Selling Drugs As Supplements
By NATASHA SINGER, New York Times
DR. PIETER COHEN is scanning the shelves inside a shop in Chinatown here when something familiar — and potentially dangerous — catches his eye.
“What’s that yellow box, behind the other one?” Dr. Cohen asks the clerk.
It is Pai You Guo, a supposedly natural weight-loss supplement from China that, according to federal authorities, has tested positive in the past for containing two hazardous drugs, including a suspected carcinogen. The product was recalled in 2009. One of Dr. Cohen’s patients in the Boston area ended up in the hospital last year with a range of ailments after taking Pai You Guo, a brand-name that, loosely translated from Chinese, means “the fruit that eliminates fat.”
But he has seen worse: kidney failure, heart problems, depression, addiction — all, he says, caused by tainted products sold openly as dietary supplements in shops across the nation and on the Internet.
“My patients are being harmed by this,” says Dr. Cohen, an internist at the nearby Cambridge Health Alliance and an assistant professor of medicine at Harvard Medical School.
Marketing drugs in the guise of supplements is illegal in the United States. Tainted Pai You Guo is just one small part of that global business. Federal authorities are struggling to identify and intercept these black-market goods, which, they warn, pose grave health risks.
The makers of legal dietary supplements — the kind found at GNC, for example — acknowledge they are reluctant to raise too many alarms. Even though there is little evidence that many dietary supplements provide real health benefits, legal supplements, from multivitamins to ginkgo biloba, are a big and growing business. Americans spent $28.1 billion on them last year, up from $21.3 billion five years ago, according to estimates from Nutrition Business Journal, a market research firm.
Many millions more are also being spent annually on black-market products, particularly those marketed for weight loss, bodybuilding and sexual enhancement. Some of these products, according to the F.D.A., contain amphetamines, synthetic steroids, laxatives and compounds like the active drug in Viagra. Officials say such products can cause heart attacks and strokes, and can damage the kidneys and liver. A few people in the United States, they say, have died after taking them.
Industry representatives say a vast majority of supplements are safe, and they fault regulators for failing to stop the influx of illegal products from places like China. But few seem willing to tackle the problem openly. Unlike, say, the fashion industry, which has lobbied for increased regulation to combat knock-off products and has vociferously publicized the issue, the supplement industry is at best waging a whisper campaign.
“We walk a fine line,” says Steve Mister, president of the Council for Responsible Nutrition, a trade group in Washington that represents supplement manufacturers and ingredient suppliers. “We want to protect consumers, but we also don’t want to alarm consumers so they stay away from the whole marketplace.”
Mr. Mister says legitimate manufacturers ensure product safety. Under federal law, supplements are defined as products that contain only supplemental dietary ingredients, like vitamins and minerals. People who knowingly make or distribute products spiked with drugs, he says, are outliers. His group recommends that people buy nationally recognized brands — like Centrum, One A Day and Nature Made — from its members and avoid those that make miracle claims.
But tainted products are not merely a fringe problem. Major chains like GNC and the Vitamin Shoppe, for example, withdrew a weight-loss brand called StarCaps from their stores three years ago after reports surfaced that the product, marketed as a papaya-based supplement, contained a powerful diuretic drug.
Meanwhile, many companies promote genuine dietary supplements with enthusiastic claims that resemble those of adulterated products, regulators say, making it hard for consumers to distinguish between the legal and the illegal, the harmless and the potentially dangerous.
Exhibit A: A tip sheet from the Council for Responsible Nutrition. Of sexual enhancement supplements for men, it says: “Regular use of a supplement might provide subtle, incremental improvement, but don’t expect to pop a supplement and be able to immediately ‘get busy.’ ”
Exhibit B: RockHard Weekend, a supplement offered for sale recently on Amazon.com. “Works in 30 minutes or less!” the pitch went. “One pill lasts the average man up to 72 hours with full control!”
Exhibit C: RockHard Laboratories, of Alpharetta, Ga., which recalled some lots of that very product in 2009, after the F.D.A. said the pills contained an analogue of the drug used in Viagra. Last year, the company recalled even more after independent tests found that some pills still contained the drug. A company news release said it planned to avoid another recall by using higher-quality ingredients and better testing. The company did not return two calls or an e-mail seeking comment.
Amazon did not respond to telephone calls and an e-mail seeking comment.
MAN UP NOW. Passion Coffee. Slim Waistline. Stiff Nights. 7 Day Herbal Slim. In the last three years, the F.D.A. has issued warnings about these and about 300 other supplements that it says have been adulterated. The agency has pressed distributors to recall tainted lots and has seized more than $1 million worth of products. Regulators have also introduced new surveillance techniques, investigated major traffickers and increased public notices in the form of alerts, an open letter to the industry and a database — all to little avail.
“It’s a remarkable tidal wave of products,” Michael Levy, acting director of the F.D.A.’s office of drug security, integrity and recalls, says while sitting at a table laden with contraband in Silver Spring, Md. “We are removing only a fraction.”
