Alaska Injury Law Blog
The most recent issue of the New England Journal of Medicine has directly called upon Congress to give the FDA the requisite authority and resources to regulate diet supplements. The article is written by Dr. Pieter Cohen, of Cambridge Hospital, and emphasized some alarming statistics:
•More than half of the adult population, about 114 million people, consume dietary supplements.
•The majority of consumers mistakenly believe that dietary supplements are approved by a government agency –- two-thirds of them thought that the government requires that labels on supplements include warnings about their potential side effects or dangers.
•The great majority of the estimated 50,000 adverse events that occur annually remain unreported to the FDA, even though manufacturers have since 2007 been required to report serious supplement-related adverse events to the FDA.
•A recent survey of more than 300 physicians who were residents in internal medicine at fifteen different U.S. training programs showed that one-third of them believed that diet supplements require FDA approval – the majority did not know that adverse events suspected to have been caused by supplements must be reported to the FDA.
The Journal emphasized that a wide range of supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Moreover, dozens of supplements have been found to be intentionally contaminated (“spiked”) with prescription medications, controlled substances, experimental compounds, or drugs already rejected by the FDA for safety concerns. As recently as July 2009, the FDA alerted the public to a list of 75 tainted weight loss products that contained undeclared medications, including the stimulant sibutramine, some at levels three times the maximum recommended daily dose. Others contains rimonabant (linked to suicide) and fenproporex (linked to addiction and suicide). Some weight loss pills, many from Brazil, combine multiple medications in a single formula, substantially increasing the risk of adverse events.
The Journal also explained how unscrupulous manufacturers were attempting to fly below the FDA’s radar by using analogues of pharmaceutical compounds. A recent analysis showed that half of 26 supplements marketed for enhancement of sexual function contained analogues of phosphodiesterase Type 5 inhibitors. Reports from three separate countries establish that the analogue of fenfluramine has been linked to liver damage, including fulminant hepatic failure requiring transplantation.
Most recently, tainted products were found being manufactured by a domestic company, American Cellular Labs, which was manufacturing supplements contaminated with anabolic steroids.
The article closed with the admonition that physicians should maintain a high index of suspicion for supplement-induced adverse effects, even when the component stated on the label are not known to cause the symptoms the patient is suffering. After recognizing that DSHEA presents “serious obstacles to the FDA’s ability to detect and eliminate contaminated supplements,” it called upon Congress to give the FDA the necessary authority and resources to regulate this industry, the author concluded that, until that regulatory authority was given: “Millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits.”
Source:
New England Journal of Medicine, Volume 361:1523-1525 October 15, 2009 Number 16