Taking vitamins: the FDA's raids on promoters of dietary supplements seem designed to keep consumers in the dark.

Ken Scott is probably the only felon in America convicted for mailing a magazine article. Scott, the owner of Highland Laboratories, a small vitamin company in rural Oregon, was sending free reprints of newspaper and magazine articles to anyone who requested them. These photocopies touted the medical benefits of the coenzyme Q10, an ingredient in a product made by his company. Warned by a Food and Drug Administration inspector that this constituted "labeling," Mr. Scott countered that he was simply reprinting research. Still, he thought it best not to rile the FDA. So he removed his company's name from the literature and contracted with his daughter's direct-mail business to handle the information packets.

That wasn't good enough. An FDA sting operation led to a 1990 raid on his home and business by eleven armed federal marshals, nine FDA agents, and a horde of local and state police officers. Given the time, money, and risk involved in going to trial, Scott decided to cut a deal; he is now serving five years of probation.

He joins a growing number of manufacturers, physicians, and alternative health-care providers raided by the FDA for making, selling, or distributing information about dietary supplements. While the FDA insists it is only protecting the public from dubious "miracle cures," critics charge the agency with trying to suppress any medicines not found in the prescription-drug industry's pharmacopoeia.

FDA Commissioner David Kessler likes to quote a sign that hangs in an FDA district office: THE WATCHDOG IS BACK, it reads, AND IT HAS TEETH. After taking control of the troubled agency in 1991, Kessler placed a new emphasis on "good, old-fashioned, straightforward enforcement." The number of food prosecutions, injunctions, and seizures rose dramatically.

In the FDA's strabismic eyes, a product must be judged as either a food (in which case it must merely contain what it says it contains, and not be poisonous) or a drug (in which case it must meet tests of efficacy as well). But are dietary supplements drugs? Is a tablet of vitamin C a food, like rice, or a drug, like Prozac? According to the agency, it depends on the manufacturer's intent. "The same product could be a food or a drug," says FDA policy spokesman Mitch Zeller. "If I were to sell bran cereal and say that it cures cancer, then it's a drug."

The 1990 Nutritional Labeling and Education Act requires "significant scientific agreement" for health claims on labels. While Zeller considers the requirement "flexible," critics say it is vague and onerous. When Senator Tom Harkin (D., Iowa) pressed Kessler on the question during congressional hearings last year, the commissioner admitted it was "hard to come up with a precise definition" of "significant scientific agreement."

In its entire history, the FDA has approved health claims for only two dietary supplements: calcium and folic acid. Zeller says the agency is currently evaluating the health merits of beta carotene and fiber. Folic acid barely squeaked by last year, on a 6 to 5 vote by the FDA Advisory Committee. Yet the FDA knew about the benefits of folic acid for almost a dozen years before the committee began considering the issue. And in 1991, two years before the committee acted, the U.S. Centers for Disease Control had recommended that pregnant women take folic acid, estimating that the supplement could prevent about 2,500 birth defects annually.

Censoring Health Claims

"It is almost impossible to get a health claim through the FDA," Senator Orrin Hatch (R., Utah) complained during last year's congressional hearings. In his closing statement, Senator Hatch attacked Dr. Kessler for the agency's stiff-necked approach. "In your testimony, you refer to the importance of allowing consumers to make informed choices about dietary supplements," he said. "But the only information that you would permit these consumers to have is that white and Asian women might take calcium for osteoporosis. While Harvard Hospital releases a study showing that Vitamin E may help prevent heart disease, a manufacturer or retailer could very easily violate the law, as you are interpreting it, for telling its customers about the study. And that does not make any sense to me, and I am sure it does not to you if you really think about it."

FDA censorship is not limited to dietary supplements. Since 1956, for example, medical studies have reported that low doses of aspirin help to prevent heart attacks. Several companies have applied for permission to market a low-dose aspirin with statements on the label to this effect. Sorry, the FDA replied: since it is intended for the treatment or prevention of disease, low-dose aspirin is a "new drug."

