At last summer's Olympic games in Sydney, Australia, Norwegian wrestler Fritz Aanes suffered two heartbreaks: He lost the bronze medal, and then he was banned from competing internationally for two years, after testing positive for the potent anabolic steroid nandrolone. Although he couldn't do much about losing his medal, Aanes protested vehemently about his drug test, arguing that he had not taken steroids. The problem, he claimed, stemmed from another source: mislabeled dietary supplements manufactured in Utah.
Aanes made a compelling case. Nandrolone had been banned since 1975, and because it was easily detected for up to a year after only one injection, it had largely disappeared from pro sports. Athletes really bent on cheating had much better (and harder to detect) drugs to choose from. Later, a lab in Cologne, Germany, confirmed that there were trace amounts of nandrolone in Aanes's Utah supplement that weren't listed on the label.
Aanes wasn't the first athlete to blame tainted American dietary supplements for a positive drug test. Three others headed for or competing in the 2000 Olympics also tested positive just for nandrolone. And the International Olympic Committee (IOC) had been getting reports about the possible supplement-steroid link since 1999, when more than 350 athletes competing around the world tested positive for the curiously pervasive compound.
Researchers suspected that not only were dietary supplements being mislabeled, but many of the U.S.-produced supplements called pro-hormones actually behaved like steroids, even though they were legally sold over the counter. The surge in positive tests for nandrolone also coincided with the spike in pro-hormone use after St. Louis Cardinals slugger Mark McGwire admitted to using androstenedione---or "andro"---while chasing the single-season home-run record in 1998. (Banned by the IOC, andro is a steroid that the body converts to both testosterone and estrogen.)
After the controversy in Sydney, the IOC warned athletes to avoid American supplements, particularly those manufactured in Utah, the "Cellulose Valley" of the U.S. supplement industry. The IOC also blasted the U.S. for poorly regulating supplement producers and asked then-White House drug czar Gen. Barry McCaffrey to review the Dietary Supplement and Health Education Act (DSHEA), which had deregulated the U.S. supplement industry in 1994.
Then Olympic officials, increasingly frustrated with the U.S. response to their concerns, went one step further and blamed the surge in nandrolone tests on a single U.S. senator: Orrin Hatch (R-Ut.). Hatch was the chief architect and sponsor of DSHEA, which among other things, prompted supplement makers to flood the market with vitamins, herbal remedies, amino acids, and other "natural products" like andro without any federal safety or purity guarantees. "[Hatch] is directly implicated in this affair," said Prince Alexandre de Merode, chairman of the IOC medical commission.
The IOC criticism was particularly biting given that Hatch's home state will be hosting the next winter games in 2002, and that one of the games' major sponsors is, in fact, a supplement company. Utah had already produced a major Olympics bribery scandal; all it needed was a reputation as the world's steroid capital just as the IOC was arriving with its drug-test lab.
So Hatch fired back at the IOC, saying that athletes could not blame their bad drug tests on him, or on the supplement industry, which he claimed was properly regulated in the U.S. "I am tired of this childish finger-pointing," Hatch said. "The last time I checked, neither the prince nor the athletes were experts in food and drug law."
The pressure from the IOC didn't seem to faze Hatch, who reiterated his belief in personal responsibility and the right of consumers to care for themselves using supplements. Gen. McCaffrey, though, did get the Drug Enforcement Agency (DEA) to study the possibility of declaring andro a controlled substance much like narcotics and anabolic steroids. The move prompted a group of pro-hormone makers to pay a lobbying visit to Hatch's Washington office to express their concerns. The group represented a rather unusual constituency for the well-respected senior senator, a pious Mormon drug warrior who abstains from tobacco, coffee, and booze and makes Christian music CDs in his spare time.
Among the visitors were representatives from Weider Nutrition International, a leading pro-hormone producer in Utah which last year was fined $400,000 by the Federal Trade Commission (FTC) for making false claims about some of its weight-loss products. Another was body-building guru, chemist, and supplement maker Pat Arnold, the "father" of pro-hormones.
