Dietary supplements can supposedly handle almost any human ailment, but some have hidden dangers. The US Food and Drug Administration (FDA) rarely takes aggressive measures, such as its recent ban on ephedra compound "fat-burning". A new report from the Institute of Medicine (IOM) concluded that the FDA is legally paralyzed when he tries to judge the safety of these substances. The report suggests a way to evaluate the supplements, but said changes in the law to give the FDA more power, are also needed.
About 4,000 were unregulated products on the US market when Congress passed the Health and Education Act Dietary Supplement (DSHEA) in 1994. Today, the FDA estimates that more than 29,000 are available, with sales exceeding $ 18 billion a year. The law authorized FDA to regulate supplements if they have a "significant or unreasonable risk of illness" but also made it difficult. The FDA must consider safe food supplements - unlike drugs or food additives - until proven otherwise
In 00, the FDA asked IOM how the agency could assess the safety of these compounds in the current legislation .. the bulk of the report describes a basic strategy: When the FDA learns of potential problems - for example, groups of consumers or healthcare professionals - it should go through the literature, writing a monograph security consult an expert panel, and then take appropriate action. It's harder than it seems. For starters, the formulations may vary, and people take multiple supplements, sometimes mixing them with prescription drugs.
The setting would be much more effective, the Committee concludes that the FDA had more data. To this end, the group, which was led by Barbara Schneeman of the University of California, Davis, recommend changes to the law. Among them: Manufacturers should be held to account all available safety data before a product hits the shelves and all serious adverse events following
"This is a first step to try to address some of the huge gaps. "in DSHEA, said Kenneth Kaiten, director of the Tufts Center for the study of drug development in Boston. A project of the House to extend the authority of the FDA is currently stalled in the conference, as a proposed Senate bill. "I think there will not be any law for some time," said Kaiten.
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