MIT: Health and Safety Concerns - Testimony before Congress Nov 3, l987.

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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.

"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.