Aspartame and Pregnancy: Consuming low calorie sweeteners does not cause premature birth

Jan 2011

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The Halldorsson and Ramazzini studies on low calorie sweeteners have been criticised by renowned scientists since their publication in 2010.

Therefore, in response to recent allegations about low calorie sweeteners, the ISA would like the French public to take note of the comments of prominent European scientists in the area of epidemiology, food toxicology and the evaluation of health risks.

  • Consuming low calorie sweeteners does not cause premature birth
  • The methodology and conclusions of these studies have already been called into question by professors La Vecchia (Italy), Larsen (Denmark) and Renwick (UK)
  • EFSA has confirmed the safety of aspartame on several occasions, refuting the conclusions of previous studies on aspartame published by the Ramazzini Institute
  • The doses given to mice in the latest Ramazzini study are very high and bear no relation to common human exposure to aspartame through the food we consume
  • ISA welcomes the steps taken by ANSES and is confident about the forthcoming results of their analyses

1. Low calorie sweeteners do not cause premature births

The use of low calorie sweeteners has been very well studied both in humans and in animals. This research has shown no adverse effects on the mother or the developing baby related to the use of low calorie sweeteners.1

The Halldorsson2 study claims that the consumption of aspartame-sweetened carbonated and non-carbonated low calorie soft drinks increase the risk of preterm delivery.

However, health authorities - EFSA, ANSES and the Joint Expert Committee on Food Additives of the United Nations Food & Agriculture Organisation and the World Health Organisation (JECFA) – have concluded many times (5 times) that aspartame is safe for the general population and for sensitive groups. Aspartame was first authorised over 30 years ago and since then an extensive amount of research has been carried out, none of which has raised any questions about the benefits of consuming foods and beverages sweetened with aspartame for either the general public or particularly sensitive groups of the population.

The methodology and conclusions of the Danish study have been called into question by many scientists:

o  Following the publication of the study by Dr. Halldorsson and his team in the American Journal of Nutrition, Professor Carlo La Vecchia, epidemiologist at the Mario Negri Institute of Pharmacological Research of the University of Milan (Centre of excellence of the World Health Organisation), responded in this same review in October 2010 that the data provided in this study do not support conclusions on the combined role of low calorie sweeteners and soft drinks (carbonated or non-carbonated) and consequently, on the potential role of low calorie sweeteners in causing premature births.

Professor John-Christian Larsen (Denmark) Head of the Department of Toxicology and Risk Evaluation at the Danish Technical Institute (DTU) commented on this study in July 20103: “Some people who do not like aspartame, for whatever reason, blame aspartame for all sorts of diseases, but I have not seen any research that has led me to doubt its safety. It is therefore quite surprising that aspartame would have an effect on the length of pregnancy. It cannot be explained biologically.

Since the Halldorsson study was published in July 2010, the Danish health authorities have never considered it necessary to revise their position that aspartame is safe.

o  In October 2010, Emeritus Professor Andrew Renwick of the School of Medicine at Southampton University (UK) highlighted the difficulty with an epidemiological study in determining the date of the beginning of a pregnancy, which has an impact on the pertinence of the observed conclusions. He also highlighted other significant trends in this study, “high consumers of beverages smoked more (indicating a possible lack of health awareness)”.

There are many factors that increase the risk of premature births, such as smoking, diabetes, poor nutrition, anaemia, stress, depression and many more, including overweight and obesity. However the study does not consider the effects associated with these risk factors.

2. Having looked at previous studies published by the Ramazzini Institute, EFSA has confirmed that aspartame does not cause cancer.

In May 2006, the European Food Safety Authority (EFSA) reconfirmed the safety of aspartame, thereby unequivocally rejecting the claims by Morando Soffritti of the Ramazzini Institute (ERF) alleging that aspartame was unsafe.

