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Like cyclamate, aspartame was discovered accidentally - in 1965 during research for ulcer drugs. Aspartame has been described by FDA and its manufacturer, G.D. Searle & Co., of Skokie, Ill., as one of the most thoroughly tested and studied additives ever approved by the agency.

Searle first sought FDA approval of aspartame in dry foods and as a table-top sweetener in March 1973. FDA approved that petition in July 1974, but challenges over the substance's safety and the validity of the company's data kept aspartame from being marketed. To resolve the safety issues, the contesting parties agreed to put the matter in the hands of a scientific board of inquiry. Before the board could meet, however, FDA had to resolve the challenge to the validity of various studies conducted for Searle. Their validity was affirmed by an outside panel of pathologists in a December 1978 report to FDA.

The board of inquiry held its hearings in early 1980. In a report to FDA the following October, the board concluded that the evidence did not support charges that aspartame consumption posed an increased risk of brain damage that could result in mental retardation or endocrine dysfunction. However, the board did recommend that aspartame's approval be withheld until more long-term animal tests were conducted on the possibility that aspartame might cause brain tumors.

With that, final action on the Searle petition rested with then FDA commissioner Arthur Hull Hayes Jr. On July 24, 1981, Hayes approved the use of aspartame in dry foods. Stating that Searle had "met its burden of proving that aspartame is safe," as required by law, Hayes said that aspartame consumption at even the "maximum projected" levels of daily consumption would "not pose a risk of brain damage resulting in mental retardation, endocrine dysfunction, or both." Hayes also noted that both he and the FDA's Center for Food Safety and Applied Nutrition disagreed with the inquiry board's recommendation for further safety studies on the risk of brain tumors. In effect, Hayes ruled that both he and the center's food experts were satisfied that the data submitted demonstrated the safety of aspartame on that issue, as well. To ensure that public consumption levels of aspartame products remained below what might be considered toxic to humans, the decision required Searle to monitor and report consumption levels to FDA.

Approval of aspartame for use in carbonated beverages followed in July 1983. The following December it also was proposed as an "inactive ingredient" in human drug products. FDA currently is reviewing petitions for other food uses for aspartame.

Foods and beverages containing aspartame are required by FDA to include a warning to individuals suffering from a rare genetic disease called phenylketonuria (PKU). The warning notes that phenylalanine, an amino acid whose intake must be restricted by PKU victims, is present in the product. Phenylalanine is an essential nutrient for humans. However, when it increases to very high levels in body fluids, those who cannot metabolize it normally can suffer brain damage and mental retardation. Those most susceptible to brain damage from PKU are infants, and all states require newborn children to be screened for the disease. A person not born with PKU does not develop it later.

Following the 1983 approval for carbonated beverage use, some scientists and consumer groups charged that aspartame was a health hazard because it broke down and exposed consumers to excessive levels of methanol. At high enough levels, methanol is a poison and can cause blindness. It also is metabolized into formaldehyde, a "known carcinogen," the critics charged. (Some inhalation tests in animals show that formaldehyde produces nasal tumors.)

The critics maintained that decomposition of aspartame could occur - and expose consumers to possibly high levels of methanol and formaldehyde - if a beverage containing the sweetener was stored for long periods at high temperatures. FDA evaluated the charges and concluded "that the levels of methanol resulting from the use of aspartame in carbonated beverages did not pose any safety issues because they were well below levels of exposure expected to produce toxicity." It was also noted that other foods - including juices, fruits and vegetables - exposed consumers to higher amounts of methanol without adverse effects.

Aspartame's widely publicized approval for use in carbonated drinks also was accompanied by an increasing number of complaints from consumers about headaches, dizziness and a wide variety of other symptoms they attributed to consuming aspartame-containing products.

In February of 1984, FDA asked the Centers for Disease Control in Atlanta to evaluate the consumer complaints received by the agency, Searle and others. FDA furnished CDC with the results of interviews conducted by its investigators with 517 of the 592 people who had reported complaints up to mid-April 1984.

After evaluating the complaints, CDC reported in November of 1984 that, although some individuals may have an "unusual sensitivity" to aspartame products, the data obtained "do not provide evidence for the existence of serious, widespread, adverse health consequences attendant to the use of aspartame." Although a wide variety of symptoms were reported, CDC said most were mild and the kind that would be "common to the general populace." Few complainants, the report said, went to a doctor with their symptoms.

CDC noted that investigations of this type are "unlikely to establish any cause-and-effect relationship" between the consumption of aspartame and the occurrence of symptoms. It acknowledged that some segments of the population might be sensitive to the sweetener but this could only be clearly established with additional clinical studies.



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