Hatch's office apparently reassured them that the senator would continue to defend their interests. Arnold later posted a report on Anabolicextreme.com about his visit, writing, "Hatch's assistants informed us of the pressure they were getting from the IOC representatives (a bunch of arrogant princes and ambassadors) to do something about the terrible andro and the unfair advantage it gives people and abuse by kids (and other silly crap). The IOC is very angry at Hatch because of his role in making supplements like andro and creatine (which they consider evil) freely available in this country. Hatch, of course, realizes how ridiculous they are."
Hatch was unavailable for comment, but he has been unapologetic in his support for the supplement industry, having battled the FDA and other federal agencies over the regulation of vitamins, herbals, and other natural medicines for more than a decade. He believes the government has no more right to restrict Americans' access to vitamin A or the herbal ma huang than to McDonald's french fries. Hatch considers his 1994 law, DSHEA, a triumph on behalf of consumer health freedom. But a close look suggests that if anything, DSHEA (or the Hatch Act, as body builders call it) has left Americans "free" to serve as guinea pigs for a multibillion-dollar industry, much of which is built on a foundation of fraudulent claims, pyramid schemes, and lousy manufacturing practices.
Since DSHEA became law, substances as varied as paint stripper, bat shit, toad venom, and lamb placenta have all been imported from overseas, bottled up---often by people with no scientific or health backgrounds---and marketed as dietary supplements to unsuspecting American consumers. Many supplements have been tainted with salmonella, arsenic, lead, pesticides, unapproved foreign prescription drugs, as well as garden-variety carcinogens. And despite their New-Age health aura, a significant portion of these "natural supplements" are stimulants, depressants, and other mood-enhancers that some medical experts believe would be classified as drugs if they were synthetic. A surprising number of these products are addictive.
Thanks to Hatch, the U.S. now has standards as low as those in many Third World countries for the sale of many products with serious, pharmacological effects. The results have been deadly. Between 1993 and 1998, the FDA linked at least 184 deaths to dietary supplements, which are now suspected of contributing to the sudden deaths of three football players in August.
Yet Hatch---as one of the Senate's most powerful Republicans who is often touted as a possibe Supreme Court justice---has resisted attempts to clean up the supplement market. There's big money in dietary supplements, and Hatch has taken his fair share in campaign contributions. But his support for the industry goes well beyond simple campaign-finance issues. Hatch is part of a deeply committed segment of the American public that believes in the right to use alternative medicine and nutritional supplements with a religious fervor.
"He is by far our greatest advocate. No one rises to the issue the way Sen. Hatch does," says Loren Israelson, executive director of the Utah Natural Products Alliance, which represents the Utah supplement industry. "He's a true believer in natural health."
Opiate of the Masses
Back in 1905, reporter Samuel Hopkins Adams wrote a famous series of stories in Colliers' magazine called "The Great American Fraud," which documented the deaths of hundreds of people from over-the-counter medicines that were peddled with promises to address "weak manhood," "lost vitality," or to give consumers "better blood." Patent medicines were widely available and promoted in the press with testimonials from people claiming to have achieved great results from these magic offerings.
Many of the products were little more than alcohol, addictive opiates, and stimulants, which made for reliable return customers. And their labels rarely revealed the products' real ingredients. Adams exposed how some headache powders, for instance, often sold by door-to-door salesmen, actually contained high levels of acetanilide, a toxic and addictive painkiller that caused heart attacks and kidney disease.
Adams' stories prompted Congress to buck well-funded lobbyists and pass the first Pure Food and Drugs Act in 1906, which prohibits interstate commerce in mislabeled or adulterated foods or drugs, and laid the groundwork for the current Food and Drug Administration (FDA).
That law, along with several others a few years later, helped curb the sale of worthless and dangerous health products. But in the late 1980s, a new wave of dubious products marketed with specious health claims began flooding the market as aging baby-boomers revived interest in alternative medicine. In 1989, a batch of the amino acid L-tryptophan, touted as a remedy for sleeping problems, anxiety, and PMS, caused 1,500 cases of a connective-tissue disorder. Thirty-eight people died.
