Men's Health Magazine Covers Supplement Litigation Handled by The Gibson Law Firm

THE DANGERS OF SUPPLEMENTS: SPECIAL REPORT

American men have a mania for pills and potions that can add muscle or stiffen their sex lives. Shady drug labs supply the demand—by dosing "natural" nostrums with illegal meds and hidden health threats.

HEATH STEVISON just wanted to put on a bit more muscle. He had a vacation in Cabo San Lucas coming up, and he hoped to make a good show of it at the beach. Weighing in at just 155 pounds, he felt he needed "a little more oomph" at the gym.

That "oomph" nearly killed him.

Stevison's saga began in the spring of 2009, when he laid down $29.99 for a bottle of M-Drol from tfsupplements.com. He read the label and took the supplement for a month before cycling off. Then he cycled back on again. The results were pretty impressive: 15 pounds of muscle in just weeks.

Along with the terrific change in his physique, however, he noticed something else: His legs and sides began to itch. By mid-July, he was waking up to bloody sheets from nights of scratching himself raw. He asked his girlfriend, who had taken charge of his laundry, whether she had switched detergents. She hadn't. Then came the day, maybe a week later, when Stevison looked in the bathroom mirror and saw that his eyes were yellow. At the time, he was working 12-hour shifts in Lake Charles, Louisiana, for a company that supplied equipment for drilling rigs.

Maybe I'm just exhausted, he told himself.

When Stevison's skin developed the same mustardy hue, and he felt so bone-crushingly tired that he could hardly lift himself out of bed, his mother carted him to the emergency room. Days of tests and one biopsy later, his physicians determined that his liver was shutting down. His chart suggested the cause: steroid ingestion. Instead of sunning himself on the beach at Cabo, Stevison found himself tethered to IV poles at Methodist Hospital in Houston. A doctor mentioned the waiting time for a new liver.

"When he started talking about transplants, all I could do was pray," Stevison says. "I was 24 years old and thought I was healthy."

Less than 3 months after Stevison checked into Methodist, the retailer bodybuilding.com recalled M-Drol and 64 other supplements for containing "ingredients that are steroids." Though M-Drol had been marketed as a supplement, the FDA had classified the product as an unapproved drug.

By law, dietary supplements must contain at least one vitamin, mineral, amino acid, enzyme, or other substance used by the body. But a growing number of supplements have also been spiked with prescription, banned, or completely untested drugs that you won't find listed on the label. Makers of these suspect potions often claim they're confused by overlapping government jurisdictions over what is and is not legal. More often the adulteration is deliberate and criminal, carried out by sellers who want to grab a share of a $27 billion market by touting a pill that really delivers. A single product can become an instant blockbuster: Before Competitive Edge Labs discontinued M-Drol, the company's gross annual revenue totaled more than $4 million—an impressive haul for an outfit with a payroll of four.

Products most likely to be spiked are those sold for weight loss, bodybuilding, and "sexual enhancement"—categories pitched largely to men. The labels use the word "supplement," but the capsules might contain steroids, erectile-dysfunction drugs such as sildenafil (the active ingredient in Viagra), or any of a number of weight-loss drugs, some of which have been pulled from the market over safety concerns. It's an old scam, but with the globalization of drug manufacturing and the ease of Internet retailing, your odds of coming across a tainted supplement are higher than ever.

"We started posting recalls and warnings in 2002," says Tod Cooperman, M.D., who runs ConsumerLab.com, an independent supplement-testing company that reports on product quality. "Only occasionally would you see this kind of recall or warning come out when we started. Now it's almost weekly."Industry reps lay the blame on a small number of products that come from a few shadowy, mostly foreign operators. But the truth is, no one really knows how many spiked supplements are out there. "We have no way of measuring this," says Michael Levy, the FDA's director of new drugs and labeling compliance.

"But we're aware of dozens of illegal products that have been marketed. We are confident we could find dozens more."

The products usually come from sophisticated operations that combine the knowledge of science with the shrewdness of organized crime, Levy says. Often the drugs are chemically modified—with atoms added or removed like Tinkertoy pieces—in order to evade detection in lab tests. The problem is, a seemingly slight change in molecular structure could have disastrous consequences. Consider that the difference between ethanol (a substance you may ingest at happy hour) and methanol (a chemical that will swiftly blind and then kill you) is one carbon atom and a couple of hydrogens. Or that removal of a single oxygen-hydrogen pair turns a decongestant into methamphetamine.

With remodeled drugs, "you're seeing not only a pharmaceutical product but an illegal one, and the side effects are unknown," says Pieter Cohen, M.D., assistant professor of medicine at the Cambridge Health Alliance, a Harvard medical school teaching affiliate.

"The danger is extremely serious."

Even if the drug is not chemically cloaked, it could still be risky. One common ingredient in adulterated weight-loss supplements is sibutramine, a prescription weight-loss drug that was withdrawn from the U.S. market because users developed greater risks for heart attacks and strokes. Also, a juiced supplement may contain a much higher dose of a drug than its legitimate counterpart, and be produced with little if any quality control.

