20^th June 2007

Claims made by Ramazzini regarding the safety of aspartame do not stand up to scientific scrutiny

  New claims made in a paper by Soffritti et al., published on line in the journal EHP on 13^th June, are based on work using the same colony of laboratory animals as an earlier study, which was heavily criticized by the European Food Safety Authority (EFSA) because of the high infection rate inherent in the colony. The high infection rate makes the data and the conclusions unreliable. The study used the same non-guideline, non-OECD[1] protocol (kept until natural death), which was abandoned many years ago as a method suitable for generating data for risk assessment.

 The study used only 2 treatment levels (20 and 100mg/kg bodyweight/day) and did not include the higher doses used in the previous study. The claimed dose-response relationship cannot, therefore, be identified.

 The data confirm suspicions that the incidences are the result of variations in the high spontaneous rates of cancers in this animal colony. The incidences in the new study were compared with the previous study, but there is no statistical analysis.

 The results of the study are in line with previous studies with this colony. Replication of flawed data does not make the data any less flawed.

Recent opinions of independent national and international risk assessment bodies on aspartame

 EFSA re-confirmed the safety of aspartame in May 2006[2], concluding, “There is no need to further review the safety of aspartame nor to revise the previously established Acceptable Daily Intake (ADI) for aspartame.”

 Having reviewed the previous Ramazzini study on aspartame, the United States Food & Drug Administration (FDA) concluded in April 2007,[3] "These data do not provide evidence to alter FDA's conclusion that the use of aspartame is safe.”

 These re-confirmations that aspartame is safe is entirely consistent with the global scientific consensus. Extensive scientific research and regulatory reviews conducted by numerous national and international food safety authorities including the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and the Food and Agriculture Organization as well as regulatory agencies in over 100 countries, have all reviewed aspartame and found it to be safe for use.

Examples of recent human clinical data on aspartame

 A study by the National Cancer Institute in the United States of over 500,000 adults concluded that there is no link between aspartame consumption and an increased risk of developing cancer[4].

 The Mario Negri Institute ( Milan , Italy ) has published results of a network of studies conducted in Italy over a 12-year period on any possible links between the use of sweeteners and an increase in risk of developing cancer.[5] This study concluded that there was no association between aspartame and other sweeteners and the risk of cancer.

Aspartame, a useful contribution to weight loss

 A recent review[6] looking at the benefits of aspartame on weight loss, weight maintenance and energy intake in adults concluded that there was a significant reduction in energy intake in consumers using products sweetened with aspartame. A conservative weight loss of around 0.2 kg/week was observed, which would correspond to a 10kg weight loss/year.

 By providing sweetness without calories, aspartame can make a useful contribution to weight control. For example, a soft drink sweetened with aspartame can have as little as one Calorie per serving.  Consumers can continue to use aspartame with confidence. Furthermore, low calorie sweeteners are suitable for diabetics, offering a sweet taste with no impact on insulin and blood sugar levels.

 For more information about aspartame, please visit the following link:

http://www.aspartame.org/aspartame_latest.html

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