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BY OUR PHARMA CORRESPONDENT
1 August, 2005: /PRNewswire/ -- The Calorie Control Council today stated that reports of a preliminary
unpublished rat study alleging that aspartame may be related to an increased risk of leukemia and lymphoma in
rats are unsupported and totally contradictory to the extensive scientific research and regulatory reviews
conducted on aspartame. Acceptance and reporting of such preliminary findings should be withheld until the
research is completed.
The Ramazzini Institute in Bologna, Italy plans to publish a study report in their own publication. Their publication,
the "European Journal of Oncology," is not included in the MedLine (National Library of Medicine) database, the
world's leading source of scientific literature. Also, the researchers at Ramazzini have not followed the
internationally established protocol for evaluation of animal carcinogenicity study findings.
All of the approved low-calorie sweeteners have been determined to be safe by the U.S. Food and Drug
Administration 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 130 countries have reviewed aspartame and found it to be safe
for use.
Four long-term carcinogenicity studies on aspartame conducted in accordance with international standards have
found no relationship between aspartame and any form of cancer. The studies were submitted to numerous
regulatory agencies, such as the FDA, which conducted exhaustive reviews of the data.
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.
When FDA approved aspartame, the FDA Commissioner noted: "Few compounds have withstood such detailed
testing and repeated, close scrutiny, and the process through which aspartame has gone should provide the public
with additional confidence of its safety."
The Ramazzini researchers' pathology slides have not been peer reviewed. The National Toxicology Program
(NTP) has established guidelines for pathology peer review in order to provide scientific consensus that study
conclusions are valid. Ramazzini researchers were asked several months ago to subject their findings to the NTP
peer review process but have not responded to the request. Additionally, the researchers reportedly have not
concluded statistical analyses of their findings.
Previous findings by these researchers at the same institution using a similar protocol have been reviewed by the
FDA's Cancer Assessment Committee, which noted that those reported data were "unreliable" due to a "lack of
critical details ... and ... questionable histopathological conclusions ...."
Based on the current information from Ramazzini, the European Food Safety Authority (EFSA) (a scientific body
charged with providing independent and objective advice on food safety issues in the European Union) stated,
"EFSA does not consider it appropriate to suggest any change in consumers' diets relative to aspartame ...."
Health Canada has also stated that based on the limited new information available, it is not recommending any
dietary changes relating to the use of aspartame.
The American Cancer Society, in addressing previous allegations of a possible link between aspartame and cancer
has stated, "Current evidence does not demonstrate any link between aspartame ingestion and increased cancer
risk."
"With billions of man-years of safe use, consumers and health professionals can be assured that aspartame is safe
for humans. And the rigorous scrutiny and battery of studies to which aspartame has been subjected should
provide people with additional confidence in its safety," stated Lyn Nabors, executive vice president of the Calorie
Control Council.
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