U.S.
Food and Drug Administration
FDA Consumer magazine
May-June 2002 (FDA response updated December 2004)
Table
of Contents
In the article posted on the FDA Web site, "Sugar Substitutes: Americans Opt for Sweetness and Lite" (November-December 1999 FDA Consumer, www.fda.gov/fdac/features/1999/699_sugar.html), I read this statement: "FDA figures show that most aspartame users only consume about 4 [percent] to 7 percent of the acceptable daily intake the agency has set for the sweetener." Can you tell me what exactly is the established acceptable limit on use of aspartame per day? And what will it do to me if I consume too much?
Barbara Harvey
Foxworth, Miss.
David G. Hattan, Ph.D., senior toxicologist in the FDA's Office of Food Additive Safety, replies:
On the basis of extensive testing in animal and human subjects, the level of daily consumption that is judged to be safe by the FDA is 50 milligrams per kilogram (mg/kg) of body weight per day. At this level, for example, a 150-pound (60-kilogram) person would need to consume almost 16 12-ounce cans of a beverage containing aspartame to reach this level of intake. The FDA estimates that the average consumer ingests only about 4 percent to 7 percent of this amount each day, the larger amount being consumed by heavier users of aspartame or by those with lower body weights. The reason that this relatively small amount of aspartame is ingested is that it is a potent sweetener, about 180 times sweeter than sugar. On a given day, someone might consume more than 50 mg/kg and even then nothing adverse is expected to happen. Intakes of aspartame at even these levels is not expected to cause any problems because it is safe to consume the acceptable daily intake level even if you do it every day for a lifetime. Thus, occasionally consuming above the 50 mg/kg/day level would not be expected to result in any effect.
The FDA considers aspartame to be one of the most thoroughly tested and studied food additives the agency has ever approved. More than 100 toxicological and clinical studies the agency has reviewed confirm that aspartame is safe for the general population. Aspartame does contain phenylalanine, which should be avoided by the small number of people--about 1 in 16,000--who have the hereditary disease phenylketonuria. Pregnant women with high levels of phenylalanine in the blood also may have trouble metabolizing the substance. In addition to including aspartame in the ingredient statement, the FDA requires that any food containing aspartame state on the label that it contains phenylalanine so that consumers can restrict intake or avoid phenylalanine if they wish to.
Table
of Contents | How
to Subscribe |
Back Issues | Editorial
Questions
FDA/Office of Public Affairs