FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. Talk Papers are not intended for general distribution outside FDA, but all information in them is public, and full texts are releasable upon request. 
T96-75                       Food and Drug Administration
November 18, 1996       Arthur Whitmore
                        
                        

                   FDA Statement on Aspartame

     A recently published medical journal article raises the
question whether any increased incidence in the number of persons
with brain tumors in the United States is associated with the
marketing of aspartame, an artificial sweetener, following the
Food and Drug Administration's approval of that food additive in
1981.  The following can be used to answer questions:
     Analysis of the National Cancer Institute's public data base
on cancer incidence in the United States -- the SEER Program --
does not support an association between the use of aspartame and
increased incidence of brain tumors.  Data from the SEER program
show that overall incidence of brain and central nervous system
cancers began increasing in 1973 and continued to increase
through 1985 in the United States.  Since 1985 the trend line has
flattened for these cancers, and in the last two years recorded
(1991 to 1993), the incidence has slightly decreased.
     The FDA stands behind its original approval decision, but
the Agency remains ready to act if credible scientific evidence
is presented to it -- as would be the case for any product
approved by the FDA.       
                                    
     The question of a relationship between brain tumors and
aspartame was initially raised when the Agency began considering
approval of this food additive in the mid-1970s.
  The agency resolved the brain tumor issue before the initial
approval of aspartame in 1981.  A Public Board of Inquiry (PBOI)
was convened in 1980 by the Agency to review the scientific data
presented by G.D. Searle and Company relating to the safety of
aspartame.  These independent scientific advisors to the Agency
concluded that aspartame did not cause brain damage.  At the same
time, they said that there was not sufficient scientific evidence
presented to the PBOI that aspartame did not cause brain tumors
in rats.  Therefore, the PBOI recommended against approval of
aspartame at that time and concluded that further study was
needed.
     In 1981 after extensive review of the record by FDA
scientists, then Commissioner Arthur Hull Hayes approved
aspartame as a food additive.  In his decision Hayes noted that 
additional scientific data from a Japanese study about the brain
tumor issue corroborated his decision.  The PBOI chairman later
wrote in a letter to Hayes that the Japanese data would have
caused that panel to give aspartame an "unqualified approval."
     "As data stood, we were unable to reach a communal feeling
of confidence in aspartame's innocuousness on this score and
expressed this unease in our report to you.  By the same token, 
we wish to express our endorsement of your final decision in this
matter," wrote Walle J. H. Nauta, M.D., Ph.D., of the
Massachusetts Institute of Technology. 
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