U.S. Federal Judge overturns ephedra ban
[[Image:fda.jpg|100px|right]]
{{date|April 15, 2005}}

A {{w|Park City, Utah|Park City}}, [[Utah]] nutritional supplement manufacturer won its appeal against the [[FDA]] on Wednesday as a Federal Judge lifted a ban and sent the case back to the agency for revised rulemaking in accordance with the court's decision. 

Judge {{w|Tena Campbell}} ruled that no further enforcement of the FDA action can take place until the FDA reviews its current regulation.

Neutraceutical claimed in its lawsuit that the product "has been safely consumed" for hundreds of years and is not harmful at low ephedrine product levels. The FDA had decided to ban the supplement based on a reverse logic that the product had to be proven safe. The lawsuit effectively argued that it is the FDA's task to prove that all dosage levels of ephedrine were unsafe. The court agreed with the manufacturer that this assumption could not be proven and, when taken in low doses, less than 10 mg,  that agree with the product labeling, ephedrine was not shown to be an "unreasonable or significant risk."

A group of private researchers claimed that ephedra was the most dangerous herbal product on the market. They collected data from poison control centers. It was not considered to be a drug and could not be controlled the way pharmaceuticals were, and was sold over the counter.

The death in 2003 of 23-year old {{w|Baltimore Orioles}} pitcher {{w|Steve Bechler}} brought a slew of negative reports on the product that foreshadowed a sharp drop in sales.

{{haveyoursay}}
== Source ==
*{{source|url=http://www.usatoday.com/sports/baseball/2005-04-14-ephedra-case_x.htm?POE=SPOISVA |title= Judge strikes down FDA ban on ephedra
 |author=AP wire services |pub= Baseball category: USATODAY.com |date=April 14, 2005}}
*{{source|url=http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=12190&zoneid=18 |title= Court Overturns FDA Ban on Low-dose Ephedra Products |author= American Herbal Products Association |pub= Natural and Nutritional Products Industry Center |date=April 14, 2005}}
*{{source|url=http://www.forbes.com/lifestyle/health/feeds/hscout/2005/04/14/hscout525167.html|title= Ephedra Ban Lifted by U.S. District Judge |author=HealthDay Staff  |pub= Forbes.com:|date=April 14, 2005}}
=== External links ===
*[http://www.ahpa.org/05_0413_USDistrictCourt_Nutraceuticals.pdf. Nutraceutical Corporation and Solaray, Inc., Plaintiffs, vs. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Defendants] and can be downloaded.    April 13, 2005 (PDF: Adobe reader required)
*[http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm ''Ephedra'' -National Institutes of Health] (April 2004)

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[[Category:Product recalls]]
[[Category:Health]]
[[Category:Science and technology]]
[[Category:North America]]
[[Category:United States]]
[[Category:Utah]]
[[Category:Food and Drug Administration]]
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A Park City, Utah nutritional supplement manufacturer won its appeal against the FDA on Wednesday as a Federal Judge lifted a ban and sent the case back to the agency for revised rulemaking in accordance with the court's decision. 

Judge  ruled that no further enforcement of the FDA action can take place until the FDA reviews its current regulation.

Neutraceutical claimed in its lawsuit that the product "has been safely consumed" for hundreds of years and is not harmful at low ephedrine product levels. The FDA had decided to ban the supplement based on a reverse logic that the product had to be proven safe. The lawsuit effectively argued that it is the FDA's task to prove that all dosage levels of ephedrine were unsafe. The court agreed with the manufacturer that this assumption could not be proven and, when taken in low doses, less than 10 mg,  that agree with the product labeling, ephedrine was not shown to be an "unreasonable or significant risk."

A group of private researchers claimed that ephedra was the most dangerous herbal product on the market. They collected data from poison control centers. It was not considered to be a drug and could not be controlled the way pharmaceuticals were, and was sold over the counter.

The death in 2003 of 23-year old Steve Bechler brought a slew of negative reports on the product that foreshadowed a sharp drop in sales.
Product recalls Health Science and technology North America United States Utah Food and Drug Administration