The FDA acknowledges that consumers have died and that it's impossible to know how many. Officials believe the victims are vastly undercounted because doctors don't always know what their patients are taking. (One study found that 69 percent of patients using supplements along with their prescription meds don't volunteer that information.) Consumers may also fail to connect the dots when symptoms arise—Heath Stevison tried to blame detergent, not M-Drol, when his health went haywire. Part of the appeal of supplements is their apparent naturalness, so they often have a veneer of being safer than prescription drugs.

Last December the FDA announced a crackdown on spiked supplements; it sent a letter to industry trade groups and implemented faster posting of tainted-product warnings on the Web. The stricter standards for production and safety aim to hold all the links in the supplement supply chain—importers, manufacturers, and ingredient suppliers among them—more accountable for any product-tainting slipups. In addition, supplement manufacturers, worried that shady suppliers may threaten their image and sales, have vowed to work with the FDA to try to rid their ranks of criminals.

Whether these actions will make a difference is unclear. Until this year, the FDA didn't have the authority to order a mandatory recall, relying instead on voluntary cooperation from distributors. Dr. Cohen checked that strategy in August 2010, by shopping online for 72 spiked supplements that were part of a March 2009 consumer alert. He was able to proceed to checkout with 36 of them.IN 2008, BART PANESSA WAS 45 YEARS OLD and ready for a new career and a warmer climate. After making his living as the owner-operator of car washes and oil-lube garages in the New York City area, he moved to Florida and began scouting around for an Internet-based business that would be simple to run. He came across Goliath Labs, a Fort Lauderdale company selling bodybuilding and sexual-enhancement supplements, including one called Ejaculoid.

"I just started laughing," Panessa says. "Who would ever come up with a product and call it Ejaculoid?" But the bottom line was no joke. "It was a 3-year-old company doing very well with very little effort. Sales were going up 20 to 30 percent a year." So he bought it. "I'm like, 'You know what? We have the whole world. We could advertise. We could really make a go, come up with some new products.'"

A few months later, his "formulator"—the consultant who comes up with supplement recipes—told Panessa about a brand-new sex-enhancing concoction from a Chinese supplier. Panessa tried it himself and found it delightfully effective. So he e-mailed the Chinese connection, a woman he knew only as "Kathy," for a batch, which he then encapsulated and bottled at his Florida plant.

Panessa, a street-smart New Yorker, suspected the new stuff worked a little too well. Sexual-enhancement supplements were being recalled with disturbing regularity for containing sildenafil or similar drugs. So in July 2009, Panessa ran independent laboratory tests. To his great relief and surprise, the results came back clean. "We're thinking at this point we have the Holy Grail," Panessa says.

Sales of Ejaculoid XXtreme were hot until July 2010, when Panessa arrived at his office to find a note from the FDA on the door. One of his shipments had been seized by U.S. customs officials at the Canadian border for containing a form of sildenafil. Panessa blanched. Not only were federal agents now after him, but he also knew his own cardiovascular problems made his use of any sildenafil-type supplement a colossally bad idea. His lab tests had missed a chemical analog of sildenafil invisible to all but the most state-of-the-art screening.

The FDA immediately posted an alert. What shocked Panessa was that a recall was surprisingly effective PR. "Our phones started ringing off the hook with people wanting it. I swear to God," he says. "I actually could have sold triple the amount just with a recall," he says. About 5,000 bottles were in the hands of shop owners and online sellers. Only about 900 of them came back.

Consider that Panessa was on the lookout for sildenafil and still sold a spiked product. He recalls the agent telling him that "99 percent of these guys don't even do a test, period." Often it's because supplement makers are happy with the sales and don't want to know more. "Everyone wants a product that works yesterday," Panessa says.

The trouble is, no legitimate supplement can deliver instant results. For example, last year Creighton University researchers published a report in the Journal of Obesity that reviewed recent randomized studies of fat-modifying weight-loss supplements. "To date," they concluded, "there is little clinical evidence to support their use." So a supplement with even a hint of remarkable success is like catnip to the dieting public, and word spreads. Especially if there's a recall; maybe it's too effective!

Even legitimate supplement makers aren't always sure their products are legal. Makers of sports supplements must comply with "a complex maze of laws that are policed by multiple government agencies with overlapping authority," says Rick Collins, an attorney in Mineola, New York, whose practice specializes in performance-enhancing substances, including steroids. Some steroids are banned outright, while others are not illegal unless they're passed off as supplements—at which point, in the eyes of the FDA, they become unapproved drugs.

Companies that have run into trouble typically offer two excuses, Collins says. "One, they claim they researched it to the extent that they found it was not specifically listed in the law as an illegal steroid," he says. "Two, they point out that virtually everybody around them was selling it everywhere. So they'll say they combined those two observations and made the assumption that it was perfectly legal to sell."

Dr. Cohen says some manufacturers also play a chemical version of brinkmanship, trying to make a product as close to illegal as possible without crossing the line. "We're talking about a very complicated situation where everyone is trying to replicate the actions of testosterone and put that into a pill that flies under the regulatory radar," he says.