Without the FDA's blessing, manufacturers cannot print anything on their labels beyond a list of ingredients. During a 1992 raid on a Houston health-food store, the FDA took more than three hundred different teas and supplements off the shelves. The products included ones with labels that made any sort of health claim ("For Better Vitality," read one bottle) or mentioned a bodily function ("Fat Burner," another label announced).

Such labels were the topic of a 1993 FDA report on health claims the agency deemed unsubstantiated. "The report gives you a flavor of the kinds of claims that are out there," says Zeller. "We're not saying that everything in it is a violation, but everything in it is unsubstantiated."

Senator Hatch blasted the FDA report as "false and misleading," noting that of the 528 products listed, 34 did not exist, 25 were cited more than once, 3 were listed more than once for the same health claim, and 17 had been removed from the marketplace before the report was released. Hatch's staff also found that one of the products was not a dietary supplement but a paperback book.

Watchdogs Off the Chain

While some of the claims listed by the FDA were clearly bogus (several products promised "prevention of AIDS"), others seem plausible. For example, the FDA cites the Life Extension Foundation's claim that vitamin C lowers cholesterol and helps prevent heart disease. William Faloon, president of the foundation, notes that these benefits are documented by rigorous studies reported in respected journals such as Epidemiology.

In 1987 FDA agents raided the Life Extension Foundation's store in Hollywood, Florida. Rather than wait for the store to open at 11 A.M., they battered in the door and began pulling vitamins off the shelves. The most chilling aspect of this raid was the confiscation of more than five thousand copies of the non-profit organization's newsletter. Mr. Faloon says the FDA also harassed the foundation's printer, threatening to seize his presses if they were used to print any more "illegal" newsletters.

As the FDA sees it, such newsletters are a kind of label. "Any printed material becomes a label when the literature is sent to the same people who buy the products," explains Nancy Lord, an attorney who has represented vitamin providers. "If it starts at the same source and goes to the same destination, it's labeling. People have even been arrested for sending books that were available at any bookstore."

Like many critics, Faloon accuses the FDA of coddling prescription-drug manufacturers and persecuting supplement makers. The big drug companies have their own complaints about the FDA, of course, but they have a cozier relationship with the agency, which is increasingly dependent on their fees for its budget. "The big pharmaceutical companies get a polite letter or phone call when there's a problem with their products," he says. "With alternative-medicine businesses, it's a battering ram on the front door. It's a whole different way of enforcing the law." Faloon cites a recent FDA press release concerning the Blood Bank of Alaska in Anchorage. Although inspectors found "numerous deficiencies in its laboratory operations, donor suitability determinations, and record keeping," the blood bank was given 30 days to submit a plan to correct the problems.

Stephen Levine, director of Nutricology, Inc., makes similar charges. "This is all protectionism for the pharmaceutical industry," he says. "They don't want our industry around." Nutricology was also raided by the FDA and told to cease distributing literature to customers. But unlike other FDA victims, Nutricology had a customer base largely consisting of health professionals. When the case went to trial, Levine had no trouble collecting more than 1,300 affidavits in support of his products, most of them from MDs.

Few vitamin manufacturers can afford a costly legal battle with the FDA, however. Levine says his company has spent almost $1 million in lawyer's fees, and other companies report legal bills in the hundreds of thousands of dollars. The government incurs similar costs. Yet in none of these cases is the purity of the product in question; the issue is simply what is printed on a bottle or in a pamphlet. Why squander tax dollars and harass citizens, argue the supplement makers, when there is no threat to the public health?

Former FDA investigator Arthur Evangelista suggests that vitamin companies are easy targets for agents pressured to make busts. "It's a numbers game for funding," he says. "If you couldn't turn out the numbers, they would shut the operation down. There was a quota. If you don't meet your numbers, you don't get promoted. So you get warning letters out, and get embargoes and injunctions against companies. I finally resigned; I thought this was crazy.

