Banning ephedra just the first step for FDA
■ The federal government has outlawed products containing ephedra, but Congress still must change the way dietary supplements are regulated.
Posted Feb. 9, 2004.
The Food and Drug Administration's ban of dietary supplements containing ephedra is a big consumer protection victory. But the American public deserves much more.
The December action, long sought by the American Medical Association, takes dozens of dangerous products off the market. More than 18,000 people reported negative reactions to supplements containing ephedrine alkaloids. The most serious of these incidents included stroke, heart attack and even death.
But these injuries need not have occurred. Indeed, the nation's experience with ephedra -- an adrenaline-like stimulant -- points out the law's inability to protect people from potentially hazardous dietary supplements.
The FDA regulates these products under the Dietary Supplement Health and Education Act of 1994. This law gives the agency the authority to take action against dangerous dietary supplements. But instead of requiring manufacturers to demonstrate that their products are safe and effective before they hit the shelves, it only allows the FDA to prove that risky products are unsafe after the fact. By the time the government can act, the damage to consumers has been done.
The agency cannot even force supplement manufacturers to report adverse events. It must rely on voluntary efforts by product makers and complaints from consumers and health professionals. The FDA estimates that voluntary reporting captures only 1% of adverse events.
Gathering adequate data to demonstrate that a supplement presents an unreasonable risk to consumers takes time. In ephedra's case, six years elapsed between the point at which the agency first raised concerns and the product ban. During that period, countless people who were hoping to shed a few pounds or to improve athletic performance consumed supplements containing an ingredient now known to cause harmful and potentially deadly circulatory system reactions.
Some say the problem lies with the FDA -- that the agency was too slow and overcautious in using the power it has to block dangerous supplements. Others say the solution lies in proposed regulations requiring "good product manufacturing practices." These rules, announced by the FDA in March 2003, would give consumers assurances that the manufacturing process meets certain quality standards and that the ingredients and product strength listed on the supplement label are accurate.
But neither argument gets at the root of the problem. What good is FDA power if it doesn't kick in before a product hits the stores? How effective can high-quality manufacturing be if the product's active ingredient is harmful or doesn't actually work?
The law must be changed. Dietary supplements must be properly tested for safety and efficacy before their debut, in addition to being held to good manufacturing standards. The way to do this is to bring supplements under the rules that govern pharmaceutical drugs. The AMA has been advocating for this solution for years.
Congress has held hearings on the issue and has heard all the arguments. Now is the time for lawmakers to act.
Ephedra-containing products are prohibited, but they are just one type of supplement. Many others, such as supposed muscle-growth products containing steroid precursors, are raising red flags among physicians, consumer groups and federal officials.
Lawmakers owe it to consumers to hold supplements to the same high standards as prescription drugs. Without this safety measure, Americans have no way to determine if they're buying snake oil or products that could truly improve their health.