The incident prompted the FDA to scrutinize the industry, and two years later, an FDA task force recommended halting over-the-counter sales of such amino acids as L-tryptophan and other supplements with therapeutic qualities. The task force also recommended limiting the dosages of vitamins and minerals, many of which are toxic in high doses. (Sixteen children died in 1991 from iron-supplement poisoning.) And the FDA asked Congress for the power to pre-approve any health claims made by manufacturers before they could market a product, and to increase the fines and penalties for violating the laws.
Not surprisingly, the supplement industry went nuts and called upon its clean-living friend to help fight back. Hatch was happy to oblige. In 1992, he passed a one-year moratorium on new supplement regulations. Meanwhile, the industry enlisted Hollywood and Christian broadcasters in a successful campaign to convince consumers that the government wanted to take their vitamins away.
With enormous public support, in 1993, Hatch introduced DSHEA and pushed the act through the Labor and Human Resources Committee on a 12-5 vote, overruling objections from his friend from Massachusetts, Edward Kennedy. Railing against the FDA from the Senate floor, Hatch declared that the agency had "repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors."
In defending DSHEA, Hatch reasoned that foods such as raw beef, seafood, and even peanut butter can be potentially dangerous, but that their risks are presumed small enough, and the consumer smart enough, that the government allows their sale unfettered. Supplements, Hatch argued, are no different. In fact, supplements such as folic acid can prevent birth defects when taken by pregnant women. If the government regulated folic acid like drugs, think how many children could be needlessly disabled!
Yet supplements, unlike food, are marketed like medicine and used like medicine by consumers. When they work (which they often do not), supplements can have serious side effects. The FDA has warned, in fact, that many popular herbal remedies, such as comfrey and chaparral, are highly toxic.
Beef may be dangerous if contaminated with bacteria, but it's not legal to sell bacteria-laden beef. And if a meat company is caught doing so, the U.S. Department of Agriculture is empowered to shut down the plant in one day. The law Hatch was proposing would force the FDA to spend years in court before it could respond to a public health crisis and pull a dangerous supplement from the market.
Consequently, the FDA did not participate in the debates over DSHEA, believing that the law was so bad it would never pass. But according to Israelson, DSHEA generated more mail to Congress than the Vietnam War. With help from Sen. Tom Harkin (D-Iowa), an alternative-medicine proponent who believes bee pollen cured his allergies, Hatch sneaked the bill through Congress in a late-night session. "I do not understand how a single member of Congress voted for it," says Larry Sasich, a pharmacist and researcher at Public Citizen's Health Research Group.
Thanks to Hatch's law, the supplement industry has grown 80 percent since 1994---and so, it seems, have its health claims. Reminiscent of Samuel H. Adams' day, health-food stores and Web sites tout such things as "horny goat weed," promised to increase male potency; valerian root and melatonin to aid sleeping; aloe vera juice designed to "support colon health"; and endless tonics, pills, and powders touting enhanced energy and well being. But just as with the turn-of-the-century patent medicines, few of these products have much science behind their claims, according to consumer advocates.
And, like Adams' headache powders, the most popular supplements today are largely products that affect the central nervous system. More than 50 percent of the nation's best-selling dietary supplements are products such as valerian, an herbal sleep-aid and anti-anxiety remedy; kava, another sedative that can so impair people's judgment that Hatch's home state passed a law banning driving under its influence; St. John's Wort, touted as herbal Prozac; and ephedra, a weight-loss aid and "energy booster" that can be easily converted into methamphetamine, its close relative.
Like their synthetic counterparts, some of these so-called dietary supplements are addictive, including valerian, which can have significant withdrawal effects; guarana (which is mostly caffeine); and, especially, ephedra. And far from being harmless alternatives to pharmaceuticals, these compounds can have some serious side effects. Between 1994 and 2000, the FDA implicated ephedra in at least 80 deaths and 1,400 cases of serious illness, including arrhythmia, hypertension, heart attacks, seizures, and strokes.
The reason for the new plethora of supplements is that Hatch's "health-freedom" law turned regulation on its head. Despite their sometimes-potent pharmacological effects, dietary supplements are now classified as foods and are presumed to be safe unless the government can prove otherwise. Drugs, on the other hand, must be proven safe by the manufacturers before going on the market.
