Text Version

Statement by Dr. Richard J. Wurtman, Director, Clinical Research Center,
Massachusetts Institute of Technology, Committee on Labor and Human
Resources:  NutraSweet:  Health and Safety Concerns - Testimony before
Congress Nov 3, l987

BEGIN................

"Vast numbers of people in America and elsewhere now consume aspartame
regularly, many sometimes eating or drinking amounts that are well in
excess of the quantities that the Food and Drug Administration assumed
people would consume when it authorized aspartame's inclusion in diet
beverages and other foods.  Thousands of people are sufficiently
convinced that they personally suffered side-effects caused by aspartame
to have written letters to the FDA about their experiences, and it can
be assumed that very many more people -- concerned about such side
effects -- have simply chosen to avoid the artificial sweetener (a
choice not always possible in a society that consumes half or more of
its meals outside the home).  Within the scientific community real
controversy persists concerning the safety of unlimited aspartame
consumption for all people, and speakers at an international conference
on aspartame (held in Washington in May, l987) identified numerous sub-
populations in which unlimited aspartame consumption could cause special
risks (e.g., pregnant  or lactating women; young children; people with a
seizure history; people taking various medications).

One group of scientists, myself included, responds with anxiety to the
ease with which relatively low aspartame doses can be shown to affect
brain composition and function in experimental animals (and worry about
the implications of such responses for the human brain); other
scientists conclude that because aspartame has not been proved to be
unsafe (in large-scale double-blind studies), it remains appropriate to
allow everyone (except for homozygous phenylketonurics) to use as much
of it as they like--and unnecessary even to indicate on food labels the
amounts of the sweetener contained therein.

How can it be that we still know so little about the health effects of
aspartame?  And the next time a new food additive is introduced to the
food supply, will aspartame's history repeat itself?  (That is, years
after its acceptance, will major doubts persist about the universal
safety of the new additive?)

I believe that many of the problems that Society has faced in assessing
the safety of aspartame could have been obviated had the use of this and
other new food additives been regulated in a manner closer to the ways
we regulate new drugs, particularly the over-the-counter drugs.  There
is no a priori reason to decide that a brand-new chemical (like
aspartame) which will be placed in the Nation's food supply--and
consumed by vast numbers of people who anticipate, perhaps incorrectly,
that it will affect only the gustatory and nutritional properties of
their foods-should be subject to less testing than one intended to be
used as a drug, by much smaller numbers of people (who take it precisely
because they desire its physiological effects and who believe, based on
adequate evidence, that these effects justify risking its possible side-
effects).  I would like specifically to propose the following:

1.  That the Food and Drug Administration be required to form standing
advisory committees, like those which advise it about over-the-counter
drugs, to determine which food-related problems actually require
solutions involving new food additives (e.g., improving appearance or
taste; reducing caloric density), and that these committees establish
mandatory criteria by which the FDA will judge the extent to which
candidate food additives actually solve the problem, and the relative
risks of their side-effects.

2.  That no new food additive be approved for sale prior to the
completion of adequate clinical testing, which will include both
unselected populations and people who might be at special risk of
suffering side-effects from the additive.  Such high-risk populations
might include infants and children--if it is intended that such
"consumers" ultimately purchase products containing the additives;
pregnant or lactating women and old people; people taking drugs which
might interact, chemically or physiologically, with the additive.

3.  That mechanisms of Post-Marketing Surveillance be established for
new food additives, requiring that companies periodically report to the
FDA any new findings that come to its attention bearing on the safety of
each additive, and that companies immediately transmit to the FDA
reports of possible adverse reactions to the additive.

4.  That any food containing any new food additive be required to
indicate, on its label, the amount of the additive present per package
and per serving, as well as that additive's RDA.

5.  That an Advisory Committee be established to recommend to the FDA
standardized tests that can be used to uncover possible effects of
candidate food additives on the nervous system and/or behavior, and that
such testing be required before the additive can be approved for sale.

END.............

More information on aspartame on www.dorway.com  In the last couple of
weeks a new study in Norway has linked aspartame with brain destruction,
especially in the areas of learning.

Betty Martini, Mission Possible International