December 13 , 2006
"Dietary Supplement Makers Must Soon Report to FDA"
Makers of dietary supplements must soon begin to report consumers’ serious reactions to their products to the Food and Drug Administration. This new requirement, approved this month, but scheduled to go into effect in one year, is designed to achieve close monitoring and regulation of the supplement industry, which has little oversight.
What would it change?
As the law stands now, the FDA must first show that a dietary supplement poses a “significant” risk to its users before it can pull the supplement off the shelf.
This is the opposite of the prescription drug market, in which drug makers must first prove that their drugs are effective and safe before they can be sold.
“With this bill, the GFA will have the tools to monitor supplements that cause dangerous health problems like heart attack, stroke, seizures and liver failure,” said Richard Durbin, an Illinois senator who began pushing for regulation of this type when a high-school athlete died after taking an herbal supplement containing ephedra.
Ephedra, an ingredient found in many dietary supplements was popular among people seeking to lose weight and increase energy. It was viewed as a problem by the FDA who had seen many reports of deaths and sicknesses caused by it for years before they could finally ban it in 2003.
The new legislation will require all makers of dietary supplements marketed in the United States to alert the FDA within 15 business days of all reports of “serious” adverse reactions and events associated with the use of their products. Death, hospitalization, birth defect, and persistent disability are examples of serious adverse reactions and events.
The new legislation will also cover over-the counter drugs.
The legislation is still waiting for the signature of President Bush, and will give the companies one year to prepare before the changes take effect.
Harmed by an ephedra or ephedrine? Please contact us today for a free consultation with an experienced attorney who can examine your case thoroughly, answer your questions, and help you recover the compensation you may be entitled to.
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