"Most of the rank and file have their hearts in the right place, but they're being fed information and being manipulated by Washington or district managers. . . . I can see covert operations and armed raids over someone giving horse steroids to children, but a vitamin company? Come on!"

The reasons for the FDA's choice of targets are often hard to fathom. In 1991, for example, the agency seized two drums of black-currant oil from Traco Laboratories in Champaign, Illinois. The FDA claimed the oil was an unsafe food additive. Denouncing the agency's "Alice in Wonderland approach," a federal judge ruled that the oil was neither unsafe nor a food additive. An appeals court upheld the decision in 1993. Yet less than four months later, the FDA made the same claim in an enforcement report.

Capable of Anything?

Given the FDA's track record, it's easy to believe it would do just about anything. But not all the charges against it are well-founded. Last year, for example, vitamin makers launched a well-orchestrated campaign warning that the FDA was on the verge of banning simple vitamin supplements as unapproved drugs. Stores put up "Stop the FDA" banners and provided stationery and stamps for customers to write angry letters to Congress. But the industry claims were false.

The confusion arose largely because of two actions taken by the FDA on June 15, 1993. One action was to request public comment about the possible health risks posed by a handful of herbs and amino acids. The other was to publish new rules for labeling dietary supplements and herbal remedies. These different issues were melded together in the public mind. The mixup grew into a nationwide legend. Messages still appear on the Internet warning that the FDA intends to snatch multivitamins from our medicine cabinets.

Dr. Kessler appeared on Larry King's radio show last December to counter the misinformation, in the process dispensing some of his own. "People think we're going to take dietary supplements off the store shelves," he told Mr. King. "That's not correct. This debate has nothing to do with access to dietary supplements. It has only to do with what can be on the label." Kessler held up a vitamin bottle and recited the list of illnesses mentioned on the label. King asked him if that meant the product could no longer be sold. "No," Kessler replied. "The product will not be removed from the store. But the label has to change."

In New Mexico, Gene S. Oden was astonished by Kessler's remarks. That label was from a product made by his company, International Nutrition, Inc. But Kessler was reading the old version. Any mention of health conditions had been removed in 1991. And contrary to what Kessler implied, this calcium supplement could not be found in stores; four months earlier, FDA agents and an armed federal marshal had raided Oden's business, seizing the entire stock of vitamins and supplements, along with computers, printers, and checkbooks.

A year later, Mr. Oden remains mystified about the raid. "The FDA inspector had been here every year," he says. "We were never warned that we were doing anything wrong. If they had [found violations], we would have corrected them." As of this writing, the company has not been charged with wrongdoing, although the FDA is holding $1 million in property as evidence.

The search warrants cited "an ongoing criminal investigation into trafficking in misbranded and unproven drugs." During the raid, as agents were carting away drums of vitamin E, beta carotene, and other vitamins and minerals, Oden argued with the FDA agent who had inspected his company all those years. Oden says the agent snapped, "Why don't you go ahead and file for a new-drug application? It's an easy form to fill out."

For Oden and other small manufacturers, that suggestion is a bitter joke. The FDA charges a $150,000 "user fee" per application, a charge that will rise to $233,000 by 1997. And that's just the beginning; there is an annual product and establishment fee of almost $100,000, which also goes up every year. All this for a single health claim. If a company wants to say that its drug is good for other conditions, each additional claim costs $75,000, a surcharge that rises annually. These FDA fees are above and beyond the cost of ushering a drug through clinical trials, which can cost up to $360 million and takes an average of seven years.

So, as a supplement maker, you have three unpalatable choices. You can spend hundreds of millions of dollars on drag trials, then pay hundreds of thousands annually to the FDA. Or you can risk prosecution. Or, of course, you can make no claims and distribute no literature, relying upon word of mouth to publicize the benefits of your product.

Intended or not, this system is an effective mechanism for suppressing public knowledge about dietary supplements. And that can't be healthy.