At the same time, DSHEA also broadened the ability of the supplement industry to make medical claims and expanded what could be marketed as supplements to include amino acids, metabolites, herbs, minerals, and botanicals. "The law is a terribly flawed law. If you grind up organs, they could be supplements. Anything can be a dietary supplement," says Dr. David Roll, a professor at the University of Utah College of Pharmacy.
DSHEA created a Monty Python-esque distinction between drugs and supplements by essentially defining both by what the manufacturer says about the product. Let's say, for instance, that Herbalife markets one of its ephedra products as a legal speed. In that case, the FDA can pull it off the market as an unapproved drug. But if Herbalife instead markets the very same product as a weight-loss aid, voila! It's a supplement, and there's virtually nothing the FDA can do to keep kids from buying it in buckets---to stay thin, of course.
Pyramids in the Desert
To understand how a teetotalling drug-warrior like Hatch became the biggest defender of the supplement industry's right to freely sell natural speed and other dubious products, it's useful to go back to his home state of Utah, whose $2.1-billion share nationwide accounts for about a fifth of America's supplement business.
Loren Israelson of the Utah Natural Products Alliance says there is a cultural affirmation of using herbs for medicine in Utah that helped give rise to the industry. Hatch, like 70 percent of his state's citizens, is a member of the Church of Jesus Christ of Latter-day Saints, and Israelson says that some believe Mormon scriptures encourage, and perhaps even mandate, the use of herbs as "God's medicine."
The belief in alternative medicine also has long sectarian roots intertwined with a Western libertarian political bent widespread in Utah. Utah Mormons tend to be intensely self-reliant people who would prefer that the federal government simply leave them---and their supplements---alone.
Orrin Hatch hails from this tradition. It informs his politics, and also seems to drive his own belief in the power of alternative medicine. Hatch, 67, who first came to Congress in 1977, works out for an hour every morning and consumes daily vitamin packs, urging his staff to follow suit. Hatch's supplement consumption goes well back to his youth, when he peddled vitamins for pocket money.
Not surprisingly, he has very close ties to the industry. His former chief of staff, Thomas Parry, is now a lobbyist for Utah's supplement industry, and even hired one of Hatch's sons in 1992 as a research assistant. Hatch's 2000 reelection campaign was managed by another former chief of staff, Kevin McGuiness, now a dietary-supplements lobbyist. Hatch also owns a small amount of stock in a small Utah vitamin company.
Close ties between members of Congress and the industries they oversee are pretty common. But the supplement industry's relationship with the squeaky-clean Hatch seems unlikely at first glance, given that a sizeable portion of the industry has a well-documented history of fraud that goes beyond the usual corporate shenanigans.
Fraud is something of a cottage industry in Utah, a state the FBI once dubbed the con-artist's paradise. A combination of trusting Mormon residents and a religious susceptibility to get-rich-quick schemes has made Utah a playground for Ponzi schemers and penny-stock swindlers (a few of whom Hatch represented as a young lawyer). Utah's most famous con-artist is the Mormon murderer, Mark Hoffman, who in 1985 killed two people in attempts to cover up his sales of forged historic documents to the highest officials of the LDS church.
Utah's hospitality to scammers has made it welcome territory for the supplement industry, particularly companies that sell their products through multilevel marketing, a technique resembling an old-fashioned pyramid scheme. Almost half (roughly 40) of Utah's supplement companies market their products not in stores, but through independent distributors who purchase expensive "kits" to set up their own door-to-door-style sales campaigns. These companies are responsible for many of those "Work at home" signs on telephone poles promising callers that they can make thousands of dollars, or the station wagons with bumper stickers that say "Lose weight now. Ask me how."
Consumer advocates consider multilevel-marketing companies something of a nuisance because many of them have been known to lie about the benefits of their products, and because they often prey on the working class with promises of quick fortunes. (A Connecticut lawsuit against the Utah firm Nu Skin found that rather than getting $5,000 to $10,000 a month as promised, 98 percent of all Nu Skin distributors earned an average of $38 a month.)
