FDA affirms safety of Aspartame

The Calorie Control Council has 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.

According to Dr. George Pauli of the FDA, "FDA requested the data from the Ramazzini study in July 2005 but we have as not yet received the data. The agency cannot, therefore, comment on the study until it has the opportunity to review the study data, in depth. 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."

The study, to be published in Environmental Health Perspectives, alleges that aspartame may be related to an increased risk of leukemia and lymphoma in rats. The design and execution of the study did not follow guidelines set up by the National Toxicology Program (NTP), the U.S. government toxicology initiative administered by the National Institute of Environmental and Health Sciences (NIEHS).

According to a report, Review of Lymphatic and Hematopoietic Cancer Incidence Trends & Consumption of Aspartame, conducted in 2005, researchers concluded that examinations of these cancer trends (from the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) program) by gender or age group found no consistent pattern that paralleled the rise in aspartame consumption and trends in the cancer incidence rates were not consistent with the proposed hypothesis suggesting a relationship between aspartame and lymphomas and leukemias.

"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.

In October 2005, NIEHS informed the Calorie Control Council, "The NTP has convened a group of pathologists to review selected histopathological lesions from the RF [Ramazzini Foundation] aspartame cancer bioassays. The NIEHS has not carried out a systematic pathology review of the RF aspartame studies." NIEHS has confirmed that it had no role in the design, performance or interpretation of the Ramazzini study and stated it is not putting NIEHS' reputation behind this study.

Ramazzini researchers did not follow internationally established protocols for evaluation of animal carcinogenicity study findings. Further, the NTP and other organizations have established guidelines for pathology peer review in order to provide scientific consensus that study conclusions are valid. Such an independent review of the pathology slides from this study has not been conducted.

NTP has recently completed three animal studies designed to evaluate whether aspartame is capable of causing cancer. These U.S. government-funded and managed studies were conducted using Good Laboratory Practices (GLP) and individuals considered experts in their profession reviewed the results. The results of these cancer studies, in which aspartame was fed at levels similar to those reportedly fed in the Ramazzini study, unequivocally indicated that "there was no evidence of carcinogenic activity [cancer] of aspartame."

Previous findings by the Ramazzini 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...." The aspartame findings from the Ramazzini researchers recently were reviewed by the expert United Kingdom Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Members of that Committee characterized aspects of the study findings as "implausible," with other aspects "cast(ing) doubt" on the entire study. Members of the committee were "critical" of the study design and the statistical approach used.

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. 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."

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.... "

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.

Also, an extensive review of aspartame's approval process was conducted by the U.S. government's General Accounting Office (GAO), an agency independent of the Executive Branch, which investigated the entire ten-year regulatory process that led to FDA's approval of aspartame as a safe food ingredient. GAO concluded, "FDA adequately followed its food additive approval process in approving aspartame.... Throughout aspartame's approval history, GAO found that FDA addressed safety issues raised internally and by outside scientists and concerned citizens."

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.

"Aspartame has a long history of safe use. Aspartame is not a carcinogen. Instead, it is a useful tool in helping people control calories and their overall weight. And, health professionals agree that overweight/obesity is a risk factor for certain types of cancer," notes Lyn Nabors, President of the Calorie Control Council.

With so many people around the world who are overweight or obese, taking steps to assure appropriate calorie intake can help people achieve a more healthful diet. Because products sweetened with aspartame taste very similar to their sugar-sweetened counterparts yet are significantly lower in calories, using products with aspartame, together with regular physical activity, can be beneficial for weight management.