Q: Is aspartame safe?

A: After reviewing scientific studies, FDA determined in 1981 that aspartame was safe for use in foods. In 1987, the General Accounting Office investigated the process surrounding FDA's approval of aspartame and confirmed the agency had acted properly. However, FDA has continued to review complaints alleging adverse reactions to products containing aspartame. To date, FDA has not determined any consistent pattern of symptoms that can be attributed to the use of aspartame, nor is the agency aware of any recent studies that clearly show safety problems.

Carefully controlled clinical studies show that aspartame is not an allergen. However, certain people with the genetic disease phenylketonuria (PKU), and pregnant women with hyperphenylalanine (high levels of phenylalanine in blood) have a problem with aspartame because they do not effectively metabolize the amino acid phenylalanine, one of aspartame's components. High levels of this amino acid in body fluids can cause brain damage. Therefore, FDA has ruled that all products containing aspartame must include a warning to phenylketonurics that the sweetener contains phenylalanine.
http://www.cfsan.fda.gov/~dms/qa-adf9.html

Deborah Halber, News Office
September 16, 1998

Even daily large doses of the high-intensity sweetener aspartame, also known as NutraSweet, had no adverse effect on study subjects' health and well-being, a visiting scientist at MIT reported in the American Journal of Clinical Nutrition last week.

"We conclude that aspartame is safe for the general population," said Paul A. Spiers, visiting scientist in the Clinical Research Center (CRC).

Mood, aggression and selected cognitive functions were tested during a study in which some of the subjects consumed doses of aspartame nearly 20 times the daily amount taken by the vast majority of the general population.

During a four-month period, subjects received either aspartame, sugar or a placebo and underwent physical and psychological testing. Some subjects were given doses of up to 45 milligrams per kilogram of body weight--the equivalent of 17 to 24 12-ounce diet beverages for males and 14 to 19 12-ounce drinks for females. In the general population, most Americans who consume aspartame take in 3 milligrams per kilogram of body weight a day, the equivalent of one or less 12-ounce diet beverage.

Despite the high consumption of aspartame, the 48 normal subjects showed no changes in mood, memory, behavior, electroencephalograms (which record the electrical signals of the brain) or physiology that could be tied to aspartame, Dr. Spiers found. Although some subjects reported headaches, fatigue, nausea and acne, the same number of incidences were reported by subjects taking placebo and sugar as those taking aspartame.

Dr. Spiers noted that these findings corroborate the results of another recent study with preschool and elementary school children that discovered no effect on their moods, activity levels, behavior or thinking after they consumed high doses of aspartame.

He recommended that if a patient reports any adverse effects from a food product, factors such as the patient's overall diet, nutrition and behavior should be carefully tested in a double-blind challenge. "Only in this way can allegations regarding the safety of any food product be properly evaluated before speculation regarding harmful effects begins," wrote Dr. Spiers and co-authors LuAnn Sabounjian of Interneuron Pharmaceuticals of Lexington; Dr. Allison Reiner of Princeton, NJ; Diane K. Myers and Judith Wurtman of the CRC; and Donald L. Schomer in the neurophysiology department at Beth Israel Deaconess Medical Center and Harvard Medical School.

The study was conducted at MIT's CRC. Electro-encephalograms were done at the Beth Israel-Deaconess Medical Center in Boston. This work was supported by a grant from the NutraSweet Co. to the Center for Brain Sciences and Metabolism Charitable Trust.
http://web.mit.edu/newsoffice/1998/aspartame-0916.html

Aspartame is a methyl ester of a dipeptide used as a synthetic nonnutritive sweetener in over 90 countries worldwide in over 6000 products. The purpose of this investigation was to review the scientific literature on the absorption and metabolism, the current consumption levels worldwide, the toxicology, and recent epidemiological studies on aspartame. Current use levels of aspartame, even by high users in special subgroups, remains well below the U.S. Food and Drug Administration and European Food Safety Authority established acceptable daily intake levels of 50 and 40 mg/kg bw/day, respectively. Consumption of large doses of aspartame in a single bolus dose will have an effect on some biochemical parameters, including plasma amino acid levels and brain neurotransmitter levels. The rise in plasma levels of phenylalanine and aspartic acid following administration of aspartame at doses less than or equal to 50 mg/kg bw do not exceed those observed postprandially. Acute, subacute and chronic toxicity studies with aspartame, and its decomposition products, conducted in mice, rats, hamsters and dogs have consistently found no adverse effect of aspartame with doses up to at least 4000 mg/kg bw/day. Critical review of all carcinogenicity studies conducted on aspartame found no credible evidence that aspartame is carcinogenic. The data from the extensive investigations into the possibility of neurotoxic effects of aspartame, in general, do not support the hypothesis that aspartame in the human diet will affect nervous system function, learning or behavior. Epidemiological studies on aspartame include several case-control studies and one well-conducted prospective epidemiological study with a large cohort, in which the consumption of aspartame was measured. The studies provide no evidence to support an association between aspartame and cancer in any tissue. The weight of existing evidence is that aspartame is safe at current levels of consumption as a nonnutritive sweetener.
http://www.informaworld.com/smpp/conten ... 0701516184

HOW THE BODY HANDLES ASPARTAME

Aspartame is composed of two amino acids, aspartic acid and phenylalanine, as the methyl ester. Amino acids are the building blocks of protein. Aspartic acid and phenylalanine are also found naturally in protein containing foods, including meats, grains and dairy products. Methyl esters are also found naturally in many foods such as fruits and vegetables and their juices.

Upon digestion, aspartame breaks down into three components (aspartic acid, phenylalanine and a small amount of methanol), which are then absorbed into the blood and used in normal body processes. Neither aspartame nor its components accumulates in the body. These components are used in the body in the same ways as when they are also derived from common foods.

Further, the amounts of these components from aspartame are small compared to the amounts from other food sources. For example, a serving of nonfat milk provides about 6 times more phenylalanine and 13 times more aspartic acid compared to an equivalent amount of diet beverage sweetened 100% with aspartame. Likewise, a serving of tomato juice provides about 6 times more methanol compared to an equivalent amount of diet beverage with aspartame.
http://www.caloriecontrol.org/aspartame.html

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