The problem, he says, is that the F.D.A. lacks the resources to stem the influx of illegal raw ingredients and finished products — mainly from Asia — to the United States. Moreover, he says, the agency cannot easily prevent adulterated products disguised as supplements from reaching the market.
That is because supplement makers in the United States can introduce new products much more easily than pharmaceutical companies. Drug makers are required to prove that their products are safe and effective, and they must obtain federal approval before going to market. But dietary supplements, by definition, contain only dietary ingredients; the federal law on supplements does not require premarket approval. That can make it easy for purveyors of spiked products to use the cover of supplements to ply their wares.
Trying to get tainted products off the market is expensive and time-consuming. Before federal officials can take action, Mr. Levy says, they must first buy suspect items or catch them at the border, and then test them in an agency lab.
Agency experts, for example, found that many weight-loss products contained sibutramine, the appetite suppressant in Meridia, a popular medicine whose manufacturer voluntarily removed it from the American market last year after a research study reported that it could increase the risk of heart attack and stroke.
Pills marketed as male sexual enhancement supplements often contain sildenafil citrate, the active ingredient in Viagra, or its analogues. But these adulterated pills sometimes contain up to seven times the recommended dose, Mr. Levy says. Another danger: some of the analogues may have never been tested for safety in humans.
“These products may work,” he says, but “if you take them, they could kill you."
Mr. Mister of the Council for Responsible Nutrition says that tainted goods are a limited problem — and one that the F.D.A. is not doing enough to curb. The agency, he says, should seize more spiked products instead of sending out warning letters and waiting for companies to take action.
Safety measures in the legitimate industry are increasing, he says. New federal guidelines, put into place in the last three years, require supplement makers to test and certify each ingredient, he says, a fail-safe against inadvertent adulteration. Supplement makers are also required to test finished goods to ensure that they match the ingredients on the label. At least one major company has gone even further. This month, the EAS Sports Nutrition brand, made by Abbott, said it had hired outside labs to independently test its products and certify them to be free of certain drugs banned by professional sports associations.
AT the mail facility at Kennedy Airport, United States Customs and Border Protection officials X-ray incoming shipments and set aside suspect items — ivory tusks, exotic seeds, trash bags full of pills. They also intercept suspicious products packaged like dietary supplements, passing them to the F.D.A. for testing.
One morning in July, a cart at the Kennedy facility is stacked high with boxes of products labeled as herbal weight-loss and impotence treatments.
All of this took almost no time to pile up.
“It’s an hour’s worth,” says Ralph Fasano, a Customs and Border Protection inspector. But, he adds, “this could have come off the conveyor in five minutes.”
Inspectors, he says, are allowed to seize items that contain controlled substances, like narcotics. But if the products’ contents include drugs approved for use in the United States, F.D.A. personnel must ship them back where they came from. Often, the products are just mailed back to the United States again, with the F.D.A.’s big red rejection sticker still on them.
“It’s a revolving door,” says Joseph Tomao, an F.D.A. compliance officer.
Mr. Fasano of Customs says: “If they can get one out of every five or six shipments through, it’s a home run for them.”
Kennedy is trying out a new hand-held device called a portable trace detector that can sniff out pharmaceuticals. Seeing it work is like watching an episode of “C.S.I.”
In an office off the main hall, Samantha McCormick, an F.D.A. investigator, prepares to test samples of JaDera, weight-loss capsules from China whose maroon labels in English say it is “100 percent natural” and contains bitter orange and mulberry leaf.
“It could,” she says, pulling on a pair of purple rubber gloves. “It could not.”
She pours the contents of a capsule into a centrifuge tube, adds isopropyl alcohol and shakes it. She filters the solution, dilutes the mixture with alcohol again and, using a syringe, squeezes a few droplets onto a test strip. She slides the strip into a slot in the detector.
Bingo. The screen lights up. It has detected sibutramine, the weight-loss drug recently taken off of the American market. Since this facility began using the device this year, it has detected the drug in 35 out of 36 packages of weight-loss products.
Next, the products are shipped in sealed bags to an F.D.A. lab in Philadelphia.
There, on an upper floor of the historic United States Customs House, one hall of lab tables and special machinery is used to test dozens of samples of each suspect product. Luella Rossi, the lab director, and her staff empty the capsules, dilute the material and then feed it into a gas chromotography-mass spectrometer detector, a device that can identify a specific substance in a sample.
One day last month, four different products from Kennedy tested positive for sibutramine. The JaDera capsules contained the highest concentration, more than 30 milligrams per unit — or roughly six times more than the starting dose of the legal medicine when it was on the market.
While the F.D.A. was still processing the test results ahead of issuing an official public alert, maroon bottles of JaDera remained widely available on the Web earlier in August, on sites like eBay and Amazon. JaDera is made in China and sold here in multiple packages, making it hard to determine which bottles might be adulterated.
A spokeswoman for eBay said earlier this month that the site’s drug policy specifically prohibited the sale of weight-loss products that have been the subject of F.D.A. warnings.