Competitive Edge Labs declined to comment on M-Drol through e-mail. But in a sworn deposition taken for a lawsuit, company employee John Dodd testified that he did not check whether the active ingredient was banned, because other products containing it were already on the market. He also could not recall anyone checking with the FDA to ask if the ingredient was illegal. During the summer of 2009, around the same time Heath Stevison came down with his life-threatening symptoms, the company decided to stop making the product, quickly selling off its remaining stock.

M-Drol's ingredients came from China; drugs masquerading as supplements often have tentacles that reach into that country. And in fact, Asia is emerging as a powerhouse for legitimate, quality pharmaceutical manufacturing. Yet neither the natural-products trade associations nor the FDA have data on the proportion of dietary supplements or their ingredients that come from abroad. Nutrition Business Journal estimates that more than 60 percent of the raw materials for vitamins alone come from China, but it has no further figures. Illegal traffickers from Asia are simply capitalizing on the resources at their doorstep—and the Internet wall of anonymity. After the Ejaculoid recall, "Kathy" changed her e-mail address; Panessa has not been able to reach her since. HE CALLED HIMSELF TOM, but his real name was Shengyang Zhou, a 30-year-old MBA living in Kunming, China. Around 2005, Zhou recognized an opportunity in America's twin obsessions with dieting and quick fixes. With a three-story factory and a staff of 20 (each paid $300 a month), he began punching out weight-loss blends such as Superslim and 2 Day Diet, along with more than two dozen other weight-loss products. E-mail orders came through his own website (2daydietshopping.com) or U.S. distributors. According to court documents, packages were shipped from China or Hong Kong to a modest tract house in Plano, Texas, which was the home of 61-year-old Qing Ming Hu. The packages bore labels like "Fuyong Logistics Center" or even "dry fruit." In one e-mail to a contact, Zhou described himself as "one of the biggest manufacturer [sic] in slimming industry," producing 100,000 boxes a month.

By 2010, Zhou had become a millionaire who boasted about his girlfriend and his Audi Q7. But unfortunately for Zhou, he was bragging to undercover feds. His product sold because it worked—thanks to the hidden sibutramine and phenolphthalein, the latter a powerful (and also banned) laxative. Zhou was quite aware that the FDA had been warning consumers about products from China that contained sibutramine. In a meeting with federal agents in Bangkok who were posing as potential American dealers, Zhou estimated that about one box in 15 would be snatched by customs.

Zhou would still be cruising around Kunming in his Audi had a multiagency federal sting not lured him to Hawaii, where he was arrested in March 2010. His Texas accomplice was taken into custody on the same day. In January of this year, both pled guilty to charges related to Zhou's other business venture, trafficking and distributing counterfeit versions of the weight-loss drug Alli.

"As best we can tell, these chemicals tend to be produced in rogue labs and small factories," says Loren Israelsen, executive director of the United Natural Products Alliance, an industry group. "They produce and then distribute it in a fairly sophisticated way." Small parcels with phony labels are hard to police. "It's a swarming effect," he says. "You just can't beat that many bugs out of the air." How many bugs? Who knows? U.S. Department of Justice officials say they cannot provide statistics on convictions for trafficking in tainted supplements.

In any case, it's unusual that someone like Zhou was caught at all. "Criminals who make money from falsified pharmaceuticals are unlikely to ever be caught," says Guy Villax, CEO of the Portugal-based pharmaceutical ingredients manufacturer Hovione. Villax is working to stop the spread of spiked supplements on both sides of the Atlantic. "The supply chain goes across so many countries and oceans," Villax says. "You know how in the old movies, when the gangsters crossed the state line and then they were never caught? This is exactly what's going on in this situation."

SIX MONTHS AFTER he was released from Methodist Hospital, Stevison returned to work. His liver appears to have repaired itself, although he will never again be able to drink alcohol, and acetaminophen is strictly off-limits. His liver wouldn't bear the strain. He also avoids supplements, even vitamins.

This avoidance is exactly what mainstream manufacturers fear. Suggestions for solutions to the problem hinge largely on your point of view, especially over the need to regulate supplements more like drugs. However, all sides largely agree on one point: The government does not have the manpower to stop the flow of bad supplements. "They don't have enough inspectors to inspect even the plants that make prescription drugs," says Steven Nissen, M.D., chairman of cardiovascular medicine at the Cleveland Clinic. "They are completely understaffed."

Bart Panessa has now bought a Canadian supplement company (largely because that country has tougher manufacturing standards), and even posts links to FDA enforcement actions on supplements as a reminder to herberex.com visitors. But he believes that as long as consumers demand supplements with instant results, shady sellers will gladly meet the need. Panessa receives regular e-mails from Asia soliciting business partnerships, including offers to supply the latest product for men who have trouble rising in the morning: sildenafil-laced coffee.

"There is no answer," he says. "You cannot stop it. It's impossible." In some lab somewhere in the world, chemists are probably fashioning the next chemically camouflaged sildenafil, readying it for market. If the government can't stop it, men themselves can. The smart ones will refuse to buy it.
 

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