Regulation of the Food Additive Aspartame

MWD-76-111: Published: Apr 8, 1976. Publicly Released: Apr 8, 1976.

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The Food and Drug Administration (FDA) published a regulation approving the use of aspartame, an artificial sweetner. Later, questions were raised regarding adverse effects of the additive on health and FDA's legal authority for allowing a food additive regulation to remain in effect when scientific evidence has raised questions about the additive's safety. Before these questions were answered, preliminary results of an agency investigation indicated discrepancies existed in the data submitted in the support of aspartame's safety.

After reviewing all the objections, the Bureau of Foods concluded that the uses of aspartame authorized by regulation were safe, considering a reasonably exaggerated intake by children and adults. The Bureau recognized the differences of opinion between FDA and the objectors which justified a hearing. The regulation approving the use of aspartame was suspended. Aspartame has not been, nor will it be, marketed until all questions about its safety have been answered.

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