(PRWEB) May 5, 2005
U.S. District Judge Tena Campbell ruled April 14 that the FDA had failed to prove that ephedra was dangerous in low doses of 10 milligrams or lower.
Judge Campbell further ruled that the FDA "lacked the authority to ban the substance without such proof," in the New York Times summary.
A lawsuit against the ban, which the FDA initiated in February 2004, was brought by Nutraceutical Corp. and Solray Inc. of Park City, Utah, a nutritional supplement manufacturer.
A complete copy of the CourtÂs decision may be found at: (United States District Court: For the District of Utah Central Division)
Case No. 2:04CV409TC
Judge Tena Campbell ruled that the FDA had not proved that its arbitrarily-set dosages of 10 milligrams (mg) or less of ephedrine-alkyloid dietary supplements (EDS) were dangerous.
In fact, Campbell said in her ruling that the FDA had rested its entire case on research offered by the agency and its advisory committee that could not determine what a safe level of an EDS would be.
"A negative inference is different from the affirmative proof required..." Campbell wrote in her opinion. "There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low dose EDS."
Late Thursday afternoon, FDA officials were evaluating whether the minimum 10 mg dose was sufficient to appeal Campbell's decision or whether more research was necessary.
"The FDA is evaluating the question of appeal," spokeswoman Kimberly Rawlings said. Rawlings said she expected a decision by early Friday.
The FDA had banned ephedra following the possible link of 155 deaths to possible ephedra use but the Federal Judge decided that the FDA had not proved its case regarding the harm caused by ephedra.
Pharmaceutical companies must prove drugs safe before they can be sold to the public at large but dietary supplements are treated as a food and are presumed innocent until proven harmful.
Judge Campbell stated in her opinion that,
"If food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited,"
Ephedra was banned only in its form as a natural dietary supplement, commonly known as the Chinese herb ma huang. The FDA never banned ephedra's over-the-counter chemical equivalent, pseudoephedrine, which is found in many over-the-counter non-prescription items like Primatene and SudaFed.
The OTC pseudoephedrine market is a 1.4 billion dollar market serviced by major pharmaceutical companies. Many industry pundits observed an inconsistency when the FDA banned natural ephedra at the health food store but not pseudoephedrine marketed by drug companies like Pfizer at the grocery store.
Sam Kazman, general counsel for the Competitive Enterprise Institute, a free-market think tank has gone on the record as stating, that the FDA is in a "deadly over-regulation mode," and is denying millions of consumers the right to make informed choices. "Because of all the publicity on ephedra, people are on notice" about its risks, he noted. "When its on the market, people have a choice."
Dr. Joshua Prager from the California Pain Medicine Center at UCLA was asked by National Public Radio anchor Michelle Norris if he'd advise patients currently taking Bextra (Banned by the FDA) to switch to aspirin. Dr. Prager responded, "Well, the first thing I would say about aspirin is if aspirin went through the FDA scrutiny that all these other drugs go through now in trying to come to market in the year 2005, it probably would not get FDA approved."
It is estimated that the number of people who are estimated to die from gastrointestinal bleeding as a result of taking NSAIDS and aspirin range from 3,500 to 16,500 per year.
From 1993 to 2003, the period studied in deciding to ban ephedra, 155 deaths were potentially linked to ephedra intake. During that time an estimated 12 to 17 million Americans ingested 3 billion doses of ephedra and the world consumer population ingests over 50 billion tablets of aspirin daily.
The conclusion is not the aspirin or ephedra are "Completely Safe", but that it may be safe enough for informed consumers when compared to its overall distribution and consumer benefit.
The analogy frequently made is that is unfortunate that some people are allergic and may die from a bee sting. Does that justify destroying all bees by regulation (and ignoring their tremendous polination benefit in agriculture and in nature.)?
The FDA provides a valuable role in protecting consumers from harmful drugs and the Federal Judiciary provides an equally valuable review process that in the end benefits all consumers.
The United States system of Government Regulation, Congressional Mandate and Judicial Review continues to work better than any other consumer protection system in the world.
US Senator Warren Hatch has commented that none of the parties involved in ephedra regulation are happy with the way ephedra has been handled and Senator Hatch is right but most consumers and regulators would agree that the ongoing ephedra controversy is solid evidence that the United States system of Congressional Mandate, Government Regulation and Judicial Review continues to work better than any other system in the world.
One thing is certain, the ephedra controversy will continue.
Useful links on the ephedra controversy are listed below:
For information on ephedra product availability visit: