Newswise — The Calorie Control Council today stated that an unpublished rat study conducted by Italy's Ramazzini Institute and presented today to media is totally contradictory to the extensive scientific research and regulatory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.
Similarly, a 2006 epidemiology study from the US National Cancer Institute, found no adverse effects linked to aspartame consumption. The study evaluated more than 500,000 men and women and 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. Further, the U.S. National Toxicology Program has recently completed three animal studies designed to evaluate whether aspartame is capable of causing cancer. The results of these cancer studies, unequivocally indicated that "there was no evidence of carcinogenic activity [cancer] of aspartame."
After thoroughly reviewing Ramazzini data from a previous study, the European Food Safety Authority's (EFSA) Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) stated in May, 2006, "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)."
All of the approved low-calorie sweeteners, including aspartame, have been determined to be safe by the FDA and other scientific and regulatory authorities worldwide. Aspartame has been safely consumed for nearly a quarter of a century and is one of the most thoroughly studied food ingredients, with more than 200 scientific studies confirming 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.
Aspartame is composed of two amino acids, aspartic acid and phenylalanine, as the methyl ester. Amino acids are the building blocks of protein. Aspartic acid and phenylalanine are found naturally in protein containing foods, including meats, grains and dairy products. Methyl esters are also found naturally in many foods such as fruits and vegetable and their juices. The body handles the components from aspartame in the same way it handles them when derived from other foods.
"An examination of the animal and human research findings by regulatory bodies in countries around the world has led repeatedly to the conclusion that aspartame is safe. In consideration of these facts, it is difficult to accept a new claim of carcinogenesis in rats ingesting large amounts of the sweetener, particularly given the extensive database that already exists showing the absence of carcinogenic effects," notes Dr. John Fernstrom Professor of Psychiatry, Pharmacology and Neuroscience at the University of Pittsburgh School of Medicine.
For more information please visit http://www.aspartametruth.net.
The Calorie Control Council, established in 1966, is an international non-profit association representing the low-calorie and reduced-fat food and beverage industry.
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