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Pieter Cohen, an internist in Massachusetts, has become a supplement sleuth, finding dangerous substances in nutritional supplements because under current regulations the FDA can’t.
Since 2005, when his patients were being sickened by a weight loss supplement containing anti-depressants and thyroid hormones, Cohen has become something of a mix of Indiana Jones and Sherlock Holmes in the supplement world. With chemist colleagues he hunts for drugs illegally buried in supplements. Then he goes public. So far, he and his collaborators have identified three hidden stimulant drugs in supplements.
But their discoveries highlight a broader problem: a dysfunctional system for policing dietary supplements. “It comes to this,” says Dr. Paul Offit,of Children’s Hospital of Philadelphia. “Essentially a private citizen [is] doing the testing to make sure what’s on the label is in the bottle. … It’s absurd.”
Under 1994’s Dietary Supplement and Health Education Act (DSHEA) regulation of supplements was made very loose. As FDA notes on its website, “unlike drug products that must be proven safe and effective… there are no provisions in the law for FDA to ‘approve’ dietary supplements.” The agency can act only after a supplement is on the market and evidence shows it’s unsafe.
Whereas the industry and many consumers celebrated DSHEA for expanding access to supplements, the act was skewered by physicians, journalists, and consumer protection groups. Meanwhile, the industry grew exponentially– about $36 billion worth of supplements were sold last year.
Cohen agrees that FDA’s supplement policing powers are too limited. But that doesn’t mean the agency has no muscle. The agency, Cohen believes, is overwhelmed by the sheer volume of supplements and discouraged by political forces from acting aggressively. When it comes to pulling a supplement ingredient, FDA’s attitude is “show us the dead bodies,” he says.
Read full, original post: The supplement sleuth