Reappraising Saccharin--and the FDA

Of all the federal agencies regulating business and consumer affairs, none is more regularly or vehemently denounced than the U.S. Food and Drug Administration. Critics have variously blasted it as arbitrary, ill-organized, arrogant, inbred and inept. There is a reason for the scourging: the FDA affects both consumers and manufacturers where they are most sensitive--in the products that they can buy or sell. The agency regulates everything from lipstick to kidney dialysis machines. All told, the FDA activity touches on 200 of every consumer dollar spent. Says an agency public relations man proudly: "The FDA intrudes on your life."

Seldom has that intrusion generated the outrage caused last month when the FDA announced that it planned to ban noncaloric saccharin as a food additive (TIME, March 21). Last week the FDA decided to hedge a little. Newly appointed Commissioner Donald Kennedy announced that the agency will go ahead with the ban, probably by midsummer --but will allow saccharin to be sold, like aspirin, as an over-the-counter drug, at least until the end of the year.

A Touch of Cynicism. Kennedy's ruling was an obvious bit of political backpedaling to escape the explosion of consumer fury caused by the original decree. It was also a somewhat clubfooted end run around the so-called Delaney clause of the 1958 amendments to the Food, Drug and Cosmetic Act, which dictates the banning of any food additives that cause cancer in humans or laboratory animals. In the case of saccharin, some Canadian rats developed bladder cancer when they were fed the sweetener in amounts that would be equivalent, in a human, to 800 cans of diet soda a day throughout his life. The Delaney clause, however, makes no mention of dosage levels. By considering saccharin a drug, the FDA allowed itself to apply less rigid standards: the agency may weigh hazard against benefit in deciding which drugs can be sold. Yet, drugs must be proved "effective," so manufacturers will have until the end of 1977 to demonstrate that saccharin can actually help to control obesity. If they cannot, saccharin will be banned as a drug as well.

The latest ruling may add a further touch of cynicism to attacks against the FDA: If saccharin is unsafe in food, what makes it acceptable in a drugstore? Certainly, the ruling has helped to make some of the criticism more pointed.

Complains Allen Fox, an aide to Senator Edward Kennedy's subcommittee on health resources and scientific research: "There is no accountability in decision making. The FDA must be reorganized internally." Dr. Sidney Wolfe, director of the Ralph Nader-affiliated Public Citizen's Health Research Group in Washington, says of the agency's initial decision to ban saccharin altogether: "The FDA wrote up its intention in one hour and 20 minutes. The furor could have been avoided if they thought of public reaction. They blew it."

Morale at the FDA is frequently bad these days, and senior positions can be hard to fill. Example: Commissioner Kennedy, a biologist, took over last month, a full three months after the resignation of his predecessor, Dr. Alexander Schmidt. In addition, Schmidt had given five months' notice of his intent to leave. Acknowledges Kennedy, who has developed a crash-course understanding of the FDA's problems: "I am learning that the agency does little that is not controversial."

Consumerist Appeal. One reason is the burgeoning scope of the FDA'S activities. The agency's budget has ballooned from $5 million in 1955 to $279 million this year. Its 7,000 employees, half of them scattered through 17 locations around Washington, are charged with regulating a staggering $200 billion worth of goods yearly. Its powers have grown steadily ever since the agency was founded in 1907 under crusading Pure-Food Advocate Harvey Wiley, chief chemist of the Department of Agriculture. In 1938, after 107 people died from use of a sulfanilamide preparation that was supposed to be a cure-all for diseases like strep throat, Congress passed a strengthened Food, Drug and Cosmetic Act, providing the cornerstone for the FDA's current powers to enforce health, purity and labeling regulations.

The FDA's power expanded even further because of the Delaney clause and the lobbying efforts of the late Senator Estes Kefauver. The Senator, an early appreciator of the political appeal of consumerism, pushed through legislation allowing the FDA to ban drugs unless they could be proved effective as well as safe. Thus the agency became involved in preventing possible products from reaching the market, as well as demanding the withdrawal of hazardous ones. Since 1962 the FDA has kept more than 6,500 prescription drugs off the market because their effectiveness could not be demonstrated. The number of over-the-counter products under evaluation has now swelled to 500,000.

Boosters can sum up the agency's merits in one word: thalidomide. In 1961-62, the stubborn skepticism of FDA Pharmacologist Dr. Frances Kelsey kept that tranquilizer from sale in the U.S.--though it was marketed in Europe and Canada, where its use by pregnant women led to the birth of many deformed babies. Critics, however, can cite another name from the same period: MER29. The FDA approved that anticholesterol drug for use, then rescinded the decision when some people who took it developed cataracts.

Value Judgments. Ever since, the FDA has preferred to err on the safe side. In the past few years it has restricted the use of hexachlorophene as a disinfectant and banned chloroform for use in cough medicines and sequential-type (imitative of natural hormone cycles) birth control pills. In 1976 the agency took off the market Red Dye No. 2, the most widely used coloring in food and cosmetics. FDA officials conceded that there was no proof that the dye was unsafe but contended that manufacturers could not prove it was safe--even though the substance had been used for 100 years under the name of amaranth. The decision raised eyebrows but no great storm of disapproval, because substitutes were available. The response to the saccharin ban was different, since in 1969 the FDA banned cyclamates, the only other artificial sweetener that had been widely added to food.

The agency's prohibitions are frequently necessary and beneficial. But the regulatory instincts of the FDA can be timeconsuming, expensive and--as in the case of Red Dye No. 2--not necessarily definitive. The FDA claims that its judgments are strictly scientific, but others disagree. Says Senate Aide Fox: "These are value judgments." Adds North Carolina Republican Congressman Jim Martin: "Many Americans are beginning to get the impression that the chief end of [FDA] regulations and the regulators is harassment." He has already lined up 184 co-signers in Congress for one measure that would help the FDA avoid ruckuses like the saccharin fuss: a loosening of the Delaney clause.

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