Ephedra ban boosts FDA powers

A US appeals court has upheld a Food and Drug Administration ban on ephedrine-containing supplements in a ruling that confirms the FDA's right to adjudicate on the safety of ingredients and supplements by employing risk/benefit analysis.

The FDA appealed against a 2005 court decision that found in favour of Utah-based Nutraceutical Corporation, a supplements supplier that challenged the FDA's right to prohibit ephedra at low dosages of 10mg or less, which it argued had a history of safe use.

The initial FDA ban came into play in April 2004 after many adverse events relating to the consumption of high-dose ephedra products, including strokes, heart attacks and deaths. It was the ephedra-related death of pro baseball pitcher Steve Bechler that sparked the FDA into action and led to the initial prohibition.

According to Utah-based industry consultant, Loren Israelson, the three-judge appeals court decision effectively bans ephedra at any dosage. The verdict delivered an unambiguous interpretation of the manner in which Congress intended for the Dietary Supplements Heath and Education Act (DSHEA) to be policed when it was enacted in 1994.

"While I continue to believe it is in the best interest of our industry for the ephedra issue to be resolved once and for all, I am troubled this decision clearly states that Congress intended that the safety standard embedded within DSHEA includes the FDA's right to use risk/benefit analysis," Israelson commented.

In a statement the FDA said: "The court found that the 133,000-page administrative record compiled by the FDA supports the agency's finding that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness and injury to users, especially those suffering from heart disease and high blood pressure. No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to enforcement action."

"In a sense, the industry largely knew this FDA rule-making was something we were going to have to live by, and this recent court ruling just clarified it," said Michael McGuffin, president of the American Herbal Products Association (AHPA). "This came as no big surprise. The AHPA has long had concerns about the FDA's ruling on ephedrine and the outcome of this case."

McGuffin questioned the FDA's risk/benefit analysis of ephedra. "The FDA refused, in its rulemaking process, to acknowledge any benefits for ephedra, even for traditional uses. If the benefit side is judged as 'zero' the outcome of any risk/benefit analysis will necessarily be skewed. But this court has now specifically stated that the FDA's risk/benefit mechanism correctly followed the Congressional directive and industry will need to evaluate the implications of this as precedent."

Nutraceuticals Corporation vowed to fight and is re-appealing in the Denver appeals court that handed down the latest verdict, and would go to the US Supreme Court if need be. "We are not giving up," its Washington DC-based lawyer Jonathan Emord said. "We're in it for the long haul."

Emord said the ruling meant the FDA had been granted the power to remove any supplement from the market where it could demonstrate health risks at high doses. "That is a very dangerous precedent because just about everything can be harmful if you take too much," Emord observed.

Although constituents of ephedra, an herbal stimulant and thermogenic also known as ma huang in traditional Chinese medicine, are used in many OTC applications such as decongestants, as a supplement ephedra was commonly used for weight loss and to boost athletic performance.

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