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[IP] FDA Approves New Sweetene

Wednesday April 1 3:55 PM EST 
FDA Approves New Sweetener Made From Sugar
By Maggie Fox, Health and Science Correspondent 

WASHINGTON (Reuters) - Sucralose, a new calorie-free sweetener 600 
times sweeter than sugar, won approval from the U.S. Food and Drug 
Administration Wednesday. 

It is designed to pass through the body without being digested -- 
somewhat like Procter and Gamble's olestra product Olean. 

"Sucralose, which is made from sugar, actually tastes like sugar," Neil 
Polo, general manager of New Jersey-based McNeil Specialty Products, 
which will sell the product, said in a statement. 

"Unlike sugar, sucralose has no calories and doesn't promote tooth 

Made by British sweeteners group Tate and Lyle Plc, and licensed to 
McNeil, a unit of Johnson & Johnson, for distribution in the United 
States, it is already sold in Canada and Australia and is approved in 
29 countries. 

"Globally, millions of consumers have been using sucralose since 1991 
in reduced-calorie and reduced-sugar products such as soft drinks, 
shelf-stable fruit drinks, jams, processed fruit products, yogurt and 
baked goods," McNeil said in a statement. 

It will compete with aspartame, which breaks down when heated and 
cannot be used in baking or food processing, and saccharine, which some 
users find unpleasant tasting and which has been linked to a risk of 
bladder cancer in rats. 

There is also acesulfame-K, which is usually used in blends with other 

"In determining the safety of Sucralose, FDA reviewed data from more 
than 100 studies in humans and animals," the agency said in a 

"Many of the studies were designed to identify possible toxic effects 
including carcinogenic, reproductive and neurological effects. No such 
effects were found, and FDA's approval is based on its finding that 
sucralose is safe for human consumption." 

"With this one we don't see any red flags," Dr. George Pauli, director 
of the division of product policy at the FDA, said in a telephone 
interview. "I guess it's not that often that we find a new sweetener to 
be safe." 

Pauli said the agency spent more than a decade deciding whether to 
approve sucralose. 

"One thing that came up about seven years ago ... is that in one of the 
pivotal studies with rats, the animals that had sucralose didn't gain 
weight like those in the control group. They didn't eat as much 

This was probably because the product was so sweet and the laboratory 
rats were fed huge amounts, but the FDA made the company go back and do 
more tests anyway. 

"Not gaining weight, not growing properly -- it could be serious if it 
was a problem," Pauli said. "It was a big setback for them to go back 
and do this.%22 

Sucralose is made through a patented process. "It starts with table 
sugar but goes through a five-step process that uses chlorine and 
replaces some of the atoms that normally would be present in sugar with 
chlorine atoms," Pauli said. 

"The result is an exceptionally stable sweetener that keeps sugar's 
taste without sugar's calories," McNeil said in its statement. "After 
consumption it passes through the body without being metabolized or 
broken down." 

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