FDA finds aspartame study flawed, reaffirms the sweeteners safety

Food & Drink Weekly, May 7, 2007

The Food and Drug Administration (FDA) has found no data to support the conclusion of a 2005 Italian study that the artificial sweetener aspartame causes cancer and will therefore not change its opinion that it is safe for use in drink and food. Aspartame was approved for use as a general purpose sweetener in U.S. food and drink products in 1981.

FDA said that it had completed its own independent review into the findings of the European Ramazzini Foundation, which had found some major shortcomings in the study, including its design, the way it was conducted, reported and interpreted. The foundation's failure to submit all the scientific data that the FDA had requested did however mean it was unable to conduct a full and definitive review. But based on the available data, it concluded that the study was flawed and was insufficient to convince the FDA to change its policy on the product.

FDA suggested that additional insight on the study findings could be provided by an internationally-sponsored pathology working group examination of appropriate tissue slides from the study.

A review of the study by the European Food Safety Authority (EFSA) also found the conclusions flawed. Iona Pratt, chair of a group of scientists who reviewed the Ramazzini study for EFSA, said that it did not reveal any evidence that would point to aspartame as a cancer causing agent.