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April 30, 2018
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The only thing Roytman's patients had in common: Each had taken OxyELITE Pro prior to getting sick. So in early September, she called the FDA to report her suspicions. To her dismay, she found that "it's not the easiest thing to contact the agency. You go through a bunch of messages and you have to keep saying that this is an emergency. Eventually, you do get to talk to a real person." Despite Roytman's attempts to convey that the situation was urgent, her calls were not returned.

Two weeks later, with the FDA still silent, The Queen's Medical Center doctors contacted the Hawaii State Department of Health. Within 24 hours, state officials reviewed the medical records and put out a health advisory. Finally, on November 9—two months after Roytman first tried to get through to the FDA—the agency announced that Dallas-based manufacturer USPlabs was voluntarily recalling OxyELITE Pro after it was found to contain a new, undeclared ingredient called aegeline. (The company's attorneys deny that it was new.) By then, the patient count in Hawaii had risen to 43, though the cause of the illnesses was still under investigation.

Back in Cleveland, Samone had landed in the ER too. After months of unexplained symptoms, one of her friends noticed that her eyes and skin had turned yellow—a classic sign of jaundice. Still, Samone showed up to her job at a market research firm. When coworkers also commented on it, she got scared. "I told my boss, 'I'm leaving early. I need to go to the hospital.'" There, a liver specialist quizzed Samone on everything she had done and eaten. "He Googled OxyELITE Pro and said, 'Do you know there's been a recall on this?'" Samone says. She thought he was talking about the first recall, and said she did. Then they checked the date and found that the new version had been recalled too, only days before. Samone listened in horror as the doctor told her how close she'd come to liver failure—and she hadn't even taken as much as the package recommended. "I still think, If I'd followed those instructions, I could be dead."

RECALLS in the age of the Internet

When the FDA discovers a supplement with an illegal ingredient (usually during one of those random searches), the agency warns the public on its website and asks manufacturers and sellers to pull their inventory in a voluntary action. Often, they cooperate; sometimes, they don't. In 2010, Cohen, who is also an internist, started treating women who'd become sick after taking a weight-loss product called Pai You Gou. It was supposed to be off the market, but his patients didn't know and kept buying it, he says. A study he conducted later revealed that at least two thirds of the weight-loss supplements that were recalled between 2009 and 2012 for containing drugs were still for sale by their manufacturers, and most of them hadn't changed their formulas.

Even if manufacturers do cooperate, consumers can't always count on stores to pull products from the shelves. "Getting the information to retailers quickly can be a challenge, " says Daniel Fabricant, Ph.D., chief executive officer of the Natural Products Association, a trade organization that alerts members (including retailers) to tainted supplements. After all, a lot of shops may not have the manpower to cull the FDA's recall announcements.

Source: www.redbookmag.com
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