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FDA Approval and Sucralose Studies: Extensive Testing and Review

Sucralose (SPLENDA^® Brand Sweetener) was discovered in 1976, and for the next 20 years was subjected to one of the most extensive and thorough safety testing programs ever conducted on a food additive.

In 1990, the safety of sucralose was confirmed by the Food and Agricultural Organization (FAO)/World Health Organization (WHO)/Joint Expert Committee on Food Additives (JECFA).

Following the US Food and Drug Administration‘s (FDA) rigorous review process, sucralose was approved in 1998 for use in 15 food and beverage categories. Sixteen months later, the FDA extended its approval of sucralose to include its use as a general-purpose sweetener in all foods, beverages, dietary supplements, and medical foods.

Today, sucralose (SPLENDA^® Brand Sweetener) is permitted for use in more than 80 countries and is used in more than 4,000 foods and beverages worldwide.

Sucralose Studies

Sucralose has been the subject of more than 110 scientific studies to establish its safety.^1-4

Click on the links below to view selected published studies using sucralose:

• Glycemic effect of a single high oral dose of the novel sweetener sucralose in patients with diabetes.

  Mezitis NHE, Maggio CA, Koch P, et al. Diabetes Care. 1996;19(9):
  1004-1005.

• Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes.

  Grotz VL, Henry RR, McGill JB, et al. J Am Diet Assoc. 2003;103(12):1607-1612.

• Dental considerations in sucralose use.

  Mandel ID, Grotz VL. J Clin Dentistry. 2002;13(3):116-118.

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(suppl 2):S1-S129.
4. Sucralose Food Additive Petition (FAP) 7A3987. Exhibit E: Safety (submissions from 2/87-7/97).