When young and middle-aged adults started showing up at the hospital with liver failure last spring, doctors in Hawaii struggled to find the thread that connected the patients. They found it in the form of a popular sports supplement, OxyElite Pro.
The supplement was linked last May to severe hepatitis, but the U.S. Food and Drug Administration, tasked with removing such dangerous substances from store shelves, did not learn of the cases until four months later. By February, months after the product was voluntarily taken off the market, there were 97 cases linked back to the supplement, including one death and three liver transplants.
These and other statistics from a new report highlight continued weaknesses in the U.S. system's ability to protect consumers from OxyElite Pro and other untested supplements. Consumers are continually being put at risk of consuming supplements tainted with harmful substances, Pieter Cohen, a professor of medicine at Harvard Medical School, writes in the April 3 New England Journal of Medicine. About half of all U.S. adults take dietary supplements, meaning that literally millions of people could be at risk.
OxyElite Pro was far from the first such problematic incident. Even five years ago the U.S. Government Accountability Office highlighted serious supplement oversight issues, warning that FDA does not have enough authority to ensure the products are safe. That report, like Cohen’s, called for supplement manufacturers to be required to register their dietary supplements. Currently, the FDA relies on voluntary notifications about supplement-related deleterious health events from clinicians and consumers through an online reporting system called MedWatch. It also hears about such events from manufacturers who receive information of serious side effects or learn of health threats from other academic, federal or state public health partners that contact the agency. The manufacturer is supposed to ensure its own product is safe and also notify FDA if its supplement contains a new dietary ingredient at least 75 days prior to marketing the product, but even that requirement is often ignored. “Firms not submitting [new dietary ingredient] notifications remain a significant concern for the agency,” says Theresa Eisenman, an FDA spokesperson.
The threat of potentially toxic nutritional supplements often comes from pharmaceuticals, steroids, stimulants or other substances that are tucked inside the supplements. Just last year, Cohen and his colleagues detected a new cousin of methamphetamine in a different sports supplement. Meanwhile, FDA found a form of an amphetamine in nine supplements.
To address the woeful monitoring of nutritional supplements, Cohen calls for the creation of a supplement response team that would include clinicians, toxicologists, pharmacologists and chemists that could respond to reports of serious supplement-related adverse events in real time. Such a system, Cohen writes, would speed up responses to help protect consumers.
Cohen also backs another proposed fix. FDA officials told GAO in a follow-up report published in 2013 that one hold-up to acting on adverse event reports is that it’s often difficult to establish a causal relationship between a product and the health problem based on the limited information in the report. One solution, FDA has said, would be setting up an adverse event reporting service like a poison control hotline, especially since some consumers already report such incidents to poison control centers. Questions posed during that call could help fill in information gaps that could speed up investigations, but FDA has said that an obstacle there would be cost. A pilot project designed to test the waters with such a system had promising results, but it did not answer questions about if a nationwide system would actually generate information faster than a traditional system, Cohen says.
The prospects for any significant immediate change, however, seem slim, given that past reform efforts have all but flatlined. Sen. Dick Durbin (D–Ill.) has repeatedly tried to pass a bill that would require supplement manufactures to register their products and to provide more safety information, but it languished in 2011. An effort to attach provisions of the bill to other legislation as an amendment last year also proved unsuccessful. The bill was then reintroduced this session with Sen. Richard Blumenthal (D–Conn.) as its cosponsor, although no one expects the legislation to move. There is also no companion legislation in the House.
The FDA Food Safety Modernization Act, signed into law in 2011, gave FDA slightly more power in this arena—providing it with new enforcement authority to order a recall when a product will likely cause serious harm or death. But with OxyElite Pro, its manufacturers ultimately voluntarily took the product off the market after FDA threatened that it would order the company to stop production otherwise. FDA has had to take action in other cases, however. The new recall authority, however, clearly does not go far enough to protect consumers.
Without sweeping legislative changes, even if Cohen’s other plans were enacted, consumers will continue to have a safety net full of holes.