Aspartame safe, study says

More than 500 studies on the synthetic sweetener, which has been in use since 1981 and is present in some 500 pharmaceutical products, were reviewed by a panel of eight scientists over 11 months.

The results were published this week in the September issue of Critical Reviews in Toxicology.

The scientists concluded: "Controlled and scientific studies confirm aspartame's safety and find no credible link between consumption of aspartame at levels found in the human diet and conditions related to the nervous system and behavior, nor any other symptom or illness.

"Aspartame is well documented to be non-genotoxic and there is no credible evidence that aspartame is carcinogenic."

This conclusion reflects the current status of the additive/excipient according to the US Food and Drug Administration (FDA) which states " aspartame is safe as a general purpose sweetener".

The 98-page review considered more than 500 studies, articles and reports conducted over the last 25 years, including unpublished works submitted to the FDA and the Department of Health and Human Services for regulatory approvals of the ingredient.

The scientific studies conducted on the safety of aspartame looked at the sweetener's potential effect on biochemical parameters, behavior, reproductive health, neurological functions and cancer and tumor development.

Some studies considered the effects of doses of aspartame in the thousands of milligrams per kilogram.

The studies covered individuals suffering from Parkinson's disease, diabetes, allergies, depression, and seizures and various categories of children, including those with hyperactivity or claiming to be sensitive to sugar.

As part of the review, the panel also analyzed the consumption levels of aspartame.

The panel found that even among the heaviest users, consumption of the sweetener remained below the accepted daily intake (ADI) levels of 50 and 40mg/kg bw/day as set out by the FDA and European Food Safety Authority respectively.

The average intake of aspartame concluded by the panel was 4.9mg/kg/day.

The report said: "Consumption remains well below established ADI levels, even among special high user sub-populations.

No credible evidence was found that aspartame is carcinogenic, neurotoxic, or has any other adverse effects on health when consumed even at levels many times the established ADI levels."

The safety of aspartame has been called into question several times since its introduction to the food and pharmaceutical industries.

Just in June a new study was released that linked aspartame consumption with an increased risk of leukemia, lymphomas and breast cancer in rats.

The study, by the European Ramazzini Foundation of Oncology and Environmental Sciences (ERF) in Italy, followed a study the foundation published in 2005 which also suggested a link between the sweetener and cancer.

When the study was published in June, the FDA at the time said the agency was interested in reviewing the study, but based on previous studies evaluated by the FDA that purported aspartame's safety, the FDA saw no reason to alter the status of the sweetener.

The FDA has still not been provided with the data from this Italian study, the agency told US-PharmaTechnologist.com yesterday.

The panel of experts, from the US, the UK and the Netherlands, included the ERF studies in its review, but dismissed the Italian's conclusions.

"Multiple expert evaluations, as well as our work, identified numerous flaws in the Italian studies.

After careful review, our panel remains completely confident in aspartame safety," report co-author and University of Maryland food toxicologist Bernadene Magnuson said in a statement.

The study, described as the most extensive review ever on the safety of aspartame, was funded by Ajinomoto Food Ingredients, a global manufacturer of aspartame.

According to the study, the sponsor was unknown to the chair and panel throughout the review process and vice versa.

The authors of the review were unavailable for comment at time of publishing.

The FDA is yet to review the report.