In a hard-hitting essay just published in the New England Journal of Medicine, Dr. Pieter Cohen of Harvard Medical School points out the health and safety deficits of the Dietary Supplements Health and Education (DSHEA) Act of 1994. He goes farther than simply recounting the lack of safety assurances by manufacturers, by also detailing how the harm done by some supplements can take months, if not years, to reach the FDA, and even longer for that agency to react.
Dr. Cohen uses the example of OxyElite Pro, an over-the-counter supplement that was responsible for several cases of liver failure and hepatitis. Although the problem began in May 2013, the FDA didn t have an inkling of the situation for 4 months. By February 2014, 97 cases including 47 hospitalizations, 3 liver transplantations and one death were linked to this supplement. The supplement was finally recalled, but, Dr. Cohen says, 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.
And this situation is not rare. He notes that over 500 dietary supplements have been found to be adulterated with pharmaceuticals or analogs of them. These include antidepressants, weight-loss medications and untested sildenafil (Viagra) analogs. This situation is no surprise, as we have explained here and here.
While DSHEA itself must await a fix from Congress (don t hold your breath: the original law was pushed through Congress by the then-and-still-powerful Senator from Utah, Orrin Hatch), Dr. Cohen s critique of the current system of detection really hits home. He recommends some additional means of detection such as using data from poison control centers. In addition, he points out that a partial fix is in the works. A Senate committee is now considering a revised bill, the Dietary Supplement Labeling Act. If passed, it would require supplement manufacturers to register products with the FDA and provide more safety information to consumers.
Dr. Ruth Kava, ACSH senior nutrition fellow, opined Clearly something needs to be done to prevent further damage by unscrupulous supplement manufacturers. Whether this labeling act will withstand the attacks of the well-financed supplement industry remains to be seen.