Preventing the next ephedra.(Viewpoint: the consumers union perspective)(dietary supplements)

In April, the seven-year battle to remove the dangerous stimulant ephedra from store shelves came to an end when a federal judge upheld the government's ban on the supplement. The Food and Drug Administration had logged nearly 17,000 adverse health reactions to ephedra, including strokes, seizures, and deaths, before imposing the ban. While CU and other consumer-safety advocates who had pushed for the ban were relieved, we also knew the war on dangerous dietary supplements was just beginning.

Before the ink was dry on the FDA decision, knockoffs were flooding the market, containing ingredients such as bitter orange, which has been linked to high blood pressure, heart attack, and stroke. And just days before the ephedra ban went into effect in April, CONSUMER REPORTS published a report on a dozen hazardous supplements that are available in the U.S. ("Dangerous Supplements: Still at Large," May 2004).

The main barrier to ensuring safe and effective dietary supplements is the federal law that regulates the products. Unlike the laws governing prescription and over-the-counter drugs, which must be proved safe and effective before they are marketed, the Dietary Supplement Health and Education Act (DSHEA), passed in 1994, allows supplements to be marketed without any safety testing or proof of effectiveness.

Nor does the law require manufacturers to tell the FDA when their products are linked to serious injuries or death, instead relying on a voluntary system that puts only about 1 percent of the information on harmful reactions to supplements in the hands of the agency. And the FDA can ban a supplement only if it can show that it poses "a significant or unreasonable risk of illness or injury."

The push for disclosure requirements is gaining momentum, however. The FDA and Congress now have recommendations from a committee asked to outline a science-based process for assessing ...