Last year Utah judge Tena Campbell ruled the FDA did not prove a daily dosage of 10mg or less of ephedra results in an unreasonable risk of illness or injury, and blocked enforcement action against Utah-based Nutraceutical Corporation if it were to sell supplements containing a daily dosage of 10mg or less of ephedra.
But last week, the US Circuit Court of Appeals in Denver overturned her decision, ruling the US Food and Drug Administration (FDA) was correct in its 2004 analysis of ephedrine products and subsequent conclusion there is no acceptable dose of the ingredient. The reversing of the decision is in effect another nail in the coffin on the matter of the legality of ephedra.
Ephedra sinica, or Ma huang, has been used in traditional Chinese medicine for thousands of years for a variety of ailments and is often used in teas.
Until the 2004 ban, it was marketed as a supplement for weight-loss and sports performance, but a number of recent studies have linked ephedrine alkaloids with adverse effects on the cardiovascular and central nervous systems which have been though in some cases to be fatal.
It has been a very emotive issue for the supplements industry. Many representatives are concerned with doing all they can to ensure supplements have a safety record that is grounded in science.
Indeed, the discovery that case reports of adverse events caused by ephedra were not passed on by one former seller to the regulatory authorities is often cited in support of a recently introduced bill that would make serious adverse events reporting mandatory.
However some parties have reacted by saying FDA is biased against herbals and has taken an exaggerated position in the issue, painting all supplements containing ephedra with the same brush.
"Here FDA banned ephedra outright, but did not prove that lower doses are toxic," Jonathan Emord, attorney for Nutraceutical told NutraIngredients-USA.com. "We believe they made an enormous error."
With the most recent review the appeals court still concluded the FDA had properly examined the facts when it ruled, in 2004, that dietary supplements containing ephedrine alkaloids present an "unreasonable risk of illness or injury". Pursuant to this the government has since seized numerous products containing the herbal ingredient.
"We find that the FDA correctly followed the congressional directive to analyze the risks and benefits of EDS [ephedrine-alkaloid dietary supplements] in determining that there is no dosage level of EDS acceptable for the market."
Pending the appeal, American Herbal Products Association (AHPA), together with other trade bodies, urged member companies and the industry at large not to jump the gun and reintroduce ephedra-containing products. But president Michael McGuffin said AHPA had has concerns about FDA's ruling on ephedrine and the outcome of this case since it refused to acknowledge any benefits for ephedra, even for traditional uses. "I strongly believe it [FDA] is not correct on the facts on ephedra," he told NutraIngredients-USA.com.
"If the benefit side is judged as 'zero,' the outcome of any risk/benefit analysis will necessarily be skewed."However, the appeals court documents conclude the FDA was balanced in its approach:
"The FDA was not arbitrary or capricious in its final rule; the FDA met its statutory burden of justifying a total ban of EDS by a preponderance of the evidence."
Emord opinioned the court appeals reversal to be an "odd decision", stating that ephedra teas are available on the market. And because tea drinkers consume varied quantities and strengths of the beverage, teas can contain higher levels of ephedra than those found in the "standardized" daily dosage of his client's product, said Emord.
Nutraceutical and Emord say they will seek a rehearing in front of the entire tenth circuit - thus 19 judges, as opposed to the 3 judges in the most recent court.
"Industry will need to evaluate the implications of this as precedent," said McGuffin.