This article in Men's Health focuses on supplements for men, but it points to easy to exploit gaps in the regulatory safety net. I'm a self-confessed junk food freak, so I take the sting out of putting gas in the car by going in to the concession for a soft drink or a candy bar. There I see the array of generic junk being sold along with lottery tickets, tobacco products and multi-packs of beer that underscore some serious information in this piece.
Who's Spiking Your Supplements?
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
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.
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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.
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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.More at the link.
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