FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-16                         Arthur Whitmore:     202-205-4144
April 1, 1998                  
                               Consumer Inquiries:  800-532-4440

FDA APPROVES NEW
HIGH-INTENSITY SWEETENER SUCRALOSE

The Food and Drug Administration today announced its approval of a new sweetener, sucralose, for use in a wide variety of food products.

Sucralose is manufactured by McNeil Speciality Products, a subsidiary of Johnson & Johnson, of New Brunswick, N.J.

Sucralose is a non-nutritive, high-intensity sweetener made from a process that begins with sucrose. It is a free-flowing, water soluble, white crystalline powder that on average is about 600 times sweeter than sugar.

Sucralose is being approved for use in baked goods, baking mixes, non-alcoholic beverages, chewing gum, coffee and tea products, confections and frostings, fats and oils, frozen dairy desserts and mixes, fruit and water ices, gelatins, puddings and fillings, jams and jellies, milk products, processed fruits and fruit juices, sugar substitutes, sweet sauces, toppings and syrups. It can also be as a "table-top sweetener" -- added directly to foods by consumers.

In determining the safety of sucralose, 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 its finding that sucralose is safe for human consumption.

All food additives that have never before been used in foods, including new sweeteners, must be approved by FDA as safe before they are marketed in the United States.

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