In April 2009, following further claims by the Ramazzini Institute about the safety of aspartame, EFSA concluded,On the basis of all the evidence currently available including the last published ERF study there is no indication of any genotoxic or carcinogenic potential of aspartame and there is no reason to revise the previously established ADI for aspartame of 40 mg/kg bw/day.

Furthermore, in April 2010, following a review of all scientific evidence available on aspartame, the report of an EFSA group of national experts on aspartame concluded, The national experts have not identified any new evidence that requires a recommendation to EFSA that the previous Opinions of EFSA and the SCF [on aspartame] need to be reconsidered.

The methodology and conclusions of the latest study by the Ramazzini Institute4 have been called into question by scientists:

In October 2010 Professor Renwick raised the following inconsistencies in relation to the study:

- “The authors’ suggestion that the statistically significant findings are relevant to humans is contradicted by human data from cancer epidemiology studies [500 000 people]5. Recent epidemiology studies have shown no evidence of any associations between various human cancers and the ingestion of intense sweeteners.6

- “The simple metabolism of aspartame into 3 normal dietary components, the absence of genotoxicity and the human epidemiology studies which show that aspartame does not produce cancer in humans. Consequently, these latest findings [Ramazzini] in animals do not indicate a concern for human health.”

It should be noted that the doses administered to mice in the Ramazzini study are extremely high and in no way correspond to the levels of exposure from food:

A woman weighing 60 kg would have to consume on a daily basis throughout her life the equivalent of 10 000 pieces of aspartame-sweetened chewing gum + 40 litres of diet drinks + 200 low-calorie milk desserts + 300 tabletop sweeteners all containing aspartame in order to be exposed to the levels tested in the study.

This level of intake is equivalent to 50 times the Acceptable Daily Intake (ADI). It should be remembered that the consumption of aspartame by the highest French consumers of low-calorie sweetened products is 7% of the ADI, or 700 times less than the doses used by the Ramazzini study.

3. These two recent studies will be reviewed by independent authorities

In response to the publication of the Danish and Italian studies, ANSES has announced that it will "examine without delay these new studies with a view to making possible recommendations to French authorities and will refer this matter, if necessary, to the European Food Safety Authority (EFSA) who is responsible for the risk evaluation."

Moreover, in its statement ANSES clearly highlights the following findings of independent food safety authorities:

- EFSA’s conclusions on previous studies on aspartame by the Ramazzini Institute – which were judged to be unsubstantiated;

- The conclusions of the AFFSA (now ANSES) review of aspartame in 2002, which evaluated around 80 scientific publications on aspartame and found that the body of this scientific evidence fails to support the claim that aspartame presents a danger to health.7

The ISA welcomes the efforts of French authorities to reassure French consumers about aspartame. The ISA is fully confident that the safety of this low calorie sweetener for all consumers will be reconfirmed.

1Safety Evaluation in Pregnancy', by Robert S. London – Jay T Rorick Jr.published in 'Clinical Evaluation of a Food Additive, Assessment of Aspartame', (Edition 1996), by Tschanz et al

2Intake of artificially sweetened soft drinks and risk of preterm delivery. Halldorsson TI et al. AJCN, 30 juin 2010

3 Article in a Danish scientific newsletter 'Ingeniøren', 15th July 2010 [Translation into English ]

4Aspartame Administered in Feed, Beginning Prenatally Through Life Span, Induces Cancers of the Liver and Lung in Male Swiss Mice. Soffritti et al. American Journal of Industrial Medicine, September 2010

5Study of the National Cancer Institute (United States) in April 2006, NCI study abstract: http://www.abstractsonline.com/aspartame

6Bosetti et al, 2009. Artificial sweeteners and the risk of gastric, pancreatic and endometrial cancers in Italy. Cancer Epidemiology Biomarkers & Prevention; 18(8) August 2009

7Rapport de l'Agence française de sécurité sanitaire des aliments sur la question d'un éventuel lien entre exposition à l'aspartame et tumeurs du cerveau. Afssa. 7 mai 2002.

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