Artificial Sweetener 'Sunett'

Should Not Be Used in Diet Soda

New Tests Needed, Cancer Experts Tell FDA

Prominent cancer experts are urging the Food and Drug Administration (FDA) to require good tests that prove the non-caloric artificial sweetener Sunett (acesulfame potassium or acesulfame K) does not cause cancer before allowing it to be used in diet soda.

Citing those experts' concern, the nonprofit Center for Science in the Public Interest (CSPI) has asked the FDA to ban the use of acesulfame. The artificial sweetener is used in some flavors of Trident and Wrigley's Freedent gum, Jell-O Sugar-Free instant puddings and gelatin desserts, Hershey's Lite Syrup, and other foods.

Acesulfame's manufacturer, the German-based Hoechst, claims that the synthetic chemical "has been extensively tested" and that those tests "establish that Sunett is safe for use, even at high concentrations." However, 10 experts who recently reviewed Hoechst's 20-year-old cancer tests concluded that those tests were seriously flawed.

Dr. David P. Rall, former director of the National Institute of Environmental Health Sciences and its National Toxicology Program (NTP), said Hoechst's tests "do not permit an assessment that use of this compound would provide a 'reasonable certainty of no harm,'" the FDA's standard for approving food additives. "In fact, there are indications that it might be carcinogenic."

The urgent need for new tests is increased by the likelihood that many millions of Americans would drink diet soft drinks containing Sunett. According to Dr. Arthur C. Upton, former director of the National Cancer Institute (NCI), "In view of the large scale consumption of acesulfame potassium by the general population that could result from its introduction as a non-nutritive beverage sweetener, appropriate steps to determine its safety should clearly be taken in advance."

Dr. Lorenzo Tomatis, former director of the International Agency for Research on Cancer (IARC), a World Health Organization agency, noted, "Since large sectors of the population may become exposed to acesulfame potassium, and among them a large proportion of children, it seems urgent that properly conducted long-term tests be initiated as soon as possible."

CSPI is asking the FDA to reject the use of the sweetener in soft drinks and to withdraw all previously granted approvals for use in other foods. Executive director Michael Jacobson and senior scientist Myra Karstadt also informed the FDA that CSPI has asked the NTP to conduct high-quality tests to determine whether acesulfame causes cancer.

"Hoechst's studies of acesulfame's carcinogenic potential were poorly designed, poorly executed, and poorly reported," said Karstadt. "High-quality testing is imperative before any new uses are even considered by the FDA." Karstadt has extensive experience in regulation of toxic chemicals, particularly carcinogens.

Jacobson said, "The FDA's job is to protect the public from possible carcinogens like acesulfame. Considering the miserable quality of the safety testing, it is incredible that the FDA previously approved some uses of acesulfame and is considering approving it for use in diet soda."

Acesulfame is present in some low-calorie varieties of General Foods International coffees, Impress hot cocoa mix, Bazooka bubblegum, Cinn-A-Burst and Twisters chewing gum, Go Lightly and Sweet 'n' Low hard candies, and Hawaiian Island Pops, among other foods. It is also the main sweetening agent in Sweet One tabletop sweetener. The FDA is now considering Hoechst's petition for use of acesulfame in nonalcoholic beverages, including soda. Allowing Sunett in soft drinks would result in a tremendous increase in use. In Canada, acesulfame is used in Diet Coke and Diet Pepsi.

Other cancer experts who joined CSPI in criticizing the Hoechst tests and calling for better studies of acesulfame's potential for causing cancer:

* Dr. Emmanuel Farber, Professor of Pathology, Jefferson Medical College, Philadelphia

* Dr. Franklin E. Mirer, Director, Health and Safety Department, International Union, United Automobile Workers, and a member of the NTP Board of Scientific Counselors

* Dr. Umberto Saffiotti, Chief of the NCI Laboratory of Experimental Pathology

* Dr. Marvin Schneiderman, former NCI Associate Director for Field Studies and Statistics

* Dr. Ellen K. Silbergeld, Professor of Epidemiology and Toxicology, University of Maryland at Baltimore, and a former member of the NTP Board of Scientific Counselors

* J. D. Wilbourn, IARC, Acting Chief of the Unit of Carcinogen Identification and Evaluation

* Dr. Sidney M. Wolfe, Director, Public Citizen's Health Research Group, and a former member of the NCI Carcinogenicity Clearinghouse

(All institutions are listed for identification purposes only.)

CSPI is a Washington-based nonprofit organization that led the effort to win passage of the 1990 Nutrition Labeling and Education Act. It is well-known for its opposition to the fat substitute olestra and for its nutrition studies of movie-theater popcorn and restaurant meals. Supported largely by the 750,000 subscribers to its Nutrition Action Healthletter, CSPI accepts no funds from industry or government.

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