Updated March 26, 2015.
By DrRich
Recently a federal judge in Salt Lake City ended the US Food and Drug Administration's ban on ephedra, which had been in place since April, 2004.
Ephedra is classified as a dietary supplement, and until banned it was popularly used to enhance athletic performance and promote weight loss. Unfortunately the stuff also enhances fatal cardiac arrhythmias and sudden death. Ephedra appears to have been the cause of more than 100 deaths in the US.
After a couple of high-profile deaths in athletes, the FDA acted to ban it.
The Neutraceutical Corporation, a Utah-based company that made and sold ephedra, immediately sued to end the ban, claiming the ban to be illegal under the 1994 Dietary Supplement Health and Education Act (DSHEA, sponsored by Senator Hatch, R-Utah). The judge ruled for the company, ordering that FDA lift the ban on ephedra, and that if it wants to reinstitute the ban it must come forward with data showing that the substance is harmful when taken in doses recommended by the manufacturer.
Various sports leagues and individual states had their own bans on ephedra, and this ruling does not affect those bans.
DrRich Comments:
The judge's ruling was legally sound but medically stupid. It is not the judge's purview to rule on the medical stupidity of laws, however.
DSHEA requires FDA to apply a different standard of proof to dietary supplements than to drugs. With drugs, pharmaceutical companies must prove their drugs to be safe and effective in large clinical trials in order to gain FDA approval (i.e., guilty until proven innocent.) With dietary supplements, the FDA must show the substances to be harmful in order to ban them (i.e., innocent until proven guilty.) Thus, while ephedra is clearly linked to the deaths of several score American athletes, it is not scientifically proven that ephedra actually caused those deaths, or that the victims were taking the "doses recommended by the manufacturer."
FDA may appeal this ruling, or may seek to assemble enough data to prove what legally needs to be proven in order to ban ephedra.
In the meantime, one wonders whether it is too late to reclassify Vioxx, Celebrex or Bextra as dietary supplements. They are clearly safer than ephedra.
By DrRich
Recently a federal judge in Salt Lake City ended the US Food and Drug Administration's ban on ephedra, which had been in place since April, 2004.
Ephedra is classified as a dietary supplement, and until banned it was popularly used to enhance athletic performance and promote weight loss. Unfortunately the stuff also enhances fatal cardiac arrhythmias and sudden death. Ephedra appears to have been the cause of more than 100 deaths in the US.
After a couple of high-profile deaths in athletes, the FDA acted to ban it.
The Neutraceutical Corporation, a Utah-based company that made and sold ephedra, immediately sued to end the ban, claiming the ban to be illegal under the 1994 Dietary Supplement Health and Education Act (DSHEA, sponsored by Senator Hatch, R-Utah). The judge ruled for the company, ordering that FDA lift the ban on ephedra, and that if it wants to reinstitute the ban it must come forward with data showing that the substance is harmful when taken in doses recommended by the manufacturer.
Various sports leagues and individual states had their own bans on ephedra, and this ruling does not affect those bans.
DrRich Comments:
The judge's ruling was legally sound but medically stupid. It is not the judge's purview to rule on the medical stupidity of laws, however.
DSHEA requires FDA to apply a different standard of proof to dietary supplements than to drugs. With drugs, pharmaceutical companies must prove their drugs to be safe and effective in large clinical trials in order to gain FDA approval (i.e., guilty until proven innocent.) With dietary supplements, the FDA must show the substances to be harmful in order to ban them (i.e., innocent until proven guilty.) Thus, while ephedra is clearly linked to the deaths of several score American athletes, it is not scientifically proven that ephedra actually caused those deaths, or that the victims were taking the "doses recommended by the manufacturer."
FDA may appeal this ruling, or may seek to assemble enough data to prove what legally needs to be proven in order to ban ephedra.
In the meantime, one wonders whether it is too late to reclassify Vioxx, Celebrex or Bextra as dietary supplements. They are clearly safer than ephedra.