A federal judge has issued a ruling lifting the Ephedra Ban consistent with the ruling and additional information on Ephedra availability found at About.com
May 15, 2005 (Press Release) --
For Immediate Release - West Palm Beach, FL - May 5, 2005:
Cathy Wong, ND, has published the following article on About.com regarding Ephedra and Ephedra Availability.
About.com : Alt.Medicine :
by Cathy Wong, ND
The ban on ephedra has been lifted.
Ephedra is a herb used for hundreds of years to treat asthma and other conditions. Because of its ability to increase metabolism, it also became popular as an ingredient in diet pills. Ephedra was taken off the market in April 2004 by the FDA after safety concerns.
One high-profile case involved Baltimore Orioles pitcher Steve Bechler. He was 23 years old when he died during spring training in February 2003. At the time, Bechler was taking diet pills containing ephedrine - the active substance in ephedra - to lose some weight.
Many people, me included, felt a complete ban on the herb was a harsh and unnecessary move. Bechler, for instance, had a history of borderline high blood pressure and abnormal liver and a family history of heart disease.
Although some media quote the number of deaths due to ephedra at 155, an FDA-commissioned report in 2003 stated in its final ruling that five deaths could be attributed directly to ephedra.
To put this number in perspective, about 12 to 17 million people consumed ephedra in 1999, reports the American Herbal Products Association. The Nutrition Business Journal estimated that sales of ephedra in 2002 were $1.25 billion.
Contrast this with the number of people killed each year because of pharmaceutical drugs. A study reported that in 106,000 people died in 1994 because of overmedication or adverse reactions to prescription drugs.
Some might call the FDA misguided.
Just look at the last few years: Vioxx and other arthritis drugs and their effect on the heart
HRT and heart disease and cancer
The ban on ephedra didn't affect the sale of over-the-counter cold medications such as decongestants which often contain ephedrine in synthetic form.
It also sparked worry that this was a sign of things to come. The ban of ephedra was the first time the FDA had removed a dietary supplement after a landmark law was created to supposedly protect our access to them. The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, amended the Federal Food, Drug, and Cosmetic Act of 1938 to change how dietary supplements are regulated and labeled. Under the DSHEA, dietary supplements were classified as foods and not drugs.
The ban was challenged by Utah-based Nutraceutical Corporation. They make an ephedra product with less than 10 mg of ephedra. The judge ruled, in accordance with the DSHEA, the FDA could not place the burden to prove safety on dietary supplement manufacturers as it does for drug and device makers.
Instead, the agency "must establish that (ephedra supplements) pose a significant or unreasonable risk by a preponderance of the evidence," Campbell wrote.
Campbell also said that the FDA couldn't prove this with low doses of ephedra.
Bruce Hough, President of Nutraceutical, commented the decision “is, in our view, about protecting the public’s access to safe and effective dietary supplements and in clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court’s ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements.”
Hough continued, “The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are “presumed to be safe.”
It allows the company to resume selling its whole herb ephedra product with less than 10 mg of naturally occuring ephedrine alkaloids per daily dose.
This information is not approved by the FDA and is not intended to cure, diagnose or treat any disease. Complete information at About.com
Cathy Wong, ND, has published the following article on About.com regarding Ephedra and Ephedra Availability.
About.com : Alt.Medicine :
by Cathy Wong, ND
The ban on ephedra has been lifted.
Ephedra is a herb used for hundreds of years to treat asthma and other conditions. Because of its ability to increase metabolism, it also became popular as an ingredient in diet pills. Ephedra was taken off the market in April 2004 by the FDA after safety concerns.
One high-profile case involved Baltimore Orioles pitcher Steve Bechler. He was 23 years old when he died during spring training in February 2003. At the time, Bechler was taking diet pills containing ephedrine - the active substance in ephedra - to lose some weight.
Many people, me included, felt a complete ban on the herb was a harsh and unnecessary move. Bechler, for instance, had a history of borderline high blood pressure and abnormal liver and a family history of heart disease.
Although some media quote the number of deaths due to ephedra at 155, an FDA-commissioned report in 2003 stated in its final ruling that five deaths could be attributed directly to ephedra.
To put this number in perspective, about 12 to 17 million people consumed ephedra in 1999, reports the American Herbal Products Association. The Nutrition Business Journal estimated that sales of ephedra in 2002 were $1.25 billion.
Contrast this with the number of people killed each year because of pharmaceutical drugs. A study reported that in 106,000 people died in 1994 because of overmedication or adverse reactions to prescription drugs.
Some might call the FDA misguided.
Just look at the last few years: Vioxx and other arthritis drugs and their effect on the heart
HRT and heart disease and cancer
The ban on ephedra didn't affect the sale of over-the-counter cold medications such as decongestants which often contain ephedrine in synthetic form.
It also sparked worry that this was a sign of things to come. The ban of ephedra was the first time the FDA had removed a dietary supplement after a landmark law was created to supposedly protect our access to them. The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, amended the Federal Food, Drug, and Cosmetic Act of 1938 to change how dietary supplements are regulated and labeled. Under the DSHEA, dietary supplements were classified as foods and not drugs.
The ban was challenged by Utah-based Nutraceutical Corporation. They make an ephedra product with less than 10 mg of ephedra. The judge ruled, in accordance with the DSHEA, the FDA could not place the burden to prove safety on dietary supplement manufacturers as it does for drug and device makers.
Instead, the agency "must establish that (ephedra supplements) pose a significant or unreasonable risk by a preponderance of the evidence," Campbell wrote.
Campbell also said that the FDA couldn't prove this with low doses of ephedra.
Bruce Hough, President of Nutraceutical, commented the decision “is, in our view, about protecting the public’s access to safe and effective dietary supplements and in clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court’s ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements.”
Hough continued, “The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are “presumed to be safe.”
It allows the company to resume selling its whole herb ephedra product with less than 10 mg of naturally occuring ephedrine alkaloids per daily dose.
This information is not approved by the FDA and is not intended to cure, diagnose or treat any disease. Complete information at About.com
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