Some of Utah's biggest companies are repeat offenders. Take Nu Skin, which claims $1 billion in annual sales, and which has been one of Hatch's biggest campaign donors. In 1997, Nu Skin agreed to pay a $1.5 million fine to settle charges with the FTC for violating a 1994 consent order that required Nu Skin to back up product claims with reliable scientific evidence. In California, distributors brought a class action against Nu Skin alleging that it was operating a pyramid scheme and had bilked some 100,000 distributors out of $75 million. Nu Skin settled for an undisclosed amount.
Nu Skin is hardly alone. The supplement industry is full of companies that have run afoul of federal and state regulators, including other big Hatch donors such as Herbalife, Rexall Sundown, and Sunrider.
Given the industry's track record, no one, especially Hatch, should have been surprised that supplement makers quickly went to work exploiting the regulatory weaknesses created by DSHEA.
In one case, a Utah company called Pharmanex (now a subsidiary of Nu Skin and a sponsor of the Utah Winter Olympics) began selling Cholestin, a supplement made with Chinese red yeast rice touted for its alleged benefits in lowering cholesterol. It didn't take long for Merck, the pharmaceutical giant, to figure out that Pharmanex was essentially selling a natural version of its prescription drug Mevacor.
Merck, which had invested millions bringing its drug to market, pressured the FDA to act. Aside from its own financial self-interest, Merck could make a compelling case: Mevacor was a prescription drug because its dosage levels and benefits had to be weighed against its risks, which include liver damage and kidney failure---problems for which users need monitoring by a doctor. (A similar drug was just pulled off the market after being linked to 31 deaths.) If Cholestin had the same ingredient, it likely had the same potential for side effects.
So in 1998, the FDA banned Pharmanex from importing red yeast rice. But U.S. District Court Judge Dale Kimball (who was appointed under Hatch's advocacy a year earlier) blocked the import ban on the grounds that Cholestin was "intended to supplement the diet," and that "Congress enacted DSHEA in recognition of the valuable role played by dietary supplements in improving health, preventing disease, and reducing health-care costs." The decision was eventually overturned, but the case showed how long it could take for the FDA to get a supplement off the market.
The Pharmanex case also suggested the possibilities available to crafty supplement makers to legally market "natural" versions of all sorts of drugs, including illicit ones. Most troubling has been the explosion in pro-hormones, a trend started with a muscle-building supplement, DHEA, a steroid hormone and chemical cousin of testosterone and estrogen. The FDA had actually banned DHEA in the '80s, but it was reclassified as a dietary supplement in 1994 under Hatch's new law, and its sales took off.
Manufacturers claimed DHEA was a magic potion that would improve the sex drive, reduce heart disease, and help the immune system. Few of the claims had been proven with solid scientific research, but researchers had found some interesting side effects. Like a lot of hormones, DHEA mixes up the endocrine system and is suspected of causing, among other things, facial-hair growth in women and breast development in men, and accelerated prostate tumor growth. Other suspected side effects are heart-rhythm disturbances, acne, scalp hair loss, and menstrual irregularities.
Nonetheless, DHEA's commercial success prompted supplement makers to come up with other legal hormone supplements like andro that, once in the body, can easily convert to testosterone, the coveted elixir of performance athletes. The medical community has warned that andro, like illegal steroids, could have dangerous side effects ranging from liver cancer to heart disease to impaired testicular function.
Dr. Gary Wadler, a professor of medicine at New York University and a member of the World Anti-Doping Federation, says there's not much difference between the steroids and pro-hormones. "Ingest a supplement and urinate a controlled substance," says Wadler. "The laws are inconsistent with physiology."
Yet andro's success drove supplement makers to even more complex chemical experiments. Hot on its heels came norandrostenedione-19, which is actually marketed as a legal version of the injectable steroid nandrolone, the same drug that turned up in the athletes in Sydney. The latest development is Andro 9, a product that makes a real mockery of the term "dietary supplement."
Andro 9 is andro spiked with an herbal called tribulus terrestris, which essentially overrides the pituitary gland in regulating the body's production of testosterone. Bodybuilders love andro 9 because regular steroids prompt the testicles to stop producing testosterone, creating the dreaded "shrinking your grapes to raisins" effect. Tribulus terrestris instructs the testicles to keep pumping. When added to andro, the herbal wildly increases the body's supply of testosterone.
