Summary

Ephedra, the common name for ephedrine alkaloids, were linked to several deaths, leading the FDA to ban the substance entirely in 2004. However, the FDA was only able to prove that high doses of ephedra posed a health risk, not doses at or below 10 mg, the newly imposed limit.

Original source:
http://www.nutraingredients-usa.com/news/news-ng.asp?n=59472-nutraceutical-may-resume

Details

• A court in Utah has overturned the FDA's outright ban on all dietary supplements containing ephedrine alkaloids, or ephedra, clearing the way for the plaintiff Nutraceutical Corporation to resume selling supplements containing 10mg or less of the naturally-occurring stimulant per daily dose, reports Jess Halliday.
• Last week Judge Tena Campbell at the US District Court of Utah ordered the FDA to carry out a dose-dependent toxicology study and impose a ban on the herbal's use only at and above the level at which it is found to produce toxicity.
• "At the moment there is no question that the ban is overturned," Jonathan Emord, counsel for Nutraceutical told NutraIngredients-USA.com.
• Moreover, the government agency is enjoined from taking any enforcement action to block Nutraceutical from selling supplements containing 10mg or less of ephedrine alkaloids per daily dose.
• Since the ban effectively obliterated the US market for ephedra in the 12 months it was in place, Nutraceutical's first step towards reintroduction would be to track down a source of the ingredient.
• It was withdrawn from the market in 2004 when the FDA's final rule banning all dietary supplements containing ephedrine alkaloids, regardless of the recommended dose, came into effect on 12 April 2004.
• The FDA introduced the ban as it deemed ephedra alkaloids to be "adulterated" and to present "an unreasonable risk of illness or injury", since they do not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death.
• "This ruling applies only to a very specific segment of the ephedra dietary supplement market and should not be misinterpreted as a complete overturn of the ephedra ban," said the Council for Responsible Nutrition (CRN) said in a statement.

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