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FDA OKs Marketing of Intense Sweetener


The Food and Drug Administration on Friday approved for general consumption a new artificial sweetener that it said was about 7,000 to 13,000 times sweeter than sugar and will carry no health warning on its label.

The sweetener, neotame, will become the most concentrated and intensely sweet sugar substitute on the market. The FDA ruling means that the sweetener can be used in such foods as baked goods, nonalcoholic beverages such as soft drinks, chewing gum, confections, frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings and syrups.

However, the approval is expected to trigger renewed criticism from those who say the sweetener is unsafe and should carry a warning label.

Neotame is a product of Chicago-based NutraSweet Co. and is chemically similar to one of its earlier products, aspartame, marketed under the brand name Equal in small, blue paper packets. Aspartame drew similar criticisms as being unsafe.

Aspartame, which has been on the market for 21 years, is about 180 to 220 times sweeter than sugar. More recently approved products such as sucralose, marketed under the brand name Splenda, are as much as three times sweeter than aspartame. But neotame sets a standard for sweetening power.

Alan M. Rulis, director of the FDA's office of food additive safety, said the concentration of neotame is so high that only very small amounts would be needed to achieve the effects of other sweeteners. Thus, the agency said, a warning label would not be needed because only small quantities would be consumed.

Nick E. Rosa, president and chief executive of NutraSweet, said in an interview Friday that the product would be great because of its "sweetness intensity and because it has an excellent taste profile even when compared to the gold standard, sugar."

The FDA said Friday that neotame had been subjected to 113 animal and human tests "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."

Neotame critics, who could not be reached for comment Friday, surfaced as early as 1999, when it was learned that neotame would be chemically similar to aspartame.

Critics pushed their cause on dozens of Internet sites, asking consumers such questions as, "Why trade one poison for another?"

Florida-based author and doctor H.J. Roberts and neurosurgeon Russell Blaylock have written extensively on what they say are the many health risks associated with aspartame.

That sweetener has been linked by critics to several illnesses, but the only official warning label on the product required by the FDA applies to people who suffer from phenylketonuria, an inherited disorder that leaves a person unable to break down phenylalanine, an amino acid. Aspartame contains that substance.

The FDA said neotame is much more chemically stable than aspartame and does not break down into phenylalanine.

Neotame is already on the market in Australia, having been approved by the Australia New Zealand Food Authority in 2001.

NutraSweet Co. is owned by J.W. Childs Equity Partners II, a Boston-based investment group.

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