- The Washington Times - Thursday, May 18, 2000

The maker of saccharin overcame a hurdle when the government said it no longer considers the artificial sweetener a cancer-causing product. Now, the company must convince Congress to remove its warning label.

The National Institute of Environmental Health Sciences (NIEHS) said Monday that studies show "no clear association" between saccharin and human cancer. But unless Congress agrees, the warning label that the popular product has carried since 1981 will remain.

"Because the scientific community is moving in that direction, hopefully it will drive the [federal Food and Drug Administration] and Congress to revisit what was done in 1977 … and change the warning label," said Jim McKenna, vice president of manufacturing and marketing of saccharin at PMC Specialties Group.

The Ohio company has been the only U.S. manufacturer of the sweetener since its troubles began in the 1970s. Saccharin had been the primary sugar substitute until a series of studies suggested it caused bladder cancer in rats.

In 1977, the FDA removed saccharin from its safe-to-use list. A short ban of saccharin's use followed, but was lifted in 1981 when FDA scientists, after yet another round of studies, concluded that it was placed on the list unfairly. The warning label remained.

Saccharin most often is sold in the form of Sweet'n Low, a tabletop sweetener. It's also used in some diet soda drinks, in toothpaste and mouthwashes, in some chewing gums and in store-brand juices.

The Calorie Control Council, an Atlanta-based association of manufacturers of low-calorie and reduced-fat foods and beverages, petitioned NIEHS to remove saccharin from the carcinogen list.

John Bucher, deputy director of the Environmental Toxicology Program, a part of the NIEHS, and a member of the board that reviewed the decision, said: "We believe there is insufficient data to establish that [saccharin] is reasonably anticipated to be a human carcinogen."

He added that the accumulation of data since the 1970s shows that bladder cancer in rats is not caused the same way as in humans, so saccharin is not necessarily a carcinogen.

The announcement, however, doesn't mean competition in the industry three other sweeteners exist today will increase.

"It's a very important decision, but it's not immediately going to trigger some major change in the way we market our product," said Mr. McKenna.

Saccharin is the second-most widely used sweetener in the country. Aspartame, approved by the FDA in 1981, is No. 1, with double the amount of use as saccharin. Acesulfame Potassium, approved in 1988, and Sucralose, approved 10 years later, also are used.

The only significant increase of saccharin use would occur if Congress removes the warning label from the sweetener.

"I think it makes a difference especially in its use in new products, because companies are hesitant with warning labels," said Lyn Nabors, executive vice president of the Calorie Control Council. "Those who have been using it don't even think about it. But if you want to introduce a new product, people are more likely to look at the label."

Overseas in Europe and Asia the market for saccharin is much bigger, because warning labels are not required. Most other saccharin makers are in Asia.

While the sweetener market received the news of saccharin's de-listing calmly, Public Citizen, a leading consumer watchdog, was in an uproar.

"I think it's clearly a carcinogen, and [saccharin] being taken off the list is making a mockery out of the independence of this program," said Dr. Sidney Wolfe, director of the Health Research Group, part of Public Citizen. "I am sure that the artificial sweetener … industry, is very happy to have it taken off the list, but that's really not a scientific reason."

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