December 2, 2013
The risky side of supplements
Nutritional pills, potions and powders sold across the nation are deemed safe until someone gets sick; the track record of one Dallas company shows why consumers should be concerned
The Food and Drug Administration can’t protect you. It didn’t protect Sonette Marras, a 48-year-old mother of seven who died in Hawaii last month. It didn’t protect Michael Lee Sparling, a 22-year-old Army private who died at Fort Bliss two years ago. Nor can it protect the more than 2,000 Americans a year who will die or suffer illness after taking over-the-counter dietary supplements. Don’t expect the FDA to protect you now. The laws it enforces protect the $30 billion-a-year industry that makes and sells the supplements, not the 53 percent of Americans who take them.
Not quite medicines, not quite food, dietary supplements fall into a regulatory black hole. A big black hole. And one of the most glaring examples of what can go wrong occurred in Dallas, where a company continued to manufacture dietary supplements with an illegal ingredient, DMAA, one year after this laboratory-made stimulant was deemed unsafe.
The story begins in1994, when Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa, introduced a federal law, the Dietary Supplements Health and Education Act, that opened the door for supplements to be sold without safety testing. This means that the pills, powders and potions on sale across the nation are deemed safe — until someone gets sick. “We don’t approve these products for safety or efficacy prior to going to market,” says Dr. Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA. “They’re not like drugs. The way the law is, firms don’t have to register their products, so dietary supplements come on to the market freely.” It’s a huge market. In 2009, 55,000 supplements were on sale in the U.S., according to the Government Accountability Office. That’s up from 4,000 in 1994, a nearly 1,300 percent increase. When a supplement is suspected to have caused deaths or illnesses, it’s up to the FDA to prove that the supplement is unsafe. “The burden is on us,” says Fabricant. “Proving that something caused harm directly is very challenging.” Jacob Geissler has taken full advantage of that challenge with his Dallas sports supplement company. The 37-year-old founded USPLabs in 2006 after graduating with a degree in nutrition from Texas A&M in the mid-1990s. In between graduating and starting USPLabs, Geissler was indicted in Bexar County in 2003 for possessing thousands of pills containing anabolic steroids. He was ordered to serve 10 years of community supervision; he served five of them before his petition for early termination was granted in 2009. By then, USPLabs was well-established. Today, the company is best known for its popular Jack3d and OxyElite Pro supplements. Both are advertised as simultaneous fat-burners and muscle-builders that will take your workout to the next level. Until July, just four months ago, both contained DMAA, which has been illegal in the U.S. since April 2012. USPLabs declined multiple requests for an interview with Geissler or another company representative. However, company officials have defended their actions elsewhere, maintaining that DMAA is safe. A statement sent to marketers stated that the company was phasing out products containing DMAA “for business reasons.” Originally developed as a nasal decongestant by Eli Lilly in the 1940s, DMAA was removed from the market in 1983 at the company’s request. Scientific studies of its effects had demonstrated increases in heart rate and blood pressure, alongside nervousness and tremors. But DMAA enjoyed a comeback after 2006. Touted as a natural deriv-
|ative of geranium, it became an active ingredient of performance-enhancing and weight-loss supplements.|
After six deaths and more than 100 reports of sickness were linked to DMAA, it was banned by the FDA in April 2012. But the U.S. Defense Department didn’t wait for an FDA ruling. Military officials had banned DMAA four months earlier after the deaths of three Fort Bliss soldiers, all young and previously healthy. Sparling, the Army private, was one of those soldiers. The 22-yearold Californian collapsed after a 10-minute run with his unit. He had taken the recommended dose of Jack3d before training. When a fourth soldier died after taking DMAA, the Defense Department convened a safety review panel and conducted a case control study of nearly 2,000 active-duty military personnel. Among the panel’s findings: 15.4 percent were taking DMAA; 40 soldiers had reported illness to a military doctor after taking the supplement, and two soldiers suffered liver failure. No other cause could be found to explain their illnesses. There were warning signs in other countries even earlier than the military ban. New Zealand suspended the sale of DMAA in 2008 after it was associated with strokes in four people. DMAA was also banned in Canada, the UK and at least six other countries. In April 2012, four months after the Defense Department’s ban, the FDA sent a warning letter to11DMAA manufacturers, including USPLabs, stating that DMAA must be removed from all products. Ten companies complied. USPLabs did not. OxyElite Pro and Jack3d continued to be manufactured with DMAA and put on store shelves. Even then, it was the Texas Department of State Health Services, not the FDA, that