Sucralose: An Excellent Safety Profile

For All Your Patients

Sucralose is the sweetening ingredient in SPLENDA® Sweetener Products, which include a no calorie sweetener and reduced calorie sugar blends.

One of the most rigorously tested food additives, sucralose has been the subject of more than 100 scientific studies to establish its safety.^1-4

Based on independent evaluations of study results, the FDA and health authorities in other countries have concluded that sucralose is suitable for use by everyone.

Read Who Can Use Sucralose? below.

Conclusions that are based on the full body of sucralose safety studies include the following:
No known side effects   No toxicity, even in test diets simulating the sweetness of 40+ pounds of sugar per day for life No bioaccumulation No carcinogenicity No genotoxicity No effects on fetal on neonatal development	No neurotoxicity No cariogenicity No effect on carbohydrate metabolism (sucralose is not hydrolyzed or broken down for energy) No calories or carbohydrates No genotoxicity No effect on short or long-term glucose control or on serum insulin levels

Read about FDA approval of sucralose and view clinical studies.

Who Can Use Sucralose?

Sucralose (SPLENDA® Brand Sweetener) is suitable for everyone, including these special populations:

People with diabetes

Although the process for making sucralose begins with sugar, it's not sugar, and is not recognized by the body as a carbohydrate. It is not metabolized for energy and it provides no calories.

Clinical trials among patients with diabetes and among normal controls have shown that sucralose has no effect on insulin levels, fasting or postprandial blood glucose levels, and long-term blood glucose control (hemoglobin A1C).^4-6  A multi-center study demonstrated that daily sucralose consumption of triple the maximum projected daily intake for 3 months had no effect on glucose homeostasis in patients with type 2 diabetes.⁶

Women who are pregnant or nursing

Sucralose can be used safely during pregnancy and by nursing mothers. Studies in animal models showed that sucralose is not actively transported across the placental barrier or from the mammary gland into breast milk.

While mothers typically have higher nutritional needs during pregnancy and nursing, sucralose may help women avoid excess calorie intake during these times. For some women, sucralose may be part of a strategy to reduce the risk of unnecessary weight gain.

Children

There is increasing concern about added sugar intake and the prevalence of overweight/obesity in children. The use of SPLENDA® Sweetener Products in place of sugar is an excellent way to help children lower their sugar and calorie intake.

References

1. Sucralose Food Additive Petition (FAP) 7A3987.8-69:2041-2268. Submitted February 9, 1987.
2. Sucralose Food Additive Petition (FAP) 7A3987.1-3:202-890. Submitted February 9, 1987.
3. Sucralose Safety Assessment. Food Chem Toxicol. 2000;38 (suppl2):S1-S129.
4. Sucralose Food Additive Petition (FAP) 7A3987. Exhibit E: Safety (submissions from 2/87-7/97).
5. Mezitis NH, Maggio CA, Koch P, et al. Glycemic effect of a single diabetes. Diabetes Care. 1996;19:1004-1005.
6. Grotz VL, Henry RR, McGill JB, et al. Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes. J Am Diet Assoc. 2003;103:1607-1612.