada, and Food Standards Australia New Zealand (FSANZ). Sucralose is one of two artificial sweeteners ranked as "safe" by the consumer advocacy group Center for Science in the Public Interest. The other is neotame. According to the Canadian Diabetes Association, the amount of sucralose that can be consumed on a daily basis over a person’s lifetime without any adverse effects is 9 milligrams per kilogram of body weight.

"In determining the safety of sucralose, the FDA reviewed data from more than 110 studies in humans and animals. Many of the studies were designed to identify possible toxic effects, including carcinogenic, reproductive, and neurological effects. No such effects were found, and FDA's approval is based on the finding that sucralose is safe for human consumption." For example, McNeil Nutritional LLC studies submitted as part of its U.S. FDA Food Additive Petition 7A3987 indicated that "in the 2-year rodent bioassays...there was no evidence of carcinogenic activity for either sucralose or its hydrolysis products..."