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The Steinberg Law Firm, P.C.

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Ephedra, Ephedrine, & Mu Huang

Ephedra, Ephedrine, and Ma Huang all refer to amphetamine-like compounds (ephedrine alkaloids) derived from a shrub-like plant found in desert regions of central Asia and other parts of the world. Ephedrine alkaloids are stimulants that act on the central nervous system. The naturally occurring chemical closely mimics the actions of synthetic norephedrine hydrochloride, which the FDA approved as a drug in 1948. Traditionally, the substance was used by Chinese physicians to treat conditions such as hay fever and asthma. Ephedra is marketed in the United States as a dietary supplement that helps people lose weight and improve energy levels. The products are marketed in a variety of forms, including pills, powders, liquid drops, and teas. The industry estimates that 3 billion doses of ephedra are sold each year.


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The Risks

While ephedra has not been proven to aid weight loss, it has been causally linked to potentially hazardous health problems when taken alone or in combination with other medications or foods. Since at least the early 1990s, the FDA has received reports of ephedra supplements causing seizures, heart attacks, strokes, and psychosis. The scientific literature suggests that ephedra can increase blood pressure in persons with normal and high pressure; predispose certain individuals to tachycardia (rapid heart rate); and cause cardiomyopathy (disease of the heart muscle), stroke, or myocardial necrosis (death of cells in the heart). The literature also associates ephedra with adverse effects on the central nervous system, such as mania, paranoid psychoses, and seizures.


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Regulation

The FDA is responsible for overseeing the federal government's regulation of drugs, medical devices, food safety, veterinary medicine, and biological products. Unlike many of these products, dietary supplements do not have to undergo pre-approval by the FDA to determine their safety or efficacy. The Dietary Supplement Health and Education Act of 1994 ("DSHEA") created a new framework for the FDA's regulation of dietary supplements as part of its oversight of food safety. DSHEA allows dietary supplement products to bear a statement describing how consumption of the supplement can affect people. Companies cannot, however, make a product statement claiming to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. Notwithstanding, the FDA cannot require packaging for these products to include dosing regimens and warning labels. Nor can the FDA require manufacturers to identify what products they make or report adverse events. This loophole has resulted in some companies marketing products as dietary supplements as opposed to over-the-counter drugs.


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Legal Matters

In 2002, the FDA asked the Justice Department to conduct a criminal investigation into the claims of Metabolife, an ephedra supplement manufacturer that has reportedly sold over 4.5 billion tablets in the last five years. The government says Metabolife was aware of numerous complaints of harmful effects while at the same time telling the FDA that it had received none. Numerous private lawsuits have been filed across the country relating to use of ephedra supplements against Metabolife and other companies. Several confidential settlements have already been obtained.


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Legal Help

If you or someone you love has been injured as a result of using ephedra supplements, you may be entitled to compensation. Please contact us for a free, no obligation legal consultation. Cases are handled on a nationwide basis through association with other law firms.

Please E-Mail Andrew E. Steinberg* for a no cost and no obligation evaluation.

*Not Certified by the Texas Board of Legal Specialization

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