Comprehensive Review of Ramazzini Study Demonstrates No Scientific Evidence of Aspartame and Cancer Link

The European Food Safety Authority (EFSA) announced today there is no reason to recommend any dietary change in regard to the low-calorie sweetener, aspartame. The report from EFSA’s Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) specifically states, “In its opinion published today, the Panel concluded, on the basis of all the evidence currently available, that there is no need to further review the safety of aspartame nor to revise the previously established Acceptable Daily Intake (ADI) for aspartame (40 mg/kg body weight).” EFSA’s statement is the result of its review of a recent study by the Ramazzini Institute, which alleged an increased risk of leukemia and lymphoma with aspartame use.

According to Dr. Herman Koeter, EFSA Acting Executive Director, “EFSA considers that the results of this new study on aspartame [by Ramazzini researchers] do not provide scientific basis for reconsidering its [aspartame’s] use in foods.”

The design and execution of the Ramazzini study did not follow guidelines set up by the National Toxicology Program (NTP), the U.S. government toxicology initiative. Ramazzini researchers did not follow internationally established protocols for evaluation of animal carcinogenicity study findings. The NTP and other organizations have established guidelines for pathology peer review in order to provide scientific consensus that study conclusions are valid. Such an independent review of the pathology slides from this study has not been conducted.

The findings by EFSA further support a recent epidemiology study from the National Cancer Institute which found no link between aspartame consumption and leukemias, lymphomas and brain tumors. The study, presented at the American Association of Cancer Research meeting in Washington, DC, on April 4, 2006, evaluated over 500,000 men and women between the ages of 50 and 69 over a five-year period. The researchers found (compared with those who did not consume aspartame) that there was no evidence of an increased risk of leukemias, lymphomas and brain tumors among those who use aspartame. The researchers report, “Our findings from this epidemiologic study suggest that consumption of aspartame-containing beverages does not raise the risk of hematopoietic or brain malignancies.”

Additionally, three recent animal studies conducted by the National Toxicology Program (NTP) designed to evaluate whether aspartame is capable of causing cancer were published in October of 2005. These U.S. government-funded and managed studies were conducted using Good Laboratory Practices (GLP). The results of these cancer studies, in which aspartame was fed to mice bred to be especially sensitive to cancer-causing agents, unequivocally indicated that “there was no evidence of carcinogenic activity [cancer] of aspartame.”

The U.S. Food & Drug Administration (FDA) also supports the fact that aspartame is a safe low-calorie sweetener. According to the FDA, “Based on the large body of evidence we have reviewed, including several studies on carcinogenicity which showed no adverse effects and data on how aspartame is metabolized by humans, we have no reason to believe that aspartame would cause cancer. Thus, it remains FDA’s position that use [of aspartame] is safe.”

Aspartame is one of the most thoroughly studied food ingredients with more than 200 studies supporting its safety. In addition to the FDA, the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and Food and Agriculture Organization, the Scientific Committee on Food of the European Union and regulatory agencies in more than 100 countries have reviewed aspartame and found it to be safe for use.

“We are pleased with EFSA’s findings as we have had major concerns about the Ramazzini study including a lack of Good Laboratory Practices, the methodology, the fact that it has not undergone the NTP peer review process, etc.,” noted Lyn Nabors, President of the Calorie Control Council. “The findings from EFSA, the NTP, and other leading regulatory and health agencies should provide consumers with confidence in the safety of aspartame,” she added.

To read the EFSA press release visit: efsa.europa.eu.

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May 5, 2006 Statements