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Ephedra Controversy Heats Up Again
18 September 2000
by Wyn Snow, Managing Editor

Ephedra is the main ingredient in several popular weight-loss products. Also known as ma huang, ephedra has appeared in almost a thousand reports (as noted in the federal Food and Drug Administration's "Adverse Events" database) of serious adverse effects ranging from disabilities to death.

FDA claims ephedra causes injuries and death

In 1997, after receiving reports of hundreds of adverse events, the FDA proposed to limit ephedra's use in weight management. However, it withdrew this proposed rule after the industry and congressional investigators challenged it, saying that the FDA did not have sound scientific evidence to support their position.

Based on even more reports of adverse events in the past three years, the FDA has begun a new investigation into the safety of ephedra. It held a two-day public meeting on this subject on August 8-9, and continues to welcome public comment through September 30th.

FDA's evidence not reliable

The FDA's adverse event reporting system for dietary supplements is both voluntary and anonymous, making it vulnerable to two very different kinds of errors. Real adverse events can be underreported -- entirely missing from the database. False reports can be included -- thereby creating erroneous information in the database.

Also, an adverse event report that is associated with a product might be caused by some other health condition or product or interaction with other products or ingredients -- thereby creating a false impression of the cause of the adverse event.

Herbalists believe ephedra is safe at reasonable dosage

Michael McGuffin, a leading herbalist and president of the American Herbal Products Association, stated in a live interview with Ted Koppel on Nightline that he does not believe people have died as a direct result of taking ephedrine. However, McGuffin does "recognize that ephedra is an herb that needs to be treated with respect."

The herbal industry has created dosage limit guidelines and specific labeling cautions for all ephedra products. [See ephedra label/dosage guidelines.] McGuffin says they have shared these guidelines with the FDA and asked them to adopt a similar regulatory control.

The evidence for safety

According to the Ephedra Education Council, more than 3 billion doses of ephedra were consumed in 1999. If those doses were consumed by 1 million people (300 doses or approximately 3-5 months of use), then approximately 0.0075 percent of those people (75) have appeared in the FDA's adverse event reports for the year.

While this is a significant number, it is modest in relation to the wide-spread use of the product and in relative terms is no greater than the number of adverse events associated with many prescriptive drugs. Also, millions of people safely consume over-the-counter cold and asthma remedies containing synthetically produced versions of the same alkaloids present in ephedra.

The evidence for risk

Ephedra contains two alkaloids that are powerful stimulants: ephedrine and pseudoephedrine. Ephedrine causes blood vessels to constrict and the heart to beat faster and stronger. Pseudoephedrine opens up air passages in the lungs and decreases nasal congestion.

Because of these actions, ephedra has been compared to adrenaline and amphetamine, both of which are also powerful stimulants to the central nervous system. Critics have said that ephedra is "nothing more than legal speed."

What is causing these adverse events?
Some of the reports of adverse events contain details that are biologically impossible, strongly suggesting that they are false reports, but it's unlikely that all of them are. Given that some of these reports probably reflect real problems, what kind of fire is causing all this smoke?




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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.