stepped in first. “We embargoed the product at the USPLabs warehouse in Dallas in May  and handed it over to FDA in June,” spokesperson Chris van Deusen said. “Under state law, we can act a little more quickly than the FDA.” USPLabs had been illegally making OxyElite Pro and Jack3d with DMAA for13 months. In July, after legal action by the FDA, USPLabs voluntarily destroyed $8.5 million worth of OxyElite Pro and Jack3d at its Dallas facility. But bottles that were already on store shelves stayed there. “We didn’t recall product,” says the FDA’s Fabricant. “But at the same time, in terms of our authority, it was a significant step to get it out of the hands of the distributor and have it voluntarily destroyed.” The largest retailer of dietary supplements, GNC, continued to sell OxyElite Pro and Jack3d until the FDA obtained seizure orders for warehouses in South Carolina and Pennsylvania in June. GNC declined requests for an interview. But in an email to The New York Times, a GNC spokesperson said, “It is hard to view this action as anything other than a biased agency action against GNC in retaliation for GNC’s stance on DMAA.” But not even the GNC seizures marked the end of OxyElite Pro and Jack3d. USPLabs, like many dietary supplement manufacturers, presented a moving target. It reformulated OxyElite Pro, under the same name, without DMAA. This time, it added a new ingredient: aegeline. An extract of the Bael tree, which grows in Southeast Asia, aegeline is deemed unsafe by the FDA. This new formulation of OxyElite Pro is linked to a fatal outbreak of liver disease that began in Hawaii and has spread to the mainland. More than 60 people have been sickened, including two who needed liver transplants. Sonette Marras, a mother of seven from Hawaii, developed liver failure and died last month. She had been taking the new formula of OxyElite Pro to lose weight she’d gained during pregnancy. The FDA sent a warning letter to USPLabs in October stating that aegeline was an illegal ingredient. A second warning letter Nov. 6 stated that all products containing the illegal ingredient should be recalled. The company voluntarily recalled OxyElite Pro three days later. GNC again acted consistently. Its stores in Hawaii continued to sell OxyElite Pro, despite a Hawaii Department of Health request to remove the product from shelves. The company later acquiesced. Dr. Sarah Park worries that there are more undetected cases of liver disease on the mainland. As the state epidemiologist for Hawaii, she was first to be notified of the cluster of liver disease associated with OxyElite Pro. “But we’re a small state,” she says. “We only have one liver transplant center, and we all talk to each other, so news of these patients got out. We call it the coconut wireless.” Larger states with multiple transplant centers — including Texas, which has14 — could miss a similar cluster of patients. Given these problems, it might seem strange that the FDA isn’t able to protect Americans. But it’s up against a powerful industry that has strong support in Washington. That takes us back to the1994 law that allows companies like USPLabs to sell supplements without safety testing, the Dietary Supplements Health and Education Act. Utah’s senior senator, Hatch, was the principal author and has been heralded as an ally of the industry ever since. Today, Utah is the Silicon Valley of the dietary supplement industry, providing the state an annual revenue of $7.2 billion. The second principal author of the law was Iowa’s Harkin. His top financial contributor since 1989 is Herbalife International, a dietary supplement company with headquarters in Grand Cayman. Herbalife’s political action committee and its employees contributed $87,636 to Harkin’s reelection campaign in 2008 and $100,000 to his eponymous public policy institute at Iowa State University in 2011. Hatch and Harkin’s support of the dietary supplement industry has not waned since1994. In fact, they hit back hard in 2011 when the FDA drafted new guidelines requiring manufacturers to submit a notification for every supplement containing an ingredient that had not been in dietary supplements before1994. This change would enable the FDA to stay on top of the burgeoning marketplace, rather than only responding to reports of illness and death after the fact. But in a strongly worded letter to the FDA, Harkin and Hatch complained that this was a “burdensome requirement that would impose substantial, additional costs on manufacturers” and that it “undermined DSHEA.” The senators urged the FDA to immediately withdraw the guidance. The FDA is working on a revision. Until the law changes, the burden is on consumers to recognize this sobering fact: Dietary supplements are not tested for safety or efficacy and are considered safe until proven otherwise. A resource-poor, often shackled government agency is doing its best to protect you, but the rules are stacked against it. The dietary supplement market is a place where caveat emptor reigns. Dr. Seema Yasmin, who served as a disease detective at the Centers for Disease Control and Prevention, is a fellow in global journalism at the University of Toronto’s Munk School of Global Affairs. Her email address is email@example.com. Follow her on Twitter at@DoctorYasmin. http://ireader.olivesoftware.com/Olive/iReader/DMN/SharedArticle.ashx?document=DMN%5C2013%5C12%5C01&article=Ar12501