FDA, Others Affirm Safety of Aspartame

The Calorie Control Council stated that a rat study conducted by Italy’s Ramazzini Institute 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.

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

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 statement further noted, “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 Calorie Control Council agrees that FDA should immediately review the findings from Ramazzini. Unfortunately, the FDA said that repeated requests for additional information on the study from Ramazzini, including pathology slides, were never honored.

Lyn Nabors, President of the Council questioned, “If Ramazzini researchers are so confident in their findings, why will they not share their slides with regulatory agencies and subject their findings to the internationally recognized standardized review process to validate pathology findings?” The National Toxicology Program (NTP) and other organizations have established guidelines for pathology peer review in order to provide scientific consensus that study conclusions are valid. Unlike the Ramazzini findings, the aspartame studies required for regulatory approval underwent extensive audit and data validation.

The U.S. NTP 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.” These studies are especially important as they were conducted using mice bred to be more sensitive to developing cancer.

“It is unfortunate that some scientists associated with NTP are lending credibility to the Ramazzini Institute and questioning the safety of aspartame when government institutions such as the NTP, the National Cancer Institute, the FDA and others have found no relationship between aspartame and cancer,” noted Nabors. Further, it is difficult to understand why Environmental Health Perspectives (EHP), a publication of the National Institute of Institutes of Environmental and Health Sciences (NIEHS) published the Ramazzini study when the design and execution did not follow guidelines set up by the NTP (the U.S. government toxicology initiative administered by NIEHS).

Interestingly, Ramazzini researchers have repeatedly provided their findings to the media prior to publication – a highly unscientific and unacceptable way of disseminating research. For most reputable journals, this would jeopardize publication. However, EHP continues to publish findings from researchers more interested in attention grabbing headlines than allowing their research to be reviewed and audited by independent scientists.

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.

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).”

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 www.aspartametruth.net.

Items of Interest

June 25, 2007 Statements