Yet in the '80s, tribulus terrestris was shown to cause a neurodegenerative condition in sheep called staggering disease, not to mention liver damage and much else. There are no data as yet on what it does to humans, but as Wadler observes, do you really need to know more, given what it does to sheep? "If tribulus terrestris was a cure for cancer, I could never get it through the FDA [because of the side effects]. Put it in a supplement and nobody looks at it," he says.
Hatch has expressed concerns that pro-hormones are being marketed to kids. But rather than authorize the FDA to take more action, his solution has been to let the DEA deal with it. Because there is very little clinical data on andro (supplement manufacturers aren't required to do any testing before they sell their stuff the way drug companies are), the DEA is now spending taxpayer money to conduct studies to prove whether or not andro causes muscle growth in lab animals. If it does, as most people suspect it will, the DEA will classify andro as a controlled substance along with other anabolic steroids.
That process has already taken months, and could drag on much longer. In the meantime, millions of Americans, including children, will be free to take the stuff, and the athletes who are in Salt Lake City next winter will likely find bottles of pro-hormones beckoning from store shelves.
A Lamb Placenta A Day
Not only have supplement companies unleashed potentially dangerous new products on the public, but like Sam Adams' patent medicines, today's supplements have become a grab bag of ingredients that may or may not work the way they are supposed to, and may or may not actually contain the ingredients listed on the bottles, leaving consumers to play Russian roulette with their health. "In terms of regulations and how we approach dietary supplements, we have a Third World approach," says Dr. Richard Ko, a supplement expert with the California Health Department.
In January, a diabetic San Francisco woman was hospitalized with life-threatening low blood sugar after taking an herbal supplement called Anso Comfort. Ads in local Asian newspapers had touted Anso Comfort as a remedy and even a substitute for prescription drugs for a wide variety of ailments, including high blood pressure and high cholesterol. Tests by the California Health Department found that the "herbal" actually contained the prescription drug Librium, an addictive tranquilizer long known to be contraindicated with the woman's diabetes medications.
It wasn't the first time a potent prescription drug has turned up in a dietary supplement in recent years. Since 1994, even prescription drugs that the FDA pulled off the market decades ago are popping up again in dietary supplements. For instance, one supplement marketed for treating attention-deficit disorder in children contains dimethylaminoethanol bitartrate, a drug developed in the 1950s and sold as a prescription until the FDA forced it off the market in 1983 because it didn't work.
Last year, the California Health Department (one of the few government agencies that regularly tests supplements) found supplements that contained the diabetes drugs glyburide and phenformin. The FDA pulled phenformin off the shelves in the 1970s because it had toxic side effects.
Part of the reason so many drugs end up in supplements is that herbals in other countries are regulated as pharmaceuticals. For instance, in China, it's legal to mix herbals with pharmaceuticals because they are identically regulated. But this same "natural Chinese medicine" is imported to the U.S. as a dietary supplement. Ko explains, "There are a lot of people who are bypassing the [FDA approval] process by declaring [foreign drugs] a dietary supplement."
To sell an over-the-counter or prescription drug, manufacturers must document their manufacturing process and are regularly inspected by state and federal regulators. Of course, their products must be approved first, passing rigorous safety and efficacy requirements that can take up to 10 years and half a billion dollars for a new drug. Before foreign drug manufacturers can sell their products in the United States, they also have to pay for FDA inspectors to check out their plants to make sure they meet the U.S.'s high standards. Even with all this, problems still happen.
The requirements for selling dietary supplements might be comic if the results weren't so potentially dangerous. While supplements sold here are technically manufactured in the United States, the raw ingredients come mostly from overseas. But there is absolutely no requirement that the manufacturer actually test those ingredients for safety and purity before selling them. Even more troubling, any yahoo can legally make a supplement. Many novices have been drawn into the supplement industry by the promise of high profit margins. The company that sold Anso Comfort was run by a guy fresh out of business school who ran a small Asian importing company and had no health or science background, according to Ko.
