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Overwhelming scientific evidence confirms aspartame safety

Drug Safety :: Overwhelming scientific evidence confirms aspartame safety

The Calorie Control Council stated that an unpublished rat study conducted by Italy?s Ramazzini Institute and presented today to media is totally contradictory to the extensive scientific research and regulatory reviews conducted on aspartame.

The U.S. Food & Drug Administration (FDA) has said they are not recommending any changes in the use of aspartame.

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.? Also, the European Food Safety Authority and other experts recently dismissed an earlier aspartame rat study by the Ramazzini Institute.

The study findings were presented over breakfast for the media ? a highly unscientific way of presenting research, especially research that has not been published in a peer-reviewed journal. However, this is not new for Ramazzini, and it suggests these researchers are more interested in attention grabbing headlines than allowing their research to be reviewed and audited by independent scientists and regulatory authorities, including the U.S. FDA.

Just last week, on April 20, 2007, FDA issued a statement that it has completed a review of the Ramazzini study, concluding that the study data made available to them by the European Ramazzini Foundation (ERF) ?do not appear to support the aspartame-related findings reported by ERF.? FDA added, ?These data do not provide evidence to alter FDA's conclusion that the use of aspartame is safe.?

In its statement, available at http://www.cfsan.fda.gov/~lrd/fpaspar2.html, FDA noted: ?Based on our review, pathological changes were incidental and appeared spontaneously in the study animals, and none of the histopathological changes reported appear to be related to treatment with aspartame.?

The FDA also said that repeated requests for additional information on the study from the ERF, including pathology slides, were never honored. The agency commented, ?Based on the available data, however, we have identified significant shortcomings in the design, conduct, reporting, and interpretation of this study. FDA finds that the reliability and interpretation of the study outcome is compromised by these shortcomings and uncontrolled variables, such as the presence of infection in the test animals.?

The allegations made by Ramazzini are at complete odds with the wealth of scientific literature demonstrating that aspartame is safe and not a carcinogen. A recent study conducted by Italian and French researchers in humans and published in the Annals of Oncology in 2006 demonstrates no association between aspartame and cancer. The researchers noted, ?In conclusion, therefore, this study provides no evidence that saccharin or other sweeteners (mainly aspartame) increase the risk of cancer at several common sites in humans.? The Italian Association for Cancer Research contributed to the study.

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