April 12 ,
2006
NIST Introduces Herbal Testing Standards for Ephedra
The National Institute of Standards and Technology (NIST) issued a new reference standard for the quality control of ephedra despite the FDA’s ban of the plant in 2004.
The reference standard covers materials such as powdered plant, ground solid oral dosage, and protein powder. The set standards were a group effort that began in 2001 between NIST, the Food and Drug Administration, and the National Institute of Health’s Office of Dietary Supplements.
In 2004, the FDA officially banned ephedra-containing supplements after the plant was found to cause serious cardiovascular problems and death.
Then in April 2005, a court in Utah ruled that the FDA didn’t meet the burden of proof that a daily dose of 10 mg or less of ephedrine supplements contributed to an unreasonable risk of injury.
The Utah ruling paved the way for the drug manufacturer Nutraceutical Corporation, who brought the lawsuit against the FDA, to continue sales of ephedrine products that contained a daily dose of 10 mg or less.
A few other companies considered the ruling an overturn and also resumed sales of low-dose ephedra supplements. However, the main supplement industry associations urged against the reintroduction of the products until the legal position is clear.
The FDA is appealing the Utah verdict.
The new ephedra standards are still relevant regardless of the ephedra ban and will aid manufacturers in making sure no products are contaminated with the hazardous plant.
Michael Baum who handles public and business affairs at NIST said the reference materials used for the standards are typical samples used to check analysis techniques. The standards will help researchers measure the results of laboratory analysis for quality control.
Ephedra and ephedra containing diet supplements have been linked to over 100 deaths and many other physical and lifelong problems nationwide. The FDA banned the controversial diet supplement in 2003. In 2005 the ban was overturned, citing evidence that low doses of ephedra did not cause any health problems.
For
more information on ephedra side effects, including
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with an attorney.
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