FDA Approves New Sugar Substitute

On May 19, the US Food and Drug Administration (FDA) approved the high-intensity sweetener advantame, developed by Japanese food and chemical corporation Ajinomoto. It is the sixth artificial sweetener to receive the green light from the agency, joining saccharin (brand name Sweet’N Low and others), aspartame (Equal and others), acesulfame potassium (Sweet One and others), sucralose (Splenda), and neotame (Newtame).

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The first new sugar substitute to receive approval in 12 years, advantame is a white powder derived from aspartame and vanillin that dissolves in water and remains stable even at high temperatures. It can be used as both a tabletop sweetener and an ingredient in cooking, and it is approved for use in a variety of foods, including baked goods, nonalcoholic beverages, chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings, and syrups.

According to Captain Andrew Zajac of the US Public Health Service and director of the FDA’s Division of Petition Review, “sugar substitutes are called ‘high-intensity’ because small amounts pack a large punch when it comes to sweetness.” And unlike sweeteners such as sugar or honey, Zajac notes, high-intensity sweeteners add few or no calories to the diet and generally do not raise blood glucose levels.

The FDA based its approval of advantame on the results of 37 animal and human studies submitted by the manufacturer. The research was designed to identify any harmful effects of the sweetener, including effects on the immune, reproductive, developmental, and nervous systems.

Advantame is chemically similar to aspartame, which requires a warning label alerting people with phenylketonuria (PKU) to the presence of phenylalanine. (People with PKU have difficulty metabolizing phenylalanine.) Because of this, the FDA evaluated whether to require a warning label for advantame as well. However, the agency determined that, because advantame is about 100 times sweeter than aspartame and only a fraction of the amount is required to achieve the same degree of sweetness, no warning label for people with PKU is necessary.

Advantame is expected to hit the US market within the next few years.

For more information, see the press release or the consumer update on the FDA Web site.

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