Bitter Sweetener

The U.S. Food and Drug Administration was under heavy attack last week. In Washington, eleven FDA physicians and other researchers told a Senate subcommittee that they had been harassed, transferred to other projects and sometimes overruled when they recommended against approval of new drugs they had tested. Another devastating blow to the FDA was the publication of the book Eating May Be Hazardous to Your Health (Simon & Schuster; $7.95). It is an expose of the agency by one of its own employees, Biochemist Jacqueline Verrett, who got her doctorate at Fordham University.

In her outspoken book, Verrett charges that the American people are ill protected against both known and suspected harmful effects from the 3,000 to 10,000 food additives, dyes and substitutes now in use. "The FDA'S performance, certainly of late, has been outrageous," she asserts. As she sees the FDA, it is a regulatory agency charged by law to protect the public's health but too much concerned with the interests of big business. It flouts the law by covering up health hazards with evasions, distortions and misstatements.

Danger to Fetuses. Recounting the cyclamate flap that shook the agency in the late 1960s, Verrett notes that as early as 1954 a National Academy of Sciences panel voiced doubts about the safety of the sweetener, which Abbott Laboratories had been authorized to market in 1951. But no further steps were taken by the FDA, and by 1968 a total of 17 million pounds of cyclamate was being consumed annually. Japanese researchers had already reported finding that in some people's bodies cyclamate breaks down in part to cyclohexylamine (CHA), which is known to be dangerous, especially to fetuses and the newborn. Verrett and others who had tested the sweetener had been circulating adverse reports within the FDA. In December 1968, the associate commissioner for science stated that cyclamates "will be removed from the GRAS [Generally Recognized As Safe] list."

By then the scientists had, in effect, been overruled by a bureaucratic device. FDA referred the question of cyclamate safety to the National Academy of Sciences and its working arm, the National Research Council. The prestige of these bodies gives a false aura of objectivity to their findings, says Verrett, because the NRC passes the buck to an advisory panel of "experts," most of whom are partly supported by the industry concerned or institutions that it finances. Such men, says Dr. Verrett, "are sometimes jokingly referred to as 'Hertz Rent-a-Scientists.' "

The committee's idea for regulating cyclamate consumption was remarkably impractical. It recommended labeling foods containing cyclamates to indicate a maximum daily safe dose of 3.5 grams for adults and 1.5 grams for children. How the committee expected cyclamate users to read a fine-print label and calculate their intake in grams, it did not say.

On Oct. 1, 1969, Dr. Verrett announced that she had injected 13,000 incubating eggs with cyclamate and CHA and produced grotesque abnormalities. The defects in the baby chicks included the seal limbs associated with thalidomide; some of the abnormalities, she says, were "actually worse than any I had seen with thalidomide." She reported her research on a national television interview and was promptly and publicly rebuked, even though she had checked with her superiors before going on the air. Largely as a result of the furor that Verrett raised, Robert H. Finch, then Secretary of Health, Education and Welfare, declared that cyclamated "general-purpose foods and beverages" would soon be taken off the market but allowed almost a year's latitude for canned fruits.

Even then, the FDA proposed to sanction continued sale of cyclamates for diabetics and the obese "under medical supervision" on a "nonprescription-drug basis." That action would have circumvented the Delaney Amendment to the food law of 1958, which forbids the use of any food additive or substitute known to cause cancer in animals. "It was," says Dr. Verrett, "the FDA'S greatest moment of low comedy." The agency's own attorneys protested that the scheme was patently illegal. Even so, it took almost a year for another advisory group, which considered "additional evidence"--actually available more than a year earlier--to condemn cyclamates. The questionable sweetener was banned at last on Aug. 27,1970.

Next, Saccharin. The battle is not yet over. The cyclamate lobby is currently pressing other studies in the hope of winning a repeal of the ban. And now the safety of saccharin, which, despite its bitter aftertaste, came back into general use after the cyclamate ban, is also in dispute. Verrett condemns saccharin because it produces deformities in developing chicks; other investigators have found that it causes bladder cancers in mice and rats.*

The trouble with the FDA, says Verrett, is the same as that in all regulatory agencies: too many of its personnel are recruited from the industries it is supposed to control. Furthermore, she says, during the cyclamate episode and others, there was evidence suggesting political dictation from the White House or from the office of the Secretary of Health, Education and Welfare. It will not be surprising if the FDA now moves to defend itself against Dr. Verrett's charges far more swiftly than it ever acted to ban dangerous drugs, dyes, additives or sweeteners.

* The FDA has just approved a new artificial sweetener, aspartame, for use on the table and in many ready-mix products, but not for soft drinks, or foods that have to be cooked. Despite some reservations about its safety, it should be generally available if saccharin is eventually banned.

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