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FDA Approves Neotame

Edited by: Mary Schroeder, M.S., R.D. & Pat Kendall, Ph.D., R.D., Colorado State - Fall 2002

In July 2002, the Food and Drug Administration (FDA) announced its approval of a new sweetener, neotame, for use as a general-purpose sweetener in a 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.

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. 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, the 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.

Source: FDA Approves New Non-Nutritive Sugar Substitute Neotame. FDA Talk Paper. U.S. Food and Drug Administration, July 5, 2002.

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