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FDA to appeal Utah ephedra ruling

15-Jun-2005

The FDA will appeal to the United States Court of Appeal for the Tenth Circuit over the Utah court ruling that the FDA had failed to meet its burden of proof that a daily dose of 10 mg or less of ephedrine alkaloids presents an unreasonable risk of illness or injury, reports Jess Halliday.

The government agency served a notice of appeal to the US District Court of Utah on 13 June.

Jonathan Emord, council for Nutraceutical Corporation , the company that brought the lawsuit against the FDA, told NutraIngredients-USA.com: "We fully expected the government to appeal."

He said that a three-judge panel will be assigned to the appeal, but that it may take a year or more for it to be heard, depending on the judges' load burden and the importance given to the case. Once it is heard, proceedings may include an oral argument after the briefing.

As to the FDA's chances of success, Emord said: "On the law, they quite clearly lose, so I hope that is what the judges will decide."

He called the ruling by Judge Tena Campbell on 13 April "a well-reasoned, strong opinion that will be very difficult to overturn."

The notice comes a month after three major industry associations, the American Herbal Products Association, Council for Responsible Nutrition and National Nutritional Foods Association sent a joint letter to a joint letter to Lester Crawford, acting commissioner of the FDA, asking that the agency make its intentions on ephedra known as quickly as possible to clear up the widespread confusion that has resulted from the ruling.

Judge Campbell ordered the FDA to carry out a dose-dependent toxicology study before imposing a ban on ephedrine alkaloids only at and above the level shown to present a risk, and enjoined it from taking any action to block Nutraceutical, the company which brought the lawsuit, from selling supplements containing 10mg or less per daily dose.

Despite this immunity, Nutraceutical has denied reports that it plans to reintroduce its low-dose ephedra product in the foreseeable future.

Nor has the ruling brought about an immediate rush to bring low dose ephedra products to the market - and not simply because the FDA's final judgment banning all products containing ephedrine alkaloids effectively wiped out sources of the herb in the US.

The industry associations have advised their members that it would be prudent to refrain from commerce in any dietary supplements containing ephedrine, whatever the dose, until the future of the controversial substance is clear.

Ephedra was marketed as a supplement for weight-loss and sports performance until the FDA's final order banning it on the grounds that it posed an unreasonable risk to health came into effect in April 2004.

A report carried out by the RAND Corporation prior to the ban suggested that it could have potentially dangerous effects on the heart. Other studies have also indicated that ephedra use raises blood pressure and otherwise stresses the circulatory system, which could lead to heart disease and stroke.

The FDA said that there is little evidence for the herbal's effectiveness other than for short-term weight loss.

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