The FDA attempts to scrutinize supplement ingredients when they're imported, but it has few resources to do the job. According to the FDA, last year there were 65,602 line entries for dietary supplement imports. Of those, inspectors detained 1,239, and of those detained shipments, 413 were refused entry to the country---not even 1 percent of all imported products
But just looking at what inspectors do catch will make you think twice about gulping the supplements in your medicine cabinet. FDA supplement detention reports have included rotting shark cartilage, filthy herbal extracts, plantain leaves containing the heart drug digitalis, lamb placenta, salmonella-contaminated mullen leaves, poisonous clematis erecta dry leaves and twigs, vitamins and supplements from unsanitary manufacturing plants, a host of unapproved prescription drugs, products with false claims on the labels, products with no English labels, no directions for their use, completely bogus labels, labels that didn't identify the manufacturer, and lots of labels that didn't match the product.
Not much stands between the rotting shark cartilage and the consumer's stomach. No one is required to make sure that your valerian isn't loaded with Valium from a fetid processing plant in Guangzhou. "People will say FDA has adequate controls [under DSHEA], but you can make a lot of money before anyone knows what you're selling," says the University of Utah's Roll.
Hatch has maintained that manufacturers are breaking the law if their product labels don't match the contents of the bottle, and that they can be prosecuted for selling dangerous products. A Hatch staffer says: "The FDA has full authority to take products off the market. They have never used that authority. The senator believes they should use it."
Indeed, few if any supplement makers have been prosecuted for mislabeling offenses under DSHEA. And for good reason. As NYU's Wadler explains, the way the law is written, "you would [practically] have to have the FDA go in bottle by bottle to see whether what's in the bottle matches what's in the label. And then they would have to go to court over [each one]."
Hatch's threats of FDA prosecutions sure aren't putting the fear of God into the supplement industry. When researchers have done random testing of supplements, they've found a disturbing number of label/content mismatches. Two years ago, the California Health Department tested more than 250 herbal products from retail stores in the state and found that 32 percent were adulterated with undeclared pharmaceuticals and/or heavy metals.
Last year, Consumerlab.com tested 25 echinacea products to see whether the ingredients matched the labels. Six of the 25 didn't have enough information on the label to even take the test. Of those remaining, only 56 percent passed muster, and one that didn't was contaminated with high levels of illness-inducing microbial bacteria, a sign that the product had been rotting before it was processed.
Other studies have found similar results, making the odds of getting a high-quality dietary supplement in a health-food store akin to getting high-quality coke from your local drug dealer.
The quality issue has even started to concern the supplement industry, and some of the better manufacturers are showing some willingness to bend on their opposition to regulation. After much bad press this past year about the potential dangers of supplements, their sales have stagnated, after experiencing 15-to-18 percent annual growth over the past five or six years. As a result, Hatch has been pushing FDA to issue a set of Good Manufacturing Practices regulations as mandated in the 1994 law. Once these rules are adopted, says one Hatch staffer, the quality of supplements should improve markedly: "Some of these products are fringe products and should be policed."
Yet in practice, since the advent of DSHEA, the FDA has had very little power to do what Hatch has suggested. As former FDA Director David Kessler wrote in The New England Journal of Medicine last year, "Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred."
Even if the FDA had more power, it still has virtually no budget for monitoring the multibillion-dollar supplement industry, according to an agency official. When Hatch's law shifted the burden for safe products onto the government, it didn't provide the FDA with any additional funds. Last year, the FDA asked for $2.5 million to beef up its adverse reaction monitoring system. Congress turned it down. The FDA's annual budget for monitoring dietary supplements is only about $6 million, its smallest program.
That's not much considering that just finding the supplement manufacturers sometimes can be a huge job; the law doesn't require supplement manufacturers to register with FDA the way drug companies must. In one case, according to a GAO report, the FDA received two reports of comas associated with a supplement, but when field inspectors tried to track down the manufacturer, they found a shuttered post office box.
Nor are supplement companies required to tell anybody when they discover problems with their products. There's evidence that they're hiding quite a few. Depositions in a lawsuit in San Francisco against E'ola---a Utah multilevel-marketing firm---after the death of a woman linked to an ephedra product revealed that the company had received 3,500 customer complaints about one of its ephedra weight-loss products. None of the complaints was ever disclosed to the FDA, according to the San Francisco Chronicle.
