Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements

[HuckleB]

http://www.nejm.org/doi/full/10.1056/NEJMp1315559

"pidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.1 Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death. Nor have any changes been made to improve the FDA's ability to detect dangerous supplements.

The FDA's delayed response — with its life-threatening consequences — is attributable to our woefully inadequate system for monitoring supplement safety. Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.

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Sweeping changes would be needed to create an effective surveillance system capable of rapidly detecting supplement-related adverse events in the United States. I believe that accurate information on every supplement sold in this country should be incorporated into databases maintained by both the FDA and poison centers. Appropriate public health responses would be expedited if all key organizations, including the poison centers, the Defense Department, local departments of public health, and manufacturers, shared reports of serious supplement-related adverse events with the FDA in real time. A supplement response team could be created, made up of expert clinicians, toxicologists, pharmacologists, and chemists. The team could be based at the CDC, the FDA, the poison centers, or an academic institution. When consumers or physicians report a serious adverse event, the supplement response team could be alerted immediately. The multidisciplinary team could then offer clinical advice to physicians as they cared for patients, provide detailed reports to the FDA, and analyze patients' unused supplements for labeled and unlabeled ingredients. Supplement manufacturers could be required to provide complete manufacturing details and additional samples as requested. These changes would ensure not only that the FDA received accurate and timely reports, but also that clinicians received expert clinical advice as they cared for affected patients.



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But even these ambitious changes would not prevent dangerous supplements from reaching consumers. If consumers and physicians are to have confidence that all supplements are safe, the law regulating supplements must be reformed. Every supplement ingredient should undergo rigorous safety testing before marketing. Until that happens, consumers and physicians cannot be assured that the pills, powders, and potions labeled as dietary supplements are safe for human consumption."



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Yes, regulation is needed badly.