Is Ephedra Legal?
Ephedra had previously been
banned in April of 2004 because of health and safety concerns over raised blood
pressure, heart attacks, and stroke. A judge in Utah recently overturned the ban
on ephedra on April 14, 2005. The ban was challenged by a Utah based company Nutraceutical
Corporation who make an ephedra product containing less than 10 mg of ephedra. The
judge ruled against the FDA saying the agency “must establish that (ephedra supplements)
pose a significant risk by a preponderance of the evidence.”
After receiving a joint letter from the American Herbal Products Association, Council
for Responsible Nutrition and National Nutritional Foods Association, the FDA gave
notice of appeal to the US District Court of Utah on June 13, 2005.
These three bodies had urged the FDA to decide in a timely manner whether or not
they were going to appeal Judge Campbell's April 13, 2005 overturning of the ephedrine
ban which was originally imposed in April of 2004. The judge had stipulated that
the FDA must carry out a "dose dependant toxicoligy study" prior to banning the
substance again. This should prove to be difficult for the FDA considering a study
like this is unethical to complete on human subjects.
It has been reported that the appeal could take up to a year to be heard in court.
FDA to
appeal Utah ephedra ruling