Ephedra
On Dec. 30, 2003, the Food and Drug Administration issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products. The FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury.
What is Ephedra (Ephedrine)?
Ephedra, also known as Ma huang, is a naturally occurring substance derived from plants, has been used for centuries in China. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy. Ephedra works by stimulating the central nervous system, much like adrenaline and caffeine.Advocates say the herb can help people lose weight, but the FDA is concerned about the seriousness of reported adverse events and their increasing number. Because these products are commonly marketed as dietary supplements, there is little or no premarket review by FDA of their safety (or effectiveness), no good dosing information, and no monitoring advice. The FDA received 140 reports of illness or death linked to ephedra alkaloids between 1997 and 1999.
The FDA Issued Regulation Prohibiting Sale
of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice
That Consumers Stop Using These Products
What health hazards has Ephedra been associated with?
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High blood pressure
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Irregular heartbeat and heart palpitations
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Nerve damage
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Injury
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Insomnia, nervousness, and dizziness
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Gastrointestinal distress and hepatitis
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Psychosis
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Tremors, headaches, and seizures
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Heart attack and stroke
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Death
How is Ephedra listed on the ingredients label?
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Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder
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Ma Huang or Ma Huang extract
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Epitonin
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Ephedrine
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Chinese Ephedra
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Pseudoephedrine and Norpseudoephedrine
Documents About FDA's February 2003 Actions on Ephedra
- Press Release (Feb. 28, 2003)
- Fact Sheet (Feb. 28, 2003)
- White Paper (Feb. 28, 2003)
- Summary of the Rand Report on Ephedra
- Sample Warning Letter
- List of Firms that Received FDA's Warning Letter
FTC Charges Direct Marketers of Ephedra Weight Loss Products With Making Deceptive Efficacy and Safety Claims (July 1, 2003)
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