Nutraceutical may resume ephedra sales after court overturns ban

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.

Whether or not the company will take advantage of this break is still not clear. Company president Bruce Hough said: "Nutraceutical has had no discussion regarding the reintroduction of an ephedra product."​

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.

The labeling on the Solaray product, now owned by Nutraceutical Corp, recommended that one capsule be taken no more than twice a day, yielding a combined dose of less than 10mg.

It was withdrawn from the market in 2004 when the FDA's final rule banning all dietary supplements containing ephedrine alkaloids, regardless of the recommended dose, came into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.

The 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a dietary supplement presents an unreasonable risk, but the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act (FDCA), which does state that this is a determining factor.

But under the FDCA dietary supplements are considered as foods, and food producers are not required to establish a benefit before sale. The court pointed out that such a standard would render potato chips illegal.

The FDCA also places the burden for proving that a dietary supplement is adulterated on the government, and states that it must demonstrate this "under conditions of use recommended or suggested in labeling"​.

After examining scientific evidence that the FDA consulted in developing its stance on ephedra, the Court determined that it had not proved that a daily dosage of 10mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury.

A spokesperson for the FDA said: "The FDA is considering all of its options with respect to next steps."​

It now 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 Emord said: "The judge's order is very well reasoned and the government will have a hard case taking it on."​

Other sectors of the industry advise that the news be received with caution.

"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.

It added that people should not jump to conclusions about the effect of the ruling on DSHEA, which it has always upheld as a good law.

"The standard of DSHEA that companies may not market dietary supplements that pose a significant or unreasonable risk of illness or injury is not questioned by yesterday's decision."​

The blanket ban on ephedra caused some companies to lose a lot of money, but it unlikely that they will receive any compensation. The regulatory takings clause of the Fifth Amendment requires the government to provide compensation when it takes private property, but Emord said that it is extremely complex and the probability of winning a case is low.

As for any ongoing litigation relating to the enforcement of the ban, he said that last week's ruling will "certainly raise serious questions in cases which are based on the final ruling, which is now suspect"​.

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.