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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.


T02-29 Media Inquiries: 301-436-2335
July 5, 2002 Consumer Inquiries: 888-INFO-FDA

FDA APPROVES NEW NON-NUTRITIVE SUGAR SUBSTITUTE NEOTAME

The Food and Drug Administration today announced its approval of a new sweetener, neotame, for use as a general-purpose sweetener in a wide variety of food products, other than meat and poultry. Neotame is a non-nutritive, high intensity sweetener that is manufactured by the NutraSweet Company of Mount Prospect, Illinois.

Depending on its food application, neotame is approximately 7,000 to 13,000 times sweeter than sugar. It is a free-flowing, water soluble, white crystalline powder that is heat stable and can be used as a tabletop sweetener as well as in cooking applications. Examples of uses for which neotame has been approved include baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings and syrups.

In determining the safety of neotame, FDA reviewed data from more than 113 animal and human studies. The safety studies were designed to identify possible toxic effects, such as cancer-causing, reproductive, and neurological effects. From its evaluation of the neotame database, the FDA was able to conclude that neotame is safe for human consumption.

New food additives, including new sweeteners, must be approved by FDA as safe before they may be marketed in the United States.

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