You can buy herbs, minerals, vitamins, powders and pills that purport to do everything from warding off colds and boosting the immune system to improving mental agility, building muscles and melting away pounds. Dietary supplements and homeopathic medicines highly diluted drugs made from natural ingredients which are taken by more than half of Americans, have grown into an estimated $25 billion industry.
But there is very little federal oversight of whether any of these supplements actually do what they say or whether they may cause harm. The sector remains one of the least regulated under current laws: the Dietary Supplement Health and Education Act of 1994 requires that the manufacturer of a dietary supplement, not the FDA, ensure its safety before it is marketed. The FDA is responsible only for taking action against any unsafe product after it's on the market.
Even then, the FDA's authority is limited. On June 16, 2009, the agency warned consumers to stop using Zicam Cold Remedy nasal gel and swabs. Because Zicam's maker, Arizona-based Matrixx Initiatives, labeled its product as a homeopathic treatment, the company was not required to seek FDA approval before selling its nasal gel and swabs. In response to reports by patients and doctors that the products destroyed users' sense of smell, the agency could only warn consumers; it could not recall the products. Manufacturers must pull them off shelves voluntarily.
"Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company's product safety data," the company, which has refused to recall Zicam, said in a statement.
The FDA recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements. To ban an unsafe product under current laws, the burden of proof of harm falls on the agency. In 2004, for example, the FDA was able to ban the herbal ingredient ephedra, used commonly in weight-loss products, after thousands of reports and many scientific studies showed a high risk of heart attack, stroke and death associated with its use. By contrast, Canada and most European countries regulate supplements more like prescription medications, requiring proof of safety and efficacy before they go to market.