New challenge to ephedra ban as appeal looms
more than a year, since a Utah court threw open to debate the FDA's
2004 final ruling banning the herbal. Now with the hearing of FDA's
appeal just one week away, a new case has been filed that
challenges the FDA's authority in seizing shipments of the herbal.
Emax Enterprises has filed a lawsuit against the FDA with the US District Court of Utah, after the government agency refused importation of a shipment of supplements containing 10mg daily doses of ephedrine alkaloids that arrived in Salt Lake City in February.
Until ephedra was banned on evidence that it can raise blood pressure and otherwise stresses the circulatory system, potentially leading to heart disease and stroke, ephedra was commonly used in weight loss supplements.
To those following the debate, the setting of the latest legal wrangle will look familiar: the US District Court of Utah was also the scene of Judge Teena Campbell's ruling in April 2005 that some interpret to be overturning of the FDAs 2004 final ruling banning the herbal.
And Jonathan Emord, the Washington DC lawyer representing Emax, also represented Nutraceutical Corporation in the first challenge to the agency's final ruling last year.
In a case brought by Nutraceutical, Judge Campbell 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.
The government agency was also enjoined from taking any enforcement action to block Nutraceutical from selling supplements containing 10mg or less of ephedrine alkaloids per daily dose.
Emord's interpretation is that the Utah ruling effectively overturned the ban, making enforcement action against Emax illegal.
His view is not shared by everyone.
A spokesperson for the FDA told NutraIngredients-USA.com that agency interprets Judge Campbell's judgement to mean that "the order remains in effect as to higher dosages of these products".
Michael McGuffin, president of the American Herbal Products Association, told NutraIngredients-USA.com in February that he does not read the ruling as overturning the ban on ephedra, but merely preventing the FDA from taking any action against Nutraceutical.
McGuffin's interpretation means that any other company wishing to reintroduce ephedra products will have to first approach the court for the go-ahead.
Nutraceutical has, in fact, opted not the reintroduce ephedra-containing supplements pending the outcome of the FDA's appeal. It will not have to wait much longer, as the oral hearing at the US Court of Appeals for the Tenth Circuit in Denver, Colorado, is set for May 8.
Emord told NutraIngredients-USA.com that, in any case, enforcement of the final rule has effectively destroyed sources of ephedra in the US, making reintroduction difficult.
Emax had managed to track down a source in China, and a small number of the other companies have also announced that they are offering ephedra once more over the internet.
The vast majority of supplement-makers however have opted to adhere to the advice issued by the main industry associations, AHPA, the Council for Responsible Nutrition and the National Nutritional Foods Association: don't even think about it until the position is clear.
Sensible advice, perhaps - and not only in the light of the millions damages and legal fees that former ephedra-sellers have had to pay out. The FSA has not yet announced any dose-dependent toxicology study. Until it does, a question mark over ephedra's safety at any dose will remain.
