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Cancer Prevention Coalition Calls on FDA to Ban Aspartame

The artificial sweetener aspartame has been shown to cause cancer in lab rats, and should be banned for human consumption, warns the Cancer Prevention Coalition.

Under the explicit provisions of the 1958 Delaney Law, which requires an automatic ban on carcinogenic food additives, the Coalition is calling on Dr. Margaret Hamburg, the newly appointed Commissioner of the U.S. Food and Drug Administration and public health advocate, to promptly ban the continued use of aspartame.

First discovered in 1965 by the pharmaceutical company G.D. Searle, aspartame is an artificial sweetener marketed by Ajinomoto Sweeteners under trademark names including Nutrasweet, Equal and Canderel.

Aspartame is the second most widely used artificial sweetener in the world. It is found in more than 6,000 products including carbonated and powdered soft drinks, hot chocolate, chewing gum, candy, desserts, yogurt, and tabletop sweeteners, as well as some pharmaceutical products like vitamins and sugar-free cough drops. More than 200 million people worldwide consume it.

The sweetener has been used for more than 30 years, having first been approved by the FDA in 1974.

After saccharin, aspartame is the commonest sweetener, consumed by over 200 million people worldwide, and represents about 60% of the artificial sweetener market.

Aspartame provides food, soft drinks, candy and chewing gum manufacturers with substantial cost savings compared to sugar, which is 200 times less sweet. Aspartame is a sweetener without calories, which helps people control their weight.

Studies of the carcinogenicity of aspartame performed by producers of the sweetener have been negative.

But Cancer Prevention Coalition Chairman Samuel S. Epstein, MD warns that the use of aspartame in foods, vitamins and pharmaceuticals is based on false safety information and political maneuvering going back more than 30 years.

In January 1976, then Food and Drug Administration (FDA) Commissioner Alexander M. Schmidt, MD testified before Congress that Hazleton Laboratories, under contract to Searle, had been charged with falsifying toxicological data on aspartame.

The FDA convened a Public Board of Inquiry to review concerns about the sweetener's carcinogenic effects in experimental animals. In 1980, the Board concluded that aspartame could "contribute to the development brain tumors."

Dr. Epstein points out that FDA then recommended that, pending confirmation of these findings, the sweetener should no longer be used.

However, then Searle Chairman Donald Rumsfeld, later Secretary of Defense in the Bush Administration, vowed to "call in his markers," to get the sweetener approved.

On January 21, 1981, the day after Ronald Reagan's inauguration, Searle re-applied to the FDA for approval to use aspartame as a food sweetener, and Reagan's new FDA commissioner, Arthur Hayes Hull, Jr., appointed a 5-person Scientific Commission to review the Board of Inquiry's decision.

It soon became clear that the panel would uphold the ban by a 3-2 decision, but Hull then installed a sixth member on the commission, and the vote became deadlocked. He then personally broke the tie in aspartame's favor.

Hull later left the FDA under allegations of impropriety, then took a position with Burston-Marsteller, the chief public relations firm for Searle and for Monsanto, which purchased Searle in 1985.

Dr. Epstein is not alone among doctors in his concern about the sweetener.

In a July 25, 2009 letter to the new FDA commissioner, H.J. Roberts, M.D., a Florida internist and diabetes expert, drew her attention to the dangerous health effects of aspartame in foods and other products.

"My own data base encompasses over 1400 individuals who have suffered major disorders that could be directly ascribed to the use of these products, including gum," wrote Dr. Roberts, who authored the books "Aspartame Disease: An Ignored Epidemic," and "Aspartame Disease: an FDA Approved Epidemic."

There have been other calls to ban the sweetener, including one in the UK earlier this year, when Member of Parliament Roger Williams cited "compelling and reliable evidence for this carcinogenic substance to be banned from the UK food and drinks market altogether."

Dr. Epstein says the evidence on the carcinogenicity of aspartame was strongly reinforced in a unique feeding test conducted on rats in an Italian laboratory.

In 2005, based on highly sensitive and life-long feeding tests in groups of about 200 rats and at doses less than usual human dietary levels, the prestigious Italian Ramazzini Foundation confirmed that aspartame is unequivocally carcinogenic. A high incidence of cancers was induced in multiple organs of the lab rats fed the sweetener, including lymph glands, brain and kidney.

Dr. Epstein says rats were fed aspartame beginning in the early fetal stage of life, resulting in their lifelong exposure to aspartame.

"This resulted in a still higher increase in the incidence of cancers at sites, including those previously reported," he says.

The Ramazzini study was reported in the November 2005 issue of "Environmental Health Perspectives," the peer-reviewed journal of the United States' National nstitute of Environmental Health Sciences.

"Our study has shown that aspartame is a multipotential carcinogenic compound whose carcinogenic effects are also evident at a daily dose of 20 milligrams per kioogram of body weight (mg/kg), notably less than the current acceptable daily intake for humans," the Ramazzini authors wrote.

Currently, the acceptable daily intake for humans is set at 50 mg/kg in the United States and 40 mg/kg in Europe.

In April 2007, the results of this study were presented by Ramazzini scientists at the Mount Sinai School of Medicine, New York.

Not surprisingly, says Dr. Epstein, these findings have been sharply challenged by the sweetener industry, major sweetener users, such as Coca-Cola, PepsiCo, Nestlé and Monsanto, and also by the industry-oriented scientific journal "Critical Reviews in Toxicology."

In view of the new scientific evidence of aspartame's carcinogenicity and the political gamesmanship that led to its original approval by the FDA, Dr. Epstein is urging the new FDA Commissioner, Dr. Hamburg, to impose an immediate ban on the use of aspartame for human consumption.

Samuel S. Epstein, MD
Professor emeritus Environmental & Occupational Medicine
University of Illinois at Chicago School of Public Health
Chairman, Cancer Prevention Coalition
Chicago, Illinois