Medicine: A Bitter Reaction to an FDA Ban

At the Golden Door, a chic fat farm in Escondido, Calif., Chef Michel Stroot wondered what he would do now to sweeten the evening’s dessert for his chubby clientele. At a Weight Watchers clinic in Manhattan, Michael Fiorentino, 38, a veteran dieter, vowed that he would travel to Europe, if necessary, to replenish his supply. At offices of the American Diabetes Association, telephones rang almost continuously as anxious callers sought advice. In Brooklyn, the Cumberland Packing Corp. suspended production of its product, Sweet ‘n Low, then resumed it to meet suddenly booming demand. On the New York Stock Exchange, the prices of some beverage-company shares temporarily took a dive. At many stores, weight-conscious buyers stripped the shelves bare of their favorite low-calorie products. Insisted Atlanta Banker William Schwartz III: “I’m going out to buy $1,000 worth of Tab. I can’t live without it.”

The nationwide flurry and concern was touched off last week by a Food and Drug Administration announcement that it was taking first steps toward halting sales of saccharin, the only noncaloric artificial sweetener approved for use in foods and beverages in the U.S. since the banning of cyclamates in 1970. Acting FDA Commissioner Sherwin Gardner emphasized that he saw no immediate hazard to public health from the chemical. Thus his agency will not immediately stop the manufacture of products containing saccharin (which account for at least $2 billion annually in sales) or recall those already on the shelves. But, Gardner insisted, “science and law dictate that saccharin be removed from food.”

The FDA’S proposed ban, expected to go into effect in July, is based on a study by the Canadian government’s health-protection laboratory in Ottawa. For three years, researchers fed rats daily doses of saccharin that amounted to 5% of their diet by weight. In the first generation of rodents, seven out of 38 developed bladder tumors, three of them malignant. In the second generation of rats—which had developed in the wombs of saccharin-fed mothers, were nursed on their milk and later given the chemical themselves—twelve out of 44 had tumors; eight of them were malignant. That was enough for the FDA. Two days after a scientific delegation from Washington picked up the results of the tests in Ottawa, the FDA and Canadian authorities announced plans to phase out saccharin.

Large Dosages. Businessmen and scientists joined the public in questioning the validity of those tests. “The FDA has overreacted,” snapped a spokesman for the Calorie Control Council, an Atlanta-based trade group. “The physiology of a rat or mouse isn’t the same as that of a human,” protested William Inman, vice president of Sherwin-Williams Co. of Cleveland, the sole U.S. producer of saccharin, whose output accounts for 65% of the 8 million lbs. consumed yearly by Americans. Researchers pointed to the enormous quantities of saccharin fed the test rats—equivalent to consumption by a human of some 800 cans of diet soda each day over a lifetime. Said Duke University Biochemist Henry Kamin: “The dosages are so large that the result means nothing.” In Albany, N.Y., Dr. Frederick Coulston revealed that his tests on monkeys—much closer to humans than are rats—revealed no harmful effects. Said he: “We gave saccharin to rhesus monkeys over 6½ years—relatively high doses six days a week.” After examining the animals, he said, “we found nothing. They are perfectly normal.”

Though the FDA admitted there was no evidence that saccharin had caused cancer in humans during the 80 years the sweetener has been used in the U.S., the agency had no choice but to seek the ban. Under a 1958 amendment to the Food, Drug and Cosmetics Act, sponsored by former New York Representative James Delaney, any food additive—no matter in what quantities—that causes cancer either in humans or lab animals must be prohibited. The same law may yet be invoked in other bans in the months ahead, though the FDA is clearly not happy with the amendment’s stringent clauses. Said an agency spokesman: “There is a need for public debate on the Delaney amendment. The ability to detect health hazards in 1958 was not as advanced as it is today. Congress has to consider whether that law is still appropriate.”

No Surprise. Whatever the results of legal moves now being considered by both manufacturers and consumer groups against the FDA’S latest action, critics of the ban can hardly claim that they were caught by surprise. Ever since animal tests in the early ’70s renewed concern that the chemical might be a carcinogen, the FDA has been slowly moving toward a ban. By 1972 it had taken the sweetener from its “generally recognized as safe” list and warned food and beverage companies to limit the saccharin levels in their products.

In his announcement, Gardner insisted that the “loss of saccharin will at worst be an inconvenience.” Most diabetes specialists disagreed. They pointed out that many of the estimated 10 million Americans who suffer from diabetes find saccharin absolutely essential to fulfill their craving for sweets. At Boston’s Joslin Diabetes Foundation, callers were urged to write strong letters of protest to their Congressmen. Exclaimed the foundation’s president, Dr. Alexander Marble: “This ban is against common sense!” The American Diabetes Association was so concerned about how to deal with the saccharin crisis that it scheduled an emergency meeting. Said Dr. Donnell Etzwiler of Minneapolis, head of the Diabetes Association: “Taking away low-calorie sweeteners may well be a more serious health threat than this cancer ‘threat.'” Diabetics are not the only ones who may be hurt by the ban. Millions of other Americans are overweight, a condition that can lead to such difficulties as hypertension and cardiovascular disease; without diet foods, their number is likely to swell.

At the very least, the FDA’S action will probably force a sharp change in the eating and drinking habits of many Americans. Such products as diet jams and jellies, sugarless chewing gum and even some familiar toothpaste tastes will have to be drastically altered. Sweet ‘n Low and other sugar substitutes may vanish from the table, forcing dieting coffee and tea drinkers to take their favorite brew straight—or with sugar. Leading soft-drink manufacturers like Coca-Cola and PepsiCo are promising to continue marketing diet drinks, presumably by reducing sugar content of some beverages, resorting to sweeteners like high-fructose corn syrup, and perhaps adding citrus or other flavorings. But some of these newcomers may be richer in calories than saccharin-sweetened brands and may not be as tasty.

Elusive Mechanism. Despite the problems with cyclamates and saccharin, many researchers are optimistic about ultimately finding a safe sugar substitute. But their task is complicated by the subtle and elusive nature of the taste mechanism. Most of the known artificial sweeteners have been discovered accidentally. To make sweeteners to order, scientists will need to learn more about the taste buds. Spread across the tongue, these clusters of cells are sensitive to the four major taste sensations: sweet, sour, bitter and salt. Physiologists believe that parts of the food molecules actually fit loosely into receptors on the cells, somewhat like a key in a lock, thereby sending a signal to the appropriate center in the brain. If the structure of the sites could ever be determined precisely, chemists might be able to fashion matching molecules that produced the desired taste sensations.

Until then, the search for sugar substitutes will continue on a largely hit-or-miss basis. One chemical, called aspartame, was found by G.D. Searle & Co. during research on an ulcer drug. The FDA had approved aspartame’s sale, but stayed that action pending a new look at Searle’s test data. Another contender to succeed saccharin is a chemical called xylitol; used as a chewing-gum sweetener in tests in Finland and the U.S., it sharply reduced formation of cavities. But it costs more than sugar and has the same number of calories.

Another promising prospect was discovered by U.S. Agriculture Department scientists: a supersweet calorie-less substance (a thousand times sweeter than sugar) made from an extract of grapefruit rinds. At the University of Pennsylvania, researchers have isolated powerful protein sweeteners from tropical berries. Yet until such substances are tested, approved and come to market, Americans will have to accommodate to a new reality: that life may quite literally no longer be as sweet.