FDA Approves New High-Intensity Sweetener Advantame

FDAMay 19, 2014 — The Food and Drug Administration today announced the new food additive, advantame, is safe for use as a general-purpose sweetener and flavor enhancer in food, except meat and poultry. New food additives must be approved by the FDA before they may be marketed in the United States. Advantame is the 6th high-intensity sweetener approved by the FDA.

High-intensity sweeteners, such as advantame, may be used in place of sugar for a number of reasons, including that they do not contribute calories or only contribute a few calories to the diet. High-intensity sweeteners also generally will not raise blood sugar levels.

Advantame  is a free-flowing, water soluble, white crystalline powder that is stable even at higher temperatures, and can be used as a tabletop sweetener as well as in cooking applications.  Advantame has been approved for use as a general-purpose sweetener and flavor enhancer and can be used in 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 evaluating the safety of advantame under the petitioned conditions of use, the FDA reviewed data from 37 animal and human studies. The safety studies were designed to identify possible toxic effects, such as reproductive, neurological, and cancer-causing effects. The FDA concluded after a thorough evaluation that advantame is safe for human consumption under the petitioned conditions of use.

Upon publication of the final rule, the food additive petition process includes a 30 day period to file objections. Objections can be submitted electronically to the FDA docket through FDA-2009-F-0303.

To submit objections by mail, send to FDA at:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All objections must include the agency name and docket number.

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