FDA reviews Italian aspartame study

The US Food and Drug Administration (FDA) has reaffirmed its position on the safety of aspartame, following a review of a European study that had linked the artificial sweetener to cancer.

The regulatory agency on Friday said it does not support the conclusion of the Italy-based European Ramazzini Foundation (ERF) study that aspartame is a carcinogen. The announcement comes after an FDA review of ERF data. The Ramazzini findings, published in 2005, followed a long-term feeding study on aspartame conducted on rats.

"Based on the available data 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," it said.

"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."

A review of the study by the European Food Safety Authority (EFSA) also found the conclusions flawed. Iona Pratt, chair of a group of scientists who reviewed the Ramazzini study for EFSA, said that it did not reveal any evidence that would point to aspartame as a cancer causing agent.

Since its discovery in 1965 aspartame has be the source of controversy within the scientific community and industry over whether it causes health problems. Some studies have indicated a health risk, some have indicated that it does not cause harm to humans. Industry has consistently denied that the artificial sweetener poses a health risk, claiming that the numerous scientific studies were faulty.

They also point to four previous long term studies sponsored by G.D. Searle, a chemical company that held the patent to aspartame, which were the basis for regulatory acceptance worldwide. Searle was later bought by Monsanto and became NutraSweet Co.

However Kathryn Knowles, a spokesperson for Ramazzini, said that the Ramazzini research was the first long term independent study relating to cancer. Knowles said the study should be a valuable lesson for industry, which can learn from the experience, no matter if it turns out to be painful.

"There should be a quality assurance partnership between researchers and the food additive industry," she said. "There should be independent evaluations using long term studies."

Steve - the fact that the FDA looked so long and hard at the study, in addition to making a statement, shows you that they are worried about aspartame. The long-term studies that G.D. Searle supposedly had done were a sham. This is the first long-term study done on rats. Of course, there have been no human studies.

To tell if this study is valid, all you have to do is read it (click on the link below). The Ramazzini study was structured very well and its findings were not "spontaneous."

What's most important is the Ramazzini spokesman's comments about ensuring quality with long-term studies before a chemical like aspartame, or for that matter, medications, come to market. This is the real problem and there are no standards in place to address it.

http://www.ramazzini.it/fondazione/docs/AspartameGEO2005.pdf