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Safety (or Not) of Supplements

Posted 4/28/2012

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This is an essay from the New England Journal of Medicine about the safety of supplements. The author is thinking more broadly than just sales aimed at cancer prevention or treatment, but the same facts hold. Bottom line is that there is virtually no oversight of these products, and there is legitimate concern about their safety -- let alone whether they are helpful. Here is the introduction and then a link to read more:

Assessing Supplement Safety - The FDA's Controversial Proposal

Pieter A. Cohen, M.D.

Recently, a well-respected dietary-supplement company in Utah announced the recall of Zotrex, a sexual enhancement supplement labeled as containing "Ophioglossum polyphyllous." The problem with Zotrex was twofold: not only is no species of ophioglossum (adder's tongue) an established dietary ingredient, but Zotrex actually contained sulfoaildenafil, an analogue of sildenafil that has never been tested in humans. By the time of the recall, the company had distributed nearly 14 million capsules containing, among other things, sulfoaildenafil (under a variety of trade names, including Stiff Nights and OMG), and thousands of customers may have inadvertently consumed the untested analogue. Although Zotrex represented a particularly brazen violation of the law, surprisingly, many new supplement ingredients are introduced into the market as Ophioglossum polyphyllous was, without any regulatory oversight.

Each year, Americans spend more than $28 billion on supplements assuming that they are both safe and effective. More than 100 million Americans consume vitamins, minerals, herbal ingredients, amino acids, and other naturally occurring products in the form of dietary supplements. By law, dietary supplements with established ingredients — ingredients that were sold in the United States before 1994 — may be marketed without any evidence of efficacy or safety.

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