Senators demand adverse event reporting from FDA
senators yesterday, who demanded that makers of vitamins and other
dietary supplements should have to report potential safety risks to
the FDA.
Industry body the American Herbal Products Assocation (AHPA) agreed that the 10-year-old Dietary Supplement Health and Education Act (DSHEA) that regulates supplements should be updated to help the government better police unsafe products, citing the mandatory reporting of serious health problems in patients as a necessary step.
The FDA however believes it has sufficient power to act against risky supplements and is not seeking any changes to the law, said Robert Brackett, director of the agency's Center for Food Safety and Applied Nutrition.
The agency is trying to make the most of its current powers under the 1994 law "before we ask for any new authority," said Brackett at a hearing before a senate governmental affairs subcommittee.
Such a response did not satisfy senator Richard Durbin, an Illinois Democrat, who proceeded to ask how the FDA can protect American consumers from risk if they are not receiving any information from these companies.
The American Medical Association (AMA-ASSN) also called for the mandatory reporting of serious health problems as well as pre-market testing requirements for supplements.
Millions of Americans take vitamins, herbs and other supplements, which are widely available in drug, grocery and health-food stores. The industry's annual sales are estimated at $18 billion.
Under the 1994 law, companies can sell supplements without putting them through the extensive safety and effectiveness testing required for pharmaceuticals.
Earlier this year the FDA banned a supplement for the first time, namely the herbal weight-loss pill ephedra, after it was linked to heart attacks, strokes and deaths.
A survey published by the Consumers Union this week suggested that 96 per cent of US consumers think supplement makers should be required to report health problems caused by their products and label them with risk information.
"Americans are telling the government it is time to ensure the safety of the dietary supplements sold in our stores," said Charles Bell, the programmes director for Consumers Union.
He conceded that many dietary supplements, including most vitamins and minerals, are generally safe, but added: "Because the law governing supplements is so weak, it took 10 years to remove ephedra from the market, despite numerous reports of disabling injuries and deaths. Congress needs to act to make sure we don't repeat this tragedy."
