Don't sell ephedra until FDA position clear, says AHPA
discouraging the dietary supplements industry from resuming sales
of ephedra products following the court ruling that the FDA failed
to prove that a daily dosage of 10mg or less presents an
unreasonable risk of illness or injury.
AHPA said it has received numerous enquiries as to whether Judge Tena Campbell's ruling clears the way for the reintroduction of ephedra. But after convening its executive committee this week, the association adopted the position that companies should not jump the gun by reintroducing their products before the FDA has declared what it plans to do next.
On April 13 Judge Campbell ordered that the FDA must 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.
She also enjoined the government agency from taking any enforcement action to block Nutraceutical from selling supplements containing 10mg or less of ephedrine alkaloids per daily dose.
Jonathan Emord, council for Nutraceutical Corporation, which brought the case against the FDA, told NutraIngredients-USA that the FDA has two options: to accept the judgment and carry out testing to determine the precise dose at which ephedrine alkaloids produce toxicity and impose a ban above that level; or exercise its right to appeal to the Court of Appeal for the Tenth Circuit.
But the FDA has said nothing more than that it interprets the ruling to mean that the ban remains in effect as to higher dosages of these ephedrine-containing products.
"FDA is considering all of its options with respect to next steps," said a spokesperson.
The ruling has stirred up renewed discussion over the herbal, which was banned last April. The opinion from some quarters is that the ruling constitutes an overturn of the FDA's ban.
At the time of the ruling Emord told NutraIngredients-USA.com: "At the moment there is no question that the ban is overturned."
AHPA's point of view has also been echoed by the Council for Responsible Nutrition, which issued a statement saying: "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."
AHPA has also expressed doubt as to the efficacy of ephedra as a weight loss ingredient, its main use prior to the ban.
"AHPA is not aware of any information that would substantiate a claim for weight loss for ephedrine alkaloids alone in amounts less than 10 milligrams per day," it said.
The association also notes that it has always interpreted the wording of the FDA's final ruling on ephedra to exclude botanical sources of ephedrine alkaloids in traditional Asian medicine. It surmises, therefore, that the court's decision has no direct impact on such goods.