The FDA has estimated that it is notified of fewer than 1 percent of all the adverse events associated with supplements, and that fewer than 10 of those reports came from manufacturers.
Without better data, FDA is hard-pressed to prove that a given product is dangerous enough to justify a court order pulling it from the shelves---especially after DSHEA deprived it of the special deference government regulatory agencies usually get when they go to court, says Public Citizen's Larry Sasich. Now, in supplement enforcement cases, instead of treating the FDA as an expert, judges must consider it no different from any street chemist.
Even when the FDA simply attempted to limit the allowable dosages of ephedra, Hatch and the supplement industry argued successfully that the FDA's data on the adverse reactions was not sufficient to merit the regulation.
To his credit, Hatch is working toward giving the FDA more resources and has gotten $2 million in additional funds to beef up the adverse-event reporting system, according to his staff. But even if the FDA could prove something like ephedra is dangerous, it would have to go after every single manufacturer individually, because DSHEA does not allow the agency to target a specific ingredient, only a product.
The problem is apparent in the FDA's attempts to get a potent thyroid drug off the supplement market. In November 1999, the FDA issued a warning against taking Utah-made weight-loss products containing tiratricol, a French prescription diet drug that has been linked to heart attacks and strokes. The agency also asked the manufacturer to voluntarily recall the product, which sent some muscle-bound meatheads into a panic. But the online magazine Testosterone assured readers that "cutting-edge" supplement manufacturers were already planning to market different thyroid analogs similar to tiratricol. Those supplements would be "naturally occurring," and "therefore protected under the DSHEA," wrote Testosterone.
The meatheads needn't have worried. Two years after the first recall, products containing tiratricol were still on the market, and the FDA had to undertake not one, but three more recalls up through September 2000.
By contrast, late last year, when a new study showed definitively that phenylpropanolamine (PPA), a common ingredient in cold remedies and over-the-counter weight-loss products (and a chemical cousin to ephedra), slightly raised the risk of stroke in women, the FDA swept into action to remove it from the market. You'd be hard put to find it on the shelves nine months later.
Pump It Up
DSHEA clearly needs to be revisited, but there's little movement afoot to do so. "Congress won't act until there's a major public health tragedy," says attorney Bruce Silverglade at the Center for Science in the Public Interest.
It ultimately took the deaths of 107 people, mostly children, from a poisoned over-the-counter elixir before Congress finally imposed the sweeping regulatory framework under the 1938 Food, Drug, and Cosmetic Act that required drugs to be proven safe and effective before marketing. Barring a massive wave of supplement-related deaths---or the death or illness of one congressman's daughter---any meaningful effort to fix DSHEA will undoubtedly require cooperation from Hatch. But the senator is unpersuaded.
Hatch believes the FDA has plenty of authority to police the supplement industry. As for the pro-hormones, Hatch wants to let the "scientists determine what is a steroid," and believes Congress should not be making drug determinations for every new product that comes on the market, according to one staffer. And if supplement makers are selling drugs as supplements, Hatch believes that "bad things should happen to them. They should go to jail," says a staffer.
Yet Hatch's record suggests the FDA will prosecute some supplement makers over his dead body---especially if those companies happen to operate in Utah. Remember that part of the reason he introduced DSHEA was that the FDA was doing then exactly what he proposes it should do now.
In Hatch's view, just because people might abuse some supplements doesn't mean that the government should make them harder to get. "If you die from taking too many ephedra, maybe the problem was you. It's not the government's fault," explains one of his staffers.
It's the kind of libertarian rhetoric you'd expect from a Western Republican senator. You might even be able to respect him for his belief in personal responsibility and faith in the common sense of American citizens---if only he were consistent about it. After all, if you take his arguments about supplements to their logical conclusion, not only should ephedra be legal, but so should amphetamines. If Americans are smart enough to self-medicate with unregulated supplements, why not let them snort coke or smoke pot?
Of course, Hatch is a drug warrior, and drug laws remain his ultimate solution to problems with supplements. If andro really is a steroid, well, gosh darn it, he says, let's make it a Schedule III drug and put those bastards in prison---but only once the scientists prove it in a clinical trial. Until then, pump it up, baby.