The active ingredient now used in many diet pills is not a controlled substance available by prescription only. Today, weight loss pills contain naturally occurring herbs and are sold without a prescription over the counter. One of the most popular herbal supplements used in diet pills has been ephedra, but in December of 2003, the FDA issued a consumer alert on the safety of diet pills containing ephedra. The alert advised consumers to stop buying and using ephedra products. In February of 2004, the United States Food and Drug Administration (FDA) officially ordered that diet pills containing ephedra be taken off the market by April 12, 2004.
The ban was applicable to the sale of all dietary supplements in the United States that contain ephedra. On April 14, 2005, a U.S. District Court judge in Salt Lake City lifted the ban on ephdra and sent it back to the FDA for further evaluation. The Utah District Court Judge ruled that the FDA did not 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. The FDA, however, is appealing the Utah verdict.
The National Institute of Standards and Technology (NIST) issued a new reference standard for the quality control of ephedra. The reference standard covers materials such as powdered plants, ground solid oral dosage, and protein powder. The 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.
Regardless of the ephedra ban and subsequent removal, the new ephedra standards are still valid. 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.
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