Mad About Vitamins

By Philip Elmer-DeWitt

It has had all the trappings of a media circus. Sissy Spacek showed up at a Beverly Hills, California, press conference urging health-conscious Americans to "start screaming at Congress and the White House." Mariel Hemingway spoke her mind to the New York Times on the issue of pill dosages and potency. Whoopi Goldberg, Randy Travis, Laura Dern and friends sent a videotape to Washington that included a shot of Mel Gibson being dragged from his home in handcuffs, saying "Gee guys, they were only vitamins!" A BATTLE ROYAL JELLY, proclaimed one headline writer. THE FDA'S WAR OF THE ROSE HIPS, wrote another.

But the dispute that has been brewing between the Food and Drug Administration and the vitamin industry for two years -- and which reached Capitol Hill last week -- is more than Hollywood's latest cause celebre. Reports that the FDA was planning to crack down on supplements touched a nerve among the 75 million Americans who take vitamins, minerals and other dietary aids every day -- including large numbers of new-age leftists and right-wing libertarians who may disagree about almost everything else but who share a basic distrust of the government-medical complex. Over the past few months, thousands of letters, postcards, faxes and e-mail messages have poured into congressional offices. Thousands of people have marched in rallies in Los Angeles, Washington and New York, some carrying preprinted signs that say ACT NOW OR KISS YOUR SUPPLEMENTS GOODBYE!

What's the ruckus about? The real issues are as difficult to sort out as the label on a bottle of complex multivitamins. Much of the uproar has been stirred by the Nutritional Health Alliance, a pressure group that accuses the FDA of trying to empty the shelves of the health-food stores and require a doctor's prescription for herbs and amino acids. "They intend to destroy the ; industry," says Gerald Kessler, executive director of NHA and founder of Nature's Plus vitamins. "They want to take 9 out of 10 supplements and call them unsafe food additives or drugs."

Not so, says David Kessler (no relation), the reform-minded FDA Commissioner who has, by and large, earned high marks for his aggressive stewardship of the much maligned agency. The FDA has no problem with 8 out of 10 supplements now on the market, he says. Its chief concern is that any health claim -- that a substance cures impotence, say, or protects against cancer -- be backed up by "significant scientific agreement." Under food-labeling laws passed by Congress three years ago and scheduled to go into effect Dec. 5, products that fail to meet this test will have to be relabeled. The products themselves, however, will not be banned. "The great vitamin ban of 1993 is a hoax," says Bruce Silverglade of the Center for Science in the Public Interest, one of several independent groups that support the FDA. "We need the government to sort fact from fiction."

While Kessler has repeatedly pledged that he has no intention of treating supplements as drugs, vitamin advocates have interpreted several recent actions as signs of a new get-tough policy. They seized on remarks made last year by an FDA deputy commissioner who cited a task-force recommendation that amino acids be regulated as drugs. If that wasn't enough to send industry leaders reaching for their stress tabs, the agency staged raids on medical practitioners and pill makers believed to be violating the law. In one episode, according to the doctor whose clinic was targeted, FDA agents were accompanied by flak-jacketed police shouting, "Freeze! Raid! Raid!"

If the FDA limited itself to protecting consumers from compounds known to pose a clear health risk, as Kessler says he means to, there would probably be nothing to argue about. The FDA points to a list of "natural" preparations that have been associated with injuries or deaths, including contaminated L- tryptophan, implicated in 1,500 cases of a connective-tissue disorder as well as 38 fatalities in 1989.

The labeling issue is harder to resolve. At first it seems perfectly reasonable that a company be prohibited from making any claim it cannot back up. Moreover, the standard by which health claims would be judged is considerably lower than the tough efficacy and safety hurdles that drugs must clear. But scientific agreement is not always easy to achieve, especially in a field as murky as nutrition. "You have five scientists in a room, and if you get two to agree, you're really getting somewhere," says Jeffrey Blumberg, a nutrition professor at Tufts University. Despite exciting new research into the value of vitamins, the FDA has allowed only a handful of health-related claims over the past 50 years. Among them: that calcium protects against osteoporosis and that folic acid taken by pregnant women can prevent neural- tube defects in their babies, a claim that was accepted by the government only three weeks ago, years after it was first reported. Many studies suggest that a class of compounds called antioxidants, including vitamins C and E and beta carotene, may help ward off cancer and heart disease, but the possible benefit has not yet been proved to FDA's satisfaction.

The vitamin industry is not defenseless. Not only does it have a sizable war chest (the industry grossed $4 billion last year) and loyal customers, it also has an influential friend in Washington: Senator Orrin Hatch. His home state of Utah has an important stake in the industry, and he himself owns 1% of a company that distributes vitamin C and iron supplements -- an apparent conflict of interest. (Hatch denies that anything is improper, saying that the company deals mainly in real estate.) He has latched onto the vitamin issue, speaking out against Kessler at every turn. In April he introduced legislation that would permanently exempt herbs, vitamins, minerals and amino acids from most FDA controls. The bill has more than 50 Senate co-signers, and nearly 200 Representatives have backed a companion measure in the House.

Though congressional support for the legislation is broad, it may not be deep. Senate minority leader Robert Dole, a cosignatory, has let it be known that he would vote against the bill in its present sweeping form. Even FDA critics concede that Hatch's proposal gives the industry too much freedom to make whatever health claims it likes. Moreover, it puts the entire burden of proof on the FDA, instead of on the manufacturer, where it belongs.

But compromise was in the air at congressional hearings last week, as Senators mugged for the cameras and traded contraband bottles of Happy Camper and Manhood Plus. Even Hatch was in a forgiving mood, conceding that his bill "may not adequately address the safety issue" and admitting that "the language is not drawn tightly enough to prevent false and misleading claims." ^ Insiders say congressional leaders are working on revised bills that would ensure easy access to vitamins but support strict policing of labels for fraudulent claims, giving protesters and the Hollywood crowd what they want while providing the FDA and consumers with what they need.

With reporting by Janice M. Horowitz/New York and Kristen Lippert-Martin and Dick Thompson/Washington