Ephedra Product demand surges as Utah Federal Judge strikes down 2004 FDA ephedra ban in a landmark ruling protecting consumer rights.
May 4, 2005 (Press Release) --
For immediate release - May 3, 2005 - West Palm Beach, FL - USA:
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.
The FDA had banned ephedra following its efforts to link 155 deaths to possible ephedra use but the Federal Judge decided that the FDA had not proved its case confirming widespread consumer suspicion that the cases have been overblown and more linked to other compounding health issues such as chronic obesity, heart disease or reckless product abuse than to ephedra itself.
Judge Campbell in drafting her ruling relied on federal law, which makes a distinction between drugs and dietary supplements which are regulated more as food items than as prescription drugs.
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,"
The FDA's ban on ephedra was not consistent or complete. 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 medications like Primatene and SudaFed and is distributed by drug companies such as Pfizer Pharmaceuticals.
The OTC Ephedra or pseudoephedrine market is a 1.4 billion dollar market that the FDA did not ban as those dollars flowed to pharmaceutical companies rather than to the natural products industry.
Many industry experts have speculated that the FDA has been favoring the pharmaceutical industry during the ephedra controversy by banning the plant or natural forms of ephedra while allowing the O-T-C Drug industry to sell billions of dollars of synthetic ephedra commonly known as pseudoephedrine that can be purchased in serving doses up to 25 mg at any neighorhood drugstore or grocery store in any amount a consumer wishes to purchase.
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."
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.
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."
From 1993 to 2003, the period the FDA studied in deciding to ban ephedra, 155 deaths were potentially linked to ephedra intake. During that time some 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", nothing is but the average consumer will conclude they are safe enough and that products like aspirin and ephedra deliver overwhelmingly more consumer good than bad and should remain available as a consumer freedom of informed choice.
Industry watchdogs and consumers groups have urged the FDA not to appeal this case which industry watchdogs assert may be used by the FDA or Pharmaceutical Industry Lobbyists to undermine DSHEA, (Dietary Supplement Health Education Act), which was enacted to protect consumer choice when purchasing natural dietary supplements.
For more information on the ongoing ephedra controversy and its potentially broader impact in blocking consumer freedoms, visit:
http://www.reason.com/rb/rb050405.shtml
For information on acquiring products containing natural ephedra, visit:
http://shop.1asecure.com/prod.cfm?ProdID=191517&StID=3883
or
http://www.bionicgirls.com
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.
The FDA had banned ephedra following its efforts to link 155 deaths to possible ephedra use but the Federal Judge decided that the FDA had not proved its case confirming widespread consumer suspicion that the cases have been overblown and more linked to other compounding health issues such as chronic obesity, heart disease or reckless product abuse than to ephedra itself.
Judge Campbell in drafting her ruling relied on federal law, which makes a distinction between drugs and dietary supplements which are regulated more as food items than as prescription drugs.
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,"
The FDA's ban on ephedra was not consistent or complete. 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 medications like Primatene and SudaFed and is distributed by drug companies such as Pfizer Pharmaceuticals.
The OTC Ephedra or pseudoephedrine market is a 1.4 billion dollar market that the FDA did not ban as those dollars flowed to pharmaceutical companies rather than to the natural products industry.
Many industry experts have speculated that the FDA has been favoring the pharmaceutical industry during the ephedra controversy by banning the plant or natural forms of ephedra while allowing the O-T-C Drug industry to sell billions of dollars of synthetic ephedra commonly known as pseudoephedrine that can be purchased in serving doses up to 25 mg at any neighorhood drugstore or grocery store in any amount a consumer wishes to purchase.
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."
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.
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."
From 1993 to 2003, the period the FDA studied in deciding to ban ephedra, 155 deaths were potentially linked to ephedra intake. During that time some 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", nothing is but the average consumer will conclude they are safe enough and that products like aspirin and ephedra deliver overwhelmingly more consumer good than bad and should remain available as a consumer freedom of informed choice.
Industry watchdogs and consumers groups have urged the FDA not to appeal this case which industry watchdogs assert may be used by the FDA or Pharmaceutical Industry Lobbyists to undermine DSHEA, (Dietary Supplement Health Education Act), which was enacted to protect consumer choice when purchasing natural dietary supplements.
For more information on the ongoing ephedra controversy and its potentially broader impact in blocking consumer freedoms, visit:
http://www.reason.com/rb/rb050405.shtml
For information on acquiring products containing natural ephedra, visit:
http://shop.1asecure.com/prod.cfm?ProdID=191517&StID=3883
or
http://www.bionicgirls.com
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