Two businesses in China that export JaDera to North America did not respond to e-mails seeking comment.
IT all started with a package from China that was intercepted in 2009 by United States Customs inspectors at the mail facility at San Francisco International Airport. The shipment contained two purportedly natural weight-loss products, Super-Slim and Meizitang, and was intended for an American citizen who distributed the products here. Around the same time, the F.D.A. issued public warnings that the brands had tested positive for sibutramine.
“The intended recipient was a small target in a big investigation,” says a special agent in the F.D.A.’s Office of Criminal Investigations, who asked for anonymity to protect continuing investigations. “Our goal was to trace the shipment back to the ultimate source of the product.”
The American distributor, referred to in court documents as “J. K.,” agreed to cooperate with investigators. That enabled the special agent, posing at first as J. K., to contact the source of the adulterated products in China.
His name was Shengyang Zhou, of Kunming, in the southwestern province of Yunnan. In dealings with undercover agents, he went by just “Tom.” Mr. Zhou told federal agents that he had manufactured the weight-loss products — in fact, he could produce “100,000 boxes a month,” according to the government’s criminal complaint.
“We knew we had a significant target at this point,” the special agent recalls. “He was dealing in commercial-sized quantities of numerous weight-loss products, and he was willing to sell them only in large amounts.”
The special agent, now using the alias Rus Henderson, placed a series of orders. The first shipment, 500 boxes of Super-Slim, arrived in November 2009. Others followed.
Soon, the agent was in regular contact with the dealer by e-mail and telephone. Mr. Zhou had a Web site displaying a variety of weight-loss products and suggested that the agent buy Alli, an over-the-counter drug containing orlistat, officially made by GlaxoSmithKline.
It turned out that, in addition to selling products labeled as natural weight-loss supplements, Mr. Zhou was also selling counterfeit Alli. The counterfeit had been packaged to mimic the genuine medicine, but the fake version contained sibutramine, not orlistat — posing a serious health hazard to consumers.
In January 2010, agents received more parcels from Mr. Zhou that contained adulterated weight-loss products, along with counterfeit Alli. The dealer had a few American distributors for the fraudulent Alli, the agent says, and “countless distributors” for the adulterated weight-loss products.
“Every day, he was routinely sending in commercial-sized orders in to the United States,” the agent says. “He had distributors in almost every state.”
The investigators concocted a plan to lure Mr. Zhou to the United States, explaining that they wanted him to work with a customs broker here so they could increase their orders. Mr. Zhou was eventually arrested in March 2010 in Hawaii. He pleaded guilty in January to charges of trafficking in counterfeit goods.
In June, a United States District Court in Denver sentenced Mr. Zhou to more than seven years in prison. He was also ordered to pay more than $500,000 to people who had been hurt by his products, including an emergency room doctor who suffered a mild stroke.
In the course of the investigation, the agents received 24,856 capsules of spiked weight-loss products and 6,000 capsules of counterfeit Alli.
How many “Toms” are still out there is unknown.
IN a cafe in Everett, Mass., Naara Ramos, a native of Brazil and former nurse, recounts her nightmare with tainted supplements.
Ms. Ramos, a patient of Dr. Cohen, used Brazilian weight-loss products for years. But when they stopped working last year, she turned to Pai You Guo. First she tried the tea version, then the capsules.
“You never feel tired. You never sleep. You never feel hungry. It feels so good,” Ms. Ramos, 46, says in Portuguese, with Dr. Cohen translating. “But, just like a drug, when you stop, you crash.”
While taking the stuff, she says, she developed heart palpitations and other symptoms of addiction; she ended up in the hospital for a week with a breakdown.
Two businesses in China that export the product to North America did not respond to e-mails seeking comment.
F.D.A. warnings about Pai You Guo seem to have had little effect on its availability.
According to a new research study by Dr. Cohen of more than 500 Brazilian women in the Boston area, one in five have used the product, and more of them took it after the recall than before. Last month, the F.D.A. lab in Philadelphia tested a new shipment of the brand, intercepted at Kennedy, and found that it contained sibutramine.
“In the current regulatory framework, is it possible to ensure the safety of what we purchase?” Dr. Cohen asks. “To me, the answer is no.”
The supplement industry argues that existing regulations work perfectly well. It blames the F.D.A. as failing to institute mandatory recalls and seize tainted goods. Reputable manufacturers and distributors are focused on their own vigilance, rather than on warning consumers about other businesses’ potentially troubled products, says Mr. Mister of the Council for Responsible Nutrition.
“We are concerned that if we alert consumers, we may unnecessarily drive them away from the marketplace,” he says. “We could make them afraid to take legitimate dietary supplements.”
But the industry may be miscalculating, says Daniel Fabricant, the director of the F.D.A.’s division of dietary supplement programs. The growing availability of tainted products represents a serious public health problem, he says — one that could taint the dietary supplement industry as a whole.
“To my mind,” he says, “it’s the biggest issue we face.”