Preventing the next ephedra In April 2004, 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. (See our May 2004 report, Dangerous supplements). 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 supplement ingredients. The report, issued by the Institute of Medicine and the National Research Council of the National Academies, suggests that federal law be updated to require supplement makers and distributors to inform the FDA of serious adverse health reactions associated with their products. The committee also recommends that before a product is marketed, manufacturers and distributors be required to provide the FDA with both favorable and unfavorable information about that product’s safety. CU supports those recommendations. A bill in Congress calls for the dangerous supplement androstenedione (andro) and many other substances related to testosterone to be regulated as controlled drugs. But it does not include DHEA, which is often touted as an anti-aging supplement and had sales of $47 million in 2002. While we support this effort to address the dangers inherent in steroids and steroid precursors, Congress should not exclude DHEA or any other steroid precursor. Furthermore, limiting the sale of individual supplements, one at a time, will not protect consumers. Other legislation pending in Congress would address broader concerns. Senate Bill 722, sponsored by Sen. Richard Durbin (D-Ill.), and House Bill 3377, sponsored by Rep. Susan Davis (D-Calif.), would require supplement makers and distributors to report to the government any adverse reactions. Both bills would enable the FDA to move quickly to halt the sale of dangerous supplements. Durbin’s bill would also require a safety review before a stimulant could be sold. CU urges Congress to act quickly to better ensure the safety of supplements.
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