FDA Statement on European Aspartame Study

FDA is issuing this statement today in response to the European Food Safety Authority (EFSA)
press release on its review of the long-term carcinogenicity study of aspartame conducted by the
European Ramazzini Foundation (ERF).

Aspartame, a low-calorie sweetener, is composed primarily of two common amino acids,

aspartic acid and phenylalanine. Each of these is also a building block for conventional foods
such as protein and natural flavor molecules.

In 2005, ERF published new findings of a long-term feeding study on aspartame conducted in
rats. Scientists from ERF concluded from their study that aspartame causes cancer and that
current uses and consumption of the sweetener should be re-evaluated.

EFSA's review of ERF's study concluded, among other things, that on the basis of all evidence
currently available to EFSA:

• ERF's conclusion that aspartame is a carcinogen is not supported by the data; and
• EFSA sees no need to further review its earlier scientific opinion on the safety of
aspartame or to revise the Acceptable Daily Intake.

Upon learning of the ERF study results, FDA requested the study data from ERF to evaluate the
findings. On February 28, 2006, the agency received a portion of the data requested. We are
actively reviewing the data provided by ERF and will complete our review of those data as soon
as possible. When FDA completes its review of the ERF study data, it will announce its
conclusion.

Since it was first approved for use in the United States, the safety of aspartame has been
questioned by some. To date, however, the agency has not been presented with scientific
information that would support a change in our conclusions about the safety of aspartame. Those
conclusions are based on a detailed review of a large body of information, including more than
100 toxicological and clinical studies regarding the sweetener's safety.