The FDA's Tattered Safety Net for Dietary Supplementstop male enhancements online


One example of the system’s shortcomings concerns Hydroxycut, a weight loss supplement first popularized in the early 2000s.

In 2004, the FDA banned ephedra—the active ingredient in Hydroxycut—after it received thousands of adverse event reports linking it to heart attacks, strokes, deaths, and other adverse events. But rather than withdrawing Hydroxycut from the market, its manufacturer reformulated the product. Despite that reformulation, reports of liver damage continued.

Martin Robertson, a Maryland resident, claimed in a lawsuit that he developed liver failure in 2008 several months after he started using Hydroxycut. “As a direct and proximate result of using Hydroxycut Regular Rapid Release Caplets,” the lawsuit says, Robertson “suffered severe mental and physical pain and suffering and has sustained permanent injuries and emotional distress.”

Iovate, the maker of Hydroxycut, denied the claims in court. The case was eventually settled.

It took the FDA seven years to compile enough reports—23 in all, including one death—to determine that Hydroxycut was causing the liver injuries, to warn consumers to stop using it, and to get the manufacturer to recall the product line.

In a 2013 report, the Government Accountability Office (GAO), a government watchdog, pointed to Hydroxycut as an example of how difficult it is for the FDA to use CAERS (PDF) to accumulate “enough evidence to discern a clear relationship” between a product and a reported health problem. “Most [reports] do not initiate or support such actions because it is difficult to establish causality between the product and the health problem based on the limited information in an AER,” the report said.

Another case from about a decade ago, with a supplement called OxyElite Pro, illustrates others flaws in the FDA’s oversight. Made by USPlabs, the supplement illegally contained a stimulant called DMAA, an amphetamine derivative linked to high blood pressure and heart attacks.

The Department of Defense, in late 2011, ordered supplements containing DMAA to be removed from stores on military bases after it said the stimulant was a possible factor in the deaths of four soldiers. A subsequent analysis of the CAERS database, captured in a study by FDA staffers, showed that the agency had received several reports citing products containing DMAA the previous year.

Months later, in April 2012, the FDA issued warning letters to firms that manufactured supplements containing DMAA, which led some companies to remove the products from the marketplace. But USPlabs continued to sell its product, reformulating OxyElite Pro with a previously unused supplement ingredient called aegeline.

In the fall of 2013, the Hawaii Department of Public Health identified 21 cases involving adults who developed liver disease after taking OxyElite Pro and submitted reports about them to CAERS. After reviewing those cases plus an additional 12 involving consumers in other states, the FDA determined that OxyElite Pro likely contributed to liver injury. USPlabs agreed to recall the product, saying it was a precautionary measure.

Daniel Fabricant, Ph.D., who led the FDA supplements office at the time and is now CEO of the industry group Natural Products Association, says the agency responded in a timely way, evaluating the reports as they came in.

But a subsequent study by FDA staffers in the journal Public Health Reports highlighted a “significant lag” between the time an incident occurred and when it was reported, and said the value of the system “depends largely on the extent to which potential reporters employ the system.”

A 2014 article in the New England Journal of Medicine by Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School who has studied supplements extensively, was more blunt: “The FDA’s delayed response—with its life-threatening consequences—is attributable to our woefully inadequate system for monitoring supplement safety.”